chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Oesophageal obstruction, Pain in extremity, Painful respiration, Peripheral swelling
Clinical narrative: Right after the 3-4 day nausea and sore arm side effects right after the forst dose, I Started getting unusual extreme head pain. Pain was so bad I could not function. I was not formerly Diagnosed with "Giant Cell Arteritis" until shortly after the Biopsy removing arteries from my head on May 5th, 2021. The Rheumatolist immediately put me on 60 Mg's of steroids and Actemra which is the only medication to combat GCA. Since Jan 27th 2021, my life has seemed to change forever as I am still trying to recover from this serious disease caused by the spike proteins to my head that I have never experianced before nor has any family member, direct or indirect. I was healthy and athletic before Jan 27 2021. Now, I CANNOT FUNCTION doing my job on my computer working with clients. I still have headaches almost daily, swollen feet, ankles and legs. Severe artheritis and pain in left side joints, Shoulder, Bicep, Elbow and forearm. Fingers go numb at night as well as toes. Extreme Leg cramps late at night, Extreme weight gain to 320 lbs from 260 lbs. in just 2.5 months. Broken blood vessells in both arms, Toes turned dark blue on left foot. Head aches and head pain still exist off and on in waves with no normal schedule. complete lack of energy all the time and when I try to push it I get fatiged quickly and have to rest or lie down. Altitudes about 4,000 ft. seem to really get me exhausted if extering any energy.. Also have stomach and upper resperatory pain. My esophagus at one point seemed to block my air passage resulting in a trip by ambulance to emergency as was have trouble breathing. There is much more to the list of effects like brain fog, memory issues etc. etc.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Weight increased
Clinical narrative: Right after the 3-4 day nausea and sore arm side effects right after the forst dose, I Started getting unusual extreme head pain. Pain was so bad I could not function. I was not formerly Diagnosed with "Giant Cell Arteritis" until shortly after the Biopsy removing arteries from my head on May 5th, 2021. The Rheumatolist immediately put me on 60 Mg's of steroids and Actemra which is the only medication to combat GCA. Since Jan 27th 2021, my life has seemed to change forever as I am still trying to recover from this serious disease caused by the spike proteins to my head that I have never experianced before nor has any family member, direct or indirect. I was healthy and athletic before Jan 27 2021. Now, I CANNOT FUNCTION doing my job on my computer working with clients. I still have headaches almost daily, swollen feet, ankles and legs. Severe artheritis and pain in left side joints, Shoulder, Bicep, Elbow and forearm. Fingers go numb at night as well as toes. Extreme Leg cramps late at night, Extreme weight gain to 320 lbs from 260 lbs. in just 2.5 months. Broken blood vessells in both arms, Toes turned dark blue on left foot. Head aches and head pain still exist off and on in waves with no normal schedule. complete lack of energy all the time and when I try to push it I get fatiged quickly and have to rest or lie down. Altitudes about 4,000 ft. seem to really get me exhausted if extering any energy.. Also have stomach and upper resperatory pain. My esophagus at one point seemed to block my air passage resulting in a trip by ambulance to emergency as was have trouble breathing. There is much more to the list of effects like brain fog, memory issues etc. etc.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Giant cell arteritis
Clinical narrative: Right after the 3-4 day nausea and sore arm side effects right after the forst dose, I Started getting unusual extreme head pain. Pain was so bad I could not function. I was not formerly Diagnosed with "Giant Cell Arteritis" until shortly after the Biopsy removing arteries from my head on May 5th, 2021. The Rheumatolist immediately put me on 60 Mg's of steroids and Actemra which is the only medication to combat GCA. Since Jan 27th 2021, my life has seemed to change forever as I am still trying to recover from this serious disease caused by the spike proteins to my head that I have never experianced before nor has any family member, direct or indirect. I was healthy and athletic before Jan 27 2021. Now, I CANNOT FUNCTION doing my job on my computer working with clients. I still have headaches almost daily, swollen feet, ankles and legs. Severe artheritis and pain in left side joints, Shoulder, Bicep, Elbow and forearm. Fingers go numb at