chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Vulvovaginal burning sensation, Vulvovaginal discomfort
Clinical narrative: yeast infection; Vaginal burning/irritation; Vaginal burning/irritation; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Nov2021 18:00 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "interstitial cystitis" (unspecified if ongoing), notes: other medical history:interstitial cystitis; "Mango allergy" (unspecified if ongoing), notes: known allergies:mango. Concomitant medication(s) included: SEROQUEL; TRAZODONE.  The following information was reported: FUNGAL INFECTION (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "yeast infection"; VULVOVAGINAL BURNING SENSATION (non-serious), VULVOVAGINAL DISCOMFORT (non-serious) all with onset 23Nov2021 21:00, outcome "recovering" and all described as "Vaginal burning/irritation". The events "yeast infection", "vaginal burning/irritation" and "vaginal burning/irritation" were evaluated at the physician office visit. Therapeutic measures were taken as a result of fungal infection, vulvovaginal burning sensation, vulvovaginal discomfort.  Follow-up (22Dec2021): 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: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Immunisation, Nausea, Poor quality product administered, Product storage error
Clinical narrative: booster was stored at 46 degrees and not at 48.; booster was stored at 46 degrees and not at 48.; booster was stored at 46 degrees and not at 48.; Patient received dose 3 (booster); Patient experienced fever, chills, N/V; Patient experienced fever, chills, N/V; Patient experienced fever, chills, N/V; Patient experienced fever, chills, N/V; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 62 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 19Oct2021 (Lot number: FH8020) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fever", start date: 21Oct2021, stop date: 23Oct2021; "chills", start date: 21Oct2021, stop date: 23Oct2021. Family history included: "DM type 1" (unspecified if ongoing), notes: Family medical history relevant to AE(s): , Father: DM type 1; "Liver cancer hepatitis infection" (unspecified if ongoing), notes: Family medical history relevant to AE(s): , Brother: Liver cancer hepatitis infection. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Date: 27Feb2021, Anatomical site of Injection: Right Deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6202, Provided by patient), administration date: 27Feb2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, Date: 20Mar2021, Anatomical site of Injection: Right Deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6202, Provided by patient), administration date: 20Mar2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: PRODUCT STORAGE ERROR (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "booster was stored at 46 degrees and not at 48."; IMMUNISATION (non-serious), outcome "unknown", described as "Patient received dose 3 (booster)"; PYREXIA (non-serious), CHILLS (non-serious), NAUSEA (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "Patient experienced fever, chills, N/V".  Follow-up (07Jan2022): The initial case was missing the following minimum criteria: due to -Unidentifiable patient. Upon receipt of follow-up information, this case now contains all required information to be considered valid.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue, Pyrexia, Vomiting
Clinical narrative: booster was stored at 46 degrees and not at 48.; booster was stored at 46 degrees and not at 48.; booster was stored at 46 degrees and not at 48.; Patient received dose 3 (booster); Patient experienced fever, chills, N/V; Patient experienced fever, chills, N/V; Patient experienced fever, chills, N/V; Patient experienced fever, chills, N/V; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 62 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 19Oct2021 (Lot number: FH8020) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fever", start date: 21Oct2021, stop date: 23Oct2021; "chills", start date: 21Oct2021, stop date: 23Oct2021. Family history included: "DM type 1" (unspecified if ongoing), notes: Family medical history relevant to AE(s): , Father: DM type 1; "Liver cancer hepatitis infection" (unspecified if ongoing), notes: Family medical history relevant to AE(s): , Brother: Liver cancer hepatitis infection. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Date: 27Feb2021, Anatomical site of Injection: Right Deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6202, Provided by patient), administration date: 27Feb2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, Date: 20Mar2021, Anatomical site of Injection: Right Deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6202, Provided by patient), administration date: 20Mar2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: PRODUCT STORAGE ERROR (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "booster was stored at 46 degrees and not at 48."; IMMUNISATION (non-serious), outcome "unknown", described as "Patient received dose 3 (booster)"; PYREXIA (non-serious), CHILLS (non-serious), NAUSEA (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "Patient experienced fever, chills, N/V".  Follow-up (07Jan2022): The initial case was missing the following minimum criteria: due to -Unidentifiable patient. Upon receipt of follow-up information, this case now contains all required information to be considered valid.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site haemorrhage
Clinical narrative: Sore muscle; Little bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "recovering", described as "Sore muscle"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 2021, outcome "unknown", described as "Little bleeding".    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "celiacs dx" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Gluten, reaction(s): "Allergy". The following information was reported: URTICARIA (non-serious) with onset 22Nov2021, outcome "recovered" (26Nov2021), described as "Hives on hands and feet". Therapeutic measures were taken as a result of urticaria. Additional information: Treatment included hydrocortisone ointment and Benadryl PO. The patient did not receive any other vaccine in four weeks. Covid prior vaccination and covid tested post vaccination was reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation
Clinical narrative: booster; experiencing a flare up; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (141003).  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization; Bnt162b2 (Dose number: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "experiencing a flare up". Therapeutic measures were taken as a result of condition aggravated.  Additional information: Patient reports prior and worsened since xeljanz: discouragement and depression at times. reports new: missed 1 week of therapy prior to receiving covid booster vaccine. no adverse events due to the missed dose. MD discontinued xeljanz due to increased flare ups, however patient was s still taking and finishing up the supply on hand. Currently experiencing a flare up and on prednisone 15mg daily.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up activities closed. Batch/lot number not available
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lip swelling
Clinical narrative: lower lip began to swell; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 14:45 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing), notes: Other medical history: asthma; "copd" (unspecified if ongoing), notes: Other medical history: copd; "hypo thyroid: Hypothyroidism" (unspecified if ongoing), notes: Other medical history: hypo thyroid; "sulfa drugs" (unspecified if ongoing); "Egg" (unspecified if ongoing), notes: Known allergies: Egg. Concomitant medication(s) included: L-THYROXINE [LEVOTHYROXINE]; ALBUTEROL [SALBUTAMOL SULFATE]. Past drug history included: Propolis for Known allergies: propolis, notes: Known allergies: propolis; Albumen for Known allergies: Albumen, notes: Known allergies: Albumen; Balsam of peru for Known allergies: balsam of peru, notes: Known allergies: balsam of peru. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 13Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 23Jan2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 14:45, outcome "unknown", described as "Booster dose"; LIP SWELLING (non-serious) with onset 08Dec2021 15:45, outcome "recovering", described as "lower lip began to swell". Therapeutic measures were not taken as a result of lip swelling.  Additional information: There was no other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Productive cough, Rhinorrhoea, SARS-CoV-2 test, Somnolence
Clinical narrative: cough; spitting of phlegm to clear lungs; runny nose; grogginess; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 17:45 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COUGH (non-serious) with onset 03Dec2021 18:00, outcome "not recovered", described as "cough"; PRODUCTIVE COUGH (non-serious) with onset 03Dec2021 18:00, outcome "not recovered", described as "spitting of phlegm to clear lungs"; RHINORRHOEA (non-serious) with onset 03Dec2021 18:00, outcome "not recovered", described as "runny nose"; SOMNOLENCE (non-serious) with onset 03Dec2021 18:00, outcome "not recovered", described as "grogginess". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, productive cough, rhinorrhoea, somnolence.  Additonal information: It was reported that there was no Covid prior vaccination and was tested for Covid post vaccination. It was also reported that there are no other vaccine in four weeks and it was not available whether there are other medications in two weeks. Lot unknown reason was misplaced/discarded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Swelling
Clinical narrative: booster; Under her armpit she has some bloating/Swollen yes/Bloating under armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 14:45 (Lot number: FJ1620) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Anatomical site of injection: Left Arm, Batch/Lot number: EP6955), administration date: 17Mar2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02, Anatomical site of injection: Left Arm, Batch/Lot number: EP6955), administration date: 07Apr2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 14:45, outcome "unknown", described as "booster"; SWELLING (non-serious) with onset Dec2021, outcome "unknown", described as "Under her armpit she has some bloating/Swollen yes/Bloating under armpit". Therapeutic measures were taken as a result of swelling.  Additional information: the patient takes Ibuprofen.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Tinnitus
Clinical narrative: She got the second shot and the noise disappeared for one month and then came back again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "After the first shot the next day she got a strong noise". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "She got the second shot and the noise disappeared for one month and then came back again". The patient underwent the following laboratory tests and procedures: blood test: result unknown.  Additional Context: The patient got a shot in Jul and from then till now she has a noise. After the first shot the next day, she got a strong noise. She got the second shot and the noise disappeared for one month and then came back again. She went from doctor to doctor and saw a neurologist. Before she went to the neurologist she went to therapist and did 4 pages of blood tests and there was nothing else. She was looking on the internet and found out the a lot of people get ear noise, called tinnitus. She went to the neurologist two weeks ago and he checked her hearing and found nothing wrong. Sent her to get an MRI and she would go to get the MRI today. The neurologist was sure it was nothing and nothing to do with her brain. Stated this happened after the first shot and it was really bothering her like when she sleeps. She did not want to take medication. Advised to consult with hcp for treatment recommendations. Stated she saw three doctors. Clarifies it was for the covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation, Metapneumovirus infection
Clinical narrative: she felt sick; Booster; metapneumovirus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "she's on chemo" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she felt sick"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; METAPNEUMOVIRUS INFECTION (non-serious), outcome "unknown", described as "metapneumovirus".  Additional information: The patient said that she was on chemo and received 3 doses of the Pfizer covid-19 vaccine. The patient said that after the booster shot, she felt sick and doctor said that it was due to a certain type of virus (metapneumovirus) that they don't know much about. She wanted to know if that virus was caused by the Pfizer vaccine.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: Both time i got very sick; 5 days of headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Both time i got very sick"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "5 days of headache".  Additional information: Customer Verbatim: I got my second covid 19 vaccine dose. Both time i got very sick. 5 days of headache and now with the second dose, 7 days later my arm is still swollen and very painful . The pain extends from my arm to my shoulder and neck. I already massaged it but is useless . I have two babies under two and I'm taking 6 pain killer every 5 hours to deal with the pain. I cannot sleep.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: A little tired after the first two Pfizer COVID vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single and administration date 19Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "A little tired after the first two Pfizer COVID vaccines".  Additional information: The events did not require emergency room or physician's office. The patient did not have other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Peripheral swelling
Clinical narrative: booster dose; body was more swollen; it hurt to squeezer her arm against her body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the parent.  A 17-year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) at the age of 17 years 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), for COVID-19 Immunization, reaction(s): "No adverse event "; Bnt162b2 (Dose no:2), for COVID-19 Immunization, reaction(s): "No adverse event ". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "body was more swollen"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "it hurt to squeezer her arm against her body".  Additional information: Caller advised patient to take ibuprofen. Caller reports that today after school it is still swollen but only hurts a little when she pushes her arm against her body.   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.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: 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 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 17:00 (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), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Sep2021 17:00, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "recovering", described as "intense pain under my left arm". Additional Information: The patient received the booster dose, within the 24 hours after receiving the vaccine, patient started to intense pain under his left arm, the same where he received the shot. It had mostly resolved, the intensity was not as bad, but he still feel it. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Immunisation, Pain, Pyrexia
Clinical narrative: she has slept pretty much all day; feels awful; achy; pain at the injection site; fatigue; fever of 102 F; Booster; 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 75-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 (Lot number: 330308D) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot Number: EN6203, Route, Anatomical Location: right arm), administration date: 22Feb2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02, Lot Number: EN6203, Route, Anatomical Location: right arm), administration date: 15Mar2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Booster"; SOMNOLENCE (non-serious) with onset 16Dec2021, outcome "not recovered", described as "she has slept pretty much all day"; FEELING ABNORMAL (non-serious) with onset 16Dec2021, outcome "not recovered", described as "feels awful"; PAIN (non-serious) with onset 16Dec2021, outcome "not recovered", described as "achy"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021, outcome "unknown", described as "pain at the injection site"; FATIGUE (non-serious) with onset 16Dec2021, outcome "unknown", described as "fatigue"; PYREXIA (non-serious) with onset 16Dec2021, outcome "not recovered", described as "fever of 102 F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of somnolence, feeling abnormal, pain, vaccination site pain, fatigue, pyrexia.  Additional information: The patient received the booster dose yesterday, 15Dec2021. Today, 16Dec2021, she relayed that she has slept pretty much all day and been in bed all day, feels awful, achy, pain at the injection site, fatigue, and a fever of 102 F. She reported having taken 2 Tylenol. She would like to know if these symptoms have been reported. The patient took her temperature and she had a 102 fever, so she was checking to see if these were normal. She wasn't feeling bad yesterday after she got the booster dose and she went to lunch. When she woke up this morning she felt awful. Her son told her to take 2 pills, but she can't think of what they were called, for the fever. She took Tylenol but she wanted the other one that she could not think of the name. The patient took a lot of pills but the first two vaccines did not bother her and she was taking them then.   Follow-up: Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: she has slept pretty much all day; feels awful; achy; pain at the injection site; fatigue; fever of 102 F; Booster; 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 75-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 (Lot number: 330308D) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot Number: EN6203, Route, Anatomical Location: right arm), administration date: 22Feb2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02, Lot Number: EN6203, Route, Anatomical Location: right arm), administration date: 15Mar2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Booster"; SOMNOLENCE (non-serious) with onset 16Dec2021, outcome "not recovered", described as "she has slept pretty much all day"; FEELING ABNORMAL (non-serious) with onset 16Dec2021, outcome "not recovered", described as "feels awful"; PAIN (non-serious) with onset 16Dec2021, outcome "not recovered", described as "achy"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021, outcome "unknown", described as "pain at the injection site"; FATIGUE (non-serious) with onset 16Dec2021, outcome "unknown", described as "fatigue"; PYREXIA (non-serious) with onset 16Dec2021, outcome "not recovered", described as "fever of 102 F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of somnolence, feeling abnormal, pain, vaccination site pain, fatigue, pyrexia.  Additional information: The patient received the booster dose yesterday, 15Dec2021. Today, 16Dec2021, she relayed that she has slept pretty much all day and been in bed all day, feels awful, achy, pain at the injection site, fatigue, and a fever of 102 F. She reported having taken 2 Tylenol. She would like to know if these symptoms have been reported. The patient took her temperature and she had a 102 fever, so she was checking to see if these were normal. She wasn't feeling bad yesterday after she got the booster dose and she went to lunch. When she woke up this morning she felt awful. Her son told her to take 2 pills, but she can't think of what they were called, for the fever. She took Tylenol but she wanted the other one that she could not think of the name. The patient took a lot of pills but the first two vaccines did not bother her and she was taking them then.   Follow-up: Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain
Clinical narrative: COVID booster dose; Chills; Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient 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 Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID booster dose"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PAIN (non-serious), outcome "unknown", described as "Aches". It was unknown if therapeutic measures were taken as a result of chills, pain.  Additional information: It was unknown that patient had covid prior vaccination. It was unknown covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Circumstance or information capable of leading to medication error, Drug ineffective, Feeling abnormal, Immunisation
Clinical narrative: Tested positive for Covid in 09Jan2022.; Tested positive for Covid in 09Jan2022.; Started feeling "under the weather" on 08Jan2022; dose number: 3; This is not necessarily an AE but this person may qualify as an at risk individual. They have marfan syndrome which puts them at risk with cardiac issues. They recently got their booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Marfan syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot number:unknown), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Lot number:unknown), administration date: 2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset Dec2021, outcome "unknown", described as "dose number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "Tested positive for Covid in 09Jan2022."; FEELING ABNORMAL (non-serious) with onset 08Jan2022, outcome "unknown", described as "Started feeling "under the weather" on 08Jan2022"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 2021, outcome "unknown", described as "This is not necessarily an AE but this person may qualify as an at risk individual. They have marfan syndrome which puts them at risk with cardiac issues. They recently got their booster shot". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive. Clinical course:  The patient had not covid prior vaccination. The patient had covid teste post vaccination.    The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow up (07Jan2022): This is a follow up spontaneous report from a contactable consumer. Updated information included: Added age of vaccination, vaccination month of administration, lab test sars-cov-2 test, suspect product coding, biological product. New events drug ineffective, covid-19 and feeling abnormal were added. Onset date of event immunisation was updated as Dec2021 from 2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for Covid in 09Jan2022.; Tested positive for Covid in 09Jan2022.; Started feeling "under the weather" on 08Jan2022; dose number: 3; This is not necessarily an AE but this person may qualify as an at risk individual. They have marfan syndrome which puts them at risk with cardiac issues. They recently got their booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Marfan syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot number:unknown), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Lot number:unknown), administration date: 2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset Dec2021, outcome "unknown", described as "dose number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "Tested positive for Covid in 09Jan2022."; FEELING ABNORMAL (non-serious) with onset 08Jan2022, outcome "unknown", described as "Started feeling "under the weather" on 08Jan2022"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 2021, outcome "unknown", described as "This is not necessarily an AE but this person may qualify as an at risk individual. They have marfan syndrome which puts them at risk with cardiac issues. They recently got their booster shot". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive. Clinical course:  The patient had not covid prior vaccination. The patient had covid teste post vaccination.    The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow up (07Jan2022): This is a follow up spontaneous report from a contactable consumer. Updated information included: Added age of vaccination, vaccination month of administration, lab test sars-cov-2 test, suspect product coding, biological product. New events drug ineffective, covid-19 and feeling abnormal were added. Onset date of event immunisation was updated as Dec2021 from 2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Immunisation, Myalgia, Pain in extremity
Clinical narrative: blisters and pain on left deltoid; arm pain; blisters and pain on left deltoid; area started to feel tender; later to "burn" with blisters; booster dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 14:15 (Lot number: 33130BA) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation; hepatitis b vaccine (HEPATITIS B VACCINE), administered in arm left, administration date 15Dec2021 (Lot number: 9AX5P) as dose 1, single for immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Note: Seasonal allergies.; "Diabetes type II" (unspecified if ongoing), notes: Note: Diabetes type II; "chronic R knee pain" (unspecified if ongoing), notes: Note: Chronic R knee pain; "anxiety" (unspecified if ongoing), notes: Note: Anxiety. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FB-EW0183), administration date: 11May2021, when the patient was 35 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FB-ER8735), administration date: 20Apr2021, when the patient was 35 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "booster dose"; MYALGIA (non-serious), BLISTER (non-serious) all with onset 16Dec2021, outcome "recovering" and all described as "blisters and pain on left deltoid"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021, outcome "recovering", described as "arm pain"; TENDERNESS (non-serious) with onset 16Dec2021, outcome "recovering", described as "area started to feel tender"; BURNING SENSATION (non-serious) with onset 16Dec2021, outcome "recovering", described as "later to "burn" with blisters". The events "blisters and pain on left deltoid", "arm pain", "blisters and pain on left deltoid", "area started to feel tender" and "later to "burn" with blisters" were evaluated at the physician office visit. Therapeutic measures were taken as a result of myalgia, pain in extremity, blister, tenderness, burning sensation. No follow-up attempts are possible. No further information is expected.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Adverse event treatment silvadene 1 % Cr and Motrin 400 mg QID (four times a day).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: blisters and pain on left deltoid; arm pain; blisters and pain on left deltoid; area started to feel tender; later to "burn" with blisters; booster dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 14:15 (Lot number: 33130BA) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation; hepatitis b vaccine (HEPATITIS B VACCINE), administered in arm left, administration date 15Dec2021 (Lot number: 9AX5P) as dose 1, single for immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Note: Seasonal allergies.; "Diabetes type II" (unspecified if ongoing), notes: Note: Diabetes type II; "chronic R knee pain" (unspecified if ongoing), notes: Note: Chronic R knee pain; "anxiety" (unspecified if ongoing), notes: Note: Anxiety. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FB-EW0183), administration date: 11May2021, when the patient was 35 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FB-ER8735), administration date: 20Apr2021, when the patient was 35 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "booster dose"; MYALGIA (non-serious), BLISTER (non-serious) all with onset 16Dec2021, outcome "recovering" and all described as "blisters and pain on left deltoid"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021, outcome "recovering", described as "arm pain"; TENDERNESS (non-serious) with onset 16Dec2021, outcome "recovering", described as "area started to feel tender"; BURNING SENSATION (non-serious) with onset 16Dec2021, outcome "recovering", described as "later to "burn" with blisters". The events "blisters and pain on left deltoid", "arm pain", "blisters and pain on left deltoid", "area started to feel tender" and "later to "burn" with blisters" were evaluated at the physician office visit. Therapeutic measures were taken as a result of myalgia, pain in extremity, blister, tenderness, burning sensation. No follow-up attempts are possible. No further information is expected.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Adverse event treatment silvadene 1 % Cr and Motrin 400 mg QID (four times a day).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Tachycardia
Clinical narrative: Today I had tachycardia which has remained at 95-120 BPM since it happened (8:30 am); Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 13:00 (Lot number: FJ8762) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 23Mar2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 02Mar2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021 13:00, outcome "unknown", described as "Booster"; TACHYCARDIA (non-serious) with onset 20Dec2021 08:30, outcome "not recovered", described as "Today I had tachycardia which has remained at 95-120 BPM since it happened (8:30 am)". Therapeutic measures were not taken as a result of tachycardia.  Additional Information: Prior vaccination within 4 weeks was reported as none. The patient had no known allergies. Prior to vaccination, patient was diagnosed with COVID-19 and since vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Respiration abnormal
Clinical narrative: booster; Patient had the Pfizer Booster dose and was taking air medication. Caller contacted before and waited for the confirmation for another booster dose of the patient.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  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: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; RESPIRATION ABNORMAL (non-serious), outcome "unknown", described as "Patient had the Pfizer Booster dose and was taking air medication. Caller contacted before and waited for the confirmation for another booster dose of the patient.". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Immunisation, Nasal congestion
Clinical narrative: received booster at the same time; Coughing; stuffy nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (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: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "received booster at the same time"; COUGH (non-serious) with onset Nov2021, outcome "unknown", described as "Coughing"; NASAL CONGESTION (non-serious) with onset Nov2021, outcome "unknown", described as "stuffy nose".  Additional information: Husband received booster at the same time. He did not experienced the same. However, in the same week, he started coughing and stuffy nose. But we assume, he caught that from the reporter.   The lot number for bnt162b2 was not provided and will be requested during follow up.