chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, SARS-CoV-2 test
Clinical narrative: DVT blood clot; pain in my right calf; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 26-year-old. The patient had COVID prior vaccination. Patient had no known allergies and other medical history. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. The patient previously took bnt162b2, dose 1 via an unspecified route of administration, administered in arm left on 05May2021 12:00 PM (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 26-year-old. Patient experienced pain in her right calf and DVT blood clot on 29Sep2021 12:00 am. Clinical course: Last week, patient went to ER with pain in her right calf. It turned out to be a DVT blood clot. She had absolutely zero benefactors as to why she could have gotten one she was young and healthy. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had been tested COVID post vaccination. The patient underwent lab tests and procedures which included nasal swab: unknown results on an unspecified date. Therapeutic measures of blood thinners were taken as a result of events. Outcome of events was not recovered.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Incorrect product formulation administered
Clinical narrative: She went to get a flu shot but instead received another booster dose.; She went to get a flu shot but instead received another booster dose.; She went to get a flu shot but instead received another booster dose.; This is a spontaneous report from a contactable other health care professional (dentist who is patient's son) via medical information team. An 89-year-old female patient (reporter's mother) received BNT162B2 (COMIRNATY; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration on 06Oct2021 (at the age of 89 years old) as dose 4 (booster), single for COVID-19 immunization. Medical history included chronic leukemia, chronic myeloblastic and myelocytic leukemia, hypertension, her platelets and neutrophils were low and medically compromised in Apr2021 because it had been for 6 months. Concomitant medications included venetoclax (VENCLEXTA) taken for chronic leukemia and been on it for over 2 years; furosemide and losartan were taken for hypertension and decitabine (DACOGEN) or azacitidine (VIDAZA) as intravenous antineoplastics once a month for three days which were taken for leukemia. She had gone back and forth and reported that she was on duo therapy. Historical vaccine included BNT162B2 (COMIRNATY; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunization; and received the third dose of BNT162B2 (COMIRNATY; Lot number and expiration date were not reported), via an unspecified route of administration in Sep2021 as dose 3 (booster), single for COVID-19 immunization. It was reported that the patient had been fully vaccinated and four weeks ago, the patient received the booster dose with third vaccination of BNT162B2. The patient went to get a flu shot but instead received another booster dose on 06Oct2021. She hasn't had any bloodwork recently and had chronic myeloblastic and myelocytic leukemia. Her platelets were low but have been fairly stable for a couple of months. Platelets were 90,000 and neutrophils were low. They have been as low as 17,000 but have been fairly stable recently. They concerned that do they need to look out for her since it had been about four weeks since the first booster dose. The reporter wanted to know regarding the recommendation regarding the administration of 4 doses of Pfizer COVID-19 vaccine. The reporter considered the events to be medically significant but not life threatening.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Off label use, Immunisation, Wrong product administered  and BNT162B2.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Neutrophil count, Off label use, Platelet count, Wrong product administered
Clinical narrative: She went to get a flu shot but instead received another booster dose.; She went to get a flu shot but instead received another booster dose.; She went to get a flu shot but instead received another booster dose.; This is a spontaneous report from a contactable other health care professional (dentist who is patient's son) via medical information team. An 89-year-old female patient (reporter's mother) received BNT162B2 (COMIRNATY; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration on 06Oct2021 (at the age of 89 years old) as dose 4 (booster), single for COVID-19 immunization. Medical history included chronic leukemia, chronic myeloblastic and myelocytic leukemia, hypertension, her platelets and neutrophils were low and medically compromised in Apr2021 because it had been for 6 months. Concomitant medications included venetoclax (VENCLEXTA) taken for chronic leukemia and been on it for over 2 years; furosemide and losartan were taken for hypertension and decitabine (DACOGEN) or azacitidine (VIDAZA) as intravenous antineoplastics once a month for three days which were taken for leukemia. She had gone back and forth and reported that she was on duo therapy. Historical vaccine included BNT162B2 (COMIRNATY; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunization; and received the third dose of BNT162B2 (COMIRNATY; Lot number and expiration date were not reported), via an unspecified route of administration in Sep2021 as dose 3 (booster), single for COVID-19 immunization. It was reported that the patient had been fully vaccinated and four weeks ago, the patient received the booster dose with third vaccination of BNT162B2. The patient went to get a flu shot but instead received another booster dose on 06Oct2021. She hasn't had any bloodwork recently and had chronic myeloblastic and myelocytic leukemia. Her platelets were low but have been fairly stable for a couple of months. Platelets were 90,000 and neutrophils were low. They have been as low as 17,000 but have been fairly stable recently. They concerned that do they need to look out for her since it had been about four weeks since the first booster dose. The reporter wanted to know regarding the recommendation regarding the administration of 4 doses of Pfizer COVID-19 vaccine. The reporter considered the events to be medically significant but not life threatening.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Off label use, Immunisation, Wrong product administered  and BNT162B2.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: got the Pfizer Covid vaccine/4 years old male; Went to (name withheld) yesterday for their flu shot but instead got the Pfizer Covid vaccine; fever; body aches; head ache/Head hurting; stomach ache; arm pain/Arm hurt; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient's father) via medical information team. This is report 3 of 4 reports.     A 4-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04Oct2021 at 16:00 (at the age of 4 years old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Patient had no medical history and there were no concomitant medications. The reporter and his wife with 2 children all went to get the flu vaccine, but were given doses of the Pfizer Covid 19 Vaccine instead. Both of the children were given full adult doses of the Pfizer Covid 19 Vaccine. On 04Oct2021, the patient started experiencing fever, body aches, head ache, stomach ache and arm pain. The reporter stated that the patient received the vaccine around 16:00. About 3 hours later the patient began to have a fever, body aches, head hurting. The patient's temperature at the time was 99.8. Reporter states they gave the patient fever reducer, Ibuprofen, and were told to take him to the hospital if the fever persisted. He states that the patient's fever lowered, he woke up at night and it was back up to 99.8 and he was complaining of a stomach ache and that his arm hurt. Reporter stated the patient's symptoms were all persisting. They were alternating Tylenol and Ibuprofen. The patient underwent lab tests and procedures which included body temperature: 99.8 on 04Oct2021. Therapeutic measures were taken as a result of fever, body aches, head ache/head hurting, stomach ache, arm pain/arm hurt. The clinical outcome of fever, body aches, head ache, stomach ache and arm pain was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Accidental overdose, Bronchial disorder, Cough, Crying, Headache
Clinical narrative: got the Pfizer Covid vaccine/4 years old male; Went to (name withheld) yesterday for their flu shot but instead got the Pfizer Covid vaccine; fever; body aches; head ache/Head hurting; stomach ache; arm pain/Arm hurt; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient's father) via medical information team. This is report 3 of 4 reports.     A 4-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04Oct2021 at 16:00 (at the age of 4 years old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Patient had no medical history and there were no concomitant medications. The reporter and his wife with 2 children all went to get the flu vaccine, but were given doses of the Pfizer Covid 19 Vaccine instead. Both of the children were given full adult doses of the Pfizer Covid 19 Vaccine. On 04Oct2021, the patient started experiencing fever, body aches, head ache, stomach ache and arm pain. The reporter stated that the patient received the vaccine around 16:00. About 3 hours later the patient began to have a fever, body aches, head hurting. The patient's temperature at the time was 99.8. Reporter states they gave the patient fever reducer, Ibuprofen, and were told to take him to the hospital if the fever persisted. He states that the patient's fever lowered, he woke up at night and it was back up to 99.8 and he was complaining of a stomach ache and that his arm hurt. Reporter stated the patient's symptoms were all persisting. They were alternating Tylenol and Ibuprofen. The patient underwent lab tests and procedures which included body temperature: 99.8 on 04Oct2021. Therapeutic measures were taken as a result of fever, body aches, head ache/head hurting, stomach ache, arm pain/arm hurt. The clinical outcome of fever, body aches, head ache, stomach ache and arm pain was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age, Pyrexia, Troponin T, Wrong product administered
Clinical narrative: got the Pfizer Covid vaccine/4 years old male; Went to (name withheld) yesterday for their flu shot but instead got the Pfizer Covid vaccine; fever; body aches; head ache/Head hurting; stomach ache; arm pain/Arm hurt; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient's father) via medical information team. This is report 3 of 4 reports.     A 4-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04Oct2021 at 16:00 (at the age of 4 years old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Patient had no medical history and there were no concomitant medications. The reporter and his wife with 2 children all went to get the flu vaccine, but were given doses of the Pfizer Covid 19 Vaccine instead. Both of the children were given full adult doses of the Pfizer Covid 19 Vaccine. On 04Oct2021, the patient started experiencing fever, body aches, head ache, stomach ache and arm pain. The reporter stated that the patient received the vaccine around 16:00. About 3 hours later the patient began to have a fever, body aches, head hurting. The patient's temperature at the time was 99.8. Reporter states they gave the patient fever reducer, Ibuprofen, and were told to take him to the hospital if the fever persisted. He states that the patient's fever lowered, he woke up at night and it was back up to 99.8 and he was complaining of a stomach ache and that his arm hurt. Reporter stated the patient's symptoms were all persisting. They were alternating Tylenol and Ibuprofen. The patient underwent lab tests and procedures which included body temperature: 99.8 on 04Oct2021. Therapeutic measures were taken as a result of fever, body aches, head ache/head hurting, stomach ache, arm pain/arm hurt. The clinical outcome of fever, body aches, head ache, stomach ache and arm pain was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Body temperature, Headache, Off label use, Pain
Clinical narrative: got the Pfizer Covid vaccine/4 years old male; Went to (name withheld) yesterday for their flu shot but instead got the Pfizer Covid vaccine; fever; body aches; head ache/Head hurting; stomach ache; arm pain/Arm hurt; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient's father) via medical information team. This is report 3 of 4 reports.     A 4-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04Oct2021 at 16:00 (at the age of 4 years old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Patient had no medical history and there were no concomitant medications. The reporter and his wife with 2 children all went to get the flu vaccine, but were given doses of the Pfizer Covid 19 Vaccine instead. Both of the children were given full adult doses of the Pfizer Covid 19 Vaccine. On 04Oct2021, the patient started experiencing fever, body aches, head ache, stomach ache and arm pain. The reporter stated that the patient received the vaccine around 16:00. About 3 hours later the patient began to have a fever, body aches, head hurting. The patient's temperature at the time was 99.8. Reporter states they gave the patient fever reducer, Ibuprofen, and were told to take him to the hospital if the fever persisted. He states that the patient's fever lowered, he woke up at night and it was back up to 99.8 and he was complaining of a stomach ache and that his arm hurt. Reporter stated the patient's symptoms were all persisting. They were alternating Tylenol and Ibuprofen. The patient underwent lab tests and procedures which included body temperature: 99.8 on 04Oct2021. Therapeutic measures were taken as a result of fever, body aches, head ache/head hurting, stomach ache, arm pain/arm hurt. The clinical outcome of fever, body aches, head ache, stomach ache and arm pain was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Wrong product administered
Clinical narrative: got the Pfizer Covid vaccine/4 years old male; Went to (name withheld) yesterday for their flu shot but instead got the Pfizer Covid vaccine; fever; body aches; head ache/Head hurting; stomach ache; arm pain/Arm hurt; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient's father) via medical information team. This is report 3 of 4 reports.     A 4-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04Oct2021 at 16:00 (at the age of 4 years old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Patient had no medical history and there were no concomitant medications. The reporter and his wife with 2 children all went to get the flu vaccine, but were given doses of the Pfizer Covid 19 Vaccine instead. Both of the children were given full adult doses of the Pfizer Covid 19 Vaccine. On 04Oct2021, the patient started experiencing fever, body aches, head ache, stomach ache and arm pain. The reporter stated that the patient received the vaccine around 16:00. About 3 hours later the patient began to have a fever, body aches, head hurting. The patient's temperature at the time was 99.8. Reporter states they gave the patient fever reducer, Ibuprofen, and were told to take him to the hospital if the fever persisted. He states that the patient's fever lowered, he woke up at night and it was back up to 99.8 and he was complaining of a stomach ache and that his arm hurt. Reporter stated the patient's symptoms were all persisting. They were alternating Tylenol and Ibuprofen. The patient underwent lab tests and procedures which included body temperature: 99.8 on 04Oct2021. Therapeutic measures were taken as a result of fever, body aches, head ache/head hurting, stomach ache, arm pain/arm hurt. The clinical outcome of fever, body aches, head ache, stomach ache and arm pain was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Injection site pain, Pharyngeal swelling, Somnolence
Clinical narrative: Started with pain up to the base of the neck, then travelled down the forearm and fingers became ice cold.  Later blurry vision and extreme exhaustion hit to a point it was hard to keep my eyes open, lips started to swell with red dots on them, then throat started to swell where it was hard to breathe.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Lip swelling, Neck pain, Pain in extremity
Clinical narrative: Started with pain up to the base of the neck, then travelled down the forearm and fingers became ice cold.  Later blurry vision and extreme exhaustion hit to a point it was hard to keep my eyes open, lips started to swell with red dots on them, then throat started to swell where it was hard to breathe.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Pharyngeal swelling, Vision blurred
Clinical narrative: Started with pain up to the base of the neck, then travelled down the forearm and fingers became ice cold.  Later blurry vision and extreme exhaustion hit to a point it was hard to keep my eyes open, lips started to swell with red dots on them, then throat started to swell where it was hard to breathe.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall, Head injury, Hypotension, Loss of consciousness
Clinical narrative: I fainted when I got up to sit in the waiting room. I hit my head on the floor when I passed out. EMT arrived and cleared me to go home shortly after. Driven home by a friend.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: I fainted when I got up to sit in the waiting room. I hit my head on the floor when I passed out. EMT arrived and cleared me to go home shortly after. Driven home by a friend.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Head injury, Syncope
Clinical narrative: I fainted when I got up to sit in the waiting room. I hit my head on the floor when I passed out. EMT arrived and cleared me to go home shortly after. Driven home by a friend.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Thyroid function test
Clinical narrative: Excessive hair loss all over scalp. Started after 1st dose of Covid Pfizer vaccine and increased dramatically after 2nd dose. Lost ~60% of hair over the next 3 months. Hair loss stopped on month 4 after vaccine and growing back.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Episodes of extreme tinnitus several times a day and night, sometimes for hours at a time! I've NEVER experienced this before.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Nausea, Rash
Clinical narrative: Blood clots in nose 10/16.  Shingles like rash on torso since 10/16.  Nausea on 10/16 and 10/17.  Extreme fatigue on 10/16 and 10/17.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Computerised tomogram, Differential white blood cell count normal, Full blood count normal, Metabolic function test
Clinical narrative: Vasovagal syncope x3 with myoclonic jerking/ convulsions (loss of bodily control during: urination during convulsions)
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myoclonus, Syncope, Urinary incontinence
Clinical narrative: Vasovagal syncope x3 with myoclonic jerking/ convulsions (loss of bodily control during: urination during convulsions)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Diarrhoea, Fatigue, Migraine
Clinical narrative: fatigue that is still ongoing, migraine for 4 days, vomiting and Diarrhea, chills, fever aches all over body for a week. Bruising that started 7 days after the vaccine, I do not bruise easy and now if you touch me I get a bruise.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: fatigue that is still ongoing, migraine for 4 days, vomiting and Diarrhea, chills, fever aches all over body for a week. Bruising that started 7 days after the vaccine, I do not bruise easy and now if you touch me I get a bruise.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Chills, Electrocardiogram, Eye haemorrhage
Clinical narrative: Spasms in chest, pain in chest, swelling of joints such as knees, wrists, fingers , feet and the areas I had my surgery (hysterectomy). I also felt body aches, headaches, tired and chills. I also had cramps in my legs and feet throughout the time. I felt sick for 7 days.  I also had gone to clinic and they said I had a urine infection and it wouldn?t go away. A blood vessel also popped in my eye. I have a photo documenting my eye issue.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Joint swelling, Malaise, Muscle spasms
Clinical narrative: Spasms in chest, pain in chest, swelling of joints such as knees, wrists, fingers , feet and the areas I had my surgery (hysterectomy). I also felt body aches, headaches, tired and chills. I also had cramps in my legs and feet throughout the time. I felt sick for 7 days.  I also had gone to clinic and they said I had a urine infection and it wouldn?t go away. A blood vessel also popped in my eye. I have a photo documenting my eye issue.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Urinary tract infection, Urine analysis, X-ray
Clinical narrative: Spasms in chest, pain in chest, swelling of joints such as knees, wrists, fingers , feet and the areas I had my surgery (hysterectomy). I also felt body aches, headaches, tired and chills. I also had cramps in my legs and feet throughout the time. I felt sick for 7 days.  I also had gone to clinic and they said I had a urine infection and it wouldn?t go away. A blood vessel also popped in my eye. I have a photo documenting my eye issue.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bed rest, Fatigue, Headache, Nausea
Clinical narrative: tiredness,headache,joint pain, nausea, during 12 - 24 hrs after booster shot.   Just bed rest, plenty of water
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Condition aggravated
Clinical narrative: Began having severe joint pain/back pain  5 days after 1st dose. Unable to lift legs to step up and unable to get up from seated position without assistance. I did already have joint pain before but it became unbearable after vaccine.   After second dose I began having chest discomfort 2 days later. Joint pain still continues .
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Today. 6 weeks after 2nd Pfizer dosage,  I experienced extreme dizziness around 9am. The dizziness continued which makes it impossible to lie down to go to sleep. My head has to remain straight up to get some relief.  I have never experienced anything of this sort. Today is the first day and it has persisted.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Full blood count, Pain in extremity, Peripheral swelling, Red blood cell sedimentation rate
Clinical narrative: Pt has developed severe L arm pain w/ mild swelling and warmth after getting her Moderna mRNA vaccination in the LUE.  She reports the injection was given high in her shoulder.  She was treated w/ diclofenac and cold compress.  CBC, ESR, and CRP were drawn.  Pt to follow up as needed.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Pt has developed severe L arm pain w/ mild swelling and warmth after getting her Moderna mRNA vaccination in the LUE.  She reports the injection was given high in her shoulder.  She was treated w/ diclofenac and cold compress.  CBC, ESR, and CRP were drawn.  Pt to follow up as needed.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria, Pruritus
Clinical narrative: Hives at injection site and on face; itchiness at injection site and on face. Cool clothes on face and Benadryl. Hives subsided from face 1.5 hours later; not injection site. Hives subsided from injection site on Monday 10/18. Injection site still itchy, red and less sore.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives at injection site and on face; itchiness at injection site and on face. Cool clothes on face and Benadryl. Hives subsided from face 1.5 hours later; not injection site. Hives subsided from injection site on Monday 10/18. Injection site still itchy, red and less sore.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Arthralgia, Blood pressure abnormal, Cardiovascular disorder, Confusional state
Clinical narrative: She showed signs of shortness of breath and fatigue/ confusion less than 2 weeks after her first dose Was hospitalized and it was determined that she had an infection that was septic  She had cardiovascular damage (blood pressure issues) Fluid build up in her body Nausea Joint and muscle pain Fatigue Injection potentially entered her bloodstream or blood vessel as she received it during her chemotherapy session
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Fluid retention, Infection, Inflammation
Clinical narrative: She showed signs of shortness of breath and fatigue/ confusion less than 2 weeks after her first dose Was hospitalized and it was determined that she had an infection that was septic  She had cardiovascular damage (blood pressure issues) Fluid build up in her body Nausea Joint and muscle pain Fatigue Injection potentially entered her bloodstream or blood vessel as she received it during her chemotherapy session
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Sepsis
Clinical narrative: She showed signs of shortness of breath and fatigue/ confusion less than 2 weeks after her first dose Was hospitalized and it was determined that she had an infection that was septic  She had cardiovascular damage (blood pressure issues) Fluid build up in her body Nausea Joint and muscle pain Fatigue Injection potentially entered her bloodstream or blood vessel as she received it during her chemotherapy session
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site bruising, Pain in extremity, Tremor
Clinical narrative: I had a seriously sore arm (Same as first dosage when given) that did not go away.  Three weeks after the injection a large hematoma  (bruise) appeared and my arm has continued to be achy and my hand with tremble occasionally if my arm rests in a certain position.  I live part time in State and discussed this my doctor in City.  It should be noted that the injection site was way lower than first shot.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Syncope
Clinical narrative: started to feel extreamly hot,then dizzy, then fainted....co workers there to catch my fall. not 100% sure ont the type of influenza shot.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid bleeding, Haemorrhage, Skin exfoliation
Clinical narrative: My left eyelid is bleeding without any known abrasion and my left arm is bleeding very easily.  Merely touching my skin seems to be peeling it off.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Physical examination
Clinical narrative: Diagnosed with shingles. Symptoms began roughly 36 hours after first round of Moderna COVID-19 vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Neuralgia
Clinical narrative: Immediate burning down my left arm to finger tips lasting 3 hrs after injection. Experienced massive headaches for 4 months after injection, requiring self dosing up to 1G of Tylenol q 6hrs each day to control. Current nerve pain in extremities.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Biliary tract disorder, Diarrhoea, Laboratory test
Clinical narrative: Extreme stomach discomfort, liquid diarrhea that lasted more than 45 days. Systemic full body hives that lasted 6 days a week following second Pfizer dose. Extreme biliary dysfunction. Extreme anxiety, panic attacks.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Panic attack, Urticaria
Clinical narrative: Extreme stomach discomfort, liquid diarrhea that lasted more than 45 days. Systemic full body hives that lasted 6 days a week following second Pfizer dose. Extreme biliary dysfunction. Extreme anxiety, panic attacks.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Very painful right arm that swelled to double normal size, red and hot to touch, fever between 100.5 and 103 degreesF, severe headache, nausea, muscle aches snd fatigue. All symptoms lasted 48 hours except right arm pain, redness and swelling which resolved after 6 days.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Very painful right arm that swelled to double normal size, red and hot to touch, fever between 100.5 and 103 degreesF, severe headache, nausea, muscle aches snd fatigue. All symptoms lasted 48 hours except right arm pain, redness and swelling which resolved after 6 days.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest X-ray, Chest discomfort, Chills, Cold sweat
Clinical narrative: Chest tightness, racing heart, chills, cold sweats, insomnia, irritation, abnormal anxiety, fever, vomiting, diarrhea, light headiness, uncontrollable shaking
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Electrocardiogram, Full blood count, Insomnia
Clinical narrative: Chest tightness, racing heart, chills, cold sweats, insomnia, irritation, abnormal anxiety, fever, vomiting, diarrhea, light headiness, uncontrollable shaking
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Palpitations, Pyrexia, Tremor, Vomiting
Clinical narrative: Chest tightness, racing heart, chills, cold sweats, insomnia, irritation, abnormal anxiety, fever, vomiting, diarrhea, light headiness, uncontrollable shaking
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test normal, Electrocardiogram, Hyperhidrosis, Lethargy
Clinical narrative: ongoing unexplained frequent nausea, lethargy, joint pain, sweating with minimal exercise
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: ongoing unexplained frequent nausea, lethargy, joint pain, sweating with minimal exercise
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Pericarditis, Troponin
Clinical narrative: Severe chest pain c/w pericarditis.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nausea, Paraesthesia, Vomiting
Clinical narrative: Headache, numbness, tingling to skin, nausea and vomiting x1.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Menstruation irregular
Clinical narrative: Periods have be one irregular and significantly lighter.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: patient admitted to hospital due to covid symptoms
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dizziness, Feeling cold, Nausea, Pain
Clinical narrative: Extremely cold, shivers, nausea, dizziness, sore body, sore arm
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Extremely cold, shivers, nausea, dizziness, sore body, sore arm
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: Numbness/tingling in both arms and both legs, extreme weakness in both arms and both legs, extreme, heightened anxiety and panic attacks, chronic headaches, dizziness, lightheadedness
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Paraesthesia
Clinical narrative: Numbness/tingling in both arms and both legs, extreme weakness in both arms and both legs, extreme, heightened anxiety and panic attacks, chronic headaches, dizziness, lightheadedness
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Started getting hives at night after vaccination.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Joint range of motion decreased, Neck pain, Nightmare
Clinical narrative: In first vaccine I had a week long back pain. Shoulder , back neck area. Didnt move my head because of pain a week.Second vaccine fever at night a lot of nightmares.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: In first vaccine I had a week long back pain. Shoulder , back neck area. Didnt move my head because of pain a week.Second vaccine fever at night a lot of nightmares.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cold sweat, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Mild but persistent fever alleviated by Advil.  Chest "soreness" started 2 days in, pounding heart and cold sweats and arm pangs went in and out over the next two days. Only comfortable with chest vertical. Symptoms abruptly vanished after 2 nights of this.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives and rash on skin; Hives and rash on skin; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for female patient that,  A 19-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0169) (at the age of 19 years old), dose 1 via an unspecified route of administration, administered in arm left on 20Apr2021 as dose 1, single, dose 2 via an unspecified route of administration, administered in arm left on 11May2021 10:00 (Formulation: Solution for injection, Batch/Lot Number: EW0179) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ascorbic acid (VITAMIN-C) taken within two weeks of vaccination for an unspecified indication, start and stop date were not reported. It was reported that on 12May2021 17:30 patient experienced urticaria and rash on skin. No treatment was received for events. No known allergies was reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Outcome for events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported; A 15 year ald female received PROQUAD yesterday; This spontaneous report was received from a registered nurse and refers to a 15 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.      On 30-SEP-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # U009261, expiration date: 19-SEP-2022) 1 dose in the left deltoid for prophylaxis (product administered to patient of inappropriate age). No additional adverse events reported.
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; PROQUAD vaccine that had undergone temperature excursion; This spontaneous report as received from a registered nurse, referring to a currently 4 years old male patient. Information regarding the patient's pertinent medical history, concurrent condition and drug reactions or allergies was not provided.    In 2021 (reported as undergone temperature excursion before calling MNSC), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # U002539 with expiration date: 24-JUL-2022, dose, strength and route were not reported) for prophylaxis. No additional AE.     Administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) experienced the temperature excursion under 13.8 degrees Fahrenheit (F) for 1 hour and 48 minutes (product storage error). The previous temperature excursions was not reported.  This is one of five reports from the same reporter.; Sender's Comments:  US-009507513-2110USA001533: US-009507513-2110USA001521: US-009507513-2110USA001664: US-009507513-2110USA001341:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a single dose of expired PENUMOVAX 23 was admnistered to a patient; This spontaneous report as received from a medical assistance refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.     The medical assistance reported that on 04-OCT-2021, the patient was vaccinated with a single dose of expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number S036495 with expiration date 13-SEP-2021, for prophylaxis (dosage, route of administration and anatomical location were not reported). The vaccine had been stored in recommended range and had never undergone a temperature excursion. No additional adverse event (AE).
Sex: U
Vaccine: HPV9
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; if Patient was meant to receive future 3rd GARDASIL 9 dose; 4 years and 364 days old or at 14 years and 364 days old; This spontaneous report was received from a nurse via a company representative referring to a patient at 4 years and 364 days old or 14 years and 364 days old of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 15-OCT-2021, it was unknown if the patient was meant to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) with the 6 month mark for 3rd dose being meant for 16-OCT-2021 for prophylaxis (circumstance or information capable of leading to medication error and product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: broke out with sores; itch; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and pruritus. On an unknown date, the outcome of the pain and pruritus were recovered/resolved.   It was unknown if the reporter considered the pain and pruritus to be related to Shingles vaccine.   Additional details were provided as follows: The case was reported by the patient. Age at vaccination was not reported. The patient got his/her 1st shingles vaccine and broke out with sores and itch for 3 weeks.  They clear at the time of reporting but did not know about taking the second.  The patient also asked anybody else had any side effects. No contact details were reported.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site erythema, Injection site pruritus, Injection site rash, Rash
Clinical narrative: chicken pox; red itchy bumps by the injection site; red itchy bumps/ they are raised/; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included Patient did not know if had chicken pox as a child..   On 4th October 2021, the patient received Shingrix. On 6th October 2021, 2 days after receiving Shingrix, the patient experienced chickenpox, itchy rash and erythropapular rash. On an unknown date, the outcome of the chickenpox, itchy rash and erythropapular rash were not recovered/not resolved.   The reporter considered the chickenpox, itchy rash and erythropapular rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient did not know if she had chicken pox as a child. The patient received the Shingrix vaccination on Monday and on Wednesday developed red itchy bumps by the injection side and over the days this spread to the chest, around the waist and on the back. They were very itchy and looked like chicken pox. The patient thought that she had chicken pox. The patient thought that the red itchy bumps she was experiencing was due to Shingrix.  She said they were raised, and they were itching terribly. She said she woke up on reporting day morning and they were all over her back.  The patient did not have the lot number because she threw away the paperwork.  She had got the shot at her doctor's office and provided consent to follow up with her doctor. This case was linked with US2021AMR212333, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR212333:same reporter
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic, Varicella
Clinical narrative: chicken pox; red itchy bumps by the injection site; red itchy bumps/ they are raised/; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included Patient did not know if had chicken pox as a child..   On 4th October 2021, the patient received Shingrix. On 6th October 2021, 2 days after receiving Shingrix, the patient experienced chickenpox, itchy rash and erythropapular rash. On an unknown date, the outcome of the chickenpox, itchy rash and erythropapular rash were not recovered/not resolved.   The reporter considered the chickenpox, itchy rash and erythropapular rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient did not know if she had chicken pox as a child. The patient received the Shingrix vaccination on Monday and on Wednesday developed red itchy bumps by the injection side and over the days this spread to the chest, around the waist and on the back. They were very itchy and looked like chicken pox. The patient thought that she had chicken pox. The patient thought that the red itchy bumps she was experiencing was due to Shingrix.  She said they were raised, and they were itching terribly. She said she woke up on reporting day morning and they were all over her back.  The patient did not have the lot number because she threw away the paperwork.  She had got the shot at her doctor's office and provided consent to follow up with her doctor. This case was linked with US2021AMR212333, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR212333:same reporter