chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 on 6/11/2021 after receiving covid vaccine on 12/22/20 and 1/11/2021  Narrative:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Sedation, Vomiting
Clinical narrative: Headache, Sedation & NauseaVomting Narrative:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Pain in extremity
Clinical narrative: Myalgia Narrative: Tight aching arm. Took Tylenol with some effectiveness.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache, Fever, chilla Narrative: called to report adverse effects after receiving her first dose of Moderna vaccine on 7/14/21. Employee complains of fever, headache, and chills. Employee called to report symptoms on 7/15/21.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site swelling, Myalgia, Tenderness
Clinical narrative: Myalgia, Swelling in right upper arm where injection administered. Swollen and painful to touch, Fatigue and chills Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Headache, Myalgia & NauseaVomiting Narrative:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Myalgia Narrative: Muscle aches
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Fully vaccinated against covid on 12/24/2020 and 1/13/21. tested positive on 6/24 and again on 6/26/2021 Narrative:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Injection site pain, Myalgia
Clinical narrative: Myalgia HOT FLASHES, PAIN AT INJECTION SITE Narrative:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Myalgia Narrative:  EXTREME FATIGUE X 1 D
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: large red local site reaction Narrative:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Muscular weakness, Myalgia
Clinical narrative: Myalgia, Reported muscle weakness, tenderness @ injection site. Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Dizziness, Headache, Fever, NauseaVomiting, Fatigue, Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Dizziness, Headache, Fever, NauseaVomiting, Fatigue, Narrative:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Discomfort, Eye pain
Clinical narrative: Headache, NauseaVomiting, Local symptoms: Pain- discomfort. General symptoms: Chills, headaches, joint pains, muscle pains, nausea, back pain , eye pain Narrative:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain, Vomiting
Clinical narrative: Headache, NauseaVomiting, Local symptoms: Pain- discomfort. General symptoms: Chills, headaches, joint pains, muscle pains, nausea, back pain , eye pain Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Myalgia, Neck pain
Clinical narrative: Headache, Myalgia & Arthralgia Narrative: Neck pain, headache, arm pain at injection site. Took Tylenol.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: DOSE 1-6/23-PAIN AT INJ SITE/NAUSEA;6/24- MYALGIA/N/V/D;6/25-HA/N/V/MYALGIA;6/26,6/27-HA/MYALGIA/FATIGUE; 6/28-HA/MYALGIA
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: DOSE 1-6/23-PAIN AT INJ SITE/NAUSEA;6/24- MYALGIA/N/V/D;6/25-HA/N/V/MYALGIA;6/26,6/27-HA/MYALGIA/FATIGUE; 6/28-HA/MYALGIA
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Sedation, Myalgia, Fever, fatigue Narrative:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Headache, Fever, NauseaVomiting, FATIGUE; COLD CHILLS Narrative:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Fever, NauseaVomiting, FATIGUE; COLD CHILLS Narrative:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Hemiparesis
Clinical narrative: right side body weakness, slurred speech, went to ER R/O stroke Narrative:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Myalgia arm pain Narrative:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Malaise, Pyrexia
Clinical narrative: COVID (+) WITH SYMPTOMS FEVER CHILLS AND HEADACHES Narrative:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID (+) WITH SYMPTOMS FEVER CHILLS AND HEADACHES Narrative:
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatinine, Blood lactate dehydrogenase, Blood test
Clinical narrative: Narrative:
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood urea, C-reactive protein, COVID-19, Fibrin D dimer, Glomerular filtration rate
Clinical narrative: Narrative:
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count, SARS-CoV-2 test positive, White blood cell count
Clinical narrative: Narrative:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: RASH AND SWELLING AROUND INJECTION SITE Narrative:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Headache, Rhinorrhoea
Clinical narrative: Narrative: COVID infection following completion of COVID vaccine series 03/10/2021 COVID vaccine dose #2 06/16/2021 reported onset of rhinorrhea, headache, loss of taste and smell; Pt admitted to close contact with his roommate who was a confirmed COVID positive case; Pt requested test to confirm COVID status 06/21/2021 COVID positive (swab)
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Narrative: COVID infection following completion of COVID vaccine series 03/10/2021 COVID vaccine dose #2 06/16/2021 reported onset of rhinorrhea, headache, loss of taste and smell; Pt admitted to close contact with his roommate who was a confirmed COVID positive case; Pt requested test to confirm COVID status 06/21/2021 COVID positive (swab)
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Myalgia, Night sweats, Oropharyngeal pain, Pyrexia
Clinical narrative: Myalgia, Fever, sore throat, chills, night sweats Narrative:
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Narrative:  Medical records show patient received COVID-29 vaccine (28 days apart, so most likely MODERNA) and experienced severe hives about 10 days after administration. He was told by clinic (no medical record documentation) in both instances that it was likely the Covid Vaccine. Patient reported this findings to clinical pharmacy specialist on 3/11/21 and explained they have improve significantly but is still recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Myalgia, Pain, Pruritus
