chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee came to the pharmacy on 09/17/21 to receive second dose of Pfizer vaccine, first dose was administered at Hospital. On 09/17/2021, Dose was administered by pharmacist at pharmacy. Upon logging information into SHOT by pharmacist, first shot was confirmed to be received on 09/09/2021.  Per patient, hospital advised to schedule next dose in "about a week". Recommendation is to separate doses by 21 days however, dose was only separated by 8 days.  Patient was monitored for 20 minutes with no observed side effects. Subsequent dose was canceled due to most recent recommendations to not repeat additional doses for second dose administered with fewer than 17 days. As of 09/21/2021, patient reported right arm soreness as side effect.   FAILURE POINT: Upon patient verification, immunization history should have been collected to ensure appropriate administration of COVID 19 Vaccine.  ACTION: Pharmacy to implement COVID Immunization card verfication/SHOTS verification prior to administration of COVID-19 vaccines
This case was reported by a physician via sales rep and described the occurrence of injection site induration in a 18-year-old male patient who received BEXSERO (batch number 1568018, expiry date 31st August 2017). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site induration and headache. On an unknown date, the outcome of the injection site induration was recovered/resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the injection site induration and headache to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in an unknown arm. The sales representative was aware about the adverse event during a speaker program. The physician described the injection site mark (induration) as a marble size mark in the arm. The injection site mark went away after about 4 days. The sales representative could call back for follow up.
I am overly fatigued. I have no energy to do anything more than go to work in a day. On the weekends, I have to rest. The extreme fatigue began after I got the flu shot and DTAP on October 4.
Nausea; lightheaded; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old female patient started to receive her first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer lot EK5730), intramuscular from 24Dec2020 12:30 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID and has not been tested for COVID-19. The patient experienced nausea and lightheaded on 25Dec2020. Events were reported as non-serious. No treatment given. The outcome of events was unknown.
Chills, headache, achy, loopy. Temp 100. Flu like symptoms for 2 days. Resolved.
Positive COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In September 2022, the patient experienced COVID-19 (Positive COVID). At the time of the report, COVID-19 (Positive COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.  Patient tested positive COVID two weeks ago and asked how long patient need to wait to get bivalent vaccine.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. Concomitant products included Celebrex. On 21st June 2018 13:45, the patient received SHINGRIX. On 21st June 2018, several hours after receiving SHINGRIX, the patient experienced fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by an Office Manager. The patient received the SHINGRIX vaccine on the left arm. The healthcare professional reported that, after receipt of SHINGRIX vaccine, the patient developed a fever later that night. The caller thought that, the patient might have taken TYLENOL and the fever was resolved within one day. This case has been linked with US2018114226, reported by the same reporter.
Had Td, stayed 20 min in lobby.  Drove home read her mail, ate lunch, states becoming dizzy when she arose from her couch.  Also stated that she has episodes of inner ear and sinus problems which cause this reaction.
After injection pt complained about being light headed then progressed to being nausea and fainting possibly passing out. Moved pt from chair to floor and lied on the floor. EMS was called. EMS took vitals. Pt recovered...Went to ER w/wife.
Patient stated he received the Pfizer two dose series, dose 1 - 3/22/21, dose 2 - 4/2/21. Patient began having intermittent fevers coupled with increasing oxygen supplementation needs on 1/18/22.
Undiluted vials reaching 56 degrees Fahrenheit; Patient administration today; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT STORAGE ERROR (non-serious), outcome "unknown", described as "Undiluted vials reaching 56 degrees Fahrenheit"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 14Sep2021, outcome "unknown", described as "Patient administration today". Additional information: The reporter indicted power outage for 3 hours and 30 minutes in refrigerator,  Undiluted vials reaching 56 degrees Fahrenheit.  The reporter was asking for stability information.  The patient administration on the day of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
JANUARY 5, I TOOK THE MODERNA  VACCINE less than a week on that friday, I had severe right back pain it started right down my right hip and now down my leg. february 29, I took  my second dose still in very severe pain and now i am taking medication.
On Saturday April 9th, I received my first Pfizer booster with lesser side effects(lethargy and fatigue) on Sunday compared to my first 2 shots. My daily runs and weight lifting starting the Monday the 11th felt extremely laborious than usual thinking it was a lingering side effect from the booster shot. On Thursday the 14th, despite lacking the physical symptoms(Fever, lethargy, loss of appetite, rib pain, elevated heart rate) from my first PE, I noticed a few drops of blood in my sputum. Hoping that it'll go away, I waited until the morning of Saturday the 15th but I saw blood again. I was admitted to the ER and CT scan showed a new but smaller PE now in my left lung. Blood work showed an elevated d-dimer value of 0.96, but far lower than my 5 from my first case of PE. All of the ER doctors and Pulmonologists were surprised to see my PE come back given my age, general health and habits.
PT COMPLAINED OF CHILLS, MUSCLE ACHES THE NEXT DAY. SATURDAY AFTER 12, HUSBAND (WHO IS A PHYSICIAN) REPORTED SHE HAD A SEIZURE. SHE NEVER LOST CONSCEINCESNESS. HE APPROXIMATES THAT IT LASTED ABOUT 15 MINUTES. SHE RECOVERED AND HAS NOT HAD A REPEAT EPISODE.
