chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Amnesia, Computerised tomogram head normal, Confusional state, Drug screen negative
Clinical narrative: Mother of patient came home on 4/12/21 to find patient wandering outside of their house with his shirt off and confused. She suspected possible drug use and brought him to his doctor the following day.  He says he does not remember anything from that day, doesn't remember taking any drugs but has taken xanax  in the past. Later that night on 4/13 patient had a seizure at home and was taken to ER. There urine drug screen was done alond with CBC, CMP, CT of head all of which was normal.  Patient has no history of seizure in the past.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count normal, Metabolic function test normal, Patient elopement, Seizure
Clinical narrative: Mother of patient came home on 4/12/21 to find patient wandering outside of their house with his shirt off and confused. She suspected possible drug use and brought him to his doctor the following day.  He says he does not remember anything from that day, doesn't remember taking any drugs but has taken xanax  in the past. Later that night on 4/13 patient had a seizure at home and was taken to ER. There urine drug screen was done alond with CBC, CMP, CT of head all of which was normal.  Patient has no history of seizure in the past.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: on 3/23/2021 we discovered the vaccine wasnt properly diluted resulting in the patient only getting a fraction of the intended dose. No adverse reaction reported to the pharmacy.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache
Clinical narrative: STARTING TWO HOURS AFTER VACCINE, PATIENT REPORTS FAIRLY CONSTANT LEFT SIDED HEADACHE. NOT INTERFERING WITH ACTIVITIES OF DAILY LIVING BUT UNCOMFORTABLE SO SOUGHT MEDICAL ATTENTION AT PRIMARY CARE CLINIC 12 DAYS LATER. WE ARE STARTING WITH OVER THE COUNTER PAIN MEDICATIONS AND WILL CLOSELY FOLLOW TO DETERMINE NEED FOR IMAGING IF SYMPTOMS ADVANCE.
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site swelling, Injection site urticaria, Urticaria
Clinical narrative: Swelling & hives to both thy's where vaccines were  placed
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: on 3/23/2021 we discovered the vaccine wasnt properly diluted resulting in the patient only getting a fraction of the intended dose. No adverse reaction reported to the pharmacy.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Electrocardiogram, Fall, Loss of consciousness
Clinical narrative: Patient passed out at he front register about 5 minutes after receiving his 2nd COVID vaccine.  He fell down but did not hit his head.  He only lost consciousness briefly and felt better quickly.  We had sat him in a chair outside and waited with him until the paramedics arrived.  The paramedics checked his blood pressure, EKG, and blood sugar.  They checked him briefly and cleared him medically.  He will wait for someone to pick him up so he does not need to drive home.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: on 3/23/21 we discovered the vaccine wasnt  properly diluted  resulting in the patient only  getting a fraction  of the intended  dose.  No adverse reaction  reported to the pharmacy.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles - single dermatome left chest - no evidewnce of dissemination
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Contusion, Electrocardiogram, Headache, Pain in extremity
Clinical narrative: Achy sore legs, small Bruise x2 on abdomen headache, chest pains
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Achy sore legs, small Bruise x2 on abdomen headache, chest pains
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: on 3/23/2021 we discovered the vaccine wasnt properly diluted resulting in the patient only getting a fraction of the intended dose. No adverse reaction reported to the pharmacy.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: on 3/23/21 we discovered the vaccine wasnt properly diluted resulting in the patient only getting a fraction of the intended dose. No adverse reaction reported to the pharmacy.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: on 3/23/2021 we discovered the vaccine wasnt properly diluted resulting in the patient only getting a fraction of the intended dose. No adverse reaction reported to the pharmacy.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: on 3/23/2021 we discovered the vaccine wasnt properly diluted resulting in the patient only getting a fraction of the intended dose. No adverse reaction reported to the pharmacy.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Haemorrhage subepidermal, Headache, Muscle disorder
Clinical narrative: Blood spots/speckles under skin on legs & arms.  Right side of neck near vein/muscle throbbing/ pulsing.  Fatigue, headache.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count normal
Clinical narrative: Blood spots/speckles under skin on legs & arms.  Right side of neck near vein/muscle throbbing/ pulsing.  Fatigue, headache.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: on 3/23/2021 we discovered the vaccine wasnt properly diluted resulting in the patient only getting a fraction of the intended dose. No adverse reaction reported to the pharmacy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: fever 101.6         aches          chills         malaise
