chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pharyngeal swelling, Pruritus, Urticaria
Clinical narrative: Anaphylactic reaction; swollen throat; eyes itching; eyes swollen; swollen lips; She had hives all around her waistband, back, arms, chest, and her hair; Palms were red; palms were very itchy; her arm was tender; A spontaneous report  was received from a consumer concerning a 71-Year-Old female patient, who was administered Moderna's COVID-19 vaccine second dose and her arm was tender, palms were itchy, palms were very red, hives all around waistband, back, arms, chest and hair, swollen throat, swollen lips, eyes swollen and eyes itching and anaphylactic reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13-Jan-2021 the patient received their first of two planned doses of mRNA-1273 (Lot Number:012L20A) Intramuscularly in the left arm. On 11-Feb-2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11-Feb-2021, patient stated her arm was tender, but she was able to sleep on her side. On 12-Feb-2021 night, her palms were very itchy. On 13-Feb-2021, approximately at 04:30 am patient stated it was like someone had a blowtorched on her palms. Her palms were very red, "as red can be" and itching tremendously. When she used the bathroom, she had hives all around her waistband, back, arms, chest and her hair. Patient went to ER. Since her ER visit, patient stated some of her spots on her chest lighten up and her hands were not as bad. Patient denies ever having trouble of difficulty breathing. Patient called again and reported new adverse events from previous one. Patient went to ER for second time on 13 Feb 2021 night and experienced unbearable itching and burning. Patient felt okay until 15-Feb-2021 and went bed and woke up 1:30 am in the morning with swollen throat and lips and she thought she was experiencing anaphylactic reaction. Her eyes were swollen, itchy and needed help.  Treatment for the event included patient put an ice pack between her hands for an hour on 13-Feb-2021. The ER gave her diphenhydramine and famotidine and patient was sent home with same medications. Patient also used arnicare gel for her whole waistband, which she stated was very cooling and helped with the burning and itching. Patient received 5 doses of steroids, diphenhydramine and famotidine after second ER visit.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The events, arm was tender, palms were itchy, palms were very red, hives all around waistband, back, arms, chest and hair, swollen throat, swollen lips, eyes swollen and eyes itching and anaphylactic reaction, were considered unknow.; 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: M
Vaccine: COVID19
Symptoms: Blood test, Peripheral swelling, X-ray limb
Clinical narrative: Right leg swelled significantly, particularly at the ankle/Achilles tendon; A spontaneous report was received from a consumer who is a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right leg swelled significantly, particularly at the ankle/Achilles tendon/peripheral swelling.   The patient's medical history was not provided. No concomitant medications were reported.  On 05 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient reported his right leg swelled up, particularly at the ankle/Achilles and crippled him. He was hospitalized. During his hospitalization the patient had the following tests performed, foot x-ray which showed no damage anatomically and blood work (no results provided).   Treatment for the event included anti-inflammatories.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, right leg swelled significantly, particularly at the ankle/Achilles tendon/peripheral swelling, was considered not resolved.; Reporter's Comments: This report concerns a male consumer who received Moderna's COVID-19 Vaccine (mRNA-1273), (Lot # not provided), and within 2 days, experienced serious, unlisted, right leg/Achilles tendon/peripheral swelling. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Cough, Fatigue, Hypotension, Influenza virus test
Clinical narrative: grade 3 reaction; Hypotensive; fatigue; cough; A spontaneous report was received from a other health care professional concerning an female patient who developed grade 3 reaction, Hypotension, fatigue and cough/ Adverse reaction: hypotension: Fatigue: cough.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch no: Unknown) for prophylaxis of COVID-19 infection.  On, 25-Jan-2021 developed a grade 3 reaction, hypotension and was admitted to ER and 26-Jan-2021 patient developed fatigue and cough. IV fluids were given as treatment.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected events of grade 3 adverse reaction and hypotension and then a NS unexpected event of cough and NS expected event of fatigue.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment was not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: Blood in right eye; A spontaneous report was received from a consumer concerning a 74 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed blood in her right eye.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number:013l2o8) on 16 JAN 2021 for prophylaxis of COVID-19 infection.    Patient woke up on 26 JAN 2021, ten days after initial dose of vaccine, with blood in her right eye. She called to ask if this was a normal side effect of the COVID vaccine. Patient scheduled an appointment with an eye doctor for evaluation and reached out to her PCP. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, blood in right eye, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: missed second dose (8 week duration between); A spontaneous report was received from a healthcare professional concerning a patient who missed second dose (8 week duration between) of mRNA-1273 vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date the patient received their first of two planned doses of mRNA-1273 (Lot # not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient missed the second dose by an 8 weeks window.   Action taken with mRNA-1273 in response to the event was not provided.  