chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: Within 1 hour of receiving 2nd vaccine, I started to get pain behind my right eye. That night, the pain turned into shooting pains on right side of head, every 3 to 45 seconds at worse. Head pain continued to Daturday, the 13th, when it stared migrating to right ear (same stabbing-type pain). By Tuesday the 16th, if further migrated to glands below my right jaw line ( same stabbing-type pain). Over last 48 hrs I have also developed scaly patches on right half of scalp. Tonight I started developing scaly rash on top of right side of face.  As of now, stabbing pains continue in right side of head, right ear, and right side of throat.   On Friday the 12th I also had swelling and tenderness under left arm. This has dissipated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Nasopharyngitis, Pyrexia
Clinical narrative: Felt like the flu. Cold chills and a fever. No nausea. Bad for 1 day the next day better. Day 3 100% ok.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Peripheral swelling, Pruritus, Rash, Rash erythematous
Clinical narrative: starting February 5, I had mild swelling in the entire left leg treated with ice and anti-inflammatories. There was no redness, swelling, or pain at injection site. Symptoms seemed to be slowly subsiding. However, Thursday 2/11/21, I had a small patch of itchy, (but not painful) red rash on back of left thigh. By Thursday evening it had doubled in size. Friday am (2/12/21) it was a little bigger still. Then by Friday after work, my entire left leg was moderate to severely swollen and the rash covered a large part of the back of right thigh and was beginning to spread to the back of left calf.  Friday evening, I visited Urgent Care. The doctor there was concerned about a possible DVT and sent me to the ER. At ER, an ultrasound revealed no DVT. At no time did I have a fever. The ER doctor admitted me to the hospital where I remained until the afternoon of Monday, February 15. During hospital stay, I was treated with IV Vancomycin twice per day. That helped quite a bit to reduce rash and swelling but it remains at a mild level. I am currently Doxycycline Hyclate 100 mg every 12 hours for 7 days. I took the first dose of the oral med at the hospital on the day of discharge.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan normal
Clinical narrative: starting February 5, I had mild swelling in the entire left leg treated with ice and anti-inflammatories. There was no redness, swelling, or pain at injection site. Symptoms seemed to be slowly subsiding. However, Thursday 2/11/21, I had a small patch of itchy, (but not painful) red rash on back of left thigh. By Thursday evening it had doubled in size. Friday am (2/12/21) it was a little bigger still. Then by Friday after work, my entire left leg was moderate to severely swollen and the rash covered a large part of the back of right thigh and was beginning to spread to the back of left calf.  Friday evening, I visited Urgent Care. The doctor there was concerned about a possible DVT and sent me to the ER. At ER, an ultrasound revealed no DVT. At no time did I have a fever. The ER doctor admitted me to the hospital where I remained until the afternoon of Monday, February 15. During hospital stay, I was treated with IV Vancomycin twice per day. That helped quite a bit to reduce rash and swelling but it remains at a mild level. I am currently Doxycycline Hyclate 100 mg every 12 hours for 7 days. I took the first dose of the oral med at the hospital on the day of discharge.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: Large, hot itchy hives first developed 1 week post vaccine. Started around bra line, then under arms, left arm (opposite vaccine site) and thighs.  Worse around entire left bicep. Subsided 1 week later with prescription steroids, antihistamine etc.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed itchy hives.  Have had them since they appeared. No treatment sought. I occasionally give in and scratch them (smile).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, body aches, fever ,  headache
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red Rash around injection site and itchy -about the size of a baseball.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pyrexia
Clinical narrative: Fever(102) for 24 hours, 911 attendant told me to take Tylenol , my blood pressure got high .
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Facial pain, Head discomfort, Musculoskeletal stiffness, Pain
Clinical narrative: Stiff Neck , Pain and discomfort , head fullness,pain to right and left side of face /ears
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pain, Pain in extremity, Pyrexia
Clinical narrative: Approximately 10 hours after my vaccine I got a low grade fever (99.7 degrees at the highest), body aches, chills, lethargy, and a mildly sore arm. Symptoms were almost completely gone within 24 hours.