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Magnetic resonance imaging head, Scan with contrast
Clinical narrative: Left sided frontal headaches with dizziness since 4-3-21
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fibrin D dimer normal, Full blood count normal, Joint swelling
Clinical narrative: RIGHT LOWER EXTREMITY CALF PRETIBIAL ANKLE AND FOOT SWELLING AND PAIN, REDNESS, SORENESS, TENDERNESS, AS PATIENT STATES, STARTED WITH SXS. APRIL 3RD, 18 HOURS AFTER GETTING HER SECOND COVID SHOT, PATIENT WORRIED THAT THIS IS TRULY A SIDE EFFECT REACTION TO COVID VACCINE
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Metabolic function test normal, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: RIGHT LOWER EXTREMITY CALF PRETIBIAL ANKLE AND FOOT SWELLING AND PAIN, REDNESS, SORENESS, TENDERNESS, AS PATIENT STATES, STARTED WITH SXS. APRIL 3RD, 18 HOURS AFTER GETTING HER SECOND COVID SHOT, PATIENT WORRIED THAT THIS IS TRULY A SIDE EFFECT REACTION TO COVID VACCINE
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Ultrasound Doppler normal
Clinical narrative: RIGHT LOWER EXTREMITY CALF PRETIBIAL ANKLE AND FOOT SWELLING AND PAIN, REDNESS, SORENESS, TENDERNESS, AS PATIENT STATES, STARTED WITH SXS. APRIL 3RD, 18 HOURS AFTER GETTING HER SECOND COVID SHOT, PATIENT WORRIED THAT THIS IS TRULY A SIDE EFFECT REACTION TO COVID VACCINE
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Chills, Heart rate increased, Lip swelling, Paraesthesia oral
Clinical narrative: Patient started complaining tingling in lips & feeling that lips will swell up 10 min after covid vaccine. Epi pen was given after which symptoms resolved. Patient believe had chills, temporary increase in pulse, BP due to covid-19 vaccine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Paraesthesia, Pruritus, Rash
Clinical narrative: Initially no complaints after injection of COVID vaccine (#1 of 2) and was released after 15-20 minutes of observation. Pt returned to clinic 1/2hr to 1hour later with c/o 1 diameter flat pink rash to R cheek, itching to body, tightness to R side of throat x3 brief episodes lasting seconds prior to returning to clinic and tingling to fingertips of L hand (reported tingling r/t anxiety; also has h/o neuropathy L hand). Pt kept for 1hr observation and was given 1 tab diphenhydramine 25mg x 1po. x3 status check stable prior to dc. VSS, aaox4, no sob, non duress, color pink, no difficulty breathing/swallowing, no swelling to mouth/tongue/thrt/other, CTAB A/P/
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Throat tightness
Clinical narrative: Initially no complaints after injection of COVID vaccine (#1 of 2) and was released after 15-20 minutes of observation. Pt returned to clinic 1/2hr to 1hour later with c/o 1 diameter flat pink rash to R cheek, itching to body, tightness to R side of throat x3 brief episodes lasting seconds prior to returning to clinic and tingling to fingertips of L hand (reported tingling r/t anxiety; also has h/o neuropathy L hand). Pt kept for 1hr observation and was given 1 tab diphenhydramine 25mg x 1po. x3 status check stable prior to dc. VSS, aaox4, no sob, non duress, color pink, no difficulty breathing/swallowing, no swelling to mouth/tongue/thrt/other, CTAB A/P/
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient presented for 2nd Moderna Vaccine on 4.19.2021.  She did not have her vaccination card with her. Moderna was administered.  When patient got home, she looked at her vaccination card and had received Pfizer for her 1st does.  When discussing with the patient, she stated that she thought she signed up for Moderna for 1st vaccine and assumed that is what she had received.  No adverse affects noted at this time.  Paitnet informed to call us if she experienced any adverse symptoms.  Patient also informed per CDC guidelines to not get another Covid vaccine.  Nurse took patient at her word that was to receive her 2nd Moderna Vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Limb discomfort, Mobility decreased, Paraesthesia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA She said she felt really dizzy so I had her sit longer than 15 minutes. She started feeling arm heaviness, tingling in hands and feet, heavy legs and head. She moved to another chair in waiting area and had difficulty  I called 911 & monitored her the whole time. Paramedics checked her vitals and all were within range  She didn't want to go to ER and they said they couldn't do anything her for her symptoms and that it was her choice. She wanted to drive home but paramedics and I did not feel comfortable with that so she asked her husband to pick her up
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient received Moderna 1st dose on 4/6/2021 and then was administered Pfizer as her second dose vaccine. Patient did not have her vaccination card with her. Patient does not remember discussing with nurse "which vaccine" she was there to receive although patient scheduled a Pfizer vaccine in our health portal. No adverse side affects noted, patient is doing well. Instructed to not get anymore Covid vaccines per CDC guidelines and to call us if she has any adverse reactions.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Impaired work ability, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient stated that on Thursday, April 15th, the top of her arm, shoulder became extremely painful where she could not move it. On Friday, she could not go to work due to the inability to move her arm and the pain, then on Saturday, she went to the ER due to the extreme pain. Dr. ordered an xray. Patient stated that pain has lessened but her arm still has no mobility. She has missed two days of work.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Patient stated that on Thursday, April 15th, the top of her arm, shoulder became extremely painful where she could not move it. On Friday, she could not go to work due to the inability to move her arm and the pain, then on Saturday, she went to the ER due to the extreme pain. Dr. ordered an xray. Patient stated that pain has lessened but her arm still has no mobility. She has missed two days of work.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dyspnoea exertional, Echocardiogram, Fatigue
Clinical narrative: Patient states after the second dose he was fatigued. Shortness of breath with exertion
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Dizziness, NauseaVomiting,  MILD HA  Narrative:  1035: C/0 DIZZINESS, NAUSEA (MILD), MILD HA 191.115 HR69 1036: NO CHANGE IN SYMPTOMS 171/103 HR71 10:45 SYMPTOMS GONE 158/96 HR 67 1055 D/C STABLE 147/88 HR 65 INTERVENTION:  WATER
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue, chills Narrative:  Other Relevant History:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue, chills Narrative:  Other Relevant History:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient stated the IM injection was not given with the correct needle size (length) - was not an IM injection per patient.  Patient given dose again 1/11/21 and 2/3/21
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Off label use, Product use issue, Vaccination site erythema, Vaccination site mass
Clinical narrative: Patient stated the IM injection was not given with the correct needle size (length) - was not an IM injection per patient.  Patient given dose again 1/11/21 and 2/3/21
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: The BNT 162 B2 vaccine was administered on the morning of Monday January 4th 2021 at approximately 11:08am, via intramuscular route. Within the next 24 hours, I started having myalgia and Paresthesia to my right leg and foot on 1/5/21, this progressively worsened. On the 6th January, the paresthesia worsened and started to occur on the left foot- anterior and dorsal surfaces. In addition, at about 21:45hrs, I started having lower back pain- severe, rated about 6/10 in severity. This progressively worsened to 10/10 in pain severity. On the 7th an, all my symptoms had worsened, despite taking Tylenol. On the 8th January 2021, I started having difficulty lifting my right foot and visited emergency room for further care. At that time I have had a series of investigations and lab work done, in addition to PCP and specialist referral including Neurologist, Physiatrist and for Physical therapy. I am still undergoing physical therapy with improvement in the weakness but I still have persistent and on going lower back pain and paresthesia in my legs and foot three months later.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Chest X-ray normal, Full blood count normal, Intervertebral disc protrusion
Clinical narrative: The BNT 162 B2 vaccine was administered on the morning of Monday January 4th 2021 at approximately 11:08am, via intramuscular route. Within the next 24 hours, I started having myalgia and Paresthesia to my right leg and foot on 1/5/21, this progressively worsened. On the 6th January, the paresthesia worsened and started to occur on the left foot- anterior and dorsal surfaces. In addition, at about 21:45hrs, I started having lower back pain- severe, rated about 6/10 in severity. This progressively worsened to 10/10 in pain severity. On the 7th an, all my symptoms had worsened, despite taking Tylenol. On the 8th January 2021, I started having difficulty lifting my right foot and visited emergency room for further care. At that time I have had a series of investigations and lab work done, in addition to PCP and specialist referral including Neurologist, Physiatrist and for Physical therapy. I am still undergoing physical therapy with improvement in the weakness but I still have persistent and on going lower back pain and paresthesia in my legs and foot three months later.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Metabolic function test normal, Musculoskeletal disorder, Myalgia, Paraesthesia
