chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: 4/9/21 at 12:30am -Metallic taste from the bottom of mouth immediate when the injection occurred  -Immediately had pain and heaviness in arm -Immediate motor function impairment. Could not hold a pencil, difficulty operating motor vehicle   4/9/21 at 10am -Sensitivity to light -Brain fog, slow thinking, difficulty with short term memory -Express desire to not communicate with anyone -Felt like I was autistic, couldn?t use the words I needed to express myself -Soreness throughout entire body -Extremely emotional/couldn?t control emotions  4/9/21 at 12:30pm -Impaired motor skills, had a difficult time typing on computer -could not operate motor vehicle due to lack of motor function -extreme brain fog and difficulty with short term memory  -Express desire to not communicate with anyone  4/10/21 -Continued brain fog, slow thinking, difficulty with short term memory -Extremely emotional/couldn?t control emotions -Soreness throughout entire body -lethargy  -Express desire to not communicate with anyone  4/11/21 -Continued brain fog, slow thinking, difficulty with short term memory -Express desire to not communicate with anyone -lethargy -Extremely emotional/couldn?t control emotions  4/12/21  -Extremely emotional/difficulty controlling emotions -lethargy -Continued brain fog, slow thinking, difficulty with short term memory  4/13/21  -Still fatigued and brain fogged.  -Don?t feel like myself.  -Continued brain fog, slow thinking, difficulty with short term memory -Gas and loss of appetite  -Atypical migraine   4/13/21 at 4:30pm -brain fog suddenly lifted, very quickly -Cognitive function restored -all symptoms essentially gone  Felt like my brain reentered my body
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bell's palsy, Blindness, Burning sensation, Corneal reflex decreased
Clinical narrative: Muscle weakness, extreme fatigue, irregular gait, arm and hand pain, numbness and burning, leg and feet numbness, pain and burning. Hand, arm, feet and leg neuropathy, 47/49/67/69%.  Bell?s palsy left side of face, inability to blink left eye, flickering vision, bright flash sensations making it impossible to drive (migraine like blindness) left side, inability to drink water. Leaks out of left side of mouth.  Inability to sense cold or hot water in hands arms legs and feet. Inability to lift even routine items. Inability to stand for more than a few (2-3) minutes. Inability to tolerate pressure to arms such as arm rest in planes, or arm rest on chairs. Pressure in calves and feet. Inability to tolerate crossed legs pressure. Inability to walk even 1 block without resting or sitting down.  Inability to lift a carry on suitcase to over head bins.  Severe Headaches, inability to sleep more than 1-2 hours due to body aches and pain in extremities.  Pain in hands holding everyday items like smart phone, smart device, etc.  Inability to lift or carry groceries.  Severe thirst.  Ringing in ears and up the back of  head and neck. Severe Neck pain.  Jaw pain and some lockjaw symptoms when eating. Jaw will lock open when trying to bite or eat.  Inability to hold lawnmower handle, paint brush, bottle of water, coffee cup etc.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dysstasia, Fatigue, Fluid intake reduced, Gait disturbance
Clinical narrative: Muscle weakness, extreme fatigue, irregular gait, arm and hand pain, numbness and burning, leg and feet numbness, pain and burning. Hand, arm, feet and leg neuropathy, 47/49/67/69%.  Bell?s palsy left side of face, inability to blink left eye, flickering vision, bright flash sensations making it impossible to drive (migraine like blindness) left side, inability to drink water. Leaks out of left side of mouth.  Inability to sense cold or hot water in hands arms legs and feet. Inability to lift even routine items. Inability to stand for more than a few (2-3) minutes. Inability to tolerate pressure to arms such as arm rest in planes, or arm rest on chairs. Pressure in calves and feet. Inability to tolerate crossed legs pressure. Inability to walk even 1 block without resting or sitting down.  Inability to lift a carry on suitcase to over head bins.  Severe Headaches, inability to sleep more than 1-2 hours due to body aches and pain in extremities.  Pain in hands holding everyday items like smart phone, smart device, etc.  Inability to lift or carry groceries.  Severe thirst.  Ringing in ears and up the back of  head and neck. Severe Neck pain.  Jaw pain and some lockjaw symptoms when eating. Jaw will lock open when trying to bite or eat.  Inability to hold lawnmower handle, paint brush, bottle of water, coffee cup etc.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Impaired driving ability, Insomnia, Magnetic resonance imaging head
