chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been experiencing a slow decline in my lung capacity. The rattling in my lungs has just gotten worse and worse. My O2 saturation readings have been getting lower. Around the 30th of November, I couldn't breathe at all. I went to the emergency room that night and at first, they thought it was pneumonia and they gave me LEVAQUIN. They confirmed pneumonia with a chest x-ray. They performed a CT scan with contrast to rule out blood clots. They performed other tests and stated it was not bacterial pneumonia, but an RSV virus with pneumonia. I spent 5 days in the hospital on fluids, breathing treatments, and oxygen. I returned home with oxygen, and they are hoping to ween me off within the next two weeks. I was also prescribed prednisone, albuterol, and coughing pearls.
This is an instance of breakthrough COVID-19 disease after which death occurred, although the primary contributing factor seems to be cardio-pulmonary arrest. It seems the COVID-19 test was only administered to establish eligibility for organ donation. The individual was vaccinated with the Moderna product on 02/11/2021 and 03/11/2021. It is not known if the individual had any symptoms of COVID-19 disease. They were admitted to hospital on 08/02/2021 and then transferred to a hospital in a different state on the same day. They tested COVID-19 positive on 08/06/2021. They remained hospitalized until their death on 08/07/2021.  As the individual died out of state, Death Certificate details are not immediately available to me at this time.   Based on a pathology report concerning a placenta, it seems this individual had a baby about 4 weeks before this adverse event (mid-July) and therefore would have been pregnant at the time of vaccination.
This spontaneous report was received from a medical assistant and refers to a 14-year-old female patient. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 21-MAR-2018, the patient was vaccinated in the right arm with improperly stored 8th dose of GARDASIL 9, intramuscularly (lot # M041990 (also reported as N041990), expiration date: 28-JUN-2019, dose, strength and frequency were not provided) for prophylaxis. Administered vaccine experienced the temperature excursion of 31 degrees Fahrenheit for 2 hours. Digital data logger was involved to capture the temperature excursion. There was no previous excursion reported. No adverse effects were reported.
3pm 1/12/06 parent noted hives, L arm swollen.  Took child to ER.  Benadryl ordered by ER.  Extreme irritability noted by parent.  Naps only 10 minutes at nap time.  Did sleep all night.  Does play at short intervals.
Patient developed increasing muscle weakness and pain 2-5 days following vaccine making it difficult to walk, type, write, and perform daily activities. All labs were normal except for very elevated creatine kinase, myoglobim, and adolase. One week from vaccine, back to normal.
Received the second dose of shingrix before than recommended; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On 15th December 2021, the patient received the 2nd dose of Shingrix. On 15th December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 11-Aug-2022 Reporter's comment: The patient received the second dose of shingrix before than recommended according to the schedule of Shingrix.  The patient did not consent to follow-up. Additional supportive information: The patient received the 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule.
No adverse event; Patient was 18 month old that was given 0.25 ml of the 12 year and up formulation; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient was 18 month old that was given 0.25 ml of the 12 year and up formulation) and NO ADVERSE EVENT (No adverse event) in an 18-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Aug-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient was 18 month old that was given 0.25 ml of the 12 year and up formulation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient was 18 month old that was given 0.25 ml of the 12 year and up formulation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient was 18 month old that was given 0.25 ml of the 12 year and up formulation).    Concomitant product use was not provided by the reporter.  It was reported that an 18 month old that was given 0.25 mL of the 12 year and up formulation. They vaccinated patient from a vial that was supposed to be 6 month to 5 year but it was actually for 12 year and up.   Nothing has been reported by parent. Patient was healthy at the time of reporting.  Treatment information was not provided.
Report 2001025671-1 describes lethargy in a 5.5 year old male who received Infanrix. This report was received from a consumer and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the vaccinee received his fifth injection of Infanrix. Post-vacicnation, the vaccinee became lethargic and slept for three hours. Additionally, he had a fever and a "hacking" cough. As of 10/24/2001, the outcomes of the events were unknown.
Hard time breathing; Body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard time breathing), PAIN (Body ache) and CHILLS (chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Hard time breathing), PAIN (Body ache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Hard time breathing), PAIN (Body ache) and CHILLS (chills) outcome was unknown. Not Provided          The patient got first dose 4 weeks back. He did not have symptoms after the first shot. Patient concomitant medication include diabetic medication Action taken with mRNA-1273 in response to the event was not applicable
Eight minutes after the shot, I started felling unwell so I started my Apple Watch to see my heart rate.  It was at 86 and a minute later it was at 116 and a minute after that it peaked at 119.  It fell to mid 90's a couple minutes later, then went up to 105 fell back to mid 90s, then rose to 117, fell back to 80, and kept rising and falling until about 3pm.      The technician told me before my shot that it would be a few minutes as they had to do something the vaccine.  I don't recall what she told me.  I think she said they had to switch a vial or something.  You'd have to ask her what happened before I had my shot.  This morning I have tingling in my thumb, forefinger and middle finger in the arm I got the shot.  I did sleep on the arm that had the shot .
