chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Skin discolouration
Clinical narrative: RIGHT EYE SWOLLEN (NO PAIN ASSOCIATED WITH THE SWELLING BUT DID ENDORSE FEELING PRESSURE RELATED TO THE SWELLING); DISCOLORATION ON THE EYE LID AND OUTER SKIN SURROUNDING THE EYE; This spontaneous report received from a pharmacist concerned a 54 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 (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  Non-company suspect vaccine (booster dose, series 2) included: BNT 162 (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 30-OCT-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 31-OCT-2021, the patient started having a strange reaction. The patient woke up and noticed that her right eye was swollen with some discoloration on the eye lid and outer skin surrounding the eye. The patient reported no changes in vision and no pain associated with the swelling but did endorse feeling pressure related to the swelling. It was stated that there was no drainage from the eye. It was told to patient to take a Benadryl (diphenhydramine hydrochloride) in the event that may be a delayed allergic reaction. At the time of reporting, symptoms were still the same with no improvement. It was advised the patient to see medical doctor for evaluation. The action taken with covid-19 vaccine ad26.cov2.s, and BNT 162 was not applicable. The patient had not recovered from right eye swollen (no pain associated with the swelling but did endorse feeling pressure related to the swelling), and discoloration on the eye lid and outer skin surrounding the eye. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Pain in extremity, Vertigo
Clinical narrative: VERTIGO; ARM WAS A BIT SORE; METAL TASTE IN MOUTH; This spontaneous report received from a patient via a company representative 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 (dose series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered in MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   In MAY-2021, few minutes after receiving the shot, the patient experienced metal taste in mouth and arm was a bit sore. In AUG-2021, the patient suddenly began having vertigo (dose series 1). The patient had been coping with it and it was finally getting a lot better.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient was recovering from metal taste in mouth and arm was a bit sore. The outcome for vertigo was unknown.  This report was non-serious.  This case, involving the same patient is linked to 20211125013 (dose series 2).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: LETHARGY; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose and 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/lot numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced really bad side effects (Fever, Lethargy, Nausea). The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the fever, lethargy and nausea was not reported. On an unspecified date, the patient received additional Non-company suspect vaccine included mrna 1273 (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. On an unspecified date, the patient experienced headache for 24 hours. The patient did not experienced fever after booster dose. The action taken with mrna 1273, was not applicable. The patient recovered from headache, on an unspecified date. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; BURNED/STUNG; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (unspecified manufacturer) for prophylactic vaccination (dose number in series 1). No events reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intravenous, batch number: 1855194 expiry: UNKNOWN) (unspecified manufacturer) dose was not reported, administered on 03-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s booster dose the patient experienced inappropriate route of vaccine administration and burned/stung. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate route of vaccine administration and burned/stung was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation, Swelling face, Urticaria
Clinical narrative: This spontaneous report received from a patient concerned an 80 year old female.  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and was not pregnant at the time of vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported,1 total administered on 10-MAR-2021 for prophylactic vaccination (dose series 1).   Non-company suspect vaccine included: MRNA 1273 (batch number: 071F21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination (dose series 2). No concomitant medications were reported.  On 03-NOV-2021 following vaccination with  MRNA 1273, the patient experienced some hives which was getting worse and also had swollen face, scaly face, hives on face and arm and hives were causing very bad itching (dose series 2) for which patient applied  water, Vaseline, cream and possibly milk.  The action taken with covid-19 vaccine ad26.cov2.s and  MRNA 1273 was not applicable.  The patient had not recovered from hives on face and arm / hives causing bad itching, swollen face, and scaly face.  This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lethargy, Pain
Clinical narrative: LITTLE LETHARGY; FEELING LIKE COMING DOWN WITH SOMETHING BUT NOT REALLY; LITTLE TIREDNESS; LESS PAIN WITH BOOSTER DOSE THAN THE FIRST SHOT; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and other pre-existing medical conditions included: The patient took her unspecified diabetes medicines as usual. The patient received covid-19 vaccine ad26.cov2.s (manufacturer unspecified, series 1) (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. On 14-MAR-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced pain at injection site. The patient was recovering from pain at injection site.  The patient received covid-19 vaccine ad26.cov2.s (series 2) (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, administered on 04-NOV-2021 for prophylactic vaccination. Concomitant medications included metformin, and metoclopramide hydrochloride.  On 04-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced less pain with booster dose than the first shot, little lethargy, had feeling like coming down with something but not really, sleepless and little tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the events of the little lethargy, less pain with booster dose than the first shot, feeling like coming down with something but not really, sleepless and little tiredness was not reported. This report was non-serious. This case, involving the same patient is linked to 20210330610.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a patient concerned a 73 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination (dose series 1). No concomitant medications were reported.  On an unspecified date, the patient experienced tired (dose series 1). She reports she was fine after a day.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from tired.  This report was non-serious.  This case, involving the same patient is linked to 20211128823.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR LOSS; This spontaneous report received from a patient concerned a 42 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: premenstrual dysphoric disorder (PMDD), temporomandibular joint (TMJ) disorder, penicillin (PCN) allergy, drug allergy (pseudoephedrine hydrochloride) ,and seasonal allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, 1 total administered on 28-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. (Dose series in number 1)  On 15-MAY-2021, following vaccination with covid-19 vaccine ad26.cov2.s the patient experienced hair loss. (Dose series in number 1)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from hair loss.  This report was non-serious.  This case, involving the same patient is linked to 20211115110.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, race and ethnic origin.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an unspecified day in past, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) 01 total, dose, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On unspecified day, following covid-19 vaccine ad26.cov2.s (dose number in series 1), the patient experienced body aches, fever and headache.   The patient recovered from body aches, fever, and headache on an unspecified day.  On an unspecified date, 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, 01 total, for prophylactic vaccination (dose number in series 2). The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.   On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2)  the patient experienced body aches, fever and headache.  The action taken with covid-19 vaccine ad26.cov2.s (dose number in series 2) was not applicable.  The patient recovered from body aches, fever and headache on an unspecified date.  This report was non-serious.  This case, involving the same patient is linked to 20211117494.(Dose number in series 1)
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received booster dose of Pfizer vaccine, even though patient is under 18 years of age. Patient received second dose of Pfizer vaccine over 6 months ago (May 2021). No immediate adverse signs of symptoms of vaccination. Patient and family were notified, and instructed to return to clinic if concerning symptoms began.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: I have a high fever of 103 and I am vomiting AT 11:03 PM
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient has been experienced sore arm since vacination date until now.  It has been more than 1 month, and patient still has the sore arm.  She was advised to take Tylenol and encouraged to see her primary care doctors.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Paraesthesia, Pyrexia
Clinical narrative: Increased heart rate, difficulty breathing, fever, anxiety, tingling in fingers and toes
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Total left arm numb and numbness in three fingers
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Thrombosis
Clinical narrative: Within 1 week of vaccination developed blood clot to 4th finger of left hand.  No prior history of clotting disorders or other medical conditions or medication use. No adverse reactions to first or second Phizer COVID vaccination. This event was triggered by the third dose. Treatment course includes initiation of Aspirin 325  daily.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Injection site pruritus, Injection site rash
Clinical narrative: rash and itchiness appeared   at the injection site 4 days later,  on Tuesday night patient begin to experience sharp pinching pain around the heart area, patient called the pharmacy on 12/02/2021 around 7 pm and was advised to have the chest pain check up, rash is normal and she can take benadryl  but chest pain need to be check out. patient then went to urgent care and is awaiting examination, follow up with patient at 8:30pm  but she has not been seen by  the doctor yet, only put in the room.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: soar arm and redness on site feels warm and itch
