chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Facial spasm, Fatigue, Grip strength decreased, Headache
Clinical narrative: 5 minutes after the injection I lost function in both arms and controlling my eyes. Couldn't hold my phone up. The pharmacist helped me to the floor and I began to convulse and spasm, especially on the left side. These convulsions, spasms, facial and body ticks came in waves of extreme, almost bone-breaking tension, then I would go limp, then repeat. It is day 9 after the injection and the convulsions, spasms, and general tremoring continues. Extreme overall body pain like electric shocks and vibrations that wake me from sleep when I can get it. The left side of the body worse. Blinding headaches began after 2 days. Left facial droop and generalized flat facial affect as I can't smile without spams. Eyes spasm when I try to look around. Extreme fatigue and irregular breathing (diaphragm spasm?). Grip strength impaired and I drop everything and food and liquids fall from my mouth. Sharp shooting electric pain through the left arm, neck, skull, face, ear, and shoulder blade. The ear will spasm to where my ear touches my shoulder and I can't move it. I cannot drive. And have had to be dependent on others for everything.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Impaired driving ability, Irregular breathing, Mobility decreased, Muscle spasms, Neck pain
Clinical narrative: 5 minutes after the injection I lost function in both arms and controlling my eyes. Couldn't hold my phone up. The pharmacist helped me to the floor and I began to convulse and spasm, especially on the left side. These convulsions, spasms, facial and body ticks came in waves of extreme, almost bone-breaking tension, then I would go limp, then repeat. It is day 9 after the injection and the convulsions, spasms, and general tremoring continues. Extreme overall body pain like electric shocks and vibrations that wake me from sleep when I can get it. The left side of the body worse. Blinding headaches began after 2 days. Left facial droop and generalized flat facial affect as I can't smile without spams. Eyes spasm when I try to look around. Extreme fatigue and irregular breathing (diaphragm spasm?). Grip strength impaired and I drop everything and food and liquids fall from my mouth. Sharp shooting electric pain through the left arm, neck, skull, face, ear, and shoulder blade. The ear will spasm to where my ear touches my shoulder and I can't move it. I cannot drive. And have had to be dependent on others for everything.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Seizure, Sleep disorder, Tremor
Clinical narrative: 5 minutes after the injection I lost function in both arms and controlling my eyes. Couldn't hold my phone up. The pharmacist helped me to the floor and I began to convulse and spasm, especially on the left side. These convulsions, spasms, facial and body ticks came in waves of extreme, almost bone-breaking tension, then I would go limp, then repeat. It is day 9 after the injection and the convulsions, spasms, and general tremoring continues. Extreme overall body pain like electric shocks and vibrations that wake me from sleep when I can get it. The left side of the body worse. Blinding headaches began after 2 days. Left facial droop and generalized flat facial affect as I can't smile without spams. Eyes spasm when I try to look around. Extreme fatigue and irregular breathing (diaphragm spasm?). Grip strength impaired and I drop everything and food and liquids fall from my mouth. Sharp shooting electric pain through the left arm, neck, skull, face, ear, and shoulder blade. The ear will spasm to where my ear touches my shoulder and I can't move it. I cannot drive. And have had to be dependent on others for everything.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye movement disorder, Loss of consciousness, Muscle spasms, Syncope
Clinical narrative: 5 minutes after the injection I lost function in both arms and controlling my eyes. Couldn't hold my phone up. The pharmacist helped me to the floor and I began to convulse and spasm, especially on the left side. These convulsions, spasms, facial and body ticks came in waves of extreme, almost bone-breaking tension, then I would go limp, then repeat. It is day 9 after the injection and the convulsions, spasms, and general tremoring continues. Extreme overall body pain like electric shocks and vibrations that wake me from sleep when I can get it. The left side of the body worse. Blinding headaches began after 2 days. Left facial droop and generalized flat facial affect as I can't smile without spams. Eyes spasm when I try to look around. Extreme fatigue and irregular breathing (diaphragm spasm?). Grip strength impaired and I drop everything and food and liquids fall from my mouth. Sharp shooting electric pain through the left arm, neck, skull, face, ear, and shoulder blade. The ear will spasm to where my ear touches my shoulder and I can't move it. I cannot drive. And have had to be dependent on others for everything.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Disease recurrence, Dizziness, Dyskinesia, Fatigue
Clinical narrative: 5 minutes after the injection I lost function in both arms and controlling my eyes. Couldn't hold my phone up. The pharmacist helped me to the floor and I began to convulse and spasm, especially on the left side. These convulsions, spasms, facial and body ticks came in waves of extreme, almost bone-breaking tension, then I would go limp, then repeat. It is day 9 after the injection and the convulsions, spasms, and general tremoring continues. Extreme overall body pain like electric shocks and vibrations that wake me from sleep when I can get it. The left side of the body worse. Blinding headaches began after 2 days. Left facial droop and generalized flat facial affect as I can't smile without spams. Eyes spasm when I try to look around. Extreme fatigue and irregular breathing (diaphragm spasm?). Grip strength impaired and I drop everything and food and liquids fall from my mouth. Sharp shooting electric pain through the left arm, neck, skull, face, ear, and shoulder blade. The ear will spasm to where my ear touches my shoulder and I can't move it. I cannot drive. And have had to be dependent on others for everything.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Muscle spasms, Paraesthesia, Seizure, Syncope
Clinical narrative: 5 minutes after the injection I lost function in both arms and controlling my eyes. Couldn't hold my phone up. The pharmacist helped me to the floor and I began to convulse and spasm, especially on the left side. These convulsions, spasms, facial and body ticks came in waves of extreme, almost bone-breaking tension, then I would go limp, then repeat. It is day 9 after the injection and the convulsions, spasms, and general tremoring continues. Extreme overall body pain like electric shocks and vibrations that wake me from sleep when I can get it. The left side of the body worse. Blinding headaches began after 2 days. Left facial droop and generalized flat facial affect as I can't smile without spams. Eyes spasm when I try to look around. Extreme fatigue and irregular breathing (diaphragm spasm?). Grip strength impaired and I drop everything and food and liquids fall from my mouth. Sharp shooting electric pain through the left arm, neck, skull, face, ear, and shoulder blade. The ear will spasm to where my ear touches my shoulder and I can't move it. I cannot drive. And have had to be dependent on others for everything.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: 5 minutes after the injection I lost function in both arms and controlling my eyes. Couldn't hold my phone up. The pharmacist helped me to the floor and I began to convulse and spasm, especially on the left side. These convulsions, spasms, facial and body ticks came in waves of extreme, almost bone-breaking tension, then I would go limp, then repeat. It is day 9 after the injection and the convulsions, spasms, and general tremoring continues. Extreme overall body pain like electric shocks and vibrations that wake me from sleep when I can get it. The left side of the body worse. Blinding headaches began after 2 days. Left facial droop and generalized flat facial affect as I can't smile without spams. Eyes spasm when I try to look around. Extreme fatigue and irregular breathing (diaphragm spasm?). Grip strength impaired and I drop everything and food and liquids fall from my mouth. Sharp shooting electric pain through the left arm, neck, skull, face, ear, and shoulder blade. The ear will spasm to where my ear touches my shoulder and I can't move it. I cannot drive. And have had to be dependent on others for everything.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Mild hives after first vaccine.  Severe hives after second vaccine.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle contractions involuntary, Pyrexia
Clinical narrative: 16-year-old one day status post Pfizer vaccination #2.  Other than the typical, known side effects of the vaccination, patient has right sided  and fasciculations at rest and with movement.  Additionally she reports numbness of the hands and feet  although sensation is intact to light touch and remainder of exam is reassuring.  The exam is not consistent with tardive dyskinesia, however in order to give patient symptomatic relief she was given Benadryl 25 mg by mouth ×1 with resolution of the fasciculations. Incidentally, the patient did develop a fever while in the urgent care, was given 650 mg of Tylenol.  Patient was discharged from the urgent care in good condition, reassuring vital signs, well-appearing with instructions to take Tylenol and Benadryl as below as needed.  Peds follow-up Monday
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Covid arm
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Palpitations, Throat tightness
Clinical narrative: What feels like anxiety attacks (Heart racing, Throat feels closed up) happen everyday usually. sometimes occur multiple times a day usually at night or late afternoon. After the first dose they started small and got bigger and more frequent after the second shot they have become smaller and a little less frequent but still occur. I should note that I used to have anxiety attacks 5 or so years ago just like this but have since stopped having attacks all together up until my first shot
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling at my sides below the ribs and above the hips.  Numbness and tingling across my torso in a horizontal line.  I can feel the nerve as if it's an electric fence.  It's a solid wire.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram, Sinus rhythm, Troponin
Clinical narrative: Two days after receiving the vaccine, the patient came to the ER with upper left chest pain. Patient had felt fine after the second vaccine and was hiking (two 14-ers). Upon coming home he had sudden chest pain.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Hemiplegia
Clinical narrative: I was diagnosed with Bell?s palsy. Left side facial paralysis. These symptoms lasted about 3 weeks during treatment
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Anxiety, C-reactive protein, Confusional state, Diarrhoea
Clinical narrative: Developed intense brain fog, confusion, memory loss, diarrhea, sleeping 10-12 hrs per day plus 2 naps per day. Was to the point that I was reaching out to touch my family members to make sure they were really standing in front of me. As an RN myself, I was very worried. Lasted for a total of 5-6 days and then completely went away. No history of mental illness other than anxiety. Was seen by PCP on day 2 of symptoms. Scheduled for MRI of the brain and complete lab work collected. No signs of inflammation or infection. If symptoms continued then would have prescribed course of steroids but symptoms went away on June 7th. 2nd dose of vaccine was on June 1st.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Full blood count, Hypersomnia, Metabolic function test, Neutrophil count
Clinical narrative: Developed intense brain fog, confusion, memory loss, diarrhea, sleeping 10-12 hrs per day plus 2 naps per day. Was to the point that I was reaching out to touch my family members to make sure they were really standing in front of me. As an RN myself, I was very worried. Lasted for a total of 5-6 days and then completely went away. No history of mental illness other than anxiety. Was seen by PCP on day 2 of symptoms. Scheduled for MRI of the brain and complete lab work collected. No signs of inflammation or infection. If symptoms continued then would have prescribed course of steroids but symptoms went away on June 7th. 2nd dose of vaccine was on June 1st.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Seizure, Serology test
Clinical narrative: Seizures on 2 separate events 16 May and 22 May in otherwise healthy male. Self-limiting. Scheduled to see neurology
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhea for four days after eating any meal, Extreme tiredness
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Slight pins and needles feeling on left side of body from neck to top of left knee a few hours after 2nd dose of vaccination.  Over the course of days, the discomfort only occurs in left hand thumb, index and middle finger.  3 weeks later, the numbness is only on index finger tip of left hand.  About 4.5 weeks later(June 14th), the burning sensation still persist only on left hand index finger tip.  Have no history of carpal tunnel.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Rash
Clinical narrative: Large lump in arm and rash throughout entire arm.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Hot flush, Injection site rash
Clinical narrative: Hot Flashes, chills, increase in non-epileptic Seizures, fever 103.7, body aches, rash around injection site, extreme exhaustion, vomiting, chest pain. Symptoms lasted 3 days with exception of rash, fever and chills which lasted 8days.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Seizure, Vomiting
Clinical narrative: Hot Flashes, chills, increase in non-epileptic Seizures, fever 103.7, body aches, rash around injection site, extreme exhaustion, vomiting, chest pain. Symptoms lasted 3 days with exception of rash, fever and chills which lasted 8days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eyelid oedema, Malaise, Pain in extremity
Clinical narrative: Usual sore arm and not feeling great, but thing I?m concerned about is left eyelid became sore soon after and later at night I noticed it was red and puffy. Not sure what to do.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no relevant medical history. The patient experienced drug allergy when treated with bisoprolol, naproxen sodium, and diazepam for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECTLY STORED VACCINE INJECTED; VACCINE STORED IN SYRINGES AT ROOM TEMPERATURE FOR 3 HOURS INSTEAD OF 2 HOURS; This spontaneous report received from a pharmacist concerned a 58 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUN-2021, the subject experienced incorrectly stored vaccine injected. On 08-JUN-2021, the subject experienced vaccine stored in syringes at room temperature for 3 hours instead of 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrectly stored vaccine injected and vaccine stored in syringes at room temperature for 3 hours instead of 2 hours was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site nodule, Injection site pain
