chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash, Swelling
Clinical narrative: mild bumps on the back of both hands / 4 or 5 bumps on each hand/ on the neck and arms; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a 68-year-old male patient who received HAB (Twinrix adult) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 17th January 2020, 4 days after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced raised rash. The patient was treated with cortisone (non-proprietary) (Cortisone Topical). On an unknown date, the outcome of the raised rash was recovered/resolved.  It was unknown if the reporter considered the raised rash to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received 1st dose of Twinrix adult and 4 days after started to notice mild bumps on the back of both hands, 4 or 5 bumps on each hand. The bumps presented on the neck and arms some time later. The patient was seen by nurse practitioner on 11th Febuary 2020 and treated with topical cortisone. For further 2nd dose of Twinrix adult, refer case ID US2020AMR253500, reporter for same reporter.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Pain, Sensitive skin
Clinical narrative: achiness and throbbing around left shoulder and chest; Sore arm; sensitive skin around left shoulder and chest; sore joints in knees and elbows/shoulder PAIN; This case was reported by a consumer and described the occurrence of chest pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th December 2020, 1 days after receiving Shingrix, the patient experienced chest pain, pain in arm, sensitive skin and soreness of joint. On 20th December 2020, the outcome of the soreness of joint was recovered/resolved. On an unknown date, the outcome of the chest pain, pain in arm and sensitive skin were not recovered/not resolved.   The reporter considered the chest pain, pain in arm, sensitive skin and soreness of joint to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix and about a day later, he began to experience a sore arm, achiness and throbbing around left shoulder and chest, sensitive skin around left shoulder and chest and sore joints in knees and elbows.  The sore joints in knees and elbows lasted about 2 days.  The patient  reported that he was still experiencing the achiness, throbbing and sensitive skin in his left shoulder and chest area and that it actually may be worsening.  No LOT number or EXP date was known.   The reporter did not consent to follow up. The case has been linked with the case US2020AMR255588 reported for wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR255588:same reporter
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Culture urine positive, Delusion, Urinary tract infection, Urine analysis
Clinical narrative: act delusional/Asking for things that are impossible; results were positive for a UTI; This case was reported by a consumer via call center representative and described the occurrence of delusion in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2020, the patient received the 1st dose of Shingrix. In December 2020, 1 week after receiving Shingrix, the patient experienced delusion (serious criteria hospitalization). On an unknown date, the patient experienced urinary tract infection. On an unknown date, the outcome of the delusion and urinary tract infection were recovered/resolved.   It was unknown if the reporter considered the delusion and urinary tract infection to be related to Shingrix.  Additional details were provided as follows: The patient had the vaccine and approximately a week later he started to act delusional. The patient was asking for things that were impossible. The patient was admitted to the hospital on 16th December 2020 for 2 weeks and is in a rehap center. An urine test was performed and results were negative. A urine culture was done 3 weeks after the urinalyses and results were positive for a UTI. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 1ml dose of Moderna Vaccine was given.; A spontaneous report  was received from a pharmacist concerning patients who received Moderna's COVID-19 Vaccine and received a 1 mL dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an undisclosed date, prior to the onset of the event, the patient received their planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  The patient received 1 mL of the Moderna COVID-19 Vaccine when the nurse did not pay attention that the dose should have been 0.5 mL. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, patient received a 1 mL dose, was resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who received 1mL of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 instead of 0.5 mL dose. There were no reported adverse events in this case of accidental overdose.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Out of specification product use
