chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site extravasation, Pain in extremity, Underdose, Vaccination site pain
Clinical narrative: her arm hurt; Patient was injected they noticed some of the liquid running down her arm to her wrist; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Media Information (under the reference 00831417).  This case involves a 68 years old female patient whose arm hurt (vaccination site pain) and was injected they noticed some of the liquid running down her arm to her wrist (injection site extravasation) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient had no other concomitant vaccines.  On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (once, 0.25 mL to 2 mL, total, lot UJ768AC and expiration date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On 27-Oct-2021, the patient developed a non-serious arm hurt (vaccination site pain) and was injected they noticed some of the liquid running down her arm to her wrist (injection site extravasation) (unknown latency) following the administration of vaccine.  No laboratory data reported.  It was reported "Caller stated that she was administering vaccine to patient, there was either a failure on the syringe portion or the needle portion and when pushing plunger in, some of the liquid came out and was running down the patient's arm. the needle was placed on the syringe tightly and there was no problem when the air was pushed out of the syringe nor did she hear any sound like a leak but when the consumer was injected they noticed it running down her arm to her wrist and she states her arm hurt. Pharmacist would like a credit and gets it from VAXSERVE."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pruritus, Injection site rash
Clinical narrative: Rash at injections site for 2+ days, itchy and continuing to grow. Headache for 2+ days. Fever for 2+ days, first 7 hours were intense followed by a slightly elevated temperature for 2+ additional days. Began 2.5 hours after injection. Joints ache for 36 hours after injection. Began 12 hours after injection. Tired for 24 hours beginning 6 hours after injection.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Rash at injections site for 2+ days, itchy and continuing to grow. Headache for 2+ days. Fever for 2+ days, first 7 hours were intense followed by a slightly elevated temperature for 2+ additional days. Began 2.5 hours after injection. Joints ache for 36 hours after injection. Began 12 hours after injection. Tired for 24 hours beginning 6 hours after injection.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain of skin, Pyrexia
Clinical narrative: Fever of 100.7, muscle aches, skin aches, fatigue
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever as high as 100.5F, body aches, pain at injection site, extremely swollen and painful lymph nodes in armpit and Under clavicle on same side as injection site. Managed fever with acetaminophen and ibuprofen for body aches
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: The night of vaccination he had a fever and half of the arm is red, swollen, warm, and with some red spots, still at the third day of the vaccine.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Electrocardiogram, Palpitations
Clinical narrative: Near constant highly uncomfortable feelings of my chest being too full, pounding heart beat, some shortness of breath, extreme levels of anxiety. Was prescribed low dosage anxiety medication after experiencing a panic attack in the Emergency Room, have not been officially diagnosed by a doctor with myocardis. I do however have the exact symptoms described by this agency, symptoms did start rapidly after the second dose after having no previous cardiac history what so ever. Have been self medicating with 1000mg of fish oil supplements daily for a month, symptoms have improved dramatically. Still I find the uncomfortable feelings in my chest do come and go depending on what I've eaten/not eaten.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: Near constant highly uncomfortable feelings of my chest being too full, pounding heart beat, some shortness of breath, extreme levels of anxiety. Was prescribed low dosage anxiety medication after experiencing a panic attack in the Emergency Room, have not been officially diagnosed by a doctor with myocardis. I do however have the exact symptoms described by this agency, symptoms did start rapidly after the second dose after having no previous cardiac history what so ever. Have been self medicating with 1000mg of fish oil supplements daily for a month, symptoms have improved dramatically. Still I find the uncomfortable feelings in my chest do come and go depending on what I've eaten/not eaten.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus, Vaccine positive rechallenge
Clinical narrative: First shot in December I woke up with ear completely full feeling. Then an engine tinnitus sound came later, all in the left ear. This has continued on and off and now is worse after getting the booster shot.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast enlargement, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: First time in my life, menstruation cycle is 12 days early than planned with thick clot droppings. Also breast size got bigger too, it was 34 before and now its 36
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Autoscopy, Depersonalisation/derealisation disorder, Feeling abnormal
Clinical narrative: Out of body, feeling of not here , foggy minded
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: She started vomiting around 11pm same day of vaccine. Projectile vomiting twice on the wall, bed, floor. Complained of headache 3 hours after vaccine. No fever.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: pt admitted to hospital and tested positive for COVID 10/30/21 s/p receiving 2 doses of Moderna on 1/22/21 & 2/19/21
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Respiratory viral panel, SARS-CoV-2 test positive
Clinical narrative: Symptoms and symptom onset date not reported. Case admitted to hospital on 10/24/21. She tested positive for Covid-19 with a respiratory panel on 10/24/21.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Foggy head feeling, out of body feeling, not here feeling,
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Electrocardiogram, Heart rate increased, Musculoskeletal stiffness
Clinical narrative: Immediate neck stiffness and woke up 12 hours later with pounding heart and ringing and pounding in ears, tingling hands and feet and light headedness   This continued for a week. The lightheadedness subsided after one week but ringing and pounding in ears remains. Resting heart rate remains elevated as well.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Tinnitus
Clinical narrative: Immediate neck stiffness and woke up 12 hours later with pounding heart and ringing and pounding in ears, tingling hands and feet and light headedness   This continued for a week. The lightheadedness subsided after one week but ringing and pounding in ears remains. Resting heart rate remains elevated as well.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: pt admitted 11/2/21 with COVID (tested positive on 10/29) s/p receiving 2 doses Pfizer on 3/5/21 & 3/26/21
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Taste disorder
Clinical narrative: Bad nausea and bad taste in my mouth.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: My periods became shorter.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Diarrhoea
Clinical narrative: Symptom onset was on 09/18/2021. Symptoms included cough, loss of taste, loss of smell, diarrhea, fatigue and chills. Case was hospitalized from 9/18/2021 through 09/26/2021.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Symptom onset was on 09/18/2021. Symptoms included cough, loss of taste, loss of smell, diarrhea, fatigue and chills. Case was hospitalized from 9/18/2021 through 09/26/2021.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Aphthous ulcer, Rash, Rash papular, Skin exfoliation
Clinical narrative: 3cm x 3cm rash L cheek slightly raised, some scaling 1cm x .2cm rash R cheek rashes upper eyelids bilateral  Rashes noted this morning; treated with .1% triamcinolone.  They are improving canker sore L upper lip appeared this evening
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Full body aches, chills, shivering, fever, stiffness/cramping
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Discomfort, Joint range of motion decreased, Limb discomfort, Magnetic resonance imaging, Manipulation
Clinical narrative: 10-28-20-Severe soreness and pain, arm felt heavy, lifting something became an effort d/t discomfort & pain picking up or getting something above my head. Home Tx: Ibuprofen, cold/warm compress, icy hot and Salonpas analgesic cream. Outcome- temporary relief. 11-18-20 - Dr. prescribed Diclofenac sodium topical gel. Outcome- Ineffective. 11-30-20 - Dr. prescribed Meloxicam and PT 12-04-20 to 01-11-21. Outcome- Pain reduced but ROM still limited. 02-22-21- Steroid injection & PT 03-09-21 to 04-13-21.Outcome- Pain/ROM improved then both came back after a few weeks. 08-18-21- Surgery: Manipulation under Anesthesia; 08-30-21- PT+ongoing. Outcome- Pain/ROM improved significantly.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain, X-ray limb
Clinical narrative: 10-28-20-Severe soreness and pain, arm felt heavy, lifting something became an effort d/t discomfort & pain picking up or getting something above my head. Home Tx: Ibuprofen, cold/warm compress, icy hot and Salonpas analgesic cream. Outcome- temporary relief. 11-18-20 - Dr. prescribed Diclofenac sodium topical gel. Outcome- Ineffective. 11-30-20 - Dr. prescribed Meloxicam and PT 12-04-20 to 01-11-21. Outcome- Pain reduced but ROM still limited. 02-22-21- Steroid injection & PT 03-09-21 to 04-13-21.Outcome- Pain/ROM improved then both came back after a few weeks. 08-18-21- Surgery: Manipulation under Anesthesia; 08-30-21- PT+ongoing. Outcome- Pain/ROM improved significantly.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Intensive care, SARS-CoV-2 test positive
Clinical narrative: Patient admitted to ICU 11/2/2021 w/COVID-19 PNA (tested positive on 10/26/2021) s/p 2 doses Pfizer on 3/26/2021 & 4/19/2021.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Randome sore throats experienced with no other symptoms. I wear a N95 Mask when outside and spray my hands with disinfecting spray when I come to my vehicle. I am never one to get a sore throat without other cold related symptoms. The pain of the sore throat is not very painful but it is felt. I have been feeling this for quite some time after the vaccinations. And my husband too.  I am able to take 400mg of Ibuprofin to get rid of the sore throat but will come back maybe 1-2 weeks later over and over like this.  And for me when I get a sore throat that means a cold is ensuing and then coughing and bad cough but these sore throats are without all that drama. I do not know if this is for sure the cause but I do think it is very suspicious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pyrexia
Clinical narrative: Chest pain, fever.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Condition aggravated, Dizziness, Tremor
Clinical narrative: Very bad uncontrollable shaking for more than an hour.  hands & teeth feet.  Dizzy.   Much, much worse than symptoms after second shot March 23/2021
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Blood test normal, Chest X-ray normal, SARS-CoV-2 test negative, Troponin I normal
Clinical narrative: Very bad uncontrollable shaking for more than an hour.  hands & teeth feet.  Dizzy.   Much, much worse than symptoms after second shot March 23/2021
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives both arms and upper legs. Treatment ; Benadryl 50 mg
