chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 05May2021 I went into an irregular heart rhythm called atrial flutter with elevated heart rate and was hospitalized.; On 05May2021 I went into an irregular heart rhythm called atrial flutter with elevated heart rate and was hospitalized.; This is a spontaneous report from a contactable Nurse (patient). A 56-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EW0150), dose 2 intramuscular, administered in Arm Left on 06Apr2021 14:45 (Age at vaccination 56 years) as dose 2, single for covid-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. The patient previously took minocin and sudafed (Known allergies). Historical vaccine included first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6202), dose 1 via an intramuscular administration on 09Mar2021 at 02:30 PM (Age at vaccination 56 years) in Arm Left as dose 1, single for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. On 05May2021 at 19:45 the patient went into an irregular heart rhythm called atrial flutter with elevated heart rate and was hospitalized. The patient was hospitalized on 05may2021. Patient went into an irregular heart rhythm called atrial flutter with elevated heart rate and was hospitalized for 2 days. Patient received Cardizem as treatment for event. Patient visited emergency care room. Facility where the most recent COVID-19 vaccine was administered at hospital. Seriousness criteria-Caused/prolonged hospitalization: Yes. The clinical outcome of events was recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Limited information of reported events preclude a comprehensive causality assessment however causal role of BNT162B2 vaccine cannot be excluded for the reported events. Underlying hypertension could be contributory to event.  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
OCCASIONAL STINGING/PULSATING PAIN; SHARP PAIN IN BOTH ARMS; SHARP PAIN ON WRIST OCCASIONALLY; This spontaneous report received from a patient concerned a 76 year old of unspecified sex. 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: 1805020, expiry: 09-JUL-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included rosuvastatin calcium. On an unspecified date, the subject experienced occasional stinging/pulsating pain, sharp pain in both arms, and sharp pain on wrist occasionally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from occasional stinging/pulsating pain, and the outcome of sharp pain in both arms and sharp pain on wrist occasionally was not reported. This report was non-serious.
Patient stated s/s development "the next morning". Reported the following, "Got side effects from the T-Dap shot. Effects inclued lightheadedness, fever, chills, body shakes, headache, joint aches, nauseous, bronchial spasms."
Full limb swelling upper R arm (inj. site) Taut, painful. Inj. site with multiple vesicles.
sudden death of a 13-year-old (place)child who had a second dose of Pfizer vaccine; This is a spontaneous report from a non-contactable consumer (columnist). A 13-year-old male patient received second dose of BNT162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that remained strangely silent over the sudden death of a 13-year-old child who had a second dose of Pfizer vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death
Swelling and redness and pain to injection site - cold compresses applied to are. Benadryl 50 mg warm compresses to area as per MD.
I was in for my standard prenatal check-up on the 24th of February and had an elevated blood pressure. I received instructions to monitor with a cuff at home. February 26 - I had elevated Blood pressure and they sent me to Medical Center Labor/Delivery unit to take tests and monitored me. My blood pressure has remained elevated - it's been about 135/85 - - so I am scheduled to be induced - Monday, March 8 2021. Gestational hypertension was the diagnosis.  Due date is March 29, 2021 and This is my third pregnancy. I have one other living child and one pregnancy ended in miscarriage.
fever 100.5; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 100.5) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever 100.5). At the time of the report, PYREXIA (fever 100.5) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  No treatment medication information was given.
Information has been received from a nurse referring to an unspecified number of patients of an unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with a doses of improperly stored RECOMBIVAX HB (dose, frequency, route of administration, lot # and expiration dates unknown). No adverse effects were reported. It was unspecified if the patients sought medical attention. Follow up information has been received on 29-APR-2015 from a healthcare worker. It was reported that more unspecified patients (unspecified number) received doses of improperly stored RECOMBIVAX HB (dose, frequency, route of administration, lot # and expiration dates unknown). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested. General details and analysis were updated.
Immediate swelling and redness of arm and pain that gradually worsened. She went to the ER and was admitted overnight.
Within 5 minutes of receiving Flumist patient began c/o feeling hot and lightheaded. Member vs. were stable. No c/o tightness in chest or problems breathing. Rested, complaints resolved within 15 minutes.
The morning after the pt. received the vaccine, she said she had a headache. Over the next 2 days, the injection site became more and more sore and hot. Eventually an area of redness/irritation had formed approximately 4 inches in diameter. As of today, the pt. says the soreness is gone and the itching seems to be going away. 10/5/14 at 7:10 pm.
Sometime after receiving the vax, the pt broke out in hives over the entire body. The event resolved within24 hours.
BODY ACHES; CHILLS; FEVER/TEMPERATURE DECREASED FROM 102.8 TO 101.5; EYES HURTING; This spontaneous report received from a patient 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: 201A24A, expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced eyes hurting. Laboratory data included: Biopsy prostate (NR: not provided) Not reported. On 25-JUN-2021, the subject experienced body aches. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever/temperature decreased from 102.8 to 101.5. On 27-JUN-2021, Laboratory data included: Body temperature (NR: not provided) Decreased from 102.8 to 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever/temperature decreased from 102.8 to 101.5, and had not recovered from eyes hurting, chills, and body aches. This report was non-serious. This case, from the same reporter is linked to 20210661848.
Patient admitted through ED with hx of lung cancer and COPD, who was recently discharged from hospital after several days of stabilization and treatment, presenting again with cough, fever, and shortness of breath.  The patient found negative for COVID-19.  His chest x-ray and CT scan of chest showed new infiltrate and the patient was admitted for further treatment of pneumonia Second test 2 days later resulted positive
Hives/rash on neck, throat and face. Itchy throat. Waited 45 minutes at the facility, it did not go away, sent home to take Benadryl. Throat was getting very itchy so stopped at nearest store, bought Benadryl at pharmacy, took 2 and waited another 30 minutes in the store for All symptoms to subside before driving home.
Developed Pancreatitis.  3/25/08 Reviewed hospital medical records of 2/12-2/14/2008. FINAL DX: Acute pancreatitis, etiology unclear. Records reveal patient experienced recurrent abdominal pain.  Started 4 days prior & resolved, recurred more severely on day of admission.  Had been on business trip out of country 2 wks prior to pain.  Seem by pcp & had outpatient US of abdomen done which was WNL & labs which revealed amylase of 59.  Sent to ER for admission.  In hospital, pain free & completely asymptomatic after initial pain med.
Migraine type headache, dry mouth, achy arms (both arms not just at injection site), heaviness in lower extremities (inability to get out of bed for several hours).
Nausea- most of the day Vomiting- >6 times in 6 hours  Diarrhea- >2 times in 3 hours
Swelling of neck started several hours after vaccine then progressively worsen to swelling of throat. Shortness of breath.
body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health care professional (patient). A 45-year old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunisation at the hospital.  Medical history included asthma, clotting disorder and allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. However, it was reported that the patient had other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID019 prior to vaccination. The patient experienced body rash, tachycardia, near syncope on 20Jan2021. As a result, the patient went to the doctor office; clinic visit and emergency room/ department or urgent care. The patient received Cortisone injections, oral steroids and antihistamine in response to the events. The events were considered as non-serious by the reporter. The outcome of event recovering. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of bnt162b2 (lot number: el3246, expiration date unknown) on 26Jan2021 at 9:30 AM via an unspecified route of administration on the left arm at a single dose for covid-19 immunization.   No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information received, the reported serious events of Generalized rash, Tachycardia and Pre-syncope were plausibly consequent to single dose for COVID-19 immunisation. The impact of this report on the benefit/risk of profile of the Pfizer drug 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.
Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness of arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness of arm). At the time of the report, VACCINATION SITE PAIN (Soreness of arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned that she had taken vaccine at Hospital. No concomitant medication nor treatment provided.
Fever chills, erythema swelling with pain @ injection site, unable to move (L) arm, neck pain WBC 22,000 to hospital admitted for sepsis.
Pain in muscles and bones; Shoulder pain, pain down both legs; Shoulder pain; Body aches/pain in muscles; Lower back pain; Extremely sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Extremely sleepy), BONE PAIN (Pain in muscles and bones), BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Shoulder pain, pain down both legs) and ARTHRALGIA (Shoulder pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy NOS, GABAPENTIN for Meningitis, CORTISONE for Rheumatoid arthritis, LORAZEPAM, ESCITALOPRAM OXALATE (LEXAPRO), COLECALCIFEROL (VITAMIN D3) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced SOMNOLENCE (Extremely sleepy). On 22-May-2021, the patient experienced BACK PAIN (Lower back pain) and MYALGIA (Body aches/pain in muscles). On 23-May-2021, the patient experienced BONE PAIN (Pain in muscles and bones), PAIN IN EXTREMITY (Shoulder pain, pain down both legs) and ARTHRALGIA (Shoulder pain). On 06-Jun-2021, BONE PAIN (Pain in muscles and bones), BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Shoulder pain, pain down both legs) and ARTHRALGIA (Shoulder pain) had resolved. At the time of the report, SOMNOLENCE (Extremely sleepy) and MYALGIA (Body aches/pain in muscles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported
Patient started having chest pain within five minutes after receiving her vaccine. She did not take her BP medications and requested to go to the hospital. BP elevated 160s/90s, heart rate 78, oxygen level 98% on RA.
Mother states child was seen for well baby visit on November 14, 2007, during visit, child received "six shots".  Following visit, mother and child returned home; "around 4:00 PM", the child began "shaking bad".  Mother indicated she had "never saw him like that."  An ambulance was called and transported the child to ER.  The temperature in the emergency was 104; mother states ER physician explained this was normal.  Child was monitored in ER for three hours, given Tylenol, no other diagnosis.  Following three hours, child was discharged from ER. Mother purchased Tylenol and Motrin, returned home and alternated medication at home.  Following this, mother and child went to visit child's grandmother.  Child was fine rest of the evening, then around midnight the shaking symptoms returned. States he was "shaking all over, eyes were white, fingers purple, foam around mouth."  Ambulance was called and transported to emergency room.  Temperature in ER was 104.  Mother related to ER staff the temp. may be related to the immunizations.  She states ER staff asked why so many vaccines were given?  Blood work and urine tests were obtained.  ER staff related to mother the tests were OK and the temp. may have been caused by the immunizations.  Child again released from ER.  Family returned to home; mother continued to administer Tylenol and Motrin every 4-6 hours as ER had instructed.  Mother states, after episode, child was fine and playing.  On January 27, 2008 mother and child were in the park.  While there, the child laid down and presented the same symptoms of eyes white, fingers purple, foam around mouth.  Temperature was 104, ambulance called, transported to ER; blood, urine tests, and x-ray were performed.  Child was admitted to the hospital from 1-27 to 2-3-08, diagnosis of flu.  Mother has since transferred care to PMD.  On March 5, 2008, child had same symptoms.  Mother states, she called the physician who instructed her to bring the child into the office.  When child was seen by PMD on March 5, diagnosis of ear infection was given.  Child's mother and grandmother concerned over repeated episodes, and have discussed concerns with child's physician.  States child has had no further episodes.  5/13/08 Reviewed hospital medical records of 1/31-2/3/08, ER records of 11/14/2007 & 3/4/2008. FINAL ER DX of 11/14/2007: febrile seizure s/p immunizations. 11/14/2007 ER records reveal patient experienced seizure activity at home, none while in ER.  Tx w/fluids & antipyretics & d/c to home   1/31-2/3/2008 hospitalization FINAL DX: febrile seizure; viral syndrome influenza A (+) w/fever & URI. Patient experienced shaking of UEs, rolling up of eyes lasting for approx 5 min.  Developed nasal congestion on day of admission.  Tx w/IV fluids & antipyretics.  Responded well & afebrile on d/c to home.   3/4/2008 ER records reveal patient experienced fever, shaking chills, wheezing.  FINAL ER DX: viral illness & fever
Nausea and vomiting started about 2 hours after receiving HPV vaccine.  Has lasted for 5 days now.  Continues to have some nausea and vomiting with upper abdominal discomfort.  Went to the ED for IV hydration and medication.
07-09-14 1000 - 'Tingling opposite arm (like my arm fell asleep) went away same day. 7/10 and 7/11, opposite arm and upper back feel like I have a bad sunburn, but there is no rash or markings. (started 07/10/14 2:00 pm). 7-14-14 "Everything is back to normal. I'm just fine."
A few hours after my 2nd dose vaccination - I experienced congestion in my lungs, fever, and my asthma has gotten worse. I called my doctor after a few days and then was prescribed with Zpack to take every once a day for 5 days but it did not help me with my condition so I went back to my doctor and they gave me another antibiotic (levofloxacin - 500mg) and I took it once a day for 10 days and it helped clear the infection in my lungs and then the doctor prescribed me with Prednisone to take for 30 days.
SECOND DOSE OF VACCINE ADMINISTERED; ADVERSE REACTIONS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1805022, expiry: unknown, and batch number: 205A21A expiry: unknown) dose was not reported, administered on 05-APR-2021, and dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced adverse reactions. On 09-SEP-2021, the patient experienced second dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the second dose of vaccine administered and adverse reactions was not reported. This report was non-serious.
she was so sick; like an airplane had crashed on me/The second one was really bad; could not take my pajamas off and could not take a shower; so sick I could not raise my arm; high fever at night; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (she was so sick), FEELING ABNORMAL (like an airplane had crashed on me/The second one was really bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take my pajamas off and could not take a shower), LIMB DISCOMFORT (so sick I could not raise my arm) and PYREXIA (high fever at night) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 027K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ILLNESS (she was so sick), FEELING ABNORMAL (like an airplane had crashed on me/The second one was really bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take my pajamas off and could not take a shower), LIMB DISCOMFORT (so sick I could not raise my arm) and PYREXIA (high fever at night). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. On 21-Feb-2021, ILLNESS (she was so sick), FEELING ABNORMAL (like an airplane had crashed on me/The second one was really bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take my pajamas off and could not take a shower) and LIMB DISCOMFORT (so sick I could not raise my arm) had resolved. At the time of the report, PYREXIA (high fever at night) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2021-395697, MOD-2021-395733 (Patient Link).
Client received 1st yellow fever vaccination on 5/22/08--Vaccine had been reconstituted for greater than 1 hour.  Client was brought back on 5/28/08 and revaccinated with Yellow Fever Vaccine.