chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia
Clinical narrative: 1st dose February 2, 2012 Pfizer lot# EL8982, 2nd dose February 20, 2021 Pfizer lot# EN6203 Symptoms: February 21, 2021 - 24 hours of mild diarrhea, chills, muscle aches, no fever All symptoms gone by February 22, 2021
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Injection site pain, SARS-CoV-2 test positive
Clinical narrative: sore arm at injection site only after 24 hours of the injection. Lasted a few days only.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: After my second dose vaccine, I woke up with body aches, headaches, chills, fever, I felt like I had the flu.  I took my temperature it was 101.6F. The following day, my fever was 102.6F and still felt fatigued, joint aches, chills, severe headaches and could not read a book due to the headaches. Throughout the day, still had the fever and it was 100.7F and I had tons of fatigue, sweating with severe headaches, body aches, I had these symptoms for a total of 10 days. The following Monday 02-01-2021, I did a Covid-19 test which was negative and I resumed back to work on 02-03-2021.     For my 1st vaccine dose which I received 12-29-2020 my symptoms were not as bad as the second dose and I experienced fatigue, headaches and one week later I was diagnosed with shingles and a rash.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: After my second dose vaccine, I woke up with body aches, headaches, chills, fever, I felt like I had the flu.  I took my temperature it was 101.6F. The following day, my fever was 102.6F and still felt fatigued, joint aches, chills, severe headaches and could not read a book due to the headaches. Throughout the day, still had the fever and it was 100.7F and I had tons of fatigue, sweating with severe headaches, body aches, I had these symptoms for a total of 10 days. The following Monday 02-01-2021, I did a Covid-19 test which was negative and I resumed back to work on 02-03-2021.     For my 1st vaccine dose which I received 12-29-2020 my symptoms were not as bad as the second dose and I experienced fatigue, headaches and one week later I was diagnosed with shingles and a rash.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Confusional state
Clinical narrative: Imbalance and confusion
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Palpitations, Pyrexia
Clinical narrative: rapid heart rate exhaustion fever
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Injection site warmth
Clinical narrative: On Saturday morning I woke up with a headache and swollen lymph nodes in my neck/collarbone area. As the day progressed, I began to have pain in my joints and muscles. I felt very tired all day as well. I also experienced skin sensitivity which basically just made my skin hurt if anything/one touched me. Sunday my headache persisted, still had pain at injection site and felt warm to the touch. Swollen lymph nodes also still there and fatigue. Monday morning symptoms of headache, injection site pain and warmth and swollen lymph nodes still felt.  Taking Tylenol to help with headache, warm compresses to help swollen lymph nodes and ice pack for injection site pain.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pain of skin, Skin sensitisation
Clinical narrative: On Saturday morning I woke up with a headache and swollen lymph nodes in my neck/collarbone area. As the day progressed, I began to have pain in my joints and muscles. I felt very tired all day as well. I also experienced skin sensitivity which basically just made my skin hurt if anything/one touched me. Sunday my headache persisted, still had pain at injection site and felt warm to the touch. Swollen lymph nodes also still there and fatigue. Monday morning symptoms of headache, injection site pain and warmth and swollen lymph nodes still felt.  Taking Tylenol to help with headache, warm compresses to help swollen lymph nodes and ice pack for injection site pain.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called and complained that on day 7 after reciving the vaccine, she experienced a tennis ball size itchy red spot at the vaccine site. She said that it is still persistent at day 8.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site induration, Injection site inflammation, Pain
Clinical narrative: Chills, fever, body aches, and headache for approximately 24 hours. Site of injection had a hard knot and inflamed for days
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, fever, body aches, and headache for approximately 24 hours. Site of injection had a hard knot and inflamed for days
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: right sided bells palsy for 2 days
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient received his 2nd dose of Moderna Covid-19 vaccine, and approximately 5-10 minutes after receiving, while in the observation area, he lost conciousness while sitting up on the bench.  Epi- Pen was administered and EMS arrived within 5 minutes, and transported him to the Clinic.   At the time of EMS arrival, the patient was conscious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Fatigue, Headache, Injection site erythema
Clinical narrative: Headache, Redness in the injection site, fever, chest pain, Tachycardia, weakness, fatigue, muscle pain
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tachycardia
Clinical narrative: Headache, Redness in the injection site, fever, chest pain, Tachycardia, weakness, fatigue, muscle pain
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Headache, Body aches, Chills, Fatigue
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 2/1/21 first , 2/18/21 second first   2/1/21   , fever started 2/19/21 am  103 temp. earlier,      102.7 temp. now ( has taken no meds so far)  Advised to take apap or ibuprofen to keep temp < 101
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Nasal congestion, Nausea
Clinical narrative: Difficulty breathing as a result of swelling back of nose, diarreha, nausea,
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Endotracheal intubation, Gastrointestinal tube insertion, Hypotension, Hypoxia
Clinical narrative: Patient experienced an episode of emesis and loss of consciousness several hours after vaccine on 2/16/21.  He was taken by EMS to the hospital and was noted to be hypoxic and hypotensive.  He was admitted to the hospital and subsequently intubated.  He was also found to have a small bowel obstruction and a nasogastric tube was placed to decompress the bowel.  He required pressor support as well.  He expired on 2/17/21.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Small intestinal obstruction, Vomiting
Clinical narrative: Patient experienced an episode of emesis and loss of consciousness several hours after vaccine on 2/16/21.  He was taken by EMS to the hospital and was noted to be hypoxic and hypotensive.  He was admitted to the hospital and subsequently intubated.  He was also found to have a small bowel obstruction and a nasogastric tube was placed to decompress the bowel.  He required pressor support as well.  He expired on 2/17/21.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Lacrimation increased
Clinical narrative: On Sunday the 2/21/2021, about 3PM I noticed that the area where I received the vaccination  was red, swollen, itching, and sore. I googled search and found it was a rare but real reaction vaccine, called COVID ARM. According to the information I read it occurs between 7-9 days after vaccination. Mine occurred exactly 7 days later. I have been putting Hydrocortisone cream with Aloe in it and on it. Today it is more sore then itching and still red. The Hydrocortisone with Aloe seemed to help.   I have also noticed my eyes have been watering a lot more since receiving the vaccine.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: On Sunday the 2/21/2021, about 3PM I noticed that the area where I received the vaccination  was red, swollen, itching, and sore. I googled search and found it was a rare but real reaction vaccine, called COVID ARM. According to the information I read it occurs between 7-9 days after vaccination. Mine occurred exactly 7 days later. I have been putting Hydrocortisone cream with Aloe in it and on it. Today it is more sore then itching and still red. The Hydrocortisone with Aloe seemed to help.   I have also noticed my eyes have been watering a lot more since receiving the vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy, Pyrexia, Uterine spasm, Vaginal haemorrhage
Clinical narrative: fever, diarrhea, lethargic x 12 hrs , vaginal spotting and pelvic cramping x 2 weeks
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Chills, Headache, Pyrexia
Clinical narrative: Body aches, chills, fever, headache
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Pyrexia
Clinical narrative: Severe chills, 100.9 temp, elevated heartrate (88 bpm) began around 9 PM, lasted 2 1/2 hours.  Used heated blankets to help convulsive chills .  Took one Extra Strength Tylenol.  Fever gradually lessened, returning to normal 48 hours after the injection.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Headache, Muscular weakness
Clinical narrative: Developed excruciating pain in back, unable to take deep breaths, severe headache, and legs weak. Instructed to report to ER or Urgent care.  She went to an ER, but did not stay due to long wait.  Symptoms subsided on their own.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Received vaccine 2/17/21. On 2/20/21 began to have sever L foot pain that continues on day reported (2/24/21).
