chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: After about 10 minutes I felt a wave of heat wash over me. Then I felt brief light-headedness and begin experiencing shortness of breath. The shortness of breath would intensify and then abate but not like a panic attack it was directly related to the shot. After about 20 minutes is subsided 9 days later I still feel weak and fatigued. There was no emergency rescue precautions available for me had at the site had the situation worsen 3 weeks prior I had The first shot of my shingles vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: After about 10 minutes I felt a wave of heat wash over me. Then I felt brief light-headedness and begin experiencing shortness of breath. The shortness of breath would intensify and then abate but not like a panic attack it was directly related to the shot. After about 20 minutes is subsided 9 days later I still feel weak and fatigued. There was no emergency rescue precautions available for me had at the site had the situation worsen 3 weeks prior I had The first shot of my shingles vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Woke up with a large round red circle that looks like a rash.  It's mildly itchy, but it is slightly sore.  I received the first dose of Moderna 10 days ago.  I looked it up online and they're calling it "covid arm"
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site warmth, Rash papular, Rash pruritic
Clinical narrative: On 2/22/2021 caller c/o of a rash that was warm, raised and "itchy" at injection site. Reports talking Tylenol and using Benadryl cream which provided relief, symptoms resolved after a few days.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Tremor
Clinical narrative: Headache, uncontrollable shaking and chill, constant cold feeling
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Dysphagia, Ear congestion
Clinical narrative: Pt states that he got his 2nd COVID shot on  25Feb  and had fever/chills/cough/congestion over the weekend then PM 28Feb visualized a swollen uvula that goes almost all the way down to his tongue.   Called nurse line at clinic 2Mar AM, current pain 8/10 with ongoing drainage to his throat, congestion, right ear congestion.  Pt also reported coughing up dark blood, unsure of whether it's coming from throat.  He tried nyquil and tylenol without relief of symptoms. Reported some dizziness, trouble swallowing and having to spit out saliva, inability to drink liquids.  Referred to ER.  followed up with Pt 3Mar AM, Pt states he was given steroids, benadryl and a numbing spray for his throat and that the swelling to his uvula has gone down, symptoms are resolving. Was told by ER that he possibly contracted COVID prior to his 2nd shot.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Enlarged uvula, Haemoptysis, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Pt states that he got his 2nd COVID shot on  25Feb  and had fever/chills/cough/congestion over the weekend then PM 28Feb visualized a swollen uvula that goes almost all the way down to his tongue.   Called nurse line at clinic 2Mar AM, current pain 8/10 with ongoing drainage to his throat, congestion, right ear congestion.  Pt also reported coughing up dark blood, unsure of whether it's coming from throat.  He tried nyquil and tylenol without relief of symptoms. Reported some dizziness, trouble swallowing and having to spit out saliva, inability to drink liquids.  Referred to ER.  followed up with Pt 3Mar AM, Pt states he was given steroids, benadryl and a numbing spray for his throat and that the swelling to his uvula has gone down, symptoms are resolving. Was told by ER that he possibly contracted COVID prior to his 2nd shot.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Streptococcus test negative, Upper-airway cough syndrome
Clinical narrative: Pt states that he got his 2nd COVID shot on  25Feb  and had fever/chills/cough/congestion over the weekend then PM 28Feb visualized a swollen uvula that goes almost all the way down to his tongue.   Called nurse line at clinic 2Mar AM, current pain 8/10 with ongoing drainage to his throat, congestion, right ear congestion.  Pt also reported coughing up dark blood, unsure of whether it's coming from throat.  He tried nyquil and tylenol without relief of symptoms. Reported some dizziness, trouble swallowing and having to spit out saliva, inability to drink liquids.  Referred to ER.  followed up with Pt 3Mar AM, Pt states he was given steroids, benadryl and a numbing spray for his throat and that the swelling to his uvula has gone down, symptoms are resolving. Was told by ER that he possibly contracted COVID prior to his 2nd shot.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: SLEEPLESSNESS
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood glucose increased, Blood test, Computerised tomogram normal, Dizziness
Clinical narrative: Vertigo (Spinning, lightheaded, nausea and loss of balance .I had to use both a cane and walker. My primary care phuysician recoemneded that I go to ER on 2/23/21 to have Cat Scan (negative), EKG (normal), blood work (normal except high glucose reading). ER doctor diagnosis was peripheral vertigo not central and discharged me with recomendation to take OTC meclizine twice daily. The spinning side effect has virtually disappeared, still some lightheaded feeling and persistent equilibrium./balance problems exist that prevemt from me driving and performing most daily activities. My Chiropractor has prefromed the  Epley Maneuver twice now but has had very little impact on my equilibrium and balance issues, I have an appointment with a specialist Nuerotologist on March 10, 2021
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Impaired driving ability, Loss of personal independence in daily activities, Nausea, Vertigo
Clinical narrative: Vertigo (Spinning, lightheaded, nausea and loss of balance .I had to use both a cane and walker. My primary care phuysician recoemneded that I go to ER on 2/23/21 to have Cat Scan (negative), EKG (normal), blood work (normal except high glucose reading). ER doctor diagnosis was peripheral vertigo not central and discharged me with recomendation to take OTC meclizine twice daily. The spinning side effect has virtually disappeared, still some lightheaded feeling and persistent equilibrium./balance problems exist that prevemt from me driving and performing most daily activities. My Chiropractor has prefromed the  Epley Maneuver twice now but has had very little impact on my equilibrium and balance issues, I have an appointment with a specialist Nuerotologist on March 10, 2021
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Glossodynia, Paraesthesia oral, Pruritus
Clinical narrative: Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper back within 5-10 minutes of injection 1-2 days after, continued tingling, pain, and swelling in tongue, hives/rash on face with itching and difficulty swallowing  Benadryl was administered at the testing site. Continued Benadryl with Zyrtec and Pepcid daily for adverse reaction through 3/3/21. Called PCP?have appt 3/4/21.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swollen tongue, Urticaria
Clinical narrative: Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper back within 5-10 minutes of injection 1-2 days after, continued tingling, pain, and swelling in tongue, hives/rash on face with itching and difficulty swallowing  Benadryl was administered at the testing site. Continued Benadryl with Zyrtec and Pepcid daily for adverse reaction through 3/3/21. Called PCP?have appt 3/4/21.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Dizziness, Hemiparesis, Hypoaesthesia, Injection site pain
Clinical narrative: Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double vision.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double vision.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, CSF culture negative, Diplopia, Dizziness, Feeling abnormal
Clinical narrative: Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double vision.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging head, Magnetic resonance imaging neck, Temperature intolerance
Clinical narrative: Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double vision.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double vision.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Fatigue, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain and limited range of motion in left arm for 4 days, pinkeye in right eye for 3 days, extreme fatigue for 2 days
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Hyperacusis, Migraine, Nausea
Clinical narrative: Fever of 102 for three  day with migraine (light sensitive, sound sensitive) for three days.   GI upset including diarrhrea.   Took tylenol for fever, zofran for nausea.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia
Clinical narrative: Fever of 102 for three  day with migraine (light sensitive, sound sensitive) for three days.   GI upset including diarrhrea.   Took tylenol for fever, zofran for nausea.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Moderna COVID-19 Vaccine EUA  Injection site soreness - feels bruised but isn't bruised. No other symptoms.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram head, Facial paralysis
Clinical narrative: Drooping Left side of face. Was advised to go to hospital for possible stroke. He was completely  tested and checked for possible stroke. Was given DX of Bell?s Palsy along with scripts for steroids and antiviral.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Frequent bowel movements, Pyrexia
Clinical narrative: Dizziness, frequent bowel movements, fever 100-101, weakness, chills
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Nausea, Pyrexia
Clinical narrative: Felt like the worst flu. Extreme nausea, fever, muscle aches, headache
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I got extremely tired, congested on 1/11 went to see PCP. I tested for Covid(results positive) and was told to continue taking Humira. I was super exhausted for days with cough.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abnormal behaviour, Blood test, Communication disorder, Confusional state
Clinical narrative: Numbness, tingling  and pain in arm from shoulder to fingers.   Stomach pain. On March 1,  early a.m.,  a mental breakdown occurred and was admitted to hospital.  Poor to no communication ability,  totally confused, doing bizarre things like turning on water and leaving room, stacking furniture, not knowing where he was.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mental disorder, Pain in extremity, Paraesthesia, Urine analysis