Clinical narrative: The BNT 162 B2 vaccine was administered on the morning of Monday January 4th 2021 at approximately 11:08am, via intramuscular route. Within the next 24 hours, I started having myalgia and Paresthesia to my right leg and foot on 1/5/21, this progressively worsened. On the 6th January, the paresthesia worsened and started to occur on the left foot- anterior and dorsal surfaces. In addition, at about 21:45hrs, I started having lower back pain- severe, rated about 6/10 in severity. This progressively worsened to 10/10 in pain severity. On the 7th an, all my symptoms had worsened, despite taking Tylenol. On the 8th January 2021, I started having difficulty lifting my right foot and visited emergency room for further care. At that time I have had a series of investigations and lab work done, in addition to PCP and specialist referral including Neurologist, Physiatrist and for Physical therapy. I am still undergoing physical therapy with improvement in the weakness but I still have persistent and on going lower back pain and paresthesia in my legs and foot three months later.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Radiculopathy, Viral test negative, Vitamin B12 normal
Clinical narrative: The BNT 162 B2 vaccine was administered on the morning of Monday January 4th 2021 at approximately 11:08am, via intramuscular route. Within the next 24 hours, I started having myalgia and Paresthesia to my right leg and foot on 1/5/21, this progressively worsened. On the 6th January, the paresthesia worsened and started to occur on the left foot- anterior and dorsal surfaces. In addition, at about 21:45hrs, I started having lower back pain- severe, rated about 6/10 in severity. This progressively worsened to 10/10 in pain severity. On the 7th an, all my symptoms had worsened, despite taking Tylenol. On the 8th January 2021, I started having difficulty lifting my right foot and visited emergency room for further care. At that time I have had a series of investigations and lab work done, in addition to PCP and specialist referral including Neurologist, Physiatrist and for Physical therapy. I am still undergoing physical therapy with improvement in the weakness but I still have persistent and on going lower back pain and paresthesia in my legs and foot three months later.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Fatigue, Headache, Hypoaesthesia oral
Clinical narrative: SHORT OF BREATH; RAPID HEART BEAT; DIZZINESS; NUMBNESS OF TONGUE; TASTE METALLIC; FATIGUE; HEADACHE; FEELING UNWELL; PALPITATIONS IN ARM; SORE ARM; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included penicillin allergy, prednisone allergy, flu shot allergy, and beta blocker allergy, and concurrent conditions included rheumatoid arthritis, and neuropathy in both arms. The patient was previously treated with methotrexate for neuropathy in both arms, rheumatoid arthritis; and experienced hydroxychloroquine allergy when treated with hydroxychloroquine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced palpitations in arm. On 12-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced feeling unwell. On 15-MAR-2021, the subject experienced short of breath. On 15-MAR-2021, the subject experienced rapid heart beat. On 15-MAR-2021, the subject experienced dizziness. On 15-MAR-2021, the subject experienced numbness of tongue. On 15-MAR-2021, the subject experienced taste metallic. On 15-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced headache. On 14-APR-2021, Laboratory data included: Platelet count (NR: not provided) unknown unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations in arm, short of breath, rapid heart beat, dizziness, feeling unwell, fatigue, and headache, and had not recovered from sore arm, numbness of tongue, and taste metallic. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint stiffness, Neck pain, Pain in extremity, Palpitations
Clinical narrative: SHORT OF BREATH; RAPID HEART BEAT; DIZZINESS; NUMBNESS OF TONGUE; TASTE METALLIC; FATIGUE; HEADACHE; FEELING UNWELL; PALPITATIONS IN ARM; SORE ARM; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included penicillin allergy, prednisone allergy, flu shot allergy, and beta blocker allergy, and concurrent conditions included rheumatoid arthritis, and neuropathy in both arms. The patient was previously treated with methotrexate for neuropathy in both arms, rheumatoid arthritis; and experienced hydroxychloroquine allergy when treated with hydroxychloroquine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced palpitations in arm. On 12-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced feeling unwell. On 15-MAR-2021, the subject experienced short of breath. On 15-MAR-2021, the subject experienced rapid heart beat. On 15-MAR-2021, the subject experienced dizziness. On 15-MAR-2021, the subject experienced numbness of tongue. On 15-MAR-2021, the subject experienced taste metallic. On 15-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced headache. On 14-APR-2021, Laboratory data included: Platelet count (NR: not provided) unknown unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations in arm, short of breath, rapid heart beat, dizziness, feeling unwell, fatigue, and headache, and had not recovered from sore arm, numbness of tongue, and taste metallic. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Dyspnoea, Fatigue, Headache