Clinical narrative: Myalgia, Arthralgia, UrticariaPruiritus, swelling, redness, throbbing, itching and hot to the touch - after 2nd dose Narrative: Sulfamethoxazole and Prednisone
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: Myalgia, Arthralgia, UrticariaPruiritus, swelling, redness, throbbing, itching and hot to the touch - after 2nd dose Narrative: Sulfamethoxazole and Prednisone
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Blood blister, Epistaxis
Clinical narrative: Narrative:  Patient reported to clinical pharmacy specialist that he received his first dose of COVID-19 vaccine and had 2 occasions of epitaxies that lasted about 15 mins. He also had what he discussed as "blood blisters" which resolved in >1 week per record documentation on 4/20/21. Patient also on warfarin for a fib and was at therapeutic range (2-3) of 2.7 around the time of vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever CHILLS Narrative:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Injection site mass, Tenderness
Clinical narrative: softball size lump reported at injection site (deltoid), armpit tender and hard; side of L breast tender; itching  Narrative:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Injection site pain, Pyrexia, Wheezing
Clinical narrative: Fever, CoughWheeze, Pain at injection site Narrative:  Per nursing report: "had her 2nd Moderna vaccine on Wednesday 06/23/2021. On 6/24/2021, developed pain at the injection site (Right Deltoid) and non-productive cough. Presented to EH today on 6/28/2021, and Feels that her cough has gotten worse (still non-productive), and has a low grade fever today 99.2."
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Pain, SARS-CoV-2 test positive
Clinical narrative: COVID POSITIVE WITH SYMPTOMS BODY ACHES AND HEADACHES Narrative:
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Chest X-ray, Chest pain, Computerised tomogram, Headache
Clinical narrative: Headache, Angina, Severe Migraine and crushing chest pain Narrative: 2 days after Booster vaccination employee experienced Severe migraine and "crushing chest pain" which she went to the ER for. She had a CT scan and CXR and given medication and a referral to Neurology
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Headache, Angina, Severe Migraine and crushing chest pain Narrative: 2 days after Booster vaccination employee experienced Severe migraine and "crushing chest pain" which she went to the ER for. She had a CT scan and CXR and given medication and a referral to Neurology
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Chills, Sore arm Narrative:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache, Arthralgia, Fever, Chills Narrative: Headache, body aches, fever 101.2, chills
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Depression, Dizziness, Fatigue
Clinical narrative: Confusion, Depression, Dizziness, Headache, NauseaVomiting, LEFT ARM AND HAND NUMBNESS TINGLING, JOINT PAIN, FATIGUE Narrative: LOST WORK TIME
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Impaired work ability, Nausea, Paraesthesia
Clinical narrative: Confusion, Depression, Dizziness, Headache, NauseaVomiting, LEFT ARM AND HAND NUMBNESS TINGLING, JOINT PAIN, FATIGUE Narrative: LOST WORK TIME
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Confusion, Depression, Dizziness, Headache, NauseaVomiting, LEFT ARM AND HAND NUMBNESS TINGLING, JOINT PAIN, FATIGUE Narrative: LOST WORK TIME
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache
Clinical narrative: Headache CHILLS, ABDOMENAL CRAMPS Narrative:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: COVID(+) HEADACHES AND NASAL CONGESTION Narrative:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Myalgia, Syncope, Vision blurred
Clinical narrative: BlurredVision, Myalgia & Syncope Narrative: Employee reports: "I took off work for one and a half hours" I'm fine today.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache Narrative:  Slight headache
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Myalgia Narrative: Pain at injection site evening of injection. Worsened next day with mild swelling. Ice packs and Ibuprofen were used.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Myalgia Narrative:  Arm sore and swollen slightly
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: SkinRash & UrticariaPruritus Narrative:  treated for systemic Urticaria
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, General symptom, Headache, Nausea
Clinical narrative: General symptoms: headaches, fatigue, nausea Narrative:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at injection site. returned 5 months later with pain persisting. poss SIRVA  Narrative:  pain to injection site persisting over 5 months. referred to treating provider.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Fatigue
Clinical narrative: Headache, Myalgia, Fever, Confirmed to have Covid 19 on 6/9/21 after fully vaccinated. congestion, fatigue, loss of taste/smell and chills.  Narrative:
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: Headache, Myalgia, Fever, Confirmed to have Covid 19 on 6/9/21 after fully vaccinated. congestion, fatigue, loss of taste/smell and chills.  Narrative:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Somnolence
Clinical narrative: General symptoms: General symptoms: Headache, fatigue- overnight including drowsiness Narrative:
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Headache, SARS-CoV-2 test positive, Wheezing
Clinical narrative: Headache, CoughWheeze, Tested positive to COVID 19 Narrative:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Malaise, Nasal congestion
