chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injection site mass, Neuralgia, Paraesthesia, Peripheral coldness
Clinical narrative: NEUROPATHY PAIN; PINS NEEDLES IN LEFT HAND; LARGE LUMP IN LEFT ARM/ PAIN IN LEFT ARM/ LUMP THAT WAS 9" NOW DOWN TO 3 (EXTENDING FROM SITE OF INJECTION TOWARD ELBOW, NOT SWELLING BUT AN INTERNAL LUMP); DROPPING THINGS/ AFFECTING ABILITY TO WORK; HAND IS COLD; This spontaneous report received from a patient via a company representative concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included brachial plexus break on right side of body, lyme disease, and brain injury, and concurrent conditions included downgraded brain tumor to brain cyst, neurontin and opiod allergy, and severe reaction to tramadol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at left arm. Concomitant medications included naproxen for drug used for unknown indication. On 13-MAR-2021, the subject experienced neuropathy pain. On 13-MAR-2021, the subject experienced pins needles in left hand. On 13-MAR-2021, the subject experienced large lump in left arm/ pain in left arm/ lump that was 9" now down to 3 (extending from site of injection toward elbow, not swelling but an internal lump). On 13-MAR-2021, the subject experienced dropping things/ affecting ability to work. On 13-MAR-2021, the subject experienced hand is cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from large lump in left arm/ pain in left arm/ lump that was 9" now down to 3 (extending from site of injection toward elbow, not swelling but an internal lump), and had not recovered from neuropathy pain, dropping things/ affecting ability to work, hand is cold, and pins needles in left hand. This report was non-serious.  Additional information received from patient on 31-march-2021 The following information was updated and incorporated :The reporter details were added, patients sex, race and ethnic origin was added, past and concomitant conditions were added. the events neuropathy, pain, dropping things, lump in the arm, hand is cold were subsumed under already presented events, Concomitant medication: naproxen was added, labelling and causality was added, seriousness criteria was updated from non-serious to serious and outcome, also updated from recovering/resolving to not recovered/not resolved, Vaccine facility address and city were added.; Sender's Comments: V1:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body ache; Headache; Fever; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for the case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body ache and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pyrexia
Clinical narrative: FELT WITHOUT STRENGTH; GAVE A TEMPERATURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced felt without strength, and gave a temperature. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt without strength, and gave a temperature. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Nausea
Clinical narrative: SORENESS AT INJECTION POINT (SHOULDER); NAUSEA; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced soreness at injection point (shoulder), nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection point (shoulder), nausea, and fatigue. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had a rash on her back, arms and neck.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Balance disorder, Dysarthria, Erythema, Fatigue
Clinical narrative: 19 hours post vaccine, overcome with  exhaustion, slurred speech, balance instability, hot flashes, red faced which felt bloated.  I obtained transportation home from work. Caffeine seemed to ease symptoms but exhaustion and balance issues remained the next day. Persistent headache remains.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush
Clinical narrative: 19 hours post vaccine, overcome with  exhaustion, slurred speech, balance instability, hot flashes, red faced which felt bloated.  I obtained transportation home from work. Caffeine seemed to ease symptoms but exhaustion and balance issues remained the next day. Persistent headache remains.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: I suddenly found my arm red, itchy, swollen, and in pain around my infection site after took 1st dose of the Moderna vaccine, and it became bigger and bigger every day. 2days later (4/5/2021), I went to the urgent care, the doctor let me take  Zyrtec and use 1% hydrocortisone cream and recommend me to talk with my primary doctor. It does not work. Today?4/7/2021), I have an appointment with my primary doctor, she recommended me to continue to use Zyrtec and use stronger topical triamcinolone cream twice daily instead of over-the-counter 1% hydrocortisone cream.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral, Physical examination
Clinical narrative: Axilla swelling on the left side
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremities)-Mild, Additional Details: got several small red areas on arms.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over back, chest and arms
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Feeling abnormal, Myalgia, Nausea
