chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Headache, Illness, Mobility decreased, Pain
Clinical narrative: I was definitely sick in the bed; Couldn't even function; Hurt; Horrible headache; I can hardly get to the bathroom infact I had to call my daughter she came to take care of me now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 78 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): "the first one put me in the bed"; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 01Oct2021, outcome "unknown", described as "I was definitely sick in the bed"; MOBILITY DECREASED (non-serious) with onset 01Oct2021, outcome "unknown", described as "Couldn't even function"; PAIN (non-serious) with onset 01Oct2021, outcome "unknown", described as "Hurt"; HEADACHE (non-serious) with onset 01Oct2021, outcome "unknown", described as "Horrible headache"; GAIT INABILITY (non-serious) with onset 01Oct2021, outcome "unknown", described as "I can hardly get to the bathroom infact I had to call my daughter she came to take care of me now".  Additional information: The patient received her COVID booster on Monday. She was fine to see on Tuesday. She was definitely sick in the bed couldn't even function and hurt and had horrible headache, she could hardly get to the bathroom infact she had to call her daughter and she came to take care of her now, she works in the health field and she advised her not to get the shot but she did. The patient have had her other two shots and they didn't bother her the first one put her in the bed as far as the concern.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Electric shock sensation, Myalgia
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jun 18, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced electric shock sensation (electrical impulse felt on left leg; wrapped all the way around the left leg) and myalgia (left calf muscle pain sort of went away, then went to right leg with same sensation), onset 2021, with outcome of unknown. Additional information: Patient had side effects from getting the first dose of the Pfizer COVID-19 vaccine Jun 18, 2021. Patient also experienced "other symptoms." No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Chills, Dizziness
Clinical narrative: Last night she really felt bad and the pain was so bad; Feeling unwell; Arthritis; Last night she really felt bad and the pain was so bad; tiredness; muscle pain; joint pain; chill; difficulty breathing; weakness; dizziness; 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 88 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "TB" (unspecified if ongoing), notes: Lives in assisted living and has had TB twice a long time ago, before the shot. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chill"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "difficulty breathing"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weakness"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; PAIN (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "Last night she really felt bad and the pain was so bad"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Malaise, Myalgia
Clinical narrative: Last night she really felt bad and the pain was so bad; Feeling unwell; Arthritis; Last night she really felt bad and the pain was so bad; tiredness; muscle pain; joint pain; chill; difficulty breathing; weakness; dizziness; 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 88 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "TB" (unspecified if ongoing), notes: Lives in assisted living and has had TB twice a long time ago, before the shot. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chill"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "difficulty breathing"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weakness"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; PAIN (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "Last night she really felt bad and the pain was so bad"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Last night she really felt bad and the pain was so bad; Feeling unwell; Arthritis; Last night she really felt bad and the pain was so bad; tiredness; muscle pain; joint pain; chill; difficulty breathing; weakness; dizziness; 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 88 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "TB" (unspecified if ongoing), notes: Lives in assisted living and has had TB twice a long time ago, before the shot. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chill"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "difficulty breathing"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weakness"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; PAIN (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "Last night she really felt bad and the pain was so bad"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Feeling abnormal, Headache, Incontinence
Clinical narrative: Hurt all over; Head would blow off and couldn't function; Feels weak/weak as a kitten; Can't get out of bed; Even her shoulders and neck are affected; She threw up; Head would blow off and couldn't function; Incontinent; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sepsis" (unspecified if ongoing), notes: Had sepsis a couple of months ago. There were no concomitant medications. Vaccination history included: Bnt162b2 ((1st dose) DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "was pooped"; Bnt162b2 ((2nd dose) DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Hurt all over"; HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset Oct2021, outcome "unknown" and all described as "Head would blow off and couldn't function"; ASTHENIA (non-serious) with onset Oct2021, outcome "unknown", described as "Feels weak/weak as a kitten"; BEDRIDDEN (non-serious) with onset Oct2021, outcome "unknown", described as "Can't get out of bed"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Oct2021, outcome "unknown", described as "Even her shoulders and neck are affected"; VOMITING (non-serious) with onset Oct2021, outcome "unknown", described as "She threw up"; INCONTINENCE (non-serious) with onset 2021, outcome "unknown", described as "Incontinent". Therapeutic measures were taken as a result of pain, headache, asthenia, bedridden, musculoskeletal discomfort, vomiting, feeling abnormal.  Additional information: Patient received the booster dose of the Pfizer COVID-19 vaccine on Monday 11Oct2021 and hurt all over, head would blow off and could not function. Patient further reported that she feels weak and can not get out of bed. She took Tylenol. Patient stated that even her shoulders and neck are affected, and mentioned that she threw up. Patient had sepsis a couple of months ago. Patient stated that her daughter works at a nursing home and would like to know if she could give her symptoms to her. After the first dose the patient was pooped. Then the second one did not bother the patient. Monday the patient got the booster shot and she hurt all over, she thought her head would blow off, and she could not function. The patient was feeling better then. This morning the patient went to the bathroom, she was inconstant, and was too tired to put the diaper back on so she curled back up in bed naked. The patient was weak as a kitten. The patient had sepsis a couple of months ago does that have anything to do with how she was feeling now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pain, Vomiting
Clinical narrative: Hurt all over; Head would blow off and couldn't function; Feels weak/weak as a kitten; Can't get out of bed; Even her shoulders and neck are affected; She threw up; Head would blow off and couldn't function; Incontinent; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sepsis" (unspecified if ongoing), notes: Had sepsis a couple of months ago. There were no concomitant medications. Vaccination history included: Bnt162b2 ((1st dose) DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "was pooped"; Bnt162b2 ((2nd dose) DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Hurt all over"; HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset Oct2021, outcome "unknown" and all described as "Head would blow off and couldn't function"; ASTHENIA (non-serious) with onset Oct2021, outcome "unknown", described as "Feels weak/weak as a kitten"; BEDRIDDEN (non-serious) with onset Oct2021, outcome "unknown", described as "Can't get out of bed"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Oct2021, outcome "unknown", described as "Even her shoulders and neck are affected"; VOMITING (non-serious) with onset Oct2021, outcome "unknown", described as "She threw up"; INCONTINENCE (non-serious) with onset 2021, outcome "unknown", described as "Incontinent". Therapeutic measures were taken as a result of pain, headache, asthenia, bedridden, musculoskeletal discomfort, vomiting, feeling abnormal.  Additional information: Patient received the booster dose of the Pfizer COVID-19 vaccine on Monday 11Oct2021 and hurt all over, head would blow off and could not function. Patient further reported that she feels weak and can not get out of bed. She took Tylenol. Patient stated that even her shoulders and neck are affected, and mentioned that she threw up. Patient had sepsis a couple of months ago. Patient stated that her daughter works at a nursing home and would like to know if she could give her symptoms to her. After the first dose the patient was pooped. Then the second one did not bother the patient. Monday the patient got the booster shot and she hurt all over, she thought her head would blow off, and she could not function. The patient was feeling better then. This morning the patient went to the bathroom, she was inconstant, and was too tired to put the diaper back on so she curled back up in bed naked. The patient was weak as a kitten. The patient had sepsis a couple of months ago does that have anything to do with how she was feeling now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: has a cold after the booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 08Oct2021 13:00 (Lot number: PF8841) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 02Oct2021; FLU, administration date 27Sep2021. Vaccination history included: Bnt162b2 (Vaccine Name: Pfizer Covid Vaccine , Lot Number: EL3247, Expiry Date: Unknown, Anatomical Location:  Right arm, caller guesses. , No. of Previous Doses: First dose, Date: 27JAN2021, Age at Immunization if date not available: 76 years, Time the Vaccination Was Given: First dose: Around 1030), administration date: 27Jan2021, when the patient was 76 years old, for Covid-19 Immunization; Bnt162b2 (Vaccine Name: Pfizer Covid Vaccine, Lot Number: EM9810, Expiry Date: Unknown, Anatomical Location:  left arm, No. of Previous Doses: Second dose, Date: 17FEB2021, Age at Immunization if date not available: 76 years, Time the Vaccination Was Given: Second dose: 1030.), administration date: 17Feb2021, when the patient was 76 years old, for Covid-19 Immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 08Oct2021, outcome "recovered", described as "has a cold after the booster dose". Therapeutic measures were not taken as a result of nasopharyngitis.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Small fibre neuropathy
Clinical narrative: She's been diagnosed with small fiber neuropathy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Feb2021 (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 (1st Dose), for COVID-19 Immunization. The following information was reported: SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "She's been diagnosed with small fiber neuropathy". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Malaise, Retching, Urinary incontinence
Clinical narrative: Dry heaves; overall feeling of unwell; no appetite; lack of bladder control; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 17:00 (Lot number: FF8841) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "high BP" (unspecified if ongoing); "Known allergy: latex" (unspecified if ongoing); "Known allergy: cholesterol meds" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If_covid_prior_vaccination: yes. The patient's concomitant medications were not reported. Past drug history included: Bactrim ds, reaction(s): "allergy"; Neosporin, reaction(s): "Allergy"; Erythromycin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Second Dose, Brand=Pfizer, Lot number=EN6207 , vaccine location=Left arm, Administration Time: 02:15 PM), administration date: 11Apr2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (First dose, Brand=Pfizer, Lot number=EW0151, Vaccine location=Left arm, Vaccine Administration Time: 02:00 PM), administration date: 18Mar2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: RETCHING (non-serious) with onset 12Oct2021 02:00, outcome "recovering", described as "Dry heaves"; MALAISE (non-serious) with onset 12Oct2021 02:00, outcome "recovering", described as "overall feeling of unwell"; DECREASED APPETITE (non-serious) with onset 12Oct2021 02:00, outcome "recovering", described as "no appetite"; URINARY INCONTINENCE (non-serious) with onset 12Oct2021 02:00, outcome "recovering", described as "lack of bladder control"; HEADACHE (non-serious) with onset 12Oct2021 02:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of retching, malaise, decreased appetite, urinary incontinence, headache. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Was the sickest I ever felt. Much worse than the two prior doses.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, 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), outcome "unknown", described as "Was the sickest I ever felt. Much worse than the two prior doses.".  Additional information: The patient was not diagnosed with covid prior to vaccination. The patient was not test for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101288014 similar report from same reporter
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Headache continued; Axillary node remains swollen; Continues to have mild pain; Axillary node pain; 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 patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 01Sep2021 11:30 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 2006 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time: 13:30, Anatomical site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EW0172), administration date: 11Aug2021, for COVID-19 Immunization, reaction(s): "Axillary lump", "Headache", "Menstrual change". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered" (03Sep2021), described as "Headache continued"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "Axillary node remains swollen"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Continues to have mild pain"; LYMPH NODE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Axillary node pain". The events "axillary node remains swollen" and "axillary node pain" were evaluated at the physician office visit.  Additional information:Headache continued until 03Sep2021. Axillary node remains swollen and continues to have mild pain. This is still an ongoing issue.  . Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: very tired/very fatigued; nauseated; 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 91-years-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "very tired"; NAUSEA (non-serious), outcome "unknown", described as "nauseated"; FATIGUE (non-serious), outcome "unknown", described as "very fatigued".  Additional Information: Caller stated this was the fourth time he had tried to speak with someone and he was age 91-years-old and received the booster shot a week ago and both were very tired and he was nauseated and he wants to know how long the side effects will last.  QR Comment: Reporter type could not be probed as consumer hung up the call abruptly, hence reporter type captured as consumer or non-healthcare professional by default. AE filed conservatively.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101368567 Same drug/AE, different patient
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: little nauseated; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 91 year-old patient received bnt162b2 (BNT162B2), administration date Oct2021 (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: NAUSEA (non-serious), outcome "unknown", described as "little nauseated"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue".  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (08Nov2021): 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101375434 same reporter/product, different patient / event.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Product lot number issue
Clinical narrative: confused with that Lot number; the lot number that was recorded in his vaccination card was "very unusual"; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 73 year-old male patient received bnt162b2 (COMIRNATY), administration date 07Oct2021 (Lot number: 30145BA) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "confused with that Lot number"; PRODUCT LOT NUMBER ISSUE (non-serious), outcome "unknown", described as "the lot number that was recorded in his vaccination card was "very unusual"".  Additional information: Caller stated that he has a 73-year-old, male patient who had a reaction to the Pfizer BioNTech COVID-19 vaccine that he received on 07 OCT 2021 at a Local Pharmacy in which the lot number that was recorded in his vaccination card was "very unusual". Caller stated that the lot number was "301458A" and does not have the information on the expiration date of the vaccine for that lot number. Caller stated that he called the pharmacy, and they were also puzzled with the lot number so caller wanted to verify if that Lot number if for the Pfizer BioNTech COVID-19 vaccine. Called Customer Service, spoke with Agent withheld and verified that the "actual lot number is 30145BA" and that a lot are getting "confused with that Lot number". Response: Provided information from Agent withheld of Customer Service, "actual lot number is 30145BA" and that a lot are getting "confused with that Lot number".  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: very tired/very fatigued; nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 65 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: Covid-19 vaccine (dose 1), for Covid-19 immunization; Covid-19 vaccine (dose 2), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "very tired/very fatigued"; NAUSEA (non-serious) with onset Oct2021, outcome "unknown", described as "nauseated".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101368325 Same drug/AE, different patient
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Anxiety, Nasopharyngitis
Clinical narrative: Hair loss; anxiety; she could feel like she may have a little of a cold if she got it; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:30 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Diagnosed 15 years ago this August; "Rapid heart beat" (unspecified if ongoing); "Chemo" (unspecified if ongoing); "Autoimmune disease" (unspecified if ongoing), notes: saw a dermatologist that said it is autoimmune disease; "She also has seasonal allergies and allergies to prescription drugs, specifically antibiotics" (unspecified if ongoing), notes: She also has seasonal allergies and allergies to prescription drugs, specifically antibiotics; "Penicillin" (unspecified if ongoing); "PICC line" (unspecified if ongoing); "ringworm and hookworm" (unspecified if ongoing); "ringworm and hookworm" (unspecified if ongoing); "Allergies to prescription drugs" (unspecified if ongoing); "allergies to prescription drugs, specifically antibiotics" (unspecified if ongoing); "allergic reaction to Bactrim, anything that has Sulfa drugs in it" (unspecified if ongoing); "They make her itch" (unspecified if ongoing), notes: has an allergic reaction to Bactrim, anything that has Sulfa drugs in it.  They make her itch; "reaction to Penicillin" (unspecified if ongoing); "It makes it difficult to breathe" (unspecified if ongoing). Family history included: "Heart attack" (unspecified if ongoing), notes: Brother and died had heart attack. Hers was caused by Stage 4 cancer and PICC line. Concomitant medication(s) included: METOPROLOL SUCCINATE, start date: 2020. Past drug history included: Bactrim, reaction(s): "Allergy_Bactrim". Vaccination history included: Bnt162b2 (Dose: 01), administration date: 03Mar2021, when the patient was 70 years old, for Covid-19 immunization, reaction(s): "she thought she was having a heart attack". The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2021, outcome "not recovered", described as "she could feel like she may have a little of a cold if she got it"; ALOPECIA (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Hair loss"; ANXIETY (non-serious) with onset 2021, outcome "not recovered", described as "anxiety".  Additional information: No prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: it's still kind a sore; Arms swelled up on my left side, under my armpit; maybe it's lymph node or something but it swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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: Covid-19 vaccine (Dose 1, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for Covid-19 Immunization. The following information was reported: LYMPH NODE PAIN (non-serious), outcome "unknown", described as "it's still kind a sore"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Arms swelled up on my left side, under my armpit; maybe it's lymph node or something but it swelled up".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: When she had the previous 2 doses she felt fatigue and common symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 (Lot number: EN6206) at the age of 69 years as dose 1, single and administered in arm right, administration date 05Apr2021 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NEXIUM taken for gastrooesophageal reflux disease (ongoing); FLU VACCINE VII taken for immunisation, administration date 04Sep2021. Vaccination history included: Fluzone shot (Adverse Event: Fluzone shot kicked her in the rear and was not used to it, Vaccine/Brand Name: Fluzone , Vaccination Date: 4 years ago), when the patient was 65 years old. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "When she had the previous 2 doses she felt fatigue and common symptoms".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, UNK, UNK, UNK, UNK
Symptoms: Anxiety, Depression, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Off Label Use; Fatigue; Seasonal Allergy; Feeling Abnormal; Dizziness; Depression; Anxiety; Dyspnoea; Malaise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 19368306 (RA). Other Case identifier(s): US-GLAXOSMITHKLINE-US2021AMR114910 (RA).  A male patient received bnt162b2 (BNT162B2) as dose number unknown, single for covid-19 immunisation; fluticasone propionate (FLONASE) (Batch/Lot number: unknown); treprostinil sodium (TYVASO) (Batch/Lot number: unknown); fluticasone propionate (FLUTICASONE PROPIONATE) (Batch/Lot number: unknown); treprostinil (TREPROSTINIL) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: AMBRISENTAN; SILDENAFIL CITRATE.  The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Off Label Use"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; SEASONAL ALLERGY (non-serious), outcome "unknown", described as "Seasonal Allergy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling Abnormal"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; DEPRESSION (non-serious), outcome "unknown", described as "Depression"; ANXIETY (non-serious), outcome "unknown", described as "Anxiety"; DYSPNOEA (non-serious), outcome "unknown", described as "Dyspnoea"; MALAISE (non-serious), outcome "unknown", described as "Malaise".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, UNK, UNK, UNK, UNK
Symptoms: Feeling abnormal, Malaise, Off label use, Seasonal allergy
Clinical narrative: Off Label Use; Fatigue; Seasonal Allergy; Feeling Abnormal; Dizziness; Depression; Anxiety; Dyspnoea; Malaise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 19368306 (RA). Other Case identifier(s): US-GLAXOSMITHKLINE-US2021AMR114910 (RA).  A male patient received bnt162b2 (BNT162B2) as dose number unknown, single for covid-19 immunisation; fluticasone propionate (FLONASE) (Batch/Lot number: unknown); treprostinil sodium (TYVASO) (Batch/Lot number: unknown); fluticasone propionate (FLUTICASONE PROPIONATE) (Batch/Lot number: unknown); treprostinil (TREPROSTINIL) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: AMBRISENTAN; SILDENAFIL CITRATE.  The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Off Label Use"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; SEASONAL ALLERGY (non-serious), outcome "unknown", described as "Seasonal Allergy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling Abnormal"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; DEPRESSION (non-serious), outcome "unknown", described as "Depression"; ANXIETY (non-serious), outcome "unknown", described as "Anxiety"; DYSPNOEA (non-serious), outcome "unknown", described as "Dyspnoea"; MALAISE (non-serious), outcome "unknown", described as "Malaise".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Parosmia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 17Jun2021 (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: 1st), when the patient was 33 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), PAROSMIA (non-serious) all with onset 01Oct2021, outcome "unknown" and all described as "I keep smelling smoke all the time even though there's no smoke and it gives me headaches". Additional information: Smelling smoke constantly and getting headache. She keep smelling smoke all the time even though there's no smoke and it gives me headaches. Follow-up attempts completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 78-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 77, in right arm, on Feb 3, 2021; and received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6201), in right arm, in 2021, single dose, for COVID-19 immunisation. Medical history included asthma (unspecified if ongoing). The patient's concomitant medications not reported. The patient had pain in extremity (her arm was just a little sore with the first 2 doses), onset 2021, with outcome of unknown. Additional information:  Her arm was just a little sore with the first 2 doses. She had difficulty reading the handwriting on the vaccination card. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: typical soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Lot number: 30130BA) at the age of 32 years as dose 1, single for covid-19 immunisation. Family history included: "sick" (unspecified if ongoing), notes: sick parents . The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "typical soreness".  Additional information: The patient had no other products. The patient had no other vaccines given the same day and no problems with vaccines in the past. No further details provided. The patient had no History of all previous immunization with the Pfizer vaccine considered as suspect.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hormone level abnormal, Malaise
Clinical narrative: my hormones level was out of the wack; Felt ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Apr2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HORMONE LEVEL ABNORMAL (non-serious) with onset 10Apr2021 12:00, outcome "not recovered", described as "my hormones level was out of the wack"; MALAISE (non-serious) with onset 10Apr2021 12:00, outcome "not recovered", described as "Felt ill". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hormone level abnormal, malaise.  Additional information: Start Taking thyroid pills- methimazole for event treatment. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. 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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropsychological test, Pain in extremity, Peripheral swelling
Clinical narrative: swelling and soreness on her arm; swelling and soreness on her arm; 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 81 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 05Feb2021 (Lot number: EN5318) at the age of 81 years as dose 1, single and administered in arm, administration date 26Feb2021 (Lot number: EL9264) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hysterectomy" (unspecified if ongoing), notes: I had hysterectomy.; "Salpingo-oophorectomy" (unspecified if ongoing), notes: I had a salpingo what you call Salpingo-oophorectomy; "bilateral oophorectomy" (unspecified if ongoing), notes: bilateral oophorectomy, hysterectomy; "eczema" (unspecified if ongoing), notes: had eczema on her face which took years to be resolved; "flu" (unspecified if ongoing), notes: after 29 she got the flu and she mentioned that she almost died. Concomitant medication(s) included: PREMARIN taken for hysterectomy, oophorectomy. Past drug history included: Tetracycline, reaction(s): "Hives"; Aspirin, notes: That is 50 somewhat years ago. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "swelling and soreness on her arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient mentioned also said she had eczema on her face which took years to be resolved and she had no perfume on her face after that. Patient does not have eczemas right now on face and she has to be careful of certain things like makeup and about any kind of creams, no perfumes. Patient reported does not even take Aspirin until she absolutely needs it. She mentioned before and she added that she is turning 82 next month and during, after 29 she got the flu and she mentioned that she almost died and she mentioned that we found out that there is hives in her bronchial tubes and she was advised that do not take any Tetracycline, had a very bad reaction to Tetracycline and she had eczema and she is being more sensitive right now.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Moderate pain at injection site (arm); mild muscle soreness throughout entire body that lasted the entire day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 17:45 (Lot number: FF2590) at the age of 34 years as dose 3 (booster dose), single for covid-19 immunisation. Relevant medical history included: "Chronic rhinitis (dust/mold allergies)" (unspecified if ongoing), notes: other medical history: Chronic rhinitis (dust/mold allergies); "dust/mold allergies" (unspecified if ongoing), notes: other medical history: Chronic rhinitis (dust/mold allergies); "dust/mold allergies" (unspecified if ongoing), notes: other medical history: Chronic rhinitis (dust/mold allergies). Concomitant medication(s) included: CLARITIN D 12 HOUR; FLONASE ALLERGY RELIEF; VITAMIN D NOS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Mar2021, when the patient was 34 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Mar2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Oct2021 02:00, outcome "recovering", described as "Moderate pain at injection site (arm)"; MYALGIA (non-serious) with onset 13Oct2021, outcome "recovering", described as "mild muscle soreness throughout entire body that lasted the entire day". Therapeutic measures were taken as a result of vaccination site pain, myalgia.  Additional information: Additional information: Moderate pain at injection site (arm) around 2 am, approximately 8 hours after vaccination with Dose 3. The next morning after Dose 3, mild injection site pain the and mild muscle soreness throughout entire body that lasted the entire day (through 24 hours post Dose 3).Treatment drug includes: Ibuprofen 24 hours post Dose 3. 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 was not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.