chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue, Headache, Incomplete course of vaccination, Nausea
Clinical narrative: developed small fiber neuropathy; her skin is on fire; first dose of Shingrix in June 2019 / never received the second dose; fever; headache; nausea; exhaustion; was on the couch for a week; This case was reported by a consumer via call center representative and described the occurrence of small fiber neuropathy in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of fever (received the Hepatitis B vaccine (manufacturer unknown) in the 90's, refer case US2021AMR056382 reported for same patient) and Typhoid vaccine.   In June 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced small fiber neuropathy (serious criteria GSK medically significant), burning skin, fever, headache, nausea, exhaustion, bedridden and incomplete course of vaccination. The patient was treated with gabapentin and pregabalin (Lyrica). On an unknown date, the outcome of the small fiber neuropathy and burning skin were not recovered/not resolved and the outcome of the fever, headache, nausea, exhaustion and bedridden were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the small fiber neuropathy, burning skin, fever, headache, nausea, exhaustion and bedridden to be related to Shingrix.  Additional details provided as follow: The patient reported that she received the first dose of Shingrix in June 2019. She experienced a fever, headache, nausea, and exhaustion after taking the vaccination. She claims that she was on the couch for a week but all of her symptoms resolved after the week. A month later, she developed small fiber neuropathy. She started Gabapentin in September 2019 and now she takes Lyrica because her skin was on fire unless she takes the medication. Her neuropathy was still unresolved and she never received the second dose of the Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR056382:same patient (hepatitis B case)
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin burning sensation, Small fibre neuropathy
Clinical narrative: developed small fiber neuropathy; her skin is on fire; first dose of Shingrix in June 2019 / never received the second dose; fever; headache; nausea; exhaustion; was on the couch for a week; This case was reported by a consumer via call center representative and described the occurrence of small fiber neuropathy in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of fever (received the Hepatitis B vaccine (manufacturer unknown) in the 90's, refer case US2021AMR056382 reported for same patient) and Typhoid vaccine.   In June 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced small fiber neuropathy (serious criteria GSK medically significant), burning skin, fever, headache, nausea, exhaustion, bedridden and incomplete course of vaccination. The patient was treated with gabapentin and pregabalin (Lyrica). On an unknown date, the outcome of the small fiber neuropathy and burning skin were not recovered/not resolved and the outcome of the fever, headache, nausea, exhaustion and bedridden were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the small fiber neuropathy, burning skin, fever, headache, nausea, exhaustion and bedridden to be related to Shingrix.  Additional details provided as follow: The patient reported that she received the first dose of Shingrix in June 2019. She experienced a fever, headache, nausea, and exhaustion after taking the vaccination. She claims that she was on the couch for a week but all of her symptoms resolved after the week. A month later, she developed small fiber neuropathy. She started Gabapentin in September 2019 and now she takes Lyrica because her skin was on fire unless she takes the medication. Her neuropathy was still unresolved and she never received the second dose of the Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR056382:same patient (hepatitis B case)
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling at the injection site; pain, tenderness /at the injection site / ongoing and low level of pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site swelling and injection site tenderness. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the injection site tenderness was recovering/resolving.   It was unknown if the reporter considered the injection site swelling and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the upper, left arm and experienced pain, tenderness and swelling at injection site. The patient reported the tenderness and swelling have subsided. Informed Pain intensity had decreased and low level pain at injection site. Reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: burning sensation; his right upper thigh start to pain; first dose/ around the end of 2019 or early 2020 / second dose around the beginning of 2021; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose at the end of 2019 or early 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced burning sensation, pain in thigh and drug dose administration interval too long. On an unknown date, the outcome of the burning sensation and pain in thigh 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 burning sensation and pain in thigh to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's wife. The patient received the 2nd dose of Shingrix at the beginning of 2021, later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter mentioned that, the patient received 2nd dose may be in his left arm and his right upper thigh started to pain with burning sensation. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Eye pruritus, Eye swelling, Hypersensitivity, Swelling face
Clinical narrative: face swollen; felt congested; Allergic reaction; burning, itching eyes / eyes were really itchy and burning; itching eyes / eyes were really itchy and burning; eyes swollen shut; scratchy throat /throat was scratchy/ burning throat; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd March 2021, 1 days after receiving Shingrix, the patient experienced facial swelling and nasal congestion. In March 2021, the patient experienced allergic reaction, burning in eyes, eye pruritus, eye swelling and throat irritation. The patient was treated with cough cold preparations nos (Cold Medicine). On an unknown date, the outcome of the allergic reaction, facial swelling and nasal congestion were unknown and the outcome of the burning in eyes, eye pruritus, eye swelling and throat irritation were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, burning in eyes, eye pruritus, eye swelling, throat irritation, facial swelling and nasal congestion to be related to Shingrix.  Additional information was provided as follows: On 3rd March 2021, within 12 hours after vaccination the patient experienced burning, itching eyes and scratchy throat and within 16 hours after vaccination the patient experienced eyes swollen. The patient took cold medicine. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation
Clinical narrative: face swollen; felt congested; Allergic reaction; burning, itching eyes / eyes were really itchy and burning; itching eyes / eyes were really itchy and burning; eyes swollen shut; scratchy throat /throat was scratchy/ burning throat; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd March 2021, 1 days after receiving Shingrix, the patient experienced facial swelling and nasal congestion. In March 2021, the patient experienced allergic reaction, burning in eyes, eye pruritus, eye swelling and throat irritation. The patient was treated with cough cold preparations nos (Cold Medicine). On an unknown date, the outcome of the allergic reaction, facial swelling and nasal congestion were unknown and the outcome of the burning in eyes, eye pruritus, eye swelling and throat irritation were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, burning in eyes, eye pruritus, eye swelling, throat irritation, facial swelling and nasal congestion to be related to Shingrix.  Additional information was provided as follows: On 3rd March 2021, within 12 hours after vaccination the patient experienced burning, itching eyes and scratchy throat and within 16 hours after vaccination the patient experienced eyes swollen. The patient took cold medicine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Reported pain / and soreness / at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:  The patient received 1st dose of Shingrix in right arm. The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced pain or soreness at the injection site. In November 2020, the patient got 2nd dose of Shingrix. The patient had Flu vaccine the same day when patient received 2nd dose of Shingrix. The patient reported she did not have symptoms with the second dose but does not recall in which arm she got the vaccine. Lot and expiration were unknown for both doses. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site extravasation
Clinical narrative: vaccine leaked during the administration from the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 3K743, expiry date 7th November 2022) for prophylaxis.   On 27th February 2021, the patient received the 2nd dose of Shingrix. On 27th February 2021, immediately after receiving Shingrix, the patient experienced injection site leaking. On an unknown date, the outcome of the injection site leaking was unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, patient received the 2nd dose of Shingrix, and the vaccine leaked during the administration from the injection site. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Fatigue, Headache
Clinical narrative: contracted COVID; Vaccine did not work out very well for him; Sweats; Fatigue; Throbbing HA; Chills; Muscle pain; Fever of 101.3; A spontaneous report was received from a consumer, concerning a 66-year-old male patient who received Moderna's COVID-19 vaccine and the vaccine did not work out very well for him (lack of effect) and he contracted COVID (COVID-19) and experienced sweats (hyperhidrosis), fatigue, throbbing headache, chills, muscle pain (myalgia) and fever of 101.3 (pyrexia).   The patient's medical history was not provided. Concomitant medications reported included dabigatran etexilate mesilate, blood pressure medication, cholesterol lowering medication and bladder medication.   On 06-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 039k20a) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 06-Jan-2021, approximately 5 hours after administration of the vaccine shot, patient experienced sweats, fatigue, throbbing headache, chills, muscle pain and fever of 101.3.    On follow-up, the patient reported that the vaccine "did not work out very well" for him and he "contracted COVID" (onset date not reported) and was in the hospital.  Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, sweats, fatigue, throbbing headache, chills, muscle pain and fever of 101.3 were considered not resolved at the time of this report.  The outcome of COVID was unknown.  Follow-up received on 01 Mar 2021 included addition of events.; Reporter's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of COVID and the product use is assessed as unlikely.  Th event was most likely pre-existing. The other events are assessed as symptoms of the COVID-19.  However, fatigue, headache, chills, muscle pain  and fever are consistent with the known safety profile of the vaccine and a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: contracted COVID; Vaccine did not work out very well for him; Sweats; Fatigue; Throbbing HA; Chills; Muscle pain; Fever of 101.3; A spontaneous report was received from a consumer, concerning a 66-year-old male patient who received Moderna's COVID-19 vaccine and the vaccine did not work out very well for him (lack of effect) and he contracted COVID (COVID-19) and experienced sweats (hyperhidrosis), fatigue, throbbing headache, chills, muscle pain (myalgia) and fever of 101.3 (pyrexia).   The patient's medical history was not provided. Concomitant medications reported included dabigatran etexilate mesilate, blood pressure medication, cholesterol lowering medication and bladder medication.   On 06-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 039k20a) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 06-Jan-2021, approximately 5 hours after administration of the vaccine shot, patient experienced sweats, fatigue, throbbing headache, chills, muscle pain and fever of 101.3.    On follow-up, the patient reported that the vaccine "did not work out very well" for him and he "contracted COVID" (onset date not reported) and was in the hospital.  Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, sweats, fatigue, throbbing headache, chills, muscle pain and fever of 101.3 were considered not resolved at the time of this report.  The outcome of COVID was unknown.  Follow-up received on 01 Mar 2021 included addition of events.; Reporter's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of COVID and the product use is assessed as unlikely.  Th event was most likely pre-existing. The other events are assessed as symptoms of the COVID-19.  However, fatigue, headache, chills, muscle pain  and fever are consistent with the known safety profile of the vaccine and a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial pain, Pruritus
Clinical narrative: face looked droopy on the left side;; itchy; felt like my face had been punched on the left side; A spontaneous report was received from a consumer concerning a 60-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pruritis, facial pain and facial paralysis.   The patient's medical history, as provided by the reporter, included bell's palsy 20 years ago. Concomitant medications were not reported. On 03 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Jan 2021, prior to receiving mRNA-1273, the patient felt itchy and like her face had been punched on the left side. On 06 Jan 2021 she felt her face looked droopy on the left side. Her dimple came back in her face. On 21 Jan 2021 her eyes was droopy and can see a line on one side, and other side doesn't have a line. It's gotten better with acupuncture. She gets acupuncture and electrostimulation; she had a horrible reaction to steroids. Her eye was stuck open for 3 months, she had a patch. Treatment for the events include 3 sessions of acupuncture. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, pruritis, facial pain and facial paralysis 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: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: received the complete Pfizer vaccination series "3 weeks ago," and were inadvertently administered a first dose of Moderna today (18Feb2021); received the complete Pfizer vaccination series "3 weeks ago," and were inadvertently administered a first dose of Moderna today (18Feb2021); A spontaneous report was received on 18 Feb 2021 from a pharmacist concerning unknown age male patient who received the complete Pfizer vaccination series 3 weeks ago and were inadvertently administered a first dose of Moderna's COVID-19 vaccine. (Interchange of vaccine products) and (Extra dose administered).  The patient medical history provided was dementia. No relevant concomitant medications were reported.  On 18 Feb 2021, patient received their first of two planned doses of Moderna's mRNA-1273 (Lot number: unknown), for the prophylaxis of COVID-19 infection. The patient received the complete Pfizer vaccine series, 3 weeks prior to the Moderna's vaccine.   Treatment for the event was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event received the complete Pfizer vaccination series 3 weeks ago and were inadvertently administered a first dose of Moderna's COVID-19 vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of interchange of vaccine products and extra dose administered for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Fatigue, Loss of consciousness
Clinical narrative: knocked her out; uncontrollable shaking; terrible neck pain; terrible neck stiffness; pain down spine; sternum hurt; toes hurt; fingers hurt; overwhelming fatigue; chills; nausea; joint pain; body pain; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, and joint pain.  The patient's medical history was not provided. Concomitant medications reported were Paxil, melatonin, red yeast rice supplement, fish oil, Hydrochlorothiazide for drug use for unknown indication.  On 28 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 in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain.  Treatment details included Tylenol and ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   At the time of reporting, the outcome of events include, overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Neck pain, Pain in extremity
Clinical narrative: knocked her out; uncontrollable shaking; terrible neck pain; terrible neck stiffness; pain down spine; sternum hurt; toes hurt; fingers hurt; overwhelming fatigue; chills; nausea; joint pain; body pain; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, and joint pain.  The patient's medical history was not provided. Concomitant medications reported were Paxil, melatonin, red yeast rice supplement, fish oil, Hydrochlorothiazide for drug use for unknown indication.  On 28 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 in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain.  Treatment details included Tylenol and ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   At the time of reporting, the outcome of events include, overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain, Tremor
Clinical narrative: knocked her out; uncontrollable shaking; terrible neck pain; terrible neck stiffness; pain down spine; sternum hurt; toes hurt; fingers hurt; overwhelming fatigue; chills; nausea; joint pain; body pain; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, and joint pain.  The patient's medical history was not provided. Concomitant medications reported were Paxil, melatonin, red yeast rice supplement, fish oil, Hydrochlorothiazide for drug use for unknown indication.  On 28 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 in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain.  Treatment details included Tylenol and ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   At the time of reporting, the outcome of events include, overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Eye haemorrhage, Headache
Clinical narrative: really bad broken eye blood vessel; ice pick type headache, quite intense headache; A spontaneous report was received from a Consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really bad broken eye blood vessel and quite intense ice pick type headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events really bad broken eye blood vessel, quite intense headache, ice pick type headache.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events include really bad broken eye blood vessel and quite intense ice pick type headache was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of headache, a causal relationship cannot be excluded. Very limited information regarding the eye hemorrhage has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme; A spontaneous report was received from a consumer concerning a 27-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced Erythema multiforme .  The patient's medical history was not provided. No concomitant product use was reported. Family history included Steven Johnson syndrome (mother had a severe form).  On 05 Feb 2021, the patient received his first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 15 Feb 2021, he noticed blistering on his arm, forearm and on his foot. He was diagnosed with Erythema multiforme (medically significant) following vaccination by his primary physician.   Treatment included topical steroids.  Action taken with mRNA-1273 with respect to the even Erythema multiforme was unknown.  The outcome of the event Erythema multiforme was resolving at the time of this report.; 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered  24 hours after vial puncture; A spontaneous report was received on 1 Feb 2021, from a Healthcare Professional Dear concerning a 21-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vaccine administered 24 hours after vial puncture.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the event(s) vaccine administered 24 hours after vial puncture.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), vaccine administered  24 hours after vial puncture was resolved; Reporter's Comments: This report refers to a case of  Expired Product Administered  for mRNA-1273, (lot number not provided) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Under 18 patient had vaccine administered; Sore arm; A spontaneous report was received from a consumer (patient's parent) for a 16-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced under 18 patient had vaccine administered and sore arm.  The patient's medical history was not provided. No concomitant product use was reported.  The reporter stated that her son was under 18 years of age and on 19-FEB-2021 Friday, the patient received their first of two planned doses of mRNA-1273 (Lot number: 02(not sure))L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient was supposed to get Pfizer vaccine, but the pharmacy had Moderna vaccine that day. The pharmacy contacted Moderna and realized that vaccine should not be administered in under 18. The patient also experienced sore arm the day of the vaccination which was recovered the same day. The reporter wanted to know how to continue.  Treatment information was not provided.  Action taken with mRNA-1273 was unknown.  The outcome of the events, under 18 patient had vaccine administered and sore arm was recovered/ resolved.  The reporter did not provide the assessment for the events under 18 patient had vaccine administered and sore arm.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number02(not sure))L20A) with  associated AE reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Systemic allergic reaction; A spontaneous report was received from a Healthcare Professional concerning a 47 years old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced the medically significant event of systemic allergic reaction/ hypersensitivity.  The patient's medical history was not provided. Concomitant product use was not provided.  On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient experienced a systemic allergic reaction and ended up in the emergency room.  On 10 Jan 2021, the patient experienced a new systemic reaction and she was back in emergency room.  The patient was treated with epinephrine.  No relevant laboratory details were included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event systemic allergic reaction was considered resolved on 10 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received the vaccine; A spontaneous report was received from a healthcare professional concerning a 17 year old patient of unknown gender who was administered the mRNA-1273 vaccine at an inappropriate age.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 22-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    The patient was 17 years old and not the appropriate age of 18 to receive the vaccine.  Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The event, product administered to patient of inappropriate age, was considered recovered.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Post procedural complication
Clinical narrative: Complication from procedure; Could not get second dose as scheduled; A spontaneous report was received from a consumer concerning a 79-year-old male patient who experienced complication from  surgery/ post procedural complication and could not get second dose as scheduled/ Inappropriate schedule of vaccine administered.   The patient's medical history or concomitant medications were not provided.     The patient received his first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly in the left dominant arm  for prophylaxis of COVID-19 infection on 08 Jan 2021.  On 08 Feb 2021 the patient underwent an outpatient surgical procedure. He could not get second dose as scheduled on 12 Feb 2021. On 18 Feb 2021, he was admitted to the hospital due to complication from procedure.    Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event could not get second dose as scheduled at the time of this report was resolved. The outcome of the event complication from procedure was unknown.; Reporter's Comments: This report refers to a case of a 79-year-old male patient who experienced  a post surgical procedure complication after the first dose  mRNA-1273 (lot #-unknown)  and could not get second dose as scheduled (Inappropriate schedule of vaccine administered). There is limited information to assess the exact post surgical complication as the surgical and description of the complication was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Movement disorder, Nausea, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: Trouble lifting her arm; Nausea that came and went; Felt tired and fatigued; Vaccination site pain; Vaccine too high on her shoulder; A spontaneous report was received from a nurse concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine too high on her shoulder/product administered at inappropriate site, trouble lifting her arm/ movement disorder, nausea, fatigue and vaccination site pain.   The patient's medical history and concomitant medications were not reported by the reporter.    On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A ) in the left shoulder for prophylaxis of COVID-19 infection.   On 02 Feb 2021, patient believed the vaccine was given too high on her shoulder, and had nausea, fatigue and pain at the injection site (shoulder and arm) which increased with movements, radiating to the upper limb and had trouble sleeping, treated with Tylenol.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events 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 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: injection was below the ideal site for deltoid injection; A spontaneous report was sent by physician concerning a patient, unknown age or gender, who received Moderna' s COVID-19 vaccine (mRNA-1273) and experienced injection below the ideal site for deltoid injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  A physician reported that a patient received the vaccine injection below the ideal site for deltoid injection. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event was considered recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Extension of second dose, more than 28 days later; A spontaneous report was received from consumer (patient's daughter) for a 74-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extension of second dose, more than 28 days later.  The patient's medical history was not provided. No concomitant product use was reported.  On 12-Jan- 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient was scheduled to receive the second dose of two planned doses of vaccine on 13-FEB-2021, but the site was closed. The patient was rescheduled to receive the second dose on 01-MAR-2021. The reporter was aware that the rescheduled dosing date is past 28 days marker. The reporter was concerned with the risk of extending out the second dose.  Action taken with 2nd dose of mRNA-1273 was unknown.  The outcome of the event, extension of second dose, more than 28 days later was recovered/resolved.  The reporter did not provide the assessment for the event extension of second dose, more than 28 days later.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Vaccination underdose; Some white liquid that was cold running down; A spontaneous report was received from other health care professional concerning a  73Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event some white liquid that was cold running down/ Vaccination site discharge, Incorrect dose administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12-JAN-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 22-FEB-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left deltoid.  On 22-FEB-2021, The patient experienced some white liquid that was cold running down.   Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 22-FEB-2021, the outcome of the event some white liquid that was cold running down was resolved.; Reporter's Comments: This report refers to a case of Vaccination site discharge and vaccination underdose for mRNA-1273, lot # 031L20A,  with no associated AEs.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Back pain, Dry mouth, Fatigue, Headache
Clinical narrative: Lips and tongue stuck together due to dry mouth; feel like autoimmune disease flared up; Both arms were sore; The back of her head ached; upper back hurt; Felt wiped out; A Spontaneous  report, was received from a consumer concerning a 84-year- old  female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, and experienced fell like autoimmune flared up (autoimmune disorder), back of her head ached (headache), both arms were sore (limb discomfort), her upper back hurt (back pain), wiped out (fatigue) and extreme dry mouth.  Patient's medical history included Sjogren's syndrome, Autoimmune thyroiditis.   On 04 Feb 2021, the patient got the first dose of mRNA-1273 (Lot number: 016M20A) intramuscular upper arm location injection prophylaxis for COVID-19 infection. After 8 hours of receiving the first dose she felt like her autoimmune disease flared up, both of her arm were sored, the back of her head ached, her upper back hurt. She felt wiped out and went to bed much earlier than she normally does. The next day, her mouth was extremely dry, her lips and tongue was stuck together (due to the dry mouth). She did not take anything to alleviate the symptoms. She has not called her healthcare provider. Consent was given for safety to follow up.  The action taken for fell like autoimmune flared up, back of her head ached, her upper back hurt ,extremely dry mouth, lips and tongue were struck together due to dry mouth and extreme dry mouth was unknown.  The outcome for the events fell like autoimmune flared up, back of her head ached, her upper back hurt ,extremely dry mouth, lips and tongue were struck together due to dry mouth and extreme dry mouth was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (pain in extremity, headache, back pain, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the event-Autoimmune disorder has been provided. The subject's history of Sjogren's syndrome may remain a risk factor for dry mouth. Further information has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Lips and tongue stuck together due to dry mouth; feel like autoimmune disease flared up; Both arms were sore; The back of her head ached; upper back hurt; Felt wiped out; A Spontaneous  report, was received from a consumer concerning a 84-year- old  female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, and experienced fell like autoimmune flared up (autoimmune disorder), back of her head ached (headache), both arms were sore (limb discomfort), her upper back hurt (back pain), wiped out (fatigue) and extreme dry mouth.  Patient's medical history included Sjogren's syndrome, Autoimmune thyroiditis.   On 04 Feb 2021, the patient got the first dose of mRNA-1273 (Lot number: 016M20A) intramuscular upper arm location injection prophylaxis for COVID-19 infection. After 8 hours of receiving the first dose she felt like her autoimmune disease flared up, both of her arm were sored, the back of her head ached, her upper back hurt. She felt wiped out and went to bed much earlier than she normally does. The next day, her mouth was extremely dry, her lips and tongue was stuck together (due to the dry mouth). She did not take anything to alleviate the symptoms. She has not called her healthcare provider. Consent was given for safety to follow up.  The action taken for fell like autoimmune flared up, back of her head ached, her upper back hurt ,extremely dry mouth, lips and tongue were struck together due to dry mouth and extreme dry mouth was unknown.  The outcome for the events fell like autoimmune flared up, back of her head ached, her upper back hurt ,extremely dry mouth, lips and tongue were struck together due to dry mouth and extreme dry mouth was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (pain in extremity, headache, back pain, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the event-Autoimmune disorder has been provided. The subject's history of Sjogren's syndrome may remain a risk factor for dry mouth. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Headache; Fever; Fatigue; Doses administered accidentally/ unintentionally > 1 month apart; A spontaneous report was received from a consumer concerning his wife, a 73-years-old female patient, who received Moderna's covid-19 vaccine (mRNA -1273) and experienced the events, headache(headache), fever(pyrexia), fatigue(fatigue) and second dosage vaccine administration past the 28 day mark (inappropriate schedule of product administration).  The patient's medical history was not provided. Concomitant medications were not reported.  On 18-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 23-FEB-2021 at 1600, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection  On 18-JAN-2021, the patient received the first dose of mRNA-1273. On 23-FEB-2021, the patient received second dose of vaccine past 28 days marker and on 24-FEB-2021, she woke up and experienced headache, fever, and fatique. As per the report, the patient's pain level was of 3 out of 10. Treatment details were not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events was not applicable.  At the time of this report, the outcome of the events, headache, fever and fatigue were unknown. The event, second dosage vaccine administration past 28 days marker, was considered to be recovered/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 events headache, fever and fatigue, a causal relationship cannot be excluded.The causality for the event inappropriate schedule of vaccine administration  is assessed as Not Applicable.