chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Estimated due date:  07/16/2021 About 5 hours after the vaccine my arm started to hurt and I started having all body aches and chills, never had a fever.  Very fatigued. At night I threw up and about 2AM I woke up drenched in sweat and I did not take my temperature. I woke up around 7AM and I had a migraine for about 2/3 hours - pounding headache. I took Tylenol, My body was really achy and my arm was like it was dead. General malaise, fatigue, it felt like I had a hangover, from my pounding headache. I threw up once again in the afternoon. Not sure if pregnancy related or the vaccine. Sunday morning I started feeling a little better. Saturday I felt horrible.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Pain, Pain in extremity, Vomiting
Clinical narrative: Estimated due date:  07/16/2021 About 5 hours after the vaccine my arm started to hurt and I started having all body aches and chills, never had a fever.  Very fatigued. At night I threw up and about 2AM I woke up drenched in sweat and I did not take my temperature. I woke up around 7AM and I had a migraine for about 2/3 hours - pounding headache. I took Tylenol, My body was really achy and my arm was like it was dead. General malaise, fatigue, it felt like I had a hangover, from my pounding headache. I threw up once again in the afternoon. Not sure if pregnancy related or the vaccine. Sunday morning I started feeling a little better. Saturday I felt horrible.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Skin discolouration, Skin swelling
Clinical narrative: Large, red, swollen welt on injection site. Raised skin and pink coloring, circular shape surrounding injection site. Warm to the touch. On and off itching. Does not interfere with mobility, no pain, but seems to be spreading slowly.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Urticaria
Clinical narrative: Large, red, swollen welt on injection site. Raised skin and pink coloring, circular shape surrounding injection site. Warm to the touch. On and off itching. Does not interfere with mobility, no pain, but seems to be spreading slowly.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Nauseas, Dizziness
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Heart rate increased, Pruritus
Clinical narrative: Itchy, chest pain immediately after injection, SOB increase HR. EMT providers on site, EKG, vitals. No medications administered.
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vital signs measurement
Clinical narrative: Itchy, chest pain immediately after injection, SOB increase HR. EMT providers on site, EKG, vitals. No medications administered.
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: Itchy, chest pain immediately after injection, SOB increase HR. EMT providers on site, EKG, vitals. No medications administered.
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling jittery, Headache, Heart rate increased, Nausea
Clinical narrative: Itchy, chest pain immediately after injection, SOB increase HR. EMT providers on site, EKG, vitals. No medications administered.
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain, Panic attack, Pruritus, Tachycardia
Clinical narrative: Itchy, chest pain immediately after injection, SOB increase HR. EMT providers on site, EKG, vitals. No medications administered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: left shoulder 6x4cm redness, itching, and pain
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Injection site erythema, Injection site rash, Injection site warmth, Rash
Clinical narrative: Moderna COVID-19 Vaccine EUA  1/11/2021: Received vaccine at around 1400 1/15/2021: 0830-0930 exposed to covid positive patient within 6 feet, both wearing masks in anatomy lab with HEPA filters present  1/17/2021: Completed PCR test. Received negative results.  1/18/2021: Rash at site of injection that migrated to chest 1/19/2021: Rash resolved by 5 cm local erythema at site of injection, warm to touch 1/19/2021: Took motrin 400 mg and Benadryl 25mg and will monitor
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Moderna COVID-19 Vaccine EUA  1/11/2021: Received vaccine at around 1400 1/15/2021: 0830-0930 exposed to covid positive patient within 6 feet, both wearing masks in anatomy lab with HEPA filters present  1/17/2021: Completed PCR test. Received negative results.  1/18/2021: Rash at site of injection that migrated to chest 1/19/2021: Rash resolved by 5 cm local erythema at site of injection, warm to touch 1/19/2021: Took motrin 400 mg and Benadryl 25mg and will monitor
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing,, stuffy, runny nose, and fatigue and malaise.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eye pruritus, Fatigue, Headache, Injection site pain
Clinical narrative: first reaction about 4 1/2 hours after injection.. fine powdery itchy rash on breasts pectoral area and ribs.  approx 30 hours after injection sudden onset fatigue, extreme pain in injection arm, uncontrolable chills, low grade fever,headache. approx 44 hours later still headache, muscle pain subsided, powdery itchy rash returned.. over chest , pectoral area , and itchy eyes and head..
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: first reaction about 4 1/2 hours after injection.. fine powdery itchy rash on breasts pectoral area and ribs.  approx 30 hours after injection sudden onset fatigue, extreme pain in injection arm, uncontrolable chills, low grade fever,headache. approx 44 hours later still headache, muscle pain subsided, powdery itchy rash returned.. over chest , pectoral area , and itchy eyes and head..
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pain, Rash
Clinical narrative: first reaction about 4 1/2 hours after injection.. fine powdery itchy rash on breasts pectoral area and ribs.  approx 30 hours after injection sudden onset fatigue, extreme pain in injection arm, uncontrolable chills, low grade fever,headache. approx 44 hours later still headache, muscle pain subsided, powdery itchy rash returned.. over chest , pectoral area , and itchy eyes and head..
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eye pruritus, Fatigue, Headache, Injection site pain
Clinical narrative: Headache, muscle ache, pain, chills, rash over body
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Headache, muscle ache, pain, chills, rash over body
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pain, Rash
Clinical narrative: Headache, muscle ache, pain, chills, rash over body
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abortion spontaneous, Exposure during pregnancy, Pregnancy, Vaginal haemorrhage
Clinical narrative: Client was pregnant at time of vaccination. She had consulted with 2 OBGYNS that are following her concerning if she should receive the covid vaccine. They both stated yes. She received her 1st covid vaccination to her left deltiod between 12pm - 1300 on 1/14/21. She did not experience any complications or feel any side effects immediately after vaccination. She was monitored by nursing staff for over 30 min to be prudent. On 1/16/21 the Sat following vaccination she began experiencing cramping in her stomach and began to bleed vaginally. She consulted w her OBGYN and was monitored. She miscarried on 1/19/21.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient began itching in both arms approximately 13 minutes after receiving the injection. The itching worsened and urticaria developed on her right wrist, left upper arm. She was given 50mg benadryl and monitored. Itching resolved and she was taken home by a co-worker. She was advised to follow up with her
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus
Clinical narrative: Itchy skin, throat swelling. Resolved with benadryl.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 1 week post injection, injection site became itchy, red, hot, swollen. The redness spread & got larger throughout the day. Determined to be a cellulitis.  Required antibiotics.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Developed severe headache post vaccination
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations starting 24 hours after vaccine was given
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Diarrhoea, Pruritus, Urticaria
Clinical narrative: 1/15/21 vaccine 10:00am 5:00 pm hives itching, chills, diarrhea, chest tightness "took Childs allergy medicine - had no Benadryl in house" 1/20/21 still has hives and itching
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 01/13: same day had staff having chill, fever 99.4, fatigue, headache.  Friday 01/15; bodyache, headache, no fever.  Sat resolved. Now back to work.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cardiovascular evaluation, Chest X-ray, Dizziness
Clinical narrative: Fainting, dizziness and weakness, trembling, BP 168/129. HR 145
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor
Clinical narrative: Fainting, dizziness and weakness, trembling, BP 168/129. HR 145
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: Soreness in arm, rash at injection site
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal, Urticaria
Clinical narrative: chest heaviness, slight hives noted to face, states she "feels funny". She was given 25mg of Benadryl po and sent to emergency dept where she was given prednisone, pepcid and benadryl. She said the symptoms subsided slightly but after 24 hours she still is "feeling funny".
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Axillary mass, Oedema peripheral, Tenderness
Clinical narrative: Small mass like /swollen/left axilla, tender at the touch /1 (1-10) pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Nausea, Rash, Vertigo
Clinical narrative: Systemic: Rash (other than injection site)-Mild, Systemic: Nausea-Severe, Systemic: Vertigo-Severe
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Differential white blood cell count normal, Dizziness, Full blood count normal
Clinical narrative: Within 1 minute of vaccine administration = immediate flush of heat, dizziness, weakness, blood pressure elevation.  Treatment = apple juice, water, monitoring blood pressure.  Better in 2 hours.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Immediate post-injection reaction
Clinical narrative: Within 1 minute of vaccine administration = immediate flush of heat, dizziness, weakness, blood pressure elevation.  Treatment = apple juice, water, monitoring blood pressure.  Better in 2 hours.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Pain
Clinical narrative: 8 hrs after vaccine staff started to have chill and bodyache and last upto 75 hrs.  Around 50hrs started to have headache and it disappeared at about 80 hrs.  Would like to report the symptoms, reactions. Feels well today and has been back to work.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncope x2
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site pain
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Hypoaesthesia
Clinical narrative: Right axillary is sore, tender. Very painful. Numbness in right leg like it is asleep
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fatigue, Headache, Heart rate increased
Clinical narrative: Woke up 1/20/21 with chills but no fever, increased heart rate of 99 when my normal is 68, dehydration, headache,  fatigue, body aches, injection site pain, nausea after eating oatmeal and coffee.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: Woke up 1/20/21 with chills but no fever, increased heart rate of 99 when my normal is 68, dehydration, headache,  fatigue, body aches, injection site pain, nausea after eating oatmeal and coffee.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Mild pain & mild pressure on left side of chest
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Reported symptom onset 11:09 of tingling outer lip area and tip of tongue. VS: BP 146/82, pulse 57, Resp 16 at 11:09. Administered 20ml Diphenhydramine Elixer by mouth at 11:16. Reports tingling resolved on tongue and "mostly gone" from lips. Alert after incident, accompanied home by husband.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; an improperly stored ROT ATEQ was administered; This spontaneous report was received from a medical assistant refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 28-DEC-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1687009, expiration date: 28-JUN-2021 for prophylaxis (dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 32.1 degrees Fahrenheit for 1 hour. Digital data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: PPV, PPV
Symptoms: Product storage error
Clinical narrative: emperature excursion and states that the vaccine was administered to patient during the excursion.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.  On 21-DEC-2020, the patient was vaccinated with improperly stored doses os pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T032003, with expiration date of 08-MAY-2022 and lot # T022294 with expiration date of 26-MAR-202 at a dose of 0.5 milliliter for prophylaxis.   The vaccines experimented temperature below 2 degrees celsius(°C) (1.3C) for 0 hours 24 minutes, time frame below 2°C (l.3C) for 0 hours 24 minutes and previous temperature excursión below 2°C (1.6 C) for 24 minutes. Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE reported; a patient was administered an expired VARlV AX; This spontaneous report was received from a pharmacist and refers to a 22-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-JAN-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, subcutaneously, lot # R023735, expiration date: 20-AUG-2020 (anatomical location not provided) for prophylaxis. There was no adverse event reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Injection was really achy; Headache; mild nausea; felt warm; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th September 2020, 8 hrs after receiving Shingrix, the patient experienced injection site pain, headache, nausea, feeling of warmth and fever. On 26th September 2020, the outcome of the injection site pain, headache, nausea, feeling of warmth and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, nausea, feeling of warmth and fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by consumer herself. The patient received Shingrix in her left deltoid and reported various reactions.  Eight hours later consumer reported the injection was really achy, then developed a headache, mild nausea, felt warm, and then went to bed due to symptoms.  Consumer reported all symptoms resolved within 24 hours.  Consumer was concerned due to not feeling robust and awful side effects as experienced with 1st dose of Shingrix.  The reporter consented to follow up. The case had been linked with US2020AMR239281 2nd dose of patient, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR239281:same reporter, Same Patient
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pharyngitis, Throat tightness
Clinical narrative: Pharyngitis; Sore throat; Sensation that his throat was closing up; This case was reported by a consumer and described the occurrence of pharyngitis in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2020, the patient received the 1st dose of Shingrix. On 9th October 2020, 5 days after receiving Shingrix, the patient experienced pharyngitis, sore throat and throat constriction. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the pharyngitis and sore throat were unknown and the outcome of the throat constriction was recovered/resolved.   It was unknown if the reporter considered the pharyngitis, sore throat and throat constriction to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's daughter. The patient received 1st dose of Shingrix and had a sensation that his throat was closing up. The patient went to the emergency department and was diagnosed with a sore throat and pharyngitis, was given steroids, and discharged. The reporter stated that emergency Room visit required. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received the Moderna vaccine; A spontaneous report was received from a consumer concerning a 17-years old, female patient who was received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced product administered to patient of inappropriate age.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, product administered to patient of inappropriate age, was considered resolved.; Reporter's Comments: This case concerns a 17 year old, female patient, who received  the first dose of the mRNA-1273 on an unknown date. The patient's medical history is not provided.  This report refers to a case of medication error where mRNA-1273 has been administered to the patient of inappropriate age.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a 17 year old; A spontaneous report was received from a health care professional concerning a 17-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine administered to a 17-year-old.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20E) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the 17-year-old patient was vaccinated. The patient was 10 days away from turning 18. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine administered to a 17-year-old, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 17 year old femaile subject with who experienced a non serious unexpected event inappropriate age at vaccine administration. There were no reported AEs associated with this event of inappropriate age at vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Product administered at inappropriate site
Clinical narrative: Received vaccine in leg; Injection site bled a little when receiving the injection; A spontaneous report was received from a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced it bled a little when receiving the injection and vaccine was given on the leg.  The patient's medical history included history of breast cancer. No concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) injection unknown route for prophylaxis of COVID-19 infection. While receiving the vaccine, the patient experienced it bled a little when receiving the injection and vaccine was given on the leg. The reporter stated that the vaccine was administered on her leg as she could not receive it on her arm due to her history with breast cancer. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The events, it bled a little when receiving the injection and vaccine was given on the leg, was considered resolved.; Reporter's Comments: This report refers to a case of product administered at inappropriate site (vaccine was given on the leg (unknown route)) for mRNA-1273 and concerns a female patient (unknown age) with history of breast cancer, who experienced the event of injection site hemorrhage. The event occurred at an unknown time after the first and only dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event of injection site hemorrhage is assessed as possibly related.  In addition, the patient did not provide contact information for follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administration error
Clinical narrative: Vaccinator poked her very hard (she felt like it hit the bone); Arm  was very sore; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced product administration error and pain in extremity.  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 on 06 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection.   The health care provided called to report she had received the Moderna vaccine on 06 Jan 2021 and the vaccinator poked her very hard (she felt like it hit bone). She feels that the injection was improperly administered. Her arm was very sore after.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, product administration error, was considered resolved on 06 Jan 2021. The out come of the event, pain in arm, is considered unknown.; Reporter's Comments: This case concerns a female patient, who, experienced a non-serious unexpected events of product administration error and a non-serious expected event of pain in extremity. There was no AEs associated with product administration error. However, the event of pain in extremity occurred the same day after mRNA-1273 (Lot# unknown) administration. 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Syringe cracked and administered 0.4 mL dose; Syringe cracked and administered 0.4 mL dose; A spontaneous report was received from pharmacist concerning a 57 year-old, male patient who received Moderna's COVID-19 vaccine and experienced an event where the syringe cracked and administered 0.4 milliliter of dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, while the patient was being administered the vaccine, the syringe cracked and only 0.4 milliliters of the dose was given. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, syringe cracked and administered 0.4 milliliter, was considered resolved.; Reporter's Comments: This report refers to a case of 57 year-old, male patient who received Moderna's COVID-19 vaccine  mRNA-1273 (Lot number: 025J20-2A) expiration date unknown, who while  being administered the vaccine, the syringe cracked and only 0.4 milliliters of the dose was given. There were no reported AEs associated with this case of  the patient was being administered the vaccine, the syringe cracked and only 0.4 milliliters of the dose was given.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect route of product administration
Clinical narrative: Serum ejected out from syringe bottom, don't know how much was injected; Pt over 65 yrs. intradermal; A spontaneous report was received from a physician concerning 65-year-old male consumer, who received Moderna's COVID-19 vaccine and the serum ejected out from syringe bottom. The patient was also administered the vaccine intradermally.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On a date that was not reported, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 0112L20A) intradermally for prophylaxis of COVID-19 infection.     During, preparation of the of mRNA-1273 vaccine some of the serum ejected out from syringe bottom. The amount of serum lost is unknown, that same syringe was used to vaccinate the patient. The healthcare professional is unsure how much vaccine was injected. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, serum ejected out from syringe bottom and administered the vaccine intradermally, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and incorrect route of product administration (Intradermal) for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to 17 year old patient; A spontaneous report was received from a healthcare facility staff member concerning a 17-years old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced product administered to patient of inappropriate age.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, product administered to patient of inappropriate age, was considered resolved.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient administered 1 ml of the vaccine; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced incorrect dose administered.  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 (Lot number 011L20A) on for prophylaxis of COVID-19 infection.   A healthcare provider called stating that 1 mL of the vaccine was administered to a patient as the patient's first dose instead of the 0.5 mL. The healthcare provider did not know which arm the vaccine was administered.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, incorrect dose administered, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vial was thawed from frozen in about 5 mins; A spontaneous report was received from a health care professional who was a 22-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vial was thawed from frozen in about five minutes.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 24 Dec 2020, during vaccine administration, the patient noticed that the vaccinator would thaw the frozen vial using their hands and periodically checking to see if it had thawed. The patient printed out the vaccine instructions and noticed the vaccinator had not followed the thawing process. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vial was thawed from frozen in about five minutes, was considered resolved on 24 Dec 2020.; Reporter's Comments: This report refers to a case of Product preparation error for mRNA-1273, lot # 026L20A, in which a 22 year old female received vaccine that was thawed in vaccinators hands over five minute time period.  There were no reported AEs associated with this case of Product preparation error.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product leakage
Clinical narrative: Vaccine leaked down the patient's arm, received only 3/4 of the dose; Vaccine leaked down the patient's arm, received only 3/4 of the dose; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced incorrect dose administered.  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 on 06 Jan 2021 in the deltoid intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, a pharmacist called to report a nurse administered the Moderna Covid-19 vaccine to a male patient today. The male patient received the first dose of the vaccine today in the deltoid muscle of unknown arm and the vaccine leaked down the patient's arm. The nurse that administered the vaccine thinks that the patient might have received only 3/4 of the dose.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, incorrect dose administered, was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of male patient who experienced vaccine leaked down the patient's arm, received only 3/4 of the dose (incomplete dose administered) for mRNA-1273, lot # and expiration date unknown. There were no reported AEs associated with this case of vaccine leaked down the patient's arm, received only 3/4 of the dose.
Sex: U
Vaccine: COVID19
Symptoms: Device use issue, Incorrect dose administered
Clinical narrative: Likely gave a patient a partial dose, liquid was dripping out on the patients arm; the needle became disconnected and liquid was dripping out on the patient's arm; A spontaneous report was received from a health care professional concerning a patient (unknown age and gender) who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced partial dose given and device use issue.   The patient's medical history was not provided.  Concomitant medication were not provided.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   On an unknown date, during administration, the needle became disconnected from the syringe and liquid was dripping out on the patient's arm. It was reported that the patient likely received a partial dose. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event is considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and device use issue for mRNA-1273 (lot # unknown). There were no reported AEs associated with this case of incorrect dose administered and device use issue.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site haemorrhage
Clinical narrative: Vaccinator hit a vein instead of the muscle; Blood shot out at the injection site; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood shooting out at the injection site and vaccinator hit a vein instead of the muscle.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient was administered the vaccine and immediately after, blood shot out onto the patient's leg. The reporter assumed the vaccinator hit a vein instead of a muscle. No treatment information was provided.  The events, blood shot out at the injection site and vaccinator hit a vein instead of the muscle, were considered resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 and concerns a patient (age and gender unknown), who experienced the event of injection site hemorrhage. The event occurred the same day after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and the event was likely due to incorrect route of administration, the event is assessed as unlikely related to mRNA-1273 vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine Administered from A Punctured Vial Beyond the 6 Hour limit; A spontaneous report was received from a pharmacist concerning a 36 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced vaccine administered from a punctured vial beyond the 6 hour limit.   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  on 31 Dec 2020 for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient received the Moderna COVID-19 vaccine in the unknown arm on 31 Dec 2020 from a vial that was used beyond the 6 hour limit. The vial was first punctured on 30 Dec 2020.   Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, experienced vaccine administered from a punctured vial beyond the 6 hour limit, was considered resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of a 36-year old female consumer who received Moderna's COVID 19 and experienced vaccine administered from a punctured vial beyond the 6-hour limit. The vaccine lot number and the consumer's medical history were not provided.  There were no reported AEs associated with this case of female consumer who received Moderna's COVID-19 vaccine and experienced vaccine administered from a punctured vial beyond the 6-hour limit.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administered Punctured Vial Beyond 6 hours; A spontaneous report was received from a pharmacist concerning a 60 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced administration from a punctured vial beyond 6 hours.  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 on 31 Dec 2020 for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient received the Moderna COVID-19 vaccine in the unknown arm on 31 Dec 2020 from a vial that was used beyond the 6 hour limit. The vial was first punctured on 30 Dec 2020.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, experienced administered punctured vial beyond 6 hours, was considered resolved on 31 Dec 2020.  The reporter did not provide an assessment of the event, out of specification product use.; Reporter's Comments: This case concerns a 60 year old female subject who experienced a nonserious unexpected event of out of specification product use.  There were no reported AEs associated with this case of out of specification product use.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vial was shaken vigorously before she received the vaccine; A spontaneous report was received from a consumer who was a female patient who was received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced out of specification product use.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   Prior to the administration of the vaccine, the vial was vigorously shaken.  The patient received their first of two planned doses of mRNA-1273 on 07 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection. Because the dose was administered from the vial that had been vigorously shaken, the patient experienced out of specification product use.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event, product preparation error, was not provided.   The event, out of specification product use, was considered recovered/resolved on 07 Jan 2021.; Reporter's Comments: This report refers to a case of Out of specification product use for mRNA-1273. There were no reported AEs associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A male patient under the age of 18 was administered Moderna's COVID-19 vaccination; A spontaneous report  was received from a nurse concerning a male patient under the age of 18 who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, a male patient under the age of 18 was administered Moderna's COVID-19 vaccination.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 7 Jan 2021, the nurse reported the Moderna COVID vaccine was given to a patient under the age of 18. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, a male patient under the age of 18 was administered Moderna's COVID-19 vaccination, was considered resolved on 4 Jan 2021.; Reporter's Comments: This case concerns a male subject under the age of 18 who experienced a non-serious unexpected event of Inappropriate age at vaccine administration.  There were no reported AEs associated with this case of Inappropriate age at vaccine administration.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Liquid was running down the subject's arm while they were injecting the vaccine; A spontaneous report was received from a nurse concerning a 49-year-old, female patient who received Moderna's COVID-19 Vaccine, and liquid was running down the patient's arm while they were injecting the vaccine.   The patient's medical history was not provided. Concomitant medications were not provided.   The patient received their first of two planned doses of mRNA-1273 (Batch number 039K20A) on 07 Jan 2021 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On an unknown date, liquid was running down the patient's arm while the vaccine was being injected.  The nurse was unsure why this had occurred.  Treatment information was not provided.   Action taken with the drug in response to the event was not applicable.   The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # 039K20A). There were no reported AEs associated with this case of incorrect dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Person under the age of 18 was administered the vaccine; A spontaneous report was received from a nurse concerning a pediatric patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, person under the age of 18 was administered the vaccine.  The patient's medical history was not provided. Concomitant medications were not reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, a patient under the age of 18 was administered the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event,  person under the age of 18 was administered the vaccine, was considered resolved.; Reporter's Comments: This case concerns a patient  under the age of 18 years and of unknown gender.  The patient's medical history is not provided.  The event occurred on an unknown date, where the patient was administered the first dose of the mRNA-1273. This report refers to a case of medication error where mRNA-1273 has been administered to the patient of inappropriate age.
Sex: U
Vaccine: COVID19
Symptoms: Device malfunction, Incorrect dose administered
Clinical narrative: Patient received some of the vaccine but not the entire 0.5 ml dose; Vanish point needle sent in the ancillary box malfunctioned; A spontaneous report  was received from a nurse practitioner concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vanish point needle sent in the ancillary box malfunctioned and the patient received some of the vaccine but not the entire 0.5ml dose.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, during vaccine administration, the vanish point needle sent in the ancillary box malfunctioned and retracted too soon. The patient received some of the vaccine but not the entire 0.5ml dose.  Action taken with mRNA-1273 in response to the events was unknown.  The events, vanish point needle sent in the ancillary box malfunctioned and the patient received some of the vaccine but not the entire 0.5ml dose, were considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and device malfunction for mRNA-1273 (lot # unknown). There were no reported AEs associated with this case of incorrect dose administered and device malfunction.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age
Clinical narrative: Immunized at age 12; Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from a physician concerning an 12-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, immunized at age 12 and administered vials that were exposed to room temperature for more than 12 hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient received a vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours. It was originally thought that the freezer which stored the mRNA-1273 vaccine died on 04 Jan 2021 at 2am, so vaccine administration occurred up until 2pm. After checking freezer temperature logs, it was discovered the freezer had died at 1:11am. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, immunized at age 12 and administered vials that were exposed to room temperature for more than 12 hours, were considered resolved on 04 Jan 2021.; Reporter's Comments: Company comment: This report refers to a case of 12- year-old patient who was administered vaccine outside the lower age limit for Moderna's mRNA-1273 vaccine,  and received a vaccine dose that had been left at room temperature more than 12 hours (lot # unknown, Exp. unknown). There were no reported AEs associated with this case of vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine and  vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours.