chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Feeling of body temperature change, Hand deformity
Clinical narrative: Intense arm pain/Pain in arm was really bad really intense; Earlier I was so cold then hot then cold/body temperature fluctuations; I can't sleep; Tendons are tightening up hands are clawing up; Talking takes up all energy; Feel like laying down; Hands forming claws; extreme fatigue/I am so tired talking is a lot of work, sitting up is hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up) and ASTHENIA (Talking takes up all energy) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up), ASTHENIA (Talking takes up all energy), FEELING ABNORMAL (Feel like laying down), HAND DEFORMITY (Hands forming claws) and FATIGUE (extreme fatigue/I am so tired talking is a lot of work, sitting up is hard). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up), ASTHENIA (Talking takes up all energy), FEELING ABNORMAL (Feel like laying down), HAND DEFORMITY (Hands forming claws) and FATIGUE (extreme fatigue/I am so tired talking is a lot of work, sitting up is hard) outcome was unknown.            This case was linked to MOD-2021-316009.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Pain in extremity, Tendon discomfort
Clinical narrative: Intense arm pain/Pain in arm was really bad really intense; Earlier I was so cold then hot then cold/body temperature fluctuations; I can't sleep; Tendons are tightening up hands are clawing up; Talking takes up all energy; Feel like laying down; Hands forming claws; extreme fatigue/I am so tired talking is a lot of work, sitting up is hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up) and ASTHENIA (Talking takes up all energy) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up), ASTHENIA (Talking takes up all energy), FEELING ABNORMAL (Feel like laying down), HAND DEFORMITY (Hands forming claws) and FATIGUE (extreme fatigue/I am so tired talking is a lot of work, sitting up is hard). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up), ASTHENIA (Talking takes up all energy), FEELING ABNORMAL (Feel like laying down), HAND DEFORMITY (Hands forming claws) and FATIGUE (extreme fatigue/I am so tired talking is a lot of work, sitting up is hard) outcome was unknown.            This case was linked to MOD-2021-316009.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Sensitive skin, Skin warm, Swelling
Clinical narrative: bottom half of arm pit that his lymph node was swollen about the size of a fist; he received his third Pfizer BioNtech covid 19 vaccine on 14SEP2021 due to be immunocompromised; he received his third Pfizer BioNtech covid 19 vaccine on 14SEP2021 due to be immunocompromised; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 44-years-old male patient received third dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 14Sep2021 as single dose for covid-19 immunization. Medical history included immunocompromised from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included first and second dose of BNT162B2 for covid-19 immunization. It was reported that patient received his third Pfizer BioNtech covid 19 vaccine on 14Sep2021 due to be immunocompromised. patient reports that last night he noticed that underneath his right arm between the pectoral and bottom half of arm pit that his lymph node was swollen about the size of a fist. patient also reports that it is rather large and noticeable. This is the same arm he received the vaccine in. Wondering if this is a normal side effect. The outcome for the event was reported as unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Lymphadenopathy, Off label use
Clinical narrative: bottom half of arm pit that his lymph node was swollen about the size of a fist; he received his third Pfizer BioNtech covid 19 vaccine on 14SEP2021 due to be immunocompromised; he received his third Pfizer BioNtech covid 19 vaccine on 14SEP2021 due to be immunocompromised; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 44-years-old male patient received third dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 14Sep2021 as single dose for covid-19 immunization. Medical history included immunocompromised from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included first and second dose of BNT162B2 for covid-19 immunization. It was reported that patient received his third Pfizer BioNtech covid 19 vaccine on 14Sep2021 due to be immunocompromised. patient reports that last night he noticed that underneath his right arm between the pectoral and bottom half of arm pit that his lymph node was swollen about the size of a fist. patient also reports that it is rather large and noticeable. This is the same arm he received the vaccine in. Wondering if this is a normal side effect. The outcome for the event was reported as unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Erythema, Injection site discolouration, Injection site haemorrhage, Injection site pain, Swelling
Clinical narrative: Pt experienced swelling, redness and pain
Age: 60.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt experienced swelling, redness and pain
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE - VACCINE ADMINISTERED TO A MINOR; DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a parent concerned a 16 year old male. The patient's weight was 165 pounds, and height was 71 inches. The patient's concurrent conditions included: asthma, eczema, allergy to cats, allergy to dogs, allergy to eggs, allergy to pollen, and dust allergy, and other pre-existing medical conditions included: The patient had an unspecified pulmonary artery issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced off label use - vaccine administered to a minor. On 15-SEP-2021, the patient experienced drug administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use - vaccine administered to a minor and drug administered to patient of inappropriate age was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hot flush, Myalgia, Nausea, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE - VACCINE ADMINISTERED TO A MINOR; DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a parent concerned a 16 year old male. The patient's weight was 165 pounds, and height was 71 inches. The patient's concurrent conditions included: asthma, eczema, allergy to cats, allergy to dogs, allergy to eggs, allergy to pollen, and dust allergy, and other pre-existing medical conditions included: The patient had an unspecified pulmonary artery issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced off label use - vaccine administered to a minor. On 15-SEP-2021, the patient experienced drug administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use - vaccine administered to a minor and drug administered to patient of inappropriate age was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: OFF LABEL USE - VACCINE ADMINISTERED TO A MINOR; DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a parent concerned a 16 year old male. The patient's weight was 165 pounds, and height was 71 inches. The patient's concurrent conditions included: asthma, eczema, allergy to cats, allergy to dogs, allergy to eggs, allergy to pollen, and dust allergy, and other pre-existing medical conditions included: The patient had an unspecified pulmonary artery issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced off label use - vaccine administered to a minor. On 15-SEP-2021, the patient experienced drug administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use - vaccine administered to a minor and drug administered to patient of inappropriate age was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE - VACCINE ADMINISTERED TO A MINOR; DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a parent concerned a 16 year old male. The patient's weight was 165 pounds, and height was 71 inches. The patient's concurrent conditions included: asthma, eczema, allergy to cats, allergy to dogs, allergy to eggs, allergy to pollen, and dust allergy, and other pre-existing medical conditions included: The patient had an unspecified pulmonary artery issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced off label use - vaccine administered to a minor. On 15-SEP-2021, the patient experienced drug administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use - vaccine administered to a minor and drug administered to patient of inappropriate age was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Dry eye, SARS-CoV-2 test
Clinical narrative: I develop severe dry eyes with the first Covid vaccine; This is a spontaneous report from a contactable Physician (patient).   A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178) via intramuscular route at the left arm on 22Jun2021 as dose 1, single for COVID-19 immunization. Medical history included hypertension and headache. The patient had no drug allergies. The patient had no COVID-19 prior to vaccination. Concomitant medications included doxazosin, metoprolol and amitriptyline for headaches, start and stop date unknown. The patient developed severe dry eyes with the first COVID vaccine, started day 3 on 25Jun2021 and worsened and lasted 2 weeks. The patient had to use eye drops frequently. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient has been tested for COVID-19. The patient delayed the second dose because of it. The event outcome was not recovered.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the event dry eyes and the suspect drug BNT162B2.,Linked Report(s) : US-PFIZER INC-202101171527 same patient, different vaccine dose/AE.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry eye, SARS-CoV-2 test
Clinical narrative: I develop severe dry eyes with the first Covid vaccine; This is a spontaneous report from a contactable Physician (patient).   A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178) via intramuscular route at the left arm on 22Jun2021 as dose 1, single for COVID-19 immunization. Medical history included hypertension and headache. The patient had no drug allergies. The patient had no COVID-19 prior to vaccination. Concomitant medications included doxazosin, metoprolol and amitriptyline for headaches, start and stop date unknown. The patient developed severe dry eyes with the first COVID vaccine, started day 3 on 25Jun2021 and worsened and lasted 2 weeks. The patient had to use eye drops frequently. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient has been tested for COVID-19. The patient delayed the second dose because of it. The event outcome was not recovered.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the event dry eyes and the suspect drug BNT162B2.,Linked Report(s) : US-PFIZER INC-202101171527 same patient, different vaccine dose/AE.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: My arm has been extremely sore since the vaccine. I cannot use my arm normally. I do no have range of motion on my arm. I can not do normal activities with my arm.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: My arm has been extremely sore since the vaccine. I cannot use my arm normally. I do no have range of motion on my arm. I can not do normal activities with my arm.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling hot, Muscle spasms, Nausea, Nervousness
Clinical narrative: On 9/18/21, the patient came to pharmacy for the first Pfizer COVID 19 vaccine. She was asked to wait 15mins afterwards for any immediate reactions and then had left the store. Hospital called in the morning on 9/21/21 to inform us that the patient's throat swelled up , she was nauseated and had tingling all over her body. This started about 45 mins after receiving the vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: On 9/18/21, the patient came to pharmacy for the first Pfizer COVID 19 vaccine. She was asked to wait 15mins afterwards for any immediate reactions and then had left the store. Hospital called in the morning on 9/21/21 to inform us that the patient's throat swelled up , she was nauseated and had tingling all over her body. This started about 45 mins after receiving the vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia, Pharyngeal swelling
Clinical narrative: On 9/18/21, the patient came to pharmacy for the first Pfizer COVID 19 vaccine. She was asked to wait 15mins afterwards for any immediate reactions and then had left the store. Hospital called in the morning on 9/21/21 to inform us that the patient's throat swelled up , she was nauseated and had tingling all over her body. This started about 45 mins after receiving the vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: Missed menstrual cycle-was supposed to begin cycle 9/14/21. It is now 9/21/21 and still have not started cycle. Took 3 different pregnancy tests- all negative. My cycle is regular and occurs ever 5 weeks. I have never skipped a monthly cycle.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Carditis, Chest pain, Decreased appetite, Gait disturbance
Clinical narrative: Lose of appetite two weeks after first shot. Lost about 20 pounds of body weight in 3 days. Extreme pain in mid/lower back affecting basic functions like walking. Pain level was 9/10.  A week or two after the second shot, I had severe pain in my chest. The best way I could have described it at the time was it felt like my esophagus was swollen. I now know fully well it was my heart that was swollen.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oesophagitis, Weight decreased
Clinical narrative: Lose of appetite two weeks after first shot. Lost about 20 pounds of body weight in 3 days. Extreme pain in mid/lower back affecting basic functions like walking. Pain level was 9/10.  A week or two after the second shot, I had severe pain in my chest. The best way I could have described it at the time was it felt like my esophagus was swollen. I now know fully well it was my heart that was swollen.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Illness, Loss of consciousness, Pyrexia
Clinical narrative: Got very sick and feverish in the middle of the night, went into the bathroom and sat down.  When I stood up I passed out on the floor, unsure for how long.    Also felt a tightness / slight pain in my chest off and on for 3 months following the vaccine, usually in the AM.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Wheezing
Clinical narrative: He felt sick the following day.(Monday) On Tuesday he still felt sick. Wednesday he felt better, but began to wheeze. He started taking his Xopanex to help him breathe. By Saturday he had to have his xopanex every 4 hours and it would not work. We increased his dosage, but it still wore off. On Sunday he was prescribed a steroid. The steroid didn?t work completely. On Friday he was prescribed more steroids and a separate bronchodilator. He finally felt better the following week.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hepatic pain, Hot flush, Hyperhidrosis, Myalgia
Clinical narrative: Muscle aches on legs and lower bag that will not resolve even after 2 weeks.  Also hot flash and sweating and pain in Liver.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Muscle aches on legs and lower bag that will not resolve even after 2 weeks.  Also hot flash and sweating and pain in Liver.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cyanosis, Electrocardiogram, Headache, Laboratory test
Clinical narrative: Chest pain; blue lips; headache.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Chest pain; blue lips; headache.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Disturbance in attention, Dyspnoea, Lethargy, Pyrexia
Clinical narrative: Dose 1:  extreme arm pain, swelling, bruising, loss of movement.  started within hours, swelling lasted 4 days, pain 6 days, bruising almost 14 days.    General malaise, low grade fever 38C 2 days Dose 2:  Fever, weakness, lethargy, trouble concentrating, 4 days.    Shortness of breath after 1 week, persistent (current through today, 21 Sept 21)
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Loss of menstrual cycle. Mentsral cycle has still not returned to date.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lactation disorder
Clinical narrative: I was a breastfeeding mother to my 4 month old daughter.  After getting my first dose I slowly starting losing my milk supply and by day 7 I couldn?t even pump a drop of milk out. I went from pumping 40 oz of milk a day to zero by day 7 after getting the Covid vaccination.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Hearing loss in right ear when horizontal and tenitis
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Human anaplasmosis, Lyme disease, Mammogram normal, Pain in extremity
Clinical narrative: June 20, 2021 - Anaplasmsis - treated with Doxycycline Hyclate 100 mg  July 12, 2021 - Lyme d. - treated with Doxycycline Hyclate 100 mg Late July 2021 - right axillary pain started with paresthesia in right forearm and hand.  Persists to present.   September 9, 2021 - sudden onset of pain and swelling in 3rd finger Right hand September 20, 2021 - pain on lateral border Left hand
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Polymerase chain reaction positive, Ultrasound breast
Clinical narrative: June 20, 2021 - Anaplasmsis - treated with Doxycycline Hyclate 100 mg  July 12, 2021 - Lyme d. - treated with Doxycycline Hyclate 100 mg Late July 2021 - right axillary pain started with paresthesia in right forearm and hand.  Persists to present.   September 9, 2021 - sudden onset of pain and swelling in 3rd finger Right hand September 20, 2021 - pain on lateral border Left hand
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Breast tenderness, Chest discomfort, Decreased appetite, Dizziness
Clinical narrative: Consistent random spotting , flesh coming out, cramps, headaches, breast tenderness, exhausted, backaches , dizzy, loss of appetite, swollen veins, chest tightness, heart rate lowered.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Heart rate decreased, Intermenstrual bleeding, Menstrual disorder
Clinical narrative: Consistent random spotting , flesh coming out, cramps, headaches, breast tenderness, exhausted, backaches , dizzy, loss of appetite, swollen veins, chest tightness, heart rate lowered.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Vasodilatation
Clinical narrative: Consistent random spotting , flesh coming out, cramps, headaches, breast tenderness, exhausted, backaches , dizzy, loss of appetite, swollen veins, chest tightness, heart rate lowered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: She started to have uneven elevated heartbeat since getting the second dose of vaccine. Initially, it was getting like 150. Now she suddenly gets in 120 , 100 even when sitting and resting.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia, Neck pain, Paraesthesia, Vision blurred
Clinical narrative: Blurry eyes -  1 day follow dose  Chest sorenes/left side/ - 2 days following Indigestion -2nd day post shot Sore neck Tingling in hands
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Gait inability, Hypoaesthesia
Clinical narrative: Feels numbness in her left left from her ankle to her thigh, she loses strength in her leg and is unable to walk.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: My right arm got tingly and then numb.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Malaise, Neurological examination abnormal
Clinical narrative: Approximately 1.5 hrs following infection, the majority of left side of the the patient's body went numb/tingly, including upper and lower extremeties and the left side of the torso. Symptoms remained for 3-4 days, gradually improving. Patient also experienced severe headache pain, body aches, fever, chills and general malaise which lasted for approximately 2 days.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia, Reflex test normal
Clinical narrative: Approximately 1.5 hrs following infection, the majority of left side of the the patient's body went numb/tingly, including upper and lower extremeties and the left side of the torso. Symptoms remained for 3-4 days, gradually improving. Patient also experienced severe headache pain, body aches, fever, chills and general malaise which lasted for approximately 2 days.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood pressure increased, Chest discomfort, Chest pain, Computerised tomogram