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-APR-2015, the patient was vaccinated with improperly stored PROQUAD lot # K018142, expiration date 10-APR-2016 (dose and route were not reported). No adverse symptoms reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of low hepatitis B antibody level in a subject of unspecified age and gender who was vaccinated with ENGERIX B. On an unspecified date the subject completed the hepatitis B vaccine series. At an unspecified time following completion of the hepatitis B vaccine series, it was discovered that the subject did not achieve titer levels to be protected. At the time of reporting the outcome of the event was unspecified. The entire hepatitis B series was repeated.
pain became more intense & the now has gone up to my mid back & shoulders/pain is constant burning,soreness,aching; pain became more intense & the now has gone up to my mid back & shoulders; pain became more intense & the now has gone up to my mid back & shoulders; Its to the point where it hurts to walk & I trip a lot; stabbing & stiffening; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201; expiry date: unknown) via an unspecified route of administration in the right arm, on 19Feb2021, at a single dose, for COVID-19 immunisation. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a Public Health Clinic/Veterans Administration facility. Medical history included chronic obstructive pulmonary disease (COPD). She had about 3 surgeries in lumbar area for fusions due to scoliosis in the past years (history of failed lumbar fusions due to scoliosis). Last one was about 5 years ago. Concomitant medications included roflumilast (DALIRESP), duloxetine, loratadine, montelukast sodium (SINGULAIR) and "Spiri". The patient previously received pethidine hydrochloride (DEMEROL) and experienced allergies; and previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264) in the right arm, on 28Jan2021 at 14:00, for COVID-19 immunisation and experienced a little lower back, bilateral hip and groin pain on 30Jan2021. The pain increased as time went on. On an unspecified date in Feb2021, after second injection, the pain (from first injection) became more intense and now has gone up to mid back and shoulders to the point where it hurts to walk, and she trips a lot. Nothing controls the pain including narcotics, heat, ice, Tylenol or ibuprofen. The pain was further described as constant burning, soreness, aching, stabbing and stiffening. The events were considered serious as the events resulted in disability or permanent damage. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.; Sender's Comments: Based on temporal association a contributory role of bnt162b2  to  the reported events  cannot  be totally  excluded.  The patient's history of scoliosis and failed lumbar fusions may also be contributory to the events.  Case will be reassessed if additional information is  received.    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.
Arm pain began in early afternoon with skin tenderness beginning in the evening, which were followed by extreme chills, body aches that hurt to be still, muscle spasms, fever (102-101.4), throbbing headache (treated with ibuprofen x2 200mg Q4hr which helped some), then around 12am became hot and sweaty with aches and spasms persisting. Was able to sleep off and on every time I turned over onto my vaccine arm I woke because of the pain. Next morning I spent the day in bed with lingering chills, muscle aches, headache, and spasms, but less than night before. High Fever persisted (101.4) and a cough with mild shortness of breath developed. The night of 2/28 I took ibuprofen (same dose as before) and Benadryl which allowed me to sleep all night. This morning (3/1) I feel better, with fatigue, lightheaded, a mild fever of  99.3, and minimal muscle aches. Cough persists.
She has severe back pain, lower back pain, shooting pain across it.; She has a history of scoliosis. It has worsened; She can barely walk and has to use her husbands cane; She has a history of scoliosis. It has worsened; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose bnt162b2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing scoliosis. The patient's concomitant medications were not reported. The caller had the Pfizer covid vaccine yesterday on 26Apr2021. She has a history of scoliosis. It has worsened. She has severe back pain, lower back pain, shooting pain across it. She can barely walk a all in 2021 and has to use her husbands cane. Caller was crying throughout the call due to the pain.
Flu-like symptoms; Fatigue; Soreness; 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 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (primary series immunization completed; unknown manufacturer), for Covid-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu-like symptoms"; FATIGUE (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "Soreness".  Additional information: Symptoms went away after a few hours. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient Sx: burning, itchiness, spreading red rash, hardness to skin and swelling.