The event missed second dose (8 week duration between), was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of a patient of unknown age and gender wo experienced   missed second dose (8 week duration between) for mRNA-1273 (Inappropriate schedule of vaccine administered). There were no reported AEs associated with this case of Inappropriate schedule of vaccine administered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: chills; fever; inappropriate schedule of vaccine; Sore for one day and a half; headache; A spontaneous report was received from a consumer and HCP concerning a 59 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events invalid dose (wasn't sure), headache, chills, fever, sore for one day and a half and inappropriate schedule of vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 26Jan2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 08Feb2021, prior to the onset of the events, the patient received their second dose (lot/batch:  031L20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient was told to come back in two weeks after the first vaccination to take the shot on 8Feb2021. On that day she had chills, low grade headache and fever for 20hs and sore for one day and a half (from 8 to 9Feb2021).  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events, headache, chills, inappropriate schedule of vaccine, sore for one day and a half and fever were recovered.; Reporter's Comments: This case concerns a 59 year old, female patient, who experienced a non-serious unexpected event of pain among other events, 1 days after receiving 2nd dose of mRNA- 1273 (Lot# 031L20A). This report also refers to a case of inappropriate schedule of vaccine for mRNA-1273, with no associated AEs. 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Loss of consciousness
Clinical narrative: Passed out; Felt lightheaded; Upset stomach; A spontaneous report  was received from a consumer concerning a 66 year old female patients who received   Moderna's  Covid 19 vaccine(mRNA1273) experienced loss of consciousness, dizziness and abdominal discomfort.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    The patient received first of two planned dose of mRNA-1273  for prophylaxis of Covid 19 infection on 14-FEB-2021 intramuscularly in left arm.   Patients felt lightheaded and fell unconscious at evening of vaccine administration. EMS was called ,but patient regained consciousness by the time EMS arrived. Patient also experienced abdominal discomfort on the day she got vaccinated. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event were considered as recovered/resolved.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 2nd dose 11 days after the first dose; A spontaneous report was received from a physician concerning a 76-year-old, female patient who received the 2nd dose 11 days after the first dose.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     Patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 6FEB2021.  On 17FEB2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.    Physician called to report that patient received the 2nd vaccine 11 days after receiving the first dose of the Moderna vaccine.Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event, received the 2nd dose 11 days after the first dose was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration, Urinary tract infection
Clinical narrative: urinary tract infection; Spots; itchiness; A spontaneous report was received from a consumer  concerning an 80 year old, female patient who developed urinary tract infection, spots (skin discolouration ) and itchiness (pruritus).   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient received the first dose of the vaccine in her left arm intramuscularly. One day after receiving the vaccine, the patient developed a urinary tract infection. She had never had one before. The patient also reported that she experienced spots and itchiness. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The events, urinary tract infection, spots and itchiness was unknown; Reporter's Comments: Very limited information regarding the reported events have been provided at this time. Patient's medical history, list of concomitant medications, onset date and are lacking including any laboratory test for UTI.  Further information has been requested
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Computerised tomogram, Headache
Clinical narrative: Blood pressure 209/100 plus; atherosclerosis renal arteries; speech changed; severe headaches; Joint pain; A Spontaneous report was received from a  Health care professional  concerning a  85 Years old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 8-jan-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On date or an unknown date, The patient experienced the events  atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain. with hospitilization and disability  Treatment provided Tylenol, Advil, Norvasc, lisinopril, codeine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were unknown; Reporter's Comments: This case concerns an 85-year-old female who had serious expected events of headache and serious unexpected speech disorder, increased blood pressure, renal artery arteriosclerosis and NS expected arthralgia.  Event onset was the same day as the first dose of mRNA-1273. Treated with Tylenol, Advil, Norvasc, lisinopril, codeine. Based on 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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Renal artery arteriosclerosis, Speech disorder, Ultrasound kidney
Clinical narrative: Blood pressure 209/100 plus; atherosclerosis renal arteries; speech changed; severe headaches; Joint pain; A Spontaneous report was received from a  Health care professional  concerning a  85 Years old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 8-jan-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On date or an unknown date, The patient experienced the events  atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain. with hospitilization and disability  Treatment provided Tylenol, Advil, Norvasc, lisinopril, codeine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were unknown; Reporter's Comments: This case concerns an 85-year-old female who had serious expected events of headache and serious unexpected speech disorder, increased blood pressure, renal artery arteriosclerosis and NS expected arthralgia.  Event onset was the same day as the first dose of mRNA-1273. Treated with Tylenol, Advil, Norvasc, lisinopril, codeine. Based on 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 dose administered