Clinical narrative: began having chest pain/ tightness and short of breath on exertion, elevated heart rate and blood pressure. No issues prior to vaccination  outcome- enlarged pulmonary artery (  had no prior heart issues)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Heart rate increased, Ventricular enlargement
Clinical narrative: began having chest pain/ tightness and short of breath on exertion, elevated heart rate and blood pressure. No issues prior to vaccination  outcome- enlarged pulmonary artery (  had no prior heart issues)
Age: 29.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Skin laceration
Clinical narrative: After receiving vaccines, patient was directed to sit in designated post-immunization observation area for 15 minutes.  While seated, patient became light-headed and lost consciousness, causing him to fall from his chair to the floor. He regained consciousness within moments and experienced no additional symptoms.  In course of falling from the chair, patient sustained a head injury, causing a minor scalp laceration.  Paramedics were summoned.  Patient declined transport to medical facility, and was urged to seek follow-up care for the injury to his head.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: Difficulty breathing, palpitations, chest pain, fast beating heart rate, diarrhea, vomit
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Difficulty breathing, palpitations, chest pain, fast beating heart rate, diarrhea, vomit
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, CSF pressure, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Ear disorder
Clinical narrative: I began having a migraine on July 2nd. On July 3rd, I had a migraine, was vomiting and couldn't walk normally. On the 4th I went to the ER after having problems with my ears. A CT scan was done and I was found to have Cerebral Venous Sinus Thrombosis which is a blood clot in the brain. I was admitted to  Medical Center where they did another more thorough CT scan and started me on heparin. I was informed that I was close to having a fatal stroke. I was kept in the hospital for 2 days and sent home to recover. It has been two and a half months and I am still having complications. I am currently seeing several doctors to monitor the blood clot as well as intracranial pressure.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Migraine, Vomiting
Clinical narrative: I began having a migraine on July 2nd. On July 3rd, I had a migraine, was vomiting and couldn't walk normally. On the 4th I went to the ER after having problems with my ears. A CT scan was done and I was found to have Cerebral Venous Sinus Thrombosis which is a blood clot in the brain. I was admitted to  Medical Center where they did another more thorough CT scan and started me on heparin. I was informed that I was close to having a fatal stroke. I was kept in the hospital for 2 days and sent home to recover. It has been two and a half months and I am still having complications. I am currently seeing several doctors to monitor the blood clot as well as intracranial pressure.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Arthralgia, Headache, Injection site pain, Lethargy
Clinical narrative: Sore throat, sores in mouth, left side of body joint pain, injection site pain, headache, sharp pain inconsistently on right side of abdomin, lethargic.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat, sores in mouth, left side of body joint pain, injection site pain, headache, sharp pain inconsistently on right side of abdomin, lethargic.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site reaction, Pain, Pain in extremity, Swelling
Clinical narrative: Arm sore by evening of receiving first shot (as to be expected). Soreness waned after a few days. Two weeks later redness and rash appeared for approximately 48 hours. Decided to do second shot the following month in opposite arm. Second shot also caused arm pain and swelling but not as severely and with no rash.  Beginning again in August 2021 the left arm at site of original vaccination keeps re-experiencing arm pain like a localized, dull aching bruise. The sensation comes and goes over periods of days. It has been reoccurring enough now that it seems lessikely attributeable to any other particular action or circumstances.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm sore by evening of receiving first shot (as to be expected). Soreness waned after a few days. Two weeks later redness and rash appeared for approximately 48 hours. Decided to do second shot the following month in opposite arm. Second shot also caused arm pain and swelling but not as severely and with no rash.  Beginning again in August 2021 the left arm at site of original vaccination keeps re-experiencing arm pain like a localized, dull aching bruise. The sensation comes and goes over periods of days. It has been reoccurring enough now that it seems lessikely attributeable to any other particular action or circumstances.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Pain
Clinical narrative: Muscle sore and shooting throbbing pain and loose of strength..