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose, headache, sore throat
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Joint pain, muscle pain, chills, low grade fever, shooting pains in head behind right ear, extreme fatigue, injection site pain and swelling
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Joint pain, muscle pain, chills, low grade fever, shooting pains in head behind right ear, extreme fatigue, injection site pain and swelling
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Hyperhidrosis, Injection site pain
Clinical narrative: Moderna COVID-19 Vaccine EUA 13:00: Proximal left arm tightness around injection sight and tenderness with raising arm above 90 degrees 18:00 Fatigue 22:00 Intermittent chills and diaphoresis 23:30 Temperature 100.0 degrees F
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pain, Skin tightness
Clinical narrative: Moderna COVID-19 Vaccine EUA 13:00: Proximal left arm tightness around injection sight and tenderness with raising arm above 90 degrees 18:00 Fatigue 22:00 Intermittent chills and diaphoresis 23:30 Temperature 100.0 degrees F
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: A rash appeared on the upper portion of my left arm about 7 days exactly from the date of the vaccine. The rash felt swollen with bumps under the skin and not the surface of the skin.  It felt more like small curdles of hard cottage cheese under the skin.  There was a slight itch, but nothing irritable.  The area was wider the next morning.  The itch was slightly more, still not irritable.  The swelling stopped and the area did not increase on the third day.  Everything began to go back to normal.  I did use Keep It Hemple - CBD oil for the itching.  I have used it for mosquito bites and itching many times.  The rash lasted for about 5-6 days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: PATIENT RECEIVED THE VACCINE ON 02/16/2021 AT 1300. PATIENT ALERTED US ABOUT HER HISTORY OF SEVERE ALLERGIC REACTION TO A THYROID MEDICATION (PATIENT CANNOT REMEMBER THE NAME), SO WE FLAGGED THE OBSERVATION AREA TO CLOSELY MONITOR HER FOR 30MINS AS PER STATE GUIDELINES. AT THE 20MIN MARK, PATIENT COMPLAINED OF LIGHTHEADEDNESS AND FEELING NAUSEOUS. WE GAVE BENADRYL  AND TOOK HER VITAL SIGNS. VITAL SIGNS ARE NORMAL WITH A 98% OXYGEN SATURATION ON ROOM AIR. PATIENT RECOVERED AND LEFT ON A STABLE CONDITION.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Unable to fully lift arm, intense/sudden pain with no factors causing it, wakes during sleep, OTC interventions not working
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: i received the covid first shot  and i am feeling fatigue, headaches, and some fever.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Condition aggravated
Clinical narrative: Arthritis in left hand (middle knuckles)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itchy, swollen, hot patch developed at injection site.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Pain, Pyrexia
Clinical narrative: Chills, fever (101.3), indigestion, body aches.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Migraine, Myalgia
Clinical narrative: I, the patient am reporting this after speaking with my neurologist today, after receiving the first dose of the covid vaccine I starting experiencing excruciating migraines, migraines that felt like when I was NOT treated for my chronic migraines. Prior to the vaccine I had been stable on topiramate and was only experiencing about 1-2 migraines a month and was fine with sumatriptan. However, after the first dose of the vaccine I experienced muscle pain across my arms/shoulder/shoulder blades/neck that attributed to my head hurting. This pain has not subsided since the second dose but has decreased in its severity. Basically, the pain is still there, but it is not as excruciating. I am able to still go about my day, and I no longer have the arm/shoulder pain, but the migraines have not gone away. After speaking to my neurologist, he feels that the vaccine most likely triggered the muscle pain as that is a very common reaction which spiked the migraines to resurface, which is why I wanted to report this AE, especially because it has caused my prophylactic treatment (topiramate) and acute treatment (sumatriptan) to BOTH fail and I am needing to have my medications readjusted in order to deal with these migraines that have not subsided over the 3 weeks since the first vaccine. My neurologist feels that these migraines MAY subside, but he cannot rule out that they may never and I may need new/stronger therapy for them.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Days 3 and 4: Nausea, chills, fever of 100 1.5 hours after Excedrin and Ibuprofen Days 3-7: headache that is not relieved with acetaminophen or ibuprofen
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Injection site pain, Myalgia
Clinical narrative: pain at injection site (1800 hrs on 16FEB2021 till about 1300 hrs on 17FEB2021), chills (0400 hrs on 17FEB2021 to 0300 hrs 18FEB2021), muscle aches (0400 hrs on 17FEB2021 to current 1300 hrs 18FEB2021), sensitivity to light (1100 hrs on 17FEB2021 to 1300 hrs on 17FEB2021), dizziness (1630 hrs on 17FEB2021 to 1730 hrs on 17FEB2021), joint pain (1100 hrs on 17FEB2021 to current 1300 hrs on 18FEB2021). Took 975 mg every 8 hours x 3 doses then took 650 mg x 1
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: pain at injection site (1800 hrs on 16FEB2021 till about 1300 hrs on 17FEB2021), chills (0400 hrs on 17FEB2021 to 0300 hrs 18FEB2021), muscle aches (0400 hrs on 17FEB2021 to current 1300 hrs 18FEB2021), sensitivity to light (1100 hrs on 17FEB2021 to 1300 hrs on 17FEB2021), dizziness (1630 hrs on 17FEB2021 to 1730 hrs on 17FEB2021), joint pain (1100 hrs on 17FEB2021 to current 1300 hrs on 18FEB2021). Took 975 mg every 8 hours x 3 doses then took 650 mg x 1
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Facial pain, Impaired work ability, Neck pain, Pain in jaw
Clinical narrative: I woke up at 3am on Tuesday with neck and jaw pain.   It was so bad on Tuesday that I stayed home from work. At 3:30 pm I took excedrin like I normally do.  I also applied Hempvana to neck and temples(I've been using for several weeks). At 8:30pm, I began to have non stop diarrhea.  I went to bed at 10pm. Today, I woke up at 3:30 am with neck and pain on right side of face.  A vein is bulging out near temple on right side of face and I have a red bump about the size of a dime in temple area. My stomach is making noises but I don't have diarrhea.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: I woke up at 3am on Tuesday with neck and jaw pain.   It was so bad on Tuesday that I stayed home from work. At 3:30 pm I took excedrin like I normally do.  I also applied Hempvana to neck and temples(I've been using for several weeks). At 8:30pm, I began to have non stop diarrhea.  I went to bed at 10pm. Today, I woke up at 3:30 am with neck and pain on right side of face.  A vein is bulging out near temple on right side of face and I have a red bump about the size of a dime in temple area. My stomach is making noises but I don't have diarrhea.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: multiple outbreaks of herpes zoster, and post herpetic neuralgia.; multiple outbreaks of herpes zoster, and post herpetic neuralgia.; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 26-SEP-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after received zoster vaccine live (ZOSTAVAX) inoculation (date not reported), the patient suffered multiple outbreaks of herpes zoster, and post herpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers currently still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of multiple outbreaks of herpes zoster and post herpetic neuralgia was considered not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Cardiovascular disorder, Deafness, Herpes zoster, Post herpetic neuralgia, Seizure
Clinical narrative: multiple outbreaks of herpes zoster; postherpetic neuralgia; hearing loss; cardiovascular issues; vision issues; seizures; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 23-OCT-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After received zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered multiple outbreaks of herpes zoster, post herpetic neuralgia, hearing loss, cardiovascular issues, vision issues and seizures. As a result of these symptoms, the patient was seen and treated by medical providers and currently still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was considered not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, hearing loss and seizures were considered to be medically significant events.
Sex: U
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: multiple outbreaks of herpes zoster; postherpetic neuralgia; hearing loss; cardiovascular issues; vision issues; seizures; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 23-OCT-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After received zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered multiple outbreaks of herpes zoster, post herpetic neuralgia, hearing loss, cardiovascular issues, vision issues and seizures. As a result of these symptoms, the patient was seen and treated by medical providers and currently still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was considered not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, hearing loss and seizures were considered to be medically significant events.
