chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pulmonary artery compression
Clinical narrative: 8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness.   Initially I noticed my knees hurting with radiating pain up into my thighs.  My head hurt, particularly at the back of my skull, near my neck.  My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder.  I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms.  She told me I could take either and alternate if I felt I needed to maximize relief.  I noticed the joins in my toes and fingers were hurting.  It was frightening to experience tightness in my chest and back muscles.  I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted.  I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get.  I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse).  I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding.  She encouraged water and more painkiller.  As the day wore on, I felt less achy and more shaky/jittery.  My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy."  As I write this 36 hours after my injection, my symptoms are subsiding.  Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body.  It isn't a fever - just an odd sensation that something is still going on.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Feeling hot, Flushing, Nausea
Clinical narrative: patient was feeling warm and flushed, she noticed her skin on her arms and chest were turning pink/red. She reported that she has a sulfa allergy and had experienced something similar. Benadryl was given when she had taken the antibiotics and the physician said that was the only thing that "saved her bacon". Patient prefers to sit vs lay down. Felt, slightly nauseated and light headed.  Gave alcohol prep to help with the nausea. IM Benadryl given per standing order. 50mg IM to Rt deltoid. Patient responded well to this and started to get normal coloring back and felt good enough to go home; declined evaluation offered by paramedics to hospital.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling abnormal
Clinical narrative: patient was feeling warm and flushed, she noticed her skin on her arms and chest were turning pink/red. She reported that she has a sulfa allergy and had experienced something similar. Benadryl was given when she had taken the antibiotics and the physician said that was the only thing that "saved her bacon". Patient prefers to sit vs lay down. Felt, slightly nauseated and light headed.  Gave alcohol prep to help with the nausea. IM Benadryl given per standing order. 50mg IM to Rt deltoid. Patient responded well to this and started to get normal coloring back and felt good enough to go home; declined evaluation offered by paramedics to hospital.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Heart rate increased, Hypotension, Laboratory test
Clinical narrative: Sharp chest pain, feeling of a lump in my throat, hypotension, elevated heart rate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial necrosis marker, Sensation of foreign body
Clinical narrative: Sharp chest pain, feeling of a lump in my throat, hypotension, elevated heart rate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Pain at injection site, fever, muscle pains
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Injection site pain/swelling/redness, fatigue. These symptoms started with sever chills about 12 hours after the vaccine dose. It was like being hit by a freight train. With ibuprofen I was able to reduce the fever for a short time, but  the side effects continued for 2 days (until 3/20/2021 7pmish). the injection site pain/swelling/redness continued for another 2 days (until 3/22/2021).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Injection site pain/swelling/redness, fatigue. These symptoms started with sever chills about 12 hours after the vaccine dose. It was like being hit by a freight train. With ibuprofen I was able to reduce the fever for a short time, but  the side effects continued for 2 days (until 3/20/2021 7pmish). the injection site pain/swelling/redness continued for another 2 days (until 3/22/2021).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thirst, Vomiting
Clinical narrative: Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Injection site pain/swelling/redness, fatigue. These symptoms started with sever chills about 12 hours after the vaccine dose. It was like being hit by a freight train. With ibuprofen I was able to reduce the fever for a short time, but  the side effects continued for 2 days (until 3/20/2021 7pmish). the injection site pain/swelling/redness continued for another 2 days (until 3/22/2021).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Nausea
Clinical narrative: Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Injection site pain/swelling/redness, fatigue. These symptoms started with sever chills about 12 hours after the vaccine dose. It was like being hit by a freight train. With ibuprofen I was able to reduce the fever for a short time, but  the side effects continued for 2 days (until 3/20/2021 7pmish). the injection site pain/swelling/redness continued for another 2 days (until 3/22/2021).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Thirst, Vaccination site erythema, Vaccination site pain