Clinical narrative: COVID test (+); symptomatic: HA, cough, nasal congestion Narrative:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID test (+); symptomatic: HA, cough, nasal congestion Narrative:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: COVID (+) SYMPTOMATIC Narrative:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: COVID (+) WITH SYMPTOMS SORE THROAT AND NASAL CONGESTION Narrative:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: COVID (+) WITH SYMPTOMS RUNNY NOSE, COUGH AND HEADACHES Narrative:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Palpitations, Tachycardia
Clinical narrative: Headache, Myalgia, Diarrhea, Palpitations & Tachycardia Narrative:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Headache, Diarrhea, sweating and fatigue Narrative:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Narrative:
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dysphagia, Endoscopy upper gastrointestinal tract abnormal
Clinical narrative: Narrative:  83 yo M with a history of Type 2 DM, diabetic peripheral neuropathy, HTN, hyperlipidemia, obesity, obstructive sleep apnea, hx of stroke with residual weakness of left arm/hand, GERD ,diverticulosis, hiatal hernia, chronic constipation, varicosities of legs, BPH, mild urinary incontinence, ED, gout, DJD, chronic knee pain, OA , spinal stenosis of L spine, depression, and history of smoking. Patient receive covid vaccinations on 2/8/21 and 3/11/21. Not much is known about patients death other than it occurred on 6/22/21. Patient had a upper endoscopy on 6/21/21 for dysphagia. Death seems to be unrelated to covid vaccinations.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Laboratory test normal, Muscular weakness
Clinical narrative: Narrative: 86 y/o c/o loss of ability to control legs and arms since receiving 1st dose of COVID19 (Modera) vaccine on 01/29/21. Did receive 2nd dose of 02/26/21. Does have h/o b/l leg weakness in the past, however patient indicates this feels different. Labs ordered and were unremarkable. Neuro consult is pending for further evaluation.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Pancreatic carcinoma
Clinical narrative: Narrative: 93 yo M with a history of pancreatic cancer, T2DM, HTN, OA of the knee, and BPH. Patient received covid vaccinations on 1/19/21 and 2/22/21. Patient died under hospice care on 6/30/21 due to complications of the patients pancreatic cancer. Death seems to be unrelated to covid vaccinations.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Death, Fatigue
Clinical narrative: Narrative:  75 yo M with a history of dysphagia, cardiac dysrhythmia, stasis ulcer due to T2DM, hypothyroid, peripheral vascular disease due to secondary DM, HLD, BCC of face, peripheral neuropathy, legal blindness, HTN, renal impairment. Patient received covid vaccination on 6/10/21. Patient was admitted to hospital on 6/14/21 due to reported symptoms after receiving covid vaccination. Complaints included fatigued, fever, and cough. Patient tested positive for covid on 6/14/21. Patient passed away on 6/30/21 in hospice with reported cause of death as SARS PNA. Covid vaccination could possibly be related to patients death.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Narrative:  75 yo M with a history of dysphagia, cardiac dysrhythmia, stasis ulcer due to T2DM, hypothyroid, peripheral vascular disease due to secondary DM, HLD, BCC of face, peripheral neuropathy, legal blindness, HTN, renal impairment. Patient received covid vaccination on 6/10/21. Patient was admitted to hospital on 6/14/21 due to reported symptoms after receiving covid vaccination. Complaints included fatigued, fever, and cough. Patient tested positive for covid on 6/14/21. Patient passed away on 6/30/21 in hospice with reported cause of death as SARS PNA. Covid vaccination could possibly be related to patients death.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Death
Clinical narrative: Narrative: 68 yo M with a history of CHF, T2DM with multiple complications, COPD, HTN, tachycardia, diastolic HF, and sleep apnea. Patient received covid vaccinations on 2/14/21 and 3/12/21. Patient death occurred on 3/22/21 but not many details known about death. Patient called the facility telephone to report unbearable left knee pain and was told to use OTC treatments. It is unknown on whether covid vaccinations contributed to patients death.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative: 72 yo M with a history of cad/MI/stent x 2,renal cell carcinoma with right nephrectomy, COPD ,colonic polyp, DM,HTN, HLD, sleep apnea, and kidney disease. Patient received covid vaccinations on 3/18/21 and 4/15/21. Patient passed away on 6/19/21 but details about his death are unknown. Patients death seems related to chronic conditions/cancer and not due to covid vaccinations.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: extreme arm pain; feels like there are needles; This is a spontaneous report received from a contactable Consumer or other non HCP from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 42-year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), administration date: May2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "extreme arm pain", "needle in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "extreme arm pain"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "feels like there are needles". The events "extreme arm pain" and "feels like there are needles" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, paraesthesia.  Additional Information: Caller would like to know if the pain will ever stop and any information that could be provided about that. Caller states that other family members have had the vaccine and they didn't have any issue. Caller states that she has taken Tylenol and Advil for the pain, and they both were not effective to help her pain. Caller does not have an NDC, Lot number, or expiration date to provide. Caller said after the first shot, her arm hurt and then she used the opposite arm for the second shot, and that probably was not a good idea. Caller confirms that she was fully vaccinated in May2021.   Follow-up attempts completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: extreme arm pain; feels like there are needles; This is a spontaneous report received from a contactable Consumer or other non HCP from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 42-year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), administration date: May2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "extreme arm pain", "needle in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "extreme arm pain"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "feels like there are needles". The events "extreme arm pain" and "feels like there are needles" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, paraesthesia.  Additional Information: Caller would like to know if the pain will ever stop and any information that could be provided about that. Caller states that other family members have had the vaccine and they didn't have any issue. Caller states that she has taken Tylenol and Advil for the pain, and they both were not effective to help her pain. Caller does not have an NDC, Lot number, or expiration date to provide. Caller said after the first shot, her arm hurt and then she used the opposite arm for the second shot, and that probably was not a good idea. Caller confirms that she was fully vaccinated in May2021.   Follow-up attempts completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: extreme arm pain; feels like there are needles; This is a spontaneous report received from a contactable Consumer or other non HCP from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 42-year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), administration date: May2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "extreme arm pain", "needle in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "extreme arm pain"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "feels like there are needles". The events "extreme arm pain" and "feels like there are needles" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, paraesthesia.  Additional Information: Caller would like to know if the pain will ever stop and any information that could be provided about that. Caller states that other family members have had the vaccine and they didn't have any issue. Caller states that she has taken Tylenol and Advil for the pain, and they both were not effective to help her pain. Caller does not have an NDC, Lot number, or expiration date to provide. Caller said after the first shot, her arm hurt and then she used the opposite arm for the second shot, and that probably was not a good idea. Caller confirms that she was fully vaccinated in May2021.   Follow-up attempts completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chills, Condition aggravated, Extra dose administered
Clinical narrative: The same day the patient received the vaccine, she went home and developed an 108 degree fever. She was taken by ambulance to the hospital, where she was stabilized. The patient reported she thought the vaccine was administered too high (above the target deltoid site), but it is difficult to confirm this a month later. A doctor at the hospital suggested to the patient that if the vaccine was administered too high, it could have gone into her bloodstream instead of into the muscle.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: The same day the patient received the vaccine, she went home and developed an 108 degree fever. She was taken by ambulance to the hospital, where she was stabilized. The patient reported she thought the vaccine was administered too high (above the target deltoid site), but it is difficult to confirm this a month later. A doctor at the hospital suggested to the patient that if the vaccine was administered too high, it could have gone into her bloodstream instead of into the muscle.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Product administered at inappropriate site, Pyrexia
Clinical narrative: The same day the patient received the vaccine, she went home and developed an 108 degree fever. She was taken by ambulance to the hospital, where she was stabilized. The patient reported she thought the vaccine was administered too high (above the target deltoid site), but it is difficult to confirm this a month later. A doctor at the hospital suggested to the patient that if the vaccine was administered too high, it could have gone into her bloodstream instead of into the muscle.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Asthenia, Nervousness, Palpitations, Panic attack
Clinical narrative: the vaccine booster; got panic attack; more anxious nervous than before; nausea; dizziness; fatigue; This is a spontaneous report received from contactable Consumer or other non-HCP. The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 19:15 (Lot number: FH8030) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0185, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 07May2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0162, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 16Apr2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021 19:45, outcome "unknown", described as "the vaccine booster"; PANIC ATTACK (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "got panic attack"; ANXIETY (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "more anxious nervous than before"; NAUSEA (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "nausea"; DIZZINESS (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "dizziness"; FATIGUE (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "fatigue". The events "the vaccine booster", "got panic attack", "more anxious nervous than before", "nausea", "dizziness" and "fatigue" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of immunisation, panic attack, anxiety, nausea, dizziness, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies reported for the patient. No other medical history has been reported. Vaccine Facility information available.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Immunisation, Nausea
