chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Asthenia, Fatigue
Clinical narrative: "debilitating reaction." / described it as "weakness or tiredness"; "debilitating reaction." / described it as "weakness or tiredness" / Fatigue problems.; she has Anemia; had / the Zostavax vaccine in 09/25/2007 / got / 1st Shingrix / on November 12th, 2019 / 2nd dose on June 18th, 2020.; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine with an associated reaction of no adverse event (received on 25th September 2007 and did not had reaction to this live vaccine) and Shingrix with an associated reaction of asthenia (received 1st dose on 12th November 2019, refer case US2021047828).   On 18th June 2020, the patient received the 2nd dose of Shingrix. On 18th June 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced weakness, fatigue and anemia. On an unknown date, the outcome of the weakness, fatigue, anemia and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the weakness, fatigue and anemia to be related to Shingrix.  Additional details were provided as follows: The patient had medical conditions that were not present when had the vaccines. At the time of reporting the patient take Thyroid medications and not received it when she took the Shingrix Vaccines. The patient received Shinrgix in left arm and had weakness or tiredness. The patient reported anemia and fatigue problems after taking vaccine. The reporter consented to follow up and did not find the lot and expiration dates of the vaccines.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021047828:same reporter
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: first dose of Shingirx on 30Nov2020 / was infected with Covid-19; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 virus test positive in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced covid-19 virus test positive. On an unknown date, the outcome of the covid-19 virus test positive was unknown.   It was unknown if the reporter considered the covid-19 virus test positive to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was reported as 77 years. The patient after receiving first dose of shingrix few months later was infected with Covid-19. The Vaccine Administration Facility is the same as Primary Reporter The reporter Consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020252515:same reporter
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Burning sensation, Carpal tunnel syndrome, Condition aggravated, Dyspepsia
Clinical narrative: Possible Carpal tunnel syndrome; inflammation everywhere in his body / inflammation in glutes, thighs, back of knees, bottom of feet, neck and shoulders; The pain in his hands ebbs and flows / pain presented in his hands and wrists; muscle aches everywhere /  The aches progressively became worse as time went on; aches are present everywhere else / aches; it feels like a storm is going on inside his body; feels burning all over his body; stomach is burning as well; This case was reported by a consumer via call center representative and described the occurrence of carpal tunnel syndrome in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) and Herpes zoster (Shingrix).   In October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced carpal tunnel syndrome, inflammation, pain in hand, muscle pain, general body pain, feeling abnormal, burning sensation and stomach burning sensation of. On an unknown date, the outcome of the carpal tunnel syndrome, general body pain, feeling abnormal, burning sensation and stomach burning sensation of were unknown and the outcome of the inflammation, pain in hand and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the carpal tunnel syndrome, inflammation, pain in hand, muscle pain, general body pain, feeling abnormal, burning sensation and stomach burning sensation of to be related to Shingrix.  Additional details were provided as follows: The patient had his first dose of Shingrix in one arm and a flu shot in the other arm at the same time in August 2020.   The patient was administered the 2nd dose of Shingrix exactly 2 months after the first. The exact vaccination dates were unknown. In either October or November the patient started to feel inflammation everywhere in his body. Then pain presented in his hands and wrists followed by muscle aches everywhere. At first it was thought to be carpool tunnel syndrome.   The pain in his hands ebbs and flows but the aches were present everywhere else. The aches progressively became worse as time went on. At the time of reporting , he had aches and inflammation in glutes, thighs, back of knees, bottom of feet, neck and shoulders. He said it feels like a storm was going on inside his body. There were aches everywhere with the exception of his head and ears.   In other words, he was symptom free from the chin up. The patient stated that the patient felt burning all over his body. He stated his stomach was burning as well. The reporter consented to follow up. The pharmacist provided permission to follow up with her for additional details such as the lot numbers of both the Shingrix and the Flu vaccine.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Possible Carpal tunnel syndrome; inflammation everywhere in his body / inflammation in glutes, thighs, back of knees, bottom of feet, neck and shoulders; The pain in his hands ebbs and flows / pain presented in his hands and wrists; muscle aches everywhere /  The aches progressively became worse as time went on; aches are present everywhere else / aches; it feels like a storm is going on inside his body; feels burning all over his body; stomach is burning as well; This case was reported by a consumer via call center representative and described the occurrence of carpal tunnel syndrome in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) and Herpes zoster (Shingrix).   In October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced carpal tunnel syndrome, inflammation, pain in hand, muscle pain, general body pain, feeling abnormal, burning sensation and stomach burning sensation of. On an unknown date, the outcome of the carpal tunnel syndrome, general body pain, feeling abnormal, burning sensation and stomach burning sensation of were unknown and the outcome of the inflammation, pain in hand and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the carpal tunnel syndrome, inflammation, pain in hand, muscle pain, general body pain, feeling abnormal, burning sensation and stomach burning sensation of to be related to Shingrix.  Additional details were provided as follows: The patient had his first dose of Shingrix in one arm and a flu shot in the other arm at the same time in August 2020.   The patient was administered the 2nd dose of Shingrix exactly 2 months after the first. The exact vaccination dates were unknown. In either October or November the patient started to feel inflammation everywhere in his body. Then pain presented in his hands and wrists followed by muscle aches everywhere. At first it was thought to be carpool tunnel syndrome.   The pain in his hands ebbs and flows but the aches were present everywhere else. The aches progressively became worse as time went on. At the time of reporting , he had aches and inflammation in glutes, thighs, back of knees, bottom of feet, neck and shoulders. He said it feels like a storm was going on inside his body. There were aches everywhere with the exception of his head and ears.   In other words, he was symptom free from the chin up. The patient stated that the patient felt burning all over his body. He stated his stomach was burning as well. The reporter consented to follow up. The pharmacist provided permission to follow up with her for additional details such as the lot numbers of both the Shingrix and the Flu vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: itchy rash at the site of her 1st shingrix shot; This case was reported by a physician via call center representative and described the occurrence of injection site rash in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. On 1st February 2021, 3 weeks after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed an itchy rash at the site 3 weeks after vaccination. She showed it to a dermatologist who told her she probably should not get the 2nd dose. The reporter did not consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: At the injection site, there was a / lump; At the injection site, there was a red lump; At the injection site / was itchy; This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site lump, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site lump, injection site erythema and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site lump, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received the 1st dose of Shingrix and  experienced the red lump which was itchy at the injection site and it took about 4 weeks to resolve. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Influenza like illness, Insomnia, Pyrexia
Clinical narrative: A very red rash / the size of my hand; A very red rash /and was very itchy; Could not sleep; Fever / were better after 24 hours; Aches / like when you have a cold / were better after 24 hours; This case was reported by a contact via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia, sleep disorder, nervous system disorder and pain.   On 15th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced fever, flu-like aching, red rash, itchy rash and insomnia. The patient was treated with paracetamol (Tylenol) and sleep medication (nos) (Sleep Medication). On an unknown date, the outcome of the fever, flu-like aching, red rash, itchy rash and insomnia were recovered/resolved.   It was unknown if the reporter considered the fever, flu-like aching, red rash, itchy rash and insomnia to be related to Shingrix.  Additional details were provided as follows: The age at event onset was not reported but it could be 74 or 75 years. The case was reported by the patient for herself. The patient had a bad reaction with the 1st dose of Shingrix. After 1st dose the patient experienced fever, aches like when she had a cold, a very red rash the size of hand her and was very itchy.  The patient could not sleep and had to take Tylenol and a medication to sleep. Patient stated because she had fibromyalgia it maybe made it worse because of this. Fever and aches were better after 24 hours but it took almost 5 to 7 days for rash to go away and the other symptoms for about 2 to 3 days. The patient also had 2nd Shingrix shot on 8th January, 2021 she took 650 mg of Tylenol and 25 mg of Benadryl one hour before the shot. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: A very red rash / the size of my hand; A very red rash /and was very itchy; Could not sleep; Fever / were better after 24 hours; Aches / like when you have a cold / were better after 24 hours; This case was reported by a contact via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia, sleep disorder, nervous system disorder and pain.   On 15th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced fever, flu-like aching, red rash, itchy rash and insomnia. The patient was treated with paracetamol (Tylenol) and sleep medication (nos) (Sleep Medication). On an unknown date, the outcome of the fever, flu-like aching, red rash, itchy rash and insomnia were recovered/resolved.   It was unknown if the reporter considered the fever, flu-like aching, red rash, itchy rash and insomnia to be related to Shingrix.  Additional details were provided as follows: The age at event onset was not reported but it could be 74 or 75 years. The case was reported by the patient for herself. The patient had a bad reaction with the 1st dose of Shingrix. After 1st dose the patient experienced fever, aches like when she had a cold, a very red rash the size of hand her and was very itchy.  The patient could not sleep and had to take Tylenol and a medication to sleep. Patient stated because she had fibromyalgia it maybe made it worse because of this. Fever and aches were better after 24 hours but it took almost 5 to 7 days for rash to go away and the other symptoms for about 2 to 3 days. The patient also had 2nd Shingrix shot on 8th January, 2021 she took 650 mg of Tylenol and 25 mg of Benadryl one hour before the shot. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster
Clinical narrative: painful sores around her waistband; shingles; This case was reported by a consumer via call center representative and described the occurrence of wrist pain in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pneumonia. Concurrent medical conditions included asthma (hospitalization for asthma). Concomitant products included budesonide, formoterol fumarate (Symbicort).   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 wrist pain and shingles. On an unknown date, the outcome of the wrist pain and shingles were unknown.   It was unknown if the reporter considered the wrist pain and shingles to be related to Shingles vaccine.  Additional details provided as follow: The patient reported case for herself. The patient stated that some time in the past (could not remember exact date), she developed painful sores around her waistband that she believed was shingles. The shingles vaccine manufacturer was unknown. The patient got the 2nd dose of the vaccine some time later. All of this occurred prior to the patient starting on Nucala. For the tolerance of Nucala, refer case US2020AMR115171.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR115171:same patient, Nucala case
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; mild case of shingles; This case was reported by a consumer described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 9th March 2021, 771 days after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follow: The case was reported by the patient herself. The age at vaccination was not reported. The reporter stated that she took the Shingrix vaccine about 2 years prior to the report and was now experiencing mild case of shingles at the time of reporting. The reporter would like to know if she could or need to get the vaccine again. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming herpes zoster were unknown. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Lyme disease
Clinical narrative: Lyme Disease; rec'd one shingrix approx 3 yrs ago / Now/ wants to finish the series.; This case was reported by a nurse via call center representative and described the occurrence of lyme disease in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced lyme disease (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the lyme disease and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the lyme disease to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age at vaccination was not applicable for 2nd dose of Shingrix. Approximately 3 years before the date of reporting, the patient received 1st dose of Shingrix and then when it was time for her 2nd immunization, she had been diagnosed with active lyme disease and was told to not get her 2nd dose of Shingrix. At the time of reporting the patient was feeling better and wants to finish the series. Till the date of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Product supply issue
Clinical narrative: big diameter of redness in injection site / went to ER and was at the hospital for 2 days; sore injection site left arm / went to ER and was at the hospital for 2 days; Fever / went to ER and was at the hospital for 2 days; Headache / went to ER and was at the hospital for 2 days; Shingrix second dose more than  6 month apart from first dose because there were no stock at that time; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) (batch number TE493, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on an unknown date, refer case US2021AMR063811). Concurrent medical conditions included guillain barre syndrome.   On 22nd July 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 (serious criteria hospitalization), injection site pain (serious criteria hospitalization), fever (serious criteria hospitalization), headache (serious criteria hospitalization) and product supply issue. On an unknown date, the outcome of the injection site erythema, injection site pain, fever, headache and product supply issue were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, fever and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix late due vaccine was not available at that moment. After receiving 2nd dose of Shingrix in left arm, the patient experienced fever, headache, big diameter of redness in injection site and sore injection site. The patient went to emergency room (ER) and was at the hospital for 2 days. On Thursday 18th March 2021, the patient would receive Covid vaccine at physician's office, but they are afraid of this shot due they do not know the causality of Shingrix side effects. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063811:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: big diameter of redness in injection site / went to ER and was at the hospital for 2 days; sore injection site left arm / went to ER and was at the hospital for 2 days; Fever / went to ER and was at the hospital for 2 days; Headache / went to ER and was at the hospital for 2 days; Shingrix second dose more than  6 month apart from first dose because there were no stock at that time; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) (batch number TE493, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on an unknown date, refer case US2021AMR063811). Concurrent medical conditions included guillain barre syndrome.   On 22nd July 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 (serious criteria hospitalization), injection site pain (serious criteria hospitalization), fever (serious criteria hospitalization), headache (serious criteria hospitalization) and product supply issue. On an unknown date, the outcome of the injection site erythema, injection site pain, fever, headache and product supply issue were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, fever and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix late due vaccine was not available at that moment. After receiving 2nd dose of Shingrix in left arm, the patient experienced fever, headache, big diameter of redness in injection site and sore injection site. The patient went to emergency room (ER) and was at the hospital for 2 days. On Thursday 18th March 2021, the patient would receive Covid vaccine at physician's office, but they are afraid of this shot due they do not know the causality of Shingrix side effects. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063811:same patient
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth, Wrong technique in device usage process
Clinical narrative: Area is warm; Palm sized redness at the injection site; Area is tender/Arm was achy; Was given by a pharmacist and she believes that he placed it too high; A spontaneous report was received from a health care professional concerning a 45 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site erythema, warmth and pain. she believes that the injection was placed too high.   The patient's medical history was not provided by the reporter. No concomitant medications were reported.  On 05 Jan 2021, prior to the onset of events, the patient received the first planned doses of mRNA-1273 (Lot number: unknown)in her left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021 the patient the injection was given by a pharmacist and she believes that he placed it too high. On 12 Jan 2021, the patient experienced a palm sized redness at the injection site, the area was warm and tender, arm was achy, and red.  Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event a palm sized redness at the injection site, the shot was given by a pharmacist and she believes that he placed it too high, the area was warm and tender, and arm was achy were  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 for the other events cannot be excluded.  Causality for this medication error (suspected wrong technique in device usage process) is not applicable.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fatigue, Magnetic resonance imaging, Somnolence
Clinical narrative: Stroke; Sleeps all the time; Extemely Tired; A spontaneous report was received from a consumer concerning, 81-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced stroke, was extremely tired and slept all the time.   The patient's medical history was not provided. No concomitant product was reported.   On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   As per reporter patient had been extremely tired and slept most of the day since injection. On 17-Feb-2021, patient experienced stroke. Magnetic resonance imaging confirmed stroke. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events experienced stroke, was extremely tired and slept all the time were considered 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: Chills, Feeling abnormal, Incorrect dose administered, Pain, Pyrexia
Clinical narrative: She thought that they put more dosages in her body; Feeling horrible; Body aches; Fever; Chills; A spontaneous report was received from a physician concerning his wife,a 54-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a thought that they put more dosages in her body, fever, chills, body aches, feeling horrible.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On 4 Feb 2021, The patient thought they put more dosages in her body. the patient also experienced the event(s) fever, chills, body aches and was feeling horrible.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The event she thought that they put more dosages in her body-was resolved on 04 Feb 2021. The outcome of events- fever, chills, body aches, feeling horrible were 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.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product physical issue
Clinical narrative: Damaged or Broken Ampule; 1st dose administered from a vial that was leaking around the stopper; A spontaneous report was received from a nurse concerning 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported product administration error (1st dose administered from a vial that was leaking around the stopper) and damaged or broken Ampule (Damaged product).  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received the first of the two planned doses of mRNA-1273 on 24-FEB-2021 (Batch: 012a21a, Expiry date: 17-Aug-2021) intramuscularly on left arm for prophylaxis of COVID-19 infection.   It was reported that reporter opened the vial and it popped cracked (Damaged product) 1st dose administered from a vial that was leaking around the stopper (product administration error ).  Treatment details included none.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome was recovered for product administration error  and not recovered for damaged product.  The assessment was not provided for the event.; Reporter's Comments: This report refers to a case of out of specification product use and Product damaged for mRNA-1273, lot # 012a21a, with no associated AEs.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Choking, Cough, Rhinorrhoea, Wheezing
Clinical narrative: felt like choking; coughing every day; Runny Nose; felt like wheezing; cold chills; A spontaneous report was received from a 70-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt like choking, coughing every day, runny nose, cold chills and felt like wheezing.  The patient's medical history included blood pressure abnormal and thyroid disorder nos. Concomitant medications included thyroid medication, blood pressure medication, fish oil, levocetirizine dihydrochloride and vitamin d.  On 18-FEB-2021, the patient received their one of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly on left arm for prophylaxis of COVID-19 infection. On the same day, patient experienced coughing and she felt sick. The patient had runny nose, cold chills and felt like she was wheezing and chocking from unspecified date in FEB-2021. The patient started using an inhaler which she got from her daughter. The doctor gave her prescription for cough medication. The patient's daughter gave her Tessalon (benzonatate) 200mg. Physician was aware of patient's symptoms. The patient was scheduled for second dose on 18-MAR-2021.  Action taken with mRNA-1273 was unknown.  The outcome of the events, felt like choking, coughing every day, runny nose, cold chills and felt like wheezing 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. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Diarrhoea, Dizziness, Fatigue
Clinical narrative: nausea; Blood pressure went up from 105/65 to 155/80; dull aches in achilles tendons; feeling of stimulation that kept them from sleeping; diarrhea; headaches; neuropathy; Explosion through their body; really dizzy; weak and wanted to lay on the floor; Fatigue; A spontaneous report was received from a consumer concerning a 69-years-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an explosion through their body/feeling abnormal, really dizzy/dizziness, weak, wanted to lay on the floor/asthenia, blood pressure went up from 105/65 to 155/80/blood pressure increased, dull aches in Achilles tendons, headaches, nausea, neuropathy/neuropathy peripheral, feeling of stimulation that kept them from sleeping/tendon discomfort, diarrhea, fatigue.  The patient's medical history was not provided. No concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 25 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot number: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, approximately 5 minutes post vaccination, the patient reported she felt like an explosion went off inside her body. She felt really dizzy, weak and wanted to lay down on the floor which last 2 days. Her blood pressure went from 105/65 to 155/80. Approximately 3 hours later her blood pressure was back in normal range. Later that day, the patient reported she experienced headaches, nausea, neuropathy, dull aches in Achilles tendon, diarrhea and had a feeling of stimulation that kept her from sleeping.   On 28 Feb 2021, the patient stated she took zolpidem to help her sleep but it did not work.   Treatment details included pseudoephedrine and zolpidem.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, blood pressure went up from 105/65 to 155/80/blood pressure increased, was considered resolved on 25 Feb 2021  The outcome of event, diarrhea, was considered resolved on 26 Feb 2021.  The outcome of events, explosion through their body/feeling abnormal, really dizzy/dizziness, weak, wanted to lay on the floor/asthenia, were considered resolved on 27 Feb 2021.  The outcome of events, dull aches in Achilles tendons, headaches, nausea, neuropathy/neuropathy peripheral, feeling of stimulation that kept them from sleeping/tendon discomfort, fatigue, were considered not recovered.; 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. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Neuropathy peripheral, Sleep deficit
Clinical narrative: nausea; Blood pressure went up from 105/65 to 155/80; dull aches in achilles tendons; feeling of stimulation that kept them from sleeping; diarrhea; headaches; neuropathy; Explosion through their body; really dizzy; weak and wanted to lay on the floor; Fatigue; A spontaneous report was received from a consumer concerning a 69-years-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an explosion through their body/feeling abnormal, really dizzy/dizziness, weak, wanted to lay on the floor/asthenia, blood pressure went up from 105/65 to 155/80/blood pressure increased, dull aches in Achilles tendons, headaches, nausea, neuropathy/neuropathy peripheral, feeling of stimulation that kept them from sleeping/tendon discomfort, diarrhea, fatigue.  The patient's medical history was not provided. No concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 25 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot number: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, approximately 5 minutes post vaccination, the patient reported she felt like an explosion went off inside her body. She felt really dizzy, weak and wanted to lay down on the floor which last 2 days. Her blood pressure went from 105/65 to 155/80. Approximately 3 hours later her blood pressure was back in normal range. Later that day, the patient reported she experienced headaches, nausea, neuropathy, dull aches in Achilles tendon, diarrhea and had a feeling of stimulation that kept her from sleeping.   On 28 Feb 2021, the patient stated she took zolpidem to help her sleep but it did not work.   Treatment details included pseudoephedrine and zolpidem.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, blood pressure went up from 105/65 to 155/80/blood pressure increased, was considered resolved on 25 Feb 2021  The outcome of event, diarrhea, was considered resolved on 26 Feb 2021.  The outcome of events, explosion through their body/feeling abnormal, really dizzy/dizziness, weak, wanted to lay on the floor/asthenia, were considered resolved on 27 Feb 2021.  The outcome of events, dull aches in Achilles tendons, headaches, nausea, neuropathy/neuropathy peripheral, feeling of stimulation that kept them from sleeping/tendon discomfort, fatigue, were considered not recovered.; 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. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon discomfort
Clinical narrative: nausea; Blood pressure went up from 105/65 to 155/80; dull aches in achilles tendons; feeling of stimulation that kept them from sleeping; diarrhea; headaches; neuropathy; Explosion through their body; really dizzy; weak and wanted to lay on the floor; Fatigue; A spontaneous report was received from a consumer concerning a 69-years-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an explosion through their body/feeling abnormal, really dizzy/dizziness, weak, wanted to lay on the floor/asthenia, blood pressure went up from 105/65 to 155/80/blood pressure increased, dull aches in Achilles tendons, headaches, nausea, neuropathy/neuropathy peripheral, feeling of stimulation that kept them from sleeping/tendon discomfort, diarrhea, fatigue.  The patient's medical history was not provided. No concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 25 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot number: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, approximately 5 minutes post vaccination, the patient reported she felt like an explosion went off inside her body. She felt really dizzy, weak and wanted to lay down on the floor which last 2 days. Her blood pressure went from 105/65 to 155/80. Approximately 3 hours later her blood pressure was back in normal range. Later that day, the patient reported she experienced headaches, nausea, neuropathy, dull aches in Achilles tendon, diarrhea and had a feeling of stimulation that kept her from sleeping.   On 28 Feb 2021, the patient stated she took zolpidem to help her sleep but it did not work.   Treatment details included pseudoephedrine and zolpidem.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, blood pressure went up from 105/65 to 155/80/blood pressure increased, was considered resolved on 25 Feb 2021  The outcome of event, diarrhea, was considered resolved on 26 Feb 2021.  The outcome of events, explosion through their body/feeling abnormal, really dizzy/dizziness, weak, wanted to lay on the floor/asthenia, were considered resolved on 27 Feb 2021.  The outcome of events, dull aches in Achilles tendons, headaches, nausea, neuropathy/neuropathy peripheral, feeling of stimulation that kept them from sleeping/tendon discomfort, fatigue, were considered not recovered.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling hot, Loss of consciousness
Clinical narrative: passed out for 15 minutes; Felt woozy; felt so overheated; Felt feverish; felt extraordinarily tired; extreme chills; extraordinarily nauseous; A spontaneous report was received from a physician concerning their patient, 66 years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed passed out for 15 minutes/loss of consciousness, felt woozy/dizziness, felt feverish/pyrexia, felt extraordinarily tired/fatigue, extreme chills/chills, extraordinarily nauseous/nausea, felt so overheated/feeling hot.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Vitamin D NOS, levothyroxine.    The patient received the first of two planned doses of mRNA-1273 (Batch number: 014M20A) on 25 Feb 2021 intramuscularly at her left non-dominant deltoid for prophylaxis of COVID-19 infection.    On 26 Feb 2021 the patient experienced noticeably sick, felt woozy and felt not quite there. By the evening of  26 Feb 2021, she felt feverish and extraordinarily tired. She got extreme chills later that night. She discloses that she normal does react to other vaccines such as the flu vaccine. The strangest side effect that happened to her was that she woke up in the middle of the night and felt ill and extraordinarily nauseous. She went to the bathroom and felt so overheated that she passed out and woke up on the floor (15minutes). Treatment of the events was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The event passed out for 15 minutes was considered resolved.The outcome of the events felt woozy, felt feverish, felt extraordinarily tired, extreme chills, extraordinarily nauseous, felt so overheated was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: passed out for 15 minutes; Felt woozy; felt so overheated; Felt feverish; felt extraordinarily tired; extreme chills; extraordinarily nauseous; A spontaneous report was received from a physician concerning their patient, 66 years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed passed out for 15 minutes/loss of consciousness, felt woozy/dizziness, felt feverish/pyrexia, felt extraordinarily tired/fatigue, extreme chills/chills, extraordinarily nauseous/nausea, felt so overheated/feeling hot.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Vitamin D NOS, levothyroxine.    The patient received the first of two planned doses of mRNA-1273 (Batch number: 014M20A) on 25 Feb 2021 intramuscularly at her left non-dominant deltoid for prophylaxis of COVID-19 infection.    On 26 Feb 2021 the patient experienced noticeably sick, felt woozy and felt not quite there. By the evening of  26 Feb 2021, she felt feverish and extraordinarily tired. She got extreme chills later that night. She discloses that she normal does react to other vaccines such as the flu vaccine. The strangest side effect that happened to her was that she woke up in the middle of the night and felt ill and extraordinarily nauseous. She went to the bathroom and felt so overheated that she passed out and woke up on the floor (15minutes). Treatment of the events was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The event passed out for 15 minutes was considered resolved.The outcome of the events felt woozy, felt feverish, felt extraordinarily tired, extreme chills, extraordinarily nauseous, felt so overheated was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received her first dose of covid vaccine from  Moderna but she can't get her second dose because it's not available in her area; A spontaneous report was received from a consumer (patient) concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) but she can't get her second dose because it's not available in her area (product dose omission issue).  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: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient reported that she received her first dose of COVID vaccine from  Moderna, but she could not get her second dose from  Moderna because it was not available in her area but she was able to receive the Pfizer COVID vaccine for her first dose and second dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The event of received her first dose of COVID vaccine from  Moderna but she can't get her second dose because it's not available in her area was considered resolved.; Reporter's Comments: This report refers to a case of  Missed Dose for mRNA-1273, lot # unknown  with no associated AEs.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Thrombosis
Clinical narrative: Blood Clot in Leg; Tenderness; A spontaneous report was received from a consumer concerning a 68-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in leg and tenderness.   The patient's medical history was not  provided by the reporter. Concomitant medications reported included diltiazem hydrochloride, atorvastatin calcium and acetyl salicylic acid.  On 13-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:031M2QA) through intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 13-Feb-2021, following administration of the vaccine, the patient had tenderness in his leg that continued until he sought out medical treatment. After medical treatment is was concluded that the patient has a blood clot in his leg and has to receive medical treatment to resolve that condition. The treatment information included rivaroxaban.   Action taken with mRNA-1273 in response to the events was not applicable.   The events, blood clot in leg and tenderness were considered recovered.; Reporter's Comments: There is not enough information to assess the causa association between the reported event of blood clot in leg and the administration if the mRNA-1273 vaccine.  Critical details such as the patient's medical history is lacking. Additional information has been requested.  Howe ever, based on temporal association between product administration and the event of tenderness, a causal relationship cannot be excluded.