chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach hurt; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurt) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurt). At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.    Reporter did not allow further contact
Hyporesponsive - mother could not awaken child this morning even when bathing him. No fever or other signs of illness.
Multiple Myeloma, Asthma, Joint Pain, Erectile Dysfunction, Pneumonia, Optic Nerve Pain. Per follow up report received 05/06/2005:  Patient had not recovered. Medical records reviewed stated patient experienced thrombocytopenia, proteinuria, anemia and compression fractures of the spine.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced hives from below chest to knees. There were fewer spots from hips to knees
Severe asthma attack, shortness of breath, unable to speak, wheezing. Patient given albuterol neb, epi pen, placed on cPAP and transported to hospital.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 22-MAR-2018, the patient was vaccinated with PEDVAXHIB lot number N003700 with expiration date on 01-NOV-2019 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Pt recvd 1st dose Hep B vax on 20MAR91 & devel localized soreness & dec strength in inject arm;
body reaction of itching from her hair to her butt and it got worse through the night; red spots on the inside of her arms all the way to her armpit/ Red spots on chest/ Red spots on back/ Red spots behind ears/ Red spots on front and back of neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (body reaction of itching from her hair to her butt and it got worse through the night) and ERYTHEMA (red spots on the inside of her arms all the way to her armpit/ Red spots on chest/ Red spots on back/ Red spots behind ears/ Red spots on front and back of neck) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 03020A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (body reaction of itching from her hair to her butt and it got worse through the night) and ERYTHEMA (red spots on the inside of her arms all the way to her armpit/ Red spots on chest/ Red spots on back/ Red spots behind ears/ Red spots on front and back of neck). At the time of the report, PRURITUS (body reaction of itching from her hair to her butt and it got worse through the night) and ERYTHEMA (red spots on the inside of her arms all the way to her armpit/ Red spots on chest/ Red spots on back/ Red spots behind ears/ Red spots on front and back of neck) had not resolved. Not Provided          No Concomitant medications were provided    This case was linked to MOD-2021-042858  (Patient Link).
Patient came to clinic for Hives but had no none hives on her body during the examine, she them needed to get her 4 year old vaccines, after they were administered mother brought pt back to clinic because Pt was having a reaction, Pt was taken back to a room immediately and a provider was notified immediately, she was evaluated by the provider and was given Benadryl here in clinic, Pt did break out in Hives on her face and arms. Provider explained to mom to give Benadryl at home if needed, Pt did not have difficulty breathing and was sent home after giving medication to help with the reaction.
administered 2nd dose too early, 1st dose on 10May2022, 2nd dose administered 23Jun2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 16-year-old female patient who received HAV (Havrix) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 23rd June 2022, the patient received the 2nd dose of Havrix. On 23rd June 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comment: The reporter declined to give patient's initials. The patient was administered her second dose of Havrix vaccine too early.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Havrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
A pharmacy student reported that an unspecified number of pts received an injection of flu shield. subsequently, the pt developed an injection site reaction characterized by a quarter-sixed area of "hot, red-wheeled indurations." No further info was available at the time of this report. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying info is provided.
pt was given a 3rd dose of shingrix upon starting to give a 4th dose it was noticed that he already had received 3 doses of it prior
negative Hepatitis-B titers; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 22-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The physician assistant reported that the patient had negative Hepatitis-B titers after completing the childhood vaccine series.  They are considering Engerix-B to administer a booster.  The name of the original Hepatitis vaccination not noted. The reporter consented to follow up. The reporter could not read the pediatric note in the chart that gave the Hep-B vaccine name and lot information.
Case number PHEH2012US016366 is an initial spontaneous report received from a pharmacist on 17 Aug 2012. This case refers to a 23-year-old male patient. He was vaccinated with MenA component of MENVEO vaccine (batch number: A11064, expiration date: Dec 2013) reconstituted with sterile water, intramuscularly on 16 Aug 2012. The patient experienced fainting spell after receiving the MenA component of MENVEO vaccine reconstitute with sterile water. The pharmacist did not report how long the fainting spell lasted. The outcome was reported as unknown. No other information was reported.
This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 31-OCT-2017, the patient was vaccinated with one dose VARIVAX for prophylaxis (lot number and expiration date were not reported). Initial exposure to VARIVAX was when patient was 4 weeks pregnant. The patient became pregnant with last menstrual period (LMP) of 03-OCT-2017 and estimated delivery date (EDD) of 10-JUL-2018.  No adverse effects were reported. It was unknown if the patient was still pregnant at the time of the report.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 5-year-old female patient who received KINRIX (batch number Y2N22, expiry date 12th February 2019). On 20th June 2017, the patient received KINRIX (intramuscular). On 20th June 2017, less than a day after receiving KINRIX, the patient experienced injection site erythema and injection site cellulitis. The patient was treated with cephalexin. On an unknown date, the outcome of the injection site erythema and injection site cellulitis were recovering/resolving. The reporter considered the injection site erythema and injection site cellulitis to be probably related to KINRIX. Additional details were provided as follows: This case was received from a licensed practical nurse. The patient received the dose of KINRIX on right thigh. After the injection, the patient went for swimming in a chlorinated pool. The patient was seen in the office and was prescribed cephalexin. The patient was improving. This case was linked with case US2017098855, reported by same reporter.
9/9/21-5:15 pm vaccine given  9/10/21-4:00am fever, body aches, headache, exhaustion  9/11/21-fever, body aches, exhaustion, rash on neck, breasts & upper stomach
I had a very sudden onset of symptoms of COVID-19. I was a first responder at the fair. I was leaving and the symptoms hit my like a ton of bricks. I had congestion and runny nose. It was like a bad cold. I found out some of my coworkers tested positive for  COVID-19. I tested at home and it was positive. The next day I contacted my doctor's office and it took them another day to get back to me. I was prescribed Paxlovid and within an hour of taking the first dose, I felt better. By the next day, my symptoms had diminished significantly. I did have some mild stomach issues and a metallic taste from the medication. The only symptom that lingered was fatigue. However, as of yesterday 07/17/2022 that fatigue is gone and I am testing negative. COVID-19 is very contagious. My wife caught it the day after I tested positive.
painful swollen arm intermittant fevers nausea headache abdominal pain and diarrhea arm pain gone ,swelling improved in 2 days fevers intermittant for one to two days headache transient abdomnal pain and diarrhea persisted for at least 4 days. abdomnal pain rated at 4/5 on third day and tenderness worse in rlq so trip to er got ct no diagnosis of appendicitis er doctor said he had seen many cases of abdominal pain and diarrhea with covid vaccine abdominal pain and diarrhea gradually faded but residual fatigue lingered
Fever of 102.7F and neurologic symptoms (irritability, inappropriate screaming spells, weakness in legs, trouble walking or sitting erect and lack of coordination). Symptoms began day 1-2 after MMR+Varicella immunizations given in local clinic and progressively resolved over the next week or so.
Is Diarrhea a side effect?; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Is Diarrhea a side effect?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Is Diarrhea a side effect?). At the time of the report, DIARRHOEA (Is Diarrhea a side effect?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was provided.  No treatment medication was provided.   Reporter did not allow further contact
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "kleinfelter's syndrome" (unspecified if ongoing); "Known allergies:Iodine based contrast dye" (unspecified if ongoing), notes: Iodine based contrast dye; "Known allergies:Iodine based contrast dye" (unspecified if ongoing), notes: Iodine based contrast dye. Concomitant medication(s) included: LYUMJEV [INSULIN LISPRO], start date: Jan2020; LANTUS, start date: Jan2013; ATORVASTATIN, start date: Jan2015; LEVOTHYROXINE, start date: Jan2015; TESTOSTERONE, start date: Jun1994; VITAMIIN C, start date: Jan2000; VITAMIN D [COLECALCIFEROL], start date: Jan2000; CALCIUM, start date: Jan2018. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
uncomfortable with covid- had booster--as does family; uncomfortable with covid- had booster--as does family; uncomfortable with covid- had booster--as does family; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820).  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ANASTROZOLE; XGEVA. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 Immunization, reaction(s): "Covid", "Drug ineffective"; Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "Covid", "Drug ineffective". The following information was reported: IMMUNISATION (medically significant), DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "uncomfortable with covid- had booster--as does family". Patient was uncomfortable with covid- had booster--as does family; pandemic causes her stress.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Pt became limp, drooling, cyanotic, unresponsive x2-3 min.  Sx resolved by the time EMS arrived.  Taken to local ER and given Motrin (did not require any benzodiazepines or other medications to break seizure).
