chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male patient between the ages of 19-24 years experienced Other Anaphylactic Shock, NEC (confirmed), (Serious, since 02-Mar-2012, until 02-Mar-2012) while enrolled in the study, treatment was at outpatient visit, treatment medications included: BENADRYL (50mg, 2Q, oral) started on 02-Mar-2012, stopped on 09-Mar-2012, unknown indications; epinephrine (0.3mg, injection) started on 02-Mar-2012, stopped on 01-Apr-2012, unknown indication; prednisone (20mg, 2QDx2D, oral) started on 02-Mar-2012, stopped on 04-Mar-2012, unknown indication. The patient was an active recruit. Adenovirus vaccine was administered on 29-Feb-2012. The patient also received RECOMBIVAX-HB on 29-Feb-2012 (lot # AHABB23AA, manufacturer SKB); meningococcal (MCV4P) on 29-Feb-2012 (lot#U4259AA manufacturer PCM), Tdap on 29-Feb-2012 (lot#AC52B074AA manufacturer PMC), and influenza (intranasal) on 29-Feb-2012 (lot#YK2207, manufacturer MED). Adverse events within 42 days of vaccination: Anaphylaxis F/U at outpatient visit on 06-Mar-2012, severity not assessed, outcome not resolved on 06-Mar-2012, disability/incapacity seriousness, treated with non-drug treatment medication included prescription and OTC; anaphylaxis F/U outpatient visit, severity not assessed, outcome resolved on 09-Mar-2012, disability/incapacity seriousness, treated with non-drug treatment. At the time of the report the outcome of the AEs were: Other Anaphylactic Shock, NEC: Unknown. The medical history of the patient was not specified. The patient's concomitant medication were unspecified. The patient's past medication were unspecified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. Action taken with suspect drugs: Adenovirus Type 4 and Type 7 Live Vaccine - Not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not related to the adenovirus vaccine.
1 week after vaccination, patient developed a palm sized red  itchy rash with hard, swollen area  in the middle of her upper arm about 3-4 inches from where her vaccine was administered.  Was almost gone within 5 days with no treatment.
Headache immediately; chills; Fever; Joint pains; Muscle aches; Fatigue; Nausea; Red bump at the injection site; At 1:00pm this afternoon I can say I am feeling like all systems are gone; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in right arm on 09Feb2021 at 12:30 (Batch/Lot Number: EM9809) as single dose for COVID-19 immunization. The patient's medical history included COVID-19 (tested positive prior to vaccination). The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID -19 immunization, on unspecified date. The patient previously took Levaquin and experienced allergies. On 09Feb2021 12:30 after vaccination the patient experienced headache immediately, then took a 2-hour nap when patient reached home. In the evening patient experienced with chills, fever, joint pains, muscle aches, fatigue, nausea along with the headache. The next morning, patient was not better so called her provider and was told to take Tylenol 2 doses before patient noticed the change in the flu like symptoms. After the 3rd dose of the Tylenol before patient got relief from the headache. Patient slept the entire day and got up at 5:00 pm and had a chicken soup and went back to bed and slept all night. When patient woke up in the morning, she felt so much better. Patient's arm was still sore, and the pain had gone down into her armpit and had a red bump at the injection site but no fever. At 1:00pm afternoon patient said she was feeling like all systems were gone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient took Tylenol for treatment and the outcome of the events was recovered on 11Feb2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
After receiving vaccine, few nights later my husband woke me up panicking over how I was breathing. When woken up I had noticed I had a sore throat which I didn?t hav before going to bed. A headache, pain in sternum, shortness of breath, coughing and to today I am still fighting the symptoms to go away.
fainted, "feels like BP low". Evaluated by EMS-Refusal to transport.
Muscles in shoulder neck on L tight painful. Fever 101 in middle of night. Tightness in chest ~0800. Headache. Symptoms continued through 10/28. Saw Dr. on 10/28 diagnosis with reaction to H1N1 vaccine. On 10/29 hoarse voice, fever 100. Headache improved but still there.
Had pain from neck to tips of fingers; RPh told her to go to ER or urgent care - she did and they said "fluke" thing hit a nerve. Should be ok in 2 days.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 60 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: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date patient had no complaints except fatigue. On 01-AUG-2021, the patient had COVID-19 antigen test which resulted in positive (suspected clinical vaccination failure and suspected covid-19 infection).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000189953.; Sender's Comments: V0- 20210834806-  covid-19 vaccine ad26.cov2.s  -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Exposed to someone who is covid positive; This is a spontaneous report from a non-contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history concomitant medications were not reported. It was reported that, the patient experienced exposed to someone who is covid positive on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 71 year old female patient who on 01-JAN-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). "Later that month" (in 2011), the patient experienced a progressive neuromuscular reaction after ZOSTAVAX (Merck). The physician stated that the patient developed muscle weakness that had been progressing. The physician stated this was not GUILLAIN BARRE syndrome. The physician stated that this had been or had becoming a significant disability / incapacity. At the time of the report the patient had not recovered. Patient's progressive neuromuscular reaction and developed muscle weakness that had been progressive were considered to be disabling by the physician. Additional information has been requested.
Shingles flare Nerve pain in known area to face/eyebrow/skin around left eye
Large area of redness, swollen and painful. Denies fever, chills, and any other abnormal symptoms. 24 hours after injection: Wide area of warmth, erythema and tenderness extending from axilla to just below elbow medially on right arm.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored VAQTA (lot # L026600, expiration date 15-MAR-2017; dose, route and dose number were not reported; temperature/time frame: 49.1 Fahrenheit / 4 hours and 30 minutes; therapy type: Digital Data Logger; previous temperature excursion: 65.2 Fahrenheit for 8 hours and 15 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I do not believe the COVID vaccine caused an adverse event.  My medical condition was already doomed. 03/29/21 - mammogram and ultrasound 04/13/21 - biopsy 04/28/21 - 2nd dose of COVID19 Pfizer vaccine 05/17/21 - surgery; diagnosis of DCIS confirmed 08/02/21 - surgery, re-incision mm/dd/21 - radiation therapy to begin
Sore throat; Tiredness; soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration on an unknown date in 2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 47-years-old) as a single dose for COVID-19 immunisation. 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 vaccine. On an unknown date, the patient experienced sore throat 3 days after 2nd vaccination. Only side effects the first 3 days were soreness and tiredness. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for the events. The clinical outcome of the events sore throat, soreness and tiredness were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
hives at injection site; swelling; itchy; redness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives at injection site), SWELLING (swelling), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced URTICARIA (hives at injection site), SWELLING (swelling), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 14-Apr-2021, SWELLING (swelling) had resolved. At the time of the report, URTICARIA (hives at injection site), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment for the event include hydrocortisone cream.
Side effect; thrush; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ADVERSE DRUG REACTION (Side effect) and CANDIDA INFECTION (thrush) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 15-Jan-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 ADVERSE DRUG REACTION (Side effect) and CANDIDA INFECTION (thrush). At the time of the report, ADVERSE DRUG REACTION (Side effect) and CANDIDA INFECTION (thrush) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Oral medication used in treatment
Information has been received from a physician and the mother of a 15 year old female with a history of hypersensitivity reactions to allergens. On 10/3/06, the pt was vaccinated IM with the first dose of 0.5ml of HPV vaccine (lot 653650/0702F. Concomitant therapy included Ortho Tri Cyclen LO started on 10/6/06. On 10/06/06, the pt developed widespread itching and hives of both upper and lower extremities. The pt did not experience respiratory symptoms. The pt was self treated with Benadryl with only mild improvement. A nurse in the local ER was consultated by phone but the pt did not require hospitalization. The symptoms resolved after one week and the pt had not experienced further problems. On 10/13/06 the pt had recovered from the event. The physician considered the event to be serious as disabling. Additional information has been requested.
Information has been received from a physician concerning an unidentified patient who was vaccinated with varicella vaccine live (Oka/Merck); instead of varicella-zoster vaccine (Oka/Merck) Varivax. There was no adverse event. It is unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
Soreness at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VACCINATION SITE PAIN (Soreness at injection site). On 13-Jan-2021, VACCINATION SITE PAIN (Soreness at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Tested positive for Covid 19 on June 1, 2022 - Fever (102.2 max) - 5 days, chills - 5 days, achy muscles - 1 week, cough (still going after 3 weeks), sore throat - 3 days, stuffy nose (still going after 3 weeks), exhaustion (3 weeks)  Kidney infection and UTI on June 10, 2022.  Back ache (1 week), fullness (10 days), abdominal pain (1 week), burning sensation when urinating (2 days).
This spontaneous report was received from a female patient of unknown age, via company representative. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient went to a pharmacy to receive her initial injection of ZOSTAVAX, lot # reported as 26815 and expiration date on 25-DEC-2018, for prophylaxis (route of administration and anatomical location were not reported). The patient was asked by the pharmacist to remain for a short time frame for post-dose observation, and within an approximately ten minute time period, the patient began to exhibit dizziness, fatigue, acceleration of heart rate and pallor. Within 20 minutes of dose administration, the patient experienced wheezing and shortness of breath. It was also reported that the patient experienced headache. Within an hour of injection, all symptoms appeared to resolve. The reporter did not assess the causal relationship between ZOSTAVAX and the events.
Employee went to immunization clinic and requested Moderna Booster vaccine before EUA had been approved and the full dose.
Nausea; Stomach problems; Feeling sick; Weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Stomach problems"; MALAISE (non-serious), outcome "unknown", described as "Feeling sick"; ASTHENIA (non-serious), outcome "unknown", described as "Weak".  Additional information: Reported that, Patient got vaccinated on Saturday at 26th or 27th some like that and can not remember and confirmed it as first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body tremors (especially legs, but less frequently arms and full body); inability to stand or walk;  diagnosed as Choreoathetosis
Tongue tingling; inner lip swelling sensation; inner lips itchy; Mild tightness in throat and bronchial; Red dot with pink circle on forehead; Shoulder pain; Diarhea; Slight headache; mild temperature 98.4 two days; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 28Mar2021 at 13:30(at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included unspecified conditions. The patient had unspecified allergies to medication, food or other products. Concomitant medications included calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), vitamin d nos (VIT D) and vitamin b complex (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. 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 vaccination. On 28Mar2021, 2minutes after the vaccination, the patient experienced tongue tingling, inner lips itchy swelling sensation. On the same day, 5 minutes after the vaccination, mild tightness in the throat and bronchial. On the same day, 1 hour after the vaccination, the patient experienced a slight headache and mild temp 98.4 usually her temperature was 97.3. On the same day, 3 hours after the vaccination, the patient experienced red dot with pink circle on forehead and shoulder pain. On the same day 18 hours after the vaccination, the patient experienced diarrhoea. On 28Mar2021, the patient underwent body temperature and the result was mild temperature 98.4. The patient was not treated with any medications for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events tongue tingling, inner lips itchy swelling sensation, mild tightness in throat and bronchial, a red dot with a pink circle on the forehead was recovered on 28Mar2021 after the duration of 1 hour. The clinical outcome of the events shoulder pain, diarrhoea, slight headache and mild temperature 98.4 was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Immediate throat tingling after injection.  No difficulty swallowing.  No respiratory distress.  Monitored for 30 minutes.  No worsening of symptoms, "just feels tingly."
dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Chronic pain.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided
pt given .25 of flu vaccine for pediatric, needs to come back in for other .25ml in one month from 10/8/19
Approximately 5-10 minutes after dose given pt mtu wheezing and c/o unable to swallow and difficulty breathing.  O2 applied for O2 sat 82%, albuterol 0.083% given.  IM BENADRYL and SC epinephrine. 6/19/08-records received with report-After Varivax injection developed red face and began wheezing and coughing. Albuterol inhaler used. PE audible wheezing, coughing and difficulty breathing. No swelling. SC epi and IM benadryl administered. Decreased wheezing. Monitored for 30 minutes, stabilized. at onset C/O thoart hurting difficulty swallowing. Now resolved.
"arm is swollen and it foes up under armpit and stated he doesn't feel good.  Narrative:  Other Relevant History:
pt was given dose after the 6 hour puncture expiration.  Pt is being offered another 2nd dose as soon as possible per cdc guidance.
Information regarding PREVNAR was received from a  healthcare professional regarding an 8 year old male patient who experienced drug ineffective and pneumonia. At 15 months of age, the patient received the fourth dose on an unspecified date. The patient's concurrent illness includes asthma with a past history of H1N1 influenza. The patient received PREVNAR at the age of 2, 4, 6, and 15 months of age. Indication for PREVNAR was immunization. Product was administered on unspecified dates at the ages of 2, 4, 6, and 15 months. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. In 2009 the patient developed swine flu and was treated and "got better" but while still sick the patient experienced symptoms of pneumonia and was treated with antibiotics and recovered. No additional information was available at the time of this report.
Ended up in hospital 4 days after shot with no platelets, mouthful of blood blisters. Sent home 12 days later. Back in hospital 30 minutes after got home with ITP. Stay in hospital for a total of 23 days. The hospital discharge summary received on 2/19/04 states fever, dysarthria, and tightness in arms/ hands.
Sudden nausea after getting up, fall, unconscious for few minutes, pulse 60 per minute, too hot, too cold, injured hand in fall. Fell on hardwood floor.Called Dr. Nurse advised I go to E.R. to check if there was head injury; delayed because of nausea. E.R afternoon.