Clinical narrative: SHORT OF BREATH; RAPID HEART BEAT; DIZZINESS; NUMBNESS OF TONGUE; TASTE METALLIC; FATIGUE; HEADACHE; FEELING UNWELL; PALPITATIONS IN ARM; SORE ARM; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included penicillin allergy, prednisone allergy, flu shot allergy, and beta blocker allergy, and concurrent conditions included rheumatoid arthritis, and neuropathy in both arms. The patient was previously treated with methotrexate for neuropathy in both arms, rheumatoid arthritis; and experienced hydroxychloroquine allergy when treated with hydroxychloroquine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced palpitations in arm. On 12-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced feeling unwell. On 15-MAR-2021, the subject experienced short of breath. On 15-MAR-2021, the subject experienced rapid heart beat. On 15-MAR-2021, the subject experienced dizziness. On 15-MAR-2021, the subject experienced numbness of tongue. On 15-MAR-2021, the subject experienced taste metallic. On 15-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced headache. On 14-APR-2021, Laboratory data included: Platelet count (NR: not provided) unknown unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations in arm, short of breath, rapid heart beat, dizziness, feeling unwell, fatigue, and headache, and had not recovered from sore arm, numbness of tongue, and taste metallic. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypoaesthesia oral, Malaise, Pain in extremity, Palpitations
Clinical narrative: SHORT OF BREATH; RAPID HEART BEAT; DIZZINESS; NUMBNESS OF TONGUE; TASTE METALLIC; FATIGUE; HEADACHE; FEELING UNWELL; PALPITATIONS IN ARM; SORE ARM; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included penicillin allergy, prednisone allergy, flu shot allergy, and beta blocker allergy, and concurrent conditions included rheumatoid arthritis, and neuropathy in both arms. The patient was previously treated with methotrexate for neuropathy in both arms, rheumatoid arthritis; and experienced hydroxychloroquine allergy when treated with hydroxychloroquine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced palpitations in arm. On 12-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced feeling unwell. On 15-MAR-2021, the subject experienced short of breath. On 15-MAR-2021, the subject experienced rapid heart beat. On 15-MAR-2021, the subject experienced dizziness. On 15-MAR-2021, the subject experienced numbness of tongue. On 15-MAR-2021, the subject experienced taste metallic. On 15-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced headache. On 14-APR-2021, Laboratory data included: Platelet count (NR: not provided) unknown unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations in arm, short of breath, rapid heart beat, dizziness, feeling unwell, fatigue, and headache, and had not recovered from sore arm, numbness of tongue, and taste metallic. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count
Clinical narrative: SHORT OF BREATH; RAPID HEART BEAT; DIZZINESS; NUMBNESS OF TONGUE; TASTE METALLIC; FATIGUE; HEADACHE; FEELING UNWELL; PALPITATIONS IN ARM; SORE ARM; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included penicillin allergy, prednisone allergy, flu shot allergy, and beta blocker allergy, and concurrent conditions included rheumatoid arthritis, and neuropathy in both arms. The patient was previously treated with methotrexate for neuropathy in both arms, rheumatoid arthritis; and experienced hydroxychloroquine allergy when treated with hydroxychloroquine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced palpitations in arm. On 12-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced feeling unwell. On 15-MAR-2021, the subject experienced short of breath. On 15-MAR-2021, the subject experienced rapid heart beat. On 15-MAR-2021, the subject experienced dizziness. On 15-MAR-2021, the subject experienced numbness of tongue. On 15-MAR-2021, the subject experienced taste metallic. On 15-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced headache. On 14-APR-2021, Laboratory data included: Platelet count (NR: not provided) unknown unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations in arm, short of breath, rapid heart beat, dizziness, feeling unwell, fatigue, and headache, and had not recovered from sore arm, numbness of tongue, and taste metallic. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Headache
Clinical narrative: 3/12/2021 first dose Pfizer vaccine  20 min lightheaded [describes as though she wasn?t completely present], intense headache. Within an hour ?shaky? - tremor in hands. Was told she looked pale. Developed severe rigors, lip tingling worse on right. Duration about 20 min of severe sx.  Subsequent severe fatigue,  slept for 4 hours.   During the night awoke with sensation of elephant sitting on chest, right arm heavy, dyspnea.  Assoc?d vaginal irritation. Went to ER - r/o MI, advised H1/H2. Sx improved overall then developed waxing and waning right sided facial tingling, numbness.  Back to baseline in 4-5 days
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Laboratory test, Paraesthesia, Troponin
Clinical narrative: 3/12/2021 first dose Pfizer vaccine  20 min lightheaded [describes as though she wasn?t completely present], intense headache. Within an hour ?shaky? - tremor in hands. Was told she looked pale. Developed severe rigors, lip tingling worse on right. Duration about 20 min of severe sx.  Subsequent severe fatigue,  slept for 4 hours.   During the night awoke with sensation of elephant sitting on chest, right arm heavy, dyspnea.  Assoc?d vaginal irritation. Went to ER - r/o MI, advised H1/H2. Sx improved overall then developed waxing and waning right sided facial tingling, numbness.  Back to baseline in 4-5 days