Clinical narrative: Muscle weakness, extreme fatigue, irregular gait, arm and hand pain, numbness and burning, leg and feet numbness, pain and burning. Hand, arm, feet and leg neuropathy, 47/49/67/69%.  Bell?s palsy left side of face, inability to blink left eye, flickering vision, bright flash sensations making it impossible to drive (migraine like blindness) left side, inability to drink water. Leaks out of left side of mouth.  Inability to sense cold or hot water in hands arms legs and feet. Inability to lift even routine items. Inability to stand for more than a few (2-3) minutes. Inability to tolerate pressure to arms such as arm rest in planes, or arm rest on chairs. Pressure in calves and feet. Inability to tolerate crossed legs pressure. Inability to walk even 1 block without resting or sitting down.  Inability to lift a carry on suitcase to over head bins.  Severe Headaches, inability to sleep more than 1-2 hours due to body aches and pain in extremities.  Pain in hands holding everyday items like smart phone, smart device, etc.  Inability to lift or carry groceries.  Severe thirst.  Ringing in ears and up the back of  head and neck. Severe Neck pain.  Jaw pain and some lockjaw symptoms when eating. Jaw will lock open when trying to bite or eat.  Inability to hold lawnmower handle, paint brush, bottle of water, coffee cup etc.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging neck, Migraine, Mobility decreased, Muscular weakness, Neck pain
Clinical narrative: Muscle weakness, extreme fatigue, irregular gait, arm and hand pain, numbness and burning, leg and feet numbness, pain and burning. Hand, arm, feet and leg neuropathy, 47/49/67/69%.  Bell?s palsy left side of face, inability to blink left eye, flickering vision, bright flash sensations making it impossible to drive (migraine like blindness) left side, inability to drink water. Leaks out of left side of mouth.  Inability to sense cold or hot water in hands arms legs and feet. Inability to lift even routine items. Inability to stand for more than a few (2-3) minutes. Inability to tolerate pressure to arms such as arm rest in planes, or arm rest on chairs. Pressure in calves and feet. Inability to tolerate crossed legs pressure. Inability to walk even 1 block without resting or sitting down.  Inability to lift a carry on suitcase to over head bins.  Severe Headaches, inability to sleep more than 1-2 hours due to body aches and pain in extremities.  Pain in hands holding everyday items like smart phone, smart device, etc.  Inability to lift or carry groceries.  Severe thirst.  Ringing in ears and up the back of  head and neck. Severe Neck pain.  Jaw pain and some lockjaw symptoms when eating. Jaw will lock open when trying to bite or eat.  Inability to hold lawnmower handle, paint brush, bottle of water, coffee cup etc.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, Pain in extremity, Pain in jaw, Photopsia
Clinical narrative: Muscle weakness, extreme fatigue, irregular gait, arm and hand pain, numbness and burning, leg and feet numbness, pain and burning. Hand, arm, feet and leg neuropathy, 47/49/67/69%.  Bell?s palsy left side of face, inability to blink left eye, flickering vision, bright flash sensations making it impossible to drive (migraine like blindness) left side, inability to drink water. Leaks out of left side of mouth.  Inability to sense cold or hot water in hands arms legs and feet. Inability to lift even routine items. Inability to stand for more than a few (2-3) minutes. Inability to tolerate pressure to arms such as arm rest in planes, or arm rest on chairs. Pressure in calves and feet. Inability to tolerate crossed legs pressure. Inability to walk even 1 block without resting or sitting down.  Inability to lift a carry on suitcase to over head bins.  Severe Headaches, inability to sleep more than 1-2 hours due to body aches and pain in extremities.  Pain in hands holding everyday items like smart phone, smart device, etc.  Inability to lift or carry groceries.  Severe thirst.  Ringing in ears and up the back of  head and neck. Severe Neck pain.  Jaw pain and some lockjaw symptoms when eating. Jaw will lock open when trying to bite or eat.  Inability to hold lawnmower handle, paint brush, bottle of water, coffee cup etc.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Thirst, Tinnitus, Trismus, X-ray
Clinical narrative: Muscle weakness, extreme fatigue, irregular gait, arm and hand pain, numbness and burning, leg and feet numbness, pain and burning. Hand, arm, feet and leg neuropathy, 47/49/67/69%.  Bell?s palsy left side of face, inability to blink left eye, flickering vision, bright flash sensations making it impossible to drive (migraine like blindness) left side, inability to drink water. Leaks out of left side of mouth.  Inability to sense cold or hot water in hands arms legs and feet. Inability to lift even routine items. Inability to stand for more than a few (2-3) minutes. Inability to tolerate pressure to arms such as arm rest in planes, or arm rest on chairs. Pressure in calves and feet. Inability to tolerate crossed legs pressure. Inability to walk even 1 block without resting or sitting down.  