Clinical narrative: the vaccine booster; got panic attack; more anxious nervous than before; nausea; dizziness; fatigue; This is a spontaneous report received from contactable Consumer or other non-HCP. The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 19:15 (Lot number: FH8030) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0185, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 07May2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0162, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 16Apr2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021 19:45, outcome "unknown", described as "the vaccine booster"; PANIC ATTACK (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "got panic attack"; ANXIETY (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "more anxious nervous than before"; NAUSEA (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "nausea"; DIZZINESS (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "dizziness"; FATIGUE (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "fatigue". The events "the vaccine booster", "got panic attack", "more anxious nervous than before", "nausea", "dizziness" and "fatigue" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of immunisation, panic attack, anxiety, nausea, dizziness, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies reported for the patient. No other medical history has been reported. Vaccine Facility information available.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Panic attack
Clinical narrative: the vaccine booster; got panic attack; more anxious nervous than before; nausea; dizziness; fatigue; This is a spontaneous report received from contactable Consumer or other non-HCP. The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 19:15 (Lot number: FH8030) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0185, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 07May2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0162, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 16Apr2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021 19:45, outcome "unknown", described as "the vaccine booster"; PANIC ATTACK (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "got panic attack"; ANXIETY (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "more anxious nervous than before"; NAUSEA (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "nausea"; DIZZINESS (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "dizziness"; FATIGUE (non-serious) with onset 10Nov2021 19:45, outcome "recovering", described as "fatigue". The events "the vaccine booster", "got panic attack", "more anxious nervous than before", "nausea", "dizziness" and "fatigue" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of immunisation, panic attack, anxiety, nausea, dizziness, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies reported for the patient. No other medical history has been reported. Vaccine Facility information available.   Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Nodule, Tenderness
Clinical narrative: Booster; painful knots on my temple and it is like its still here. It feels like my, back side of my face is like so huge; back side of my face is like so huge.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FH8027) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 21Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Allergy" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC taken for diabetes mellitus; ZYRTEC taken for hypersensitivity. Past drug history included: Tylenol, reaction(s): "headaches", notes: (Dose: 400mg) twice and only 2 tablets each time. . Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 17Nov2021, outcome "unknown", described as "painful knots on my temple and it is like its still here. It feels like my, back side of my face is like so huge"; SWELLING FACE (non-serious) with onset 17Nov2021, outcome "unknown", described as "back side of my face is like so huge.". Therapeutic measures were taken as a result of swelling face.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Immunisation, Swelling face
Clinical narrative: Booster; painful knots on my temple and it is like its still here. It feels like my, back side of my face is like so huge; back side of my face is like so huge.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FH8027) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 21Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Allergy" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC taken for diabetes mellitus; ZYRTEC taken for hypersensitivity. Past drug history included: Tylenol, reaction(s): "headaches", notes: (Dose: 400mg) twice and only 2 tablets each time. . Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 17Nov2021, outcome "unknown", described as "painful knots on my temple and it is like its still here. It feels like my, back side of my face is like so huge"; SWELLING FACE (non-serious) with onset 17Nov2021, outcome "unknown", described as "back side of my face is like so huge.". Therapeutic measures were taken as a result of swelling face.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Severe hives and swelling of lips that has lasted 3 months and continues.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Severe hives and swelling of lips that has lasted 3 months and continues.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Asthenia, Grip strength decreased, Injection site erythema, Lip swelling, Lymphadenopathy
Clinical narrative: Pt received first dose of Moderna vaccine on 11/13/21 and started noticing swelling of her lips/tingling of her face 30 minutes after the vaccination.  The swelling and tingling sensation went away 10 minutes later.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Neuralgia
Clinical narrative: Pt received first dose of Moderna vaccine on 11/13/21 and started noticing swelling of her lips/tingling of her face 30 minutes after the vaccination.  The swelling and tingling sensation went away 10 minutes later.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Lip swelling, Paraesthesia, Swelling
Clinical narrative: Pt received first dose of Moderna vaccine on 11/13/21 and started noticing swelling of her lips/tingling of her face 30 minutes after the vaccination.  The swelling and tingling sensation went away 10 minutes later.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Agitation, Amnesia, Anticoagulant therapy, Cardiac imaging procedure, Cardio-respiratory arrest
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: patient was deceased and Pharmacy was informed on 12/9/2021
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram normal, Confusional state, Death, Electrocardiogram
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: patient was deceased and Pharmacy was informed on 12/9/2021
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial necrosis marker increased
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: patient was deceased and Pharmacy was informed on 12/9/2021
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: patient was deceased and Pharmacy was informed on 12/9/2021
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient, 16 year old mistakenly received booster shot on 12/5/21 before it was FDA approved on 12/10/21.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient, 16 year old mistakenly received booster shot on 12/5/21 before it was FDA approved on 12/10/21.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus left ear; Dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 at 13:00 (Lot number: FJ1620) at the age of 27 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). Concomitant medication included: FLU SHOT taken for Immunization, start date: 19Nov2021, stop date: 19Nov2021.  Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0167; Route of administration: Unspecified), administration date: 12May2021, when the patient was 27 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8731; Route of administration: Unspecified), administration date: 19Apr2021, when the patient was 27 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 at 13:00, outcome "unknown", described as "Dose number=3"; TINNITUS (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Tinnitus left ear". The event "Tinnitus left ear" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional Information: Therapeutic measures for "tinnitus left ear" included treatment with PREDNISONE. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Tinnitus
Clinical narrative: Tinnitus left ear; Dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 at 13:00 (Lot number: FJ1620) at the age of 27 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). Concomitant medication included: FLU SHOT taken for Immunization, start date: 19Nov2021, stop date: 19Nov2021.  Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0167; Route of administration: Unspecified), administration date: 12May2021, when the patient was 27 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8731; Route of administration: Unspecified), administration date: 19Apr2021, when the patient was 27 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 at 13:00, outcome "unknown", described as "Dose number=3"; TINNITUS (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Tinnitus left ear". The event "Tinnitus left ear" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional Information: Therapeutic measures for "tinnitus left ear" included treatment with PREDNISONE. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspepsia
Clinical narrative: Abdomen pain from booster; Digestive issues from booster; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdomen pain from booster) and DYSPEPSIA (Digestive issues from booster) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091021A and 013M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL).   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ABDOMINAL PAIN (Abdomen pain from booster) and DYSPEPSIA (Digestive issues from booster). At the time of the report, ABDOMINAL PAIN (Abdomen pain from booster) and DYSPEPSIA (Digestive issues from booster) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided. After patient's booster dose on 02 Nov 2021, 4 to 5 days later she had a lot of abdomen pain, digestive issues, amylase was not elevated though.   This case was linked to MOD-2021-407131 (Patient Link).
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: product storage error; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (product storage error) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT STORAGE ERROR (product storage error) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported. Reporter stated that The box of vials was received from the state of Colorado on Oct  14 2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and MYALGIA (body aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-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 FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, FATIGUE (fatigue) and MYALGIA (body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       She reports she is on concomitant medications for years. No treatment medication details was reported.   This case was linked to MOD-2021-407240, MOD-2021-407241 (Patient Link).