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: 3/12/2021 first dose Pfizer vaccine  20 min lightheaded [describes as though she wasn?t completely present], intense headache. Within an hour ?shaky? - tremor in hands. Was told she looked pale. Developed severe rigors, lip tingling worse on right. Duration about 20 min of severe sx.  Subsequent severe fatigue,  slept for 4 hours.   During the night awoke with sensation of elephant sitting on chest, right arm heavy, dyspnea.  Assoc?d vaginal irritation. Went to ER - r/o MI, advised H1/H2. Sx improved overall then developed waxing and waning right sided facial tingling, numbness.  Back to baseline in 4-5 days
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematocrit normal, Headache, Histamine normal, Hypoaesthesia, Limb discomfort
Clinical narrative: 3/12/2021 first dose Pfizer vaccine  20 min lightheaded [describes as though she wasn?t completely present], intense headache. Within an hour ?shaky? - tremor in hands. Was told she looked pale. Developed severe rigors, lip tingling worse on right. Duration about 20 min of severe sx.  Subsequent severe fatigue,  slept for 4 hours.   During the night awoke with sensation of elephant sitting on chest, right arm heavy, dyspnea.  Assoc?d vaginal irritation. Went to ER - r/o MI, advised H1/H2. Sx improved overall then developed waxing and waning right sided facial tingling, numbness.  Back to baseline in 4-5 days
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Nervousness, Pallor, Paraesthesia, Paraesthesia oral
Clinical narrative: 3/12/2021 first dose Pfizer vaccine  20 min lightheaded [describes as though she wasn?t completely present], intense headache. Within an hour ?shaky? - tremor in hands. Was told she looked pale. Developed severe rigors, lip tingling worse on right. Duration about 20 min of severe sx.  Subsequent severe fatigue,  slept for 4 hours.   During the night awoke with sensation of elephant sitting on chest, right arm heavy, dyspnea.  Assoc?d vaginal irritation. Went to ER - r/o MI, advised H1/H2. Sx improved overall then developed waxing and waning right sided facial tingling, numbness.  Back to baseline in 4-5 days
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count normal, Skin test positive, Tremor, Tryptase, Vulvovaginal discomfort
Clinical narrative: 3/12/2021 first dose Pfizer vaccine  20 min lightheaded [describes as though she wasn?t completely present], intense headache. Within an hour ?shaky? - tremor in hands. Was told she looked pale. Developed severe rigors, lip tingling worse on right. Duration about 20 min of severe sx.  Subsequent severe fatigue,  slept for 4 hours.   During the night awoke with sensation of elephant sitting on chest, right arm heavy, dyspnea.  Assoc?d vaginal irritation. Went to ER - r/o MI, advised H1/H2. Sx improved overall then developed waxing and waning right sided facial tingling, numbness.  Back to baseline in 4-5 days
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count normal
Clinical narrative: 3/12/2021 first dose Pfizer vaccine  20 min lightheaded [describes as though she wasn?t completely present], intense headache. Within an hour ?shaky? - tremor in hands. Was told she looked pale. Developed severe rigors, lip tingling worse on right. Duration about 20 min of severe sx.  Subsequent severe fatigue,  slept for 4 hours.   During the night awoke with sensation of elephant sitting on chest, right arm heavy, dyspnea.  Assoc?d vaginal irritation. Went to ER - r/o MI, advised H1/H2. Sx improved overall then developed waxing and waning right sided facial tingling, numbness.  Back to baseline in 4-5 days
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Areflexia, CSF glucose normal, CSF protein increased, CSF red blood cell count, CSF white blood cell count increased
Clinical narrative: The initial symptoms were tingling and numbness in both feet. It then became back pain and shooting pain in both legs. He was admitted to Hospital on Tuesday, March 23rd, where he remains currently. He has been diagnosed with Guillian Barre' Syndrome. He is unable to move his limbs and had to be intubated.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: The initial symptoms were tingling and numbness in both feet. It then became back pain and shooting pain in both legs. He was admitted to Hospital on Tuesday, March 23rd, where he remains currently. He has been diagnosed with Guillian Barre' Syndrome. He is unable to move his limbs and had to be intubated.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Bacterial test negative, CSF glucose normal, CSF oligoclonal band absent, CSF protein increased
Clinical narrative: The initial symptoms were tingling and numbness in both feet. It then became back pain and shooting pain in both legs. He was admitted to Hospital on Tuesday, March 23rd, where he remains currently. He has been diagnosed with Guillian Barre' Syndrome. He is unable to move his limbs and had to be intubated.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF red blood cell count positive, CSF white blood cell count increased, Cytomegalovirus test, Cytomegalovirus test negative, Demyelinating polyneuropathy