Clinical narrative: Numbness, tingling  and pain in arm from shoulder to fingers.   Stomach pain. On March 1,  early a.m.,  a mental breakdown occurred and was admitted to hospital.  Poor to no communication ability,  totally confused, doing bizarre things like turning on water and leaving room, stacking furniture, not knowing where he was.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Periorbital swelling, Pruritus, Rash, Sensory disturbance
Clinical narrative: Reaction started on 2.27 mid-morning- she began having a sensation in the back of her neck. Rash began on the nap of neck- swollen bumps.  traveled around the front of the neck and then cheeks and eyes.  Continued near tear ducks and all-around eye. Both eyes began to swell on 2.28 and she went to the ED for treatment.  They gave her a steroid shot and benadryl IM. Discharged home, with no medications, but instructed to take benadryl as needed. She is taking benadryl every 6-8 hours for itching.   She is not fully recovered due to itching and continued rash.  Follow up appointment with PCP the end of this week begin of next.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Pallor, Pyrexia, Tremor
Clinical narrative: About 12 hours after receiving the shot, my wife woke up to severe chills and shaking (with teeth chattering).  She advised that she couldn't even pick up and put on her glasses.  She woke me and I was able to provide her a heating pad that over about 15 minutes reduced the shivering and chills. Her face was so pale that her freckles literally disappeared.  I was ready to call 9-1-1, but she asked me not to (because they would not have let me go with her).  So, I monitored her and gave her two Tylenols.  For the ensuing 24 hours, she ran a 100-degree fever, had slight chills, and took Tylenol tablets periodcially.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Fatigue, Migraine
Clinical narrative: Ocular migraine activity (flashers) lasting for at least 48 hours (still ongoing); fatigue
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Epistaxis, Pain
Clinical narrative: Temp 101, bodyaches, nose bleed from both nose, sleep non-stop nearly 20 hours straight the next day, got better by 3rd day but this time not fast like the first time, took a couple more days to feel normal.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Musculoskeletal chest pain, Pain
Clinical narrative: Weakness, body aches, right chest wall pain
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Confusional state, Dizziness, Fatigue, Headache
Clinical narrative: Weakness, body aches, right chest wall pain
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Weakness, body aches, right chest wall pain
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Weakness, body aches, right chest wall pain
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Mobility decreased
Clinical narrative: Dizziness for about 24 hours; had to lay down for entire time
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: In observation patient noticed a new onset of tingling and itching on her upper extremities.  Administered benadryl with no relief and subsequently given epi pen. Patient has prior allergy to flu and pneumonia vaccine. Advised by PCP to take benadryl prior to COVID vaccine which patient took. Patient presented to ED subsequent day as itching continued. No lip swelling or tongue swelling or difficulty breathing.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Muscular weakness
Clinical narrative: Very sore and weak left arm and mostly at the joint. I am a belly sleeper. Little soreness at the vaccination spot though.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Face and neck skin rash. Raised bumpy inflamed red rash
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Lymphadenopathy, Skin mass
Clinical narrative: I'm aware of the food like symptoms; Swollen lymph node on the back of the neck / grape size lump on the back; grape size lump on the back; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, enlargement of lymph nodes and skin mass. On an unknown date, the outcome of the influenza-like symptoms, enlargement of lymph nodes and skin mass were unknown.   It was unknown if the reporter considered the influenza-like symptoms, enlargement of lymph nodes and skin mass to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received the shingles vaccine the second one last night of reporting. The patient was aware of the flu like symptoms which was not of concerns. The patient was curious to know if that vaccine could cause a swollen lymph node on the back of the neck, the patient had a grape size lump on the back.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain at the injection site; Redness / at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient had the first dose in the left arm. The patient experienced redness and pain at the injection site. Both had resolved after a few days. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021029290:Same reporter
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness, Feeling cold, Heart rate increased