Clinical narrative: KNOT FORMED AT INJECTION SITE; KNOT LOOKS BRUISED; SORENESS AT THE INJECTION SITE/KNOT FEELS SORE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced soreness at the injection site/knot feels sore. On 06-JUN-2021, the subject experienced knot formed at injection site. On 06-JUN-2021, the subject experienced knot looks bruised. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at the injection site/knot feels sore, knot formed at injection site and knot looks bruised was not reported. This report was non-serious.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Skin discolouration
Clinical narrative: LITTLE PINK COLOR OF THE CHEEK; This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's past medical history included childhood asthma, and concurrent conditions included high blood pressure, mold allergy, dust allergy, and allergy to trees. The patient experienced severe allergic reaction when treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) NEGATIVE. On 22-MAY-2021, the subject experienced little pink color of the cheek. The action taken with covid-19 vaccine was not applicable. The patient recovered from little pink color of the cheek on 22-MAY-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: MENSTRUAL BLEEDING; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included period ceased. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced menstrual bleeding. The action taken with covid-19 vaccine was not applicable. The outcome of menstrual bleeding was not reported. This report was non-serious. This case, from the same reporter is linked to 20210621127.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced expired vaccine use. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine use was not reported. This report was non-serious. This report was associated with product quality complaint: 90000182243. The suspected product quality complaint has been confirmed to be to be voided (no PQC was identified) based on the PQC evaluation/investigation performed.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: SHARP HOT PAIN THROUGHOUT BODY; DIFFICULTY CONCENTRATING; INJECTION SITE PAIN/BURNING; FATIGUE; SHARP PAIN IN FOREHEAD; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced sharp hot pain throughout body. On 26-MAY-2021, the subject experienced difficulty concentrating. On 26-MAY-2021, the subject experienced injection site pain/burning. On 26-MAY-2021, the subject experienced fatigue. On 26-MAY-2021, the subject experienced sharp pain in forehead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain/burning on 26-MAY-2021, and had not recovered from sharp hot pain throughout body, difficulty concentrating, fatigue, and sharp pain in forehead. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Underdose
Clinical narrative: ADMINISTERED AN EXPIRED VACCINE THAT WAS OUTSIDE IT'S 6 HOUR WINDOW OF BEING KEPT AT 36 TO 46 DEGREES; WRONG DOSE WAS ADMINISTERED 0.3 ML INSTEAD OF 0.5 ML; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) .3 ml, administered on 09-JUN-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUN-2021, the subject experienced administered an expired vaccine that was outside it's 6 hour window of being kept at 36 to 46 degrees. On 09-JUN-2021, the subject experienced wrong dose was administered 0.3 ml instead of 0.5 ml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered an expired vaccine that was outside it's 6 hour window of being kept at 36 to 46 degrees and wrong dose was administered 0.3 ml instead of 0.5 ml was not reported. This report was non-serious.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: ADMINISTERED TO 17 YEAR OLD; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced administered to 17 year old, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered to 17 year old and off label use was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Migraine, Pain assessment