Hematoma to right shoulder circled with redness. It happened immediately, EMT Was Called and patient did recover. NO other information given regarding patients recovery.
on 11/22/07 increased fussiness and decreased movement of (L) extremities <24 hr after; immunization. Symptoms persisted >48 hr resulting in ER visit and evaluation on 11/24/07 of - MRI an that date revealed (R) hemisphere MCA stroke.  12/18/2007 D/C summary received in addition to MR received yesterday for DOS 11/24-12/12/2007 with D/C DX: Acute middle cerebral artery infarct and stroke, etiology thought to be thrombotic. Left hemiparesis.   Infant presented to ER on 11/24/2007 after parents noted pt was not moving L side of body.  Pt had been fussy and running a fever since the morning following vax.  Pt was seen on 11/23/07 by PCP, but sx had improved and no significant neurological impairment noted other than decreased strength in RUE.  Pt brought to ER with abnormal looking smile.  Asymmetry noted on PE with L sided weakness.  Decreased tone and spontaneous movement on L side.  On assessment stroke is gauged to be 2 or more days old and possibly clinically improving.  Repiratory difficulty/apnea noted and pt intubated. Extubated 12/1/07. No eveidence of seizures. Consults by neurology, physical med & rehab, pediatric hematology. Txd with Lovenox.  D/C on ASA and Lovenox. 1/15/2010 Patient still has sequelae from adverse event and physician believes he always will. Patient is able to use left side and appendages but reports they are weaker and slower than right side.
3RD DOSE COVID VACCINE GIVEN 1/4/22, MODERNA, #027H21B;  pt had a positive COVID test on 9/23/22 from the Medical Center; taken to ED with AMS; pt declined; admitted to hospice on the same day for dyspnea and pt died in hospice.
Can I take Tylenol because I do have allergies issues; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 20May2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient asked if the patient can take paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN) or antihistamine, because the patient did have allergies issues. The outcome of the event was unknown.
p/ pt recv vax in 9/96 pt lab tests revealed in 9/97 negative varicella antibody titer.
Immediately after the shot I started feeling tingling in my left hand fingers. At 2 pm I started feeling warm, not feverish. 12 hours after the shot I started feeling achy and cold. When I woke up on March 25th, I was achy, with chills and internal heat, no fever though. Basically every muscle hurt and I really couldn't move.  I spent the entire day in bed unable to eat or even move. I had to take the day off from work.   I think I had Covid in Feb 2020 before testing began. The symptoms I felt in February 2020 were exactly the same beginning 12 hours after the vaccine.
Chills -- 11pm-3am Fever (102F) -- 3am-11am (9/10/10) Severe headache -- 3am-11am (9/10/10) Stiff joints -- 3am-3pm
Narrative:  Patient tested positive for COVID-19 and was hospitalized despite full vaccination. Last vaccine was on 07/02/2021 which was the second injection of Moderna. No booster documented to date
Chest discomfort; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chest discomfort on an unspecified date. The outcome of the event was unknown.  No follow up attempts needed. Information on lot/batch number cannot be obtained.
fever; Chills; headache; Body Aches; forgetting stuff worsening; This is a spontaneous report from a contactable consumer (male patient reported for himself). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 (at the age of 48-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included allergies, migraines, nerve pain, acid reflux, JC levels getting too high, ongoing pneumonia, ongoing COVID-19. The patient concomitant medications included teriflunomide (AUBAGIO), hydrocodone bitartrate, paracetamol (NORCO), gabapentin, omeprazole (PROTONIX), azelastine, fluticasone propionate (FLONASE ALLERGY RELIEF), montelukast sodium (SINGULAIR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), allergy shots. The patient experienced fever, chills, headache, body aches, forgetting stuff worsening on 18Mar2021. The patient underwent lab tests and procedures which included JC levels getting too high. Outcome of the events was recovered on an unspecified date in 2021.  No further information was reported. Information on lot/batch number has been requested.
Woke up with stiffness in head and neck; Arm is sore; Injection felt like it burned him; He feels like hes getting the flu; Slight headache; He is unsure if he is nauseous but he is not eating; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Woke up with stiffness in head and neck), PAIN IN EXTREMITY (Arm is sore), BURNING SENSATION (Injection felt like it burned him), INFLUENZA LIKE ILLNESS (He feels like hes getting the flu) and HEADACHE (Slight headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 291P21A, 044A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE in September 2021. Past adverse reactions to the above products included Whooping cough with INFLUENZA VACCINE.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Woke up with stiffness in head and neck), PAIN IN EXTREMITY (Arm is sore), BURNING SENSATION (Injection felt like it burned him), INFLUENZA LIKE ILLNESS (He feels like hes getting the flu), HEADACHE (Slight headache) and NAUSEA (He is unsure if he is nauseous but he is not eating). At the time of the report, MUSCULOSKELETAL STIFFNESS (Woke up with stiffness in head and neck), PAIN IN EXTREMITY (Arm is sore), BURNING SENSATION (Injection felt like it burned him), INFLUENZA LIKE ILLNESS (He feels like hes getting the flu), HEADACHE (Slight headache) and NAUSEA (He is unsure if he is nauseous but he is not eating) outcome was unknown.            Concomitant medication information was not reported. Treatment information was not reported.  Patient also reported that people who got Pfizer first shot, felt flu like symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Batch number for Dose 3 was updated.