Inability to lift a carry on suitcase to over head bins.  Severe Headaches, inability to sleep more than 1-2 hours due to body aches and pain in extremities.  Pain in hands holding everyday items like smart phone, smart device, etc.  Inability to lift or carry groceries.  Severe thirst.  Ringing in ears and up the back of  head and neck. Severe Neck pain.  Jaw pain and some lockjaw symptoms when eating. Jaw will lock open when trying to bite or eat.  Inability to hold lawnmower handle, paint brush, bottle of water, coffee cup etc.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Contracted covid 19.  Sick now for 6 days.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: 2 days after the shot had cropping anxiety (I've only had this style of anxiety after drinking too much caffeine). It's come in strong waves from then ti up now (now being 4 days later)
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Vital signs measurement
Clinical narrative: Irregular heartbeat. Sometimes my heart stops for a second or two and then restarts with a large kick. This is especially felt while resting or even sleeping and will shake the bed.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Tenderness
Clinical narrative: ?Numbness? like feeling in the little finger of the left hand. Finger is tender anytime I have my hand in water (washing dishes, taking shower etc.) Noticed symptoms shortly after having  the shut. It is not going away.  Initially, symptoms were present in the little finger and ring finger. Other initial  symptoms include  same feeling slightly on the left eye and left foot. Symptoms in the little finger (left hand) persist.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, SARS-CoV-2 test, Vertigo
Clinical narrative: Vertigo after third dose starting 3 days after vaccination; Vertigo after third dose starting 3 days after vaccination; This is a spontaneous report from a contactable physician, the patient. A 65-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: A7484) via an unspecified route of administration in the left arm on 26Aug2021 at 13:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19) and patient stated she had one long haul symptom of vertigo after COVID. Concomitant medications included levothyroxine sodium (SYNTHROID), amlodipine (MANUFACTURER UNKNOWN), irbesartan (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN);  all for an unknown indication from an unknown dates and unknown if ongoing. The patient received hepatitis b vaccine/hepatitis a vaccine (MANUFACTURER UNKNOWN) for hepatitis within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an unspecified route of administration in the left arm on 15Dec2020 (at the age of 64-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ8686) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously took aspirin (MANUFACTURER UNKNOWN) and tramadol (MANUFACTURER UNKNOWN) and experienced drug allergy to both. On 29Aug2021, 3 days after vaccination after third dose, the patient experienced vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with Dramamine (MANUFACTURER UNKNOWN). On an unknown date, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the event vertigo was resolving at the time of this report.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: Sore elbow/ pain on wrist; Joint mild inflammation; Pain on forearm muscle; Sore arm when picking heavy objects with hand; Numbness while sleeping; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 20Apr2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 30Mar2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 12:00, the patient experienced sore elbow, joint mild inflammation, pain on forearm muscle and wrist, sore arm when picking heavy objects with hand and numbness while sleeping. On 06May2021, the patient underwent for nasal swab COVID-19 test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of the events sore elbow/ pain on wrist, joint mild inflammation, pain on forearm muscle, sore arm when picking heavy objects with hand and numbness while sleeping was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Sore elbow/ pain on wrist; Joint mild inflammation; Pain on forearm muscle; Sore arm when picking heavy objects with hand; Numbness while sleeping; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 20Apr2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 30Mar2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 12:00, the patient experienced sore elbow, joint mild inflammation, pain on forearm muscle and wrist, sore arm when picking heavy objects with hand and numbness while sleeping. On 06May2021, the patient underwent for nasal swab COVID-19 test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of the events sore elbow/ pain on wrist, joint mild inflammation, pain on forearm muscle, sore arm when picking heavy objects with hand and numbness while sleeping was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Rash
