chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: For 3 weeks / Large red patch / on her upper arm where the injection was given; Had a poor reaction' / stabbing stomach pain; Had a poor reaction'  / shins ached; Had a poor reaction'  / Fever; Had a poor reaction'  / racing heart/palpitations; Felt so bad / sat on the sofa with her front door unlocked / called her neighbors / in case she needed help; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 59EA2, expiry date August 2020) for prophylaxis.   Previously administered products included PNEUMOCOCCAL VACCINE with an associated reaction of nonspecific reaction (had reaction in 2018) and Shingrix with an associated reaction of pyrexia (received 1st dose on 19th April 2019, refer case US2021009441). Concurrent medical conditions included low blood pressure and drug allergy (Allergic to thimerosal, cilantro and codeine). Concomitant products included medication unknown (Bioidentical Hormones (Generic Ingredient Unknown)).   On 29th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema, stomach pain, leg pain, fever, heart racing and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, stomach pain, leg pain, fever, heart racing and feeling bad were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, stomach pain, leg pain, fever, heart racing and feeling bad to be related to Shingrix.  Additional details were reported as follows: The patient reported case for herself. The patient was healthy, had no kidney problems, no heart issues and exercises daily. The concomitant medication included thyroid medication. The patient got both Shingrix shots at the same pharmacy.   The patient received Shingrix and stated the expiration date listed was August 2020 which did not match the expiration date in our system. The patient had a poor reaction to the second shot symptoms included stabbing stomach pain, shins ached, fever, and racing heart palpitations and stated that lives alone and she felt so bad that she sat on the sofa with her front door unlocked in case she had to call 911. The patient called neighbors to let them know what was going on in case she needed help and said for 3 weeks she had a large red patch, about the size of a dessert plate, on her upper arm where the injection was given. All these events resolved and stated she did try to call to report her experience but we were closed for holiday Labor Day weekend. The reporter did not consent to follow up and did not want to share her physician contact information because the Shingrix injections were given at the pharmacy not the physician's office.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021009441:Same reporter, Same patient. 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Incorrect route of product administration, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Shingrix vaccine was inadvertently administered subcutaneously; area grew to softball size and had a 2-3cm induration; was burning hot and massive; area grew to softball size/massive; was burning hot and massive; This case was reported by a physician and described the occurrence of injection site induration in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included shingles (had a prior episode many years earlier). Previously administered products included Zostavax (dose received on an unknown date).   In October 2020, the patient received the 1st dose of Shingrix (subcutaneous) and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). In October 2020, unknown after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site induration, injection site burning, injection site swelling and feeling hot. On an unknown date, the outcome of the injection site induration, injection site burning, injection site swelling and feeling hot were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site induration, injection site burning, injection site swelling and feeling hot to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient had no history of allergies. The patient was inadvertently administered Shingrix vaccine via subcutaneous route, which led to intramuscular formulation administered by other route. The patient simultaneously received Influenza vaccine (Flu vaccine administered via intramuscular route in other arm). Less than 4 months after the vaccine, the patient experienced no pain when the vaccines was administered but area grew to softball size and had the 2 to 3 centimeter induration, was burning hot and massive, which lasted 2 weeks. The patient had local symptoms only, no systemic adverse effects. The patient willing decide to receive the 2nd dose. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: First dose made me really sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient had the first dose of Shingles vaccine and it made the patient really sick. For tolerance to the 2nd dose of Shingrix, refer case US2021AMR041513.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041513:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle pain; Fever; This case was reported by a physician via call center representative and described the occurrence of muscle pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain and fever. On an unknown date, the outcome of the muscle pain and fever were unknown.   It was unknown if the reporter considered the muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patients experienced usual muscle pain and fever. Physician did not have any additional information regarding the events or the patients (demographics).  Declined follow up. This case has been linked with US2021057184 and US2021AMR057595 by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR057595:Same reporter. Patient #2. US-GLAXOSMITHKLINE-US2021057184:Same reporter. Patient #1. US-GLAXOSMITHKLINE-US2021AMR057595:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Injection site pain, Pain, Pyrexia
