chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye disorder, Fatigue, Illness, Interchange of vaccine products
Clinical narrative: feeling unwell/ generally feeling unwell; looked tired; glassy eyed; Looks tired and sick; like he has a cold; Dose 1, Dose 2, Dose 3 :Moderna / Dose 4: Pfizer; Chills; feeling shaky; Looks tired and sick; like he has a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 04:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 11Oct2022, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Oct2022, outcome "unknown", described as "Dose 1, Dose 2, Dose 3 :Moderna / Dose 4: Pfizer"; NASOPHARYNGITIS (non-serious), ILLNESS (non-serious) all with onset 11Oct2022, outcome "unknown" and all described as "Looks tired and sick; like he has a cold"; NERVOUSNESS (non-serious) with onset 11Oct2022, outcome "unknown", described as "feeling shaky"; EYE DISORDER (non-serious) with onset 11Oct2022, outcome "unknown", described as "glassy eyed"; FATIGUE (non-serious) with onset 11Oct2022, outcome "unknown", described as "looked tired"; MALAISE (non-serious) with onset 11Oct2022 at 04:00, outcome "unknown", described as "feeling unwell/ generally feeling unwell". Therapeutic measures were taken as a result of chills, nervousness, nasopharyngitis, malaise, fatigue, eye disorder, illness.  Additional information: The reporter stated that the patient received the new booster dose "this morning" and "around 4pm" he started feeling unwell. The reporter added that "he" was having "chills, looked tired, feeling shaky, and generally feeling unwell" and when she checked up on him, he was "glassy eyed". She added that her significant other received 3 doses of Moderna vaccines before receiving this new booster dose. She also mentioned that she gave him 2 Tylenol. She wanted to know if the symptoms will persist and is there anything he could take to combat these symptoms.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Nervousness
Clinical narrative: feeling unwell/ generally feeling unwell; looked tired; glassy eyed; Looks tired and sick; like he has a cold; Dose 1, Dose 2, Dose 3 :Moderna / Dose 4: Pfizer; Chills; feeling shaky; Looks tired and sick; like he has a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 04:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 11Oct2022, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Oct2022, outcome "unknown", described as "Dose 1, Dose 2, Dose 3 :Moderna / Dose 4: Pfizer"; NASOPHARYNGITIS (non-serious), ILLNESS (non-serious) all with onset 11Oct2022, outcome "unknown" and all described as "Looks tired and sick; like he has a cold"; NERVOUSNESS (non-serious) with onset 11Oct2022, outcome "unknown", described as "feeling shaky"; EYE DISORDER (non-serious) with onset 11Oct2022, outcome "unknown", described as "glassy eyed"; FATIGUE (non-serious) with onset 11Oct2022, outcome "unknown", described as "looked tired"; MALAISE (non-serious) with onset 11Oct2022 at 04:00, outcome "unknown", described as "feeling unwell/ generally feeling unwell". Therapeutic measures were taken as a result of chills, nervousness, nasopharyngitis, malaise, fatigue, eye disorder, illness.  Additional information: The reporter stated that the patient received the new booster dose "this morning" and "around 4pm" he started feeling unwell. The reporter added that "he" was having "chills, looked tired, feeling shaky, and generally feeling unwell" and when she checked up on him, he was "glassy eyed". She added that her significant other received 3 doses of Moderna vaccines before receiving this new booster dose. She also mentioned that she gave him 2 Tylenol. She wanted to know if the symptoms will persist and is there anything he could take to combat these symptoms.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder, Blood test, Inflammation
Clinical narrative: stating the inflammation factor in his body is 5 and a half times higher than the upper limit on the test, measuring 106; 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 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD DISORDER (non-serious), outcome "unknown", described as "stating the inflammation factor in his body is 5 and a half times higher than the upper limit on the test, measuring 106". 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller mentions that she already had Covid and already took the vaccine; Caller mentions that she already had Covid and already took the vaccine; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller mentions that she already had Covid and already took the vaccine". Clinical course: Transferring agent stated that the caller was a nurse calling for her neighbor. The caller stated that her neighbor was 67 years old. The caller stated that the Pfizer Covid 19 Vaccine was not available and asked if it was out of stock. Transferring agent stated that the caller mentioned that the caller already had Covid and already took the vaccine. Caller came onto the line and immediately asked if the transferring agent was from overseas. Caller stated that the transferring agent talked too fast, if she talked any faster, she could be a recording. Caller did not verified or clarified about the statement provided by the transferring agent about the caller, herself, having already had Covid and already taken the vaccines. This report was concerning the caller herself. Then attempting to clarify information from the transferring agent the caller became upset, stated she did not need to do any reports. Caller remained upset. Stated that for her own self, she was already vaccinated, and double booster dosed and didnot provide the name of the vaccines she was referring to. The caller never verified which vaccines she herself received, or the statement from the transferring agent about how the caller mentioning that the caller already has had Covid and already took the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events  drug ineffective and COVID 19 and the suspect drug  BNT162b2