Clinical narrative: The initial symptoms were tingling and numbness in both feet. It then became back pain and shooting pain in both legs. He was admitted to Hospital on Tuesday, March 23rd, where he remains currently. He has been diagnosed with Guillian Barre' Syndrome. He is unable to move his limbs and had to be intubated.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electromyogram abnormal, Enterovirus test negative, Epstein-Barr virus test negative, Fungal test, Guillain-Barre syndrome
Clinical narrative: The initial symptoms were tingling and numbness in both feet. It then became back pain and shooting pain in both legs. He was admitted to Hospital on Tuesday, March 23rd, where he remains currently. He has been diagnosed with Guillian Barre' Syndrome. He is unable to move his limbs and had to be intubated.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes simplex test negative, Lumbar puncture, Magnetic resonance imaging spinal abnormal, Motor dysfunction, Sensory disturbance
Clinical narrative: The initial symptoms were tingling and numbness in both feet. It then became back pain and shooting pain in both legs. He was admitted to Hospital on Tuesday, March 23rd, where he remains currently. He has been diagnosed with Guillian Barre' Syndrome. He is unable to move his limbs and had to be intubated.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Treponema test negative
Clinical narrative: The initial symptoms were tingling and numbness in both feet. It then became back pain and shooting pain in both legs. He was admitted to Hospital on Tuesday, March 23rd, where he remains currently. He has been diagnosed with Guillian Barre' Syndrome. He is unable to move his limbs and had to be intubated.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Computerised tomogram, Electromyogram, Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: The initial symptoms were tingling and numbness in both feet. It then became back pain and shooting pain in both legs. He was admitted to Hospital on Tuesday, March 23rd, where he remains currently. He has been diagnosed with Guillian Barre' Syndrome. He is unable to move his limbs and had to be intubated.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Laboratory test, Lumbar puncture, Magnetic resonance imaging, Movement disorder
Clinical narrative: The initial symptoms were tingling and numbness in both feet. It then became back pain and shooting pain in both legs. He was admitted to Hospital on Tuesday, March 23rd, where he remains currently. He has been diagnosed with Guillian Barre' Syndrome. He is unable to move his limbs and had to be intubated.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: The initial symptoms were tingling and numbness in both feet. It then became back pain and shooting pain in both legs. He was admitted to Hospital on Tuesday, March 23rd, where he remains currently. He has been diagnosed with Guillian Barre' Syndrome. He is unable to move his limbs and had to be intubated.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: LINGERING PAIN IN UPPER LEFT ARM; BURNING SENSATION; COULD NOT RAISE ARM/COULD NOT REACH FOR CERTAIN THINGS OR TURN AROUND; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol, and non smoker, and other pre-existing medical conditions included no known allergies ,no drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch/ lot no was not reported and has been requested.  No concomitant medications were reported. On MAR-2021, the subject experienced burning sensation. On MAR-2021, the subject experienced could not raise arm/could not reach for certain things or turn around. On MAR-2021, the subject experienced sore arm. Laboratory data included: X-ray (NR: not provided) no finding was found. On 12-MAR-2021, the subject experienced lingering pain in upper left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lingering pain in upper left arm, and the outcome of burning sensation, sore arm and could not raise arm/could not reach for certain things or turn around was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Hypokinesia, Pain, Pain in extremity, X-ray
Clinical narrative: LINGERING PAIN IN UPPER LEFT ARM; BURNING SENSATION; COULD NOT RAISE ARM/COULD NOT REACH FOR CERTAIN THINGS OR TURN AROUND; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol, and non smoker, and other pre-existing medical conditions included no known allergies ,no drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch/ lot no was not reported and has been requested.  No concomitant medications were reported. On MAR-2021, the subject experienced burning sensation. On MAR-2021, the subject experienced could not raise arm/could not reach for certain things or turn around. On MAR-2021, the subject experienced sore arm. Laboratory data included: X-ray (NR: not provided) no finding was found. On 12-MAR-2021, the subject experienced lingering pain in upper left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lingering pain in upper left arm, and the outcome of burning sensation, sore arm and could not raise arm/could not reach for certain things or turn around was not reported. This report was non-serious.
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient was hospitalized X1 and died within 60 days of receiving a COVID vaccine series
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient was hospitalized X1 and died within 60 days of receiving a COVID vaccine series
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exposure during pregnancy, Foetal death, Haematocrit decreased, Haemoglobin decreased, Induced labour
Clinical narrative: Pt had Pfizer COVID vaccine on 3/6 and presented to hospital with intrauterine fetal demise @ ~26wks.  Pathology of placenta c/w maternal floor infarction
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume normal, Mean platelet volume increased, Nucleated red cells
Clinical narrative: Pt had Pfizer COVID vaccine on 3/6 and presented to hospital with intrauterine fetal demise @ ~26wks.  Pathology of placenta c/w maternal floor infarction
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count normal, Red blood cell count normal, Red cell distribution width increased, Stillbirth, White blood cell count normal
Clinical narrative: Pt had Pfizer COVID vaccine on 3/6 and presented to hospital with intrauterine fetal demise @ ~26wks.  Pathology of placenta c/w maternal floor infarction
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Foetal death
Clinical narrative: Pt had Pfizer COVID vaccine on 3/6 and presented to hospital with intrauterine fetal demise @ ~26wks.  Pathology of placenta c/w maternal floor infarction
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exposure during pregnancy, Infarction, Stillbirth
Clinical narrative: Pt had Pfizer COVID vaccine on 3/6 and presented to hospital with intrauterine fetal demise @ ~26wks.  Pathology of placenta c/w maternal floor infarction
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle.  I've been in menopause since I was 47. I'm now 56. Bleeding started 3 days after the injection.  I'm still bleeding,  today is April 22. My obgyn did an ultrasound and said the lining of my uterus has thickened and she conducted an in office  "mini" D&C for a biopsy.  From those results, my progesterone dose was doubled.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy uterus, Endometrial hyperplasia, Menopause, Menstrual disorder, Ultrasound uterus
Clinical narrative: Menstrual cycle.  I've been in menopause since I was 47. I'm now 56. Bleeding started 3 days after the injection.  I'm still bleeding,  today is April 22. My obgyn did an ultrasound and said the lining of my uterus has thickened and she conducted an in office  "mini" D&C for a biopsy.  From those results, my progesterone dose was doubled.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Uterine dilation and curettage
Clinical narrative: Menstrual cycle.  I've been in menopause since I was 47. I'm now 56. Bleeding started 3 days after the injection.  I'm still bleeding,  today is April 22. My obgyn did an ultrasound and said the lining of my uterus has thickened and she conducted an in office  "mini" D&C for a biopsy.  From those results, my progesterone dose was doubled.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Paraesthesia, Syncope
Clinical narrative: Symptoms: Extreme pain immediately after injection at site, closely followed by racing heart and winded and dizzy, followed by sweating, blurred vision and confusion.  Don't remember hitting horn to alert officials. Got out of car, dizzy and stumbled. Blacked out and fell to pavement. Don't remember falling, woke up with extreme mind cloudiness, drowsiness, and hands were numb to touch but felt extreme pressure on palms. When pressure subsided, finger tips felt inflamed.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood pressure measurement, Blood test, Confusional state, Dizziness
Clinical narrative: Symptoms: Extreme pain immediately after injection at site, closely followed by racing heart and winded and dizzy, followed by sweating, blurred vision and confusion.  Don't remember hitting horn to alert officials. Got out of car, dizzy and stumbled. Blacked out and fell to pavement. Don't remember falling, woke up with extreme mind cloudiness, drowsiness, and hands were numb to touch but felt extreme pressure on palms. When pressure subsided, finger tips felt inflamed.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Feeling abnormal, Heart rate, Hyperhidrosis
Clinical narrative: Symptoms: Extreme pain immediately after injection at site, closely followed by racing heart and winded and dizzy, followed by sweating, blurred vision and confusion.  Don't remember hitting horn to alert officials. Got out of car, dizzy and stumbled. Blacked out and fell to pavement. Don't remember falling, woke up with extreme mind cloudiness, drowsiness, and hands were numb to touch but felt extreme pressure on palms. When pressure subsided, finger tips felt inflamed.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site pain, Loss of consciousness, Palpitations, Somnolence
Clinical narrative: Symptoms: Extreme pain immediately after injection at site, closely followed by racing heart and winded and dizzy, followed by sweating, blurred vision and confusion.  Don't remember hitting horn to alert officials. Got out of car, dizzy and stumbled. Blacked out and fell to pavement. Don't remember falling, woke up with extreme mind cloudiness, drowsiness, and hands were numb to touch but felt extreme pressure on palms. When pressure subsided, finger tips felt inflamed.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Symptoms: Extreme pain immediately after injection at site, closely followed by racing heart and winded and dizzy, followed by sweating, blurred vision and confusion.  Don't remember hitting horn to alert officials. Got out of car, dizzy and stumbled. Blacked out and fell to pavement. Don't remember falling, woke up with extreme mind cloudiness, drowsiness, and hands were numb to touch but felt extreme pressure on palms. When pressure subsided, finger tips felt inflamed.