Clinical narrative: Dosing error (deviation for the recommended 100 mcg dose); A spontaneous report was received from a healthcare professional concerning a unknown patient who received Modern's COVID-19 vaccine (mRNA-1273) and doing error (deviation for the recommednded 100 mcg dose).  The patient's medical history and concomitant medication were not reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  The health care professional deviated the recommended dose 100 mcg (dosage error) on an unknown date.  No Laboratory details provided.  No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The event was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273,  with no associated AEs.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Nausea, Vomiting, Wrong technique in device usage process
Clinical narrative: feeling really nauseated; vomiting; Patient states when the vaccine was being administered, half the dose squirt out; another syringe was administered in addition to the previous dose; A spontaneous report was received from a consumer concerning a 76-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling really nauseated, vomiting, when the vaccine was being administered, half the dose squirt out (accidental underdose) and another syringe was administered in addition to the previous dose (extra dose administered).   The patient's medical history was not provided.   Concomitant product use was not provided.   On 21-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 26-Jan-2021, the patient reported feeling really nauseated and vomiting.  She stated that she was sick for ten days.  Additionally, when the vaccine was administered, patient stated that half of the dose squirt out and another syringe was administered in addition to the first dose.    Laboratory details were not provided.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events, feeling really nauseated, vomiting, when the vaccine was being administered, half the dose squirt out (accidental underdose) and another syringe was administered in addition to the previous dose (extra dose administered), was not reported.    The outcome of the events, feeling really nauseated, vomiting, when the vaccine was being administered, half the dose squirt out (accidental underdose) and another syringe was administered in addition to the previous dose (extra dose administered), were recovered/resolved.; Reporter's Comments: This case concerns a 76 year old, female patient, who experienced a non-serious expected event of Nausea, vomiting, 7 days after receiving 1st dose of mRNA- 1273 (Lot# Unknown). This report also refers to a case of wrong technique in device usage process and accidental overdose for mRNA-1273 (lot # unknown), with no associated AEs. Very limited information regarding this event has been provided at this time.
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Some of liquid comes out of syringe and doctor did not receive complete 0.5 ml dose; Some of liquid comes out of syringe and doctor did not receive complete 0.5 ml dose; A spontaneous report was received from a healthcare professional concerning a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the liquid came out of the syringe and did not receive complete 0.5 ml dose.  The patient's medical history was not reported. No Relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events, the patient received their second dose of mRNA-1273 intramuscularly  for prophylaxis of COVID-19 infection.   On 27 Jan 2021, the patient experienced the events of some of the liquid came out of the syringe and did not receive complete 0.5 ml dose.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.    The outcome of the events some of the liquid came out of the syringe and did not receive complete 0.5 ml dose were considered resolved on 27 Jan 2021.; Reporter's Comments: This report refers to a case of vaccine underdose and syringe issue for mRNA-1273, lot # unknown with no associated AEs.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue
Clinical narrative: may have received an incomplete dose; Patient may have received an incomplete dose because the vial leaked during administration.; A spontaneous report was received from a pharmacist concerning  a 31-year-old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced accidental underdose and syringe connection issue.   The patient's medical history and concomitant medications were not reported.  On 27-Jan-2021 the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) for prophylaxis of COVID-19 infection.  On 27-Jan-2021, the patient experienced an accidental underdose as the vial leaked during administration.  No Laboratory details provided.  No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the events, accidental underdose and syringe connection issue, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Accidental underdose and Device connection issue for mRNA-1273 (lot/batch: 028L20A) with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: It was administered to an individual who is 17 years old; A spontaneous report was received from a pharmacist concerning a 17 years old patient who received Moderna's COVID-19 vaccine (mRNA-1273).  Medical history was not reported. Concomitant medication was not reported.  On an unknown date, prior to the onset of the events it was administered to an individual who is 17 years old, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  Action taken with mRNA-1273 in response to the event It was administered to an individual who is 17 years old was not provided.  