Dizziness - started 2 weeks after 2nd shot, and I'm still dizzy as of today Watery and itchy eyes - started 3 weeks after shot, and it's still occurring Blurry vision / ocular migranes - started 2 weeks after 2nd shot, and it's still occurring
dizziness; cried due to injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and VACCINATION SITE PAIN (cried due to injection site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (cried due to injection site pain). On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, VACCINATION SITE PAIN (cried due to injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
COVID Breakthrough case Symptoms began: 10/21/2021 Lab confirmed: 10/25/2021
2 days after injection patient had redness, arm swelling, and pain at the injection site which did not improve after 7 days. Patient saw her primary care doctor and was given oral steroids.
Went to bed at 10:00 PM the day of the TDaP and flu shots, no problems that day. Awoke at 1:00 AM in pain all over, and suffering from chills. Severe shooting pains in head, tremors in hands, extreme thirst, strange sensations in legs resulting in involuntary stretching and flexing. Difficulty walking, still shivering under several layers of blankets. Too unwell to take temperature. Could not sleep at all, pain so bad. Hip and shoulder joints especially painful. Heart racing, breathing shallow. Nausea, could only sip water. Symptoms continued through the morning, began to subside around noon, but still in pain and with raging headache and instability walking. Temperature at noon was 100. Spent most of day lying down under blankets. Ate some toast at 7:00 PM. Still had pain and headache. Took 400mg ibuprofen with toast. At 9:00 PM the headache and pain suddenly went away. Not gradual... All at once, like a switch had been flipped.
Patient has been having 2-3 severe nose bleeds with nasal congestion since receiving nasal H1N1 vaccine at her school on Thurs. Nov. 19th, 2009.
Thumbing in ear like a heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Thumbing in ear like a heartbeat) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced TINNITUS (Thumbing in ear like a heartbeat). At the time of the report, TINNITUS (Thumbing in ear like a heartbeat) outcome was unknown. Not Provided          No relevant concomitant medications were reported. Treatment information for the event was not provided.
Sharp pain in head; Arm red big baseball size; Warm arm; Arm hurt to touch; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Sharp pain in head), ERYTHEMA (Arm red big baseball size), BURNING SENSATION (Warm arm), MYALGIA (Arm hurt to touch) and FATIGUE (Really tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 04B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Thyroid activity decreased, Acid reflux (oesophageal), Cholesterol, Allergy NOS, Neuropathy (in feet), Asthma and COPD. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), LORATADINE and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, SALBUTAMOL (VENTOLIN [SALBUTAMOL]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) for Asthma and COPD, ATENOLOL for Blood pressure management, ATORVASTATIN for Cholesterol, GABAPENTIN for Neuropathy peripheral, LEVOTHYROXINE for Thyroid activity decreased, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced HEADACHE (Sharp pain in head), ERYTHEMA (Arm red big baseball size), BURNING SENSATION (Warm arm), MYALGIA (Arm hurt to touch) and FATIGUE (Really tired). The patient was treated with IBUPROFEN for Head pain, at a dose of 800 mg three times a day. At the time of the report, HEADACHE (Sharp pain in head), ERYTHEMA (Arm red big baseball size), BURNING SENSATION (Warm arm), MYALGIA (Arm hurt to touch) and FATIGUE (Really tired) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history or concurrent conditions were not reported. On 10-NOV-2015, the patient was vaccinated with improperly stored dose of M-M-R II lot # L000459, expiry date 06-JAN-2017, (dose and route of administration were not provided). The vaccine was stored in temperature 46.F for 15 hours. No concomitant therapies were reported. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Felt yucky in the afternoon stated that his mouth felt numb and the next morning he said he felt very tired and noticed his whole jaw was numb and noticed he couldn't talk good and his lip was sagging. He went to ER.
Beginning at 2 pm the following day after 2nd injection, I had fever, chills and body aches, which lasted for 8 hours. On 11/10/2021 after working a normal day without fever and minimal body aches, I managed with Tylenol and Advil. At 5 pm on 11/10/2021, I noticed a diffuse rash across my chest, between my breast and across my stomach. It was flat and bright red. In conjunction with said rash I've have been experiencing tightness/pressure in my chest along with SOB even with O2 saturation at 97%.
develop seizures after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (develop seizures after the vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient never had COVID positive test or diagnosis. Patient did not have any acute or chronic illness at the time of vaccination.     On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (develop seizures after the vaccine) (seriousness criterion medically significant). At the time of the report, SEIZURE (develop seizures after the vaccine) was resolving.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient's height was reported as 6 foot 1 inches.   No concomitant medications were reported.  Patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Patient had sought medical care (office visit, Urgent care, ER, hospitalized) due to adverse event.   Patient did not experience similar event in the past.  No treatment  medications were reported.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, serious, adverse event of special interest Seizure which was medically significant and occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, serious, adverse event of special interest Seizure which was medically significant and occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
No additional AE reported; administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On 03-AUG-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot number: U002534, expiration date: 24-JUL-2022, for prophylaxis (route of administration was not provided) after a temperature excursion occurred (incorrect product storage).   The vaccine experienced temperature excursion of 10.7 degree Fahrenheit for 30 minutes on an unknown date, and of 6 to 14 degree Fahrenheit for 9 hours and 15 minutes, 14 degree Fahrenheit to 46 degree Fahrenheit for 1 hour and 45 minutes on 23-JUL-2021.
This medically confirmed spontaneous report (initial receipt 27-Oct-2014) concerns a 63 year old female patient. The patient had a medical history of hypertension. On 23-Oct-2014 at 09.30 am, the patient received intramuscular AFLURIA (batch number not reported) at 0.5 ml. On 23-Oct-2014, immediately after receiving her vaccination, the patient began to feel lightheaded as if she would faint. She also noticed a metallic taste in her mouth. Her skin became pale and face flushed with blood pressure at 110/72 and heart rate at 68. Her speech became slightly slurred. She exhibited no shortness of breath or urticarial. Emergency Medical Response was called. One and half hour later, her blood pressure was 180/100 and heart rate was 60. Her vertigo completely subsided. She was transported to the hospital for observation. Outcome was reported as unknown. Reporter's comments: The reporter assessed the events as serious (hospitalisation).
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 61-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included FLUCELVAX. On 13th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th October 2018, immediately after receiving SHINGRIX, the patient experienced tiredness, cold sweat, nausea, fever and shivering. On 14th October 2018, the outcome of the tiredness, cold sweat, nausea, fever and shivering were recovered/resolved. It was unknown if the reporter considered the tiredness, cold sweat, nausea, fever and shivering to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's spouse. The patient received SHINGRIX on the right deltoid. Right after receiving SHINGRIX, the patient felt tired, cold sweat, nausea, fever and was shivering. The symptoms were lasted 24 hours. On the same day of SHINGRIX vaccination, the patient also received FLUCELVAX on the left deltoid.
This case was reported by a consumer and described the occurrence of swollen leg in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unspecified) for prophylaxis. The reporter is the subject's father. A physician or other health care professional has not verified this report. On an unspecified date on or before 15 May 2006, the subject received a dose of Dtpa at an unspecified site of injection (dose number and lot number not provided). At an unspecified time after vaccination with Dtpa, on an unspecified date on or before 15 May 2006, the subject experienced swollen leg, erythema of leg, and leg "was warm to the touch." At the time of initial reporting, 15 May 2006, the outcome of the events was not reported. Report received via Merck & Co., Inc.
rash on his forearm by his elbow/He said that the rash is also on the back of his of calf; injection site soreness; a little achy; tired; itching; could not sleep well; This is a spontaneous report from a contactable consumer (reporter).  A 50-year-old male patient received bnt162b2 (BNT162B2, lot number EK5734), via an unspecified route of administration on 18Dec2020 18:30 at single dose for COVID-19 immunization.  Medical history included asthma. He said that he took no other medication except for a multivitamin and his asthma medication. The patient said that within 5 hours of receiving the vaccine, he was a little achy and had injection site soreness. He said that he felt a little tired on Friday (18Dec2020) and Saturday (19Dec2020), but by Sunday (20Dec2020) it was gone. He said that starting Monday (21Dec2020), he noticed a rash on his forearm by his elbow. He said that his skins was normally sensitive and dry. He thought maybe it was not the vaccine and said that he used hand sanitizer that may have bothered it. He said that the rash was on the back of his tricep now though. He said that the rash was also on the back of his of calf. He said that it was itching. He stated that he treated it with triamcinolone cream for rash from his kid and it did not do anything. He said that he was following up with this primary care physician about this. He stated that it was so itchy and he could not sleep well. The outcome of the event tired was recovered on 20Dec2020 while for other events was unknown.
No additional AE; patient was administered VAXNEUVANCE after it experienced a supported temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-AUG-2023, the patient was vaccinated with improperly stored dose (Product storage error) of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, pre-filled syringe, 0.5 ml, lot # reported and confirmed as: X004289, expiration date reported and confirmed as: 10-DEC-2024 (site and route of administration were not provided) for prophylaxis. Temperature excursion information: 11.2 degree Celsius for 2 hours 36 minutes; no previous temperature excursion. There were no side effects reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2308USA004183:02447220 US-009507513-2308USA003975:02447218 US-009507513-2308USA004087:02447221
Symptoms started several hours after recieving injection on 6/29/07.  C/o chills, severe headache, nausea, mild fever, body aches, and dizziness.  Also c/o arm soreness.  Pt continues to have these symptoms in equal intensity today (6/30/07).
dizziness, throat slightly closing, tongue swell, red face and neck, odd taste and drymouth, heart palpitations. This happened right when I left cvs after the 15 min, I should have went back inside. drove home and felt worried so stopped and grabbed bendaryl and spoke to a pharmacist at a Walgreens. Symptoms went away. Next day felt a little off. throat funny/tongue funny but not like the first day.
Pt reported (and insisted a report be filed) - H/A - flu-like symptoms - weakness - short duration of tachycardia - SOB - UTI.