Clinical narrative: the top of my head is feeling numb; I have a rash on my legs, no itching; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (the top of my head is feeling numb) and RASH (I have a rash on my legs, no itching) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to Fluocinonide). Concomitant products included ASCORBIC ACID (VITAMIN C ACID), VITAMIN D NOS, FISH OIL and PROBIOTICS NOS for an unknown indication.    On 23-Aug-2021 at 6:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021 at 3:30 AM, the patient experienced HYPOAESTHESIA (the top of my head is feeling numb) and RASH (I have a rash on my legs, no itching). At the time of the report, HYPOAESTHESIA (the top of my head is feeling numb) and RASH (I have a rash on my legs, no itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient visited Doctor's office to make sure everything was Ok.   On an unknown date, Body temperature was 97.3F and Blood pressure was 90/60mmHg No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Significant follow up-outcome reported; Updated Race information, Ethnicity, Vaccine facility information. Added body temperature and  Bloos pressure in narrative.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Extremely excessive menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Extremely excessive menstrual bleeding) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Extremely excessive menstrual bleeding). At the time of the report, HEAVY MENSTRUAL BLEEDING (Extremely excessive menstrual bleeding) had not resolved.            Relevant concomitant medications were not reported.  Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache every day since second shot-that's now 4 months; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache every day since second shot-that's now 4 months) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to sulfa).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache every day since second shot-that's now 4 months). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. On 25-Aug-2021, HEADACHE (Headache every day since second shot-that's now 4 months) had not resolved.            Incomplete information provided regarding the concomitant drugs was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: red rash on upper left arm; Red rash on upper left arm, itchy; Red rash on upper left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red rash on upper left arm), VACCINATION SITE PRURITUS (Red rash on upper left arm, itchy) and VACCINATION SITE ERYTHEMA (Red rash on upper left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and Immune disorder (NOS).     Concurrent medical conditions included Immune disorder (NOS) and Thyroid hormones decreased.    On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced VACCINATION SITE RASH (red rash on upper left arm), VACCINATION SITE PRURITUS (Red rash on upper left arm, itchy) and VACCINATION SITE ERYTHEMA (Red rash on upper left arm). At the time of the report, VACCINATION SITE RASH (red rash on upper left arm), VACCINATION SITE PRURITUS (Red rash on upper left arm, itchy) and VACCINATION SITE ERYTHEMA (Red rash on upper left arm) had not resolved. Not Provided          No concomitant medications was provided by the reporter.  Patient applied hydrocordisone cream for relief.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Myalgia, Pyrexia, Vomiting
Clinical narrative: Sweats; Throwing up; Fever; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), VOMITING (Throwing up), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), VOMITING (Throwing up), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweats), VOMITING (Throwing up), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Burning sensation, Dizziness, Dry eye, Nausea
Clinical narrative: Got J&J vaccine @ 5:30 PM in R Arm. within 20 minutes felt sympathetic pain in my L arm @ same spot on L arm as R arm injection.   Went to bed at 10:30pm. woke @ 3AM feeling like I needed to move - got up for a drink and became aware of feeling like I spread  over my entire body - not exactly the same as chills and/or fever - literally felt like pepperminty cool burn/tingle all over whole body. Felt faintness w/waves of  nausea - had to squat twice like when you feel like you are about to faint/brown or black out so you feel the need to get close to the floor.  Had waves of abdominal cramps that felt like strong period cramps.   eyes feel dry - irritatingly dry - and I have not been wearing contacts.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Got J&J vaccine @ 5:30 PM in R Arm. within 20 minutes felt sympathetic pain in my L arm @ same spot on L arm as R arm injection.   Went to bed at 10:30pm. woke @ 3AM feeling like I needed to move - got up for a drink and became aware of feeling like I spread  over my entire body - not exactly the same as chills and/or fever - literally felt like pepperminty cool burn/tingle all over whole body. Felt faintness w/waves of  nausea - had to squat twice like when you feel like you are about to faint/brown or black out so you feel the need to get close to the floor.  Had waves of abdominal cramps that felt like strong period cramps.   eyes feel dry - irritatingly dry - and I have not been wearing contacts.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Extreme leg cramps in calves that happen at night that did not occur prior to injection.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Extra dose administered, Lethargy, Lymphadenopathy
Clinical narrative: Tender, swollen, and enlarged lymph node(s) under left armpit. It hurts to bring arm down. This reaction was not experienced with first and second shots; however, I didn?t start taking methotrexate until after the second shot.   I slept beginning Saturday evening and was not functional all day Sunday. I experienced lethargy, chills, vivid dreams, but no fever.  My lymph node began to feel terribly uncomfortable Monday, but I am not sure if it was evident on Sunday, because I slept the entire day.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tenderness
Clinical narrative: Tender, swollen, and enlarged lymph node(s) under left armpit. It hurts to bring arm down. This reaction was not experienced with first and second shots; however, I didn?t start taking methotrexate until after the second shot.   I slept beginning Saturday evening and was not functional all day Sunday. I experienced lethargy, chills, vivid dreams, but no fever.  My lymph node began to feel terribly uncomfortable Monday, but I am not sure if it was evident on Sunday, because I slept the entire day.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; PROQUAD that underwent a temperature excursion was administered to the patient; This spontaneous report was received office staff member and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.       On 10-AUG-2021, the patient was vaccinated with an improperly store dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), lot # T032145 expiration date 20-MAR-2022 (dose and route were not reported) for prophylaxis. The vaccine underwent a temperature excursion from 6 to 14 (12.6°F) Fahrenheit degrees (°F)  for 45 minutes. There was no previous temperature excursion. No additional adverse effect and no product quality complain were reported.       This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2109USA001014:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Nurse callls and reports a dose of PROQUAD was inadvertently given via intramuscular route instead of subcutaneous; No other adverse events (AE) reported; This spontaneous report was received from a Registered Nurse concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD),  lot number reported and validated as T037955, expiration date reported and validated as 09-MAY-2022, intramuscular as prophylaxis (vaccination scheme and site of administration was not reported) (subcutaneous injection formulation administered by other route). No adverse events were reported.
Sex: F
Vaccine: MMRV
Symptoms: Rash, Rash vesicular, Urticaria vesiculosa
Clinical narrative: a 4 year old girl developed a "vesicular rash" on her upper legs and groin area within 12 hours of receiving PROQUAD; he girl had urticaria and vesicles on her forehead.; This spontaneous report was received from a company representative on behalf of a physician referring to a 4-year-old female patient. The patient's pertinent medical history, concomitant therapies, previous drug reactions, or allergies were not reported.     On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).  On the same day, 12 hours after receiving the aforementioned vaccine the patient developed a "vesicular rash" (rash vesicular) on her upper legs and groin area. Additionally, the patient experienced urticaria and vesicles on her forehead (urticaria vesiculosa).  It was unknown by the reporter if the patient sough medical attention, if laboratory diagnostics and if studies were performed due to the event, or if she received any treatments for the event. The outcome of the events was unknown by the reporter. On 16-AUG-2021,Identification Program packet was faxed to physician per article instructions.   The causality assessment  between Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), rash vesicular and urticaria vesiculosa was not reported. As of 16-AUG-2021, all telephone attempts trying to obtain additional information has been unsuccessful. Also, program information was provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; administration of expired MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's  medical history, concurrent conditions and concomitant medications was provided.   On 17-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(recombinant human albumin (rHA))(strength, dosing schedule and route of administration were not reported) lot # S025157, expiration date: 13-AUG-2021, 0.5 milliliter for prophylaxis. Administered dose was evaluated as supported. No additional adverse events reported.
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events reported; a 12 month old patient received an extra dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a 12 month old female patient. No information regarding her medical history, drug reactions/allergies or concomitant therapies were was provided.  On 02-AUG-2021, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 1 dose, lot # U002538, expiration date 24-JUL-2022 (exact dose and route of administration were not provided), for prophylaxis. On 16-AUG-2021, the patient was vaccinated with an extra dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 1 dose, lot # T035409, expiration date 14-APR-2022 (exact dose and route of administration were not provided), for prophylaxis. The patient did not experience any adverse event. She did not have any fever.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site warmth, Peripheral swelling
Clinical narrative: allergic reaction to shingles vaccine; allergic reaction to shingles vaccine/a major reaction in the area/there was itching and redness/it was over 2 inches in diameter, the redness; allergic reaction to shingles vaccine/a major reaction in the area/It made her arm swell and was extremely hot; allergic reaction to shingles vaccine/a major reaction in the area/It made her arm swell and was extremely hot; allergic reaction to shingles vaccine/a major reaction in the area/there was itching and redness; This spontaneous report was received from a 68-year-old White female patient via Pfizer. The patient was referring to herself. No information regarding the patient's medical history, concurrent conditions, and concomitant medications was provided. The patient had a history of allergy to lisinopril (manufacturer unknown) (case # 2108USA005499).  On an unknown date in 2013 (reported as 8 years ago), the patient was vaccinated with zoster vaccine live (manufacturer unknown) (reported as shingles vaccine) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in 2013 (reported as 8 years ago), the patient had a major allergic reaction to zoster vaccine live (manufacturer unknown) in the area of the vaccination. It was further described that the patient's arm was swollen and was extremely hot. There was also itching and redness around the vaccination site. The redness was inch and a half to 2 inches in diameter. The patient put ice on vaccination site as a treatment for the events, but she stated that it "never took the heat away". The redness was over after about 6 weeks to 2 months (date not specified). The outcome of the rest of the events was unknown (it was reported that the swelling did not go away for 6 weeks).  The events were considered to be related to the suspect vaccine, as the patient reported that the events were an allergic reaction to zoster vaccine live (manufacturer unknown).  This is one of two cases received from the same reporter and referring to the same patient.; Sender's Comments:  US-009507513-2108USA005499:
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: allergic reaction to shingles vaccine; allergic reaction to shingles vaccine/a major reaction in the area/there was itching and redness/it was over 2 inches in diameter, the redness; allergic reaction to shingles vaccine/a major reaction in the area/It made her arm swell and was extremely hot; allergic reaction to shingles vaccine/a major reaction in the area/It made her arm swell and was extremely hot; allergic reaction to shingles vaccine/a major reaction in the area/there was itching and redness; This spontaneous report was received from a 68-year-old White female patient via Pfizer. The patient was referring to herself. No information regarding the patient's medical history, concurrent conditions, and concomitant medications was provided. The patient had a history of allergy to lisinopril (manufacturer unknown) (case # 2108USA005499).  On an unknown date in 2013 (reported as 8 years ago), the patient was vaccinated with zoster vaccine live (manufacturer unknown) (reported as shingles vaccine) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in 2013 (reported as 8 years ago), the patient had a major allergic reaction to zoster vaccine live (manufacturer unknown) in the area of the vaccination. It was further described that the patient's arm was swollen and was extremely hot. There was also itching and redness around the vaccination site. The redness was inch and a half to 2 inches in diameter. The patient put ice on vaccination site as a treatment for the events, but she stated that it "never took the heat away". The redness was over after about 6 weeks to 2 months (date not specified). The outcome of the rest of the events was unknown (it was reported that the swelling did not go away for 6 weeks).  The events were considered to be related to the suspect vaccine, as the patient reported that the events were an allergic reaction to zoster vaccine live (manufacturer unknown).  This is one of two cases received from the same reporter and referring to the same patient.; Sender's Comments:  US-009507513-2108USA005499:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no other adverse events reported; a dose of MMR II was administered today via IM route versus subcutaneous route as ecommended in the prescribing information; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On 19-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(recombinant human albumin (rHA))(strength and dosing schedule were not reported) lot # T012808, expiration date: 14-APR-2022, 0.5 milliliter, intramuscularly for prophylaxis. The dose was administered intramuscular (IM) versus subcutaneous route as recommended in the prescribing information. No other adverse events reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; VAQTA administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 09-AUG-2021, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # T023913; expiration