Clinical narrative: Was on a blood thinner; A spontaneous report was received from a consumer who is a 89-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was on a blood thinner.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included a blood thinner.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient called to report she was given the Moderna COVID-19 vaccine while on a blood thinner (name not of drug not provided). The patient stated that she did not know she wasn't supposed to get the vaccine until she read the paperwork.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, was on a blood thinner, were considered resolved on 14 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (Lot number: not provided). The patient was given the mRNA-1273. while on a blood thinner (name not of drug not provided). The patient stated that she did not know she wasn't supposed to get the vaccine until she read the paperwork.  There were no reported AEs associated with his case of out of specification product use.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered a Moderna COVID-19 vaccine to a 16 year old; A spontaneous report  was received from a healthcare facility staff member concerning a 16-years-old patient who received Moderna's COVID-19 Vaccine and experienced Moderna's COVID-19 vaccine was administered to a 16-year-old.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 31 Dec 2020, the patient received their planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection at the age of 16-years-old. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, Moderna's COVID-19 vaccine was administered to a 16-years-old, was resolved.; Reporter's Comments: This case concerns a 16 year old patient who received their planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. There were no reported adverse events in this case of  product administered to patient of inappropriate age
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: Rectal bleeding/ Bleeding from the rectum; A spontaneous report was received from a consumer concerning a 67-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced rectal bleeding.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Xarelto, Sotalol, Synthroid, Vitamin D, Calcium Vitamin b12, Clonazepam, Hydrocodone and Metamucil.   On 26 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 032L20R) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.    On 27 Jan 2021, the patient experienced rectal bleeding. The subject informed that she got the vaccine for the first time on 26 Jan 2021 and did not tell them that she takes Xarelto. Later she experienced bleeding from her rectum while taking a bowel movement. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event rectal bleeding was not reported.; Reporter's Comments: This case concerns a 67year old female patient with medication history  within two weeks prior to the event, included Xarelto, Sotalol, Synthroid, Clonazepam, Hydrocodone and Metamucil. who experienced a serious unexpected event of Rectal haemorrhage. The event occurred approximately one day after first dose of the study medication administration. Based on medication the patient is taking, Xarelto which is blood thinner, the event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product contamination physical
Clinical narrative: Vaccine that had dark grey particulate matter present had been administered to the patient.; Vaccine that had dark grey particulate matter present had been administered to the patient; A spontaneous report was received from a healthcare professional concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) where a dark grey particulate presented inside the vial, but a dose had already been administered to the patient.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, the patient received her first of two planned doses of mRNA-1273 (Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, patient received the vaccine which already contained dark grey particulate matter inside the vial.  Treatment information was not provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event, a dose had already been administered to the patient and a dark grey particulate presented inside the vial, was resolved.; Reporter's Comments: This report refers to a case of Product  contamination physical and poor quality product administered for mRNA-1273, lot # 010M20A. There were no reported AEs associated with this case of Product contamination physical and poor quality product administered .
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: received another 50% more vaccine; A spontaneous report  was received from a nurse concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt vaccine rolling down her arm. The nurse told her that in that case, their protocol was to administer another 50% dose which she received.  The patient's medical history was not provided. Concomitant medications was not provided by the reporter.     On 18 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:010M20A) intramuscularly for prophylaxis of COVID-19 infection.    On18 JAN 2021, patient received her first injection of Moderna vaccine and she felt the vaccine rolling down her arm. The nurse told her that in that case, their protocol was to administer another 50% dose which she received.   Action taken with mRNA-1273 in response to the events was not reported.   The event, vaccine rolling down her arm and received another 50%more vaccine was considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Got shocked as when she pull out the shot/injection, she wiped her arm; A spontaneous report  was received from a consumer, a 31-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and "got shocked as when she pull out the shot/injection, she wiped her arm."   The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 01 Feb 2021, during administration of the vaccine, the patient "got shocked as when she pull out the shot/injection, she wiped her arm". The patient was concerned whether she had received the complete dose or not. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore the action taken in response to the event was not applicable.  The event, "got shocked as when she pull out the shot/injection, she wiped her arm," was considered resolved on 01 Feb 2021.; Reporter's Comments: This report refers to a case of Accidental underdose for mRNA-1273, lot # 012M20A. There were no reported AEs associated with this case of Accidental underdose.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site warmth
