chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: itching without rash in the right arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching without rash in the right arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 025A21A and 077D21B) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 3 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (itching without rash in the right arm). In March 2021, PRURITUS (itching without rash in the right arm) had resolved.     After second dose and first booster patient experienced itching without rash in the right arm but it lasted 1 week and a half. Caller stated the patient was under concomitant medications but did not want to provide additional information. No treatment medication was provided.   This case was linked to MOD-2022-657189 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: itching without rash in the right arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching without rash in the right arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 025A21A and 077D21B) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 3 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (itching without rash in the right arm). In March 2021, PRURITUS (itching without rash in the right arm) had resolved.     After second dose and first booster patient experienced itching without rash in the right arm but it lasted 1 week and a half. Caller stated the patient was under concomitant medications but did not want to provide additional information. No treatment medication was provided.   This case was linked to MOD-2022-657189 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: On a monoclonal therapy and tested positive; On a monoclonal therapy and tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "On a monoclonal therapy and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: The patient stated that he already had the 4 vaccines and he was on a monoclonal therapy and tested positive. Reporter asked for how long could they get bivalent after being negative for COVID virus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Interchange of vaccine products, Wrong product administered
Clinical narrative: dose number=1, Janssen; dose number=2, Pfizer; dose number=1, Janssen; dose number=2, Pfizer; is bivalent= False; rigors/ chills; extremely fatigued; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen (Dose number=1), for Covid-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "dose number=1, Janssen; dose number=2, Pfizer"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "dose number=1, Janssen; dose number=2, Pfizer; is bivalent= False"; CHILLS (non-serious), outcome "recovered", described as "rigors/ chills"; FATIGUE (non-serious), outcome "recovered", described as "extremely fatigued". The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: He had 3 Moderna + last one was Pfizer; Positive COVID test on 13Sep2022/with return of signs and symptoms on 25Sep2022; Positive COVID test on 13Sep2022/with return of signs and symptoms on 25Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 13Sep2022, outcome "not recovered" and all described as "Positive COVID test on 13Sep2022/with return of signs and symptoms on 25Sep2022"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "He had 3 Moderna + last one was Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Positive; (25Sep2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Discharge, Seborrhoea, Skin texture abnormal, Swelling, Swelling face
Clinical narrative: His face and head swelled up; His face and head swelled up; discharge started coming out of his face; face started getting oily; rubbery texture to his face; 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 male patient received BNT162b2 (BNT162B2), in 2021 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: SWELLING (non-serious), SWELLING FACE (non-serious) all with onset 2022, outcome "unknown" and all described as "His face and head swelled up"; DISCHARGE (non-serious) with onset 2022, outcome "unknown", described as "discharge started coming out of his face"; SEBORRHOEA (non-serious) with onset 2022, outcome "unknown", described as "face started getting oily"; SKIN TEXTURE ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "rubbery texture to his face".  Additional information: The patient received Pfizer vaccine around the same time last year. About 6-8 months later Jan2022-Apr2022, might have been Feb2022 he was out somewhere and his face and head swelled up and discharge started coming out of his face. He normally had dry skin over his face started getting oily. In that moment there was a weird rubbery texture to his face. The patient noticed that it started happening only in certain environments and certain locations. He believed in 5-8 years it would go away but he did not want to have to deal with it his whole life.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: diagnosed with psoriasis; 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 90-year-old female 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 included: "she only has one kidney" (unspecified if ongoing), notes: she only has one kidney; "had cancer" (unspecified if ongoing), notes: had cancer 20 years ago.; "had a hard time hearing" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer.), for Covid-19 immunization. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "diagnosed with psoriasis". Additional information: Caller was looking for something to calm down the rash. After the patient received her most recent Pfizer booster shot, she experienced a rash all over her body and was diagnosed with psoriasis. Caller wanted to know what to do to treat her condition. She had rashes from the palm of her hands and head and was covered all over her body. Caller cannot take medication as she only has one kidney and had cancer 20 years ago. She had a hard time hearing and requested to speak loud and clear.  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: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feel sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing), notes: Had Afib and takes a blood thinner and heart pill to slow the heart down. Takes something else for the heart. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6201, Expiration date: Unknown), administration date: 15Feb2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "positive for Covid after one dose vaccine", "positive for Covid after one dose vaccine", "sick"; BNT162b2 (DOSE 1, SINGLE, Lot number: EN6201, Expiration date: Unknown), administration date: 15Feb2021, when the patient was 76-year-old, for COVID-19 immunisation, reaction(s): "Then went and got the shot for it. Afterwards, went back to the doctor because she was falling down"; BNT162b2 (DOSE 2, SINGLE, Lot number: EN9581, Expiration date: Unknown), administration date: 08Mar2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "With the previous doses of Covid-19 vaccine, she felt sick after receiving them"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FC3183, Expiration date: Unknown), administration date: 27Sep2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "feel sick". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feel sick".  Additional information: It was reported that, that caller previously tested positive for Covid. Had it really bad, a long time there, she was really sick. Didn't want it again. Actually had Covid before, twice. The first time, was down for 6 weeks, probably. Then went and got the shot for it. Afterwards, went back to the doctor because she was falling down. Tested again positive and it wasn't as bad as the firs time, because she had the shot. Clarified further that caller had not had any Covid vaccines prior to first time testing positive for Covid. When she was positive for Covid the second time, she had received just one dose of the Covid vaccine, prior. Concomitant Products/Medical Conditions: Had Afib and took a blood thinner and heart pill to slow the heart down. Took something else for the heart. Prior to vaccination (within 4 weeks), the patient was not diagnosed with Covid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210413 same patient, different vaccine dose/AE;
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: With the previous doses of Covid-19 vaccine, she felt sick after receiving them; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 2, single (Lot number: EN9581) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "takes a blood thinner" (unspecified if ongoing), notes: Had Afib and takes a blood thinner; "heart pill to slow the heart down" (unspecified if ongoing), notes: heart pill to slow the heart down. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1, LOT: EN6201), administration date: 15Feb2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "Tested again positive and it wasn't as bad as the firs time, because she had the shot", "Tested again positive and it wasn't as bad as the firs time, because she had the shot"; BNT162b2 (Dose:1, LOT: EN6201), administration date: 15Feb2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "With the previous doses of Covid-19 vaccine, she felt sick after receiving them", "Then went and got the shot for it. Afterwards, went back to the doctor because she was falling down.". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "With the previous doses of Covid-19 vaccine, she felt sick after receiving them".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210413 same patient, different vaccine dose (first dose), different AE.;
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever; chills; headache; muscle aches; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 24 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2022, outcome "unknown"; HEADACHE (non-serious) with onset 2022, outcome "unknown"; MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "muscle aches"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "tiredness". 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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; headache; muscle aches; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 24 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2022, outcome "unknown"; HEADACHE (non-serious) with onset 2022, outcome "unknown"; MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "muscle aches"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "tiredness". 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: Pain in extremity
Clinical narrative: sore 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 77-year-old female 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 was not reported. Concomitant medication(s) included: LIVALO. Past drug history included: Sodium lauryl sulfate for allergic to sodium lauryl sulfate, notes: allergic to sodium lauryl sulfate. Vaccination history included: Bnt162b2 (Caller states all of her Covid-19 Vaccines and boosters have been Pfizer, Dose number unknown, Booster dose), for Covid-19 immunization; Bnt162b2 (Caller states all of her Covid-19 Vaccines and boosters have been Pfizer, Dose 2), for Covid-19 immunization; Bnt162b2 (Caller states all of her Covid-19 Vaccines and boosters have been Pfizer, Dose 1), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional Information: She stated all of her COVID-19 Vaccines and boosters had been Pfizer. She stated that she had no reactions to any of them, except a sore arm for about an hour. She stated that she kept an ice pack in her freezer for after shots so that she can put it on for an hour or two. She stated that she had no fever or any other side effects.  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: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: She has been throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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. Vaccination history included: Covid-19 vaccine (primary immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "She has been throwing up".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products, Pain in extremity, Pharyngeal disorder, Vocal cord disorder
Clinical narrative: 4th dose got Moderna; throat and vocal cords were struggling; throat and vocal cords were struggling; mild sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history included: "rare bone disease" (unspecified if ongoing), notes: A rare bone disease. It is a genetic disease. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 4), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (DOSE: 3), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (DOSE: 2), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (DOSE: 1), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "unknown", described as "mild sore arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "4th dose got Moderna"; PHARYNGEAL DISORDER (non-serious), VOCAL CORD DISORDER (non-serious), outcome "unknown" and all described as "throat and vocal cords were struggling". Additional information: Patient has never been immunocompromised, and has rarely got the flu. This is not the flu. She hasn't had a fever the whole time. She had a mild sore arm. Her throat and vocal cords were struggling. She's not in the hospital and she's not dying so she's very thankful for what Pfizer has accomplished.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test, X-ray
Clinical narrative: 4th dose got Moderna; throat and vocal cords were struggling; throat and vocal cords were struggling; mild sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history included: "rare bone disease" (unspecified if ongoing), notes: A rare bone disease. It is a genetic disease. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 4), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (DOSE: 3), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (DOSE: 2), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (DOSE: 1), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "unknown", described as "mild sore arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "4th dose got Moderna"; PHARYNGEAL DISORDER (non-serious), VOCAL CORD DISORDER (non-serious), outcome "unknown" and all described as "throat and vocal cords were struggling". Additional information: Patient has never been immunocompromised, and has rarely got the flu. This is not the flu. She hasn't had a fever the whole time. She had a mild sore arm. Her throat and vocal cords were struggling. She's not in the hospital and she's not dying so she's very thankful for what Pfizer has accomplished.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (non-serious) with onset Sep2022, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Additional information: On 26Sep2022, the patient took Paxlovid treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: We have been receiving all the Pfizer COVID vaccines /are still getting COVID; We have been receiving all the Pfizer COVID vaccines /are still getting COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female 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; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: as a child. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "We have been receiving all the Pfizer COVID vaccines /are still getting COVID".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Inverted Papilloma" (unspecified if ongoing), notes: Inverted Papilloma; "Pre Diabetes" (unspecified if ongoing), notes: Pre Diabetes; "Chronic Inflammation" (unspecified if ongoing), notes: Chronic Inflammation; "Known allergies: Penicillins" (unspecified if ongoing), notes: Known allergies: Penicillins. The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Known allergies: levaquin", notes: levaquin; Demerol, reaction(s): "Known allergies: demerol", notes: Known allergies: demerol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 27Sep2022 to 02Oct2022 as treatment for Covid-19.   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 the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I just feel itchy, very itchy for no reason; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose number unknown (booster), single (Lot number: GJ5342, Expiration Date: 17Nov2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Oct2022, outcome "unknown", described as "I just feel itchy, very itchy for no reason". No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 30Dec2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, the patient received paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201213034 Same patient, different drug, different AE;
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: fever; chills; headache; sore arm; swollen lymph node; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node".   Additional information: It was unknown that if the patient had other vaccine in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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 included: "Crohn's" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (06Oct2022) Positive, notes: COVID rebound, tested positive again 06Oct. It was reported that the patient experienced covid-19 on an unspecified date and received Paxlovid as treatment from 23Sep2022 to 27Sep2022. The patient tested positive again on 06Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dyspnoea, Fatigue
Clinical narrative: I had high dose flu vaccine (Unspecified flu vaccine) and after 48 hours later I had the Pfizer BioNTech Bivalent; I am getting tired fast; Achy joints; Shortness of breath; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 14:00 as dose number unknown (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 04Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer), for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Oct2022, outcome "unknown", described as "I had high dose flu vaccine (Unspecified flu vaccine) and after 48 hours later I had the Pfizer BioNTech Bivalent"; ARTHRALGIA (non-serious) with onset Oct2022, outcome "unknown", described as "Achy joints"; CHILLS (non-serious) with onset Oct2022, outcome "unknown"; FATIGUE (non-serious) with onset Oct2022, outcome "unknown", described as "I am getting tired fast"; DYSPNOEA (non-serious) with onset Oct2022, outcome "unknown", described as "Shortness of breath". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, arthralgia, dyspnoea, chills. Additional information: Naproxen (treatment). No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: I had high dose flu vaccine (Unspecified flu vaccine) and after 48 hours later I had the Pfizer BioNTech Bivalent; I am getting tired fast; Achy joints; Shortness of breath; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 14:00 as dose number unknown (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 04Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer), for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Oct2022, outcome "unknown", described as "I had high dose flu vaccine (Unspecified flu vaccine) and after 48 hours later I had the Pfizer BioNTech Bivalent"; ARTHRALGIA (non-serious) with onset Oct2022, outcome "unknown", described as "Achy joints"; CHILLS (non-serious) with onset Oct2022, outcome "unknown"; FATIGUE (non-serious) with onset Oct2022, outcome "unknown", described as "I am getting tired fast"; DYSPNOEA (non-serious) with onset Oct2022, outcome "unknown", described as "Shortness of breath". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, arthralgia, dyspnoea, chills. Additional information: Naproxen (treatment). No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died three minutes after she got the Pfizer Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP, (friend of patient's child), Program ID.  A female 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: DEATH (death, medically significant), outcome "fatal", described as "died three minutes after she got the Pfizer Covid 19 vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died three minutes after she got the Pfizer Covid 19 vaccine
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia, Sensitive skin
Clinical narrative: very sensitive skin; lower ext weakness; tingling in my feet; 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), 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: SENSITIVE SKIN (non-serious), outcome "unknown", described as "very sensitive skin"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "lower ext weakness"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in my feet".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Pyrexia
Clinical narrative: Sore left arm at injection site; fever; chills; dizziness; Headache; altered hearing in right ear (similar to tinnitis); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FISH OIL; ISTALOL; OCUVITE [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;SODIUM SELENATE;TOCOPHERYL ACETATE;ZINC OXIDE]; ROSUVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841, Location of injection: Arm Left, Vaccine Administration Time: 14:00 PM), administration date: 16Dec2021, when the patient was 58-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left), administration date: 10Mar2021, when the patient was 57-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 17Feb2021, when the patient was 57-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022); VACCINATION SITE PAIN (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022), described as "Sore left arm at injection site"; TINNITUS (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022), described as "altered hearing in right ear (similar to tinnitis)"; CHILLS (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022); DIZZINESS (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022); PYREXIA (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022), described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, chills, dizziness, headache, tinnitus.  Additional information: No other vaccine in four weeks, no covid prior vaccination, no covid tested post vaccination. Other medications in two weeks: Rosuvastatin, Istalol, Occuvite, Fish Oil, Viatmin.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: Sore left arm at injection site; fever; chills; dizziness; Headache; altered hearing in right ear (similar to tinnitis); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FISH OIL; ISTALOL; OCUVITE [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;SODIUM SELENATE;TOCOPHERYL ACETATE;ZINC OXIDE]; ROSUVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841, Location of injection: Arm Left, Vaccine Administration Time: 14:00 PM), administration date: 16Dec2021, when the patient was 58-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left), administration date: 10Mar2021, when the patient was 57-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 17Feb2021, when the patient was 57-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022); VACCINATION SITE PAIN (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022), described as "Sore left arm at injection site"; TINNITUS (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022), described as "altered hearing in right ear (similar to tinnitis)"; CHILLS (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022); DIZZINESS (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022); PYREXIA (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022), described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, chills, dizziness, headache, tinnitus.  Additional information: No other vaccine in four weeks, no covid prior vaccination, no covid tested post vaccination. Other medications in two weeks: Rosuvastatin, Istalol, Occuvite, Fish Oil, Viatmin.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right 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 included: "Hypertension" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: doxycycline, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. ,Linked Report(s) : US-PFIZER INC-202201212947 Same patient, different drugs and events;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted Covid and had been vaccinated with Comirnaty; contracted Covid and had been vaccinated with Comirnaty; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted Covid and had been vaccinated with Comirnaty".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.