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site rash
Clinical narrative: an allergy; rash around the area where it was given; This case was reported by a consumer via interactive digital media and described the occurrence of allergy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced allergy and injection site rash. On an unknown date, the outcome of the allergy was unknown and the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the allergy and injection site rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient experienced a rash around the area where the Shingrix was given, which lasted about a week. The physician stated that it was an allergy. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced in February 2020). Concurrent medical conditions included colorectal cancer (survivor missing 36 lymph missing). Concomitant products included valaciclovir hydrochloride (Valtrex) and gabapentin.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the spouse of the patient. The age at vaccination was not reported, however could be 58 or 59 years. The patient experienced shingles in February 2020, after healing, the patient took his 1st Shingrix vaccine. Valtrex was used as a treatment for shingles. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2021018356.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021018356:Same patient 2nd dose
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vertigo
Clinical narrative: Vertigo; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of tinnitus (1st dose received on 29th October 2020 experienced ringing in ear and hearing loss refer case US2021021183). Concomitant products included fluticasone propionate (Flonase), methylprednisolone (Medrol) and sulfamethoxazole + trimethoprim (Bactrim Ds).   On 27th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced vertigo and pain in arm. On an unknown date, the outcome of the vertigo and pain in arm were recovered/resolved.   It was unknown if the reporter considered the vertigo and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient had vertigo and arm soreness after 2nd vaccination with Shingrix. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021021183:Same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: itching at the injection site; lumps on her left arm / lumps at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site itching and injection site lump. On an unknown date, the outcome of the injection site itching and injection site lump were recovered/resolved.   It was unknown if the reporter considered the injection site itching and injection site lump to be related to Shingrix.  Additional details were provided as follows:  The patient reported for herself. The patient had lumps and itching at the injection site (left arm). The events lasted for 3 months. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose, Wrong technique in device usage process
Clinical narrative: Injected with a long needle that hit her bone; Most of the content of the syringe spilled out; Most of the content of the syringe spilled out; A spontaneous report was received from a consumer concerning a female patient of unknown age. The patient had her second dose of the vaccine and she was injected with a long needle that hit her bone and while the nurse who was administrating the vaccine tried to pull out the syringe, most of the content of the syringe spilled out.  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 not provided) on an unknown date.  The patient received their second of two planned doses of mRNA-1273 (batch number not provided) in the for prophylaxis of COVID-19 infection.    The agent said the patient had her second dose of the vaccine and she was injected with a long needle that hit her bone and while the nurse who was administrating the vaccine tried to pull out the syringe , most of the content of the syringe spilled out. She is not sure if she needs to get another short or not.  Treatment information was not unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided.   The outcome of the events was unknown.; Reporter's Comments: This report refers to a case of wrong technique in device usage process, underdose, and device connection issue for mRNA-1273 (lot# unknown) with no associated AEs reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; A spontaneous report was received on 09 FEB 2021 from a consumer concerning an 81-year-old, male patient who received Moderna's COVID-19 vaccine and experienced stroke.  The patient's medical history provided were, Alzheimer and Parkinson's disease. No relevant concomitant medications were reported. On 28 JAN 2021, patient received their first of two planned doses of mRNA-1273(Batch number 027L20A) injection for the prophylaxis of COVID-19 infection.  On 03 FEB 2021, within 7 days of receiving vaccine, patient experienced a stroke. On 03 FEB 2021, patient was admitted to hospital. Patient was due for his second shot of Moderna's COVID-19 vaccine on 26 Feb 2021. Patient's hospital can only provide Pfizer's vaccine and not Moderna's COVID-19 vaccine. But patient wanted to get Moderna's COVID-19 vaccine. Patient's wife wanted to know the way she could arrange the administration of the Moderna's COVID-19 vaccine in the hospital for her husband. Treatment for the event was not provided.   Action taken the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, stroke, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's elderly age is considered a risk factor.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine administered to 17 year old; A spontaneous report was received from a nurse concerning a 17-year- old male patient, resulted in the event of inappropriate age of dose of administration.  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: 012L20A) on 20 Jan 2021, in left arm for the prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient received vaccine who was under the age of 18 years old.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, resulted in the event of inappropriate age of dose of administration, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 012L20A) with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Vial dropped from 4 ft to the floor and doses were administered; A spontaneous report was received from a consumer concerning a patient  (no gender or age information provided) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: vial dropped from 4 feet to the floor and doses were administered.  The patient's medical history was not provided. Concomitant product use was not reported.  On 10 Feb 2021, prior to the onset of the event, the patient was administered a dose (unknown if dose 1 or dose 2) of mRNA-1273 (Lot #: unknown, arm/location unknown) for prophylaxis of COVID-19 infection.  On 10 Feb 2021, at the facility where the reporter was volunteering, an unpunctured vial was dropped from approximately 4 feet to the floor but the vial did not break. The reporter argued with the doctor that the vial should not be used per his understanding that administration instructions say to "Swirl gently after thawing and between each withdrawal. Do not shake."  The reporter was concerned as the vial got shaken up instead of swirled when it was dropped from the 4 foot height.  The doctor still asked the nurse to use that vial.  No lot number or expiration date was available. There was no product available to retrieve as that vial was administered that day.  Action taken with mRNA-1273 in response to the event was unknown.  The event, vial dropped from 4 feet to the floor and doses were administered, was considered resolved.; Reporter's Comments: This report refers to a case of Product preparation issue for mRNA-1273 (lot # unknown) with no associated adverse events. The vial was dropped from 4 feet to the floor and doses were administered. Event occurred the same day as vaccine administration. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16-year-old received the first dose of Moderna Covid-19 by accident; A spontaneous report was received from a consumer concerning a 16-year-old, male patient who received the first dose of Moderna COVID-19 vaccine (mRNA-1273) by accident/MedDRA PT: Product administered to patient of inappropriate age.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient received first dose of Moderna COVID-19 vaccine by accident.   Action taken mRNA-1273 in response to the event was unknown. However, it was reported the patient was taken to receive the second dose of Moderna COVID-19 vaccine but was denied to him because he was a minor  The event, 16-year-old received the first dose of Moderna Covid-19 by accident, was resolved on 13 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (Lot # 013L20A) with no associated AEs.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: dose to a 16 year old; A spontaneous report was received from a healthcare professional (HCP) concerning a 16-year-old, male consumer who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, a 16-year-old patient was administered the first dose of the Moderna vaccine.  No other information was received. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was unknown.  The event, vaccine given to a patient less than 18-years-old, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number 013L20A) with no associated AEs reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: underage son received Covid vaccine; A spontaneous report was received from the mother of a 17 year old male patient.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 02 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  The patient was 17 tears old (underage). No treatment information was provided.   Action taken with the mRNA-1273 was not reported.  The outcome of the event, product administered to patient of inappropriate age, was considered resolved on 02 Jan 2021.; Reporter's Comments: This case concerns a 17 year old male who received their first of two planned doses of mRNA-1273 (Lot number: unknown intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Some of the vaccine leaked down her right arm; A spontaneous report was received from a consumer concerning a 66-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine leaked down her right arm.  The patient's medical history was not provided. Concomitant product use was not provided.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) for prophylaxis of COVID-19 infection.    On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 309K20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection and the vaccine leaked down her right arm.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event vaccine leaked down her right arm was considered resolved.; Reporter's Comments: This case report concerns a non-serious unexpected event of a 66-year-old female patient who experienced vaccine leaked down her right arm (Incomplete dose administered) for mRNA-1273, lot # 309K20A. There were no reported AEs associated with this case of incomplete dose administered
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: A patient had the vaccine running down her arm after administration; most of that vaccine came pouring down arm; A spontaneous report was received from a pharmacist, concerning a 28-year-old, female patient, who received Moderna's COVID-19 vaccine and a patient had the vaccine running down her arm after administration/ underdose.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On an unknown date, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis.  On an unknown date, the pharmacist reported that a patient was administered the vaccine and most of the vaccine came pouring down her arm. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, a patient had the vaccine running down her arm after administration was considered as resolved on 11-Feb-2021.; Reporter's Comments: This report refers to a case of underdose and exposure via skin contact with no associated AEs reported.
Sex: M
Vaccine: COVID19
Symptoms: Product monitoring error
Clinical narrative: I'm on a blood thinner; A spontaneous report was received from an eighty two-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and during vaccination he forgot to disclose that he was on blood thinner Eliquis.  The patient's medical history was not provided.   The patient received their first of two planned doses of mRNA-1273 (BATCH # 031M20A) on 10 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient stated I got my first dose of the Moderna vaccine today (10 Feb 2021). I forgot to tell them I'm on blood thinner. No further information was reported.  Treatment, action taken with RNA-1273 in response to the event  and the outcome of the event were was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: the injection was administered subcutaneously instead of intramuscularly; A spontaneous report  was received from a health care professional, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and nurse is concerned that the injection was administered subcutaneously instead of intramuscularly.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that the injection was administered subcutaneously instead of intramuscularly. The reporter wanted to know if administered subcutaneously, should a third dose be given due to insufficient protection.  Action taken with study drug was not applicable as the subject had already received both scheduled doses  The outcome of the event, nurse is concerned that the injection was administered subcutaneously instead of intramuscularly was resolved.; Reporter's Comments: This is a case of incorrect route of administration of the second dose of two planned doses of mRNA-1273 (lot # unknown) with no reported adverse events.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First moderna shot on 1/12 and due for his second shot, turned away due to being 17 years; A spontaneous report was received from a consumer (patient's mother), regarding a 17 years-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), which resulted in, first Moderna shot on 1/12 and due for his second shot, turned away due to being 17 years (product administered to patient of inappropriate age).  The patient's medical history was not reported. No concomitant medications were reported.  On 12 JAN 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  The consumer reported that the patient was given his first Moderna shot on 12 JAN 2021. On 10 FEB 2021, the patient was due for his second shot and turned away due to patient being 17 years. The consumer contacted their primary care physician and trying to find out a way to get the patient his second shot, so the first one does not go waste. The consumer would like to enroll the patient in the trial for the second shot. No treatment medication information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, first Moderna shot on 1/12 and due for his second shot, turned away due to being 17 years, was recovered on 12 JAN 2021.; Reporter's Comments: This case concerns a 17 year old male who received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: <18 years old received the 1st dose of the moderna covid-19 vaccine; A spontaneous report was received from a healthcare professional concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No concomitant medications were reported.  On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-20A) intramuscularly for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the reporter stated that after a vaccination drive thru they had a surplus vaccine of the vaccination site so they called in people to vaccinate. A family (mother, father and son) were vaccinated but the son was below 18 years of age and this wasn't confirmed before vaccination so he received the 1st dose of the Moderna covid-19 vaccine on 09 Jan 2021. No adverse events reported and no treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The event, <18 years old received the 1st dose of the moderna covid-19 vaccine, was considered resolved on 09 Jan 2021.; Reporter's Comments: This case concerns a 17 year old male who received fist dose of mRNA-1273 (Lot number: 025J20-20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of  product administered to patient of inappropriate age.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: immunizer by mistake instead of giving 1 shot of Moderna ended up giving 2 shots to the patient; A spontaneous report was received from a pharmacist concerning an unknown patient, of unknown age, who was administered Moderna's COVID-19 vaccine and reported that the immunizer by mistake instead of giving one shot of Moderna ended up giving two shot to the patient/extra dose administered.  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 (Lot number: unknown) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.   The reporter mentioned the immunizer by mistake instead of giving one shot of Moderna ended up giving two shot to the patient on an unknown date. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not applicable.  The outcome of event, the immunizer by mistake instead of giving one shot of Moderna ended up giving two shot to the patient was considered as resolved.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to pediatric patient (under 18); A spontaneous report was received from a nurse, concerning a 17 year old female patient who was administered Moderna's COVID-19 vaccine and was to receive second dose of Moderna Covid vaccine (product administered to patient of inappropriate age).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19-JAN-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   The patient went to the administering site to receive second dose of Moderna Covid vaccine. She was a pediatric patient.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, administered vaccine to pediatric patient (under 18)  was considered as resolved on 19-JAN-2021.; Reporter's Comments: This case concerns a 17 year old female who received fist dose of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of  product administered to patient of inappropriate age
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: pharmacist administered second vaccine on day 18; A spontaneous report was received from a pharmacist, concerning a 19-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the pharmacist administered second vaccine on day 18 (PT: Inappropriate schedule of product administration).  The patient's medical history was not provided. Concomitant medications included erythromycin, promethazine, dextromethorphan.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   On 15 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 031L20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   On 16 Feb 2021, pharmacist reported that the patient received second dose of vaccination on day 18, after his first dose.   Action taken with mRNA-1273 was not applicable.  The outcome of the event pharmacist administered second vaccine on day 18 was resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273 (lot number 031l20A) with no associated AEs reported.
Age: 4.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: female patient received ADACEL instead of DAPTACEL/ NO AE; four year patient received ADACEL vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00459383).  This case involves a 4-years-old female patient who received 0.5 mL DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (frequency: once, batch number: C5609AA, expiry date: 04-Apr-2021 via an intramuscular route in right thigh) who was intended for scheduled fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong vaccine administered and product administered to patient of inappropriate age) on 03-Feb-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  No adverse effects reported.   Staff reports that physician requesting information who was at a different clinic on that and requested for contact. Discussed use in children less than 10 years-old.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the DAPTACEL batch number for this case.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: I had headache and nausea for the rest of the day that I got the vaccine. After that I was fine.  As a result I didn't feel like doing anything but laying down. Also as expected, I had pain at the injection site.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash started  on 2/16/2021. T7, T8 right side from midline back to midline anterior torso. Treated with Valtrex 1 grm TID
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No reaction on previous exposure to drug, Paraesthesia
Clinical narrative: Patient received 2nd Moderna dose during vaccination clinic, which is her employer.  She previously received her 1st Moderna dose, with no adverse reactions reported to Pharmacy, on 1/15/2021.   On Monday, 2/22/21, patient reported to her school nurse, located at SSchool, that she developed a "tingling sensation from the bend of the arm down to the top of the hand."  She reports this began on 2/12/21, the day she received the vaccine, and states it "has not gotten better nor worse" since.  The school nurse, may be reached at mobile phone number.  Both nurse and Executive Secretary to the Superintendent Schools, advised patient to see her primary care provider as soon as possible.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Covid Arm . 8-10 inch light red, itchy rash extending equally up and down arm from injection site.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: nausea/vomiting; tiredness
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Amnesia, Balance disorder, Cognitive disorder, Developmental regression, Eye movement disorder
Clinical narrative: About a week after the injection, my son began to lose cognitive ability.  We had been reading chapter books, like Charlie and the Chocolate Factory before the vaccine, about a week after the vaccine, he was no longer able to remember the names of the characters or follow the plot.  We'd been reading books like James and the Giant Peach, Winnie the Pooh, the Jungle Book, for over 6 months and discussing them at length.  He lost this ability.  We went back to reading picture books that he'd loved 2 years before.   About 2 weeks after the vaccine, around christmas, he started losing his balance.  He was falling multiple times a day.  He fell down a few half-flights of stairs. In early Jan. 2019, I took him to the ER because he said "There was a flash of light and I lost my thinking." and he fell down an entire flight of stairs.  I took him to his pediatrician for a follow up and to try to find out if he might be having seizures.    Both the pediatrician and I noticed an eye-roll tic that showed up about the same time. I felt that this was related to the falls and what I believe is seizure activity.  His sleep is different around the times that he has these falls, and his language is different- he regresses.  I was referred to a neurologist, and we followed up with a 24-hour EEG in 10/19. He did not have any seizures while in the hospital, he does have BECTS brainwaves.    We have no way of treating any of this, as seizure disorders can only be diagnosed if a seizure is actually seen.  His cognitive decline stopped after about 2 months, and by the end of Feb. 2019, he was again learning and moving forward.  He was able to start reading books like Charlie and the Chocolate factory in fall of 2019-- a year later.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Fall, Language disorder, Photopsia, Seizure like phenomena, Sleep disorder
Clinical narrative: About a week after the injection, my son began to lose cognitive ability.  We had been reading chapter books, like Charlie and the Chocolate Factory before the vaccine, about a week after the vaccine, he was no longer able to remember the names of the characters or follow the plot.  We'd been reading books like James and the Giant Peach, Winnie the Pooh, the Jungle Book, for over 6 months and discussing them at length.  He lost this ability.  We went back to reading picture books that he'd loved 2 years before.   About 2 weeks after the vaccine, around christmas, he started losing his balance.  He was falling multiple times a day.  He fell down a few half-flights of stairs. In early Jan. 2019, I took him to the ER because he said "There was a flash of light and I lost my thinking." and he fell down an entire flight of stairs.  I took him to his pediatrician for a follow up and to try to find out if he might be having seizures.    Both the pediatrician and I noticed an eye-roll tic that showed up about the same time. I felt that this was related to the falls and what I believe is seizure activity.  His sleep is different around the times that he has these falls, and his language is different- he regresses.  I was referred to a neurologist, and we followed up with a 24-hour EEG in 10/19. He did not have any seizures while in the hospital, he does have BECTS brainwaves.    We have no way of treating any of this, as seizure disorders can only be diagnosed if a seizure is actually seen.  His cognitive decline stopped after about 2 months, and by the end of Feb. 2019, he was again learning and moving forward.  He was able to start reading books like Charlie and the Chocolate factory in fall of 2019-- a year later.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Thinking abnormal
Clinical narrative: About a week after the injection, my son began to lose cognitive ability.  We had been reading chapter books, like Charlie and the Chocolate Factory before the vaccine, about a week after the vaccine, he was no longer able to remember the names of the characters or follow the plot.  We'd been reading books like James and the Giant Peach, Winnie the Pooh, the Jungle Book, for over 6 months and discussing them at length.  He lost this ability.  We went back to reading picture books that he'd loved 2 years before.   About 2 weeks after the vaccine, around christmas, he started losing his balance.  He was falling multiple times a day.  He fell down a few half-flights of stairs. In early Jan. 2019, I took him to the ER because he said "There was a flash of light and I lost my thinking." and he fell down an entire flight of stairs.  I took him to his pediatrician for a follow up and to try to find out if he might be having seizures.    Both the pediatrician and I noticed an eye-roll tic that showed up about the same time. I felt that this was related to the falls and what I believe is seizure activity.  His sleep is different around the times that he has these falls, and his language is different- he regresses.  I was referred to a neurologist, and we followed up with a 24-hour EEG in 10/19. He did not have any seizures while in the hospital, he does have BECTS brainwaves.    We have no way of treating any of this, as seizure disorders can only be diagnosed if a seizure is actually seen.  His cognitive decline stopped after about 2 months, and by the end of Feb. 2019, he was again learning and moving forward.  He was able to start reading books like Charlie and the Chocolate factory in fall of 2019-- a year later.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fatigue, Pyrexia
Clinical narrative: 2-17-21 mid after noon started experiencing fever, cold sweats, fatigue. Took advil and states it helped. reports light headedness, advised that is not common and should get seen at an urgent care to r/o other potential causes.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased
Clinical narrative: Patient received 2 doses of COVID-19 vaccination in same arm on same day (several minutes apart). No symptoms reported, aside from anxiety-induced blood pressure elevation
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Extra dose administered, Incorrect dose administered by device
Clinical narrative: Patient received 2 doses of COVID-19 vaccination in same arm on same day (several minutes apart). No symptoms reported, aside from anxiety-induced blood pressure elevation
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Biliary colic, Chills, Fatigue, Vomiting
Clinical narrative: Symptoms occurred about a week after the first AND the second covid vaccination.   Lot number of first is EI9262 and of second (as above) EN6201.     In addition to expected fatigue and chills (I experienced no sore arm or fever)  I developed symptoms of gallbladder attack with extreme abdominal pain and vomiting.  These lasted for just over 2 days.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin reaction
Clinical narrative: Pt states the night after receiving the covid vax she had redness, pain and swelling at the injection site.  Pt stated that about 8 days later that she developed a rash surrounding the injection site and still has it.  Pt contacted her PCP and they told her she may have an allergic reaction to the covid vax but did not suggest taking any medication.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: sore arm  - started about 24 hrs later and lasted about 2 days severe headache - started about 24 hrs later and persists still chills and sweating - started about 36 hours later and persists still stomach ache and diarrhea  - started the 15th, worsened over days and still persists fever - although I felt like I had a fever i did not record a fever until the 21st-22nd--it was 100.2