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR, stop date: 28Sep2022; SYNTHROID.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID-19 treatment with anti-viral product Paxlovid from 29Sep2022 till 04Oct2022. Symptoms came back 4 days after completing Paxlovid, starting on 07Oct2022, for which no treatment was received and patient was recovering at the time of this report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Fatigue, Illness
Clinical narrative: sick; She has a split entry house and when going up and down stairs, breathing is harder; she tires out faster, but it goes away; 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 66-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Lot number: ER8727) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She is allergic to Sulfa" (unspecified if ongoing), notes: She is allergic to Sulfa.; "She later stated she had a bladder infection in the 1980's", start date: 1980 (unspecified if ongoing), notes: She later stated she had a bladder infection in the 1980's.; "she was hot and face was red and flushed" (unspecified if ongoing), notes: she was hot and face was red and flushed.; "she was hot and face was red and flushed" (unspecified if ongoing), notes: she was hot and face was red and flushed; "she was hot and face was red and flushed" (unspecified if ongoing), notes: she was hot and face was red and flushed; "She had a Hysterectomy when she was 18" (unspecified if ongoing), notes: She had a Hysterectomy when she was 18.; "She found out she was born with 2 uteruses and 1 kidney" (unspecified if ongoing), notes: She found out she was born with 2 uteruses and 1 kidney. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6202, Anatomical location: Injected in left arm.), administration date: 24Feb2021, when the patient was 65-year-old, for Covid-19 immunization, reaction (s): "headache", "chills", "dizziness", "fever", "leg cramps", "body aches and Joint aches", "body aches and Joint aches". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; DYSPNOEA EXERTIONAL (non-serious), outcome "recovering", described as "She has a split entry house and when going up and down stairs, breathing is harder"; FATIGUE (non-serious), outcome "recovering", described as "she tires out faster, but it goes away".  Follow-up (12Oct2022): The initial case was missing the following minimum criteria: ICH-Unspecified. AE. Upon receipt of follow-up information on (12Oct2022), this case now contains all required information to be considered valid. Additional information: Reporter's information, patient's details, product details and medical history added. Historical vaccine added. Suspect product coding updated. New event and concomitant therapy added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224579 Same reporter/ Patient and different dose and event;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: sick; when she saw him coming to her, it was like a fisheye peephole in an apartment; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 12Oct2022, this case now contains all required information to be considered valid.   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 65-year-old female patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 65 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "She had a Hysterectomy" (unspecified if ongoing), notes: She had a Hysterectomy when she was 18.; "She only has one kidney, and later stated she was only born with one" (unspecified if ongoing), notes: She only has one kidney, and later stated she was only born with one; "She found out she was born with 2 uteruses" (unspecified if ongoing), notes: She found out she was born with 2 uteruses; "allergic to Sulfa" (unspecified if ongoing); "she had a bladder infection", start date: 1980 (unspecified if ongoing), notes: she had a bladder infection in the 1980s; "she was hot and face was red and flushed" (unspecified if ongoing), notes: she was hot and face was red and flushed, but no hives.; "she was hot and face was red and flushed" (unspecified if ongoing), notes: she was hot and face was red and flushed, but no hives.; "she was hot" (unspecified if ongoing), notes: she was hot and face was red and flushed, but no hives.; "They took the uteruses out" (unspecified if ongoing), notes: They took the uteruses out. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Dosage text: Unknown Dose, Vaccine Lot Number:  EN6202), administration date: 24Feb2021, when the patient was 65-year-old, for Covid-19 immunization, reaction(s): "tired", "chills", "Joint aches", "Headache", "Dizziness", "leg cramps", "Fever", "body aches"; BNT162b2 (Dose 2, Vaccine Lot Number:  ER8727, Vaccine Lot Expire Date: Unknown), administration date: 17Mar2021, when the patient was 65-year-old, for Covid-19 immunization, reaction(s): "Sick", "She has a split entry house and when going up and down stairs, breathing is harder and she tires out faster, but it goes away". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "when she saw him coming to her, it was like a fisheye peephole in an apartment".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224579 similar report from same reporter;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; 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 66-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "She only has one kidney, and later stated she was only born with one" (unspecified if ongoing), notes: She only has one kidney, and later stated she was only born with one; "allergic to Sulfa", start date: 1980 (unspecified if ongoing), notes: She is allergic to Sulfa - diagnosed in 1980's.; "bladder infection", start date: 1980 (unspecified if ongoing), notes: She later stated she had a bladder infection in the 1980's and was prescribed a medication that had sulfa in it that her doctor said she was allergic to, but she cannot remember the name and does not have a lot or expiration.; "Hysterectomy" (unspecified if ongoing), notes: She had a Hysterectomy when she was 18., They took the uteruses out.; "She found out she was born with 2 uteruses" (unspecified if ongoing), notes: She found out she was born with 2 uteruses. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number:  EN6202, Anatomical Location: left arm, Administration time: late morning.), administration date: 24Feb2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "Joint aches", "headache", "chills", "dizziness", "fever", "leg cramps", "body aches", "tires out faster", "when going up and down stairs, breathing was harder"; BNT162b2 (DOSE 1, SINGLE, Lot Number:  EN6202, Anatomical Location: left arm, Administration time: late morning.), administration date: 24Feb2021, when the patient was 65-year-old, for Covid-19 Immunization, reaction(s): "sick"; BNT162b2 (DOSE 2, SINGLE, Lot Number: ER8727, Anatomical Location: left arm,), administration date: 17Mar2021, when the patient was 65-year-old, for Covid-19 Immunization, reaction(s): "sick"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FF2587, Anatomical location: Injected in unsure if left or right arm), administration date: 20Oct2021, when the patient was 65-year-old, for Covid-19 Immunization, reaction(s): "when she saw him coming to her, it was like a fisheye peephole in an apartment", "Sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: It was reported that, every time she got vaccine, she got 5th one on Monday (10Oct2022), she got sick.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224579 similar report from same reporter;
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Feeling hot, Headache
Clinical narrative: feel very terrible/feels horrible; neckache; body aches; light headed; cold chills; nauseous; bad headache; feels very warm; sick; fever; all his previous doses were Moderna this was his first Pfizer dose; 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 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ibuprofen for muscle pain, notes: sometimes take Ibuprofen 200mg for muscle pain. Vaccination history included: Moderna covid-19 vaccine (States all his previous doses were Moderna .), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Oct2022, outcome "unknown", described as "all his previous doses were Moderna this was his first Pfizer dose"; PYREXIA (non-serious) with onset 12Oct2022, outcome "unknown", described as "fever"; MALAISE (non-serious), outcome "unknown", described as "feel very terrible/feels horrible"; NECK PAIN (non-serious), outcome "unknown", described as "neckache"; PAIN (non-serious), outcome "unknown", described as "body aches"; DIZZINESS (non-serious), outcome "unknown", described as "light headed"; CHILLS (non-serious), outcome "unknown", described as "cold chills"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; HEADACHE (non-serious), outcome "unknown", described as "bad headache"; FEELING HOT (non-serious), outcome "unknown", described as "feels very warm"; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient had received Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), vaccine. Stated that all his previous doses were Moderna this was his first Pfizer dose. He stated that they usually make him sick, and this was the first Pfizer one he has had the rest were the Moderna. He was asking if he could take Ibuprofen for his experienced side effects. Reported he has a bad headache, feels nauseous and was drinking water most of the day. He had the paperwork that was given to him and stated all fevers made him feel this way and he was wanting to know if he could take Ibuprofen. He wanted to know if his temperature went down, he would feel better. His Cold chills started about 1:30pm and took his temperature and it was 102. Stated this has happened with all the vaccines he had got.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Interchange of vaccine products, Malaise, Nausea, Neck pain
Clinical narrative: feel very terrible/feels horrible; neckache; body aches; light headed; cold chills; nauseous; bad headache; feels very warm; sick; fever; all his previous doses were Moderna this was his first Pfizer dose; 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 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ibuprofen for muscle pain, notes: sometimes take Ibuprofen 200mg for muscle pain. Vaccination history included: Moderna covid-19 vaccine (States all his previous doses were Moderna .), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Oct2022, outcome "unknown", described as "all his previous doses were Moderna this was his first Pfizer dose"; PYREXIA (non-serious) with onset 12Oct2022, outcome "unknown", described as "fever"; MALAISE (non-serious), outcome "unknown", described as "feel very terrible/feels horrible"; NECK PAIN (non-serious), outcome "unknown", described as "neckache"; PAIN (non-serious), outcome "unknown", described as "body aches"; DIZZINESS (non-serious), outcome "unknown", described as "light headed"; CHILLS (non-serious), outcome "unknown", described as "cold chills"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; HEADACHE (non-serious), outcome "unknown", described as "bad headache"; FEELING HOT (non-serious), outcome "unknown", described as "feels very warm"; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient had received Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), vaccine. Stated that all his previous doses were Moderna this was his first Pfizer dose. He stated that they usually make him sick, and this was the first Pfizer one he has had the rest were the Moderna. He was asking if he could take Ibuprofen for his experienced side effects. Reported he has a bad headache, feels nauseous and was drinking water most of the day. He had the paperwork that was given to him and stated all fevers made him feel this way and he was wanting to know if he could take Ibuprofen. He wanted to know if his temperature went down, he would feel better. His Cold chills started about 1:30pm and took his temperature and it was 102. Stated this has happened with all the vaccines he had got.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: feel very terrible/feels horrible; neckache; body aches; light headed; cold chills; nauseous; bad headache; feels very warm; sick; fever; all his previous doses were Moderna this was his first Pfizer dose; 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 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ibuprofen for muscle pain, notes: sometimes take Ibuprofen 200mg for muscle pain. Vaccination history included: Moderna covid-19 vaccine (States all his previous doses were Moderna .), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Oct2022, outcome "unknown", described as "all his previous doses were Moderna this was his first Pfizer dose"; PYREXIA (non-serious) with onset 12Oct2022, outcome "unknown", described as "fever"; MALAISE (non-serious), outcome "unknown", described as "feel very terrible/feels horrible"; NECK PAIN (non-serious), outcome "unknown", described as "neckache"; PAIN (non-serious), outcome "unknown", described as "body aches"; DIZZINESS (non-serious), outcome "unknown", described as "light headed"; CHILLS (non-serious), outcome "unknown", described as "cold chills"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; HEADACHE (non-serious), outcome "unknown", described as "bad headache"; FEELING HOT (non-serious), outcome "unknown", described as "feels very warm"; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient had received Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), vaccine. Stated that all his previous doses were Moderna this was his first Pfizer dose. He stated that they usually make him sick, and this was the first Pfizer one he has had the rest were the Moderna. He was asking if he could take Ibuprofen for his experienced side effects. Reported he has a bad headache, feels nauseous and was drinking water most of the day. He had the paperwork that was given to him and stated all fevers made him feel this way and he was wanting to know if he could take Ibuprofen. He wanted to know if his temperature went down, he would feel better. His Cold chills started about 1:30pm and took his temperature and it was 102. Stated this has happened with all the vaccines he had got.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain, Product use issue, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: I had a big red rash; I had a big red rash/ splotch on my left arm; fever; sore; Other vaccine same date product: Flu and Pneumonia shot administered on 01Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2022 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 01Oct2022 as unk unk, single (Batch/Lot number: unknown), in right arm for immunisation; influenza vaccine (INFLUENZA VACCINE), on 01Oct2022 as unk unk, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Bone spur" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: MELOXICAM; GLUCOSAMINE. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 01Oct2022, outcome "unknown", described as "Other vaccine same date product: Flu and Pneumonia shot administered on 01Oct2022"; RASH ERYTHEMATOUS (non-serious) with onset 02Oct2022 at 13:00, outcome "recovered", described as "I had a big red rash"; RASH MACULAR (non-serious) with onset 02Oct2022 at 13:00, outcome "recovered", described as "I had a big red rash/ splotch on my left arm"; PYREXIA (non-serious) with onset 02Oct2022 at 13:00, outcome "recovered", described as "fever"; PAIN (non-serious) with onset 02Oct2022 at 13:00, outcome "recovered", described as "sore". It was unknown if therapeutic measures were taken as a result of rash erythematous, rash macular, pyrexia, pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: they tested me for COVID; Positive, notes: then I had COVID again.  Additional information: Patient stated that I was sick and then every time I tested to see if I could get everything worked out, I, I, they tested me for COVID. I got sick twice, but I didn't know. I got sick 3 or 4 times but anyway. Then I had COVID again. While discussing Pfizer, the patient stated, "You're the ones that gave me my shot for the COVID and whatever."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: earlier Pfizer COVID vaccines, I had fevers the next day/she had a fever of 100-101 degrees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing), notes: Caller states that she just takes an unspecified thyroid medication; does not think it is relevant. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose:01, EP6955; Anatomical Location: Unknown.), administration date: 18Mar2021, when the patient was 63-year-old, for Covid-19 immunization, reaction(s): "Fever"; BNT162b2 (Dose:02, Lot Number: Reported by the caller as being either CRM29 or LRM29; Anatomical Location: Unknown.), administration date: 15Apr2021, when the patient was 63-year-old, for Covid-19 immunization, reaction(s): "Fever"; flu shot, administration date: 06Oct2022, when the patient was 64-year-old, for immunisation; tetanus shot, administration date: 29Sep2022, when the patient was 64-year-old, for immunisation. The following information was reported: PYREXIA (non-serious) with onset 03Nov2021, outcome "unknown", described as "earlier Pfizer COVID vaccines, I had fevers the next day/she had a fever of 100-101 degrees". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-Up (17Oct2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224743 same pateint/event/drug, different dose;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fevers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing), notes: takes an unspecified thyroid medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot Number: FK9895/EP6955), administration date: 18Mar2021, when the patient was 63-year-old, for Covid-19 Immunization, reaction(s): "Fever"; BNT162b2 (Dose 2, Lot Number: Reported by the caller as being either CRM29 or LRM29), administration date: 15Apr2021, when the patient was 63-year-old, for Covid-19 Immunization, reaction(s): "Fever"; BNT162b2 (Dose 3, Lot Number: 32030BD), administration date: 02Nov2021, when the patient was 63-year-old, for Covid-19 Immunization, reaction(s): "Fever". The following information was reported: PYREXIA (non-serious) with onset 03Apr2022, outcome "unknown", described as "fevers". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: For all four earlier Pfizer COVID vaccines, the patient had fevers the next day. They ranged from 100 to 101 degrees. Patient denied any other medications, medical conditions, labs, testing, or treatments relevant to these events. She was just taking an unspecified thyroid medication; did not think it was relevant. No vaccines administered on same date of the Pfizer suspect. No AE required a visit to emergency room/physician office.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224743 Same patient/vaccine/event, different dose number;
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Facial pain, Weight
Clinical narrative: Sharp pain in elbow / severe pain in right elbow/ pain in ankle; like ankle was breaking / ankle like was broke; Pain in cheek / severe pain in my cheek; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "Flu" (unspecified if ongoing), notes: Gets flu very badly every year. Concomitant medication(s) included: ELIQUIS; CARTIA [DILTIAZEM HYDROCHLORIDE]; LOSARTAN; METFORMIN; LEVOTHYROXINE; METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]. Vaccination history included: BNT162b2 (1st dose, Lot number: EL9265), administration date: 09Feb2021, when the patient was 82-year-old, for Covid-19 immunization; BNT162b2 (2nd dose, Lot number: EN6200), administration date: 02Mar2021, when the patient was 82-year-old, for Covid-19 immunization; BNT162b2 (3rd dose, Lot number: FF2589), administration date: 14Oct2021, when the patient was 82-year-old, for Covid-19 immunization. The following information was reported: FACIAL PAIN (non-serious) with onset Sep2022, outcome "recovered", described as "Pain in cheek / severe pain in my cheek"; ARTHRALGIA (non-serious) with onset Sep2022, outcome "recovered", described as "Sharp pain in elbow / severe pain in right elbow/ pain in ankle; like ankle was breaking / ankle like was broke". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient experienced severe pain in random parts of the body that goes away after couple of seconds. The pain was in her right elbow, left cheek, and right ankle. The first time she had experienced it on her elbow, like a lightning bolt hit her elbow and it hurts so bad and nearly dropped to ground and then was gone like after 2 seconds. Then a few days later, she had severe pain in her cheek, no teeth involvement, lasted for 1-2 sec and was gone. The other day she was walking at the mall she got such a severe pain in her ankle and thought she broke her ankle. She just stood a minute and then it went away. Events started a couple days after the shot right after like 2-3 days. She stated that it never happened to her and haven't take any shot aside from the covid-19 vaccine. Patient wanted to know if she can get her flu vaccine on top of the vaccine, if it is safe to get it. She's planning to have it at the end of this week or next week. She also mentioned that she is going in next few days for an appointment and wants blood work done and is due for the blood work.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CELEBREX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Reporter stated that COVID 19 Treatment was done with paxlovid and treatment start date was 12Oct2022 and stop date was 13Oct2022. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: she is running a slight fever, she is like 100.2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 12Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 12Oct2022, outcome "not recovered", described as "she is running a slight fever, she is like 100.2". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that, reporter stated,  need to know what to do with mother, she got the Pfizer COVID vaccination today and she was running a slight fever, she was like 100.2. Reporter was requested to contact nearest HCP in case of emergency.  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: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Covid symptoms returned and tested positive approximately 8 days after 2 st positive test; Covid symptoms returned and tested positive approximately 8 days after 2 st positive test; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Feb2021 at 09:00 as dose 1, single (Lot number: 007m20a), in right arm, on 18Mar2021 at 09:00 as dose 2, single (Lot number: 002b21a), in right arm and on 16Sep2021 at 14:00 as dose 3 (booster), single (Lot number: 036c31a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: currently taking Letrozole; "known allergies; Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE taken for breast cancer (ongoing). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05May2022 at 14:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid symptoms returned and tested positive approximately 8 days after 2 st positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (10Oct2022) Positive, notes: Covid symptoms returned and tested positive approximately 8 days after 2 st positive test. Covid rebound . Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine received and no other medication in 2 weeks. After completing 5 days of Paxlovid, and having a week of no symptoms, Covid symptoms returned and tested positive approximately 8 days after 2st positive test. Covid rebound.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electromyogram, Hypoaesthesia, Magnetic resonance imaging, Nerve injury
Clinical narrative: Aug2021 started to feel numbness on bottom of feet. By Oct2021 numbness encompassed feet and ankle.; Sural nerve damage; Idiopathic Peripheral Neuropathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 22Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing). Concomitant medication(s) included: NABUMETONE. The following information was reported: HYPOAESTHESIA (disability) with onset 21Aug2021, outcome "not recovered", described as "Aug2021 started to feel numbness on bottom of feet. By Oct2021 numbness encompassed feet and ankle."; NEUROPATHY PERIPHERAL (disability, medically significant) with onset 21Aug2021, outcome "not recovered", described as "Idiopathic Peripheral Neuropathy"; NERVE INJURY (disability) with onset 21Aug2021, outcome "not recovered", described as "Sural nerve damage". The events "aug2021 started to feel numbness on bottom of feet. by oct2021 numbness encompassed feet and ankle.", "sural nerve damage" and "idiopathic peripheral neuropathy" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) negative, notes: Results of all testing was negative for injury or disease; Electromyogram: (unspecified date) Sural nerve damage; Magnetic resonance imaging: (unspecified date) negative, notes: Results of all testing was negative for injury or disease; SARS-CoV-2 test: (14Sep2022) Negative, notes: Other. Therapeutic measures were taken as a result of hypoaesthesia, nerve injury, neuropathy peripheral.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: Aug2021 started to feel numbness on bottom of feet. By Oct2021 numbness encompassed feet and ankle.; Sural nerve damage; Idiopathic Peripheral Neuropathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 22Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing). Concomitant medication(s) included: NABUMETONE. The following information was reported: HYPOAESTHESIA (disability) with onset 21Aug2021, outcome "not recovered", described as "Aug2021 started to feel numbness on bottom of feet. By Oct2021 numbness encompassed feet and ankle."; NEUROPATHY PERIPHERAL (disability, medically significant) with onset 21Aug2021, outcome "not recovered", described as "Idiopathic Peripheral Neuropathy"; NERVE INJURY (disability) with onset 21Aug2021, outcome "not recovered", described as "Sural nerve damage". The events "aug2021 started to feel numbness on bottom of feet. by oct2021 numbness encompassed feet and ankle.", "sural nerve damage" and "idiopathic peripheral neuropathy" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) negative, notes: Results of all testing was negative for injury or disease; Electromyogram: (unspecified date) Sural nerve damage; Magnetic resonance imaging: (unspecified date) negative, notes: Results of all testing was negative for injury or disease; SARS-CoV-2 test: (14Sep2022) Negative, notes: Other. Therapeutic measures were taken as a result of hypoaesthesia, nerve injury, neuropathy peripheral.