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: finger laceration of the administrator; Syringes that had the finger flange break after administration; finger flange break after administration; the removable flange safety guard not present; This spontaneous report was received from a health care professional via a company representative referring to a female patient of unknown age. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   The reporter stated that multiple hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringes had a finger flange break and the removable flange safety guard was not present (# 2102USA004230).   The reporter advised that one of these episodes resulted in a finger laceration to the administrator of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S028738; expiration date 03-APR-2022) on 08-FEB-2021.   The reporter said that when the employee attempted to push the plunger down to give the injection, the flange broke and the employee's right thumb was cut by a sharp edge of the broken flange. The administrator received assistance by the healthcare provider there and the right thumb was repaired using "skin glue and then sterile strips and a dressing".  At the time of the report, the patient had recovered from the event. There was no damage noted to the syringe or the flange area prior to the administration of the vaccine. It was reported that the syringe was not cracked ant the syringe was broken into 2 or more pieces at syringe finger flange.  This is one of several reports received from the same source. 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: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2102USA004230:
Age: 86.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rash, Small intestinal haemorrhage, Wrong technique in product usage process
Clinical narrative: bleeding internally in small intestine; cut Eliquis in half; rash on shoulder and neck; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-013205) license party for apixaban (ELIQUIS).  This case was received via Pfizer Inc (Reference number: 2021125505) on 05-Feb-2021 and was forwarded to BMS on 08-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of SMALL INTESTINAL HAEMORRHAGE (bleeding internally in small intestine) in 86-year-old male patient who received apixaban (Eliquis) tablet for an unknown indication. The occurrence of additional non-serious events is detailed below. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for Prevention. Product or product use issues identified: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (cut Eliquis in half). Concurrent medical conditions included Gout (diagnosed two or three years ago). On an unknown date, the patient started Eliquis (Oral) 2.5mg half tablet by mouth twice daily. On 07-Jan-2021, the patient started Covid-19 Vaccine (Intramuscular) intramuscular injection in right arm. Further treatment periods at the same dose started on 01-Feb-2021. In January 2021, the patient experienced RASH (rash on shoulder and neck). On an unknown date, the patient experienced SMALL INTESTINAL HAEMORRHAGE (seriousness criterion medically significant). The patient was treated with salicylic acid (Eucerin [Salicylic Acid]) for Rash. The action taken with Eliquis(Oral) was unknown. At the time of the report, SMALL INTESTINAL HAEMORRHAGE outcome was unknown and RASH did not resolve. Cardiologist recommended patient to take apixaban for palpitation of the heart that he has every so often. Eliquis at 2.5mg tablet twice a day and then patient found out he was bleeding to death, clarifies he was bleeding internally in his small intestine. So he cut his Eliquis in half and he was currently taking half of 2.5mg tablet twice a day. He got the Pfizer covidl19 shot. He has developed a rash on his shoulder and neck. He also stopped using his laundry soap since he was not sure if it was his laundry soap. For Eliquis(Oral), the reporter did not provide any causality assessments.; Sender's Comments: BMS Medical Evaluation Comment: This patient had small intestine hemorrhage while on apixaban. Based on the anticoagulant nature of apixaban, its contributory role in small intestine hemorrhage is considered possible.
Sex: U
Vaccine: COVID19
Symptoms: Completed suicide
Clinical narrative: Suicide; A spontaneous report was received from a consumer concerning a patient, of unknown age/gender, who received Moderna's COVID-19 vaccine and experienced suicide.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, the patient received mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date the patient experienced suicide.  Treatment information was not provided.   Action taken with the mRNA-1273 in response to the event was not reported.   The patient died on unknown date. The cause of death was reported as suicide. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Suicide
Sex: M
Vaccine: COVID19
Symptoms: Diplegia, Disorientation, Fatigue, Malaise, Pyrexia
Clinical narrative: Paralysis legs intermittent; Disoriented; Malaise; Fatigue; Fever; A spontaneous report was received from a consumer concerning an 85-year-old, Asian, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever (pyrexia), malaise, fatigue, disorientation, and intermittent leg paralysis (diplegia).  The patient's medical history included stroke and hypertension. No relevant concomitant medications were reported.  On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K202A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced symptoms of fever, malaise, fatigue, disorientation, and intermittent leg paralysis.   Treatment for the event included acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event fever and disorientation was reported resolved on 20 Jan 2021.The outcome for the event paralysis legs intermittent was reported resolved on 22 Jan 2021. The outcome for the event fatigue and malaise was reported as resolved on 23 Jan 2021.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Dyspnoea, Headache, Influenza like illness
