chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: had a very sore left shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shoulder soreness. On an unknown date, the outcome of the shoulder soreness was recovered/resolved.   It was unknown if the reporter considered the shoulder soreness to be related to Shingrix.  Additional details were reported as follows: The reporter was  the patient's wife. The patient received his first dose in the week of November 25th 2020 in the left arm. He had a very sore left shoulder for a week following that dose. For tolerance of 2nd dose refer case US2021AMR053866. This is 1 of 4 linked cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021053253:same reporter (wife´s case) US-GLAXOSMITHKLINE-US2021AMR053770:same reporter (wife´s case US-GLAXOSMITHKLINE-US2021AMR053866:same patient, same reporter, 2nd dose
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Memory impairment
Clinical narrative: dose 1 of Shingrix on August 30, 2018 / received dose 2 of Shingrix on April 11, 2019; decreased short term memory; difficulty sleeping; fatigue; headache; brain fog; This case was reported by a consumer via call center representative and described the occurrence of short-term memory impairment in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LP5Y, expiry date 27th February 2021) and (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.   On 30th August 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 11th April 2019, the patient received the 2nd dose of Shingrix. On 30th August 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced short-term memory impairment, difficulty sleeping, fatigue, headache and foggy feeling in head. On 11th April 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the short-term memory impairment, difficulty sleeping, fatigue, headache and foggy feeling in head were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the short-term memory impairment, difficulty sleeping, fatigue, headache and foggy feeling in head to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and experienced headache, fatigue, difficulty sleeping, brain fog and decreased short term memory. The patient was seen by the headache specialist and underwent testing and the cause of the headache had not been determined. The event were unresolved. The patient received the 2nd of Shingrix later than recommended schedule time, which led to lengthening of the vaccination schedule. The patient had no events after 2nd dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: large area of cellulitis around the injection site.; redness at the injection site; alot of pain at the injection site; Shingrix administered subcutaneously, instead of intramuscularly; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site cellulitis, injection site erythema, injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site cellulitis was not recovered/not resolved and the outcome of the injection site erythema and injection site pain 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 cellulitis, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient believed that, the shingrix was administered subcutaneously, instead of intramuscularly which led to intramuscular formulation administered by other route. The patient experienced redness and a lot of pain at the injection site, as well as a large area of cellulitis around the injection site. The reporter did not consent to follow-up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Breast pain, Facial pain, Neck pain, Pain in extremity
Clinical narrative: Developed left sided swelling / has not resolved; Severe pain on her face; Severe pain on her / neck; Severe pain on her / back; Severe pain on her / breast; Severe pain on her / arm and leg; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced swelling, facial pain, neck pain, back pain, breast pain and pain in extremity. The patient was treated with muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the swelling, facial pain, neck pain, back pain, breast pain and pain in extremity were not recovered/not resolved.   It was unknown if the reporter considered the swelling, facial pain, neck pain, back pain, breast pain and pain in extremity to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient had received second dose of shingrix vaccine four months ago of the reporting date. The patient developed left sided swelling and severe pain on her face, neck, back, breast, arm  and legs. Her health care provider prescribed muscle relaxer but she did not know the name of it.  The patient was still having pain and the swelling was not resolved and it's been 4 months. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Developed left sided swelling / has not resolved; Severe pain on her face; Severe pain on her / neck; Severe pain on her / back; Severe pain on her / breast; Severe pain on her / arm and leg; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced swelling, facial pain, neck pain, back pain, breast pain and pain in extremity. The patient was treated with muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the swelling, facial pain, neck pain, back pain, breast pain and pain in extremity were not recovered/not resolved.   It was unknown if the reporter considered the swelling, facial pain, neck pain, back pain, breast pain and pain in extremity to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient had received second dose of shingrix vaccine four months ago of the reporting date. The patient developed left sided swelling and severe pain on her face, neck, back, breast, arm  and legs. Her health care provider prescribed muscle relaxer but she did not know the name of it.  The patient was still having pain and the swelling was not resolved and it's been 4 months. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Illness, Myalgia, Nausea, Pain