Clinical narrative: Experiencing Chills; Experiencing / Fever; Experiencing / Body aches; Injection site pain; Discomfort; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever, general body pain, injection site pain and discomfort. On an unknown date, the outcome of the chills was not recovered/not resolved and the outcome of the fever, general body pain, injection site pain and discomfort were unknown.   It was unknown if the reporter considered the chills, fever, general body pain, injection site pain and discomfort to be related to Shingrix.  Additional details provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received 2nd dose on an unknown date and experienced chills, fever, body aches and injection site pain. The patient asked any treatment for his discomfort.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction to both shingrix and moderna; This case was reported by a other health professional via interactive digital media and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included MRNA 1273 VACCINE (MODERNA (MRNA RIBONUCLEIC ACID VACCINE)) for prophylaxis.   On an unknown date, the patient received Shingrix and MODERNA (MRNA RIBONUCLEIC ACID VACCINE). On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   The reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter need to tell the patient why the patient had allergic reaction to both Shingrix and moderna vaccine.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site nodule, Injection site warmth, Myalgia
Clinical narrative: Red Knot appear at the injection site; Red Knot appear at the injection site / Redness and Heat have decreased; had a big Hot, Red Knot appear at the injection site / Redness and Heat have decreased; muscle achiness in his legs and shoulders; Fatigue; Arm was sore to touch; Swelling; This case was reported by a consumer and described the occurrence of injection site nodule in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 11th January 2021, 2 days after receiving Shingrix, the patient experienced injection site nodule, injection site erythema, injection site warmth, myalgia, fatigue, pain in arm and swelling. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site nodule, myalgia, fatigue, pain in arm and swelling were not recovered/not resolved and the outcome of the injection site erythema and injection site warmth were recovering/resolving.   It was unknown if the reporter considered the injection site nodule, injection site erythema, injection site warmth, myalgia, fatigue, pain in arm and swelling to be related to Shingrix.  Additional details were reported as follows: The patient had a big hot, red Knot appear at the injection site.  He stated his arm was sore to the touch. He also reported fatigue and muscle achiness in his legs and shoulders.  On 14th January 2021, he still had a mark on his arm.  The redness and heat had decreased, but the size of the Knot had increased.  His physician was aware and had recommended ice and tylenol.  The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: Red Knot appear at the injection site; Red Knot appear at the injection site / Redness and Heat have decreased; had a big Hot, Red Knot appear at the injection site / Redness and Heat have decreased; muscle achiness in his legs and shoulders; Fatigue; Arm was sore to touch; Swelling; This case was reported by a consumer and described the occurrence of injection site nodule in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 11th January 2021, 2 days after receiving Shingrix, the patient experienced injection site nodule, injection site erythema, injection site warmth, myalgia, fatigue, pain in arm and swelling. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site nodule, myalgia, fatigue, pain in arm and swelling were not recovered/not resolved and the outcome of the injection site erythema and injection site warmth were recovering/resolving.   It was unknown if the reporter considered the injection site nodule, injection site erythema, injection site warmth, myalgia, fatigue, pain in arm and swelling to be related to Shingrix.  Additional details were reported as follows: The patient had a big hot, red Knot appear at the injection site.  He stated his arm was sore to the touch. He also reported fatigue and muscle achiness in his legs and shoulders.  On 14th January 2021, he still had a mark on his arm.  The redness and heat had decreased, but the size of the Knot had increased.  His physician was aware and had recommended ice and tylenol.  The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Headache, Pain, SARS-CoV-2 test positive
Clinical narrative: Headache; Fever of 99.6; chills; Body Aches/Achiness; Corona virus infection; tested positive for COVID; This case was reported by a consumer via call center representative and described the occurrence of headache in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On 16th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 17th January 2020, 1 days after receiving Shingrix, the patient experienced headache, fever, chills, general body pain, covid-19 and coronavirus test positive. On 18th January 2020, the outcome of the headache, fever, chills and general body pain were recovered/resolved. On an unknown date, the outcome of the covid-19 and coronavirus test positive were unknown.   It was unknown if the reporter considered the headache, fever, chills, general body pain, covid-19 and coronavirus test positive to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient received the dose of Shingrix on left arm and 1 day after the vaccination patient had a headache, a fever, chills and body aches. The fever was reported as 99.6 degree F. The patient also stated that he was tested positive for COVID. The symptoms of headache, fever, chills and body aches lasted for one day. The reporter did not consent to follow up. All information was not available at the time of reporting. Note: The vaccination and event onset and outcome year was not clear if it was 2020 or 2021, hence year was conservatively kept as 2020 with respect to reported description. The clarification has been raised for the same.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Pain, Vaccine positive rechallenge
Clinical narrative: Pain at injection site; Redness at the injection site; Dose 1 of Shingrix on January 20, 2020, and dose 2 in August 2020; Body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eczema and arthritis (unspecified). Previously administered products included Shingrix with an associated reaction of pain (1st dose received in Januray 2020 also experienced injection site pain after receiving 1st dose on 20th January 2020 for futher tolerance refer case US2021AMR015150).   In August 2020, the patient received the 2nd dose of Shingrix (intramuscular). In August 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site pain, injection site erythema and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the general body pain was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient had eczema and arthritis unspecified in past. Patient received the dose of Shingrix and experienced body ache which lasted a day and then resolved also experienced injection site redness and injection site pain which was not resolved till the time of reporting. Patient received 2nd dose later than recommended time interval ,which led to lengthening of the schedule. The reporter consented to follow up. This case was linked with US2021AMR015150 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR015150:Same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Had a little soreness in the arm; Rash developed on the opposite side that ran down the back / like spider bites; Injection site felt like a bee sting; Injection site / it turned red / "looked ugly"; Injection site / swelled up / "looked ugly"; Injection site / was warm to the touch / "looked ugly"; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number B9YS2, expiry date 10th October 2022) for prophylaxis.   Previously administered products included shingrix (received 1st dose on unknown date).   On 18th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd March 2021, 12 days after receiving Shingrix, the patient experienced injection site stinging, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the patient experienced pain in arm and rash. On an unknown date, the outcome of the pain in arm and rash were recovered/resolved and the outcome of the injection site stinging, injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, rash, injection site stinging, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional information was provided as follows: The reporter stated that, after vaccination, the patient initially had a little soreness in the arm, but then a rash developed on the opposite side that ran down the back. The patient stated that it looked like spider bites, this reaction was resolved. On day 12 after receiving 2nd dose, the injection site felt like a bee sting and it was then turned to red, swelled up, was warmth to touch and looked ugly.  This reaction was not resolved and was ongoing. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Had a little soreness in the arm; Rash developed on the opposite side that ran down the back / like spider bites; Injection site felt like a bee sting; Injection site / it turned red / "looked ugly"; Injection site / swelled up / "looked ugly"; Injection site / was warm to the touch / "looked ugly"; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number B9YS2, expiry date 10th October 2022) for prophylaxis.   Previously administered products included shingrix (received 1st dose on unknown date).   On 18th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd March 2021, 12 days after receiving Shingrix, the patient experienced injection site stinging, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the patient experienced pain in arm and rash. On an unknown date, the outcome of the pain in arm and rash were recovered/resolved and the outcome of the injection site stinging, injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, rash, injection site stinging, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional information was provided as follows: The reporter stated that, after vaccination, the patient initially had a little soreness in the arm, but then a rash developed on the opposite side that ran down the back. The patient stated that it looked like spider bites, this reaction was resolved. On day 12 after receiving 2nd dose, the injection site felt like a bee sting and it was then turned to red, swelled up, was warmth to touch and looked ugly.  This reaction was not resolved and was ongoing. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Fatigue, Pyrexia
Clinical narrative: very Fatigue; low fever from 99.4 to 100 /  it is off and on; Clammy; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2021, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, less than a week after receiving Shingrix, the patient experienced fatigue, fever and clamminess. On an unknown date, the outcome of the fatigue, fever and clamminess were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, fever and clamminess to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's spouse. The patient received 1st dose of Shingrix vaccine in his right arm. The patient experienced running low fever from 99.4 to 100 degree F every day and reporter mentioned it as it was off and on. The patient being clammy and very fatigue. Till the time of reporting, the symptoms had not resolved. The reporter consented to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: fever; chills; shaking; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 13th January 2021 11:00, the patient received the 2nd dose of Shingrix. On 13th January 2021, 10 hrs after receiving Shingrix, the patient experienced fever, chills, shaking and headache. On 14th January 2021, the outcome of the fever, chills, shaking and headache were recovered/resolved.   It was unknown if the reporter considered the fever, chills, shaking and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was patient herself. The patient about 10 hours later of vaccination, began to get a fever, chills, shaking and a headache. The patient reported that going to bed and the adverse effects were resolved about 8 hours later when she awoke. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Developed a painful herpes rash; Developed a painful herpes rash; This case was reported by a consumer and described the occurrence of herpes virus infection in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes virus infection and painful rash. The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the herpes virus infection and painful rash were not recovered/not resolved.   It was unknown if the reporter considered the herpes virus infection and painful rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received her second shingrix vaccine and she had developed a painful herpes rash that had not resolved till the reporting date. The physician had prescribed her an antiviral, but she did not know the name of the medication.  No other information was provided. The reporter did not consent to follow-up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pustule
Clinical narrative: broke out in one pock (pox) on her buttocks  / in another pock (pox) on her abdomen; has cold sores on her lips; This case was reported by a consumer via call center representative and described the occurrence of smallpox in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   In November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th March 2021, between 3 and 5 months after receiving Shingrix, the patient experienced cold sores lip. On an unknown date, the patient experienced smallpox (serious criteria GSK medically significant). On an unknown date, the outcome of the smallpox and cold sores lip were not recovered/not resolved.   The reporter considered the smallpox and cold sores lip to be related to Shingrix.  Additional details were reported as follows: This case was reorted by patient herself About a week later after receiving Shingrix, she broke out in one pock (pox) on her buttocks that cleared up after about a week. An unknown amount of time passed, and she broke out in another pock (pox) on her abdomen. This also cleared up in an unknown amount of time.  The patient stated that she noticed on the day of reporting that she has another pock on her buttocks and has cold sores on her lips. Lot number and expiry date were unknown. The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: first dose / around 08/2018  / had some injection site pain.; This case was reported by a other health professional and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in May 2018), nerve pain (right trochanteric nerve pain in May 2018) and chickenpox.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself, who was a retired physical therapist. The patient received 1st dose in her left arm and she had some injection site pain. The reporter did not have Shingrix lot number. The reporter did not want to provide pharmacy information. The reporter did not consent to follow-up. For tolerance of 2nd dose, refer case US2021AMR061122.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061122:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: Administering other patients for last 2 weeks that were in syringes for over 6 hours; Administering other patients for last 2 weeks that were in syringes for over 6 hours; A spontaneous report  was received from a Healthcare Professional concerning 30 unknown patients, who received Moderna's COVID-19 vaccine (mRNA-1273) from the extra unused doses in syringe which was brought back to pharmacy (PT: Product storage error)  and being used for administering to patients  for last 2 weeks that were in syringes for over 6 hours.(PT- Product Administration Errors)  The patient's medical history, was not  provided by the reporter. No Concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) for prophylaxis of COVID-19 infection.   On an unknown date, Health Care Professional (HCP) reported that, extra unused doses in syringe were brought back to pharmacy and being used for administering other patients for last 2 weeks that were in syringes for over 6 hours. HCP stated that it was first dose for all patients. She was one of the recipients of dose of vaccine from that syringe.  . Treatment for the event not reported.   Action taken with mRNA-1273 in response to the events Product storage error and Product administration error  was not reported.   The outcome of the event is resolved on an unknown date.; Reporter's Comments: This report refers to a case of Product storage error and Product administration error  for mRNA-1273, lot # 041L20.  with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: drops leaked during the administration of the vaccine; could not tell if the leak came from syringe of patient's arm; A spontaneous report was received from a healthcare professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced drops leaked during the administration of the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that when an injection was administered to the patient, it was noticed that some of the vaccine leaked out.  The nurse who administered the vaccine stated that she was unable to tell whether the leak came from the syringe or the patient's arm.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, drops leaked during the administration of the vaccine, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # unknown)  with no associated AEs reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Injection received in wrong location; Pain at injection site; A spontaneous report was received from a consumer concerning 54-years-old, white female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain at injection and injection received in wrong location.  The patient's medical history was not provided. Current conditions included diabetes. The concomitant medications were not reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot: 011L20A) intramuscularly and on 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot: 004M20A) below deltoid for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient received injection at the wrong location (below deltoid) and experienced pain at the injection site  The patient was advised to consult health care professional.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  On 18 Feb 2021, the event of  injection received in wrong location was resolved while on 20 Feb 2021, the event of pain at injection resolved.  The reporter did not provide an assessment for the events pain at injection and injection received in wrong location.; Reporter's Comments: This report refers to a case of product administered at inappropriate site  for mRNA-1273 (lot # 004M20A with second dose) with reported event of vaccination site pain.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dyspnoea, Illness, Immunodeficiency
Clinical narrative: Mycoplasma pneumoniae pneumonia; Chills; Violently sick; labored breathing; Oxygen saturation low; vaccination site pain; immunodeficiency; A spontaneous report was received from a consumer concerning a 79-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced mycoplasma pneumoniae pneumonia, chills, illness, labored breathing, vaccination site pain, immunodeficiency, and oxygen level saturated.  The patient's medical history included congestive heart failure, pulmonary disease, immune system disorder history of 22 stents placed in her heart, peripheral artery disease, coronary artery disease, regurgitating food  and covid-19 test. No relevant concomitant medications were reported.    On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 15 Feb 2021, approximately 1day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, she developed chills and became violently sick. Her oxygen was 94 at home but dropped into the 80s at the facility. She has had to have 40-50% oxygen. At first, they thought she might have aspiration pneumonia because she has had problems keeping food down and regurgitating in the past. They did tests and told us she has Mycoplasma pneumonia. The doctor said if she had a normal immune system, she could just take something over the counter, but not with her because her immune system is low. They did four COVID tests because they thought she might have had a false negative, but all of them have been negative. So, at least we know she doesn't have COVID. Her oxygen has been in the 90s, but she still says she is having a hard time breathing and it is labored. She continues to be in intensive care. Treatment for the event included oxygen .   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.   The outcome of the events mycoplasma pneumoniae pneumonia, chills, illness, labored breathing, vaccination site pain, immunodeficiency, and oxygen level saturated were unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events (chills and vaccination site pain) and the administration of the mRNA-1273 cannot be excluded. However, the event of Mycoplasma pneumonia is Unlikely related to mRNA-1273. The events- illness, dyspnoea, oxygen saturation decreased could be due to mycoplasma pneumonia.  However, the subject's history of weak immune system may remain as a risk factor.
Sex: F
Vaccine: COVID19
Symptoms: Mycoplasma test positive, Oxygen consumption, Oxygen saturation decreased, Pneumonia mycoplasmal, Vaccination site pain
Clinical narrative: Mycoplasma pneumoniae pneumonia; Chills; Violently sick; labored breathing; Oxygen saturation low; vaccination site pain; immunodeficiency; A spontaneous report was received from a consumer concerning a 79-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced mycoplasma pneumoniae pneumonia, chills, illness, labored breathing, vaccination site pain, immunodeficiency, and oxygen level saturated.  The patient's medical history included congestive heart failure, pulmonary disease, immune system disorder history of 22 stents placed in her heart, peripheral artery disease, coronary artery disease, regurgitating food  and covid-19 test. No relevant concomitant medications were reported.    On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 15 Feb 2021, approximately 1day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, she developed chills and became violently sick. Her oxygen was 94 at home but dropped into the 80s at the facility. She has had to have 40-50% oxygen. At first, they thought she might have aspiration pneumonia because she has had problems keeping food down and regurgitating in the past. They did tests and told us she has Mycoplasma pneumonia. The doctor said if she had a normal immune system, she could just take something over the counter, but not with her because her immune system is low. They did four COVID tests because they thought she might have had a false negative, but all of them have been negative. So, at least we know she doesn't have COVID. Her oxygen has been in the 90s, but she still says she is having a hard time breathing and it is labored. She continues to be in intensive care. Treatment for the event included oxygen .   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.   The outcome of the events mycoplasma pneumoniae pneumonia, chills, illness, labored breathing, vaccination site pain, immunodeficiency, and oxygen level saturated were unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events (chills and vaccination site pain) and the administration of the mRNA-1273 cannot be excluded. However, the event of Mycoplasma pneumonia is Unlikely related to mRNA-1273. The events- illness, dyspnoea, oxygen saturation decreased could be due to mycoplasma pneumonia.  However, the subject's history of weak immune system may remain as a risk factor.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Delirium, Pain in extremity, Pyrexia
Clinical narrative: delirious; arm pain; developed a temperature of 103; vomiting; Chills; A spontaneous report was received from a health care professional concerning a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain ,vomiting, chills,fever 103'F and was delirious.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021 , prior to the onset of the events the patient received his first of two planned doses of mRNA-1273 (lot/batch:unknown ) via unknown route of administration and unknown anatomical location for prophylaxis of COVID-19 infection.  On 23 Jan 2021. the patient experienced significant arm pain and as the night went on began vomiting, chills and developed a temperature of 103 and was delirious at the point where he was taken to emergency room. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events significant arm pain, vomiting, chills, fever and delirium was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: delirious; arm pain; developed a temperature of 103; vomiting; Chills; A spontaneous report was received from a health care professional concerning a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain ,vomiting, chills,fever 103'F and was delirious.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021 , prior to the onset of the events the patient received his first of two planned doses of mRNA-1273 (lot/batch:unknown ) via unknown route of administration and unknown anatomical location for prophylaxis of COVID-19 infection.  On 23 Jan 2021. the patient experienced significant arm pain and as the night went on began vomiting, chills and developed a temperature of 103 and was delirious at the point where he was taken to emergency room. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events significant arm pain, vomiting, chills, fever and delirium was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diverticulitis; A spontaneous report was received from a consumer concerning a unspecified age, female patient who received Moderna's COVID-19 vaccine and was hospitalized for diverticulitis.   The patient's medical history was diverticulitis.  Concomitant product use was not provided by the reporter.  On 28 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   The patient experienced diverticulitis (preexisting condition) since an unknown date due to which the patient was hospitalized on 21 Feb 2021. The vent diverticulitis was considered medically significant.  Treatment for the event included blood transfusion.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event diverticulitis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; however association is confounded by medical history of diverticulitis
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Product colour issue
Clinical narrative: Blood pressure up and down; Vaccine was purple and not clear in vial; A spontaneous report, was received from a consumer (patient), a 70 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced blood pressure up and down (blood pressure fluctuation), and vaccine was purple and not clear in vial (product colour issue).    The patient's current conditions included allergy to dye and anaphylaxis. Concomitant medications were not reported.  On 24 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for the prophylaxis of COVID-19 infection.    On an unknown date in Feb 2021, after receiving the vaccine, the patient had her blood pressure up and down. The patient stated that the vaccine was purple and not clear in the vial on 24 Feb 2021, and still the pharmacist gave her.  The patient was hospitalized for her blood pressure fluctuations. Treatment information was not provided.    Action taken with second dose of mRNA-1273 in response to the events was not provided.  The outcome of the event, blood pressure up and down was not reported and that of event vaccine was purple and not clear in vial was recovered on 24 Feb 2021. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start  of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; A spontaneous report was received from a consumer concerning a 85-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 08 Feb 2021, approximately three days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced medically significant event Bell's palsy.  Treatment details for event Bell's palsy included antiviral medication.  Action taken with mRNA-1273 in response to the event Bell's palsy was not reported.  The outcome of the event Bell's palsy was not recovered.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Heart rate, Oedema
Clinical narrative: Could not stabilize her heart rhythm; Heart beats per minute went up and down; build up of body fluids; A spontaneous report was received from a consumer concerning a 75-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart beats per minute went up and down (atrial fibrillation) and could not stabilize her heart rhythm (arrhythmias).  The patient's medical history included three-year history of atrial fibrillation and cardioversion. No concomitant medication were provided.  On 21 Jan 2021, patient received her first of two planned doses of mRNA-1273 (Batch Number 042L20A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, approximately one day prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Batch Number 03/L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 19 Feb 2021, the patient's heart beats per minute went up and down from 73 bpm to 128 bpm. The patient stayed in atrial fibrillation for four days and on an unknown date the patient went to the Emergency Room (ER). On 24 Feb 2021, Wednesday the patient was admitted to the hospital. Cardioversion was performed to return heartbeat to a normal rhythm as patient's heart rhythm was not stable with intravenous (IV) medication. The patient was buildup of body fluid.  Laboratory details included cardioversion.  Treatment information for events could not stabilize her heart rhythm (arrhythmias) include Flecainide.  Action taken with mRNA-1273 in response to the events heart beats per minute went up and down (atrial fibrillation) and could not stabilize her heart rhythm (arrhythmias) was not reported.  The outcome of the events heart beats per minute went up and down (atrial fibrillation) and could not stabilize her heart rhythm (arrhythmias) was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded