chrisvoncsefalvay/vaers-outcomes huggingface dataset:
approximately 20 min after receiving vaccine patient reported headache and pressure in the temple region bilateral. she had completed her 15 min. obersvation period and had already walked to her vehicle when symptoms began. she immediately returned to observation for evaluation vital signs were peim 6/10 hr 64 b/p 130/67 SAT 99% temp36 c. patient sat on chair offered water and observed for 30 min. patient was discharged with a complete resolution of symptoms accompanied by her son
hallucination; fever; fast heartbeat; Sick; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein, lot number and expiration date unknown), at a single dose, and influenza vaccine at an unspecified dose, both, via an unspecified route of administration, on an unspecified date for immunization. Medical history included heart trouble, asthma and low blood trouble/low blood sugar. The patient's concomitant medications were not reported. Patient was concerned about getting the Covid- 19 vaccine. Patient would like to know if she can get the covid vaccine with her history of medical conditions. The patient reported that the last time she got a flu and pneumonia shot together it made her sick on an unspecified date. She had a fast heart beat, fever and hallucinations, all on an unspecified date. She was told it could have been too much giving them together. She would be getting the Covid-19 vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Information has been Roche Pharmaceutical (manufacturer report # 540009) a 64 year old female reported she was vaccinated with VAQTA and RECOMBIVAX HB vaccine and subsequently experienced severe flu-like symptoms. Additional information is not expected.
Patient had previously been vaccinated on 03/04/21 for the first series of Moderna, patient had done well with the vaccination and it was decided that it was best he complete the series.  Patient and father consented to the second dose and had a recovery time of 15 minutes.  Patient denied any symptoms at that time and went home.
Symptoms: vomiting, shakes, fever, body aches, lethargy, weakness, loss of appetite, migraine, chest pains, difficulty breathing, wheezing, shortness of breath.
At approximately 14 hrs. after vaccine received, patient developed fever of 101 degrees, body aches, sore throat, laryngitis, nasal congestion. Fever and body aches lasted 48 hrs.
Rash on elbows, knee and ankle joint rash and swelling. Spread to arms and legs. Had a fever one week prior 8/1 through 8/6. Baby seemed not content.
Immediately after vaccines given (MMR, Varicella, influenza to right leg) (HIB, HEP B, IPV to left leg) child developed hives to right leg and face. Child taken to treatment room and Benadryl 12.5mg administered, child observed for one hour and hives then resolved.
CARDIAC EVENT; This spontaneous report received from a patient via a company representative concerned a 42 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 01-MAY-2021, the subject experienced cardiac event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac event on 08-MAY-2021. This report was non-serious.
Information has been received from a medical assistant concerning a 19 year old female with no known pertinent medical history or drug reactions/allergies who on 11-JUN-2008 was vaccinated with a first dose of GARDASIIL (lot# 660391/0063) 0.5 ml, IM. Concomitant therapy included ZOLOFT. On 12-JUN-2008 the patient experienced face and mouth numbness, pain in her left arm and leg and shortness of breath after receiving GARDASIL. The patient sought unspecified medical attention. Additional information has been requested.
At occurrence of symptoms pt. visited ER & neurologist, informed student health 4/24/13 at time of an unrelated visit. See enclosed ER report obtained with student's knowledge. The patient presents with a complaint of headache. The pain is generalized to the neck. The onset was sudden. The course has been increasing. The headache began 3 days(s) ago. The pain is characterized as: sharp. The pain severity is moderate. The headache was precipitated by: Unknown. Worse with movement. Worse with light. Associated symptoms: (-) diplopia, (-) eye pain, (-) facial pain, (+) fever, (-) nasal discharge, (-) nausea, (+) neck pain, (+) photophobia, (-) rash, (-) vertigo, (-) visual disturbance, (+) vomiting. Prior Related Problems: There are no prior related problems.
This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE INDURATION, the second episode of VACCINATION SITE INDURATION, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA and VACCINATION SITE SWELLING in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chronic fatigue (symptoms worse after the vaccine) in 1990 and Epstein-Barr virus infection in 1990. Concomitant products included SERTRALINE, DOXYCYCLINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced the first episode of VACCINATION SITE INDURATION, VACCINATION SITE PAIN and VACCINATION SITE ERYTHEMA. On 10-Mar-2021, the patient experienced the second episode of VACCINATION SITE INDURATION, VACCINATION SITE SWELLING and VACCINATION SITE PAIN. On 25-Feb-2021, VACCINATION SITE PAIN and VACCINATION SITE ERYTHEMA had resolved. On 14-Mar-2021, last episode of VACCINATION SITE INDURATION, VACCINATION SITE SWELLING and VACCINATION SITE PAIN had resolved. ON 10mar2021, post vaccination, the patient reported that she experienced pain, swelling, redness at the injection site. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes on 11-May-2021: Follow-up information received on 11-May-2021 will be processed with initial report. Follow-up updated patient demographics, concomitant medications, adverse events start/stop dates and outcome. On 14-Jun-2021: No specific follow-up information recorded.
Heart palpitations, shortness of breath, headache, body ache, and dizziness.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Enlarged heart; 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. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 13Mar2021, for COVID-19 Immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 2021, outcome "unknown", described as "Enlarged heart".  Additional Information: The patient received booster shot on 17Dec2021.   Follow-up attempts completed. No further information is expected.
Got shot at 4:30pm, woke up next day at 3:30am with very concentrated headache near forehead, pain at injection site (left arm), mild nausea and some tiredness. 100.1 fever at 6:32am, 101.3 fever at 9:16am, 100.5 fever at 11:00am. Very tired throughout day, headache lasted most of day. Tried to get out of bed to do laundry but was too lightheaded to finish and had to go sit down. Cold pack on forehead was only treatment I used. The next day fever was gone but still very tired - tried to go outside for a walk but turned around quickly due to nausea / tiredness. Back at work on day 3 and feeling totally fine.
POSITIVE COVID TEST -  09/11/2021 (after the booster) - severe fatigue for weeks, congestion, cough lasted months  POSITIVE HOME TEST - 02/15/2022 - congestion, runny nose, headache, sinus pressure, slight cough  This time I did receive a monoclonal antibody infusion on 02/17/2022. (5 day duration of symptoms)
Mother noted 3 1/2cm X 5cm localized reaction to left deltoid area on 6/19/01 when preparing pt for babysitter. Area reddened and warm to touch. Pt alert and oriented X 3 with no illness. Mother using cool wash cloth to area and Tylenol prn.
Information has been received from a registered nurse concerning a male who was vaccinated with a dose of varicella virus vaccine live and developed a varicella breakthrough described as over 100 lesions. It was noted that the child was afebrile, but was itchy. It was also noted that there was an outbreak at the patient's school which affected many children who were not vaccinated. Unspecified medical attention was sought. There was no product quality complaint involved. At the time of the report the patient was 6 years of age. Follow up information indicated that there were no new events reported. The reporter also indicated that two other patients (WAES0405USA01135 and 0406USA01135) had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized with acute pancreatitis within 6 weeks of receiving COVID vaccination.
fever w/no other apparent cause 1 day p/vax;fever persisted 4 days then resolved;temp 102 to 103;
Not taking the 2nd dose; Itchy after the 1st dose; Ringing in ears after 1st dose; Felt like had the worst flu ever had after 1st dose; Arm swollen after 1st dose; Arm hot after 1st dose; Feet hurt after 1st dose/ Arm felt like bees biting after the 1st dose; Neck stiff after 1st dose; Couldn't eat after 1st dose; Nauseous after 1st dose; Temperature of 101.4 F after 1st dose; Exploding headache after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not taking the 2nd dose), PRURITUS (Itchy after the 1st dose), TINNITUS (Ringing in ears after 1st dose), INFLUENZA (Felt like had the worst flu ever had after 1st dose) and PERIPHERAL SWELLING (Arm swollen after 1st dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020, Nausea and Diarrhea.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not taking the 2nd dose), PRURITUS (Itchy after the 1st dose), TINNITUS (Ringing in ears after 1st dose), INFLUENZA (Felt like had the worst flu ever had after 1st dose), PERIPHERAL SWELLING (Arm swollen after 1st dose), FEELING HOT (Arm hot after 1st dose), PAIN IN EXTREMITY (Feet hurt after 1st dose/ Arm felt like bees biting after the 1st dose), MUSCULOSKELETAL STIFFNESS (Neck stiff after 1st dose), FEEDING DISORDER (Couldn't eat after 1st dose), NAUSEA (Nauseous after 1st dose), PYREXIA (Temperature of 101.4 F after 1st dose) and HEADACHE (Exploding headache after 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not taking the 2nd dose), PRURITUS (Itchy after the 1st dose), TINNITUS (Ringing in ears after 1st dose), INFLUENZA (Felt like had the worst flu ever had after 1st dose), PERIPHERAL SWELLING (Arm swollen after 1st dose), FEELING HOT (Arm hot after 1st dose), PAIN IN EXTREMITY (Feet hurt after 1st dose/ Arm felt like bees biting after the 1st dose), MUSCULOSKELETAL STIFFNESS (Neck stiff after 1st dose), FEEDING DISORDER (Couldn't eat after 1st dose), NAUSEA (Nauseous after 1st dose), PYREXIA (Temperature of 101.4 F after 1st dose) and HEADACHE (Exploding headache after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: high (High) high and 101.4 (High) Temperature of 101.4 F after 1st dose.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment using  tylenol, gatorade,green tea was reported Concomitant medication information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: nni
On 11/10/00, flu vaccine given to right deltoid and pt had no problems at the time. She states that, 4 hours later, had pain to arm and felt heavy. On 11/16/00, continued to have pain which had increased along with limited ROM. Examined in clinic on 11/21/00 and referred for evaluation with worker's compensation doctor.
patient age wasn't double verified before vaccination. Patient's parent stated date of birth as 08-02-2004. Responsible party then changed date of birth to 08-02-2010. making patient and 11yrs old only eligible for pfizer peds. Medical staff failed catch or calculate pt age before administering 12& up vaccine to an 11yr old. pt was observed for 15 minutes with no adverse reaction to the vaccine.
Worsening hormonal migraines not responding to normal treatment . Had to go on steroid pack and migraine resolved after 1 week
Information has been received from a female patient, with iodine allergy and "severe food allergies", who on approximately 09-MAY-1977, at the age of 18 months old, was vaccinated with MMR II. There was no concomitant medication. The patient reported that when she was 18 months old, she received the MMR II and immediately after receiving the vaccine she became paralyzed for several days. The consumer reported that she was not hospitalized but was under the care of a physician and she recovered about a week after MMR II. Upon internal review paralysis was determined to be an other important medical event. Additional information is not expected.
This spontaneous report as received from a nurse refers to a patient of unknown age. No current condition was reported. No historical medication was reported. Approximately in 2014, the patient was vaccinated with VAQTA lot # J005713, expiration date 25-OCT-2015 (dose, strength and route was not reported). No concomitant medication was reported. Nurse stated that an unspecified number of patients received (unspecified doses in series) VAQTA that was stored at 47F for 120 hours. Nurse also reported that temperature issue occurred on 29-JUN-2014 through 03-JUL-2014 so doses administered somewhere after 04-JUL-2014 and 23-SEP-2014. No adverse event was reported. The outcome of VAQTA stored at 47F for 120 hours was unknown. This is one of the several reports. Additional information has been requested.
Severe arm rash the size of a baseball welt; Muscle pain; Had a fever for five days; Severe leukopenia; Could not walk; A spontaneous report was received from a pharmacist who was a 35-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt.    The patient's medical history was not provided. No concomitant medication use was reported.  On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date in Jan 2021, the patient's white blood cell count decreased which was considered severe leukopenia. Additionally, she experienced a fever for five days that would not decrease with paracetamol or ibuprofen, had muscle pain, and could not walk.  On 25 Jan 2021, the patient had a severe arm rash the size of a baseball welt. Treatment for the arm rash included diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt, was unknown.; Reporter's Comments: This case concerns a 35-years-old female patient, who experienced a serious unexpected event of leukopenia, a non-serious unexpected event of gait disturbance, rash and non-serious expected event of myalgia, and pyrexia. The event of rash occurred on day 4 after first dose of mRNA-1273, lot # unknown. Remaining events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown.  Laboratory tests revealed severe leukopenia (details not provided). Treatment included Tylenol, Ibuprofen and Benadryl. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Severe, painful chills, headache, muscle aches, low grade fever, weakness, generalized pain, paleness.
Pt recvd vax & w/in 24 hrs devel hives on face, chest, hands & feet; w/in 48 hrs devel wheezing; treated in MD office; took DPH;
This spontaneous report was received from a physician concerning to a patient of unknown age and gender. On 20-FEB-2013 the patient was vaccinated with a dose of MMR II (lot number H013041, expiration date 17-JUL-2014) (dose and route not reported). The vaccine administered was improperly stored, was exposed to 66F since 21-JAN-2013. No adverse effect reported. This case is linked to the following MARRS cases: 1304USA007561, 1304USA008125, 1304USA008126, 1304USA008127, 1304USA008128. Additional information has been requested.
I am considering not getting the second shot; diarrhea; vomiting; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 12:30 (Lot number: EN6202) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "large prostate" (unspecified if ongoing), notes: Diagnosed years ago, he had a part of his prostate shaved off surgically years ago and he has been put on medicine and is following with the urologist.; "slight high blood pressure" (unspecified if ongoing), notes: Diagnosed a long time ago, many years ago.; "Surgery" (unspecified if ongoing), notes: he had a major surgery, but no additional details provided. The patient took concomitant medications. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "I am considering not getting the second shot"; NAUSEA (non-serious) with onset 10Mar2021 22:00, outcome "recovered" (Mar2021), described as "Nausea"; DIARRHOEA (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "diarrhea"; VOMITING (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "vomiting".  Additional information: No Prior Vaccinations (within 4 weeks). The patient did not visit to Emergency room or Physician's office. No Family Medical History Relevant to AE. The patient had coffee and toast. The caller is on daily medication and hasn't had this reaction before, so he does not believe they caused this reaction. The caller mentions he takes a low dose blood pressure medication. No additional details provided regarding his other medications. Patient was scheduled for 28 days after Tuesday for his second dose, which he did not think he's going to get, because of the reaction they had.  No follow-up attempts are possible. No further information is expected.
Site: Bruising at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient informed Rph that she always faint.Was called after 10minutes .Rph laid her on carpet .Patient woke up. Called 911.
The day after the vaccination, started out with tiredness; 3rd day I felt pressure on my chest; day 5 start having difficulty of breathing, day 7-10 difficulty off breathing with cough and phylum; day 5 start having difficulty of breathing, day 7-10 difficulty off breathing with cough and phylum; Day 10 my temperature is increased from 97.2 F to 99.5 F. Because of the difficulty of breathing, I feel lightheaded; Day 10 my temperature is increased from 97.2 F to 99.5 F. Because of the difficulty of breathing, I feel lightheaded; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Ep7533), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:00 (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), amoxicillin and allergy pills taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). The patient was not pregnant at the time of vaccination. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient reported that, the day after the vaccination, started out with tiredness (07Apr2021 14:00) and the 3rd day she felt pressure on her chest (Apr2021), day 5 started had difficulty of breathing (Apr2021), day 7-10 difficulty off breathing with cough and phylum (Apr2021). Day 10 her temperature was increased from 97.2 F to 99.5F (Apr2021). Because of the difficulty of breathing, she felt lightheaded when she moves around (Apr2021). Taken Mucinex and inhaler to manage her symptoms. There was no treatment for the events tiredness, body temperature increased and lightheadedness. The patient underwent lab tests and procedures which included temperature: 97.2 to 99.5 fahrenheit (increased from 97.2 F to 99.5F) on Apr2021. Therapeutic measures (mucinex and inhaler) were taken as a result of events chest pressure, breathing difficult and productive cough. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a health professional concerning a patient in the first grade who was vaccinated with a dose of Varivax. On 01-MAR-2006 the patient experienced chickenpox. Additional information has been requested.