chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pyrexia, Syncope
Clinical narrative: High fever during night of vaccine (did not check with thermometer). Felt dizzy next morning and fainted twice. Felt better by that afternoon.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Eye pain, Muscle fatigue
Clinical narrative: Arm pain but it was tolerable, but extreme joint pain, as well as extreme muscle pain, fatigue, and eye pain. Tinnitus and dizziness. Also had chills. Remained pretty consistent for a day and half.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Tinnitus
Clinical narrative: Arm pain but it was tolerable, but extreme joint pain, as well as extreme muscle pain, fatigue, and eye pain. Tinnitus and dizziness. Also had chills. Remained pretty consistent for a day and half.
Age: 23.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; VAQTA was inadvertently administered after its labeled expiry date; This spontaneous report was received from a registered nurse and refers to a 23-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medication provided. On 26-JAN-2021 the patient was vaccinated with expired hepatitis a vaccine, inactivated(VAQTA) vial, 1 dose, lot # S037821 with expiration date on 07-JAN-2021 (exact dose, route of administration were unknown) for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Joint pain; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown.   The reporter considered the joint pain to be possibly related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The reporter wanted to know how long it would take before the joint pain goes away from Shingrix shot.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253490:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Got sick as heck; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient stated that he/she would never take another dose, did one time got sick as heck. Also stated that they could take all of their vaccines and stick it where the sun did not shine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm sore /  I had with initial shot; Arm / swollen /  I had with initial shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were unknown.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experinced arm sore and swollen.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254720:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No adverse event
Clinical narrative: Get the HepB vaccines / I did / A "titer" test / showed I didn't have any antibodies against HepB; This case was reported by a other health professional via interactive digital media and described the occurrence of therapy non-responder in a adult patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, several years after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient worked in healthcare for 30 yrs and was recommended the HepB vaccines and patient received. Several years later had blood drawn for a titer test and it showed and did not had any antibodies against HepB. The reporter siblings and patient had our childhood shots. All but one of us was fine. The patient eldest sister not at all and developed encephalitis which was one of the rarest side effects and was fine until 8 yrs old when started having seizures and falling down a lot.  By the time the patient sister was 10 and could no longer walk talk or even sit up or feed and eventually developed cerebral palsy and lost most of her sight and hearing. The patient sister lived until was 30 but had to live in a nursing facility due to the high level of care required. It was def a catastrophic disease and it changed the whole course of family's life.  The reporter asked could vaccine cause terrible side effects that can affect the rest of life. The vaccines are not to be taken lightly and take several years to properly study and test. Even if the vaccine was taken it did not guarantee that would developed antibodies anyway. This case linked with US2020AMR254828, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254828:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: have fever 102.5; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd December 2020, the patient received Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient said that took Shingrix day before the report and had fever 102.5 was that normal. The information regarding consent to follow up was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient had a reaction to the Shingrix vaccine and had a rash for over 2 weeks. The information regarding consent to follow up was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Product administered to patient of inappropriate age
Clinical narrative: Patient was younger than 50; Slight pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 46-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had outbreaks of shingles 2 to 6 times a year for the past 10 years or so).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain and inappropriate age at vaccine administration. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 45 or 46 year. After receiving the 1st dose of Shingrix, the patient felt an immediate difference and got slight pain for 2 months and they felt as if the body was fighting off. The reporter consented to follow-up. For tolerance to the 2nd dose of Shingrix, refer case US2021AMR033905; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR033905:Same reporter, same suspect, same patient, 2nd dose
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough
Clinical narrative: coughing; This case was reported by a consumer via call center representative and described the occurrence of cough in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In September 2018, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced cough. The patient was treated with medication unknown (Inhalers (Unknown Medication)). On an unknown date, the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the cough to be related to Shingrix.  Additional details were provided as follows: The reporter was a friend of the patient.   In July 2018, the patient received 1st dose of Shingrix. The patient had been to multiple doctors and prescribed inhalers that did not relieve the coughing.  The patient was diagnosed with gastroesophageal reflux disease but after testing, that was ruled out. The reporter consented to follow up. No phone available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: nauseous, she thought it was stomach flu; really ached whenever she moved her arm; became really sick with fever; chills; headache; pain in left arm (injection site pain)/ Arm pain described as high rate of pain; swollen arm; nauseous, she thought it was stomach flu; This case was reported by a consumer and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included anaphylactoid shock (after she took Lodine).   In October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, 6 hrs after receiving Shingrix, the patient experienced fever, chills, headache, pain in arm, swelling arm, nausea, stomach flu and pain upon movement. In October 2020, the outcome of the fever, chills, headache, pain in arm, swelling arm, nausea, stomach flu and pain upon movement were recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache, pain in arm, swelling arm, nausea, stomach flu and pain upon movement to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient was really sick with fever, chills and headache. She also experienced pain in left arm (injection site pain, never got red but it was swollen and really ached whenever she moved her arm.. The arm pain described as high rate of pain.  The patient felt nauseous, she thought it was stomach flu. The lot number was unknown and reporter said she would call back with lot number.  The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: nauseous, she thought it was stomach flu; really ached whenever she moved her arm; became really sick with fever; chills; headache; pain in left arm (injection site pain)/ Arm pain described as high rate of pain; swollen arm; nauseous, she thought it was stomach flu; This case was reported by a consumer and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included anaphylactoid shock (after she took Lodine).   In October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, 6 hrs after receiving Shingrix, the patient experienced fever, chills, headache, pain in arm, swelling arm, nausea, stomach flu and pain upon movement. In October 2020, the outcome of the fever, chills, headache, pain in arm, swelling arm, nausea, stomach flu and pain upon movement were recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache, pain in arm, swelling arm, nausea, stomach flu and pain upon movement to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient was really sick with fever, chills and headache. She also experienced pain in left arm (injection site pain, never got red but it was swollen and really ached whenever she moved her arm.. The arm pain described as high rate of pain.  The patient felt nauseous, she thought it was stomach flu. The lot number was unknown and reporter said she would call back with lot number.  The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: Shivers; Cold; This case was reported by a pharmacist via call center representative and described the occurrence of shivers in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced shivers and cold. On an unknown date, the outcome of the shivers and cold were recovered/resolved.   It was unknown if the reporter considered the shivers and cold to be related to Shingrix.  Additional details were provided as follows: The patient had experienced colds/shivers after receiving 1st dose of Shingrix. The reporter also stated that the patient did not experience swelling, shortness of breath, paralysis, or anything like that. The reporter consented to follow-up and provided contact information. This case has been linked with US2020254940, reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020254940:Same reporter, same suspect, same patient, diferent dose (1st dose)
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given second dose vaccine on 3 Feb 2021, first dose was given on 2 Feb 2021; A spontaneous report was received from a physician concerning a 58-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, given second dose vaccine on 3 Feb 2021, first dose was given on 2 Feb 2021.    The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 02 Feb 2021. On 03 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in arm for prophylaxis of COVID-19 infection.  On 03 Feb 2021, the second dose Moderna COVID vaccine was given to a patient, with the administrator unknowingly as unaware about the first dose had been administered the day before on 02 Feb 2021. 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 event was not applicable.   The outcome of the event, inappropriate schedule of vaccine administered, was considered resolved on 03 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Sub-cutaneous injection; A spontaneous report was received from a healthcare professional concerning a 77-year old, female who received Moderna's COVID-19 vaccine (mRNA-1273) sub-cutaneous instead of intramuscularly.   The medical history was not provided. Concomitant medications included heart medication, blood pressure medication, blood thinner, and cholesterol pills.  On 04 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) subcutaneous for prophylaxis of COVID-19 infection.  On 04 Feb 2021, the patient received vaccine subcutaneous route instead of intramuscular route.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was resolved.; Reporter's Comments: This case concerns a 77-year old female patient  who received their first of two planned doses of mRNA-1273 (Lot 030L20A), reporting Incorrect route of product administration without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pericarditis
Clinical narrative: Acute pericarditis; Soreness on the left shoulder (injection site); A spontaneous report was received from a consumer who was also a 75-years-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced soreness on the left shoulder (injection site)/ injection site soreness and acute pericarditis/ pericarditis.  The patient's medical history was not provided. Concomitant medications were not reported.  On 16 Jan 2021, seven days prior to onset of the events, the patient received their first two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for the prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced soreness on the left shoulder (injection site), tiredness, headache, and chest pain.   On 02 Feb 2021, he had difficulty breathing even with his continuous positive airway pressure (CPAP) machine and called 911. He was taken to emergency room (ER) and was diagnosed with acute pericarditis.  Treatment included ibuprofen, pantoprazole, and colchicine.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, soreness on the left shoulder (injection site and acute pericarditis, was not reported.; Reporter's Comments: This case concerns a 75 year old male subject, who experienced a serious unexpected event of Pericarditis and a non-serious expected event of injection site pain after first dose of mRNA1273 (Lot# 039K20A). Very limited information has been provided regarding the event of pericarditis at this time. Further information has been requested.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Respiratory failure
Clinical narrative: Hypoxic failure secondary to acute on chronic diastolic heart failure; Shortness of breath; Weak; Tired; A spontaneous report was received from a healthcare professional concerning a 90-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypoxic failure secondary to acute on chronic diastolic heart failure, shortness of breath, tired, and weak.  The patient's medical history, as provided by the reporter, included chronic diastolic heart failure. Concomitant product use was not provided.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A), intramuscularly for prophylaxis of COVD-19 infection.  On 16 Jan 2021, the patient had shortness of breath, was tired and weak. He was taken to the hospital and diagnosed with hypoxic failure secondary to acute on chronic diastolic heart failure. Treatment for the events included intravenous (IV) bumetanide. The patient was discharged home with oxygen on an unknown date.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, hypoxic failure secondary to acute on chronic diastolic heart failure, shortness of breath, tired, and weak, was unknown.; Reporter's Comments: Based on  the diagnosis of hypoxic failure secondary to acute on chronic diastolic heart failure provided by the hospital, the event is assessed as unlikely related to mRNA-1273. Further information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure via skin contact, Underdose, Wrong technique in product usage process
Clinical narrative: Do not feel that the medication was delivered into arm; Heard a click as withdrew the needle, fluid squirted; Do not feel that the medication was delivered into arm; A spontaneous report was received from a consumer concerning a 73-year-old female patient who experienced heard a click as withdrew the needle, fluid squirted and do not feel that the medication was delivered into arm.   The patient's medical history included cancer.  Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medication, rapid heartbeat medication, medication for a blood clot in their lung, vitamins and minerals      The patient received their first of two planned doses of mRNA-1273 on 08 Jan 2021.  On 05 Feb 2021 the patient received their second of two planned doses of mRNA-1273 (LOT #031L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    Patient had their first dose of the Moderna vaccine on 08Jan2021 in their left arm, and their second dose on Friday 05Feb2021 in their right arm, both at the Health Department. During the administration of the second dose, the patient heard a click noise, and as the syringe was pulled out they noticed some fluid came out. Patient wants to know if they got the full dose, or not, and what to do regarding this.  Patient provides consent for Safety to follow up Lot# for the second dose is 031L20A.  Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of heard a click as withdrew the needle, fluid squirted and do not feel that the medication was delivered into arm was considered as resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Vaccine underdose and Wrong technique of vaccine administration for mRNA-1273, lot number 031L20A,  with no associated AEs.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Do not feel that the medication was delivered into arm; Heard a click as withdrew the needle, fluid squirted; Do not feel that the medication was delivered into arm; A spontaneous report was received from a consumer concerning a 73-year-old female patient who experienced heard a click as withdrew the needle, fluid squirted and do not feel that the medication was delivered into arm.   The patient's medical history included cancer.  Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medication, rapid heartbeat medication, medication for a blood clot in their lung, vitamins and minerals      The patient received their first of two planned doses of mRNA-1273 on 08 Jan 2021.  On 05 Feb 2021 the patient received their second of two planned doses of mRNA-1273 (LOT #031L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    Patient had their first dose of the Moderna vaccine on 08Jan2021 in their left arm, and their second dose on Friday 05Feb2021 in their right arm, both at the Health Department. During the administration of the second dose, the patient heard a click noise, and as the syringe was pulled out they noticed some fluid came out. Patient wants to know if they got the full dose, or not, and what to do regarding this.  Patient provides consent for Safety to follow up Lot# for the second dose is 031L20A.  Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of heard a click as withdrew the needle, fluid squirted and do not feel that the medication was delivered into arm was considered as resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Vaccine underdose and Wrong technique of vaccine administration for mRNA-1273, lot number 031L20A,  with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: while it was administered, the syringe came off the needle and some of the dose ran down the arm; syringe came off the needle and some of the dose ran down the arm; A spontaneous report  was received from a Health Professional concerning patient who was administered Moderna's COVID-19 vaccine.  The patient medical history was not included. Patient concomitant was not included  On unknown date, the patient received their second of two planned doses of mRNA-1273 (Lot number: Unknown) prophylaxis of COVID- 19 infection.  Pharmacist states a patient received the second dose of the Moderna Covid-19 vaccine and while it was being administered, the syringe came off the needle and some of the dose ran down the arm. Don't know how much of the vaccine the patient received and wants to know if and when they should receive another dose.  Treatment of these event (s) were not provided.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported; Reporter's Comments: This report refers to a case of device connection issue, and underdose for mRNA-1273 with no associated AEs.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Fatigue, Hallucination
Clinical narrative: Cold and clammy; Fever of 104 F; Injection site pain; Headache; Muscle pain; Chills; Joint Pain; Fatigue; Nausea; Hallucinations; Tachycardia; Felt Unwell; A spontaneous report was received from a healthcare professional, concerning a 41-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced hallucinations, injection site pain, headache, muscle pain (arthralgia), chills, joint pain, fever of 104 F (pyrexia) with fatigue, nausea, felt unwell (malaise), tachycardia and felt cold and clammy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration on unknown date.  On 05 Feb 2021 at 10:00 am prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Feb 2021, approximately at 18:00 patient developed injection site pain, headache, muscle pain, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy. On 08 Feb 2021, patient was cold and clammy and heart rate was 110-120 bpm. Patient treated symptoms at home. No treatment information was provided.  Consent for safety follow up was given.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, experienced injection site pain, headache, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy were unknown. On 08 Feb 2021, The event, muscle pain considered resolved.; Reporter's Comments: This case concerns a 41 year old, female patient, who experienced a serious unexpected event of Hallucination after receiving second dose of mRNA-1273.  Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Malaise, Myalgia, Nausea
Clinical narrative: Cold and clammy; Fever of 104 F; Injection site pain; Headache; Muscle pain; Chills; Joint Pain; Fatigue; Nausea; Hallucinations; Tachycardia; Felt Unwell; A spontaneous report was received from a healthcare professional, concerning a 41-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced hallucinations, injection site pain, headache, muscle pain (arthralgia), chills, joint pain, fever of 104 F (pyrexia) with fatigue, nausea, felt unwell (malaise), tachycardia and felt cold and clammy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration on unknown date.  On 05 Feb 2021 at 10:00 am prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Feb 2021, approximately at 18:00 patient developed injection site pain, headache, muscle pain, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy. On 08 Feb 2021, patient was cold and clammy and heart rate was 110-120 bpm. Patient treated symptoms at home. No treatment information was provided.  Consent for safety follow up was given.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, experienced injection site pain, headache, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy were unknown. On 08 Feb 2021, The event, muscle pain considered resolved.; Reporter's Comments: This case concerns a 41 year old, female patient, who experienced a serious unexpected event of Hallucination after receiving second dose of mRNA-1273.  Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Vaccination site pain
Clinical narrative: Cold and clammy; Fever of 104 F; Injection site pain; Headache; Muscle pain; Chills; Joint Pain; Fatigue; Nausea; Hallucinations; Tachycardia; Felt Unwell; A spontaneous report was received from a healthcare professional, concerning a 41-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced hallucinations, injection site pain, headache, muscle pain (arthralgia), chills, joint pain, fever of 104 F (pyrexia) with fatigue, nausea, felt unwell (malaise), tachycardia and felt cold and clammy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration on unknown date.  On 05 Feb 2021 at 10:00 am prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Feb 2021, approximately at 18:00 patient developed injection site pain, headache, muscle pain, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy. On 08 Feb 2021, patient was cold and clammy and heart rate was 110-120 bpm. Patient treated symptoms at home. No treatment information was provided.  Consent for safety follow up was given.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, experienced injection site pain, headache, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy were unknown. On 08 Feb 2021, The event, muscle pain considered resolved.; Reporter's Comments: This case concerns a 41 year old, female patient, who experienced a serious unexpected event of Hallucination after receiving second dose of mRNA-1273.  Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine administered subcutaneously; A spontaneous report was received from a consumer concerning a 72-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administration by subcutaneous route (: Incorrect route of product administration).   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 09 Feb 2021, after administration of the vaccine, the patient asked the provider how the vaccine was administered, and the provider said subcutaneously. Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The event, administration by subcutaneous route, was considered recovered/resolved on 09 Feb 2021.; Reporter's Comments: This case concerns a 72-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 016M20A), reporting Incorrect route of product administration without any associated adverse events.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: reaction to an Influenza vaccine; Initial information received on 05-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an adult patient who experienced reaction to an influenza vaccine (vaccination complication), while he/she received vaccine INFLUENZA VACCINE.   The patient's past vaccination(s) included INFLUENZA VACCINE in JUN-2018 and PNEUMO 23. The patient's medical history, past medical treatment(s) and family history were not provided.   On an 29-Nov-2018, the patient received a 0.5 mL dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot JD029AB and expiry date 05-Feb-2019) via intramuscular route in deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious reaction to an influenza vaccine (vaccination complication) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that the patient had a reaction to an Influenza vaccine that was received in 2018 and also another vaccine Pneumo. It was not a severe reaction. This came up in conversation as the COVID vaccine was being discussed.  No relevant laboratory tests were reported   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as unknown for reaction to an influenza vaccine.
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Patient died from a flu shot; Initial information was received on 12-Feb-2021 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media.  This case involves a male patient (age unspecified) who died (death), after he received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events before death.  It was unknown if there were laboratory data/results available.   It was not reported if the patient received any corrective treatment before death.  It was unknown if an autopsy was done. The cause of death was not clearly specified (patient was died from flu shot).  At the time of reporting it was reported that, product name was not provided and it was reported via public post on the Sanofi flu shot campaign hence reporter assumed that the consumer was referring to the Sanofi flu vaccine.  There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from involved a male patient (age unspecified) who died (death) after administration of INFLUENZA VACCINE. The time to onset is unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient died from a flu shot
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus
Clinical narrative: Arm is red, itchy and swollen, feels hard to touch. Started in the evening after vaccination and has gotten worse. I'm trying Benadryl today because it's more swollen and itchy than previous days. I'm scheduled to see my primary care doctor 2/22/21.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Dizziness, Fall, Feeling abnormal
Clinical narrative: Patient previously had dizzy spills, but about a week after receiving the vaccine her dizzy spills began to get worse. The whole prior she kept saying I am just not right. On the 2/7/21 she a COVID test done, a nurse came to her house and preformed. On the morning of the 8th patient was on the phone with someone else and patient asked this person to call me and go check on her. Within 5 minutes I was over at her house, and I found her on the floor, she on her belly facedown. It looked like she was on the toilet, and it looked like she fall getting her off, she was still wet, she still felt warm. I called the ambulance and immediately  began CPR. When EMS arrived they took over the CPR and transported her to the Hospital. The EMS was there for about 40 minutes and used an machine to preform the compressions. She was pronounced deceased at the hospital.  No autopsy was done.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Resuscitation, SARS-CoV-2 test negative
Clinical narrative: Patient previously had dizzy spills, but about a week after receiving the vaccine her dizzy spills began to get worse. The whole prior she kept saying I am just not right. On the 2/7/21 she a COVID test done, a nurse came to her house and preformed. On the morning of the 8th patient was on the phone with someone else and patient asked this person to call me and go check on her. Within 5 minutes I was over at her house, and I found her on the floor, she on her belly facedown. It looked like she was on the toilet, and it looked like she fall getting her off, she was still wet, she still felt warm. I called the ambulance and immediately  began CPR. When EMS arrived they took over the CPR and transported her to the Hospital. The EMS was there for about 40 minutes and used an machine to preform the compressions. She was pronounced deceased at the hospital.  No autopsy was done.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: CHILLS, BODY ACHES, FATIGUE
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Feeling abnormal, Feeling drunk, Full blood count normal
Clinical narrative: 2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and palpitations.   Vision (only have one eye) has been hazy when looking at computer.  This is still on going.  Work up done by optometrist  at this point eye checks ok but problem persist.    Referral to ophthalmologist is place.  Feeling of fogginess in head - "drunk like feeling" persisted for several weeks.  This still seems to be on going.  Palpitations and some check pain.  - This was never a finding prior to 2nd dose of vaccine.   This has resolved.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Magnetic resonance imaging head abnormal, Metabolic function test normal, Palpitations, Red blood cell sedimentation rate increased
Clinical narrative: 2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and palpitations.   Vision (only have one eye) has been hazy when looking at computer.  This is still on going.  Work up done by optometrist  at this point eye checks ok but problem persist.    Referral to ophthalmologist is place.  Feeling of fogginess in head - "drunk like feeling" persisted for several weeks.  This still seems to be on going.  Palpitations and some check pain.  - This was never a finding prior to 2nd dose of vaccine.   This has resolved.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: 2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and palpitations.   Vision (only have one eye) has been hazy when looking at computer.  This is still on going.  Work up done by optometrist  at this point eye checks ok but problem persist.    Referral to ophthalmologist is place.  Feeling of fogginess in head - "drunk like feeling" persisted for several weeks.  This still seems to be on going.  Palpitations and some check pain.  - This was never a finding prior to 2nd dose of vaccine.   This has resolved.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Injected limb mobility decreased, Lymphadenopathy, Neck pain
Clinical narrative: swollen left arm down though elbow area, swollen underarm area, swollen and pain left side of breast up near under arm,   could not lift left arm, painful down arm, up neck area, still having pain in arm. Pain is subsiding gradually daily, still noticeable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: swollen left arm down though elbow area, swollen underarm area, swollen and pain left side of breast up near under arm,   could not lift left arm, painful down arm, up neck area, still having pain in arm. Pain is subsiding gradually daily, still noticeable.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: STRONG CHILLES, FEVER  SINTOMES ONE DAY.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Rash, Sensation of foreign body, Urticaria
Clinical narrative: Within 10 minutes started with lump in throat chest discomfort.  Progressed to coming, rash and hives.     Given zofran, Epi, benadryl, Pepcid and solumedrol. All iv
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Anti factor Xa assay normal, Antinuclear antibody negative, Antiphospholipid antibodies, Antithrombin III, Asthenia
Clinical narrative: -Approximately 5 hours after injection, developed 12 hours of chills (no fever), diffuse aching, fatigue, and very low energy. -Approximately 3 days after vaccine noted difficulty completing usual daily exercise routine-stamina appeared low. -Approximately 3-5 days after vaccine noted difficulty completely taking in deep breath, with "catch" or discomfort in substernal area. -During early morning hours of day 7 after vaccine, was awakened with sharp, intense toothache pain right flank.  With change of position was able to get comfortable after which pain resolved.  This reoccurred the next two nights prompting ED visit. -First ED visit focused on right flank pain and CT Abdomen and pelvis was negative except for "atelectasis" right lung base -Due to more pleuritic symptoms, second ED visit occurred, and CT chest with contrast demonstrated bilateral PEs (approximately 5 on right and 2 on left) with evidence for RV strain -Hospitalized and started on anticoagulation (Lovenox SQ for one dose and then Eloquis). Echocariogram confirmed mild RV dilatation.  Interventional Radiology did not feel removal/lysis of clots necessary. -Completed exhaustive evaluation with Hematology--no underlying clotting disorder identified to date -Have returned to 100% activity without significant symptoms at present
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Atelectasis, Cardiolipin antibody, Chest discomfort, Chills, Coagulation factor V level
Clinical narrative: -Approximately 5 hours after injection, developed 12 hours of chills (no fever), diffuse aching, fatigue, and very low energy. -Approximately 3 days after vaccine noted difficulty completing usual daily exercise routine-stamina appeared low. -Approximately 3-5 days after vaccine noted difficulty completely taking in deep breath, with "catch" or discomfort in substernal area. -During early morning hours of day 7 after vaccine, was awakened with sharp, intense toothache pain right flank.  With change of position was able to get comfortable after which pain resolved.  This reoccurred the next two nights prompting ED visit. -First ED visit focused on right flank pain and CT Abdomen and pelvis was negative except for "atelectasis" right lung base -Due to more pleuritic symptoms, second ED visit occurred, and CT chest with contrast demonstrated bilateral PEs (approximately 5 on right and 2 on left) with evidence for RV strain -Hospitalized and started on anticoagulation (Lovenox SQ for one dose and then Eloquis). Echocariogram confirmed mild RV dilatation.  Interventional Radiology did not feel removal/lysis of clots necessary. -Completed exhaustive evaluation with Hematology--no underlying clotting disorder identified to date -Have returned to 100% activity without significant symptoms at present
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram thorax, Dyspnoea, Echocardiogram abnormal, Electrocardiogram ST-T segment abnormal
Clinical narrative: -Approximately 5 hours after injection, developed 12 hours of chills (no fever), diffuse aching, fatigue, and very low energy. -Approximately 3 days after vaccine noted difficulty completing usual daily exercise routine-stamina appeared low. -Approximately 3-5 days after vaccine noted difficulty completely taking in deep breath, with "catch" or discomfort in substernal area. -During early morning hours of day 7 after vaccine, was awakened with sharp, intense toothache pain right flank.  With change of position was able to get comfortable after which pain resolved.  This reoccurred the next two nights prompting ED visit. -First ED visit focused on right flank pain and CT Abdomen and pelvis was negative except for "atelectasis" right lung base -Due to more pleuritic symptoms, second ED visit occurred, and CT chest with contrast demonstrated bilateral PEs (approximately 5 on right and 2 on left) with evidence for RV strain -Hospitalized and started on anticoagulation (Lovenox SQ for one dose and then Eloquis). Echocariogram confirmed mild RV dilatation.  Interventional Radiology did not feel removal/lysis of clots necessary. -Completed exhaustive evaluation with Hematology--no underlying clotting disorder identified to date -Have returned to 100% activity without significant symptoms at present