Age: 43.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Blister, Headache, Pyrexia
Clinical narrative: Varicella Blisters occurred starting on day 15, low grade fever and headaches starting on day 13
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration, Interchange of vaccine products, Nausea
Clinical narrative: Incorrect mRNA COVID-19 product inadvertently administered for the 2nd dose in the primary series:  Patient came to pharmacy requesting first dose of Pfizer vaccine.  After receiving the Pfizer vaccine he then stated that he had the 1st dose of Moderna vaccine on 04/16/2021.  He indicated that when he had the Moderna vaccine, he was nauseated and felt dizzy the following day.  His primary care physician had instructed him to wait 6 months and restart with the Pfizer vaccine.    Per agency guidance, pharmacy advised him the following: (1) Pfizer dose that he received will then count as his 2nd dose in the primary series (2) Do not repeat dose (3) Wait 6 months and receive Pfizer booster dose
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen arm pit, swollen glands, swollen lymph nodes
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: All over body aches within hours of shot, to the point of incapacity, muscle cramping and being unable to move. Upon waking at 0630 on 12/2: Fever of 102.7 that does NOT respond to fever reducing meds or fluids; fainting; chills; dizziness; fatigue; brain fog and mild confusion. As 2121 on 12/2, patient is sleeping following taking 440mg Aleve, 50mg Benadryl and 32 of gatorade.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms, Pain, Pyrexia, Syncope
Clinical narrative: All over body aches within hours of shot, to the point of incapacity, muscle cramping and being unable to move. Upon waking at 0630 on 12/2: Fever of 102.7 that does NOT respond to fever reducing meds or fluids; fainting; chills; dizziness; fatigue; brain fog and mild confusion. As 2121 on 12/2, patient is sleeping following taking 440mg Aleve, 50mg Benadryl and 32 of gatorade.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Injection site pain, low grade fever (100.4 at last check), headache, fatigue
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Oedema peripheral
Clinical narrative: Significant swelling and soreness under arm pit beginning during night between 26th and 36th hours after Moderna booster shot, and continuing beyond 48th hour after dose. Early extension of soreness into chest area.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: The dosage was not diluted and more than the recommended amount was administered
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Painfull Red Hot Hard Knot at injection site, under left arm out is in painful when moving arm of just being still. Fever/chills and a red hive rash on upper chest.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Painfull Red Hot Hard Knot at injection site, under left arm out is in painful when moving arm of just being still. Fever/chills and a red hive rash on upper chest.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Painfull Red Hot Hard Knot at injection site, under left arm out is in painful when moving arm of just being still. Fever/chills and a red hive rash on upper chest.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: Very ill, pain in arm that didn't go away.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Amenorrhea. First time I can ever remember missing a period. I am not on birth control or sexually active. I have month over month tracking of all my mensuration cycles.   There have been no other life changes aside from me receiving the vaccine booster on November 20, 2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Full blood count, Gait inability, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: 11/09/2021 patient felt muscle aches, tingling on hands and feet, 11/16/2021 rush her to hospital because of severe pain on both upper and lower extremities, admitted at hospital until 11/17/2021, readmitted on 11/20/2021 because patient cannot walk anymore, due to weakeness/paralysis. Diagnosed for Guillane barre syndrome from Moderna booster shot she got on 11/02/2021
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Myalgia, Pain in extremity, Paraesthesia, Paralysis
Clinical narrative: 11/09/2021 patient felt muscle aches, tingling on hands and feet, 11/16/2021 rush her to hospital because of severe pain on both upper and lower extremities, admitted at hospital until 11/17/2021, readmitted on 11/20/2021 because patient cannot walk anymore, due to weakeness/paralysis. Diagnosed for Guillane barre syndrome from Moderna booster shot she got on 11/02/2021
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient is 16yo and with underlying health conditions (mental health ) and received a third dose.    Patient is not immuno-compromised.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Feeling abnormal, Seizure, Tremor
Clinical narrative: Patient called and stated she had 2 episodes of "seizures" at midnight of the day she received the injection.  Reported the incident 3 days later.  Describes the reaction as uncontrollable violent shaking from her ankles to her neck.  She was in a fog but she remembers trying to hold her hands together to keep them from shaking and then she started crying.  husband witnessed this but neither know how long it lasted. Pt was afebrile
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Felt slightly nauseous in stomach, slight headache.  Limited diet to foods that seemed to settle stomach - toast, etc.  Lasted all day..
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Hepatitis, Illness, Inflammation, Psoriasis
Clinical narrative: I took the first shot and my psoriasis started to act up and inflamed. I was very ill and I also went to see the doctor and he was concerned that my liver was inflamed.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Lethargy, Lymphadenopathy, Myalgia
Clinical narrative: fever reaching 101 degrees and lasting for approximately 5 hours in total flu-like symptoms (muscle aches, tiredness/lethargy), swollen lymph nodes, sore throat - these symptoms lasted approximately 44 hours At 45 hours post-vaccination (after showering), I noticed hives covering my body from my neck to my hips, both front and back (on my back and my abdomen). These hives lasted almost a full 2 days, and I am still slightly itchy today (5 days post-vaccination). In addition to these symptoms, I had a sore arm from the injection, which was to be expected, but I did not develop a severe rash at the injection site as I did with my second Moderna injection on 03/12/2021. Overall, the benefits of the vaccine far outweigh these side effects, yet I was asked by my pharmacist to report them. Thank you.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pruritus, Pyrexia, Urticaria
Clinical narrative: fever reaching 101 degrees and lasting for approximately 5 hours in total flu-like symptoms (muscle aches, tiredness/lethargy), swollen lymph nodes, sore throat - these symptoms lasted approximately 44 hours At 45 hours post-vaccination (after showering), I noticed hives covering my body from my neck to my hips, both front and back (on my back and my abdomen). These hives lasted almost a full 2 days, and I am still slightly itchy today (5 days post-vaccination). In addition to these symptoms, I had a sore arm from the injection, which was to be expected, but I did not develop a severe rash at the injection site as I did with my second Moderna injection on 03/12/2021. Overall, the benefits of the vaccine far outweigh these side effects, yet I was asked by my pharmacist to report them. Thank you.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood glucose normal, Chest X-ray normal, Chest discomfort, Chest pain, Chills
Clinical narrative: 12/1/2021 Admitted with chest pain, headache, chills, and fever x1 day. Described in the midsternal region as "sore" and "pressure" by patient, which occurs every few minutes and lasts a few seconds. Myocarditis work-up.  12/2/2021, 8pm: Pt. does not complain of any pain or discomfort.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram ST segment depression, Headache, Metabolic function test normal, Pyrexia
Clinical narrative: 12/1/2021 Admitted with chest pain, headache, chills, and fever x1 day. Described in the midsternal region as "sore" and "pressure" by patient, which occurs every few minutes and lasts a few seconds. Myocarditis work-up.  12/2/2021, 8pm: Pt. does not complain of any pain or discomfort.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: 12/1/2021 Admitted with chest pain, headache, chills, and fever x1 day. Described in the midsternal region as "sore" and "pressure" by patient, which occurs every few minutes and lasts a few seconds. Myocarditis work-up.  12/2/2021, 8pm: Pt. does not complain of any pain or discomfort.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Ejection fraction, Electrocardiogram ST segment abnormal, Troponin increased
Clinical narrative: 12/1/2021 Admitted with chest pain, headache, chills, and fever x1 day. Described in the midsternal region as "sore" and "pressure" by patient, which occurs every few minutes and lasts a few seconds. Myocarditis work-up.  12/2/2021, 8pm: Pt. does not complain of any pain or discomfort.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Moderate fatigue and a decent  headache that resolved with Tylenol. All of it lasted a total of 8/9 hours.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given a pediatric dosage of 0.2ml. Patient is 14yr of age and should have been given the adult Pfizer version of the vaccine. Age was noticed by RN giving the vaccine after administration. Patient displays no adverse reaction and no harm done during administration. Mother of minor was notified of error.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Hypoaesthesia, Muscular weakness, Sensory loss