Clinical narrative: Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Injection site pain/swelling/redness, fatigue. These symptoms started with sever chills about 12 hours after the vaccine dose. It was like being hit by a freight train. With ibuprofen I was able to reduce the fever for a short time, but  the side effects continued for 2 days (until 3/20/2021 7pmish). the injection site pain/swelling/redness continued for another 2 days (until 3/22/2021).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Severe chills, fever of 101, nausea/vomiting, extreme thirst, headache, body aches (joint pain), Injection site pain/swelling/redness, fatigue. These symptoms started with sever chills about 12 hours after the vaccine dose. It was like being hit by a freight train. With ibuprofen I was able to reduce the fever for a short time, but  the side effects continued for 2 days (until 3/20/2021 7pmish). the injection site pain/swelling/redness continued for another 2 days (until 3/22/2021).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red inflammation near injection site (left upper arm). Hot, itchy and swollen. Approximately 30 hours after shot.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Within a week of COVID-19 vaccine I had an outbreak of shingles in my left eye.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Light headedness and Nausea. Reclined patient provided 4L O2 via NC, dizziness resolved. Slight nausea upon leaving, felt much better. Friend provided ride home. Pulse was 82/regular
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Chest X-ray, Chest discomfort, Dyskinesia, Electrocardiogram
Clinical narrative: Within 10 minutes of injection, patient started to say her eyes were moving by themselves behind her eye sockets and she was feeling alot of "snapping" in her body.  Her blood pressure and pulse were higher than normal and she could not keep her eyes open well. She was observed by nurses for approx 30 minutes and those symptoms seemed to subside although she was not steady walking. Midway into our 30 minute drive home it all started again, this time she said she felt heaviness in her chest but was pointing to her throat.  I immediately drove her directly to the ER. Was monitored for 4 hours and was release to go home, be observed and follow up with Neurologist when possible.  Throughout the night, she continued to say she was shaking alot on the inside and her eyes were still moving involuntarily.   3/20/19 at 8:30 am I called her Neurologist to inform her patients symptoms were continuing.  I waited 8 hours and called back only to have her tell her service I was to call patients Primary Physician.  Which I did.  Dr. was on call and quickly  prescribed medication to help calm patients symptoms.  She prescribed Valium 2mg q 6 hours. 3/21/19:  Patient is still experiencing shakiness, involuntary eye movement and fatigue.  She does not have arm pain at injection site.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Gait disturbance, Heart rate increased, Hypertension, Laboratory test
Clinical narrative: Within 10 minutes of injection, patient started to say her eyes were moving by themselves behind her eye sockets and she was feeling alot of "snapping" in her body.  Her blood pressure and pulse were higher than normal and she could not keep her eyes open well. She was observed by nurses for approx 30 minutes and those symptoms seemed to subside although she was not steady walking. Midway into our 30 minute drive home it all started again, this time she said she felt heaviness in her chest but was pointing to her throat.  I immediately drove her directly to the ER. Was monitored for 4 hours and was release to go home, be observed and follow up with Neurologist when possible.  Throughout the night, she continued to say she was shaking alot on the inside and her eyes were still moving involuntarily.   3/20/19 at 8:30 am I called her Neurologist to inform her patients symptoms were continuing.  I waited 8 hours and called back only to have her tell her service I was to call patients Primary Physician.  Which I did.  Dr. was on call and quickly  prescribed medication to help calm patients symptoms.  She prescribed Valium 2mg q 6 hours. 3/21/19:  Patient is still experiencing shakiness, involuntary eye movement and fatigue.  She does not have arm pain at injection site.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Urine analysis
Clinical narrative: Within 10 minutes of injection, patient started to say her eyes were moving by themselves behind her eye sockets and she was feeling alot of "snapping" in her body.  Her blood pressure and pulse were higher than normal and she could not keep her eyes open well. She was observed by nurses for approx 30 minutes and those symptoms seemed to subside although she was not steady walking. Midway into our 30 minute drive home it all started again, this time she said she felt heaviness in her chest but was pointing to her throat.  I immediately drove her directly to the ER. Was monitored for 4 hours and was release to go home, be observed and follow up with Neurologist when possible.  Throughout the night, she continued to say she was shaking alot on the inside and her eyes were still moving involuntarily.   3/20/19 at 8:30 am I called her Neurologist to inform her patients symptoms were continuing.  I waited 8 hours and called back only to have her tell her service I was to call patients Primary Physician.  Which I did.  Dr. was on call and quickly  prescribed medication to help calm patients symptoms.  She prescribed Valium 2mg q 6 hours. 3/21/19:  Patient is still experiencing shakiness, involuntary eye movement and fatigue.  She does not have arm pain at injection site.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Body temperature increased, Loss of consciousness
Clinical narrative: Blood pressure dropped to 65, body temp shot up, passed out
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Diarrhoea, Fatigue, Nausea
Clinical narrative: Sudden nausea with fever and mild diarrhea and weakness and also achy joints. After about thirty minutes, symptoms past but had a tired/sleepy. Rested for about three hours and felt better. Did not take any medications.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sudden nausea with fever and mild diarrhea and weakness and also achy joints. After about thirty minutes, symptoms past but had a tired/sleepy. Rested for about three hours and felt better. Did not take any medications.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Body Rash/Hives
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Visual impairment, Vital signs measurement
Clinical narrative: Sat down, grabbed phone and couldnt see it, told husband to get somebody, escorted to cot via wheelchair due to feeling light headed and nauseous. Pt continuously monitored until 10:40 when she was escorted out via wheelchair and accompanied by RN and patient husband.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ear ringing
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Recurring cough; intermittent; increased incidence at night (possible relation to supine position)
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Throat clearing, Throat irritation
Clinical narrative: Clearing throat, scratchy throat, headache.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Raised tattoo on the same arm as the vaccine occurred about four hours later.   Paper cut the next day in the am, blood was really thin, watery. Again, paper cut about 42 hours after vaccine, thin blood.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Currently experiencing itchy rash,bumps primarily on feet but some other areas of body as well
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Feeling cold, Tremor
Clinical narrative: Pt said she felt dizzy and "off" and that she needed to lie down. Brought into medical bay via wheelchair, (she was already in one) Laid down. Reported felt cold, blankets given, vitals taken and stable. Pt was shakey at times but reported she felt fine. Vitals remained stable. Shakiness subsided within 10 mins. Then pt rested comfortably for about 20 mins. sat up. VS stable. Left in her wheel chair at 11:20, felt much better.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nodule, Pain
Clinical narrative: general fatigue, body aches, soreness near the left clavicle area with a nodule/bump being the center of the soreness. Noticed approximately 24 hours after the vaccination.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pruritus
Clinical narrative: Back was itchy, normal for him, no hives visible. Allergy to grasses, normally itchy with runny nose and eyes. Itchiness deteriorated after sitting. released at 5:05pm
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain in extremity
Clinical narrative: Soreness in arm with injection site started shortly after shot.  6+ hours later, both arms were extremely sore, though the non-injection arm may have been sore from having arm suspended for 4-5 hours of driving in one day.   Only soreness in injection arm remained the next day.  Moderate/noticeable fatigue lasted until second day after vaccination, when soreness and fatigue were barely noticeable.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chillblains, Rash
Clinical narrative: Large arm rash. Not treatment.  Pernio of toes on/off for few weeks. No known covid exposure. Negative for COVID.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Pyrexia
Clinical narrative: high fever, body aches, sob with in 12 hours of vaccine.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Flatulence, Hyperhidrosis, Vomiting
Clinical narrative: Profuse vomiting after Covid injection, painful abdomen. This AM prior to vaccine vomitis continued, stated feels like severe gas. Profuse sweating, pain in upper abdomen, pain in mid back after vomiting. HR 112, SaO2 99% with 4l via NC.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Peripheral sensory neuropathy
Clinical narrative: First vaccination uneventful. Second vaccination uneventful except for expected arm soreness and mild fatigue the following day. However, approximately 2.5 weeks post 2nd vaccination I began to experience peripheral neuropathic symptoms  on the dorsal surfaces of bilateral hands (C6-7 dermatomes). It felt as if I were in a shower with a fine mist hitting both hands - even though the hands themselves were completely dry!. Only occurred while outdoors walking. No pain/numbness/weakness. Lasted roughly 10 days, starting to abate over last 48 hours! Coincidentally, had my first haircut (professional) in a year 3 days ago. I mentioned that it felt good to get out now that I was fully vaccinated. Without suggestion, the hair cutter mentioned that her 81-82 year old mother had had a 2nd vaccination and started feeling ?bugs crawling on the backs of her hands.? My eyes were like saucers because this was a totally-unsolicited remark which closely mimicked the symptoms I was experiencing. Fortunately, they seem to be resolving....!
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Folliculitis, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Had localized itch on back prior to vaccine. Within days or at most a couple weeks of receiving the second dose of my vaccine I started to have symptomatic dermatographia with scratching that manifested as follicular urticaria. This became more widespread where ever I was itchy and scratched. Im being treated with antihistamines and it is improving but not resolved.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeding disorder, Malaise, Pyrexia, Vomiting
Clinical narrative: Starting two days after shot was exhausted, taking naps every day which is highly unusual and has never happened to me after any vaccination. Six days after the vaccine I woke up with a medium level fever (101.5) and spent the next 24 hours unable to keep down food or even liquids. When I drank one gulp of water with Tylenol, I would vomit it back up. Six times in one day. Fever reduced to 100 by evening but still  feeling very unwell . Hopefully it subsides by tomorrow
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed a large circular rash on left arm
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting diarrhea
Sex: U
Vaccine: VARCEL
Symptoms: Product preparation error
Clinical narrative: No additional AEs/ There was no adverse event; if STERILE DILUENT used to reconstitute MMR II can be interchanged with VARlVAX; if STERILE DILUENT used to reconstitute MMR II can be interchanged with VARlVAX; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 16-FEB-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) injection, dose reported as 1 time dose, lot # T025946 (Lot No. T025946 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck)), expiration date: 30-JUL-2022 (dose number, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of vaccine was reconstituted using sterile diluent (STERILE DILUENT) (lot number and expiration date were not reported) that came with the measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (preparation issue and product quality issue). The shortage of appropriate diluent was noted when product was received on unspecified date in February 2021 (reported as last week). No pictures were available and product would not be retrieved.  The nurse practitioner reported that the regulatory authority advised that it was acceptable to mix the measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) diluent with the varicella virus vaccine live (oka/merck)(VARIVAX). There was no adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA007096:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; a patient was administered an expired dose of MMR II.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 15-FEB-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, lot # S004118, expiration date: 11-FEB-2021 (dose number, dose, route of administration and anatomical location were not reported) for prophylaxis.  There was no previous temperature excursions. No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional adverse events reported; he vaccine sat outside of the refrigerator for 20-25 minutes and was placed back in the fridge.; This spontaneous report was received from a nurse and refers to a child patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown date, one of the medical assistants drew up hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and she was going to give it to a child. The nurse reported that the medical assistant reported that the child then began to "freaked out" so the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not given and series was not started on this patient. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) sat outside of the refrigerator for 20-25 minutes at room temperature and was placed back in the fridge. On 22-FEB-2021, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered to a different child. The patient did not experience any symptoms and enquired if the patient needs to be re-vaccinated. No additional adverse events were reported. No product quality complaint was reported. There were no previous temperature excursions and data digital logger was not filled. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report as received from an office manager to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2ml, lot # 1691300, expiration date: 24-NOV-2021, orally for prophylaxis.    Administered dose of vaccine underwent the temperature excursion of 54 degrees Fahrenheit for 43 hours. Digital data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: no additioanl adverse event; PNEUMOVAX 23 that underwent a temperture excursion was administered; This spontaneous report has been received from a health professional referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T031820 with expiration date of 10-MAY-2022 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature between 2°C to 8°C during a time frame of 4 hours and 40 minutes. No previous temperature excursions were reported. No adverse event. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Syncope, Vaccination complication
Clinical narrative: Faint; Dizzy; Slight reaction; Very tired; A spontaneous report, was received from a consumer (patient), a 74 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced faint (syncope), dizzy (dizziness), slight reaction (vaccination complication) and very tired (fatigue).  The patient's current conditions included atrial fibrillation, back trouble and peripheral neuropathy (diagnosed years ago). The patient had medication allergies to pain medications and non-steroidal anti-inflammatory drugs (NSAIDs). Concomitant products included digoxin, carisoprodol, metamizole sodium and warfarin sodium.  On 09-FEB-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 09FEB--2021, after receiving the vaccine, the patient had a slight reaction and became very tired, faint and dizzy. The patient's husband helped her to bed. The next morning on 10-FEB-2021, the events were resolved. The patient was scheduled for next Moderna vaccine (second dose) on 09-MAR-2021. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to events was unknown.  The outcome of the events, faint, dizzy, slight reaction and very tired was recovered/resolved on 10-FEB-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Fatigue, Hypertension, Vaccination site pain
Clinical narrative: Abnormal Implant afib link recorder reading; Pain at injection site; Fatigue; High blood pressure; A spontaneous report was received from a 77 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced high blood pressure, abnormal afib implant recorder reading, pain at injection site, and fatigue.  The patient's medical history included atrial fibrillation and . The concomitant medications included Eliquist (apixaban).  On 02-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 04-Feb-2021 the patient experienced high blood pressure. On 05-Feb-2021, the patient experienced pain at injection site, fatigue and abnormal afib implant recorder readings. On 09-Feb-2021, the patient consulted a physician for abnormal afib implant recorder readings.  Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the events, high blood pressure, abnormal afib implant recorder reading, pain at injection site, and fatigue., was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic failure, Palpitations, Renal failure, Vomiting
Clinical narrative: Kidneys and liver shutting down; Kidneys and liver shutting down; Heart started racing 3 days later; Vomiting; A spontaneous report was received from  a consumer concerning a 39-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart racing, kidney failure, liver failure,vomiting and death.   The patient's medical history included Sjogren's syndrome, Hashimoto's, inflammatory joint disease, osteoporosis, osteoarthritis. She has history of fractured tail bone and leg in three places. Concomitant medications included D3 2 pills a day, folic acid, B12, and calcium citrate. She was allergic to 15 different antibiotics two of which she had anaphylaxis; had huge autoimmune issues; had had reaction to Pneumovax vaccine.   On an unown date ,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  Approximately after three days of receiving  second dose vaccine patient experienced heart racing and went to the emergency room .The patient started vomiting and developed a kidney and liver failure. And on the next day she died.Autopsy is doing and the results are not available at the time of report.  Action taken with mRNA-1273 in response to the events was reported as not applicable.   The events heart racing, kidney failure, liver failure and death were considered serious and medically significant.  The outcome of the events renal failure,hepatic failure,palpitations and vomiting was considered as Fatal.; Reporter's Comments: This is a case of death in a 39year-old female subject with unknown medical history of anaphylactic reactions, allergic reactions to pneumovax vaccine, Sjogren's syndrome, Hashimoto's, inflammatory joint disease, osteoporosis, osteoarthritis, who died 4 days after receiving second dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Renal failure; Hepatic failure
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: swollen left armpit (same arm as injection), possibly swollen glands; swollen left armpit (same arm as injection), possibly swollen glands; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received the second dose of BNT162B2 (brand=Pfizer), lot no. EL3247, via an unspecified route of administration (left arm) on 16Feb2021 12:45 PM at a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ibuprofen, clindamycin, adapalene, and levonorgestrel (MIRENA). Historical vaccine included first dose of BNT162B2 (brand=Pfizer, lot no. EL3247) for COVID-19 immunisation on 26Jan2021 12:45 PM (left arm) at a workplace clinic. No other vaccine in four weeks. No COVID prior to vaccination. The patient experienced swollen left armpit (same arm as injection), possibly swollen glands on 17Feb2021 07:00 AM. No COVID test post vaccination. The outcome of the events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: swollen left armpit (same arm as injection), possibly swollen glands; swollen left armpit (same arm as injection), possibly swollen glands; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received the second dose of BNT162B2 (brand=Pfizer), lot no. EL3247, via an unspecified route of administration (left arm) on 16Feb2021 12:45 PM at a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ibuprofen, clindamycin, adapalene, and levonorgestrel (MIRENA). Historical vaccine included first dose of BNT162B2 (brand=Pfizer, lot no. EL3247) for COVID-19 immunisation on 26Jan2021 12:45 PM (left arm) at a workplace clinic. No other vaccine in four weeks. No COVID prior to vaccination. The patient experienced swollen left armpit (same arm as injection), possibly swollen glands on 17Feb2021 07:00 AM. No COVID test post vaccination. The outcome of the events was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at site of injection; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 13:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included dupuytren's contracture, and allergies: Latex. Concomitant medications included acetaminophen; and colecalciferol (VITAMIN D 3); taken for unspecified indications, start and stop dates were not reported.  The patient experienced sore arm at site of injection on 17Feb2021 17:00. The patient did not receive treatment for the event. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Body aches; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). This 37-year-old male patient received the second dose of BNT162B2 (UNSPECIFIED TRADE NAME; lot number EL3247) via an unspecified route of administration in the left arm on 17Feb2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, was not allergic to medications, foods or other product, and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number EL3247) on 27Jan2021 at 10:00 (at the age of 37-years-old) in the left arm for COVID-19 immunisation. On 18Feb2021 the patient experienced body aches, chills, and headache. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of body aches, chills and headache were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore shoulder; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced a sore shoulder on the first one. The outcome of the events was unknown. The second dose was scheduled for 16Feb2021 however was canceled due to weather.  Information on lot/ batch number has been requested
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Bad headache; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 13:15 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation.  Medical history included diabetes mellitus, asthma, and GERD. Concomitant medications included alprazolam; omeprazole; sitagliptin (JANUVIA [SITAGLIPTIN]); all taken for unspecified indications, start and stop dates were not reported.  The patient previously took flagyl [metronidazole]: Known allergies: Flagyll. On 18Feb2021, the patient experienced bad headache, nausea, and vomiting. The patient did not receive treatment for the events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive after the first dose; tested positive after the first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose on 25Jan2021 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Caller was calling for her parents who tested positive after the first dose. Their first dose was last 25Jan. Caller was asking if they could take the second dose after they tested positive or they had to wait for a certain time before getting the second dose. COVID-19 test was positive on an unspecified date. The outcome of events was unknown.  The information about lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021209375 the same reporter, product and adverse events in different patients
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: diagnosed with neurocardiogentic syncope; P.O.T.S/-POTS; tired the next day; experienced a headache for a couple hours; This is a spontaneous report from a contactable nurse. The nurse reported similar events for 2 patients. This is 1st of 2 reports. A 58-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 02Mar2021 as single dose for COVID-19 immunisation. Medical history included open heart, prostate cancer, lyme disease, neobladder, and sepsis, all from Aug2020; and blood pressure (abnormal). Concomitant medication included fludrocortisone for blood pressure (abnormal). Reporter stated that her husband seemed tired the next day, although husband says he wasn't. Today, 05Mar2021, patient experienced a headache for a couple hours, and was tired today. On an unspecified date, the patient was diagnosed with neurocardiogenic syncope and Postural orthostatic tachycardia syndrome (POTS) and given medication Florinef 0.1mg. Patient had been taking for about a week. Reporter was asking if it would cause issues with the vaccine since it was a corticosteroid and if it would cause issues if he was going to get a flu shot. Reporter was also asking what the efficacy after the first dose was. Outcome of events was unknown.  Information about the Lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021261960 same drug/reporter/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: infection/ flare up of diverticulitis (a reoccurring condition); This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 68; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, in Feb2021, as SINGLE DOSE for covid-19 immunisation.  The patient medical history included ongoing diverticulitis. The patient's concomitant medications were not reported. The patient received the first injection of the Pfizer vaccine 2 weeks ago. The patient received amoxil/clav 875mg for an infection/ flare up of diverticulitis (a reoccurring condition). The patient would like to know if it will it interact and when should the patient get the 2nd shot. Outcome was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Delirium, Feeling abnormal
Clinical narrative: delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination.   No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Movement disorder, Nausea, Neck pain, Pain in extremity
Clinical narrative: delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination.   No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination.   No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.