chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach is sensitive; Mild headache; Chills; Fever of 99.9 degrees Fahrenheit; Diarrhea; Sever headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach is sensitive), DIARRHOEA (Diarrhea), HEADACHE (Sever headache), PYREXIA (Fever of 99.9 degrees Fahrenheit) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Sever headache). On 12-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 13-Mar-2021, the patient experienced PYREXIA (Fever of 99.9 degrees Fahrenheit). On 14-Mar-2021, the patient experienced CHILLS (Chills). On 15-Mar-2021, the patient experienced HEADACHE (Mild headache). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach is sensitive). On 14-Mar-2021, DIARRHOEA (Diarrhea), HEADACHE (Sever headache), PYREXIA (Fever of 99.9 degrees Fahrenheit) and CHILLS (Chills) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach is sensitive) and HEADACHE (Mild headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 99.9 (High) 99.9 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a pharmacist referring to a newborn (numbered 84). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperatures dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 09-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Seen in clinic on 3/17/06 for axilla pain after immunization on 3/16/06. Temp 101.
Within 5 minutes of receiving the injection, my heart rate increased to 125 BPM
The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. On or about 03-MAR-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a Pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 22-JUL-2014, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Intermittent dizzyness, increased fatigue and "tired vision" starting 5 Days after injection
Approx 12 hours after injection, severe chills, fever of 101.5, headache, muscle pain. Fever spiked quickly but subsided within 6 hours.  Chills were pretty severe. 24 hours after injection most symptoms are either gone entirely or low enough to not be bothersome. I am only filing this report because I have never experienced any bothersome symptoms from any previous vaccination including pneumococcal, flu, MMR, etc.
Persistent swelling, hives, anaphylaxis (over 30 days). Able to suppress with prednisone 20mg daily. No long-term solution yet
right deltoid, red area 5-6 inches across, 7-8 inches, long hot to touch, painful.
Severe arthritis flare, severe soft tissue pain whole body, unable to get out of bed or chair by myself lasting 3 weeks untill able to get on Prednisone
Not reported until 09/10/2014.  *I do not feel this is the result of the vaccine.   *Patient has pain at injection site and pain with abduction.  She has a history of nerve impingement syndrome.
Good evening. Was made application of the product ZOSTAVAX suspension for subcutaneous injection on August 24, 2015. On November 9, 2015 I developed herpes. I never had anything herpes. I have all affected skin photos. What is the offers to be taken? I am very concerned about the occurrence. I have a fever, pain in the region of injuries, general discomfort. Which provides that you guys will take? whom should I look for in my city.
Heart palpitations / arrythmias.  Premature Ventricular Contractions.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 27-OCT-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot# reported as L0010144, expiration date 24-MAR-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reports 2.5 X 1.5 inch welt over IMZ site - patient also states has had to use inhaler more frequently but is not having swelling of mouth, face, lips or difficulty breathing.
OFF LABEL USE; VACCINE WAS WITHDRAWN ON THE PREVIOUS DAY OF VACCINATION AT NOON AND GIVEN ON THE DAY OF REPORT AT NOON; ADMINISTRATED 0.3 ML OF VACCINE; VACCINE ADMINISTRATED TO 12 YEARS PATIENT; This spontaneous report received from a health care professional concerned a 12 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced off label use. On 15-SEP-2021, the patient experienced vaccine was withdrawn on the previous day of vaccination at noon and given on the day of report at noon. On 15-SEP-2021, the patient experienced administrated 0.3 ml of vaccine. On 15-SEP-2021, the patient experienced vaccine administrated to 12 years subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use, vaccine was withdrawn on the previous day of vaccination at noon and given on the day of report at noon, administrated 0.3 ml of vaccine and vaccine administrated to 12 years patient was not reported. This report was non-serious.
Twenty-Seven (27) months of Medical Records Can Be Provided.  Symptoms have persisted to the present time. No prognosis. No definitive treatment.
blotches below his navel. It is itchy, irritating, and they are growing/area below navel started to irritate; Affected area is itchy; blotches below his navel. It is itchy, irritating, and they are growing/affected area is growing and spreading; blotches below navel/hair follicle growing two blemish or flat mole; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (blotches below his navel. It is itchy, irritating, and they are growing/area below navel started to irritate), RASH MACULAR (blotches below navel/hair follicle growing two blemish or flat mole), RASH PRURITIC (Affected area is itchy) and RASH (blotches below his navel. It is itchy, irritating, and they are growing/affected area is growing and spreading) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RASH MACULAR (blotches below navel/hair follicle growing two blemish or flat mole). On 26-Mar-2021, the patient experienced RASH PRURITIC (Affected area is itchy) and RASH (blotches below his navel. It is itchy, irritating, and they are growing/affected area is growing and spreading). On an unknown date, the patient experienced SKIN IRRITATION (blotches below his navel. It is itchy, irritating, and they are growing/area below navel started to irritate). At the time of the report, SKIN IRRITATION (blotches below his navel. It is itchy, irritating, and they are growing/area below navel started to irritate), RASH MACULAR (blotches below navel/hair follicle growing two blemish or flat mole), RASH PRURITIC (Affected area is itchy) and RASH (blotches below his navel. It is itchy, irritating, and they are growing/affected area is growing and spreading) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2021: Significant Follow-up received on 28-Mar-2021: Events updated and Events start date updated On 12-May-2021: Non-significant follow-up received on 12-May-2021: Reporter Contact details added
Injection site is red; Injection site is burning; Injection site is itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA, INJECTION SITE PAIN, and INJECTION SITE PRURITUS in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00027911) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA, INJECTION SITE PAIN, and INJECTION SITE PRURITUS. At the time of the report, INJECTION SITE ERYTHEMA, INJECTION SITE PAIN, and INJECTION SITE PRURITUS outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
The pt developed cluster migraine headaches, aches and pains in his joints and muscles. *Follow-up report 2/19/03: From PT's parents: "There is no change he is still disable. He is my son and lives at home with us."
5 days post-vaccination patient experienced mild malaise, stuffy nose and low grade fever (not recorded). The same day she noted redness on injection site.  P.E. 1 week post-vaccination-erythematous band 1x4 cm on back left arm, superficial, with no underlying induration.  No associated lymph nodes and remainder P.E. negative. Gradual improvement.  1 week later patient developed a mild (her words) "allergy rash," which improved after a few days.  Patient indicated a history of "egg allergy" (hives).
On 2/4/09 in received 1st dose of JE vaccine. He presented to the office for his 2nd dose of japanese encephalitis vaccine at the 1 week follow up interval. 2 days after administration of 1st dose of vaccine pt reported tactile fever. 3 days after administrator noted rash over right anterior abdominal wall and stinging sensation about the adjacent skin. On examination the has 1 patch of erythema measuring ~ 5x3cm with a few vesicular eruptions. He also complains of stinging sensation along the dermatome with testing. Probable shingles eruption. He will see his PCP for further evaluation and possible treatment of shingles.
I had 3 skipped menstrual cycles and then a very long and heavy cycle which stopped and restarted 3 days later.  I had cramping and nausea with the cycle which is totally abnormal for me.
I developed tinnitus in my left ear that lasted for 3 months. Also sometimes accompanied by a headache at my left temple.
I am currently breastfeeding and my infant had an upset stomach the day after I received the vaccine. I got a headache approximately 6 hours after receiving vaccine. I got uncontrollable chills for about 2 hours. My headache lingered for approximately 3 days. My injection site was sore for approximately a week.
Patient stated he developed a rash on both forearms approximately 3 weeks after receiving his second dose
acute febrile episode w/single focal sz approx 32 hrs p/vax;
Sore arm; Swollen like marble; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE SWELLING (Swollen like marble) in a 77-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 11-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 IN EXTREMITY (Sore arm) and VACCINATION SITE SWELLING (Swollen like marble). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE SWELLING (Swollen like marble) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications are provided. The reporter patient have blood drawn appointment for regular check-up on 12 Apr 2021. Patient questioned if vaccination is going to affect the blood work.   This case was linked to US-MODERNATX, INC.-MOD-2021-068611 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068611:
PHARMACIST ADMINISTERED VACCINE FROM PUNCTURED VIAL 28 HRS AFTER OPENING THE VIAL (RECOMMENDED 6 HOURS); 6HR EXCURSION IN THE FRIDGE; VACCINE GIVEN FROM PUNCTURED VACCINE VIAL (28HRS AFTER OPENING); This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 25-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced pharmacist administered vaccine from punctured vial 28 hrs after opening the vial (recommended 6 hours). On 25-MAY-2021, the subject experienced 6hr excursion in the fridge. On 25-MAY-2021, the subject experienced vaccine given from punctured vaccine vial (28hrs after opening). The action taken with covid-19 vaccine was not applicable. The outcome of the pharmacist administered vaccine from punctured vial 28 hrs after opening the vial (recommended 6 hours), 6hr excursion in the fridge and vaccine given from punctured vaccine vial (28hrs after opening) was not reported. This report was non-serious.
Pt. received a flu vaccine on 08/05/21, forgot she had received a flu vaccine then came back on 09/29/21 for a flu vaccine and received a second flu vaccine in error
7OCT93 @ well child check, mom stated that last visit 9AUG93 pt recvd vax & 4-5 hrs p/inject pt cried for 2 hrs straight, high pitched cry; no other signs for sx p/that was a little bit crabby for a couple days;
difficulty in breathing; breakout in hives; could not swallow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 38 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "severe gluten allergy" (unspecified if ongoing), notes: Caller said that she has a severe gluten allergy. The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "difficulty in breathing"; URTICARIA (non-serious), outcome "unknown", described as "breakout in hives"; DYSPHAGIA (non-serious), outcome "unknown", described as "could not swallow".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11:42 am patient felt dizzy and palpitations 10-12 minutes after receiving vaccine.  11:47 am  patient evaluated by EMS BP 168/110, Pulse 120, EKG done. patient reporting feeling better but wishes to to seen in ED.  11:54 am patient transported to hospital by EMS
Stomach pain, diarrhea, other gastrointestinal issues, and muscle swelling occurred.  The gastrointestinal issues began two days after, and is still ongoing 4 days after.  The swelling began 3 days after.
Three days after receiving the vaccine I woke up with my left hand and arm swollen and could barely get my wedding ring off my finger.  My hand and wrist does have pain in them at times and does make this bothersome and at times difficult to use at my line of work for the developmentally disabled.  This is the arm that I was given the vaccination in.
Started getting short of breath around 3:30.  I was not sick before this. Around 7:30 it got worse. On 5.15/21 breathing got really bad all day. Tried to go to bed around 10pm but breathing go to where I could hardly catch a breath. Had to calll 911. Oxygen go to 82%. Diagnosed with pneumonia both lungs and sepsis. Admitted same day and discharged on 5/22/21 with an oxygen tank. They also had delivered an oxygen concentrator to my home. Was discharged and I should not have been. Discharged without any medication. I could hardly walk and was very dizzy. On 6/3/21 I saw pulmonologist and my oxygen level was at 80% without my oxygen.   Had to start respiratory therapy but could not go due to no transportation.
Severe pain in right should. near injection site. Pain comes and goes without regard to activity. Pain is still present as of day 17 post immunization.
6/2/19 4pm patient received 1 dose of Boostrix on right arm and 1 dose of Shingrex on left arm. At around 9pm 6/2/19, patient experienced pain on left arm. On 6/4/19, patient experienced redness and swelling on left arm. On 6/6/19, patient states pain and swelling improved, but there is itchiness near injection site on left arm.
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 for prophylaxis. On an unknown date, 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, muscle pain, fever, headache, shivering, injection site erythema and tiredness. On an unknown date, the outcome of the injection site pain, muscle pain, fever, headache, shivering, injection site erythema and tiredness were unknown. It was unknown if the reporter considered the injection site pain, muscle pain, fever, headache, shivering, injection site erythema and tiredness to be related to SHINGRIX. Additional details were provided as follow: This case was reported by the patient's husband. The age at vaccination was not reported. The patient was experiencing pain and redness around the injection site as well as muscle pain, tiredness, headache, shivering and fever after her SHINGRIX injection.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Report about COVID treatment: Yes; If vaccine received: Yes. Other medication in 2 weeks: Unknown. COVID vaccine details: Vaccine brand: Pfizer / BioNTech, vaccine brand unknown: False, vaccine administration date Nov2022, vaccine lot unknown: True, vaccine lot unknown reason: Not available/provided to reporter at the time of report completion, vaccine dose number unknown: true, vaccine dose number unknown reason: unknown. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: Unknown. Did you/the patient previously receive a COVID-19 Vaccine?: Yes.
I had two sore arms the same after receiving my three vaccinations. I also had a small fever of 100.3 degrees. The effects were very mild and completely expected after having three vaccinations administered at once.
limp, pale, high pitched scream x 3 hrs; a few hrs p/vax mom called the next day to describe event-pt was not examined;
Constant abdominal pain, worse after eating began ~24 hours after injection and has continued through date of report.   Large increase in fibromyalgia pain beginning one week after injection.
Extreme Nausea and lethargy throughout the next day. Vomited multiple times in the morning.  Felt warm, but did not take temperature. Diarrhea in the evening. Sense of nausea persisted. Very tired and slept when not in the bathroom. Felt lightheaded, but no longer nauseated today (the subsequent day). Diarrhea persists.
Patient vaccinated x3 (Pfizer) -- > 4/9/21, 4/30,21, 11/7/21  Patient admitted to Medical Center ICU on 1/23/22 after testing positive for COVID19
Patient came to office with parent for second GARDASIL and flu vaccine. Reviewed allergies, no previous reactions to vaccines. GARDASIL administered in left deltoid. Flu vaccine administered in right deltoid. Patient stated she felt okay. Patient stood up, then fell to the ground. Unclear if patient hit head. Patient's body shook for 2 seconds. Patient opened eyes. RN called for assistance. Dr. and nursing staff came to room. Blood pressure 104/60, heart rate 81. Dr. stayed in room for 15 minutes to monitor patient. Patient drank 20 oz water, states she feels okay. Denies pain or light headedness. Patient stood and walked without difficulty. Per Dr., okay for patient to leave office. Advised parent to call office with any questions, concerns, or if any new symptoms arise. Patient left office in stable condition with mother.
Itchy, red, left arm swollen 18cm x 15cm area around injection site.  Onset 3 days after injection.  Seen in office 12/26/07.
About 1 month after receiving vaccine, I tested positive for COVID-19. I had just disembarked a ship that I had been on for 10 days.