Clinical narrative: Hour or so after vaccine felt numbness on one side of face and jaw, increasing as time went by, felt exactly like getting local anesthetic at dentist, touched with hand and had no sensation, muscles not responding, completely numb.  Went back to pharmacy and they told me to sit there for a while and gave me a bottled water.  I went home after about 20 minutes as symptoms did not get worse and no other symptoms developed (other than feeling light-headed and a bit unsteady).  Symptoms went away by early evening, and feeling slowly returned to my face.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chest pain, Neuralgia, Painful respiration
Clinical narrative: The 2nd day after getting the Pfizer covid 2nd shot, around 11:20 am. I felt like somewhere above stomach (maybe liver?) had an exploding pain,  in addition almost every vain/nerve connecting to the organ were in pain as well. I tried to shout to my husband's for help who was in another room. However, the pain gets even worse if I tried to move or say something. The pain lasted for a few minutes, and went away. The pain would came back every half an hour to an hour, and started migrating to other organs after a while. So my lung started to hurt, it hurts even more badly if I tried to breathe in air; so I had to stay very still. In the afternoon I felt the pain in my chest, and it was so painful that my whole back hurts (it's like the pain is penetrating through my body to my back). The last time I felt any pain was that night, about 11:00PM, before I went to bed. The pain did not  come back afterwards. I didn't seek medical attention because everytime the pain comes, it would go away in like 5 -10 mins. Did not take any medication to treat the symptoms either.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain, Vascular pain
Clinical narrative: The 2nd day after getting the Pfizer covid 2nd shot, around 11:20 am. I felt like somewhere above stomach (maybe liver?) had an exploding pain,  in addition almost every vain/nerve connecting to the organ were in pain as well. I tried to shout to my husband's for help who was in another room. However, the pain gets even worse if I tried to move or say something. The pain lasted for a few minutes, and went away. The pain would came back every half an hour to an hour, and started migrating to other organs after a while. So my lung started to hurt, it hurts even more badly if I tried to breathe in air; so I had to stay very still. In the afternoon I felt the pain in my chest, and it was so painful that my whole back hurts (it's like the pain is penetrating through my body to my back). The last time I felt any pain was that night, about 11:00PM, before I went to bed. The pain did not  come back afterwards. I didn't seek medical attention because everytime the pain comes, it would go away in like 5 -10 mins. Did not take any medication to treat the symptoms either.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Electrocardiogram abnormal, Heart rate increased, Hyperhidrosis
Clinical narrative: Within 30 min I had sharp chest pains .very intense sweating high blood pressure high heart rate and an abnormal ekg a week later..2 weeks later was placed on an anti inflammation med for suspected myocarditis
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Laboratory test, Myocarditis
Clinical narrative: Within 30 min I had sharp chest pains .very intense sweating high blood pressure high heart rate and an abnormal ekg a week later..2 weeks later was placed on an anti inflammation med for suspected myocarditis
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Autonomic nervous system imbalance, Chest X-ray, Dizziness, Electrocardiogram
Clinical narrative: After receiving both the 1st and the 2nd doses of the COVID-19 Pfizer vaccines, long haul symptoms of dysautonomia significantly worsened as well as developing peripheral neuropathy.  This specific event that led to going into the Emergency Room involved  palpitations, tachycardia,  dizziness, numbness in hands, lower left leg pain.  It was dismissed by the ER doctors as anxiety after tests came back normal, but patient was able to finally get referred to a neurologist due to the numb hands which led to a correct diagnosis and medications to reduce the symptoms. Vaccine-induced symptoms have resolved due to treatment.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Full blood count, Hypoaesthesia, Metabolic function test, Neuropathy peripheral
Clinical narrative: After receiving both the 1st and the 2nd doses of the COVID-19 Pfizer vaccines, long haul symptoms of dysautonomia significantly worsened as well as developing peripheral neuropathy.  This specific event that led to going into the Emergency Room involved  palpitations, tachycardia,  dizziness, numbness in hands, lower left leg pain.  It was dismissed by the ER doctors as anxiety after tests came back normal, but patient was able to finally get referred to a neurologist due to the numb hands which led to a correct diagnosis and medications to reduce the symptoms. Vaccine-induced symptoms have resolved due to treatment.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Tachycardia, Ultrasound scan
Clinical narrative: After receiving both the 1st and the 2nd doses of the COVID-19 Pfizer vaccines, long haul symptoms of dysautonomia significantly worsened as well as developing peripheral neuropathy.  This specific event that led to going into the Emergency Room involved  palpitations, tachycardia,  dizziness, numbness in hands, lower left leg pain.  It was dismissed by the ER doctors as anxiety after tests came back normal, but patient was able to finally get referred to a neurologist due to the numb hands which led to a correct diagnosis and medications to reduce the symptoms. Vaccine-induced symptoms have resolved due to treatment.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea
Clinical narrative: Diarrhea that's not slowed down by Imodium for 2+ weeks now.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sharp pain in vaccination area 4 months after vax
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: My daughter began to have very bad menstral cramps which she has never had
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via media via a company representative concerned a patient of unspecified age and sex and unknown race and ethnicity. 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 administration not reported, batch number: unknown expiry: unknown) dose was not reported, start therapy date were not reported 1 total administered for prophylactic vaccination (dose number series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke. It was reported that " yes just stick up your ass , I had stroke after I coerced into taking your vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211157095-COVID-19 VACCINE AD26.COV2.S-Stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Fatigue, Headache
Clinical narrative: SIDE EFFECTS; TIREDNESS; HEADACHE; This spontaneous report received from a patient via a company representative 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: 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/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects, tiredness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness, and headache, and the outcome of side effects was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure fluctuation, Blood pressure measurement, Blood test, Body temperature
Clinical narrative: SHORTNESS OF BREATH; ERRATIC BLOOD PRESSURE; APPETITE LOSS; WEIGHT LOSS 5 LBS; DIZZINESS AND LIGHT HEADEDNESS; TIGHTNESS IN CHEST; MIGRANE; HARMONE FLUCTUATIONS; KIDNEY DISEASE FLARED UP; JOINT PAIN; FATIGUED; NAUSEA; INJECTION SITE PAIN; ELEVATED PLATELET COUNT; RASHES UNDER BOTH ARMS IN THE ARMPIT AREA; FEVERISH; MUSCLE ACHES/ LOTS OF ACHES AND PAIN POST VACCINATION; SLEPT FOR 36 HOURS; MEMORY WAS VERY HAZY; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa drug allergy, stage1 kidney disease, penicillin allergy, and migrane. The patient experienced drug allergy when treated with amoxicillin/clavulanate potassium, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included lisinopril, and propranolol. On JUL-2021, the patient experienced memory was very hazy. On 21-JUL-2021, the patient experienced slept for 36 hours. On 21-JUL-2021, the patient experienced muscle aches/ lots of aches and pain post vaccination. On 21-JUL-2021, the patient experienced feverish. Laboratory data included: Body temperature (NR: not provided) 103 F. On AUG-2021, the patient experienced rashes under both arms in the armpit area. On 03-NOV-2021, the patient experienced elevated platelet count. Laboratory data included: Blood test (NR: not provided) ELEVATED PLATELET COUNT. On an unspecified date, the patient experienced shortness of breath, erratic blood pressure, appetite loss, weight loss 5 lbs, dizziness and light headedness, kidney disease flared up, tightness in chest, migrane, harmone fluctuations, joint pain, fatigued, nausea, and injection site pain. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) ERRATIC. Treatment medications (dates unspecified) included: pramocaine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from erratic blood pressure, appetite loss, muscle aches/ lots of aches and pain post vaccination, and feverish, and memory was very hazy on JUL-2021, was recovering from weight loss 5 lbs, had not recovered from elevated platelet count, shortness of breath, rashes under both arms in the armpit area, dizziness and light headedness, nausea, fatigued, joint pain, injection site pain, and migrane, and the outcome of tightness in chest, slept for 36 hours, kidney disease flared up and harmone fluctuations was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Decreased appetite, Dizziness, Dyspnoea, Fatigue
Clinical narrative: SHORTNESS OF BREATH; ERRATIC BLOOD PRESSURE; APPETITE LOSS; WEIGHT LOSS 5 LBS; DIZZINESS AND LIGHT HEADEDNESS; TIGHTNESS IN CHEST; MIGRANE; HARMONE FLUCTUATIONS; KIDNEY DISEASE FLARED UP; JOINT PAIN; FATIGUED; NAUSEA; INJECTION SITE PAIN; ELEVATED PLATELET COUNT; RASHES UNDER BOTH ARMS IN THE ARMPIT AREA; FEVERISH; MUSCLE ACHES/ LOTS OF ACHES AND PAIN POST VACCINATION; SLEPT FOR 36 HOURS; MEMORY WAS VERY HAZY; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa drug allergy, stage1 kidney disease, penicillin allergy, and migrane. The patient experienced drug allergy when treated with amoxicillin/clavulanate potassium, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included lisinopril, and propranolol. On JUL-2021, the patient experienced memory was very hazy. On 21-JUL-2021, the patient experienced slept for 36 hours. On 21-JUL-2021, the patient experienced muscle aches/ lots of aches and pain post vaccination. On 21-JUL-2021, the patient experienced feverish. Laboratory data included: Body temperature (NR: not provided) 103 F. On AUG-2021, the patient experienced rashes under both arms in the armpit area. On 03-NOV-2021, the patient experienced elevated platelet count. Laboratory data included: Blood test (NR: not provided) ELEVATED PLATELET COUNT. On an unspecified date, the patient experienced shortness of breath, erratic blood pressure, appetite loss, weight loss 5 lbs, dizziness and light headedness, kidney disease flared up, tightness in chest, migrane, harmone fluctuations, joint pain, fatigued, nausea, and injection site pain. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) ERRATIC. Treatment medications (dates unspecified) included: pramocaine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from erratic blood pressure, appetite loss, muscle aches/ lots of aches and pain post vaccination, and feverish, and memory was very hazy on JUL-2021, was recovering from weight loss 5 lbs, had not recovered from elevated platelet count, shortness of breath, rashes under both arms in the armpit area, dizziness and light headedness, nausea, fatigued, joint pain, injection site pain, and migrane, and the outcome of tightness in chest, slept for 36 hours, kidney disease flared up and harmone fluctuations was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hormone level abnormal, Hypersomnia, Injection site pain, Memory impairment, Migraine
Clinical narrative: SHORTNESS OF BREATH; ERRATIC BLOOD PRESSURE; APPETITE LOSS; WEIGHT LOSS 5 LBS; DIZZINESS AND LIGHT HEADEDNESS; TIGHTNESS IN CHEST; MIGRANE; HARMONE FLUCTUATIONS; KIDNEY DISEASE FLARED UP; JOINT PAIN; FATIGUED; NAUSEA; INJECTION SITE PAIN; ELEVATED PLATELET COUNT; RASHES UNDER BOTH ARMS IN THE ARMPIT AREA; FEVERISH; MUSCLE ACHES/ LOTS OF ACHES AND PAIN POST VACCINATION; SLEPT FOR 36 HOURS; MEMORY WAS VERY HAZY; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa drug allergy, stage1 kidney disease, penicillin allergy, and migrane. The patient experienced drug allergy when treated with amoxicillin/clavulanate potassium, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included lisinopril, and propranolol. On JUL-2021, the patient experienced memory was very hazy. On 21-JUL-2021, the patient experienced slept for 36 hours. On 21-JUL-2021, the patient experienced muscle aches/ lots of aches and pain post vaccination. On 21-JUL-2021, the patient experienced feverish. Laboratory data included: Body temperature (NR: not provided) 103 F. On AUG-2021, the patient experienced rashes under both arms in the armpit area. On 03-NOV-2021, the patient experienced elevated platelet count. Laboratory data included: Blood test (NR: not provided) ELEVATED PLATELET COUNT. On an unspecified date, the patient experienced shortness of breath, erratic blood pressure, appetite loss, weight loss 5 lbs, dizziness and light headedness, kidney disease flared up, tightness in chest, migrane, harmone fluctuations, joint pain, fatigued, nausea, and injection site pain. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) ERRATIC. Treatment medications (dates unspecified) included: pramocaine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from erratic blood pressure, appetite loss, muscle aches/ lots of aches and pain post vaccination, and feverish, and memory was very hazy on JUL-2021, was recovering from weight loss 5 lbs, had not recovered from elevated platelet count, shortness of breath, rashes under both arms in the armpit area, dizziness and light headedness, nausea, fatigued, joint pain, injection site pain, and migrane, and the outcome of tightness in chest, slept for 36 hours, kidney disease flared up and harmone fluctuations was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Platelet count increased, Pyrexia, Rash
Clinical narrative: SHORTNESS OF BREATH; ERRATIC BLOOD PRESSURE; APPETITE LOSS; WEIGHT LOSS 5 LBS; DIZZINESS AND LIGHT HEADEDNESS; TIGHTNESS IN CHEST; MIGRANE; HARMONE FLUCTUATIONS; KIDNEY DISEASE FLARED UP; JOINT PAIN; FATIGUED; NAUSEA; INJECTION SITE PAIN; ELEVATED PLATELET COUNT; RASHES UNDER BOTH ARMS IN THE ARMPIT AREA; FEVERISH; MUSCLE ACHES/ LOTS OF ACHES AND PAIN POST VACCINATION; SLEPT FOR 36 HOURS; MEMORY WAS VERY HAZY; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa drug allergy, stage1 kidney disease, penicillin allergy, and migrane. The patient experienced drug allergy when treated with amoxicillin/clavulanate potassium, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included lisinopril, and propranolol. On JUL-2021, the patient experienced memory was very hazy. On 21-JUL-2021, the patient experienced slept for 36 hours. On 21-JUL-2021, the patient experienced muscle aches/ lots of aches and pain post vaccination. On 21-JUL-2021, the patient experienced feverish. Laboratory data included: Body temperature (NR: not provided) 103 F. On AUG-2021, the patient experienced rashes under both arms in the armpit area. On 03-NOV-2021, the patient experienced elevated platelet count. Laboratory data included: Blood test (NR: not provided) ELEVATED PLATELET COUNT. On an unspecified date, the patient experienced shortness of breath, erratic blood pressure, appetite loss, weight loss 5 lbs, dizziness and light headedness, kidney disease flared up, tightness in chest, migrane, harmone fluctuations, joint pain, fatigued, nausea, and injection site pain. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) ERRATIC. Treatment medications (dates unspecified) included: pramocaine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from erratic blood pressure, appetite loss, muscle aches/ lots of aches and pain post vaccination, and feverish, and memory was very hazy on JUL-2021, was recovering from weight loss 5 lbs, had not recovered from elevated platelet count, shortness of breath, rashes under both arms in the armpit area, dizziness and light headedness, nausea, fatigued, joint pain, injection site pain, and migrane, and the outcome of tightness in chest, slept for 36 hours, kidney disease flared up and harmone fluctuations was not reported. This report was non-serious.