The outcome of the event It was administered to an individual who is 17 years old was resolved.  The reporter did not provide the assessment of the event It was administered to an individual who is 17 years old to study drug.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 with no associated AEs.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; A spontaneous report was received from a Dentist (healthcare professional)  concerning a 16 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22-jan-2021, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.  No Treatment information has been provided.   Action taken with mRNA-1273 in response to the events was unknown/ not reported.   The outcome, vaccine administered to a 16-year old male, was considered resolved on 22 Jan 2021.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administered for mRNA-1273 with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: They have used a 5/8 inch needle so she believes it was administered subcutaneously; A spontaneous report was received from a healthcare facility staff member concerning a 51-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced incorrect route of product administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) in the right arm for prophylaxis of COVID-19 infection.  On 30-DEC-2020,  it was reported that a 5/8 inch needle was used and the reporter believed that the vaccine was administered subcutaneously.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event,  incorrect route of product administration was considered recovered/resolved.; Reporter's Comments: This report refers to a case of inappropriate route of vaccine administration for mRNA-1273 (lot/batch: 026L20A)  with no associated AEs.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Device leakage, Incorrect dose administered
Clinical narrative: The vaccine leaked out of the vial, it ran down to his elbow; The vaccine leaked out of the vial, it ran down to his elbow; A spontaneous report was received from a consumer, regarding himself, a 53-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273), where vaccine leaked out of the vial, it ran down to his elbow.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (MOD-2021-021503) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 02 Feb 2021, the vaccine leaked out of the vial, it ran down to his elbow. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events vaccine leaked out of the vial, it ran down to his elbow was considered as resolved on 02 Feb 2021.; Reporter's Comments: This case concerns a 53-year-old male who experienced nonserious unexpected events of Device leakage and Incorrect dose administered for mRNA-1273 (lot # unknown) without associated adverse events.  He reported that vaccine leaked out of the vial, it ran down to his elbow. The events occurred the same day as the first dose of mRNA-1273.  Event outcome resolved.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A county inadvertently gave a 16 year old for the first dose of Moderna; A spontaneous report was received from a HCP concerning a 16 Years-old patient of unknown gender who experienced  the first dose of Moderna given by a county inadvertently.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  A county inadvertently gave a 16 year old for the first dose of Moderna. Treatment details were not provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event- inappropriate age at vaccine administration was unknown.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with no reported AEs.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient of 17YO received the vaccine; A spontaneous report was received from a health care professional concerning a 17 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event patient of 17YO received the vaccine was resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot #unknown)  with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient of 17YO received the vaccine; A spontaneous report was received from a health care professional concerning a 17 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event patient of 17YO received the vaccine was resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash papular
Clinical narrative: red spots/blotches on his ankles, hips, back, and chest; little red bumps come up; skin rash; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunization. Medical history included cancer sores and history of cancer, both from unspecified dates and unspecified if ongoing. Concomitant medications were not reported. On unspecified dates the patient experienced red spots/blotches on his ankles, hips, back, and chest, little red bumps come up and skin rash, all reported as non-serious. The patient called to state that he received the first dose of the Pfizer COVID-19 vaccine "about 2 and a half weeks ago" but did not remember the exact date. He stated that his next dose was on 05Feb2021. He called because he had an adverse event and wanted to know what to do. He stated that he had red spots/blotches on his ankles, hips, back, and chest which started after the vaccine was given. He stated he had a history of cancer. He reported that "I am fine except these little red bumps come up. I have no problem. I have these spots come up and they started down around my ankle and move onto my hips and I have few spots on the back but I do not know if the vaccine caused it or something else, so I thought I better report it anyhow." He stated that he had not experienced anything, "just this skin rash or whatever you want to call it". The patient then inquired if anyone else reported this before. He stated that he just wanted to know if this had anything to do with the COVID-19 vaccine or not. He also stated that "I do have a 'scan' doctor that takes care of cancer sores (further clarification was unknown) for me but I do not know (incomplete sentence)." The clinical outcomes of the events red spots/blotches on his ankles, hips, back, and chest, little red bumps come up and skin rash were all unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypoaesthesia, Paraesthesia, Throat tightness, Tongue disorder
Clinical narrative: Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Difficulty swallowing; Throat started to feel like it was closing up; Tongue got thick; Little blurred vision; This is a spontaneous report from a contactable consumer (the patient).  A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 26Jan2021 at 15:46 PM, (at the age of 69-year) as a single dose for COVID-19 immunization. Medical history included hypertension, pacemaker insertion. Concomitant medication was not reported, however, the patient reported that she takes medicines for hypertension, and is on blood thinners. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on 26Jan2021, after receiving the vaccination she did wait a half hour and the only symptoms she thought at the vaccination visit was a little blurred vision, which was temporary and went away. At 16:30, about 45 minutes to 1 hour after she left the vaccination center, as she was driving home, she informed that she was feeling numbness in her face around her cheeks and mouth/face was really tingling and numb, and she had difficulty swallowing;  her throat started to feel like it was closing up and her tongue was really thick.  She stated she tried to stay calm and forced herself to drink a bottle of water. She had no idea where there was any emergency area since she was not familiar with the area and tried to calm herself down and took sips of water and made sure she was breathing okay and it all went away. The reaction lasted 10-15 minutes and seem to resolve when she was able to calm herself down. She stated it was scary, and once she calmed down it all went away.  She was concerned about receiving the second dose. She did not go to a physician or emergency room, but says she probably should have. The clinical outcome of little blurred vision, feeling numbness in her face around her cheeks and mouth/her face was really tingling and numb, difficulty swallowing, throat started to feel like it was closing up, and tongue got thick was recovered.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Difficulty swallowing; Throat started to feel like it was closing up; Tongue got thick; Little blurred vision; This is a spontaneous report from a contactable consumer (the patient).  A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 26Jan2021 at 15:46 PM, (at the age of 69-year) as a single dose for COVID-19 immunization. Medical history included hypertension, pacemaker insertion. Concomitant medication was not reported, however, the patient reported that she takes medicines for hypertension, and is on blood thinners. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on 26Jan2021, after receiving the vaccination she did wait a half hour and the only symptoms she thought at the vaccination visit was a little blurred vision, which was temporary and went away. At 16:30, about 45 minutes to 1 hour after she left the vaccination center, as she was driving home, she informed that she was feeling numbness in her face around her cheeks and mouth/face was really tingling and numb, and she had difficulty swallowing;  her throat started to feel like it was closing up and her tongue was really thick.  She stated she tried to stay calm and forced herself to drink a bottle of water. She had no idea where there was any emergency area since she was not familiar with the area and tried to calm herself down and took sips of water and made sure she was breathing okay and it all went away. The reaction lasted 10-15 minutes and seem to resolve when she was able to calm herself down. She stated it was scary, and once she calmed down it all went away.  She was concerned about receiving the second dose. She did not go to a physician or emergency room, but says she probably should have. The clinical outcome of little blurred vision, feeling numbness in her face around her cheeks and mouth/her face was really tingling and numb, difficulty swallowing, throat started to feel like it was closing up, and tongue got thick was recovered.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Condition aggravated, Lymph node pain, Pain, Pleurisy
Clinical narrative: Pain on the lymph nodes/lymph nodes hurting; Hurting really bad; Pleurisy before getting the vaccine/after getting the vaccine it got really bad; Pleurisy before getting the vaccine/after getting the vaccine it got really bad; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261; Expiration date: 31May2021) on 21Jan2021 (07:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the clinic (not a military facility). Medical history included being a diabetic from 2005 and ongoing (was not on insulin, only on pills); ongoing chronic obstructive pulmonary disease (COPD) in her 50's (also reported as "it has been a while"), and was not on oxygen; ongoing anxiety attack; had a problem with her left lymph nodes in her breast; and had pleurisy that was not really that bad (taking paracetamol (TYLENOL)). Concomitant medication included ongoing metformin for being diabetic. In Jan2021, the patient had developed pain on the lymph nodes after receiving the vaccination; and the patient was hurting really bad. The patient was previously diagnosed with pleurisy (prior to the vaccination), and it was described as "bad enough for her to take Tylenol" and it was just distracting before. After getting the vaccination, in Jan2021, the patient's pleurisy got really bad, and stated that the vaccine might have attacked her lymph nodes especially the lymph nodes on her left breast, left chest, under arm and back, and that she thought the vaccine had made the pleurisy worse. The patient's condition was so bad that she had to go back to the doctor; events resulted into physician office visit. The patient was informed to take two ibuprofen 200 mg a day as treatment for the reported events. The patient had a chest-ray in Jan2021 after the doctor had diagnosed her with pleurisy (results were not provided). The outcome of the events was not recovered for 'pleurisy that got really bad'; and was unknown for 'pain on the lymph nodes' and 'hurting really bad'.
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time prolonged, Photopsia, Vision blurred, Vitreous floaters
Clinical narrative: Eye issues flashes; Floaters; blurred vision; low White Blood Counts; High PTT; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 11:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol. The patient did not have allergies to medications, food, or other products (unspecified). The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: atorvastatin calcium (LIPITOR), vitamin D NOS, and macrogol 3350 (MIRALAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021, the patient experienced eye issues flashes, floaters, blurred vision, and "IRH", new sudden onset. Follow up bloodwork revealed low white blood counts and high PTT. The patient stated treatment was received: cautious observation (as reported). The clinical outcome of eye issues flashes, floaters, blurred vision, low white blood counts, and high PTT was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: Eye issues flashes; Floaters; blurred vision; low White Blood Counts; High PTT; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 11:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol. The patient did not have allergies to medications, food, or other products (unspecified). The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: atorvastatin calcium (LIPITOR), vitamin D NOS, and macrogol 3350 (MIRALAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021, the patient experienced eye issues flashes, floaters, blurred vision, and "IRH", new sudden onset. Follow up bloodwork revealed low white blood counts and high PTT. The patient stated treatment was received: cautious observation (as reported). The clinical outcome of eye issues flashes, floaters, blurred vision, low white blood counts, and high PTT was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Gastrointestinal stoma complication, Pain, Pyrexia, Vomiting
Clinical narrative: has had a fever since this time; her ileostomy had a blockage that day and she vomited all night; her ileostomy had a blockage that day and she vomited all night; it was very severe and sore and she is just getting over the soreness; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1283, first dose) solution for injection intramuscular in left deltoid on 18Jan2021 at 14:20 (at the age of 73-years-old) at single dose for COVID-19 vaccination. Medical history included ongoing type 2 diabetes, ongoing active carcinoid cancer of liver, ongoing Ileostomy from Jul2002, surgery in 2001, second primary colon tumor, acid reflux and neuropathy in feet and legs. Concomitant medications included amlodipine besilate for blood pressure, lisinopril for blood pressure, metformin, sitagliptin phosphate (JANUVIA) and gabapentin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient has had a fever since this time on 18Jan2021 and was very severe and sore and she is just getting over the soreness in Jan2021. Temperature was 102 F on 18Jan2021, 101 F on 19Jan2021, the having a fever in varying degrees like 99 F or 100 F after in Jan2021. On 18Jan2021, her ileostomy had a blockage that day and she vomited all night. Treatment for the event fever included ibuprofen (ADVIL). The outcome of the event fever was not recovered. The outcome of the events vomited and ileostomy had a blockage was unknown. The outcome of the event pain was recovering.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: I have a temp of 100; feel tired; arm is really sore; achy; This is a spontaneous report from a contactable consumer, reporting for herself.  A 78-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Jan2021 at 14:45 (at the age of 78 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included restless legs, high blood pressure, and prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 27Jan2021 at 08:00, the patient experienced temperature of 100, feels tired and achy plus the arm is really sore. The patient did not receive treatment for the events. The clinical outcome of temperature of 100, feels tired and achy plus the arm is really sore was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.