Clinical narrative: Atrial fibrillation; Cold body temperature especially in the feet; fast heart rate; dizziness; A spontaneous report was received from a consumer regarding her husband, an 86-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced fast heart rate/heart rate increased, cold body temperature/coldness, dizziness and atrial fibrillation.   The patient's medical history was not included. Concomitant medications were not reported.  On 27 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 06 Feb 2021, approximately 10 days after the patient received the vaccine, he experienced a fast heart rate, dizziness, cold body temperature, and atrial fibrillation. (The wife reports that they purchased an EKG machine, and this is what the machine showed them. Unaware if he had this before the vaccine or not.)  Treatment information was not provided.   Action taken with mRNA-1273 was unknown.  The outcome of the events, fast heart rate, cold body temperature, dizziness and atrial fibrillation, was unknown.; Reporter's Comments: Although a temporal association exist, the event occurred 9 days after vaccine administration and very limited information regarding this patient's medical history concomitant medications were event is also confounded by the patient's advanced age.  Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest discomfort, Electrocardiogram, Myocardial necrosis marker, Vaccination site pain
Clinical narrative: Pressure between shoulder blades. It went away then started again on carotid then down arm; Sore arm; hot feeling initially; A spontaneous report was received from a consumer, who was a 66-year-old, female patient who received Moderna's COVID-19 vaccine and who experienced a serious adverse event of chest discomfort requiring hospitalization (reported as:  "heart attack like symptoms, pressure between shoulder blades that went away and then started again on her carotid then down her arm" and in addition non-serious events of sore arm, and hot feeling. The patient's medical history included borderline type 2 diabetes and allergies to adhesive tape, bleach and chlorine.  Concomitant product use was not provided.   The patient received her first of two planned doses of mRNA-1273 (LOT 012M20A) on 05-Feb-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Initially on 05-Feb-2021, patient experienced a sore arm that was warm to the touch.  However, on 15-Feb-2021, she reported having had heart attack-like symptoms. She stated that it started as pressure between shoulder blades that initially went away and then started again on her carotid and travelled down her arm.  She thought it was from loading wood.  The patient then went to Emergency Room (ER) where she received a nitro pill which alleviated the pain.  The EKG, cardiac enzyme tests, nuclear imaging and stress test were all negative according to the patient's report.  She reported having been hospitalized for 2 days.   Treatment for the event included a nitroglycerin tablet.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, sore arm, hot feeling initially, heart attack like symptoms, pressure between shoulder blades that went away and then started again on her carotid then down her arm, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship for events cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Pressure between shoulder blades. It went away then started again on carotid then down arm; Sore arm; hot feeling initially; A spontaneous report was received from a consumer, who was a 66-year-old, female patient who received Moderna's COVID-19 vaccine and who experienced a serious adverse event of chest discomfort requiring hospitalization (reported as:  "heart attack like symptoms, pressure between shoulder blades that went away and then started again on her carotid then down her arm" and in addition non-serious events of sore arm, and hot feeling. The patient's medical history included borderline type 2 diabetes and allergies to adhesive tape, bleach and chlorine.  Concomitant product use was not provided.   The patient received her first of two planned doses of mRNA-1273 (LOT 012M20A) on 05-Feb-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Initially on 05-Feb-2021, patient experienced a sore arm that was warm to the touch.  However, on 15-Feb-2021, she reported having had heart attack-like symptoms. She stated that it started as pressure between shoulder blades that initially went away and then started again on her carotid and travelled down her arm.  She thought it was from loading wood.  The patient then went to Emergency Room (ER) where she received a nitro pill which alleviated the pain.  The EKG, cardiac enzyme tests, nuclear imaging and stress test were all negative according to the patient's report.  She reported having been hospitalized for 2 days.   Treatment for the event included a nitroglycerin tablet.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, sore arm, hot feeling initially, heart attack like symptoms, pressure between shoulder blades that went away and then started again on her carotid then down her arm, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship for events cannot be excluded.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Product administered to patient of inappropriate age, Pruritus
Clinical narrative: Bruised arm; Itchy; Accidental administration of the Moderna COVID-19 Vaccine to a patient who is 15 years old; A spontaneous report ( was received from a pharmacist concerning a 15-year-old, female patient to who accidently received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental administration of the Moderna COVID-19 vaccine to a patient who is 15 years old/product administered to patient of inappropriate age, itchy/pruritus and bruised arm/contusion.  The patient's medical history was not provided. No concomitant product use was reported.  On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L29A) in the right arm intramuscularly for prophylaxis of COVID-19 infection.    On 25 Jan 2021, a 15-year-old female patient received an accidental dose of the Moderna COVID-19 vaccine and experienced an itchy arm.   On 28 Jan 2021, the reporter noted the patient had a bruised arm.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, accidental administration of the Moderna COVID-19 Vaccine to a patient who is 15 years old/product administered to patient of inappropriate age, was considered resolved on 25 Jan 2021.  The outcome of the events, itchy and bruised arm, were considered unknown.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 12L29A, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine not administered correctly; A spontaneous report was received from a physician who was also a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the vaccine was not administered correctly.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient reported that he doesn't think the vaccine was administered correctly. He stated that he had no arm tenderness or pain after receiving the vaccine.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine not administered correctly, was resolved on 23 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: while receiving the 2nd dose, syringed leaked some of it; the syringe leaked some of it; A spontaneous report  was received from a Pharmacist regarding a patient of unspecified age and gender who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and while receiving the second dose, the syringe leaked some of it (Incomplete dose administered/syringe leak).  The patient's medical history was not provided.  Concomitant medications were not provided.   On an unspecified date, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.   While receiving the vaccine, the syringe leaked and some of it came out.   Action taken with mRNA-1273 vaccine was not applicable as the patient received both planned doses.  The events were considered resolved.; Reporter's Comments: This report refers to a case of a patient of unspecified age and gender who experienced non-serious unexpected events the syringe leaked some of it (incomplete dose administered/ syringe leak) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Incomplete dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Dose administered from a not fully thawed vial; A spontaneous report was received from a nurse, concerning a 67 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in dose administered from a not fully thawed vial (incorrect dose administered).   The patient's medical history was not reported. Concomitant medication reported was simvastatin.  On 28 Jan 2021, prior to the onset of the event, the patient received female first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  It was reported that the vials were stored in the refrigerator. After that, one of the vials was punctured and a dose was administered to a patient. Also, syringes were pre-filled with doses of the same vial (vials still contain some doses). The healthcare professional visually observed the vials and noticed that the suspension was not fully thawed to the patient on 28 Jan 2021. No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the even, dose administered from a not fully thawed vial was recovered on 28 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # unknown)  with no associated AEs reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient was given an extra 0.5ml dose right after that; A spontaneous report was received from a Healthcare Professional concerning a 65-years-old, female patient who received Moderna COVID-19 vaccine (mRNA-1273)  who was administered an invalid dose, some of the content of the dose slipped through the syringe and the patient was given an extra 0.5ml dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the event, the patient received their first dose of the two planned doses of mRNA-1273 (Batch Number 042l28), unknown route in the right arm for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient received an extra dose of the vaccine right after the patient received an invalid dose.  It was reported that the patient was administered an invalid dose on her right arm and 15 minutes later some of the content of the dose slipped through the syringe and the patient was given an extra 0.5ml dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event patient was given an extra 0.5ml dose was considered recovered.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273. There were no reported AEs associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Chills, Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: Received 1st dose of vaccine at 17 yrs old; Low grade temperature; Chills; Sore arm at the injection site; A spontaneous report was received from a nurse  concerning her daughter, a 17-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) (product administered to patient of inappropriate age) and experienced chills, sore arm at the injection site (vaccination site pain) and  low grade temperature (body temperature decreased).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.    On 29 Dec 2020, the patient received 1st dose of vaccine at the age of 17 years and experienced chills, sore arm at the injection site (injection site pain) and low-grade temperature. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events received 1st dose of vaccine at 17 yrs old was considered resolved on 29 Dec 2020. The outcome of events chills, sore arm at the injection site and low-grade temperature were not reported at the time of this report.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age and associated adverse events of chills, vaccination site pain, and  low body temperature decreased. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Vaccine doses administered 23 days apart; Dizziness; Headache; Nausea; Body aches; Extreme fatigue; A spontaneous report was received on 08-Feb-2021 from a pharmacist concerning a 54 years aged female patient who received Moderna's COVID-19(mRNA-1273) and developed severe headache,dizziness, nausea, body aches, extreme  fatigue, and the vaccine doses administered 23 days apart.  The Patient medical history includes several autoimmune disorders.  Concomitant medications include tylenol, aleve, enbrel, and muscle relaxants.   On 06-Jan-2021, patient received her first dose  of mRNA-1273 (Batch:unknown) intramuscularly on her left arm shoulder deltoid muscle for the prophylaxis of covid-19 infection.  On 29-Jan-2021, prior to the onset of events patient received her second dose of mRNA-1273(Batch;041L20) intramuscularly on her left arm shoulder deltoid muscle for the prophylaxis of Covid-19 infection.  On 29-Jan-2021, patient experienced  severe headache, dizziness, nausea, body aches, extreme fatigue that resolved on 08 Feb 2021.  No laboratory information was provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable  The outcome of the events were recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # 041L20)  with reported associated AEs after the second dose of severe headache, dizziness, nausea, body aches, and extreme  fatigue. Based on the current available information and temporal association between the use of the product after the second dose and the start date of the events, a causal relationship cannot be excluded
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Vaccine doses administered 23 days apart; Dizziness; Headache; Nausea; Body aches; Extreme fatigue; A spontaneous report was received on 08-Feb-2021 from a pharmacist concerning a 54 years aged female patient who received Moderna's COVID-19(mRNA-1273) and developed severe headache,dizziness, nausea, body aches, extreme  fatigue, and the vaccine doses administered 23 days apart.  The Patient medical history includes several autoimmune disorders.  Concomitant medications include tylenol, aleve, enbrel, and muscle relaxants.   On 06-Jan-2021, patient received her first dose  of mRNA-1273 (Batch:unknown) intramuscularly on her left arm shoulder deltoid muscle for the prophylaxis of covid-19 infection.  On 29-Jan-2021, prior to the onset of events patient received her second dose of mRNA-1273(Batch;041L20) intramuscularly on her left arm shoulder deltoid muscle for the prophylaxis of Covid-19 infection.  On 29-Jan-2021, patient experienced  severe headache, dizziness, nausea, body aches, extreme fatigue that resolved on 08 Feb 2021.  No laboratory information was provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable  The outcome of the events were recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # 041L20)  with reported associated AEs after the second dose of severe headache, dizziness, nausea, body aches, and extreme  fatigue. Based on the current available information and temporal association between the use of the product after the second dose and the start date of the events, a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered, Syringe issue
Clinical narrative: The needle came off the syringe and some of the dose went down the patient's arm; The needle came off the syringe and some of the dose went down the patient's arm; The needle came off the syringe and some of the dose went down the patient's arm; A spontaneous report was received from a pharmacist, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and where the needle came off the syringe and some of the dose went down the patient's arm.  The patient's medical history was not provided. Concomitant medications use was not provided.  On an unspecified date, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, while administrating vaccine the needle came off the syringe and some of the dose went down the patient's arm. The reporter was unsure of the dose that was delivered to the patient. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, the needle came off the syringe and some of the dose went down the patient's arm was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of incorrect dose administered, exposure via skin contact and syringe issue for mRNA-1273 (lot # unknown)  with no associated AEs reported.
Sex: U
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Pruritus
Clinical narrative: pain; itching; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced pain and itching (pruritus), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious pain and itching (pruritus) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that product name was not provided. Since this is a public post on the Sanofi flu shot campaign The Race for 200M we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: patient took the flu shot, arm felt as were bitten by something pain and itching applied ice and Rubbing alcohol and tried my best not to scratch.  It is unknown if patient physician provided consent to be contacted. It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  Corrective treatment: applied ice and rubbing alcohol.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache
Clinical narrative: Patient taken to ED by EMS after COVID vaccine. Patient with SOB, dizziness, and HA after first COVID vaccine.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Injection site swelling, Pain, Pyrexia
Clinical narrative: FEVER AND SWELLING AT INJECTION SITE.   BODY ACHE,  FEVER 100.1, FATIGUE, SLEPT FOR MOST OF DAY ANF NITE BETTER  ON 3/3/21
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: FEVER AND SWELLING AT INJECTION SITE.   BODY ACHE,  FEVER 100.1, FATIGUE, SLEPT FOR MOST OF DAY ANF NITE BETTER  ON 3/3/21
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: After lunch a steak and having one beer and two glasses  of red wine I felt nausea and stared vomiting after that OK and went to sleep
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain
Clinical narrative: Left axilla and breast pain since injection received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia oral
Clinical narrative: Patient received first dose of Pfizer COVID Vaccine and reported headache and lip tingling per observation. Given benadryl 25mg x 1.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Dizziness, Incorrect dose administered, Injection site pain
Clinical narrative: Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general malaise, lasting almost 2 days
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general malaise, lasting almost 2 days
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Malaise
Clinical narrative: Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general malaise, lasting almost 2 days
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain
Clinical narrative: Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general malaise, lasting almost 2 days
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: having Tinnitus
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Impaired work ability, Pain, Pain in extremity
Clinical narrative: pt states that about a week after getting the covid vax that she has developed severe pain from the upper part of her right hip down to her knee.  Pt had an appt w/ Dr. on 2/25/2021 regarding her symptoms.  She was prescribed tramadol HCL 50mg and methylprednisolone 4mg.  Pt states she is going to have to contact her doctor since this medicine is not working and she is still in severe pain.  She has been off from work for a week but had to go back and states it is very difficult since she cant hardly get up and down.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Eye pain, Headache, Ocular discomfort
Clinical narrative: I had a headache and my eyes hurt. The back of my eyes were very painful/pressure. this occurred for several days. It got less severe as time went on.  My eyes continue to be tired and I have a slight headache. there is no change in vision that I am aware. I am concerned about receiving the second COVID vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Nasal congestion
Clinical narrative: Stuffy Nose came on and subsided within 24 hours also have had upset tummy with diarrhea on and off since vaccine
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Movement disorder, Paraesthesia
Clinical narrative: less than 12 hours my whole right side went limp, i woke up to get ready for work the day after the shot and my whole right side was limp and numb, as i was trying to get dressed  the use of my arm and leg came back around slowly, the whole right side was tingley all day. and it made me sick
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared  day after injection as well as burning.  Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm  sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Near death experience, Neck pain
Clinical narrative: Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared  day after injection as well as burning.  Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm  sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared  day after injection as well as burning.  Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm  sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, Hypertension, Laboratory test, Vision blurred
Clinical narrative: Severe pain in my head. Blood pressure went up high. blurred vision. Continues today.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Fever, chills, massive headache, sore and red arm, incredible fatigue and some body aches for 2 nights (like 60 hours)
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, massive headache, sore and red arm, incredible fatigue and some body aches for 2 nights (like 60 hours)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Vomiting
Clinical narrative: Throwing up, falling from weakness.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Baseball sized itchy rash on injection site. Resolved within 4 days
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Fatigue, Influenza like illness, Pain
Clinical narrative: After my second injection, I , the day after, had severe flu like conditions, aches, chills, feverish, extreme fatigue. The second day after my reaction, two days after I received it, I had so much fatigue that I could do nothing, but lie in bed. The third day, I felt a little better but was again fatigued and could not do anything but rest. I began to feel a little better after the third day but two weeks later I still have fatigue but can still function. The Saturday after I received the injection on Sunday I slept 11 hours.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: After my second injection, I , the day after, had severe flu like conditions, aches, chills, feverish, extreme fatigue. The second day after my reaction, two days after I received it, I had so much fatigue that I could do nothing, but lie in bed. The third day, I felt a little better but was again fatigued and could not do anything but rest. I began to feel a little better after the third day but two weeks later I still have fatigue but can still function. The Saturday after I received the injection on Sunday I slept 11 hours.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Exposure during pregnancy, Fatigue
Clinical narrative: Patient received Moderna vaccine on 2/23/21 and presented to hospital on 03/02/21 with symptoms of covid-19 infection. Tested positive at birth center on 03/01/21 and began feeling symptomatic on 02/28-03/01. Patient is symptomatic and has had maternal tachycardia, fever, fatigue, myalgias, cough, shortness of breath. Of note, there is associated fetal tachycardia. Patient is preterm and today is a 22 y/o G2P0010 at 34+4. Has thus far received adequate prenatal care with no pregnancy complications.