Clinical narrative: cellulitis in the leg; bad chills; flu like symptoms; headache; Nausea; high fever; short breathing; A spontaneous report  was received from a consumer, concerning her husband, a male of unreported age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg.  The patient's medical history was not included. Products known to have been used by the patient were not provided. Prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 041L20) for prophylaxis of COVID-19 infection.  On 04 Feb 2021, after the mRNA-1273 vaccine was given, the patient experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg.Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: cellulitis in the leg; bad chills; flu like symptoms; headache; Nausea; high fever; short breathing; A spontaneous report  was received from a consumer, concerning her husband, a male of unreported age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg.  The patient's medical history was not included. Products known to have been used by the patient were not provided. Prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 041L20) for prophylaxis of COVID-19 infection.  On 04 Feb 2021, after the mRNA-1273 vaccine was given, the patient experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg.Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: had a sore arm, so sore that he ended in the hospital for 2 days; he couldn´t move his arm; it still hurts and goes into his neck; A spontaneous report was received from a consumer concerning, an 80-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sore arm, he couldn't move his arm, and it still hurts and goes into his neck.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# not provided]) intramuscularly for prophylaxis of COVID-19 infection.   The patient's wife stated that the patient had the vaccine and then 5 days later he had a sore arm, so sore that he ended up in the hospital for 2 days (dates not provided). The patient couldn't move his arm and it still hurts and goes into his neck. The patient did not plan on receiving the 2nd dose of the vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of he ended in the hospital for 2 days, he couldn't move his arm and it still hurts and goes into his neck were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Haemorrhage
Clinical narrative: bleeding from right ankle / lost a lot of blood; saw a pencil eraser/red looking spot; A spontaneous report was received from a non-healthcare professional (caregiver) concerning a 76 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and hemorrhage and erythema.  Medical history included being mentally challenged. Concomitant medication included unspecified cholesterol medication, two unspecified blood pressure medications, baby aspirin, vitamin D, and lorazepam.  On 04 Feb 2020, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient experienced bleeding from a pencil eraser red looking spot on the right ankle, had lost a lot of blood.  The bleeding had stopped and no treatment was reported.  Action taken with the mRNA-1273 in response to the event was not reported.  The outcome of the event of hemorrhage was considered resolved. The outcome of the event erythema was unknown.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain
Clinical narrative: soreness; flu; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age started to receive BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on an unspecified date, as a single dose for COVIF-19 immunization. Medical history was not reported.  Concomitant medications included pravastatin , 1 tablet once a day.  The patient reported that she got the first dose of the vaccine and experienced soreness and flu but is okay. She was about Pravastatin and if it will interference with the COVID vaccine. The clinical outcome of the events was recovered.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness in arms and legs; Tingling and numbness in arms and legs; This is a spontaneous report from a contactable consumer.  A 32-years-old non-pregnant female patient  received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), Lot number=EL9263, via an unspecified route of administration, in left arm (at the age of 32 years-old) on 23Jan2021 at 17:00  as a single dose for COVID-19 immunization.  Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to the vaccination, the patient was not diagnosed with COVID-19.Concomitant medications included escitalopram oxalate (LEXAPRO), minerals nos, vitamins nos (PRENATAL VITAMINS).  The patient previously took epinephrine and experienced a drug allergy. On 23Jan2021 at 17:15, the patient experienced tingling and numbness in arms and legs. The patient was not hospitalized for the events nor was treatment received. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysgeusia, Myalgia
Clinical narrative: Forty minutes after the vaccination, the top of my shoulders were a little achy - across my back. This lasted around one hour.; Forty minutes after the vaccination, the top of my shoulders were a little achy - across my back. This lasted around one hour.; I had a metallic taste in my mouth; This is a spontaneous report from a contactable  consumer.  A 65-years-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), lot number= EL9262, via an unspecified route of administration, in the right arm, on 22Jan2021 at 14:00  (at the age of 62 years-old) as a single dose for COVID-19 immunization. The vaccine administration was given at a hospital. The patient  did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor was diagnosed with COVID-19 prior to the vaccination. Medical history included being a breast cancer survivor.  Concomitant medication included montelukast sodium (MONTELUCAST) daily, received within 2 weeks of vaccination. The patient previously took LEVAQUIN and LIVALO and experienced an allergy.  On 22Jan2021 at 14:45, at forty minutes after the vaccination, the patient reported that the top of her shoulders were a little achy - across the back and also experienced a metallic taste in her mouth. This lasted around one hour. The patient was not hospitalized for the events nor received treatment. The clinical outcome of the events was not reported. Since the vaccination, the patient has not been tested for COVID-19.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Peripheral swelling
Clinical narrative: Swelling of forearm by 60%; muscle spasms in pectorial muscle; This is a spontaneous report from a contactable consumer.  A 36-years-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), lot number=EL3247, via an unspecified route of administration in the left arm,  on 22Jan2021 at 08:45 (at the age of 36 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a doctors office/urgent care. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) received within 2 weeks of vaccination.  On 23Jan2021 at 0800, the patient experienced swelling of forearm by 60%, and muscle spasms in pectoral muscle. The patient was not hospitalized for the event nor received treatment. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: accelerated heart rate (up to 120 bpm); This is a spontaneous report from a contactable  consumer.  A 74-years-old male patient  received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), lot number= EL9262, via an unspecified route of administration, in left arm, on 20Jan2021 at 15:00 (at the age of 74 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Medical history included heart failure, chronic kidney disease, bronchiectasis, heart attack 3 years previous. Concomitant meditations were received (not specified) within 2 weeks of the vaccination. On 20Jan2021, the patient experienced accelerated heart rate (up to 120 bpm) lasting 10 hours, starting approx 2-3 hours after injection. The patient was not hospitalized for the event nor received treatment. The clinical outcome of the event was recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Dizziness, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: started to feel a little lightheaded like my blood sugar was low; started to feel a little lightheaded like my blood sugar was low; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; some mild numbness of my tongue, face, and scalp; some mild numbness  tongue, face, and scalp; some mild numbness  tongue, face, and scalp; headache; This is a spontaneous report from a  contactable physician (patient).  A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3248), via an unspecified route of administration on 21Jan2021, on 15:45 as single dose for covid-19 immunisation .  The patient medical history was not reported.  Concomitant medications included multivitamin. No other vaccines  were given within 4 weeks prior to the COVID vaccine.  The patient previously took amoxicillin and experienced allergies, amoxicillin and experienced urticaria.  on 22Jan2021, at 17:30, the patient started to feel a little lightheaded like my blood sugar was low, tongue started tingling, which then progressed to lips, face, and then halfway back the scalp, some mild numbness of my tongue, face, and scalp and  headache; the events were reported as non-serious. The events were elaborated as follows: the patient  indicated started to feel a little lightheaded like her blood sugar was low. About 15 minutes after, she  had initially started to feel lightheaded, her tongue started tingling, which then progressed to her lips, face, and then halfway back of her scalp. The paresthesias were intermittent in those areas and then some mild numbness of the tongue, face, and scalp followed. All the symptoms subsided after about 30-40 minutes.  She said she may have had a mild headache afterwards. No motor symptoms were noted. Purely sensory and it seemed in the trigeminal nerve distribution. The outcome of the events was 22Jan2021; no symptoms have occurred since the 22Jan202.   Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: started to feel a little lightheaded like my blood sugar was low; started to feel a little lightheaded like my blood sugar was low; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; some mild numbness of my tongue, face, and scalp; some mild numbness  tongue, face, and scalp; some mild numbness  tongue, face, and scalp; headache; This is a spontaneous report from a  contactable physician (patient).  A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3248), via an unspecified route of administration on 21Jan2021, on 15:45 as single dose for covid-19 immunisation .  The patient medical history was not reported.  Concomitant medications included multivitamin. No other vaccines  were given within 4 weeks prior to the COVID vaccine.  The patient previously took amoxicillin and experienced allergies, amoxicillin and experienced urticaria.  on 22Jan2021, at 17:30, the patient started to feel a little lightheaded like my blood sugar was low, tongue started tingling, which then progressed to lips, face, and then halfway back the scalp, some mild numbness of my tongue, face, and scalp and  headache; the events were reported as non-serious. The events were elaborated as follows: the patient  indicated started to feel a little lightheaded like her blood sugar was low. About 15 minutes after, she  had initially started to feel lightheaded, her tongue started tingling, which then progressed to her lips, face, and then halfway back of her scalp. The paresthesias were intermittent in those areas and then some mild numbness of the tongue, face, and scalp followed. All the symptoms subsided after about 30-40 minutes.  She said she may have had a mild headache afterwards. No motor symptoms were noted. Purely sensory and it seemed in the trigeminal nerve distribution. The outcome of the events was 22Jan2021; no symptoms have occurred since the 22Jan202.   Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Feeling hot, Joint range of motion decreased, Joint warmth
Clinical narrative: This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There were no concomitant medications.  The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There were no concomitant medications.  The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Gait disturbance, Hypoaesthesia, Limb discomfort, Myelopathy
Clinical narrative: This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There were no concomitant medications.  The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.