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest X-ray, Chest discomfort, Cough, Dyspnoea
Clinical narrative: Cough, sob, fever, all over body aches, swelling at inj site.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gastrooesophageal reflux disease, Headache, Injection site erythema
Clinical narrative: Cough, sob, fever, all over body aches, swelling at inj site.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Pain, Painful respiration, Pyrexia
Clinical narrative: Cough, sob, fever, all over body aches, swelling at inj site.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Cough, sob, fever, all over body aches, swelling at inj site.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: I have never skipped/missed s period or been more than 2 days late . I am now a week late with my period.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: I missed my period for 3 months. From February - May 2021.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal
Clinical narrative: patient received pfizer covid vaccine dose #1 on 9/11/2021 at a vaccine clinic. patient, then, experienced a chest pain after the pfizer vaccine. patient went to the QMC ER and was evaluated for chest pain. 12-lead EKG - normal. Chest XR - normal. no labs were drawn in ER. patient followed up in our clinic today. Patient was still having chest pain and was referred to Cardiology for rule out pericarditis.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Migraine
Clinical narrative: Two weeks after vaccine my period began abruptly. I began having excruciating cramps as soon as I woke up and around 5:30 that evening, I took a shower, trying to ease the aching in my lower abdomen. I looked down & my shower floor was covered in blood. It was not stopping & I began to feel lightheaded. I got out & realized the shower drain was actually clogged with massive clots the size of quarters & silver dollars. I had not been sexually active so I knew I wasn?t having a miscarriage-but it looked like I was. It lasted 2 weeks, I was actually anemic from passing so much blood.  Every couple of weeks this happens now. I?ve been having blinding migraines & was prescribed multiple medications that I only take if necessary. My periods were always light & regular. This is taking a toll on my quality of life & I?m pissed.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Two weeks after vaccine my period began abruptly. I began having excruciating cramps as soon as I woke up and around 5:30 that evening, I took a shower, trying to ease the aching in my lower abdomen. I looked down & my shower floor was covered in blood. It was not stopping & I began to feel lightheaded. I got out & realized the shower drain was actually clogged with massive clots the size of quarters & silver dollars. I had not been sexually active so I knew I wasn?t having a miscarriage-but it looked like I was. It lasted 2 weeks, I was actually anemic from passing so much blood.  Every couple of weeks this happens now. I?ve been having blinding migraines & was prescribed multiple medications that I only take if necessary. My periods were always light & regular. This is taking a toll on my quality of life & I?m pissed.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Patient receiving his J&J vaccination and the vaccine leaked out, so when the needle was inserted into the Patient arm there was no vaccine to push. Technician stated she was 100% sure there was no fluid that was pushed into the PT arm.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Bumps On Back Of Tongue & Throat Chest Pain Dizziness  Nauseous  Diarrhea  Fever Headache  Exhaustion  Pain At Injection Site
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pyrexia, Rash, Tongue eruption
Clinical narrative: Bumps On Back Of Tongue & Throat Chest Pain Dizziness  Nauseous  Diarrhea  Fever Headache  Exhaustion  Pain At Injection Site
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling; soreness; warm-to-touch; red. Went away for 4 days then came back and started to itch. After taking Motrin, swelling went down but still sore and the red patch has grown.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Injection site discomfort, Injection site pruritus, Pruritus
Clinical narrative: After reviewing the first injection of Moderna covid vaccine I  begin to feeling itching and discomfort at the injection site but didn't get bothered much by it and considered as normal injection site symptom. A couple of days later, l noticed a red/ purplish in color circular itchy patch on the side of my breast then, more appeared in the chest area, then one on my right upper arm then another on the left side of my neck then two spots in the middle of my back. These spots had rapidly multiplied during the course of 2-3 weeks but mainly in the previous mentioned areas (chest back arms & neck. The second dose on 8/31 made them erupt more in the stomach and lower back area.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Oligomenorrhoea
Clinical narrative: Period came almost two weeks early, lasted for 1.5 weeks. Usual period is at the same time each month and only 4 days.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Emotional disorder, Headache
Clinical narrative: The day of the vaccine I had a dead arm. Fever and shivers. Headache followed second and third day along with heart palpitations after coughing in the shower, I went really lightheaded, emotional and my heart was pounding heavily
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Palpitations, Pyrexia
Clinical narrative: The day of the vaccine I had a dead arm. Fever and shivers. Headache followed second and third day along with heart palpitations after coughing in the shower, I went really lightheaded, emotional and my heart was pounding heavily
Sex: M
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: his thyroid is not working, "zero"/problems with his thyroid/problems with his thyroid; This is a spontaneous report from a contactable consumer (patient's mother) reported for her son. A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced his thyroid is not working, "zero"/problems with his thyroid. His endocrinologist says, it was a reaction to the vaccine, and does not know how long it will last. She knows her son had problems with the second dose. He had problems with his thyroid. The doctor said there was nothing to do and the doctor could not give him Synthroid. The doctor said her son had to wait it out. Her son asked how long if it would be 6 months to one year and the doctor did not know. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp (consumer). A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No, NDC number, Expiry Date: was not reported), via an unspecified route of administration on 11Apr2021 as 1stdose, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced allergic reaction on Apr2021.  Patient had to visit emergency room from unspecified to unspecified. Dates for patient are telling her to get the second dose from unspecified to unspecified. Reason for no lot number of Covid vaccine was patient was unwilling to complete the report. Patient had her second dose, but if she has already had an allergic reaction does she need the second dose because she does not know what to do. Investigation assessment was not provided. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: I'm experiencing severe pain in the chest that doesn't go away, very strong, not normal; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient reported for herself). A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ew0151), dose 2 via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 (at the age of 25-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. No known allergies were reported. Concomitant medications included camellia sinensis, levocarnitine, taurine (FAT BURNER L CARNITINA COMPLEX) taken for an unspecified indication, start and stop date were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ew0179), dose 1 via an unspecified route of administration, administered in left arm on 28Apr2021 at 12:30 (at the age of 25-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines on the same date the COVID vaccine was administered. Other medications the patient received within 2 weeks of vaccination included fat burner. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 29Apr2021 at 16:00, the patient experienced severe pain in the chest that did not went away, very strong, not normal. The event had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. No treatment was received for the event. The outcome of the event was reported as not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received and contains no new information.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Dyspnoea, Pain, Pyrexia
Clinical narrative: High fever body aches shortness breath lost appetite dizziness; High fever body aches shortness breath lost appetite dizziness; High fever body aches shortness breath lost appetite dizziness; High fever body aches shortness breath lost appetite dizziness; High fever body aches shortness breath lost appetite dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (High fever body aches shortness breath lost appetite dizziness), DYSPNOEA (High fever body aches shortness breath lost appetite dizziness), DIZZINESS (High fever body aches shortness breath lost appetite dizziness), DECREASED APPETITE (High fever body aches shortness breath lost appetite dizziness) and PYREXIA (High fever body aches shortness breath lost appetite dizziness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 07-Sep-2021, the patient experienced PAIN (High fever body aches shortness breath lost appetite dizziness), DYSPNOEA (High fever body aches shortness breath lost appetite dizziness), DIZZINESS (High fever body aches shortness breath lost appetite dizziness), DECREASED APPETITE (High fever body aches shortness breath lost appetite dizziness) and PYREXIA (High fever body aches shortness breath lost appetite dizziness). On 09-Sep-2021, PAIN (High fever body aches shortness breath lost appetite dizziness), DYSPNOEA (High fever body aches shortness breath lost appetite dizziness), DIZZINESS (High fever body aches shortness breath lost appetite dizziness), DECREASED APPETITE (High fever body aches shortness breath lost appetite dizziness) and PYREXIA (High fever body aches shortness breath lost appetite dizziness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Reoccurring migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Reoccurring migraine) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Penicillin allergy.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 08-Apr-2021, the patient experienced MIGRAINE (Reoccurring migraine). At the time of the report, MIGRAINE (Reoccurring migraine) had not resolved.            No concomitant medication was reported. No treatment medication was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Previously sick with COVID.). Concurrent medical conditions included Sulfonamide allergy (sulfa drug allergy), Allergy to antibiotic (ciprofloxacin allergy), Drug allergy (Celebrex allergy), Contrast media allergy (dye), Iodine allergy (betadyne allergy), Soy allergy, Food allergy (Wheat ), Fish allergy, Shellfish allergy and Bee sting.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 05-Sep-2021, HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided