chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red area at site 50 cent piece area, hot to touch. Advised cold compresses, MOTRIN. Patient mother to bring her in to be checked if symptoms persist/worsen. Phone call in 2 days. Mother not returned call.
About 24 hours after I received my shot, I started feeling stomach pain and cramping. This lasted nearly two weeks. I would sometimes spit up at night but had no major gastrointestinal issues besides the pain. On day 12 of these symptoms,  I finally went to urgent care. They said it was likely ulcers and gave me a prescription proton-pump inhibitor. I recovered about a week after visiting urgent care. I had  no issues after this until I received my booster.  Eight months later on 11/12, I received my booster shot (Pfizer). About a 24 hours, I started feeling identical symptoms from when I got my first dose. I did not seek medical attention and self-medicated with OTC pepcid. The symptoms resolved themselves in about a week and a half.
Patient fainted after given immunization, closed eyes laid down, fluids, sugar, cool cloth applied to forehead, start to finish 20 minutes.
18 month old female with swelling, erythema and pruritus of right thigh, 1 day after administration of Prevnar. Seen in clinic 2 days after vaccine. No fever, no pain and no difficulty ambulating. Rx given for Benadryl. Seen the next day and pt's right thigh with less swelling and less erythema.
Fever, chills, extreme/severe muscle pain especially in lower back, severe dizziness. Lasted about 18 hours.
High INR 3.7; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO INCREASED (High INR 3.7) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced INTERNATIONAL NORMALISED RATIO INCREASED (High INR 3.7). At the time of the report, INTERNATIONAL NORMALISED RATIO INCREASED (High INR 3.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, International normalised ratio: 3.7 (High) INR is high at 3.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  Concomitant medications included Blood thinners. No treatment information was provided.
like a lot of itchy/stopped itching; started to get red; reaction; started having bruises on the legs and hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (like a lot of itchy/stopped itching), ERYTHEMA (started to get red), CONTUSION (started having bruises on the legs and hands) and VACCINATION COMPLICATION (reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced CONTUSION (started having bruises on the legs and hands). On an unknown date, the patient experienced PRURITUS (like a lot of itchy/stopped itching), ERYTHEMA (started to get red) and VACCINATION COMPLICATION (reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (like a lot of itchy/stopped itching) had resolved and ERYTHEMA (started to get red), CONTUSION (started having bruises on the legs and hands) and VACCINATION COMPLICATION (reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patients information lost while documenting and RA crashed.
HEADACHE; This spontaneous report received from a patient via a company representative concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included obesity. 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 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced headache. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 2021. This report was non-serious.
administered this to a patient one day shy of their 4th birthday with no adverse event; Initial information received on 02-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves unknown gender and 3-year-old (one day before of their 4th birthday) patient who was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received unknown dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (batch number, expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (immunization) one day shy / before of their 4th birthday with no adverse event (product administered to patient of inappropriate age) (same day latency).  Reportedly, reporter queried if there is a grace period for Quadracel to be given? Reporter administered this to a patient one day shy of their 4th birthday. Reporter cannot find anything other than the age is from 4-7 years. Forwarding this information out of an abundance of caution. As you can see below, an office administered a dose of Daptacel one day before the recommended administration at 4-6y for the 4th DTaP and 5th poliovirus vaccine dose. Since Daptacel is approved for use in children 6mo through 6 years, they were not sure whether this qualified as a incident, but after speaking to one of the Directors, they thought it was best to be report, just in case. Reporter was able to provide the requested information, including links to CDC's and state's guidance on dose timing for what is considered a valid dose administration.   It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
15 hours after - Chills, Body aches, tired and blood pressure fluctuations.  By 6/20 these issues subsided.  Six days later (6/22) I started having problems breathing and had chest pains.  I was unable to do  any kind of exercise, going up stairs, walking long distances, all make me lose my breath and get lightheaded and have to sit down.  By 7/7/14, the symptoms have gotten a little better, but I am still struggling to breath during normal activities.
low grade fever, headache, multiple body aches including neck, back, abdomen, hips and legs,mild diarrhea, frequent and painful urination and worsening of asthma.
sore arm; could not walk and developed extreme muscle pain, joint pain, fever, chills, fever, headache, and; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore arm) and GAIT DISTURBANCE (could not walk and developed extreme muscle pain, joint pain, fever, chills, fever, headache, and) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (sore arm) and GAIT DISTURBANCE (could not walk and developed extreme muscle pain, joint pain, fever, chills, fever, headache, and). The patient was treated with PARACETAMOL (TYLENOL) for Paracetamol, at an unspecified dose and frequency and SIMETICONE (ALKA SELTZER ANTI GAS) at an unspecified dose and frequency. At the time of the report, PAIN (sore arm) and GAIT DISTURBANCE (could not walk and developed extreme muscle pain, joint pain, fever, chills, fever, headache, and) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-052653 (E2B Linked Report).; Sender's Comments:  MOD-2021-052653:2nd dose
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 29-FEB-2016, the patient was vaccinated with improperly stored MMR II lot # K022284, expiry date 12-NOV-2016 (dose, route and site of administration were not reported). Temperature excursion was noted at 49.1 Fahrenheit for 13.5 hours. There was no previous temperature excursion. This is one of several reports received from the same source. Additional information has been requested.
5"x4" area of redness and warmth. No streaks. No pain. No limited mobility. Area of induration at injection site x 3 cm.
Patient received pneumonia vaccine per hospital protocol.  She had previously had fevers and after the vaccine was given she had fever spike and had swelling at injection site and hives on neck and arm.  She was treated with acetaminophen and then ibuprofen.  Symptoms subsided and at discharge her only instruction was to apply ice to the site if soreness continued.
chills,muscle aches,h/a,dizzy,arm pain,t100.0;APAP,IV NaCl
Symptoms began at 10am  on Sept 18 and lasted until approx 7am on Sept 20. Difficulty breathing - shortness of breath, chest pain, extreme muscle and joint pain all over body, severe headache, fatigue to the point I could not get out of bed, chills, fever, injection site swelling
FOLLOWING INJECTIONS, PATIENT REQUESTED TO WAIT IN THE WAITING ROOM. 8:35 A.M.  PATIENT'S HUSBAND CAME TO THE WINDOW STATING THAT HIS WIFE DID NOT FEEL WELL.  PATIENT WAS C/O FEELING LIGHTHEADED.  VITALS AT THE TIME OF VISIT WERE STABLE: T:97.6, HR: 98, B/P 120/84, RR 18. PATIENT WAS GIVEN A COOL CLOTH TO PLACE ON FOREHEAD AND ALLOWED TO REST UNTIL FEELING BETTER, APPROXIMATELY 10 MINUTES.  PATIENT RECOVERED AND REQUESTED TO GO HOME.
On January 28th at 3 pm i received the Moderna Covid-19 shot. I received dose 1 of 2.  Later that same day at 8 pm in the evening  my right arm where i received the injection started hurting. I had a small bump around the injection site It was also tender to the touch. I Iced my arm I also applied hot compress to the injection site. I also had some chills as well. I took acetaminophen to relieve the discomfort. Today is 1/2/2021 and i am feeling a lot better. My arm has stopped bothering me. I don't have a bump around the injection site and it isn't tender to the touch. I have also stopped taking the acetaminophen and i don't have any chills. I only had this reaction for one day.
He has some petechia with COVID last summer.  He had significant (worse) petechiae immediately after the first COVID vaccination.  It is resolving with time.
5OCT93 pt recvd vax & on 7OCT93 pt crying constantly weight losss 7oz; refusing breast milk; OM;
N93.9 - Abnormal uterine and vaginal bleeding, unspecified VAGINAL BLEEDING ABDOMINAL CRAMPING
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient race was provided as W.  No concomitant medication information provided  No treatment medication information provided   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Included patient age and date of birth
Patient fainted immediately following vaccination. Initial BP was 147/107; decreased to 132/88 within about 30 minutes and patient was released to home.
7-2-09 per report taken, pt. had c/o cellulitis on R. upper arm which was tender, hot to touch, itchy and firm to touch. Area affected was 4-5 in diameter.
Information has been received from a registered pharmacist concerning a male patient who in approximately October 2011, was vaccinated with a dose of PNEUMOVAX 23 (Lot #671401/1158AA) 0.5 ml, intramuscularly or subcutaneously. The registered pharmacist reported that on an unspecified date, the patient experienced pain in his left arm to where that patient could not lift his arm after receiving PNEUMOVAX 23. On an unspecified date, the patient sought unspecified medical attention. At the time of the report, the patient was recovering. The patient experienced pain in his left arm and could not lift his arm were considered to be disabling by the registered pharmacist. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "obesity with prediabetes" (unspecified if ongoing); "obesity with prediabetes" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "chronic herpes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive; (20Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid from 08Jul2022 to 13Jul2022.  Clinical Course: Patient has received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
No symptoms at time of dose, was observed for 15 mins for safety. Reactions began 2 hrs afterward, at home. Migraine, extreme fatigue, fever of 100.1 lasted from Friday 1/22 to Monday 1/25 between doses of Advil. Saturday 1/23, redness, swelling, pain, hot at injection site growing from golf ball size to softball size by Sunday morning. Began spreading inflammation around shoulder and inside arm. Slight hives visible Monday 1/25. Itching present.
At 6:00 PM on 11/30/05, became very nauseated. At 7:00 AM on 12/1/05, upon rising, was dizzy, pale with headache. At 11:00 AM on 12/1/05 after eating began to feel better. No temp or localized reaction at site.
In yrs past I got fever, cold chills w/i the 3-5 days after shot. Did not have shot last 2 yrs. But this yr red, hot, swollen in the area around the shot & just below site. Emp states she also had swollen neck glands this week since receiving the flu vaccine on 10/18/10. Swollen/red area is 70mm x 75mm in size.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 12-JUN-2014 the patient was vaccinated with an expired ZOSTAVAX (lot # J000783, expiry date 30-APR-2014) (dose, route, indication not reported). No adverse events were reported. The patient outcome was unknown. Additional information is not expected.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2017, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2017, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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 considered related. Additional information has been requested.
Needle failure, injected volume less than 0.45ml; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number PA77M, expiry date 24th September 2023) for prophylaxis.   On 7th September 2022, the patient received the 2nd dose of Shingrix. On 7th September 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 07-Sept-2022 Reporter's comment: The health care professional experienced a needle failure while she was injecting Shingrix second dose. To be on the safe side the reporter stated that the final volume injected was less than 0.45 ml. The permission to create a Medical information account was declined. The reporter did not consent to follow-up. Additional supportive information: The patient received less than 0.45 ml of Shingrix vaccine due to needle failure, which led to incomplete dose administered.
1130 Post vaccination reports feeling light headed w/dizziness and episode of syncope; vitals assessed BP 100/56 P98 02 sat 99% RA Medical monitoring x 30 min, feet elevated. Maintains alert answering questions, reports hx "low blood pressure and "fainting with blood draws".  Declines po hydration, snack / crackers provided reports "feeling better" : BP 113/87 P65 12pm Released from facility home w/self
pt exp malaise & joint pain following vax w/Hep B vax; No further details were provided;
Fever, cough x 3d, vomiting x 1d poss influenza. 11/17 and 11/30 Medical records received for DOS 11/13/09-11/14/09.  Final DX: Acute febrile illness in child, influenza like symptoms Diff walking, bil LE edema x 4days, fever. vomiting, HA, myalgia, cough. On PE no edema noted, bil calf muscle tenderness. Gradually resolving. D/C to home in good condition.
On March 26, 2021 the right side of my head felt like I had chills.  The sensation grew to the right side of my face where it felt like splinters were under the skin.  By Sunday night, March 28,, 2021 bumps appeared on my face and scalp.  On March 29, 2021 the doctor diagnosed me with Herpes zoster without complication.
Skip periods and have not had period or any spotting for 6 months up until a week after the first shot; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 12Mar2021 at 12:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, birth control and infrequent menstruation- oligomenorrhoea (take birth control continuously so skip her periods and have not had her period or any spotting for 6 months up until a week after her first shot). Concomitant medications included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL); fluconazole, vitamin D NOS (MANUFACTURER UNKNOWN) and birth control (unspecified), all for unknown indication and from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had been on birth control continuously hence skipped periods and not had period or any spotting for 6 months up until a week after first shot on 16Mar2021. On 16Mar2021, the patient had spotting menstrual. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event spotting menstrual was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384998 same reporter/product/event , different patient.
This spontaneous report was received from a pharmacist and refers to a 18-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was provided. On 28-APR-2017, the patient was vaccinated with a first dose of GARDASIL 9 injection, 1 dose (route, lot #, expiration date were not reported) for prophylaxis of human papilloma virus (HPV). On 21-AUG-2017, the patient was vaccinated with a second dose of GARDASIL 9 injection, 1 dose (route, lot #, expiration date were not reported) for prophylaxis of human papilloma virus (HPV). On 28-OCT-2017, the patient was vaccinated with a third dose of GARDASIL 9 injection, 1 dose (route, lot #, expiration date were not reported) for prophylaxis of human papilloma virus (HPV). No adverse effects were reported.