Clinical narrative: STOMACH ACHES; FELT LOUSY AND FUNKY; SICK TO HIS STOMACH; FEVER; MUSCLE ACHES; This spontaneous report received from a parent concerned a 33 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included autism, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: 25/MAY/2021) dose was not reported, administered on 29-MAR-2021 about 09:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced stomach aches. On 29-MAR-2021, the subject experienced felt lousy and funky. On 29-MAR-2021, the subject experienced sick to his stomach. On 29-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced muscle aches. Laboratory data included: Body temperature (NR: not provided) 98.2 (unit not provided) at about 18:30, 103.4 (unit not provided) at approximately 20:30. Treatment medications included: paracetamol. On 30-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.6 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches on 29-MAR-2021, was recovering from fever, had not recovered from muscle aches, and the outcome of felt lousy and funky and sick to his stomach was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: STOMACH ACHES; FELT LOUSY AND FUNKY; SICK TO HIS STOMACH; FEVER; MUSCLE ACHES; This spontaneous report received from a parent concerned a 33 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included autism, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: 25/MAY/2021) dose was not reported, administered on 29-MAR-2021 about 09:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced stomach aches. On 29-MAR-2021, the subject experienced felt lousy and funky. On 29-MAR-2021, the subject experienced sick to his stomach. On 29-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced muscle aches. Laboratory data included: Body temperature (NR: not provided) 98.2 (unit not provided) at about 18:30, 103.4 (unit not provided) at approximately 20:30. Treatment medications included: paracetamol. On 30-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.6 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches on 29-MAR-2021, was recovering from fever, had not recovered from muscle aches, and the outcome of felt lousy and funky and sick to his stomach was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: I was extremely tired, achy all over and had a very bad headache that started about 14 hours after the shot and lasted 30 hours.  The next day was a little tired but no other symptoms have occurred after that.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Vital signs measurement
Clinical narrative: Patient stated she had a history of fainting with blood draws. Patient stated she did eat before vaccination. Nurse on hand as well as another person to assist if needed. Patient was administered vaccination by medic within 3 min started feeling nauseated and sweating she lost consiouness. Medic and public health nurse able to lie on floor patient safe and did not hit her head. Ambulance staff paremedic on site. B/p taken 90/58, O2 98% 66 Pulse. Cool cloth to head and ice packs to neck. Within a minute Patient regained cauntiousness. Juice given. Patient was able to eat a cookie. Stated she was feeling better. Assisted tranfer to wheelchair to monitoring station for additional 30 min. Patient declined to be taken to local hospital via medics. B/p reassed at 0112 10/98 100% o2 68 pulse. Patient able to talk and drink water without any problems. Patient was present with husband. Patient monitored a aditional 30 min. before leaving. Patient gait steady and no slurring of speech. Patient was advised if any problems arise to seek 911. Patient stated she would not be driving home her Husband would.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Confusional state, Fatigue, Flank pain
Clinical narrative: Reported fever, chills, chest pain, sweating, body aches, fatigue, and confusion 4/2/21-4/3/21. Symptoms resolve by 4/4/21. Right rib/flank pain started 4/6/21, rated 2/10,  increased  in frequency today 4/7/21.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Musculoskeletal chest pain, Pain, Pyrexia
Clinical narrative: Reported fever, chills, chest pain, sweating, body aches, fatigue, and confusion 4/2/21-4/3/21. Symptoms resolve by 4/4/21. Right rib/flank pain started 4/6/21, rated 2/10,  increased  in frequency today 4/7/21.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: Pale, dizzy, hot sweating; no meds passed; allergy to penicillin
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo and dizziness.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Sore at site of injection, left arm.  became sleepy.  severe aches in legs and arms and feet.  chills and sweats.  very thirsty. sore head. diarrhea
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Thirst
Clinical narrative: Sore at site of injection, left arm.  became sleepy.  severe aches in legs and arms and feet.  chills and sweats.  very thirsty. sore head. diarrhea
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury, Loss of consciousness, Vision blurred
Clinical narrative: Patient passed out, fell out of her chair and hit her head hard after receiving her shot. Once she went down, two nurses ran to her assistance where they propped the patient's feet up on a chair and got her some water. Patient reported blurred vision, had a goose egg on the back of her head but did not appear to be mentally foggy.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dysphagia, Fatigue, Head discomfort
Clinical narrative: Within a few minutes I became extremely dizzy and disoriented a bit, immediately following I had extreme difficulty swallowing as if I had a ball in my throat.  Nurses recognized and immediately gave me Benadryl.  Today I feel a lot of pressure in my head, fatigue, tingling in lips and right hand.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Sensation of foreign body
Clinical narrative: Within a few minutes I became extremely dizzy and disoriented a bit, immediately following I had extreme difficulty swallowing as if I had a ball in my throat.  Nurses recognized and immediately gave me Benadryl.  Today I feel a lot of pressure in my head, fatigue, tingling in lips and right hand.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain, Pain in extremity, Skin warm
Clinical narrative: Swollen nodes under armpit and above clavicle. Feels hot  and burning pain under armpit and arm.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Covid arm, my upper left arm is very swollen, red, and itchy.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Oropharyngeal discomfort, Pharyngeal paraesthesia, Skin discolouration, Skin warm
Clinical narrative: Warm and tickling in throat.  No signs or symptoms of distress.  PS02 100%  pulse 99  Respirations even and unlabored. Skin pink warm and dry.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient started with numbness and tingling on her left side of her face after 15 minutes of observation in the store.  During the next 30 minutes the numbness moved to her right side of her face and lips.  Patient was instructed to contact her PCP after she left the store.  Patient was no experiencing any other symptoms.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Hypoaesthesia
Clinical narrative: Adverse effect of vaccine, initial encounter (Primary). Word finding difficulty. Decreased sensation. Comments: left side of face, Neuro exam today reassuring however it would be difficult to fully "rule out" any more serious adverse reactions without intracranial imaging. Offered head CT but patient declined. Anxiety, To help mitigate anxiety when due for second vaccine. Lorazepam (ATIVAN) 1 mg tablet; Take 0.5-1 tablets by mouth every 8 hours as needed for Anxiety.  Dispense: 1 tablet; Refill: 0. Patient given the following instructions and/or handouts: If your symptoms continue and you change your mind about wanting to proceed with a brain scan to rule out blood clots. Return if symptoms worsen or fail to improve. Total time spent on patient's care today including pre-visit work, face to face time, education or counseling, documentation etc. was 30 minutes.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: BLURRY VISION, DIFFICULTY FOCUSING.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Parkinson's disease, and arthritis, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on left arm on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever over 101, headache, body aches, lasted 1 day
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram abdomen, Computerised tomogram head, Hypoaesthesia, Lumbar puncture
Clinical narrative: Tingling, rapid fire sharp nerve pain, numbness through out body.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Neuralgia, Paraesthesia
Clinical narrative: Tingling, rapid fire sharp nerve pain, numbness through out body.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Chills, Lumbar puncture, Paraesthesia
Clinical narrative: Tingling, rapid fire sharp nerve pain, numbness through out body.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Tingling, rapid fire sharp nerve pain, numbness through out body.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Hypoaesthesia, Paraesthesia, Pyrexia, Tremor
Clinical narrative: Tingling, rapid fire sharp nerve pain, numbness through out body.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: The patient fainted shortly after the vaccine. Patient stated that this has happened twice in the past with other vaccinations. He feels this had nothing to do with the vaccination its self.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Nausea
Clinical narrative: Fever, Nausea, Headache, Body Ache, Chills, Tired, Stomachache (throwing up)
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever, Nausea, Headache, Body Ache, Chills, Tired, Stomachache (throwing up)
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Patient reported 1 week after vaccination left elbow turned black and is still black. Does not remember bumping it in any way. No pain.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: SHE FELT ANXIOUS, FELT DIZZY AND SWEATING, WE TOOK HER BLD PRESSURE 104/75 HR 68. AFTER SHE RELAXED AND LIE PAT DOWN AND ELEVATE FEET,. SHE FELT BETTER HER BLD PRESSURE WENT UP TO 113/82  HR 80. O2 ST 98%. FOLLOW UP WITH HER ON 4/7/2021. SHE FELT COMPLETLETY FINE.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Myalgia, Panic attack
Clinical narrative: Normal muscle aches within the first 24 hours.  After that, creeping anxiety and panic attack similar to one that happened while I was positive with Covid in December of 2020.  Had anxiety including increased heart rate and impending sense of doom requiring a trip to counselor.  During Covid positivity, had severe anxiety and panic attack--also some hallucinations and severe paranoia.  However, I was too ill at home to be fully aware of the extent of the problem and was too anxious to seek help.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Cold sweat, Hyperhidrosis, Injection site erythema, Injection site pruritus
Clinical narrative: On April 1, 2021 @ 9:30 Pm, Started with nausea then cold sweats and then went into more intense nausea and sweating profusely.  Also began vomiting.  This went on until 6:30 AM April 2, 2021 and then the vomiting stopped.  Then cramping throughout body, hands, feet, legs all body.  Had temp 101.8.  Took Tylenol and was able to sleep a bit.  April 3, 2021 less body cramping and able to hold hold down clear liquids.  Also on April 2, 2021 Left Arm 2x3 inch site became red, swollen and itchy and this lasted until April 4, 2021.  As today April 7, 2021 is getting better but still recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Muscle spasms, Nausea, Vomiting
Clinical narrative: On April 1, 2021 @ 9:30 Pm, Started with nausea then cold sweats and then went into more intense nausea and sweating profusely.  Also began vomiting.  This went on until 6:30 AM April 2, 2021 and then the vomiting stopped.  Then cramping throughout body, hands, feet, legs all body.  Had temp 101.8.  Took Tylenol and was able to sleep a bit.  April 3, 2021 less body cramping and able to hold hold down clear liquids.  Also on April 2, 2021 Left Arm 2x3 inch site became red, swollen and itchy and this lasted until April 4, 2021.  As today April 7, 2021 is getting better but still recovering.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: tested positive for COVID-19 after being fully vaccinated (experiencing  sx; fever, cough, sore throat, shortness of breath, fatigue, chills, headache, and runny nose).
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19 after being fully vaccinated (experiencing  sx; fever, cough, sore throat, shortness of breath, fatigue, chills, headache, and runny nose).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity
Clinical narrative: 1. Sore arm lasting roughly 48-60 hours post vaccination; 2. Headache lasting roughly 48 hours post vaccination; 3. Malaise lasting roughly 36-48 hours post vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received 2nd dose vaccine of Moderna and should have received 2nd dose of Pfizer
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Severe pain upper left are and fatigue lasting 2 days
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: MULTIPLE SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection and route of admin were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced multiple side effects. The action taken with covid-19 vaccine  was not applicable. The outcome of multiple side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210354511.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Mobility decreased, Muscle twitching, Pain
Clinical narrative: Immediate heavy bleeding and extreme swelling, pain and tenderness.  Headache 30 min after receiving 1st dose, and has not faded 30 hrs later. Unable to lift arm all the way up and forward due to pain and tightness in arm. Twitching of muscles in same arm as injection . Administrator of injection said I was worst bleeder he has seen since day 1, and advised and ice pack for swelling. Pain and swelling in arm is tremendous.  Muscle of injection site is hard and very painful. OTC medications not helping with pain or swelling.  Reluctant to go for 2nd dose.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Skin tightness, Swelling, Tenderness
Clinical narrative: Immediate heavy bleeding and extreme swelling, pain and tenderness.  Headache 30 min after receiving 1st dose, and has not faded 30 hrs later. Unable to lift arm all the way up and forward due to pain and tightness in arm. Twitching of muscles in same arm as injection . Administrator of injection said I was worst bleeder he has seen since day 1, and advised and ice pack for swelling. Pain and swelling in arm is tremendous.  Muscle of injection site is hard and very painful. OTC medications not helping with pain or swelling.  Reluctant to go for 2nd dose.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Flushing, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Mild, Additional Details: Patient had a rash on chest, back, stomach starting day after vaccine. Patient consumed nuts on 4-6-2021, but she thinks she already had rash when she consumed nuts
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Pyrexia, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Mild, Additional Details: Patient had a rash on chest, back, stomach starting day after vaccine. Patient consumed nuts on 4-6-2021, but she thinks she already had rash when she consumed nuts
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure abnormal, Chest pain, Dizziness, Dry mouth
Clinical narrative: Patient complained of shortness of breath, chest pain, dizziness, nausea and vomiting and dry mouth.  Patient only ate crackers and half granola bar since 4:30AM.    Blood pressure 220/120, anxious
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea, Vomiting
Clinical narrative: Patient complained of shortness of breath, chest pain, dizziness, nausea and vomiting and dry mouth.  Patient only ate crackers and half granola bar since 4:30AM.    Blood pressure 220/120, anxious
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient completed Covid 19 vaccine series on 01/07/2021 and was diagnosed with Covid 19 on 4/5/2021
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: Felt a ball to the throat. B/P 155/88, HR 87, O2Sat 98%, T 97. 12:42pm Patient left Park stating that he feels better.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture positive, Coordination abnormal, Fatigue, Grip strength decreased, Immunoglobulin therapy
Clinical narrative: On the same day of COVID vaccine patient received her Immune globulin injection that she receives monthly (refer to med list). March 29th 2021- patient started having decreased strength and coordination in hands.  March 31st 2021- patient was very sleepy and slept over 24 hours April 1st 2021- Could not feed herself and was very uncoordinated with her hands/arms.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Loss of personal independence in daily activities, Lumbar puncture, Somnolence, Staphylococcus test positive
Clinical narrative: On the same day of COVID vaccine patient received her Immune globulin injection that she receives monthly (refer to med list). March 29th 2021- patient started having decreased strength and coordination in hands.  March 31st 2021- patient was very sleepy and slept over 24 hours April 1st 2021- Could not feed herself and was very uncoordinated with her hands/arms.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Rash pruritic
Clinical narrative: RED BLOTCHES ITCHING ON CHEST, BLOTCHES ON STOMACH ON THIGHS AND ALL OVER TOPS OF FEET AND BOTH LEGS; SEVERE CHILLS; This spontaneous report received from a patient concerned an 85 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart attacks, and concurrent conditions included penicillin allergy, and tetracycline allergy. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) once a total dose was not reported, administered on 23-MAR-2021 at  left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) Normal. On 23-MAR-2021, the subject experienced severe chills. On 27-MAR-2021, the subject experienced red blotches itching on chest, blotches on stomach on thighs and all over tops of feet and both legs. Treatment medications (dates unspecified) included: cortisone, and paraffin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills on 24-MAR-2021, and had not recovered from red blotches itching on chest, blotches on stomach on thighs and all over tops of feet and both legs. This report was non-serious. This case, from the same reporter is linked to 20210355358.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hive on face under left eye.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Fatigue, Heart rate increased, Hypotension, Nausea
Clinical narrative: Fever 100.8, severe body aches, severe fatigue, rapid heart rate, high glucose level, low blood pressure, nausea. This lasted for 12 hours yesterday. Today is severe fatigue and body aches.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 100.8, severe body aches, severe fatigue, rapid heart rate, high glucose level, low blood pressure, nausea. This lasted for 12 hours yesterday. Today is severe fatigue and body aches.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak on back and left side.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccine positive rechallenge
Clinical narrative: Severe tinnitus, continuous since first injection.  No change or abatement since.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Flushing, Skin warm
Clinical narrative: Patient was observed post Covid-19 immunization for 30 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  warmness,flushed, "jitterness". Symptoms occurred 21 minutes into her 30 minute observation. Assessment : Time of assessment 1154.  Alert and oriented. Nausea, Unlabored, breathing, Heart rate normal Actions taken:  Vitals sign taken  1158AM 140/73,69HR, 98%, 1217PM 124/97,86HR,95% Patient was observed an additional 32 minutes after symptoms occurred.   Medications administered: No medication administered.   Disposition: Instructed to see primary doctor for non-severe reactions. Instructed to call 911 or be seen in Emergency Room for severe reactions. Patient sated "jitterness" was down from a 10 to a 2.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia
Clinical narrative: Slight upset stomach, chills, headache, muscle soreness.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Flushing, Hypoaesthesia, Wheezing
Clinical narrative: Approximately 5 minutes post vaccination patient experienced right arm numbness, followed by flushing of her arms, chest & cheeks;  after another 10 minutes patient  began coughing and wheezing  at which time Epi was administered and wheezing stopped, and patient was placed on 5L oxygen. Approximately 2-3 minutes later, coughing & wheezing restarted, at which time 120 mg Kenalog was administered together with an SVN treatment.  Paramedics were called to transport patient to the ER for observation. Patient was seen the following day in office or follow up and is doing well.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Mild, Additional Details: Pt notes mild lymph node swelling. She has been alternating Bayer and extra strength Tylenol. Doesn't report pain to touch. She has called her Md who advised that she speak to site where vaccine was administered. She will also try Bendryl for possible histamine response.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient brought to site by father for COVID vaccination. Father completed form and gave incorrect age and DOB of patient in order to have child vaccinated. Patient is 15 years 7 months old, and father wrote he was 16 years 7 months and changed DOB on consent form to reflect this age. Patient only had school ID which has no birth date and vaccine was given. After vaccine given, staff who are responsible for ensuring vaccine transferred to immunization tracking system noticed the patient's DOB was incorrect and notified author. Patient was off site when they noticed and had no reported adverse effects while waiting the recommended 15 minutes.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Nausea, Pain
Clinical narrative: Started with body aches, chills, and nausea. Nausea and vomiting, more severe body aches and abdominal pain continued throughout night of receiving vaccine. Also had a mild fever and severe fatigue. Fatigue and aches persisted on day 2, but other effects began to subside. By day 3, I was able to function normally again.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Started with body aches, chills, and nausea. Nausea and vomiting, more severe body aches and abdominal pain continued throughout night of receiving vaccine. Also had a mild fever and severe fatigue. Fatigue and aches persisted on day 2, but other effects began to subside. By day 3, I was able to function normally again.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 9a next day body aches with low grade fever
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There is no adverse reaction, the vaccines was given to 17 yrs old patient. Talk to the patients's mom, Pt is doing good. there are no symptons of any reaction.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tachycardia
Clinical narrative: Patient had chills and fever accompanied by tachycardia with heart rate in the 130's
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle spasms, Pyrexia, Visual impairment
Clinical narrative: 12 hours after vaccine, woke to high fever and muscle cramps, violent shivering, splitting headache, spotty vision
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fell out of chair #7 in pharmacy. This author caught patient and brought to floor. EMS called at 12:44. Nurse on site took patients BP 108/66. Could not get HR. EMS arrived at 12:52. EMS evaluated patient. Gave patient cold water. Patient declined hospital transfer. Patient was over 18 and EMS gave her paper that stated she declined hospital care. EMS left 12:57.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fell out of chair #7 in pharmacy. This author caught patient and brought to floor. EMS called at 12:44. Nurse on site took patients BP 108/66. Could not get HR. EMS arrived at 12:52. EMS evaluated patient. Gave patient cold water. Patient declined hospital transfer. Patient was over 18 and EMS gave her paper that stated she declined hospital care. EMS left 12:57.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cough, Diplopia, Dizziness, Dysphonia
Clinical narrative: VOICE SOUNDED LITTLE FUNNY; BODY NOT MOVING (BARELY ABLE TO  STAND-UP); WHOLE BODY PAIN, BODY HURTING; DIZZINESS; DOUBLE VISION; COUGH; FELLING HORRIBLE; FEVER (100.7F); BAD HEADACHE; NAUSEA-FELT LIKE VOMITING; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and acute infectious colitis, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included for acute infectious colitis. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced double vision. On 28-MAR-2021, the subject experienced cough. On 28-MAR-2021, the subject experienced felling horrible. On 28-MAR-2021, the subject experienced fever (100.7f). On 28-MAR-2021, the subject experienced bad headache. On 28-MAR-2021, the subject experienced nausea-felt like vomiting. On 28-MAR-2021 04:00, the subject experienced body not moving (barely able to stand-up). On 28-MAR-2021 04:00, the subject experienced whole body pain, body hurting. On 29-MAR-2021, the subject experienced voice sounded little funny. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from whole body pain, body hurting, body not moving (barely able to stand-up), fever (100.7f), dizziness, bad headache, double vision, nausea-felt like vomiting, cough, and felling horrible, and had not recovered from voice sounded little funny. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: VOICE SOUNDED LITTLE FUNNY; BODY NOT MOVING (BARELY ABLE TO  STAND-UP); WHOLE BODY PAIN, BODY HURTING; DIZZINESS; DOUBLE VISION; COUGH; FELLING HORRIBLE; FEVER (100.7F); BAD HEADACHE; NAUSEA-FELT LIKE VOMITING; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and acute infectious colitis, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included for acute infectious colitis. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced double vision. On 28-MAR-2021, the subject experienced cough. On 28-MAR-2021, the subject experienced felling horrible. On 28-MAR-2021, the subject experienced fever (100.7f). On 28-MAR-2021, the subject experienced bad headache. On 28-MAR-2021, the subject experienced nausea-felt like vomiting. On 28-MAR-2021 04:00, the subject experienced body not moving (barely able to stand-up). On 28-MAR-2021 04:00, the subject experienced whole body pain, body hurting. On 29-MAR-2021, the subject experienced voice sounded little funny. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from whole body pain, body hurting, body not moving (barely able to stand-up), fever (100.7f), dizziness, bad headache, double vision, nausea-felt like vomiting, cough, and felling horrible, and had not recovered from voice sounded little funny. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: VOICE SOUNDED LITTLE FUNNY; BODY NOT MOVING (BARELY ABLE TO  STAND-UP); WHOLE BODY PAIN, BODY HURTING; DIZZINESS; DOUBLE VISION; COUGH; FELLING HORRIBLE; FEVER (100.7F); BAD HEADACHE; NAUSEA-FELT LIKE VOMITING; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and acute infectious colitis, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included for acute infectious colitis. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced double vision. On 28-MAR-2021, the subject experienced cough. On 28-MAR-2021, the subject experienced felling horrible. On 28-MAR-2021, the subject experienced fever (100.7f). On 28-MAR-2021, the subject experienced bad headache. On 28-MAR-2021, the subject experienced nausea-felt like vomiting. On 28-MAR-2021 04:00, the subject experienced body not moving (barely able to stand-up). On 28-MAR-2021 04:00, the subject experienced whole body pain, body hurting. On 29-MAR-2021, the subject experienced voice sounded little funny. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from whole body pain, body hurting, body not moving (barely able to stand-up), fever (100.7f), dizziness, bad headache, double vision, nausea-felt like vomiting, cough, and felling horrible, and had not recovered from voice sounded little funny. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Headache, Heart rate, Heart rate increased
Clinical narrative: VOICE SOUNDED LITTLE FUNNY; BODY NOT MOVING (BARELY ABLE TO  STAND-UP); WHOLE BODY PAIN, BODY HURTING; DIZZINESS; DOUBLE VISION; COUGH; FELLING HORRIBLE; FEVER (100.7F); BAD HEADACHE; NAUSEA-FELT LIKE VOMITING; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and acute infectious colitis, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included for acute infectious colitis. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced double vision. On 28-MAR-2021, the subject experienced cough. On 28-MAR-2021, the subject experienced felling horrible. On 28-MAR-2021, the subject experienced fever (100.7f). On 28-MAR-2021, the subject experienced bad headache. On 28-MAR-2021, the subject experienced nausea-felt like vomiting. On 28-MAR-2021 04:00, the subject experienced body not moving (barely able to stand-up). On 28-MAR-2021 04:00, the subject experienced whole body pain, body hurting. On 29-MAR-2021, the subject experienced voice sounded little funny. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from whole body pain, body hurting, body not moving (barely able to stand-up), fever (100.7f), dizziness, bad headache, double vision, nausea-felt like vomiting, cough, and felling horrible, and had not recovered from voice sounded little funny. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: VOICE SOUNDED LITTLE FUNNY; BODY NOT MOVING (BARELY ABLE TO  STAND-UP); WHOLE BODY PAIN, BODY HURTING; DIZZINESS; DOUBLE VISION; COUGH; FELLING HORRIBLE; FEVER (100.7F); BAD HEADACHE; NAUSEA-FELT LIKE VOMITING; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and acute infectious colitis, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included for acute infectious colitis. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced double vision. On 28-MAR-2021, the subject experienced cough. On 28-MAR-2021, the subject experienced felling horrible. On 28-MAR-2021, the subject experienced fever (100.7f). On 28-MAR-2021, the subject experienced bad headache. On 28-MAR-2021, the subject experienced nausea-felt like vomiting. On 28-MAR-2021 04:00, the subject experienced body not moving (barely able to stand-up). On 28-MAR-2021 04:00, the subject experienced whole body pain, body hurting. On 29-MAR-2021, the subject experienced voice sounded little funny. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from whole body pain, body hurting, body not moving (barely able to stand-up), fever (100.7f), dizziness, bad headache, double vision, nausea-felt like vomiting, cough, and felling horrible, and had not recovered from voice sounded little funny. This report was non-serious.