Clinical narrative: heat on the arm, which is warm to the touch; redness on arm; second dose administered subcutaneously; A spontaneous report was received from a health care professional (HCP) concerning a 91-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the second dose administered subcutaneously, redness on arm, and heat on the arm.  The patient's medical history was not provided. Concomitant medications reported included Senna, Zoloft, Risperdal, Aspirin, Aricept, finasteride, Lasix and multivitamins.  on 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K208) . On 26 Jan 2021, approximately 28 days after the first dose, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012M20A) subcutaneously for prophylaxis of COVID-19 infection.  The HCP stated that the patient's second dose was inadvertently administered subcutaneously. The patient experienced redness and heat on the arm, which was warm to the touch. Treatments of these events included Benadryl and Tylenol.  The event, second dose administered subcutaneously was resolved.  The events, redness on arm, and head on the arm were not resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 and concerns a 91 year-old, male patient, who experienced the events of redness on arm, and heat on the arm. The events occurred the same day after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old female received Moderna vaccine; A spontaneous report was received from a nurse concerning a 17-year-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 07Jan2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  The patient was administered mRNA-1273 vaccine at age 17 on 07Jan2021 . No treatment information was provided.  Action taken with the first dose of mRNA-1273 in response to the event was not reported.    The event, a 17 year-old female patient received Moderna vaccine, was considered resolved.; Reporter's Comments: This case concerns a 17-year old female who received her first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine was administered; A spontaneous report was received from a healthcare facility staff member concerning an 82-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  and was administered expired vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29 Jan 2021, the patient received planned dose of mRNA-1273 (Lot umber: 025L20A)  (it was not reported if this was dose 1 or dose 2) intramuscularly at unspecified site for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the vaccine vial was punctured and was set to expire at 15:30. On 29-Jan-2021, the physician accidently administered the expired vaccine to the patient. The vial was discarded after the mistake was realized.  Action taken with mRNA-1273 in response to the event was not reported.   The event expired vaccine was administered, was considered recovered / resolved on 29-Jan-2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Incontinence, Loss of consciousness, Syncope
Clinical narrative: Vasovagal syncope; I suffered incontinence; Blood pressure dropped; A spontaneous report was received from a 29-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vasovagal syncope, blood pressure dropped, and incontinence.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included multivitamin and fish oil.  On 27 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Approximately five minutes after receiving the vaccine, the patient experienced vasovagal syncope. The patient reported his blood pressure dropped too much and he passed out for about ten seconds. He also suffered incontinence. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 27 Jan 2021, the outcome of the events, experienced vasovagal syncope, blood pressure dropped, and incontinence, were considered resolved.; Reporter's Comments: This case concerns 29-year-old male patient, who experienced non serious unexpected events of blood pressure decreased with vasovagal syncope and incontinence. The events occurred 5 minutes after the first dose of mRNA-1273 vaccine.  No treatment was reported, and outcome of reported events was reported as resolved.  All events were assessed as related to mRNA-1273 vaccine due to temporal association.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Hearing loss in left ear; A spontaneous report was received from a 77-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hearing loss in the left ear.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 23 Jan 2021, the patient started to experience hearing loss in the left ear. Tinny sound in left ear. Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, hearing loss in the left ear, was unknown.; Reporter's Comments: This case concerns a 77 year-old, male patient, who experienced event of hearing loss in the left ear . The event occurred 2 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: found a piece of particulate matter in one of the moderna vaccine; A spontaneous report  was received from a pharmacist concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine and it was noted "a piece of particulate in one of the Moderna vaccines (poor quality vaccine administered).   There were no medical history and concomitant medications reported.  On 01-Feb-2021, the patient received a dose of mRNA-1273 (Batch number 042L20A) (injection site not provided) for prophylaxis of COVID-19 infection.  It was not specified if it was their first or second dose.   On 01-Feb-2021, the pharmacist reported their clinic found a piece of particulate matter (poor quality vaccine administered) in one of the Moderna vaccine vials. At the time of finding the particulate matter, they had administered vaccine doses to 6 patients. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, a piece of particulate was found in one of the Moderna vaccines (poor quality vaccine administered) was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who received a dose of mRNA-1273 (Batch number 042L20A) (injection site not provided) for prophylaxis of COVID-19 infection and the clinic found a piece of particulate matter (poor quality vaccine administered) in one of the Moderna vaccine vials. It was not specified if it was their first or second dose. There were no reported adverse events in this case of poor quality vaccine administered.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient did not receive the full amount in the syringe; A spontaneous report  was received from a healthcare professional concerning a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the event, did not receive the full amount of dose in the syringe.  The patient's medical history was not provided by the reporter. Concomitant medications were not reported.  On an unspecified date, one day prior to the onset of event, the patient received their first two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. The patient did not receive the full amount of dose in the syringe.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event, did not receive the full amount of dose in the syringe, was considered resolved on unspecified date.; Reporter's Comments: This case concerns a female patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: not all vaccine went in her arm, she states some gurgled out; A spontaneous report  was received from a female patient, unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and not all vaccine went in her arm, she stated some gurgled out.  There were no medical history or concomitant medications reported.   On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient reported that, not all the vaccine went into her arm, and some of the vaccine gurgled out of arm when getting the vaccine. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, "not all vaccine went in her arm, she states some gurgled out" was considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to the product administration error for mRNA-1273 (Lot number: Unknown).  This case concerns a female patient of unknown age, who experienced incomplete dose administration. There were no reported AEs associated with this case of incomplete dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: There was a Moderna vaccine given to a 17 year old; A spontaneous report was received from a healthcare professional concerning a 17-years old, unknown gender patient of unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, "COVID-19 vaccine given to a 17-year-old patient".  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of event, the patient received their first dose of mRNA-1273 (Lot number: unknown), for prophylaxis of COVID-19 infection.  It was reported that, the healthcare professional while working at a clinic last week , after doing research, she found that there was a mix up. There was a Moderna vaccine given to a 17-year-old patient on an unknown date. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event "Moderna vaccine given to a 17 year old", was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Sex: M
Vaccine: COVID19
Symptoms: Death, Sepsis
Clinical narrative: Sepsis; A spontaneous report was received from a consumer post , concerning an approximately 55-year-old, male physician who received Moderna's COVID-19 vaccine (mRNA-1273) and developed sepsis, resulting in death.  There was no medical history provided. There were no concomitant medications provided.  On an unknown date (Thursday), the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   According to the post,  two days after vaccine administration, the patient died of sepsis on Saturday.    Action taken with mRNA-1273 in response to the event was not applicable.  The event, sepsis, was considered fatal.    The patient's date of death was not provided.  The cause of death was reported as sepsis.; Reporter's Comments: This case concerns a 55-year-old, male subject, who experienced a serious unexpected event of Sepsis. Sepsis occurred after first dose of mRNA-1273 vaccine administration. On an unknown date, two days after vaccine administration, the patient died of sepsis.  Treatment for the event was not provided. The patient's medical history was not provided. The patient is a physician. Concomitant product use was not reported.  Very limited information regarding this event has been provided at this time and no definite diagnosis or autopsy report have been provided. Based on the current available information and temporal association between the use of the product and the start date of the event of Sepsis, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Sepsis
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Rash
Clinical narrative: Rash; Vaccine first dose administered subcutaneously; A spontaneous report  was received from a consumer, 34 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced rash and "vaccine first dose administered subcutaneously".  The patient's medical history was not provided. No concomitant medications were reported.  On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: 026L20A), subcutaneously in the left arm for the prophylaxis of COVID-19 infection.  On 07 Jan 2021, the patient received her first dose which pulled up the fat on the back of her left arm and administered the vaccine subcutaneously. On 14 Jan 2021, one week after the first dose, the patient experienced rash and went away on an unknown date in 2021.   On 04 Feb 2021, the patient received the second planned dose of mRNA-1273 (batch number: 030L20A), intramuscularly for the prophylaxis of COVID-19 infection. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event rash was resolved on an unknown date in 2021 and "vaccine first dose administered subcutaneously", was considered as resolved on 07 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 and concerns a 34 year-old, female patient, who experienced the event of rash. The event occurred 1 week after the first dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Felt a couple or few drops running down arm/entire dose wasn't administered; A spontaneous report was received from a consumer, unknown patient of an unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) which resulted in few drops running down arm and entire dose wasn't administered to patient.  The patient's medical history was not provided. No concomitant medications were reported.  On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient felt a couple or few drops running down bared arm and entire dose wasn't administered. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event "few drops running down arm and entire dose wasn't administered to patient" was considered as resolved on 16 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown age and gender who received their first of two planned doses of mRNA-1273 (batch number: unknown), for prophylaxis of COVID-19 infection which resulted in few drops running down arm and entire dose wasn't administered to patient. There were no reported adverse events after the vaccine was administered in this case of incorrect dose administered and exposure via skin contact.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Flushing, Hyperhidrosis, Palpitations, Swelling
Clinical narrative: sudden onset lower lip angioedema- only on the right side of my lip; This is a spontaneous report from a contactable Other HCP. This other HCP reported different events for the same patient during diffferient vaccination dose. This case is referred to the second vaccine dose A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL3247 intramuscular on 13Jan2021 12:30 second dose at SINGLE DOSE for covid-19 immunisation. Facility type vaccine: Hospital . Vaccine location: right arm Medical history included asthma, eczema, hypersensitivity, anxiety and depression. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20), bupropion hydrochloride (WELLBUTRIN XL), fluoxetine hydrochloride (PROZAC), rizatriptan (RIZATRIPTAN), salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levocetirizine dihydrochloride (XYZAL), betamethasone (BETAMETHASONE). The patient previously took aspirin and experienced rash. The patient experienced flushing, palpitations and hyperhidrosis after the first dose of bnt162b2 vaccine. The patient experienced sudden onset lower lip angioedema- only on the right side of my lip on 16Jan2021 20:30 with outcome of recovered. The action taken was not applicable. Therapeutic measures were taken: benadryl  inhaler self treated, consultation w/allergist and allergy testing. The reporter stated "developed sudden onset lower lip angioedema only on the right side of my lip. I took 50mg benadryl and my inhaler and monitored- I never developed itching, additional swelling, difficulty breathing or other symptoms of anaphylaxis. Swelling had resolved by morning. I had no other new exposures that have yet been identified, although I am going through a work up with an allergist."; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021073355 Same patient/ drug, different dose/AE.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Profuse nose bleed/ I woke up with another profuse nose bleed. Bled very heavily for 1/2 hour; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 75-year-old female patient who received first dose of bnt162b2 (Covid-19, Lot#: EL3247), via an unspecified route of administration on 16Jan2021 at 05:30 PM on Right arm at single dose for covid-19 immunisation. She is not pregnant. Facility type vaccine was other. No other vaccine in four weeks. Medical history included Known allergies and pacemaker, a-fib, pulmonary embolism. Concomitant medications included apixaban (ELIQUIS), fexofenadine hydrochloride (ALLEGRA), simvastatin and escitalopram. The following day she had a profuse nose bleed. Ended up at Urgent Care. They were able to stop it after 15 min. An ENT Dr cauterized one of her nostrils. On Sunday, 24Jan, at 3:00 am, she woke up with another profuse nose bleed. Bled very heavily for 1/2 hour. Drs. are trying to find reason for this profuse bleeding. Unknown yet. The event started from 17Jan2021 02:00 PM. AE resulted in: [Emergency room/department or urgent care]. The outcome of the event was not recovered. Treatment was received included Dr.'s visit. Nose bleeding stopper. Saline drops. No covid prior vaccination. No covid tested post vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope; passed out; This is a spontaneous report from a contactable pharmacist reported that a 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular on the left arm on 25Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received flu vaccine on an unspecified date for immunization and experienced fever. On 25Jan2021, the patient was experienced syncope and passed out. She woke up within the next couple of minutes and was monitored. The patient eaten food. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, syncope and passed out, and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association, and lacking alternative explanations.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Urticaria
Clinical narrative: hives; anxious; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right leg on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home/senior living facility. Medical history included COVID prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced hives and was anxious, the patient was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events hives and anxious was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the urticaria and anxiety. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pruritus, Urticaria
Clinical narrative: trouble breathing; Patient experienced itching on legs arms and face along with hives; Patient experienced itching on legs arms and face along with hives; Headache getting severe by the minute; This is a spontaneous report from a contactable pharmacist. A 29-year-old female patient received 2nd dose of bnt162b2 (BNT162B2; lot number EN5318) on 25Jan2021 intramuscular at right arm for COVID-19 immunization. Medical history was not reported. The patient had no COVID prior to vaccination. Historical vaccine include BNT162B2 for COVID-19 immunization. The patient had no other vaccine in weeks, concomitant drugs was none. The patient experienced headache getting severe by the minute. Patient experienced itching on legs arms and face along with hives and trouble breathing. Event start date was 25Jan2021. One epinephrine was received. Patient was taken to the hospital. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events headache, dyspnea, urticaria and pruritus are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria
Clinical narrative: headache with hives; headache with hives; This is a spontaneous report from a contactable pharmacist. A 46-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right arm on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home. Medical history included latex allergy, mushrooms allergy. The patient has no covid prior vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 first dose at the right arm on unspecified date for Covid-19 immunization. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced headache with hives and was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events headache with hives was unknown.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of headache with hives cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received the first dose of bnt162b2 (Lot number: EL3249), via an unspecified route of administration in left arm on 21Jan2021 09:00 at single dose for covid-19 immunization. Medical history included hypertension (HTN), atrial fibrillation, Allergies to Sulfa. Concomitant medication included diltiazem, apixaban (ELIQUIS), metoprolol, budesonide, formoterol fumarate (SYMBICORT). The patient experienced urinary tract infection (UTI) on 24Jan2021 14:00. The patient received the Antibiotics as treatment. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was no pregnant. The outcome of event was recovered on Jan 2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood pressure decreased, Hepatic enzyme increased
Clinical narrative: syncopal episodes; Vomited 40+ times; blood pressure dropped to 70/40; Elevated bilirubin; elevated liver enzymes (ALT, AST); elevated liver enzymes (ALT, AST); This is a spontaneous report from a contactable other health professional (patient herself). A 25-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration on 28Dec2020 12:30 in right arm at single dose for covid-19 immunization. The patient had COVID prior vaccination.  Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced vomited 40+ times, syncopal episodes, blood pressure dropped to 70/40, elevated bilirubin, elevated liver enzymes (ALT (alanine aminotransferase), AST (aspartate aminotransferase)) on 28Dec2020 19:30. Events resulted in emergency room/department or urgent care. IV fluids were received for events. The patient was not tested COVID post vaccination. Outcome of elevated bilirubin was recovered on an unspecified date, and outcome of other events were recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vomiting
Clinical narrative: syncopal episodes; Vomited 40+ times; blood pressure dropped to 70/40; Elevated bilirubin; elevated liver enzymes (ALT, AST); elevated liver enzymes (ALT, AST); This is a spontaneous report from a contactable other health professional (patient herself). A 25-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration on 28Dec2020 12:30 in right arm at single dose for covid-19 immunization. The patient had COVID prior vaccination.  Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced vomited 40+ times, syncopal episodes, blood pressure dropped to 70/40, elevated bilirubin, elevated liver enzymes (ALT (alanine aminotransferase), AST (aspartate aminotransferase)) on 28Dec2020 19:30. Events resulted in emergency room/department or urgent care. IV fluids were received for events. The patient was not tested COVID post vaccination. Outcome of elevated bilirubin was recovered on an unspecified date, and outcome of other events were recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.