date 31-MAR-2022; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The storage temperature was 9 Celsius degrees for 5 minutes. There was no previous temperature excursion. No additional adverse event or product quality complaint (PQC) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023913; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No side effects reported at this time; accidently given PROQUAD and VARlVAX instead of VARlVAX and MMR-II; accidently given PROQUAD and VARlVAX instead of VARlVAX and MMR-II; This spontaneous report was received from a medical assistant referring to a 1 year old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 23-AUG-2021, the patient was accidently given measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml (1 dose, lot # T032149, expiration date 20-MAR-2022) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml (1 dose, lot # U007471, expiration date 08-MAR-2023), both intramuscularly (IM) for prophylaxis, instead of varicella virus vaccine live (oka/merck) (VARIVAX) and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered and accidental overdose). Therefore, the patient inadvertently received an extra dose of Varicella. No side effects reported at the time of reporting.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no other adverse events; patient received PROQUAD with VARIVAX in error; MMR II was intended instead of PROQUAD; patient received PROQUAD with VARIVAX in error; MMR II was intended instead of PROQUAD; This spontaneous report was received from a licensed practical nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 20-AUG-2021, the patient was vaccinated in error with varicella virus vaccine live (oka/merck) (VARIVAX) lot # T033166, expiration date 29-SEP-2022, 1 dose and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(albumin status: recombinant Human albumin (rHA)) (PROQUAD) lot # T034826, expiration date reported as 29-APR-2022 but upon internal validation established as 11-APR-2022 for prophylaxis. Caller reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was intended instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Caller did nor report error occurred due to product confusion. No other adverse events reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: inadvertently administered after its labeled expiry date; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.      The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 19-AUG-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (dose, route of administration, and anatomical location were not provided) lot # T018670, expiration date 11-JUL-2021 as prophylaxis.   The vaccine hepatitis A vaccine, inactivated (VAQTA), was inadvertently administered after its labeled expiration date, according to the nurse.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: no adverse event; The patient was accidently administered GARDASIL 9 subcutaneous not intramuscular as recommended; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies.  On 23-AUG-2021, the patient was accidently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, at a dose of 0.5 milliliter (ml) by subcutaneous route (lot number T025369, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 01-DEC-2022) (frequency, anatomical location and vaccination scheme were not reported), as prophylaxis (incorrect route of product administration). No additional adverse events were reported. 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: T025369; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; The caller reported a supported temperature excursion for PROQUAD (lot: U006313, expiration: 24AUG2022) which has been administered.; This spontaneous report was received from a nurse, referring to a 5-year-old male patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 27-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number U006313 had been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA), expiration date reported and upon internal validation established as 24-AUG-2022) as prophylaxis (product storage error).  The administered dose of the vaccine was stored in a temperature of 38.8 degrees Fahrenheit (F) for 8 hours 0 minutes and 0 seconds. There was no previous temperature excursion reported. It was unknown if a digital data logger was involved. No adverse events were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA008073: US-009507513-2108USA007980:
Sex: M
Vaccine: HEP
Symptoms: Vaccination failure, Viral titre decreased
Clinical narrative: Vaccination failure; Hepatitis B titer drawn which showed that he was not immune; This spontaneous report has been receive from a nurse regarding to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dosage regimen were not reported) for vaccination when he was a child.   On an unspecified date, the patient now as an adult, the patient presented hepatitis b titer drawn which showed that he was not immune. At the reporting time, the outcome of the events was unknown.   The causality assessment between the events and dose of hepatitis b vaccine (recombinant) (manufacturer unknown) was not reported.
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, Product storage error
Clinical narrative: No further information is available; a patient received improperly stored vaccine on 8/20/2021; This spontaneous report was received from a medical assistant, referring to a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 20-AUG-2021, the patient was vaccinated with one dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number U009262, expiration date was reported and validated as 19-SEP-2022) as prophylaxis (product storage error). No further information was available.  The vaccine underwent a temperature excursion of minus (-) 3.3 degrees Celsius (C) for 4 hours and 52 minutes. There was no previous temperature excursion.