Clinical narrative: MIGRAINE ON RIGHT FRONT SIDE; FEELING SLEEPY; LACK OF ENERGY; HEADACHE ON RIGHT FRONT  SIDE; FATIGUE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included tested positive for covid-19. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced migraine on right front side. On 10-JUN-2021, the subject experienced feeling sleepy. On 10-JUN-2021, the subject experienced lack of energy. On 10-JUN-2021, the subject experienced headache on right front side. On 10-JUN-2021, the subject experienced fatigue. Laboratory data included: Pain scale (NR: not provided) 7. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on right front side, feeling sleepy, lack of energy, headache on right front side, and fatigue on 11-JUN-2021. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: MIGRAINE ON RIGHT FRONT SIDE; FEELING SLEEPY; LACK OF ENERGY; HEADACHE ON RIGHT FRONT  SIDE; FATIGUE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included tested positive for covid-19. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced migraine on right front side. On 10-JUN-2021, the subject experienced feeling sleepy. On 10-JUN-2021, the subject experienced lack of energy. On 10-JUN-2021, the subject experienced headache on right front side. On 10-JUN-2021, the subject experienced fatigue. Laboratory data included: Pain scale (NR: not provided) 7. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on right front side, feeling sleepy, lack of energy, headache on right front side, and fatigue on 11-JUN-2021. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Fatigue, severe body aches, arm pain at injection site, chills, high fever (101 degrees Fahrenheit), headache
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fatigue, severe body aches, arm pain at injection site, chills, high fever (101 degrees Fahrenheit), headache
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Extreme heavy menstrual period. So far lasting more than 4 weeks. Previous periods have been normal. Blood tests normal. No fibroids/polyps. Doctors cannot figure out cause. Birth control not working to stop period.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough
Clinical narrative: PATIENT STARTED COUGHING AFTER RECEIVING THE VACCINE.  BROUGHT TO MED OBS 1  BP 168/85 HR 86 RESP24 OXYGEN STS 99 ON ROOM AIR SHE STATES THAT SHE HAS BEEN HAVING HEADACHES, CHILLS PRIOR TO VACCINE, HER DOCTOR TOLD HER THAT THEY DID NOT WANT HER BP OVER 130/70 AND IT WAS 112/68. SHE STATES SHE HAS DEVELOPED SOME PAIN IN HER SHOULDER 10:07 HR 87  RESP 22  BP 155/87 LEFT ARM  OXYGEN SATS 100% ROOM AIR 10:12 HR 83  RESP 22  BP 140/83 LEFT ARM OXYGEN SAT 98 ROOM AIR 10:17 HR 73 RESP 18  BP 139/80 LEFT ARM  OXYGEN 100  PATIENT FELT BETTER SHE LEFT AT 11:15 WITH A FRIEND
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: Patient was given normal saline opposed to the active vaccine
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This form is being submitted as patient and parent stated he was 12 but in fact his DOB states he is under the age of 12, not realized until after the injection was given
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysstasia, Gait disturbance, Headache
Clinical narrative: Extreme fever  extrem chills extreme  trembling and puking. All lasting for over 12 hour. Joint pain so severe could not stand or walk in an upright position. Extreme haedache and head ache continues daily
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Extreme fever  extrem chills extreme  trembling and puking. All lasting for over 12 hour. Joint pain so severe could not stand or walk in an upright position. Extreme haedache and head ache continues daily
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Patient was given Normal Saline opposed to active vaccine
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient  was given normal saline opposed to active vaccine
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Computerised tomogram, Dizziness, Headache
Clinical narrative: Consistent headaches for 20 days, nausea, dizziness, chest tightness, heart palpitations.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: Consistent headaches for 20 days, nausea, dizziness, chest tightness, heart palpitations.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Patient was given Normal Saline opposed to active vaccine
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicectomy, Appendicitis, Computerised tomogram, Laparoscopic surgery
Clinical narrative: Acute appendicitis requiring laparoscopic appendectomy
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Sensation of foreign body
Clinical narrative: A few days after receiving the injection, subject started complaining about feeling like he has a lump in his throat. Now a week past and he still has the same sensation. Difficulty swallowing.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Systemic: Stroke-Medium, Additional Details: Caregiver mentioned patient received vaccine on 6/4/21, and was admitted to hospital for a stroke on 6/8/21.  Please note this was 4 days after the vaccination, unsure if this is related to vaccine or other health factor.  However, have still reported per protocol.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Flushing, Hyperhidrosis, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: pt is afraif of shots had a little panic and was lightheaded. pt felt better and left pharmacy
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient lost consciousness within 15 minutes after vaccine administration. Patient was transitioned to supine position and quickly recovered
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Nausea-Medium, Additional Details: Patient's symptoms match those of "COVID Arm".
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Nausea-Medium, Additional Details: Patient's symptoms match those of "COVID Arm".
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site bruising, Injection site erythema, Injection site pruritus, Limb discomfort
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient is describing pain and tingling and heaviness in the left arm starting one day after recieving 2nd covid vaccine *(pfizer). Shooting pain going up the arm as well, not improving so far
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient is describing pain and tingling and heaviness in the left arm starting one day after recieving 2nd covid vaccine *(pfizer). Shooting pain going up the arm as well, not improving so far
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Paraesthesia, Paraesthesia oral
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: itching all over body, lips and tongue were tingling
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: itching all over body, lips and tongue were tingling
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Patient was given normal saline opposed to active vaccine
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dyspnoea, Electrocardiogram, Fall, SARS-CoV-2 test negative
Clinical narrative: I was playing ice hockey on April 10, 2021 when I started to experience shortness of breath.  Coming to the bench between shifts is part of the game and that time on the bench is used to recover (both for your muscles and for your cardiovascular system).  However, towards the latter part of the game, I continued to be short of breath even while sitting on the bench.  Then in the last 10 minutes or so of the game, I fell to the ice for no reason.  It was as if my muscles had just totally failed.  I thought the shortness of breath may have been a sign of a Covid infection since I had not reached the 14 day period after my second shot.  So I went to urgent care to get a Covid test.  My test came back negative, but the doctor was concerned with my symptoms, so he took an x-ray of my heart and an ECG.  He said that he noticed a blur around my heart, but didn't have any explanation.  He thought I was in very good health, so he gave me a list of heart specialists to contact if I had another 'episode'.  Fortunately, I did not have another episode.  The only reason that I am submitting this incident is because I understand the administration is having an emergency meeting to review cases of an inflamed heart.  I am not sure my situation was an inflamed, but I wanted to have my episode documented in case my situation was a temporary adverse reaction to the vaccine.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Flushing, Hyperhidrosis, Hyperventilation
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: panic attack-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild, Additional Details: patient went through anxiety/panic attack. resolved within 15 minutes with no complications.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: panic attack-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild, Additional Details: patient went through anxiety/panic attack. resolved within 15 minutes with no complications.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received normal saline opposed to active vaccine
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fear of injection, Flushing, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient received first dose of pfizer vaccine with in 2 minutes passed out parents then told me later he has Aspergers and is very much afraid of needles has had reactions before after getting shots but none quite this severe patient was sitting and when he passed out he did not hit his head mother was beside him and helped him down called ems patient did not want to be transported to hospital left rx 20 minutes later
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient received first dose of pfizer vaccine with in 2 minutes passed out parents then told me later he has Aspergers and is very much afraid of needles has had reactions before after getting shots but none quite this severe patient was sitting and when he passed out he did not hit his head mother was beside him and helped him down called ems patient did not want to be transported to hospital left rx 20 minutes later
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Became fatigued, headache, nauseous, extremely sore at injection site, body soreness
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Bell's palsy, Computerised tomogram head normal, Laboratory test normal
Clinical narrative: Bells Palsy Acutely developed 5/31/2021 Went to ER and head ct / labs normal Started on doxycycline (we are lyme endemic) and prednisolone
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Medium, Systemic: Weakness-Medium
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Nausea, Syncope, Tinnitus
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Medium, Systemic: Weakness-Medium
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Injection site itching
Age: 4.17
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Large patch of redness, swelling and itching around vaccination site.  Continued for about 7 days.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhoid operation, Haemorrhoids thrombosed
Clinical narrative: Thrombosed Hemorrhoids, first thrombosed hemorrhoid was resolved through opening of the vein and draining of the hemorrhoid  by the oatient  The 2nd will be resolved today by a colorectal surgeon to cut open and drain the hemorrhoid
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Tinnitus
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Systemic: Vomiting-Mild
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Systemic: Vomiting-Mild
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase increased, Dizziness, Dry mouth, Exposure during pregnancy, Full blood count
Clinical narrative: I was 36 weeks and 5 days pregnant at the time I received my 2nd dose of the Moderna vaccination. This is my 2nd pregnancy, both low risk, and my due date is June 21. I have been monitoring my blood glucose regularly as I failed the glucose tolerance test but have had no problems with high blood glucose levels and do not have gestational diabetes. My normal BP during this pregnancy has been in the 90-100/50's-60's range. I got my 2nd vaccine on May 29 around 9:15 am, by 9:21 I suddenly got a strong feeling as if I was about to vomit, then my heart began to pound and was racing, then I felt dizzy and light headed, then my mouth went extremely dry. I told the people at the pharmacy that I was ill and they had me sit in the vaccination room, took my blood pressure and gave me water and an ice pack. The blood pressure cuff was not the right size, but read my BP as being 117/72. After sitting for about 30 minutes I began to feel better so I went to sit in the observation area again. I waited until it was an hour after I felt sick before leaving to do shopping. I walked the store for about 30 minutes before returning to the pharmacy. I kept getting waves of nausea, heart palpitations, and dizziness and extreme dry mouth, I was feeling very lethargic. By the time I got back to the pharmacy I was begining to feel out of it and decided to call the paramedics. They took my BP again and it was 127/41. I began to shake by the time the paramedics arrived and needed help onto the stretcher to take me out to the ambulance. In the ambulance my BP was 149/85.  I began to feel better on my way to the ER, but kept getting waves of nausea/ feeling like my BP was high/dizziness with the addition of heat flashes. I told the nurses and doctor at the ER that I thought I was having a reaction to my vaccine and described what happened, but they only treated me for nausea and on my discharge papers said I was there because of nausea. They gave me anti-nausea medicine and after a few hours they gave me the option of going home or staying to get I.V fluids. I chose to get I.V. fluids and stayed a few hours longer until I felt less out of it and like the waves of sickness were less intense/ frequent. I continued experiencing waves of sickness until June 9th and spent most of that time on bed rest.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Hot flush, Lethargy, Nausea
Clinical narrative: I was 36 weeks and 5 days pregnant at the time I received my 2nd dose of the Moderna vaccination. This is my 2nd pregnancy, both low risk, and my due date is June 21. I have been monitoring my blood glucose regularly as I failed the glucose tolerance test but have had no problems with high blood glucose levels and do not have gestational diabetes. My normal BP during this pregnancy has been in the 90-100/50's-60's range. I got my 2nd vaccine on May 29 around 9:15 am, by 9:21 I suddenly got a strong feeling as if I was about to vomit, then my heart began to pound and was racing, then I felt dizzy and light headed, then my mouth went extremely dry. I told the people at the pharmacy that I was ill and they had me sit in the vaccination room, took my blood pressure and gave me water and an ice pack. The blood pressure cuff was not the right size, but read my BP as being 117/72. After sitting for about 30 minutes I began to feel better so I went to sit in the observation area again. I waited until it was an hour after I felt sick before leaving to do shopping. I walked the store for about 30 minutes before returning to the pharmacy. I kept getting waves of nausea, heart palpitations, and dizziness and extreme dry mouth, I was feeling very lethargic. By the time I got back to the pharmacy I was begining to feel out of it and decided to call the paramedics. They took my BP again and it was 127/41. I began to shake by the time the paramedics arrived and needed help onto the stretcher to take me out to the ambulance. In the ambulance my BP was 149/85.  I began to feel better on my way to the ER, but kept getting waves of nausea/ feeling like my BP was high/dizziness with the addition of heat flashes. I told the nurses and doctor at the ER that I thought I was having a reaction to my vaccine and described what happened, but they only treated me for nausea and on my discharge papers said I was there because of nausea. They gave me anti-nausea medicine and after a few hours they gave me the option of going home or staying to get I.V fluids. I chose to get I.V. fluids and stayed a few hours longer until I felt less out of it and like the waves of sickness were less intense/ frequent. I continued experiencing waves of sickness until June 9th and spent most of that time on bed rest.