chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: 15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat tightness, sensation of difficulty swallowing. Then abdominal pain, nausea, then feeling of something really wrong, I didn?t feel well, then got weaker and weaker, couldn?t lift arms, and felt extremely fatigued, trouble staying awake.  Taken by ambulance to medical center.  On route,  ambulance stopped and another team came in. I was given epinephrine, zofran, Benadryl, and maybe a steroid? Not sure.  When I arrived at hospital, t think I was given dexamethasone and famotidine.  I was barely awake but could speak. Could not hold anything. After several hours, they woke me up, I felt myself again, and I was discharged.  Following days I felt exhausted and dizzy, and had a headache. Took prednisone for five days.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Swollen left eye and surrounding area. Used cold compresses and took an antihistamine pill. After 3 hours, swelling is slightly less.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Dizziness, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Became extremely fatigued and began to have sore throat on 3/16. Daughter also became ill and tested positive for COVID 19 on 3/16. Tested on 3/17 via rapid test and was determined to be positive. Over the course of the next few days developed increased HR, SOB, dizziness, fatigue, nausea, and heart palpatations that have lasted approx 1 week.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Oropharyngeal pain, Palpitations, SARS-CoV-2 test false positive
Clinical narrative: Became extremely fatigued and began to have sore throat on 3/16. Daughter also became ill and tested positive for COVID 19 on 3/16. Tested on 3/17 via rapid test and was determined to be positive. Over the course of the next few days developed increased HR, SOB, dizziness, fatigue, nausea, and heart palpatations that have lasted approx 1 week.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Had vaccine, came home, went to bed, and has had a runny nose since.  Took a dose of Benadryl and still continues to have the runny nose, but has not continued with that.  She also has a sore throat, no temperature, no dizziness, weakness or anything other than the runny nose and sore throat.  Is not going to take 2nd vaccine due to this severe reaction.   Has been using saline, iodine and peroxide in her vaporizer to keep her lungs open.   Has not called her doctor.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysstasia, Paraesthesia
Clinical narrative: After I left the facility, driving home I notice that my back was starting to hurt, so I turned on the heat on my back . When I got home, I had difficulty getting out of my car.  I  sat in a chair and within the next few minutes I was not able to stand. My husband had to come help me get up and stand, there was pain across my lower back like pin needles and up part of my spine. I took Motrin and it helped it subside somewhat not much.  The second day it continued but later started to ease a little but I was not able to walk upright.  Third day, 3/24,  it is starting to ease up and I am able to walk upright, there is still discomfort.   I have contacted my physician to report the issue.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Influenza like illness, Limb discomfort
Clinical narrative: Covid arm morning after vaccine, chills, fever, muscle aches, headache, loss of appetite, felt like worse flu for 1.5 days after onset of symptoms.  First symptom hit approx 7 hours after vaccine and lasted 1.5-2 days.   Also had covid arm 9 days after first vaccine but it was worse after second vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Covid arm morning after vaccine, chills, fever, muscle aches, headache, loss of appetite, felt like worse flu for 1.5 days after onset of symptoms.  First symptom hit approx 7 hours after vaccine and lasted 1.5-2 days.   Also had covid arm 9 days after first vaccine but it was worse after second vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Patient had a large red, raised area to her Right deltoid. It measured 5in x 2in was red and hot, 5 days after vaccine was administered. Patient also swelling to the right side of her body and underarm.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: DUPLICATE VACCINES GIVEN ON 11/14/2019 AND 03/23/2020. THE DUPLICATE VACCINES ARE HEP A, VARICELLA, MMR.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pts DOB was not recognized during screening processes and vaccine was administered.  Called and spoke w/ Pts mother (caregiver) and confirmed that although and MD told her to get the children vaccinated, Moderna has not been approved yet for this age group.   Vaccine dose #2 will not be given until further information is released
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: headache, tiredness, low fever, muscle aches, injection site pain.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt reports that just over two hours after vaccination, he had about 4-5 hives show up on his right forearm. They were slightly itchy. After about 24 hours post vaccination, the hives he reports decreased to half their original size. He did take one dose of Benadryl, but did not require any further medical treatment.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia, Taste disorder
Clinical narrative: I have noticed an alteration in my taste of peanut butter only. Peanut butter of all brands gives a foul metallic type taste that invades my mouth AND nose like fumes. No other reaction as far as I can tell occurs. No hives no itching no swelling. I was taking no new medications at that time and was not sick. I have never had any issues eating Peanut butter and I am not currently pregnant.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Electrocardiogram, Metabolic function test, Pain in extremity
Clinical narrative: Pt felt pain in arm, dry mouth, dizzy, lightheaded
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vision blurred
Clinical narrative: 3-23-21 4:16PM PT STATES 'EYES FEEL WEIRD, HARD TO REFOCUS QUICKLY AND EARS RINGING'. PT PLACED IN CHAIR. A/O, PINK, W/D, RESP REG WITH EASE. PERLA. NO NEURO DEFICIT. GOOD MOTOR/SENSORY NOTED. COMFORT GIVEN. 4:17PM STATES SHE 'FEELS BETTER NOW'. 4:25PM AMBULATORY TO EXIT - GAIT BRISK AND STEADY. NO DISTRESS NOTED. 3-24-21 9:45AM PT STATES SHE 'FEELS MUCH BETTER'.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Throat swelling
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Haemoglobin decreased, Syncope
Clinical narrative: PT via wheelchair to ER c/o dizziness after he received second dose of covid vaccine today at noon. Pt's son stated he had no issues with the first dose. The patient had a syncopal episode in the ED lobby while waiting for a room. Upon review in the ED, patient with Hgb of 6.5. Prior history of Crohns and GI issues/bleeding.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Chills/Fever, Body Ache, Nausea, very sore arm.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient was given the vaccine, stated she feels like she was going to faint. Patient was given water & benadryl. Onsite EMS was called vitals Hr 84 BP 101/66. 4:42 she felt better and went home.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Hypoaesthesia
Clinical narrative: After about 40 minutes after administration, developed left facial numbness and chest pain rating 2/10.   First response called and patient taken to ER for further monitoring.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac function test, Chest pain, Flushing, Headache, Hypoaesthesia
Clinical narrative: After about 40 minutes after administration, developed left facial numbness and chest pain rating 2/10.   First response called and patient taken to ER for further monitoring.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Limb discomfort, Throat irritation, Throat tightness
Clinical narrative: After about 40 minutes after administration, developed left facial numbness and chest pain rating 2/10.   First response called and patient taken to ER for further monitoring.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Eye pain, Headache, Laboratory test, Ocular discomfort
Clinical narrative: Continuous right side headache starting February 14, 2021. Right side headache, scalp burning & sensitivity, orbit pain, right temple pain, pain at base of skull, forehead pain & sensitivity. right eye discomfort
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Skin burning sensation
Clinical narrative: Continuous right side headache starting February 14, 2021. Right side headache, scalp burning & sensitivity, orbit pain, right temple pain, pain at base of skull, forehead pain & sensitivity. right eye discomfort
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea, and body shaking started 2 minutes after injection; chills, fever, severe headache, muscle aches started after
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Nausea, and body shaking started 2 minutes after injection; chills, fever, severe headache, muscle aches started after
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Arm pain - difficult to raise, lift  & move arm, began at 12:30pm on 3/23/21 & is more intense now at 7:02am on 3/24/21; headache - 5:30am on 3/24/21; neck pain & stiffness, 5:30am on 3/24/21
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dysarthria, Malaise, Pallor, Syncope
Clinical narrative: Pt had history of anaphylaxis related to bee stings. We asked if he had ever had a reaction to another vaccine and he said no. Pt came up saying he wasn't feeling well during the observation period, within about 5-10 minutes after receiving the vaccination. He look very pale and clammy. I asked if he was ok and he shook his head. Tried to grab a chair for him and he started to collapse. With some help I was able to get him to the ground without injury. We called 911 and I grabbed an epipen. I tried to assess the patient, and he was unable to tell me if he was having any trouble breathing or if his lips/mouth/tongue was swelling. He was conscious but couldn't speak coherently. I administered the epipen to his right lateral thigh due to his history of anaphylaxis with bee stings. We were able to lay him down while waiting for the ambulance. His color started to return and he was able to respond to questions, but was still slightly confused. He did tell me at this point that he has had similar reactions after vaccines and blood work. The paramedics arrived and took the patients vitals and took him to the hospital.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood test, Cerebrovascular accident, Computerised tomogram, Dizziness
Clinical narrative: pt had a headache and some dizziness.  Next day he had gargled speech and unsteady on his feet so 911 was called.  He was transported by EMT to ER .  They started TPA protocol  upon arrival in the ER.  He had CT, MRI, Doppler study of heart and carotid, blood work.  He was diagnosed w/ a stroke and then admitted to ICU where he was kept overnight.  He saw a cardiologist, Internist, and Neuro doctors.  He speech was clear by 3/21/2021 and was released to FU w/ his physicians.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Headache, Intensive care, Magnetic resonance imaging, Speech disorder
Clinical narrative: pt had a headache and some dizziness.  Next day he had gargled speech and unsteady on his feet so 911 was called.  He was transported by EMT to ER .  They started TPA protocol  upon arrival in the ER.  He had CT, MRI, Doppler study of heart and carotid, blood work.  He was diagnosed w/ a stroke and then admitted to ICU where he was kept overnight.  He saw a cardiologist, Internist, and Neuro doctors.  He speech was clear by 3/21/2021 and was released to FU w/ his physicians.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: pt had a headache and some dizziness.  Next day he had gargled speech and unsteady on his feet so 911 was called.  He was transported by EMT to ER .  They started TPA protocol  upon arrival in the ER.  He had CT, MRI, Doppler study of heart and carotid, blood work.  He was diagnosed w/ a stroke and then admitted to ICU where he was kept overnight.  He saw a cardiologist, Internist, and Neuro doctors.  He speech was clear by 3/21/2021 and was released to FU w/ his physicians.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dysphonia, Throat tightness
Clinical narrative: "Approximately 15 minutes following the patient's initial vaccine shot, the observation nurse reported that patient began to feel throat tightening, and feeling clamy. Observation nurse also noticed that patient's voice began to become raspy. The nurse checked the patient's vitals and reported that they were normal, and proceeded to take the patient to the ED for further evaluation. Patient received diphenhydramine 25mg IV x 1, famotidine 40mg PO x 1, methylprednisolone 125mg x 1.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: On day 9 after the first dose,  He Had an unprovoked seizure for the first time ever. He never had seizures his entire life. We took him to the emergency room , all tests were normal (including CT scan). Subsequently, he had his first-ever EEG that came back normal as well.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising, Injection site pruritus, Injection site urticaria
Clinical narrative: 3/16 RIGHT ARM ITCHING HAD HIVES ON  SHOT SITE FOR A COUPLE DAYS THEN LOOKED LIKE BRUISES FOR A COUPLE DAYS. STILL ITCHES ALITTLE
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood pressure increased, Condition aggravated, Heart rate increased, Psoriasis
Clinical narrative: Patient developed elevated heart rate to 120 beats/minute, elevated blood pressure to 180/110, elevated fasting glucose readings to 250 (normally <150), psoriasis flare and profound fatigue. All of the above symptoms developed within 48 hours of administration of the 1st vaccine and have persisted, with some improvement, for up to 9 days.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Injection site pain, Migraine, Muscle tightness
Clinical narrative: Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain Muscle tightness in neck and shoulders Soreness at injection site
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Pruritus
Clinical narrative: Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain Muscle tightness in neck and shoulders Soreness at injection site
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: HIV test negative, Lymphadenopathy, Myalgia, Oral disorder, Oropharyngeal pain
Clinical narrative: A few days after the vaccine my lymph nodes in my upper cervical area high in my neck area swollen which caused me to have a sore throat. A single small ulcerative lesion appeared in the upper soft palate of my mouth so I went to a walk in clinic and had a strep done which was negative. D/t the ulcers appearing in my mouth I had and HIV test done which also came back negative. I had a small low grade fever and muscle aches also associated but the lesion in my mouth is what caused the major concern which slowly resolved over the next few weeks.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: A few days after the vaccine my lymph nodes in my upper cervical area high in my neck area swollen which caused me to have a sore throat. A single small ulcerative lesion appeared in the upper soft palate of my mouth so I went to a walk in clinic and had a strep done which was negative. D/t the ulcers appearing in my mouth I had and HIV test done which also came back negative. I had a small low grade fever and muscle aches also associated but the lesion in my mouth is what caused the major concern which slowly resolved over the next few weeks.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Fall, Hemiplegia, Hypoaesthesia
Clinical narrative: 2/22/21- Resident began falling multiple time and reporting loss of feeling in her Rt leg. Sent to ER. Diagnosis with multiple acute CVA and Rt sided hemiplegia
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Tremor
Clinical narrative: extreme chills and shakes  lasting several hours.  /   headache/
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Moderna COVID-19 Vaccine EUA
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Node in Clavicle
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Rash papular, Rash pruritic
Clinical narrative: The left arm has a softball sized rash that is itchy and has raised bumps. There is a ring on the outer part of the inflamed area.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Palpitations, Throat tightness
Clinical narrative: pt received vaccine at approximately 0730 in am. Waited his 15 minutes. He feels since he received the vaccine his heart is racing, and feels like his throat is tightening. He denies wheezing, has no angioedema. No exacerbating or alleviating factors, symptoms constant. Denies fever, chills, chest pain, shortness of breath or palpitations. Former smoker. No rash present. Pulse Ox is normal 96-99. One blood pressure reading was elevated, temp normal.   Treated with solumedrol, pepcid, benedryl, iv fluids. Observed for one hour, discharged home with steroids and antihistamine. Advised not to take 2nd covid vaccine by ER provider.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Hypersomnia
Clinical narrative: Tiredness, Chills, Joint Pain, Mild Nausea.  I started getting the chills during the night (night of receiving my second dose), and was cold most of the next day.  I was very tired, slept most of the day, and felt some joint pain and mild nausea.  I woke up today (second day after second shot) feeling a little tired, but basically fine, without symptoms.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Tiredness, Chills, Joint Pain, Mild Nausea.  I started getting the chills during the night (night of receiving my second dose), and was cold most of the next day.  I was very tired, slept most of the day, and felt some joint pain and mild nausea.  I woke up today (second day after second shot) feeling a little tired, but basically fine, without symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no AE; a temperature excursion involving VARIVAX (...) the VARIVAX was administered; This spontaneous report was received from a registered nurse and refers to patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 22-FEB-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # T021821, expiration date: 25-JUN-2022) (route of administration was not reported) for prophylaxis. Administered doses of vaccine experienced the temperature excursion of -7.4 degrees Celsius for 3 hours and 54 minutes. The event was reported due to digital data logger. There were not previous temperature excursions. There was no product to retrieve and no other adverse events (AEs) reported.; Sender's Comments:  US-009507513-2102USA008721: US-009507513-2102USA008774: US-009507513-2102USA008793: US-009507513-2102USA008814: US-009507513-2102USA009013:
Sex: F
Vaccine: PPV
Symptoms: Respiratory distress
Clinical narrative: severe respiratory reaction; This spontaneous report as received from a female patient of unknown age, referring to herself. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.  On an unknown date in 2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot# and expiration date were unknown) for vaccination.         On an unknown date in 2013, the patient experienced severe respiratory reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). It lasted for over 2 years and was a "rough time". The outcome of severe respiratory reaction was unknown. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and severe respiratory reaction was related.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA004014:
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: respiratory reaction; This spontaneous report was received from a consumer,  referring to a female patient of unknown age. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot# and expiration date were unknown) for vaccination.         On an unknown date, the patient experienced respiratory reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of respiratory reaction was unknown. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and respiratory reaction was related.     This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA003984:
Sex: F
Vaccine: HPV9
Symptoms: Neuroblastoma
Clinical narrative: she belives it caused her sister neuroblastoma; Information has been received from a nurse reporting on the sister of unknown age of a consumer. The patient's concurrent conditions, medical history or concomitant medication were unknown.  On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient experienced neuroblastoma. It was unknow if the patient was treated for the event. The consumer declined the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine because she believed it caused her sister's neuroblastoma. The outcome of the event was not reported.  The causality assessment was not provided by the nurse.  Upon internal review, neuroblastoma was considered to be medically significant.
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported; a 9 month old patient was administered ROTATEQ; This spontaneous report was received from a physician assistant and refers to a 9 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unspecified date in March 2021 (reported as last week), the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 mL by mouth (lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration). No adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AE reported; adverse event involving vaccines MMR II (stored in freezer) and VARIVAX; This spontaneous report was received from a medical assistant and refers to a 12 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-MAR-2021, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) 0.5 mL, lot # S039319, expiration date 04-DEC-2021 (route of administration and anatomical location were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL, lot # T022315, expiration date 30-JUN-2022 (route of administration and anatomical location were not provided) for prophylaxis. The vaccines were stored in a temperature between - 50 degrees Celsius (C) to 8 C (-1.6 C) for 1 hour 36 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse event reported; Temperature excursion/ VARIVAX was administered to a patient; This spontaneous report as received from an office manager to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-FEB-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 1 time dose, lot # T022315, expiration date 30-JUN-2022 (dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine experienced temperature excursion of 5.5 degrees Celsius for 21 hours. There was no previous temperature excursion. Digital data logger was not involved. There was no adverse event reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA003680:
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Epistaxis, Fatigue, Thrombosis
Clinical narrative: lost appetite; so tired, thought could not get out of bed; Big/ huge clots, came out in a spit; had 3 nose bleeds; A spontaneous report was received from a 77-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 3 nose bleeds/ Epistaxis, big/huge clots, clot came out in a spit/ Thrombosis, tiredness/ Fatigue, and loss of appetite/ Decreased appetite.  The patient's medical history was not provided. No concomitant product use was reported.  On 12 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 13-Feb-2021, the patient experienced 3 nose bleeds with huge blood clots. The bleeding was persistent throughout the day, stopping at the intervals and later on the same day it was reported the patient had a huge clot come out in spit. On 14 Feb 2021, the patient was tired, could not get out of bed, and had lost appetite. On 18-Feb-2021, the patient woke up feeling normal.  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not provided.  The outcomes of the events were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Had to travel out of the country and missed getting his 2nd dose; A spontaneous report was received from a physician who received Moderna's COVID-19 vaccine (mRNA-1273) but missed the second vaccination dose (missed dose).  The patient's medication history was not provided. Concomitant product use was not reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, he was scheduled for second dose but missed the vaccination dose as he had to travel out of the country.  The treatment medications were not reported  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event was considered resolved on 27 Jan 2021.; Reporter's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Gastric ulcer, Pain in extremity
Clinical narrative: Has a pain on an ulcer on the upper stomach; Sore arm; A spontaneous report was received from a consumer concerning a 76-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/ pain in extremity and has a pain on an ulcer on the upper stomach/ gastric ulcer.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 19 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 029K20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced sore arm and a medically significant event, pain on an ulcer on the upper stomach.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm and has a pain on an ulcer on the upper stomach was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Flatulence
Clinical narrative: Fluttering of the heart; Gassy; A spontaneous report was received from a consumer concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fluttering of the heart/cardiac flutter, and gassy/flatulence.  The patient's current condition included mitral prolapse. Concomitant medications included olmesartan medoxomil and carvedilol.  On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) in the right arm for prophylaxis of COVID-19 infection.  The patient experienced the events fluttering of the heart, gassy on the evening of 05 Feb 2021 and the next day 06 Feb 2021 as well.  Treatment details included gas medication, bananas and electrolytes.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fluttering of the heart, gassy was unknown.; Reporter's Comments: Very limited information regarding rest of the events has been provided at this time. Further information has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: Pain in my heart; A spontaneous report was received from an 81 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in heart.  The patient's medical history included heart problem and concomitant medications included Metoprolol.   On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced pain in her heart and went to emergency care. The patient said the doctor asked for stress test but the patient could not walk on the treadmill so she was given a shot instead of walking. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event, pain in my heart, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysstasia, Feeling abnormal, Gait inability, Intervertebral disc protrusion
Clinical narrative: Lost all muscle control; Could not walk; Could not stand up; Brain fog; Bulging disc; Fever of 101 degrees Fahrenheit; A spontaneous report was received from a consumer concerning a 78-years-old, male patient, who received Moderna's covid-19 vaccine (mRNA -1273) and experienced events, lost all muscle control(muscle weakness), could not walk(gait inability) or could not stand up(dysstasia), fever(pyrexia), brain fog(feeling abnomal) and a bulging disc(intervertebral disc protrusion).  The patient's medical history was not provided. Concomitant medications included a shingles vaccine.   On 06 FEB 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 FEB 2021, the patient received the mRNA-1273 vaccine and on 28 FEB 2021, the patient received Shingles vaccine. On 04 MAR 2021, the patient was hospitalized with the events lost all muscle control, could not walk or stand up, fever and brain fog. On an unspecified date in MAR 2021, the lab tests performed included, stress test and MRI and found a bulging disc and he had a fever of 101 degrees Fahrenheit. Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, brain fog, was considered to be not resolved.  The outcome of the events, bulging disc, lost all muscle control, could not walk or stand up and fever,  was unknown.  Patient's consent to follow-up with safety was obtained.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, confounding factor is the Shingles vaccine, which was received 4 days before the symptoms vs Moderna vaccine which was received 26 days prior to the symptoms starting.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Muscular weakness, Pyrexia, SARS-CoV-2 test
Clinical narrative: Lost all muscle control; Could not walk; Could not stand up; Brain fog; Bulging disc; Fever of 101 degrees Fahrenheit; A spontaneous report was received from a consumer concerning a 78-years-old, male patient, who received Moderna's covid-19 vaccine (mRNA -1273) and experienced events, lost all muscle control(muscle weakness), could not walk(gait inability) or could not stand up(dysstasia), fever(pyrexia), brain fog(feeling abnomal) and a bulging disc(intervertebral disc protrusion).  The patient's medical history was not provided. Concomitant medications included a shingles vaccine.   On 06 FEB 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 FEB 2021, the patient received the mRNA-1273 vaccine and on 28 FEB 2021, the patient received Shingles vaccine. On 04 MAR 2021, the patient was hospitalized with the events lost all muscle control, could not walk or stand up, fever and brain fog. On an unspecified date in MAR 2021, the lab tests performed included, stress test and MRI and found a bulging disc and he had a fever of 101 degrees Fahrenheit. Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, brain fog, was considered to be not resolved.  The outcome of the events, bulging disc, lost all muscle control, could not walk or stand up and fever,  was unknown.  Patient's consent to follow-up with safety was obtained.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, confounding factor is the Shingles vaccine, which was received 4 days before the symptoms vs Moderna vaccine which was received 26 days prior to the symptoms starting.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hyperhidrosis, Inappropriate affect, Loss of consciousness
Clinical narrative: Fainted, unconscious for few minutes; Sweating; Funny feeling; Feeling very weak; A spontaneous report was received from a consumer who was also a 59-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced fainted, unconscious for few minutes/loss of consciousness, sweating/hyperhidrosis, funny feeling/inappropriate affect and feeling very weak/asthenia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) on 07 Feb 2021.   On 07 Mar 2021, approximately 2 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029A21A) via an unknown route in the left non dominant arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021, patient experienced sweating, patient felt funny, fainted and was unconscious for few minutes and patient felt very weak.   No treatment was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events were not reported.; Reporter's Comments: This case concerns a 59-year-old female who experienced a serious unexpected event of loss of consciousness along with nonserious events of unexpected asthenia, inappropriate affect and hyperhidrosis.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: her arm was swollen/ hand was also swollen; the joint in her shoulder felt like it was going to split off. It was extremely painful; her arm was swollen/ It was extremely painful; had been awake two nights unable to sleep due to pain; The pain was also creeping up her neck; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En7200), via an unspecified route of administration in left arm on 16Feb2021 at 14:00 at single dose for covid-19 immunisation. The relevant medical history included latex allergy and bee allergy, all from an unspecified date. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), modafinil and unspecified thyroid medication. The patient stated that her arm was swollen and the joint in her shoulder felt like it was going to split off. It was extremely painful. Her hand was also swollen and she had to remove her rings. She had been awake two nights unable to sleep due to pain. The pain was also creeping up her neck. The events started on 18Feb2021 at 22:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment included steroids and pain killers sling for arm. No covid prior vaccination and no covid tested post vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Cough, Fatigue, Headache
Clinical narrative: started about 15 hours after dose # 2 on 18Feb2021.I had flu like  symptoms.; achy legs; achy back; chills; fatigue; Headache; runny nose; mild cough; This is a spontaneous report from a contactable consumer. This 73-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (Lot number: EN6200) at single dose for covid-19 immunization on 18Feb2021 (08:15 AM, at left arm). Relevant history included allergies with Sulfa drugs. Relevant concomitant drug was unknown. The patient received the first dose of BNT162B2 (Lot number: EN9625) for covid-19 immunization on 28Jan2021 (08:15 AM, at left arm). The patient did not receive other vaccine in four weeks. No other medications received in two weeks. The patient stated about 15 hours after dose # 2 on 18Feb2021, at 11:30 PM, she started to have flu like symptoms (achy legs and back, chills, and headache which recovered by 7:00 am the following day. Started about 7 am the day following, very runny nose(used 2 boxes of tissue in 24 hours) and had intermittent headache and fatigue. At the reporting time (day 3) and she was still having very runny nose and mild cough. No treatment was received.  Outcome of event was resolving. The patient was not infected COVID prior vaccination. The patient did not  have COVID test post vaccination.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Rhinorrhoea
Clinical narrative: started about 15 hours after dose # 2 on 18Feb2021.I had flu like  symptoms.; achy legs; achy back; chills; fatigue; Headache; runny nose; mild cough; This is a spontaneous report from a contactable consumer. This 73-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (Lot number: EN6200) at single dose for covid-19 immunization on 18Feb2021 (08:15 AM, at left arm). Relevant history included allergies with Sulfa drugs. Relevant concomitant drug was unknown. The patient received the first dose of BNT162B2 (Lot number: EN9625) for covid-19 immunization on 28Jan2021 (08:15 AM, at left arm). The patient did not receive other vaccine in four weeks. No other medications received in two weeks. The patient stated about 15 hours after dose # 2 on 18Feb2021, at 11:30 PM, she started to have flu like symptoms (achy legs and back, chills, and headache which recovered by 7:00 am the following day. Started about 7 am the day following, very runny nose(used 2 boxes of tissue in 24 hours) and had intermittent headache and fatigue. At the reporting time (day 3) and she was still having very runny nose and mild cough. No treatment was received.  Outcome of event was resolving. The patient was not infected COVID prior vaccination. The patient did not  have COVID test post vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red rash on chest and on the back; This is a spontaneous report from a contactable other health care professional (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: El9262) in left arm on 19Feb2021 11:00 AM at single dose for Covid-19 Immunisation. Medical history included osteoporosis. Concomitant medications included teriparatide (FORTEO). Patient was not pregnant, no known allergies. No other vaccine in four weeks. Historical Vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3247) in left arm on 01Feb2021 12:00 PM for Covid-19 Immunisation. Patient experienced red rash on chest and on the back on 21Feb2021 09:00 AM with outcome of not recovered. No treatment was received. If COVID prior vaccination was No. If COVID tested post vaccination was No.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache; Muscle Aches; This is a spontaneous report from a contactable consumer (the parent). A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 20Feb2021 10:15 (at the age of 24-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: allergies (unspecified), ADD (attention deficit hyperactivity disorder), and allergies sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient had no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 30Jan2021 (at the age of 24-years-old), as a single dose for COVID-19 immunization. On 21Feb2021 (reported as "at 08:00"), the patient experienced headache and muscle aches. Treatment included ibuprofen. The clinical outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    Information on the lot number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blood count, Blood count abnormal, Large intestinal haemorrhage, Platelet count, Platelet count decreased
Clinical narrative: husband's blood count was very low, was bleeding in colon; husband's blood count was very low, was bleeding in colon; his platelet count became too low; This is a spontaneous report received from a contactable consumer (patient's wife) and from the Pfizer-sponsored program. An 86-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 86-years-old on 06Feb2021 (also reported as 13Feb2021, pending clarification, Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included heart condition. Concomitant medication included warfarin sodium (COUMADIN) taken for heart condition, start and stop date were not reported. The patient received the 1st dose on 06Feb2021 (also reported as 13Feb2021) but missed the 2nd dose on 06Mar2021 (lot reported as "EL9269") because he was hospitalized. She mentioned that he is taking Coumadin everyday for his heart condition and his platelet count became too low. Wife wanted to know timing of the second dose. Her husband's blood count was very low, was bleeding in colon. He was on Coumadin after the hospital he will be going to the rehab. The patient underwent lab tests and procedures which included blood count: very low and platelet count: too low on unspecified dates. Therapeutic measures were taken as a result of Colonic hemorrhage and Platelet count low. The outcome of the events was unknown. The case was assessed as serious due to hospitalization (husband's blood count was very low, was bleeding in colon).  Information on the lot/batch number has been requested.