Clinical narrative: muscle aches; pain /  it hurt everywhere; nausea; being very sick from vaccine and felt like dying; felt like dying; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced muscle pain, pain, nausea, sickness and impending doom. On an unknown date, the outcome of the muscle pain, pain, nausea, sickness and impending doom were recovered/resolved.   The reporter considered the muscle pain, pain, nausea, sickness and impending doom to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself. In December 2020 or January 2021 (2 to 3 months ago), the patient received 1st dose of Shingrix and reported being very sick from vaccine and felt like dying. The patient explained her actual symptoms by describing that she experienced muscle aches, pain, and nausea and also stated that it hurt everywhere. The patient reported that all of these symptoms started on the late afternoon she received the vaccine and resolved the next day. The reporter did not consent to follow-up. No other information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Rash pruritic, Rash vesicular
Clinical narrative: intense blistery rash; rash was also itchy and blotchy /itching; rash was also itchy and blotchy / blotchiness; This case was reported by a consumer via call center representative and described the occurrence of blistery rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd January 2021, 3 days after receiving Shingrix, the patient experienced blistery rash, itchy rash and blotchy rash. On an unknown date, the outcome of the blistery rash, itchy rash and blotchy rash were not recovered/not resolved.   It was unknown if the reporter considered the blistery rash, itchy rash and blotchy rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported but could be 62 or 63 years. The patient received the 1st dose of Shingrix in left deltoid. The patient developed an intense blistery rash from her elbow to her wrist on her right arm and the rash was also itchy and blotchy. The patient stated that although it was now less severe, she still had the rash, itching and blotchiness.   The reporter did not consent to follow-up. No other information was reported.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash, Vaccination failure
Clinical narrative: suspected vaccination failure; Patient got HZ after getting shingrix series / Rash started / 1 month post his second dose / increased and worsened 2 months post second dose; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number FY5H2, expiry date 25th May 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number NE49X, expiry date 23rd August 2022) for prophylaxis.   The patient's past medical history included herpes zoster.   On 9th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix and 1 month after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and rash. On an unknown date, the outcome of the vaccination failure, herpes zoster and rash were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient had previous history of Herpes zoster prior to receiving Shingrix series. The patient experienced Herpes zoster after getting Shingrix series. The patient reported no immediate side effects but stated a rash started to form 1 month post his second dose. The rash then increased and worsened 2 months post second dose. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dysstasia, Headache, Loss of personal independence in daily activities
Clinical narrative: fever / went as high as 102; shivers; headaches; body pain; pain level was / 5 out of 10 and was in "all my joints" /  knees, hips, neck, and bottom of her feet; pain level was about a 5 out of 10 / was in / neck; pain level was about a 5 out of 10 / was in / bottom of her feet; could not stand; had to lay down for 2 days (due to the pain).; 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.   The patient's past medical history included shingles (prior outbreaks on 2 occasions). Previously administered products included Zostavax (prior vaccination with the other shingles vaccine).   On 5th March 2021, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, less than a week after receiving Shingrix, the patient experienced fever, shivers, headache, general body pain, joint pain, neck pain, foot pain, difficulty in standing and activities of daily living impaired. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the fever, shivers, headache, general body pain, joint pain, neck pain, foot pain, difficulty in standing and activities of daily living impaired were recovered/resolved.   The reporter considered the fever, shivers, headache, general body pain and joint pain to be related to Shingrix. It was unknown if the reporter considered the neck pain, foot pain, difficulty in standing and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received 1st dose in her left deltoid. The patient did not have the lot number and expiration date but did provide the contact information of her doctor's office where she received the shot. The patient experienced severe side effects of all the symptoms. The patient experienced fever, shivers and headaches and she said they all resolved after 2 days and she was fine now.  The reporter mentioned that her fever went as high as 102 degree C and she thought that it perhaps would have gone higher but she took Advil and that brought it down. The patient also had body pain and pain level was about a 5 out of 10 and was in all her joints including her knees, hips, neck, and bottom of her feet.  The patient could not stand and had to lay down for 2 days due to the pain. The reporter consented to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever / went as high as 102; shivers; headaches; body pain; pain level was / 5 out of 10 and was in "all my joints" /  knees, hips, neck, and bottom of her feet; pain level was about a 5 out of 10 / was in / neck; pain level was about a 5 out of 10 / was in / bottom of her feet; could not stand; had to lay down for 2 days (due to the pain).; 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.   The patient's past medical history included shingles (prior outbreaks on 2 occasions). Previously administered products included Zostavax (prior vaccination with the other shingles vaccine).   On 5th March 2021, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, less than a week after receiving Shingrix, the patient experienced fever, shivers, headache, general body pain, joint pain, neck pain, foot pain, difficulty in standing and activities of daily living impaired. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the fever, shivers, headache, general body pain, joint pain, neck pain, foot pain, difficulty in standing and activities of daily living impaired were recovered/resolved.   The reporter considered the fever, shivers, headache, general body pain and joint pain to be related to Shingrix. It was unknown if the reporter considered the neck pain, foot pain, difficulty in standing and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received 1st dose in her left deltoid. The patient did not have the lot number and expiration date but did provide the contact information of her doctor's office where she received the shot. The patient experienced severe side effects of all the symptoms. The patient experienced fever, shivers and headaches and she said they all resolved after 2 days and she was fine now.  The reporter mentioned that her fever went as high as 102 degree C and she thought that it perhaps would have gone higher but she took Advil and that brought it down. The patient also had body pain and pain level was about a 5 out of 10 and was in all her joints including her knees, hips, neck, and bottom of her feet.  The patient could not stand and had to lay down for 2 days due to the pain. The reporter consented to follow-up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Headaches; Became lightheaded; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number Y2D94, expiry date 21st September 2021) for prophylaxis.   On 8th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced headache and light headedness. On an unknown date, the outcome of the headache and light headedness were not recovered/not resolved.   It was unknown if the reporter considered the headache and light headedness to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of Shingrix and began to experienced headaches and became lightheaded. Till the time of reporting, the patient was still experiencing the symptoms. The reporter did not consent to follow-up.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine administered to 16 year old; A spontaneous report was received from a pharmacist (a PharmD) concerning a 16-year old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) at the age of 16 years old (product administered to patient of inappropriate age).  The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The vaccine was administered to a 16-year-old patient.  Action taken with mRNA-1273 in response to the event was not applicable.   The event, received vaccine at the age of 16 years old, was considered resolved.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: vaccine given subcutaneous in Buttocks; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) subcutaneous in buttocks site(Product administered at inappropriate site ).      The patient's medical history not provided.  On 19th JAN 2021 onset of the events, the patient received their one of two planned doses of mRNA-1273 subcutaneous in buttocks site and HCP wants to know what to do.      On 20th JAN 2021, Agent called back HCP at 12:55pm on 20Jan2021 and was unable to reach. Submitting AE with limited info.    Treatment has not provided.   Action taken with mRNA-1273 in response to the events was not reported.     On 20th JAN 2021, the outcome of the event Product administered at inappropriate site is Resolved.; Reporter's Comments: This report refers to a case of Product administered at inappropriate site for mRNA-1273, lot # unknown with no associated AEs.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Peripheral swelling
Clinical narrative: Received both the 1st and 2nd dose on Feb 14, 2021; Swollen arm; Headache; A spontaneous report was received from a family member concerning a 72 years old, female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event received both the 1st and 2nd dose on Feb 14, 2021/Inappropriate schedule of vaccine administered, swollen arm, and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Feb 2021, the patient received her first and second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 14 Feb 2021, the patient received both the 1st and 2nd dose of the vaccine. The patient experienced a headache and a very swollen arm. Ice was used to treat the swelling, and it went down.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, Inappropriate schedule of vaccine administered, was considered recovered on 14 Feb 2021. The outcome of the event, swollen arm, was considered recovering, and the outcome of the event, headache, was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with associated AEs of swollen arm and headache reported. .
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received the vaccine; A spontaneous report was received from a consumer concerning a 17, year old female patient who received mRNA-1273 for prophylaxis of COVID-19 infection.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 15- Jan- 2021 for prophylaxis of COVID-19 infection.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The event, drug administered to patient of inappropriate age, was reported.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd appointment for 12Mar2021. 46 days apart; A spontaneous report  was received from a consumer concerning a 90 years of age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reporting Inappropriate schedule of product administration.  The patient's medical history was not provided. No concomitant were reported.   On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown)  in the unknown route for prophylaxis of COVID-19 infection.   On 25 Jan 2021, prior to receiving mRNA-1273, patient got 2nd appointment for 12 Mar 2021 which was 46 days apart. No treatment  information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event,  2nd appointment for 12 Mar 2021 which was 46 days apart  was considered as recovered.; Reporter's Comments: This case concerns a 90 year-old female patient who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Pain in extremity, Pyrexia
Clinical narrative: 21 days gap between 2 doses of vaccine; Felt like dork; Fever that night; Sore arm; A spontaneous report, was received from a consumer (patient's wife), concerning a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced sore arm (pain in extremity), felt like dork (feeling abnormal), fever at night (pyrexia), and only 21 days gap between 2 doses of vaccine (inappropriate schedule of product administration).  The patient's medical history included COVID-19 diagnosis on 01 Dec 2020. No relevant concomitant medications were reported.  On 13 Jan 2021, 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 13 Jan 2021, the patient experienced arm sore after the vaccine was administered. On 14 Jan 2021, on the next day, the patient experienced felt like dork and run a fever at night. On 03 Feb 2021, the patient got the second vaccine which was only 21 days gap between the two doses of vaccine. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm, felt like dork, fever at night were not reported and that of event only 21 days gap between 2 doses of vaccine was considered as recovered on 03 Feb 2021.; 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.  The causality of the event of inappropriate schedule of product administration is assessed as not applicable.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Insomnia, Leukaemia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Her doctor said she may have possible leukemia; Soreness; Redness the size of a quarter, Redness was 2 inches round, Redness is 4.5 inches in length and 3.5 inches in width; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Rash; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Terrible pain on her arm; A spontaneous report was received from a consumer who was also a 81-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced soreness, pain at the injection site, couldn't sleep, vaccination site pain,  redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width. Patient's doctor suspecting leukemia.    The patient's medical history included COVID 19 infection on 13 Oct 2020. Products known to have been used by the patient, within two weeks prior to the event, included hydroxyurea nonspecific.  On 13 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection.  On 13 Feb 2021 at night 11pm, patient began to feel pain at the injection site. Patient reported that patient couldn't sleep all of Saturday night, every time patient turned, it was painful. By Monday, the pain turned into just soreness, however, patient developed redness the size of a quarter at the injection site. Two days before reporting, the redness was 2 inches round and currently the redness is 4.5 inches in length and 3.5 inches in width, which indicates that it was spreading. Patient reached out to patient's doctor. Patient also reported some itching at the injection site last night. The patient also reported Rash, terrible pain on arm, and COVID-arm reaction. Patient's also reported that her doctor is suspecting a leukemia.  Treatment for the event included ice on the area 3 times a day, 15 minutes at a time.  Action taken with mRNA-1273 in response to the events was not provided.  The events,  soreness, pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash, were considered recovered on an unspecified date and The outcome of  the event leukemia is unknown.  Addition information Additional information received on 01 Mar 2021 included outcome of the events , pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash and reported patient was suspecting leukemia.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: Her doctor said she may have possible leukemia; Soreness; Redness the size of a quarter, Redness was 2 inches round, Redness is 4.5 inches in length and 3.5 inches in width; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Rash; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Terrible pain on her arm; A spontaneous report was received from a consumer who was also a 81-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced soreness, pain at the injection site, couldn't sleep, vaccination site pain,  redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width. Patient's doctor suspecting leukemia.    The patient's medical history included COVID 19 infection on 13 Oct 2020. Products known to have been used by the patient, within two weeks prior to the event, included hydroxyurea nonspecific.  On 13 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection.  On 13 Feb 2021 at night 11pm, patient began to feel pain at the injection site. Patient reported that patient couldn't sleep all of Saturday night, every time patient turned, it was painful. By Monday, the pain turned into just soreness, however, patient developed redness the size of a quarter at the injection site. Two days before reporting, the redness was 2 inches round and currently the redness is 4.5 inches in length and 3.5 inches in width, which indicates that it was spreading. Patient reached out to patient's doctor. Patient also reported some itching at the injection site last night. The patient also reported Rash, terrible pain on arm, and COVID-arm reaction. Patient's also reported that her doctor is suspecting a leukemia.  Treatment for the event included ice on the area 3 times a day, 15 minutes at a time.  Action taken with mRNA-1273 in response to the events was not provided.  The events,  soreness, pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash, were considered recovered on an unspecified date and The outcome of  the event leukemia is unknown.  Addition information Additional information received on 01 Mar 2021 included outcome of the events , pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash and reported patient was suspecting leukemia.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Exposure via skin contact
Clinical narrative: most of the vaccine leaked down the patient's arm; most of the vaccine leaked down the patient's arm; A spontaneous report was received from a healthcare professional concerning a female patient of unknown age who was administrated Moderna's COVID-19 vaccine incorrectly.   The patient's medical history was not provided. No relevant concomitant medications were not reported.  On 26 Jan 2021 or 28 Jan 2021, prior to the onset of the symptoms, the patient received their (unknown if 1st or 2nd) dose of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  While administrating the vaccine, most of the vaccine leaked down the patient's arm. The reporter reported the patient was very unhappy about the event. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, most of the vaccine leaked down the patient's arm, was considered resolved.; Reporter's Comments: This report refers to a case of underdose and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: employee received the 2nd dose of the Moderna Covid-19 Vaccine on day 12; A spontaneous report was received from a HCP concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate schedule of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Batch number unknown) intramuscularly for prophylaxis of COVID-19 infection.  The patient received the 2nd dose of the Moderna's COVID-19 Vaccine on day 12 instead of the usually 24-24days interval between the 1st and 2nd doses.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event of inappropriate schedule of vaccine administration was recovered.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration  without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose on day 21; A Spontaneous report was received from a healthcare Professional concerning a 50-years-old male patient who received 2nd dose of Moderna COVID-19 vaccine (mRNA-1273) on day 21.  The patient's medical history was not provided. No concomitant medications or labs were reported.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20A) on 06-Jan-2021. The patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the into right arm for prophylaxis of COVID-19 infection.   The reporter stated that physician at the facility received the 2nd dose of Moderna COVID-19 vaccine on day 21. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable  The outcome for the event was stated as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 030L20A for second dose) with no associated AEs reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Hyperpyrexia, Nausea, Vaccination site pain
Clinical narrative: temperature 109 F; dizzy; she feels nauseous; arm is hurting; A spontaneous report  was received from a consumer concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced the events body temperature 109F, she feels nauseous, arm is hurting, dizzy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) for prophylaxis of COVID-19 infection.    On 03-FEB-2021 the patient experienced the events body temperature 109F (medically significant), she feels nauseous, arm is hurting, dizzy.   Treatment information included paracetamol (Tylenol).  Laboratory data included body temperature which was 109 F.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events body temperature 109F, she feels nauseous, arm is hurting, dizzy 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: Contraindicated product prescribed
Clinical narrative: One pilll of Mycophenclate; A spontaneous report was received from a consumer concerning a 77 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received one pill of Mycophenclate.   The patient's medical history included chronic obstructive pulmonary disorder (COPD). Concomitant product use included unspecified blood pressure medication, unspecified inhaler, calcium levomefolate, unspecified cholesterol medications, lamotrigine, estradiol and levothyroxine sodium.  The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on an unknown date. On 23 Feb 2021, one day prior to the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 24-Feb-2021, the patient had an appointment with pulmonologist for COPD. The pulmonologist added Mycophenclate which weakens immune system. The patient took one pill of mycophenclate on advice of pulmonologist.  Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event, one pill of mycophenclate, was unknown.; Reporter's Comments: This report refers to a case of Contraindicated product prescribed and taken by the patient 1 day after mRNA-1273 vaccine, lot # unknown with no associated Adverse Events.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Underdose
Clinical narrative: Large bubble in syringe - she doesn't think she got the full dose; Slight pain in arm; A spontaneous report was received from a consumer (United States) concerning a 74-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight pain in arm/pain in extremity after the vaccine and didn't get the full dose/ under dose.   The patient's medical history was unknown. Concomitant product use was unknown.   On 26 Jan 2021, the patient received their first of two planned doses of mrna-1273, batch number not provided intramuscularly in an unknown site for prophylaxis of COVID-19 infection.  On 26th Jan 2021, the patient had received Moderna vaccine. She was given a syringe with vaccine and told to have a seat. Patient realized that there was a large bubble inside the syringe.  After receiving the dose patient has a slight pain in her arm and she felt that she didn't receive the whole dose.  .   Treatment information was unknown.  Action taken with mrna-1273 in response to the event was unknown.  The outcome of the event, slight pain in the arm was unknown. The outcome of the event, didn't get full dose was resolved.; 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.  The causality for the event of underdose is assessed as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death after second dose; A spontaneous report was received from a consumer concerning a female patient of unknown age, who experienced severe symptoms post first dose of Moderna's Covid-19 vaccine (mRNA-1273) and death shortly after her second dose.    The patient's medical history was not provided.  Concomitant medication was not provided by the reporter.   No lab data was not provided  On unspecified date, the patient received her second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    It was reported that shortly after receiving the second dose of mRNA-1273, the patient died.   Treatment information was not provided/unknown.    Action taken with the drug in response to the events is not applicable.  The patient died on an unknown date. Plans for an autopsy were not reported; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: death
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Loss of consciousness, Peripheral swelling, Skin discolouration
Clinical narrative: Tired; Passed out, was semi-unresponsive; Vein was hit on vaccination; Arm blew up after the shot (swelled); Arm was still back and blue; Extreme weakness; Wanted to sleep/slept for 24 hours/slept the rest of the day; A spontaneous report was received from a consumer, concerning herself, a 71-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and was passed out, was semi-unresponsive; vein was hit on vaccination; arm blew up after the shot (swelled); arm was still back and blue; extreme weakness; wanted to sleep/slept for 24 hours/slept the rest of the day and tired.~  The patient's medical history includes leukemia ongoing since on an unspecified date and was not being treated. Concomitant medications were not reported.  On 23-Feb-2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 injection, (Lot/Batch number: 001A21A) intramuscularly in their left arm for prophylaxis of COVID-19 infection.   On 23-Feb-2021, after the second dose of vaccine, the patient's arm blew up (swelled) and passed out, duration unknown, followed by less responsive with extreme weakness and sleepiness. Patient was sent to the ER (Emergency Room) where she was administered with fluids and anti-nausea medication and was released. Patient also informed that her vein was hit during the vaccination. Patient slept for 24 hours. On 24-Feb-2021, she was only awake for five hours. She again slept the rest of the day. At the time of this report, patient's arm was still back and blue, and was still tired but she was also much improved and is staying hydrated.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome for the event, arm was still back, and blue was considered not resolved at the time of this report. The outcome for event tired was resolving at the time of this report. The outcome for events, passed out, was semi-unresponsive; vein was hit on vaccination; arm blew up after the shot (swelled); extreme weakness; wanted to sleep/slept for 24 hours/slept the rest of the day were resolved on 23-Feb-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site injury
Clinical narrative: Tired; Passed out, was semi-unresponsive; Vein was hit on vaccination; Arm blew up after the shot (swelled); Arm was still back and blue; Extreme weakness; Wanted to sleep/slept for 24 hours/slept the rest of the day; A spontaneous report was received from a consumer, concerning herself, a 71-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and was passed out, was semi-unresponsive; vein was hit on vaccination; arm blew up after the shot (swelled); arm was still back and blue; extreme weakness; wanted to sleep/slept for 24 hours/slept the rest of the day and tired.~  The patient's medical history includes leukemia ongoing since on an unspecified date and was not being treated. Concomitant medications were not reported.  On 23-Feb-2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 injection, (Lot/Batch number: 001A21A) intramuscularly in their left arm for prophylaxis of COVID-19 infection.   On 23-Feb-2021, after the second dose of vaccine, the patient's arm blew up (swelled) and passed out, duration unknown, followed by less responsive with extreme weakness and sleepiness. Patient was sent to the ER (Emergency Room) where she was administered with fluids and anti-nausea medication and was released. Patient also informed that her vein was hit during the vaccination. Patient slept for 24 hours. On 24-Feb-2021, she was only awake for five hours. She again slept the rest of the day. At the time of this report, patient's arm was still back and blue, and was still tired but she was also much improved and is staying hydrated.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome for the event, arm was still back, and blue was considered not resolved at the time of this report. The outcome for event tired was resolving at the time of this report. The outcome for events, passed out, was semi-unresponsive; vein was hit on vaccination; arm blew up after the shot (swelled); extreme weakness; wanted to sleep/slept for 24 hours/slept the rest of the day were resolved on 23-Feb-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blindness, Chills, Fatigue, Paraesthesia
Clinical narrative: Vision loss; Balance issues; Tingling in Extremities; Fatigue; Chills; A spontaneous report was received from a consumer concerning a 34-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vision loss, tingling in extremities, paraesthesia, balance issues, fatigue and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) on an unspecified date in Jan 2021 intramuscularly. On 12-Feb-2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of Covid-19 infection.   On 13 Feb 2021, Patient experiencedvision loss, tingling in extremities, paraesthesia, balance issues, fatigue and chills. Laboratory details included an increased white blood cell count..Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, action taken with the drug in response to the events is not applicable.  The outcomes of the events of vision loss, tingling in extremities, balance issues, fatigue, and chills were considered as 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.