Due to my loss of taste and smell from the previous dose, my vaccination was delayed. They thought I had contracted COVID and I had to be tested before they would administer the vaccine. Therefore, I got the vaccine 2 days outside of the normal window. Starting about 3 hours after receiving the vaccine, my arm became sore and I was very achy. I had a headache and severe muscle and joint aches. I could feel it "move through my system" and it felt like a severe flu. These symptoms lasted for about 12 hours. I still had the loss of taste and smell from the previous dose.
Itchy hands and palms lasted for 3 days. Rash on both left and right upper arms not by the injection site.  On 1/14 the right half of my lower lip swelled up and would continue to do so until 1/15 around about 0730 after taking a benadryl.   Symptoms and issues seem to happen sporadically without a pattern or warning.
Called 4-25-07 1:15 pm reported induration et rash with itching located on (R) posterior arm around injection site. States noticed this am, was size of "silver dollar". At noon was size of apple. Recommended Benadryl. Advised to take to doctor of spreads et becomes more generalized over body, et to take to ER if any shortness of breath.
w/in 5min p/vax pt became cold, clammy, nauseous;pt recovered w/in 10 to 15min;this is 1 of 3 pt from this site to devel these sx following an inj;
dose administered past the expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the expiry date) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the expiry date). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received contains Significant information: Patient details updated. Product start date, expiry date were added.
Patient reports that after recieiving dose 1 of the covid  on Jan 5thvaccine he felt fatigue.  then when he got his allergy shot on the 11th of Jan he had fatigue and cramps.  he then had increased frequency and pain of migraines. he then develops muscle spasms which persisted.  also reports erectile dysfunction. all symptoms worsened after he received his second covid vaccine on the 26th of January. he tried treating his headaches tih rizatriptan and naproxen whcih helped a little.
Slept drank a lot of fluids and just felt fatigued on Monday; Flu like symptoms; Sore arm; Hurts all over; She thought she was dying and she could not function; She thought she was dying and she could not function; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Apr2021 (Lot number: ER8737) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Hurts all over"; ANXIETY (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset Apr2021, outcome "unknown" and all described as "She thought she was dying and she could not function"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Apr2021, outcome "unknown", described as "Flu like symptoms"; PAIN IN EXTREMITY (non-serious) with onset 23Apr2021, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset 26Apr2021, outcome "unknown", described as "Slept drank a lot of fluids and just felt fatigued on Monday"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "Chills".  Additional information included: The patient had her first dose on last Friday. The patient's arm was sore the same night where she received the vaccine and then through the weekend she had flu like symptoms. She thought she was dying and she could not function. The patient was supposed to have the next dose on 10May2021 and was scared to get the second dose if the symptoms were going to be worse. The patient had flu like symptoms including chills, hurting all over. The patient didn't have headache. The patient took Pfizer covid shot because she doesn't want covid. The patient stated that she was fat. Her sore arm was the least of it. It was more sore than a flu shot, but she anticipated that. That was the least of her problems. It was not like she couldn't live with it.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report obtained from a contactable consumer (patient's mother). A 16 year old female patient received, on 24Aug2018 (in the morning), the second dose of TRUMENBA at single dose, for immunization. Relevant medical history and concomitant medications were none. On 24Aug2018, around 9:40 AM, the patient developed headache, chills and was feeling bad. The events were described as following: "very bad headache and cold chills, and she was feeling horrible". The patient took ibuprofen for the headache. The mother confirmed that her daughter did not have these symptoms before the vaccination. The patient did not recover from the events at time of this report.  The information on the lot number has been requested.
About a week and a half after receiving vaccine, for about the next 2- 2.5 months I experienced tingling/numbness in fingers and feet, problems with balance, muscle twitching, and vertigo type symptoms..  This caused me to start seeing a chiropractor for the first time in my life because it was starting to interfere with daily activities.  I first noticed it when helping my daughter with homework, if looking down at things that were at a lower level, I experienced dizziness.
This medically confirmed spontaneous report (initial receipt 02-OCT-2014) concerns a female patient. On 30-SEP-2014, the patient was administering AFLURIA pre-filled syringe (batch number: T57606) to a student. During the administration, AFLURIA syringe hub broke. The nurse was believed to be injured as she filed an incident report. The reporter believed that there was no administrative error from the nurse. Outcome was not reported.