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Pain
Clinical narrative: pain in the left arm in the injection area, extreme body pain and dizziness (3 days)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Chest X-ray, Chest pain, Chronic kidney disease, Computerised tomogram thorax
Clinical narrative: Chest pain, SOB, worsening kidney disease, elevated Ddimer, Admitted to the hospital for observbation.  Follow up with cardiology
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Electrocardiogram, Fibrin D dimer increased, Full blood count
Clinical narrative: Chest pain, SOB, worsening kidney disease, elevated Ddimer, Admitted to the hospital for observbation.  Follow up with cardiology
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Troponin
Clinical narrative: Chest pain, SOB, worsening kidney disease, elevated Ddimer, Admitted to the hospital for observbation.  Follow up with cardiology
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on both arms and behind knees after 4 hours of jnjection
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Insomnia, Interchange of vaccine products, Mania, Tachyphrenia
Clinical narrative: Became slightly manic with  Moderna today as well as J&J vaccines. Can't sleep, thoughts are racing. With J&J this lasted only abt half a day. I'm reporting because it's not listed as side effect even though a friend had some mental issues as well (found out after mentioned it, not before mental symptoms. Possible short-term mental issue should be listed as I thought they couldn't be. Again, it was only after I spoke to my friend that it had to be caused by vaccine, no other reason was likely. I thought I was imagining vaccine could cause this as possible mental side effects were not listed.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Migraine, Tinnitus
Clinical narrative: Tinnitus very strong and getting worse month by month. Migrains, lack of concentration and dizziness after 3 mo. from shot
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Confusional state, Injection site pain, Loss of consciousness
Clinical narrative: Aside from experiencing typical vaccine side effects of fever, pain at injection site,  and joint pain, around 15 hours post vaccine I became nauseous followed by blurred vision, chest pain and ringing in my ears. I either fainted or had a seizure but no way to confirm which as I was alone at the time. I did awake on the floor after being unconscious though and was very confused for approximately 30 minutes or so.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Seizure, Syncope, Tinnitus
Clinical narrative: Aside from experiencing typical vaccine side effects of fever, pain at injection site,  and joint pain, around 15 hours post vaccine I became nauseous followed by blurred vision, chest pain and ringing in my ears. I either fainted or had a seizure but no way to confirm which as I was alone at the time. I did awake on the floor after being unconscious though and was very confused for approximately 30 minutes or so.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Aside from experiencing typical vaccine side effects of fever, pain at injection site,  and joint pain, around 15 hours post vaccine I became nauseous followed by blurred vision, chest pain and ringing in my ears. I either fainted or had a seizure but no way to confirm which as I was alone at the time. I did awake on the floor after being unconscious though and was very confused for approximately 30 minutes or so.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Fibrin D dimer, Full blood count, Hypoaesthesia, Metabolic function test
Clinical narrative: Pt experienced nausea, numbness, tingling and gradual ascending muscle weakness of LE.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Paraesthesia
Clinical narrative: Pt experienced nausea, numbness, tingling and gradual ascending muscle weakness of LE.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular period
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headaches and extreme fatigue.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got my Shingrix shot too soon, before 2 months; This case was reported by a consumer via (ShingrixChatbot) interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingrix shot too soon, before 2 months, earlier than the recommended interval, which led to shortening of vaccination schedule. The patient asked question, would it still be effective. The patient stated his/her pharmacist has not been able to give an answer. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the two required shingles vaccines / 3 years ago / shingles; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had two required shingles vaccines three years ago of reporting and diagnosed with shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got it/ got bad case of the shingles/ suspected vaccination failure; got bad case of the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included rituximab for product used for unknown indication and prednisone for product used for unknown indication.   On an unknown date, the patient received Shingrix, rituximab at an unknown dose and frequency and prednisone at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with rituximab was unknown. The action taken with prednisone was unknown. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The reporter had not been able to find information on whether or not to get Shingrix vaccine if he/she got it when immune compromised in 2019 when he/she got the vaccine. The patient got bad case of the shingles after taking prednisone and rituximab. The patient stated did not want to get vaccine again if he/she did not need it though. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: fluarix vaccine was give to a patient on 2 separate days; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 52-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 3na4m, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA PFS).   On 27th October 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The flu fluarix vaccine was given to a patient on two separate days, which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; SLIGHT FEVER; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, slight fever, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, slight fever, and extreme fatigue. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia
Clinical narrative: Could not sleep last night; Fatigue; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep last night), FATIGUE (Fatigue) and HEADACHE (Slight headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced INSOMNIA (Could not sleep last night), FATIGUE (Fatigue) and HEADACHE (Slight headache). At the time of the report, INSOMNIA (Could not sleep last night) had resolved and FATIGUE (Fatigue) and HEADACHE (Slight headache) outcome was unknown.            Concomitant medication  include High blood pressure medication.  No Treatment medication was provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-365274 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigued after the first vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued after the first vaccination.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigued after the first vaccination.). At the time of the report, FATIGUE (fatigued after the first vaccination.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient had passed away on 24OCT2021 (after second dose of moderna) . Cause of death was Covid-Pneumonia. No relevant concomitant product were reported No treatment medication was provided   This case was linked to MOD-2021-366293 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Diagnosed with a Breakthrough case of COVID-19; Diagnosed with a Breakthrough case of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Diagnosed with a Breakthrough case of COVID-19) and COVID-19 (Diagnosed with a Breakthrough case of COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced DRUG INEFFECTIVE (Diagnosed with a Breakthrough case of COVID-19) and COVID-19 (Diagnosed with a Breakthrough case of COVID-19). On 04-Aug-2021, DRUG INEFFECTIVE (Diagnosed with a Breakthrough case of COVID-19) had resolved. At the time of the report, COVID-19 (Diagnosed with a Breakthrough case of COVID-19) had resolved.            No concomitant medications were provided. No treatment medications were reported.  It was reported that the patient was fine now.  Company comment- This case concerns a 64 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI event of COVID-19. The event occurred approximately 6 months 2 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. Drug ineffective was considered as an additional event. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 65 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI event of COVID-19. The event occurred approximately 6 months 2 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. Drug ineffective was considered as an additional event. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Sneezing
Clinical narrative: tickle in the nose; Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (tickle in the nose) and SNEEZING (Sneezing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL DISCOMFORT (tickle in the nose) and SNEEZING (Sneezing). At the time of the report, NASAL DISCOMFORT (tickle in the nose) and SNEEZING (Sneezing) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: had fever that stayed in the 99°F range; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had fever that stayed in the 99°F range) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (had fever that stayed in the 99°F range). At the time of the report, PYREXIA (had fever that stayed in the 99°F range) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99°F range.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.  Patient took second dose on 26Feb2021 and booster dose on 25Oct2021.  Treatment information was unknown.   This case was linked to MOD-2021-365851 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 026L20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered beyond 12 hours post puncture for booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours post puncture for booster dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson COVID-19 Vaccine (First dose administered using Johnson and Johnson COVID-19 vaccine) on 27-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 Vaccine.   On 27-Oct-2021 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours post puncture for booster dose). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours post puncture for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  The vial was in the refrigerator for 24 hours after punctured and didn't undergo any temperature excursions.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Axillary mass
Clinical narrative: the full dose instead of the half dose; Her daughter got it and has a lump under her armpit which she did not get after either of her first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (the full dose instead of the half dose) and AXILLARY MASS (Her daughter got it and has a lump under her armpit which she did not get after either of her first 2 doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced AXILLARY MASS (Her daughter got it and has a lump under her armpit which she did not get after either of her first 2 doses). On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (the full dose instead of the half dose). On 22-Oct-2021, ACCIDENTAL OVERDOSE (the full dose instead of the half dose) had resolved. At the time of the report, AXILLARY MASS (Her daughter got it and has a lump under her armpit which she did not get after either of her first 2 doses) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-366021 (Patient Link).
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave a Moderna vaccine to a 17-year-old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave a Moderna vaccine to a 17-year-old) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave a Moderna vaccine to a 17-year-old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave a Moderna vaccine to a 17-year-old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications was not provided by the reporter.   Gave a Moderna vaccine to a 17-year-old on the 18th and parent wish to get a second dose for the patient.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Menopause (At the age of 40.).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm) had resolved.            No concomitant product use was provided by the reporter. Reporter stated that Patient took cold packs as treatment medication
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration, Wrong technique in device usage process
Clinical narrative: 2nd dose beyond approved interval; Pt may be got 0.1ml; gave a 2nd dose with faulty syringe and needle came off; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond approved interval), ACCIDENTAL UNDERDOSE (Pt may be got 0.1ml) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (gave a 2nd dose with faulty syringe and needle came off) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012S21A and 022C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy NOS. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETIRIZINE [CETIRIZINE HYDROCHLORIDE]) for Allergy NOS, OMEPRAZOLE for an unknown indication.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond approved interval), ACCIDENTAL UNDERDOSE (Pt may be got 0.1ml) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (gave a 2nd dose with faulty syringe and needle came off). On 27-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond approved interval), ACCIDENTAL UNDERDOSE (Pt may be got 0.1ml) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (gave a 2nd dose with faulty syringe and needle came off) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Hurt, all night long, my left arm throbbed; It was hot; so sick; Chest Hurt; Headache, head was throbbing; Completely wiped out; Getting sick to my stomach; Dizzy, Got the shakes; Felt strange; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt strange), PAIN (Hurt, all night long, my left arm throbbed), VACCINATION SITE WARMTH (It was hot), ABDOMINAL DISCOMFORT (Getting sick to my stomach) and DIZZINESS (Dizzy, Got the shakes) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 013M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced FEELING ABNORMAL (Felt strange). On 26-Oct-2021, the patient experienced ABDOMINAL DISCOMFORT (Getting sick to my stomach) and DIZZINESS (Dizzy, Got the shakes). On an unknown date, the patient experienced PAIN (Hurt, all night long, my left arm throbbed), VACCINATION SITE WARMTH (It was hot), ILLNESS (so sick), CHEST PAIN (Chest Hurt), HEADACHE (Headache, head was throbbing) and FATIGUE (Completely wiped out). At the time of the report, FEELING ABNORMAL (Felt strange), PAIN (Hurt, all night long, my left arm throbbed), VACCINATION SITE WARMTH (It was hot), ABDOMINAL DISCOMFORT (Getting sick to my stomach), DIZZINESS (Dizzy, Got the shakes), ILLNESS (so sick), CHEST PAIN (Chest Hurt), HEADACHE (Headache, head was throbbing) and FATIGUE (Completely wiped out) outcome was unknown.            No Treatment medication reported. No Concomitant medication reported.   This case was linked to MOD-2021-366180 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Pain, Vaccination site warmth
Clinical narrative: Hurt, all night long, my left arm throbbed; It was hot; so sick; Chest Hurt; Headache, head was throbbing; Completely wiped out; Getting sick to my stomach; Dizzy, Got the shakes; Felt strange; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt strange), PAIN (Hurt, all night long, my left arm throbbed), VACCINATION SITE WARMTH (It was hot), ABDOMINAL DISCOMFORT (Getting sick to my stomach) and DIZZINESS (Dizzy, Got the shakes) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 013M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced FEELING ABNORMAL (Felt strange). On 26-Oct-2021, the patient experienced ABDOMINAL DISCOMFORT (Getting sick to my stomach) and DIZZINESS (Dizzy, Got the shakes). On an unknown date, the patient experienced PAIN (Hurt, all night long, my left arm throbbed), VACCINATION SITE WARMTH (It was hot), ILLNESS (so sick), CHEST PAIN (Chest Hurt), HEADACHE (Headache, head was throbbing) and FATIGUE (Completely wiped out). At the time of the report, FEELING ABNORMAL (Felt strange), PAIN (Hurt, all night long, my left arm throbbed), VACCINATION SITE WARMTH (It was hot), ABDOMINAL DISCOMFORT (Getting sick to my stomach), DIZZINESS (Dizzy, Got the shakes), ILLNESS (so sick), CHEST PAIN (Chest Hurt), HEADACHE (Headache, head was throbbing) and FATIGUE (Completely wiped out) outcome was unknown.            No Treatment medication reported. No Concomitant medication reported.   This case was linked to MOD-2021-366180 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: My daughter just had a miscarriage; Maternal exposure during pregnancy; Based on the current case data, this case has been classified as invalid. This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (My daughter just had a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (My daughter just had a miscarriage) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (My daughter just had a miscarriage) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication is provided by reporter. No treatment was provided. Company Comment: This is a case of maternal exposure during pregnancy of this female patient, unknown age with no disclosed medical history, who experienced the serious, unexpected event of spontaneous abortion. The patient received the unspecificied dose of vaccine at  unknown weeks of gestation. Spontaneous abortion occurred on unknown date after the unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This is a case of maternal exposure during pregnancy of this female patient, unknown age with no disclosed medical history, who experienced the serious, unexpected event of spontaneous abortion. The patient received the unspecificied dose of vaccine at  unknown weeks of gestation. Spontaneous abortion occurred on unknown date after the unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.