night as well as toes. Extreme Leg cramps late at night, Extreme weight gain to 320 lbs from 260 lbs. in just 2.5 months. Broken blood vessells in both arms, Toes turned dark blue on left foot. Head aches and head pain still exist off and on in waves with no normal schedule. complete lack of energy all the time and when I try to push it I get fatiged quickly and have to rest or lie down. Altitudes about 4,000 ft. seem to really get me exhausted if extering any energy.. Also have stomach and upper resperatory pain. My esophagus at one point seemed to block my air passage resulting in a trip by ambulance to emergency as was have trouble breathing. There is much more to the list of effects like brain fog, memory issues etc. etc.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Right after the 3-4 day nausea and sore arm side effects right after the forst dose, I Started getting unusual extreme head pain. Pain was so bad I could not function. I was not formerly Diagnosed with "Giant Cell Arteritis" until shortly after the Biopsy removing arteries from my head on May 5th, 2021. The Rheumatolist immediately put me on 60 Mg's of steroids and Actemra which is the only medication to combat GCA. Since Jan 27th 2021, my life has seemed to change forever as I am still trying to recover from this serious disease caused by the spike proteins to my head that I have never experianced before nor has any family member, direct or indirect. I was healthy and athletic before Jan 27 2021. Now, I CANNOT FUNCTION doing my job on my computer working with clients. I still have headaches almost daily, swollen feet, ankles and legs. Severe artheritis and pain in left side joints, Shoulder, Bicep, Elbow and forearm. Fingers go numb at night as well as toes. Extreme Leg cramps late at night, Extreme weight gain to 320 lbs from 260 lbs. in just 2.5 months. Broken blood vessells in both arms, Toes turned dark blue on left foot. Head aches and head pain still exist off and on in waves with no normal schedule. complete lack of energy all the time and when I try to push it I get fatiged quickly and have to rest or lie down. Altitudes about 4,000 ft. seem to really get me exhausted if extering any energy.. Also have stomach and upper resperatory pain. My esophagus at one point seemed to block my air passage resulting in a trip by ambulance to emergency as was have trouble breathing. There is much more to the list of effects like brain fog, memory issues etc. etc.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: moderna GIVEN TO SOMEONE UNDER 18
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: j&J GIVEN TO SOMEONE UNDER 18
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: j&j GIVEN TO SOMEONE UNDER 18
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVE TO SOMEONE UNDER 18
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO SOMEONE UNDER 18
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot 2018-is it too late to get a second shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information were received as follows: The case was reported by patient. The age at vaccination was not applicable for this report. The patient received 1st shot in 2018 and it was too late to get 2nd shot. It was unknown if the patient received 2nd dose till the time of reporting, which led to incomplete course of vaccination. Follow up would not be possible no contact details were provided.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Change in menstration; spotting between periods; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 17Sep2021, when the patient was 29 years old, for Covid-19 immunization, reaction(s): "covid test result=Positive", "covid test result=Positive". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Change in menstration"; INTERMENSTRUAL BLEEDING (non-serious) with onset 17Nov2021, outcome "not recovered", described as "spotting between periods". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, intermenstrual bleeding.  Additional information: No other vaccine in four weeks and no other medications in two weeks. Covid prior vaccination and tested post vaccination. No known allergies.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Change in menstration; spotting between periods; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 17Sep2021, when the patient was 29 years old, for Covid-19 immunization, reaction(s): "covid test result=Positive", "covid test result=Positive". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Change in menstration"; INTERMENSTRUAL BLEEDING (non-serious) with onset 17Nov2021, outcome "not recovered", described as "spotting between periods". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, intermenstrual bleeding.  Additional information: No other vaccine in four weeks and no other medications in two weeks. Covid prior vaccination and tested post vaccination. No known allergies.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; Keeping him up all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: FC3182) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose of the Pfizer Covid Vaccine: Received on 06Aug2021; Lot Number: FA7484; NDC and Expiry Date: Unknown by the caller; Given in the caller's left arm.), administration date: 06Aug2021, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 03Sep2021, outcome "not recovered", described as "Tinnitus"; INSOMNIA (non-serious) with onset Sep2021, outcome "unknown", described as "Keeping him up all night".  Additional information: Caller stated that he received his second dose of the vaccine last 27Aug2021 and since 03Sep2021, he started experiencing tinnitus. He mentioned his tinnitus started worsening and it is keeping him up all night. He mentioned that his doctor said there is nothing he can do with his tinnitus and referred him to have it check by an ENT. Caller denies any other medications, medical conditions, labs, testing, or treatments relevant to these events. Caller states that he had a high dose flu vaccine on 28Sep2021 and a Pneumonia vaccine on 06Oct2021. Caller does not know the NDC, Lot Numbers, or Expiry Dates for these vaccines.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: Tinnitus; Keeping him up all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: FC3182) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose of the Pfizer Covid Vaccine: Received on 06Aug2021; Lot Number: FA7484; NDC and Expiry Date: Unknown by the caller; Given in the caller's left arm.), administration date: 06Aug2021, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 03Sep2021, outcome "not recovered", described as "Tinnitus"; INSOMNIA (non-serious) with onset Sep2021, outcome "unknown", described as "Keeping him up all night".  Additional information: Caller stated that he received his second dose of the vaccine last 27Aug2021 and since 03Sep2021, he started experiencing tinnitus. He mentioned his tinnitus started worsening and it is keeping him up all night. He mentioned that his doctor said there is nothing he can do with his tinnitus and referred him to have it check by an ENT. Caller denies any other medications, medical conditions, labs, testing, or treatments relevant to these events. Caller states that he had a high dose flu vaccine on 28Sep2021 and a Pneumonia vaccine on 06Oct2021. Caller does not know the NDC, Lot Numbers, or Expiry Dates for these vaccines.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: I was 7 months pregnant when I received the first dose of the vaccine. My son was born normal term with a VERY rare bleeding disorder with no family history and a heterzygous gene mutation (indicating disease was not inherited). He was diagnosed with Factor 1 deficiency. We were hospitalized Medical center in NICU for 29 days and currently are followed by  Children's Cancer care and hematology clinic. We have all documentation and I'm just not sure who to reach out to notify CDC. I am currently a nurse practitioner at cancer care and hematology clinic.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood fibrinogen, Delivery, Exposure during pregnancy, Intensive care
Clinical narrative: I was 7 months pregnant when I received the first dose of the vaccine. My son was born normal term with a VERY rare bleeding disorder with no family history and a heterzygous gene mutation (indicating disease was not inherited). He was diagnosed with Factor 1 deficiency. We were hospitalized Medical center in NICU for 29 days and currently are followed by  Children's Cancer care and hematology clinic. We have all documentation and I'm just not sure who to reach out to notify CDC. I am currently a nurse practitioner at cancer care and hematology clinic.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acne, Arthralgia, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: I'm not sure if that is the right Lot number as it is hard to read on my card.   It is three months later after receiving my COVID booster shot in my right upper arm and my arm muscles, and at times deep in my shoulder joint, continue to ache and are sore to the point of waking me up at night. At times, my right forearm is sore as well. I'm not sure if this is an effect of the vaccination or if the nurse administered it too high on my arm but I felt it should be reported because of the continuing time and level of pain.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Injection site scab
Clinical narrative: I'm not sure if that is the right Lot number as it is hard to read on my card.   It is three months later after receiving my COVID booster shot in my right upper arm and my arm muscles, and at times deep in my shoulder joint, continue to ache and are sore to the point of waking me up at night. At times, my right forearm is sore as well. I'm not sure if this is an effect of the vaccination or if the nurse administered it too high on my arm but I felt it should be reported because of the continuing time and level of pain.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: I'm not sure if that is the right Lot number as it is hard to read on my card.   It is three months later after receiving my COVID booster shot in my right upper arm and my arm muscles, and at times deep in my shoulder joint, continue to ache and are sore to the point of waking me up at night. At times, my right forearm is sore as well. I'm not sure if this is an effect of the vaccination or if the nurse administered it too high on my arm but I felt it should be reported because of the continuing time and level of pain.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she said she felt pressured to get it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6203, Expiration Date: May2021) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Covid-19 Dose #1: 11Feb2021, Lot: EL9265, Expiry: May2021, Time: unknown, maybe lunchtime, Anatomical Location: Left Arm), administration date: 11Feb2021, when the patient was 31 years old, for COVID-19 Immunization, reaction(s): "body was shaking, could not sleep", "arm really sore", "lump in arm that was hard", "body was shaking, could not sleep", "she said she felt pressured to get it.", "Shaking like Parkinson's type of shaking". The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "she said she felt pressured to get it.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:The patient did not receive any additional vaccines on same date. No AE required to visit emergency room or physician office, and patient messaged her doctor but her doctor said it would go away. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Patient has completed the 2 doses of Covid shots, and she is currently pregnant in her 1st trimester, she had Covid in mid-January. No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Investigation, SARS-CoV-2 test
Clinical narrative: she said she felt pressured to get it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6203, Expiration Date: May2021) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Covid-19 Dose #1: 11Feb2021, Lot: EL9265, Expiry: May2021, Time: unknown, maybe lunchtime, Anatomical Location: Left Arm), administration date: 11Feb2021, when the patient was 31 years old, for COVID-19 Immunization, reaction(s): "body was shaking, could not sleep", "arm really sore", "lump in arm that was hard", "body was shaking, could not sleep", "she said she felt pressured to get it.", "Shaking like Parkinson's type of shaking". The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "she said she felt pressured to get it.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:The patient did not receive any additional vaccines on same date. No AE required to visit emergency room or physician office, and patient messaged her doctor but her doctor said it would go away. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Patient has completed the 2 doses of Covid shots, and she is currently pregnant in her 1st trimester, she had Covid in mid-January. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Dizziness, Ear pain, Fatigue
Clinical narrative: Migraines and I had nausea, body aches, debilitating fatigue and dizziness. Sharp pain in right ear and on right side of skull.   I have adrenall insufficiency and take daily doses of hydrocortisone. I have had to triple my dose to control the dizziness, fatigue, and migraines and to be able to do laundry, clean my house, and prepare meals.  Will NOT be getting any more Covid jabs!
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Migraine, Nausea, Pain, Urinary tract infection
Clinical narrative: Migraines and I had nausea, body aches, debilitating fatigue and dizziness. Sharp pain in right ear and on right side of skull.   I have adrenall insufficiency and take daily doses of hydrocortisone. I have had to triple my dose to control the dizziness, fatigue, and migraines and to be able to do laundry, clean my house, and prepare meals.  Will NOT be getting any more Covid jabs!
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast abnormal, Breast mass, Mammogram abnormal, Triple negative breast cancer
Clinical narrative: I got my 1st vaccine in March and in May I felt a lump in my left breast. Got a mammogram done in August and it was abnormal. Biopsy in September confirmed triple negative brest cancer.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Mild Hives on cheek and back Treated with Benadryl and Cetirizine Resolve in 70 minutes
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Guillain Barre synd  Only one vaccine administered (booster)
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Bnt162b2 (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain, Injection site warmth, Loss of personal independence in daily activities, Peripheral swelling
Clinical narrative: Arm swelling; Arm movement decreased; arm pain; Arm pain itchy; thigh pain; lump at the site; heat at the site; arm pain at the site of the injection; Information was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act via the Agency (VAERS # 857145).  Information has been received from a registered nurse, concerning a 15-year-old female patient with seasonal allergy and chronic kidney disease (one kidney). The patient's pertinent medical history was not provided. At the time of vaccination, the patient was not taking any concomitant therapies and no illness were present (and up to one month prior).  On 11-JAN-2020 at 10:34, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular in the left arm, Lot # reported as 162191, at the physician's office, for prophylaxis.         On 11-JAN-2020 at 17:00, reported as the evening of the vaccine's day, the patient started with arm pain at the site of injection (vaccination site pain). Within 24 hours, the patient experienced severe pain, lump at the site (vaccination site mass), and heat at the site (vaccination site warmth). 72 hours after the shot, her thigh started with severe pain (pain in extremity) when touched but no injury was noted to that area. The left deltoid continued o be painful, hot to touch, and interfering with activity. The patient was scheduled for sick child visit on 20-JAN-2020 but since arm was much improved one week later from the onset of symptoms, follow-up appointment was cancelled. At the time of the report, the patient recovered from all the adverse events. The causality assessment between the events and suspect therapy was not provided by the reporter.    Lot Number 162191 is not valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast). Lot number does not match any Company product as confirmed by Lot Verification team.  Follow up information has been received from the registered nurse on 17-FEB-2022.  The lot number of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe was updated to 1621931 with expiration date on 26-JAN-2022.  Vaccine was administered in the left deltoid. The patient's concurrent conditions included chronic kidney disease stage 1. The patient was born with one kidney.   On 14-JAN-2020, the patient experienced arm swelling, decreased arm mobility, arm pain and itchiness. On 18-JAN-2020, the patient recovered from decreased arm mobility, arm pain and itchiness. She recovered on an unspecified date from arm swelling. No treatment was required for the events.  The events were considered related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Thinking abnormal
Clinical narrative: Arm swelling; Arm movement decreased; arm pain; Arm pain itchy; thigh pain; lump at the site; heat at the site; arm pain at the site of the injection; Information was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act via the Agency (VAERS # 857145).  Information has been received from a registered nurse, concerning a 15-year-old female patient with seasonal allergy and chronic kidney disease (one kidney). The patient's pertinent medical history was not provided. At the time of vaccination, the patient was not taking any concomitant therapies and no illness were present (and up to one month prior).  On 11-JAN-2020 at 10:34, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular in the left arm, Lot # reported as 162191, at the physician's office, for prophylaxis.         On 11-JAN-2020 at 17:00, reported as the evening of the vaccine's day, the patient started with arm pain at the site of injection (vaccination site pain). Within 24 hours, the patient experienced severe pain, lump at the site (vaccination site mass), and heat at the site (vaccination site warmth). 72 hours after the shot, her thigh started with severe pain (pain in extremity) when touched but no injury was noted to that area. The left deltoid continued o be painful, hot to touch, and interfering with activity. The patient was scheduled for sick child visit on 20-JAN-2020 but since arm was much improved one week later from the onset of symptoms, follow-up appointment was cancelled. At the time of the report, the patient recovered from all the adverse events. The causality assessment between the events and suspect therapy was not provided by the reporter.    Lot Number 162191 is not valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast). Lot number does not match any Company product as confirmed by Lot Verification team.  Follow up information has been received from the registered nurse on 17-FEB-2022.  The lot number of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe was updated to 1621931 with expiration date on 26-JAN-2022.  Vaccine was administered in the left deltoid. The patient's concurrent conditions included chronic kidney disease stage 1. The patient was born with one kidney.   On 14-JAN-2020, the patient experienced arm swelling, decreased arm mobility, arm pain and itchiness. On 18-JAN-2020, the patient recovered from decreased arm mobility, arm pain and itchiness. She recovered on an unspecified date from arm swelling. No treatment was required for the events.  The events were considered related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: V ARlVAX underwent a temperature excursion and was then administered; This spontaneous report has been received from a clinic administrator and refers to a 10-year-old patient. The patient's medical history, concurrent conditions, concomitant therapies, and drugs reactions or allergies were not reported.  On 18-JAN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter, lot U022732 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) with a n expiration date on 20-JUL-2023, administered as prophylaxis (formulation, strength, frequency, anatomical injection site and route of administration were not provided).   Administered dose of vaccine experienced temperature excursion of 12.0 degrees Fahrenheit (F) for 9 hours and 38 minutes. There was previous temperature excursions (9.7 degree Fahrenheit for 2 hours and 41 minutes; 10.8 degree Fahrenheit for 2 hours and 45 minutes; 10.6 degree Fahrenheit for 4 hours and 16 minutes; 11.1 degree Fahrenheit for 3 hours and 14 minutes; 10.9 degree Fahrenheit for 4 hours and 43 minutes; 10.8 degree Fahrenheit for 2 hours and 17 minutes; 18.3 degree Fahrenheit for 2 hours and 36 minutes; 18.7 degree Fahrenheit for 3 hours and 4 minutes; 12.4 degree Fahrenheit for 9 hours and 43 minutes; 17.4 degree Fahrenheit for 24 hours and 00 minutes; 19.9 degree Fahrenheit for 10 hours and 57 minutes. (product storage error).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA006001: US-009507513-2202USA005934:
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Product storage error
Clinical narrative: No adverse event/ No known pt adverse reactions; Indavertently administered improperly stored GARDASIL 9/ Temps went out of range. Vaccines given despite temp excursion.; This spontaneous report was received from a licensed practical nurse (L.P.N.) regarding a 12-year-old male patient. The patient's medical history included vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (one previous dose) and influenza vaccine (FLUZONE [INFLUENZA VACCINE]) (two previous doses). His concurrent conditions, concomitant therapies, drug reactions, and allergies were not provided.  On 12-JAN-2022, the patient was vaccinated with improperly stored: second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number U007667, with an expiration date of 23-MAY-2023, intramuscularly (dose, strength and formulation were not reported) for prophylaxis and with the third dose of influenza vaccine (FLUZONE [INFLUENZA VACCINE]) lot number: UT7317JA, expiry date: 30-JUN-2022, intramuscularly (dose, strength and formulation were not reported) for prophylaxis (product storage error). There were no additional adverse event (no adverse event). Administered dose of vaccine experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes, respectively. There were no previous excursions reported. Digital data logger was involved. As of 18-FEB-2022, additional information had been requested.  This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007818: US-009507513-2202USA007812: US-009507513-2202USA002574: US-009507513-2202USA007813:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ROTATEQ was administered to a 16 week old; No adverse event; This spontaneous report was received from a nurse, and refers to a 16 week old patient of unknown age. No information was received concerning the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, at the age of 16 weeks, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1742433 with expiration date on 19-SEP-2022 for prophylaxis. The dose was 2 mililliters administered per oral route.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Incorrect dose administered, No adverse event, Wrong technique in product usage process
Clinical narrative: Caller stated a patient was administered PEDVAX HIB and PENTACEL. No additional AE.; Caller stated a patient was administered PEDVAX HIB and PENTACEL. No additional AE.; This spontaneous report was received from a nurse prescriber (nurse practitioner) and refers to a patient of unspecified age or gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 02-MAR-2022, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter (mL) (vaccination scheme frequency, route of administration and anatomical site of application ere not provided; lot number T000883 that was verified to be a valid lot number with an expiration date reported and established as 28-MAY-2022) for prophylaxis. On the same date, the patient also received diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) 0.5 milliliter (mL) (vaccination scheme frequency, route of administration, anatomical site of application and indication were not provided; lot number U70138A with an expiration date reported as 10-SEP-2022) (product use issue).  No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; reporting the administration of expired PROQUAD; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 03-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) 0.5 ml, lot #: T025508, expiration date: 23-JAN-2022 (formulation, strength, site and route of administration were not provided) for prophylaxis (expired vaccine used). There was no additional event reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neurological symptom, Post herpetic neuralgia
Clinical narrative: multiple outbreaks of herpes zoster, post herpetic neuralgia and other serious NEUROLOGICAL PROBLEMS; multiple outbreaks of herpes zoster, post herpetic neuralgia and other serious NEUROLOGICAL PROBLEMS; multiple outbreaks of herpes zoster, post herpetic neuralgia and other serious NEUROLOGICAL PROBLEMS; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (dose, route of administration, anatomical location, lot # and expiry date not reported) as recommended for routine adult health maintenance and for the prevention of shingles. After receiving zoster vaccine live (ZOSTAVAX) the patient suffered sustained severe and permanent personal injuries like multiple outbreaks of herpes zoster, post herpetic neuralgia and other serious neurological problems. As a result of these symptoms, the patient was seen and treated by medical providers.The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: PPV
Symptoms: Immunisation reaction, Peripheral vascular disorder, Thrombosis
Clinical narrative: I noticed one of the veins in my underarm was swollen in th same arm/ I have a blood clot i my upper right arm/ have to be evaluated for DVT; I noticed one of the veins in my underarm was swollen in th same arm/ I have a blood clot in my upper right arm/ have to be evaluated for DVT; This spontaneous report was received from a female patient of unknown age reporting on herself, via a company representative. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.    On 23-FEB-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml syringe, lot number U010534 with expiration date 31-OCT-2022, in the right arm for prophylaxis (route of administration was not reported).     The patient reported that on 04-MAR-2022 she noticed one of the veins in her underarm was swollen in the same arm of the vaccine. On 09-MAR-2022, she went to see the primary-care physician (PCP), who told her that she had a blood clot (Thrombosis) in her upper right arm and that this should be evaluated for deep vein thrombosis (DVT). The outcome of thrombosis and deep vein thrombosis was not reported.  The causal assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. The PCP believed that it should be reported as an adverse reaction to the pneumococcal vaccine.  Upon internal review, the events of thrombosis and deep vein thrombosis were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Ill-defined disorder
Clinical narrative: Bell's palsy; Other zoster-related conditions; Information has been received from lawyer regarding a case in litigation, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided. On and or about 31-DEC-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not provided), as long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by healthcare providers for bell's palsy and other zoster-related conditions (ill-defined disorder). As a direct and proximate result of vaccination with zoster vaccine live (ZOSTAVAX), the patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. At the time of the report, the outcome of bell's palsy and ill-defined disorder was determined to be not recovered. The reporter considered bell's palsy and ill-defined disorder to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, bell's palsy was determined to be medically significant.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Vaccination failure
Clinical narrative: She had a poor response to the MMR and varicella vaccines as a child; Literature Report. This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a child female patient of unknown age. Information regarding the patient's concurrent conditions, medical history and concomitant therapies was not reported.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, and route of administration were not reported) and with varicella virus vaccine (Manufacturer unknown) (strength, dose, and route of administration were not reported). Both administered for prophylaxis.   On an unknown date, it was found that the patient had a poor response to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine (Manufacturer unknown) (vaccination failure). The outcome of the poor response to the vaccines was not reported.   The authors determined the patient's poor response to be related to the vaccines: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine (Manufacturer unknown).    A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; reported expired dose of V ARlV AX administered; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, or concurrent conditions were not reported.  On 15-MAR-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002846 and expiration date 23-JAN-2022, 0.5 milliliter subcutaneously for prophylaxis. No additional events were reported.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: BUT THEY DO KILL MY MOM; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. The reporter reported that, "But they DO kill my Mom. Looking at YOU at pfizer at moderna tx at social media. Keep peddling your poison." It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of but they do kill my mom was fatal. This report was serious (Death).; Sender's Comments: V0: 20220322463-covid-19 vaccine ad26.cov2.s-  But they do kill my mom (Death). The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH