chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he got Covid; he got Covid; 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 male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other Conditions: No. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "he got Covid".   Clinical course: I got the Prevnar 20 shot a week and a half ago on Saturday and two days later I found out I got Covid. I've had four of the Pfizer COVID-19 immunizations, the last being in Jul2022. How can the Covid infection affect the efficacy of Prevnar 20?" Got Prevnar 20 on 05Nov2022, started feeling poorly soon after, probably 07Nov2022 or 08Nov2022, didn't do a Covid test at first but is pretty sure caller had Covid the entire time, but did the test 13Nov2022 and tested positive but thinks caller had Covid starting the beginning of that week. Just thought caller was having a reaction to the Prevnar 20, like an immune response, at the beginning and started feeling like reaction was going on way too long, had a pretty bad sore throat, so tested and tested positive for Covid. Indication: Turned 65 in July and then coming and flu season and still Covid being around caller thought was a good idea to be vaccinated for pneumonia, standard thing. Confirmed all 4 doses were the Pfizer BioNTech COVID-19 vaccine. Lack of efficacy for the Pfizer BioNTech COVID-19 vaccine, got Prevnar 20 vaccine 05Nov2022 and 2 days later came down with Covid-19. Had 4 doses of the Pfizer BioNTech COVID-19 vaccine, with the most recent dose being in Jul2022. Calling more in regards to Prevnar 20 about efficacy of Prevnar 20 vaccine since contracted Covid after getting Prevnar 20. Had Covid also in Jan2022. Had Covid also in Jan2022.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: He believes he has a history of COVID-19 which occurred from 02Jan2022-15Jan2022; He believes he has a history of COVID-19 which occurred from 02Jan2022-15Jan2022; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): MOD22-029370 (Moderna).  A 78-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 06Jan2021 as dose 2, 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "He believes he has a history of COVID-19 which occurred from 02Jan2022-15Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2020) Positive, notes: He later received an antibody test in Dec2020 which showed strongly positive for covid-19 vaccine antibodies; (unspecified date) Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included, reporter received an antibody test on an unspecified date in Dec2020 which showed strongly positive for covid-19 vaccine antibodies. Reporter believed that he had a history of covid-19 which occurred from 02Jan2022 to 15Jan2022. He took robitussin DM (dextromethorphan-guaifenesin) by day and whiskey by night for his symptoms. But there were no lab tests available at that time.  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 available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events-Vaccination Failure and COVID-19
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Naproxen sodium, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid on 07Nov2022 to 11Nov2022 for treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201308884 same patient and drug, different dose number and event;
Age: 59.0
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 contactable reporter(s) (Consumer or other non 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 14Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 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 included: "Asymptomatic CAD" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "carpal tunnel" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01May2018; VITAMIN D3, start date: 10Jan2018; MAGNESIUM; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Erythromycin, reaction(s): "Known allergies:Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Nov2022) Negative; (13Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2weeks. The patient stated that they started Paxlovid on 04Nov2022. After completing paxlovid on wed 08Nov, she felt well and tested negative -2 days later. (Thursday 10Nov) On Sunday, 13Nov she started to have a mild sore throat and some nasal congestion and tested positive. She have continued with worsening symptoms positive. She have continued with worsening symptoms of nasal congestion ,cough , chills, body aches and low-grade fever.  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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal congestion
Clinical narrative: cough; stuffy nose; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included: MUCINEX. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COUGH (non-serious) with onset 17Nov2022, outcome "recovering"; HEADACHE (non-serious) with onset 17Nov2022, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 17Nov2022, outcome "recovering", described as "stuffy nose". Therapeutic measures were not taken as a result of cough, nasal congestion, headache.  Additional information: The patient had no known allergies other medical history. The patient did not received any other vaccine within the four weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 8-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose number unknown (orange cap; 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 completed; unknown manufacturer), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Nov2022, 1 week after the suspect product(s) administration, outcome "unknown", described as "A little itchy."; URTICARIA (non-serious) with onset Nov2022, 1 week after the suspect product(s) administration, outcome "unknown", described as "every day he is waking up with hives on his neck and torso primarily/some facial involvement"; RASH (non-serious) with onset Nov2022, 1 week after the suspect product(s) administration, outcome "unknown", described as "the rash did get one week after taking the Product". Therapeutic measures were taken as a result of urticaria, pruritus, rash.  Additional reporter: The physician has a patient who is 8 years old. She is calling in regard to the Pfizer COVID-19 Vaccine pediatric dose, 5 to 11 years of age. On 14Nov2022, the patient had the vaccine. This week for the last 5 days, every day he is waking up with hives on his neck and torso primarily. None on his extremities. Today there is some facial involvement. Everyday he gets this and every day it goes away; next day same thing, he gets it, and it goes away. This cycle continues to repeat himself. The patient was given Zyrtec, antihistamine, and she stated that he is responding to it, but hard to say. The patient also experienced a little itchy. The physician mentioned that it is more just a concern as to why this is happening and wondering if there could be an association with the vaccine. Physician confirms the symptoms didn't start immediately, but 1 week after getting the product. The rash did get one week after taking the product. The physician would like to know if there is any information on how long it will last. 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, SARS-CoV-2 test
Clinical narrative: All her doses of the covid vaccine were manufactured by Pfizer, she had 4 total doses/covid positive after 4 doses of Pfizer covid vaccine; All her doses of the covid vaccine were manufactured by Pfizer, she had 4 total doses/covid positive after 4 doses of Pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), in Jan2020 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "All her doses of the covid vaccine were manufactured by Pfizer, she had 4 total doses/covid positive after 4 doses of Pfizer covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: covid positive after 4 doses of Pfizer covid vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Paxlovid started on 11Nov2022 indication was covid positive. She had all her booster shots. She thought her first dose was in Jan2020. All her doses of the covid vaccine were manufactured by Pfizer, she had 4 total doses. She was positive after 4 doses of Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Spontaneous hives that began after the injection; itching in the face that began after the injection; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 14:00 as dose 4 (booster), single (Lot number: 59267030402) at the age of 24 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 3 (1st booster), Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 22Sep2022, outcome "not recovered", described as "Spontaneous hives that began after the injection"; PRURITUS (non-serious) with onset 22Sep2022, outcome "not recovered", described as "itching in the face that began after the injection". The events "spontaneous hives that began after the injection" and "itching in the face that began after the injection" required physician office visit. Therapeutic measures were taken as a result of urticaria, pruritus. Additional information: the patient did not have covid prior to vaccination and has not been tested for covid post vaccination. The patient has no known allergies and other medical history. The treatment received by the patient is an antihistamine therapy.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Back pain, Fall, Muscle spasms
Clinical narrative: Behind their knees, the back half of our legs are cramped and swollen with pain; Behind their knees, the back half of our legs are cramped and swollen with pain/ hands are swollen; His face is swollen as well; He's been using a walker for about 1 week; He fell on Friday; they went to the orthopedic clinic who told them it was arthritis.; joint pain; muscle and back pain; muscle and back pain; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 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 completed unknown manufacturer.), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), MYALGIA (non-serious) all with onset 2022, outcome "unknown" and all described as "muscle and back pain"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Behind their knees, the back half of our legs are cramped and swollen with pain"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Behind their knees, the back half of our legs are cramped and swollen with pain/ hands are swollen"; SWELLING FACE (non-serious), outcome "unknown", described as "His face is swollen as well"; WALKING AID USER (non-serious), outcome "unknown", described as "He's been using a walker for about 1 week"; FALL (non-serious), outcome "unknown", described as "He fell on Friday"; ARTHRITIS (non-serious), outcome "unknown", described as "they went to the orthopedic clinic who told them it was arthritis."; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201309624 same reporter/ product/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Swelling face, Walking aid user
Clinical narrative: Behind their knees, the back half of our legs are cramped and swollen with pain; Behind their knees, the back half of our legs are cramped and swollen with pain/ hands are swollen; His face is swollen as well; He's been using a walker for about 1 week; He fell on Friday; they went to the orthopedic clinic who told them it was arthritis.; joint pain; muscle and back pain; muscle and back pain; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 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 completed unknown manufacturer.), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), MYALGIA (non-serious) all with onset 2022, outcome "unknown" and all described as "muscle and back pain"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Behind their knees, the back half of our legs are cramped and swollen with pain"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Behind their knees, the back half of our legs are cramped and swollen with pain/ hands are swollen"; SWELLING FACE (non-serious), outcome "unknown", described as "His face is swollen as well"; WALKING AID USER (non-serious), outcome "unknown", described as "He's been using a walker for about 1 week"; FALL (non-serious), outcome "unknown", described as "He fell on Friday"; ARTHRITIS (non-serious), outcome "unknown", described as "they went to the orthopedic clinic who told them it was arthritis."; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201309624 same reporter/ product/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Haemorrhage, Pruritus, Rash
Clinical narrative: bleeding; bit by ticks or fleas; rash all over; itching; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  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: HAEMORRHAGE (medically significant), outcome "unknown", described as "bleeding"; ARTHROPOD BITE (non-serious), outcome "unknown", described as "bit by ticks or fleas"; RASH (non-serious), outcome "unknown", described as "rash all over"; PRURITUS (non-serious), outcome "unknown", described as "itching". Therapeutic measures were taken as a result of haemorrhage, arthropod bite, rash, pruritus.  Additional information: She had a reaction to a previous dose - she stated last time she thought she had been bit by ticks or fleas from walking in the grass. She had a rash all over her body. It was itching and bleeding. She used lotion and ointment to sooth it.   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 event bleeding  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201309622 Same reporter, same drug, same patient, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: friend who cant even walk at all after receiving the COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID.  A patient (no qualifiers provided) 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: GAIT INABILITY (medically significant), outcome "unknown", described as "friend who cant even walk at all after receiving the COVID vaccine". 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 information, the reported serious event Gait Inability cannot be excluded for the suspect product BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Protein urine present, Urine abnormality, Urine protein/creatinine ratio
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose number unknown (booster), single (Lot number: GH9702) 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; Manufacturer unknown), for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 2022, outcome "unknown", described as "Chronic stomach pain"; URINE ABNORMALITY (non-serious) with onset 2022, outcome "unknown", described as "Foamy urine"; NAUSEA (non-serious) with onset 2022, outcome "unknown"; PROTEIN URINE PRESENT (non-serious) with onset 2022, outcome "unknown", described as "Tested positive for protein in his urine"; WHITE BLOOD CELL COUNT DECREASED (non-serious) with onset 2022, outcome "unknown", described as "his white blood cell count is low". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient has received the Pfizer Booster, the Bivalent Booster (Clarified as: Pfizer Covid-19 Vaccine Bivalent) approximately, three to four weeks ago and subsequent to receiving that Booster he has had foamy urine and chronic stomach pain and nausea. He tested positive for protein in his urine and his white blood cell count was low. Those were the only changes.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose number unknown (booster), single (Lot number: GH9702) 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; Manufacturer unknown), for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 2022, outcome "unknown", described as "Chronic stomach pain"; URINE ABNORMALITY (non-serious) with onset 2022, outcome "unknown", described as "Foamy urine"; NAUSEA (non-serious) with onset 2022, outcome "unknown"; PROTEIN URINE PRESENT (non-serious) with onset 2022, outcome "unknown", described as "Tested positive for protein in his urine"; WHITE BLOOD CELL COUNT DECREASED (non-serious) with onset 2022, outcome "unknown", described as "his white blood cell count is low". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient has received the Pfizer Booster, the Bivalent Booster (Clarified as: Pfizer Covid-19 Vaccine Bivalent) approximately, three to four weeks ago and subsequent to receiving that Booster he has had foamy urine and chronic stomach pain and nausea. He tested positive for protein in his urine and his white blood cell count was low. Those were the only changes.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Chills; fatigue; sweating; headache; body aches; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 45 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 16Nov2022, outcome "recovering"; PAIN (non-serious) with onset 16Nov2022, outcome "recovering", described as "body aches"; COUGH (non-serious) with onset 16Nov2022, outcome "recovering"; FATIGUE (non-serious) with onset 16Nov2022, outcome "recovering"; HEADACHE (non-serious) with onset 16Nov2022, outcome "recovering"; HYPERHIDROSIS (non-serious) with onset 16Nov2022, outcome "recovering", described as "sweating". Therapeutic measures were not taken as a result of chills, fatigue, hyperhidrosis, headache, pain, cough.  Additional information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Chills; fatigue; sweating; headache; body aches; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 45 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 16Nov2022, outcome "recovering"; PAIN (non-serious) with onset 16Nov2022, outcome "recovering", described as "body aches"; COUGH (non-serious) with onset 16Nov2022, outcome "recovering"; FATIGUE (non-serious) with onset 16Nov2022, outcome "recovering"; HEADACHE (non-serious) with onset 16Nov2022, outcome "recovering"; HYPERHIDROSIS (non-serious) with onset 16Nov2022, outcome "recovering", described as "sweating". Therapeutic measures were not taken as a result of chills, fatigue, hyperhidrosis, headache, pain, cough.  Additional information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 35.0
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) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 35 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Exercise induced asthma" (unspecified if ongoing); "Known allergy: Bactrim" (unspecified if ongoing); "dishydrotic eczema" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN XL, start date: 01Jan2019. 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: Negative, notes: Rebound - tested positive after testing negative; Positive, notes: Rebound - tested positive after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  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: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: mild facial redness; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 9-month-old female patient received BNT162b2 (BNT162B2), on 21Oct2022 as dose 1 (maroon cap), single (Batch/Lot number: unknown) at the age of 9 months for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious) with onset 21Oct2022, outcome "recovered", described as "mild facial redness". Additional information: The reporter stated that a patient received their 1st dose of the vaccine and then within 1 hour developed mild facial redness. The facial redness resolved on its own; it was very mild. The patient's parents still want her to receive dose number 2. Caller was asking if it is safe to give her the 2nd dose. Patient received the first dose on 21Oct2022. The caller wanted to know if it would be safe for a 9-month-old patient to receive the second dose of the Pfizer-BioNTech Covid 19 Vaccine (maroon cap). The patient developed a mild facial redness after receiving the 1st dose on 21Oct2022 and the patient was 9 months and 18 days old when she received the first dose.   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 given in narrative, the causal relationship between the event and the suspect drug BNT162B2 cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Choking, Dysphagia, Hypotension
Clinical narrative: Choking; Difficulty Swallowing; Low blood pressure; 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 48-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 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: CHOKING (medically significant) with onset 2022, outcome "unknown"; DYSPHAGIA (non-serious) with onset 2022, outcome "unknown", described as "Difficulty Swallowing"; HYPOTENSION (non-serious) with onset 2022, outcome "unknown", described as "Low blood pressure". The events "choking", "difficulty swallowing" and "low blood pressure" required emergency room (ER) visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (2022) Low. The report was not related to a study or programme. The patient states she ended up in the ER 3 days after receiving the vaccine and while in the ER, she had low blood pressure as well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Vaccination site mass
Clinical narrative: knot on her left arm where she had been getting the Pfizer Covid-19 vaccine; 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 72-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing); "Anemic" (ongoing), notes: she has always been anemic.; "Allergies" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, start date: 06Oct2022 (ongoing); FERROUS SULFATE taken for anaemia, start date: 2022 (ongoing); FEXOFENADINE HYDROCHLORIDE taken for hypersensitivity (ongoing); FLUTICASONE PROPIONATE nasal taken for hypersensitivity (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0161, Anatomical location: Left arm), administration date: 15Apr2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "All of those doses were administered into her left arm. She noticed a knot on her left arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: EW0167, Anatomical location; Left arm), administration date: 03May2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "All of those doses were administered into her left arm. She noticed a knot on her left arm". The following information was reported: VACCINATION SITE MASS (non-serious) with onset Nov2022, outcome "not recovered", described as "knot on her left arm where she had been getting the Pfizer Covid-19 vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass.  Additional information: Reporter thought he was concerned because she hadn't been to him in a minute. On 08Sep2022 when she saw him her blood pressure was high. He wanted her to go get a blood pressure reading, but she couldn't so then they just went up to 10mg of Amlodipine. She couldn't find nowhere because they shut the blood pressure cuffs down. She needs to get a blood pressure cuff for her home. Patient receiving concomitant medication One-A-Day Vitamin. All of those doses were administered into her left arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201309901 Same patient and drug, event separated in time;US-PFIZER INC-202201309902 Same patient and drug, event separated in time;US-PFIZER INC-202201309903 Same patient, different drug/event;
Sex: U
Vaccine: COVID19
Symptoms: Heart rate irregular, Ventricular extrasystoles
Clinical narrative: have noticed i have gotten PVC(Premature ventricular contractions); on Sep2021 I noticed that i started having extra beats on heart; 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 patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: VENTRICULAR EXTRASYSTOLES (medically significant) with onset Sep2021, outcome "unknown", described as "have noticed i have gotten PVC(Premature ventricular contractions)"; HEART RATE IRREGULAR (non-serious) with onset Sep2021, outcome "unknown", described as "on Sep2021 I noticed that i started having extra beats on heart". The events "have noticed i have gotten pvc(premature ventricular contractions)" and "on sep2021 i noticed that i started having extra beats on heart" required physician office visit. Additional information: Reporter stated getting third shot of the mRNA vaccine early Jan2021. On Sep2021, noticed to have started having extra beats on heart. Patient went and saw an EP (Electrophysiologist) and they have noticed patient have gotten PVC (Premature ventricular contractions).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain, Pain in extremity
Clinical narrative: Sore arm; Body ache; Stomach discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 11:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D3; ATORVASTATIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot no: EL3247; Location of injection: Arm right; Vaccine administration time: 10:30), administration date: 02Feb2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot no: EL3247; Location of injection: Arm right; Vaccine administration time: 10:30), administration date: 23Feb2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot no: FH8027; Anatomical location of injection: Arm right; Vaccine administration time: 10:00), administration date: 03Dec2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 16Nov2022 at 22:00, outcome "recovered" (Nov2022), described as "Body ache"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2022 at 22:00, outcome "recovered" (Nov2022), described as "Sore arm"; ABDOMINAL DISCOMFORT (non-serious) with onset 16Nov2022 at 22:00, outcome "recovered" (Nov2022), described as "Stomach discomfort". Therapeutic measures were not taken as a result of pain in extremity, pain, abdominal discomfort.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. AEs did not result in physician office visit or emergency room visit.
Age: 35.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 35 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic sinusitis" (unspecified if ongoing). The patient took concomitant medications Birth Control (brand=Mylan) from Jan2019 to Nov2022. 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: (unspecified date) Positive, notes: Treatment of COVID-19; (17Nov2022) Positive, notes: Tested Positive for Covid again 4 days after finishing course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 09Nov2022 to 13Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0161) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anemic" (ongoing), notes: has always been anemic.; "High blood pressure" (ongoing); "Allergies" (ongoing); "Multivitamin multimineral supplement" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing); FEXOFENADINE HYDROCHLORIDE taken for hypersensitivity (ongoing); FLUTICASONE PROPIONATE taken for hypersensitivity (ongoing). The following information was reported: VACCINATION SITE MASS (non-serious), outcome "not recovered", described as "noticed a knot on her left arm where she had been administered those doses". Therapeutic measures were not taken as a result of vaccination site mass.  Additional information: The patient also received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Lot number: EW0167) in left arm and received BNT162b2 (BNT162B2), on 03May2021 as dose 3 (booster), single (Lot number: FL3197) in left arm for covid-19 immunisation. It was reported that a knot on her left arm where the patient had been getting Pfizer Covid-19 Vaccines and booster doses. Caller clarified that the patient had received 3 doses of Pfizer Covid-19 Vaccine in total including the first two doses, and then the third dose which was her booster. All of those doses were administered into her left arm. The patient noticed a knot on her left arm where the patient had been administered those doses a couple of weeks ago, around beginning of Nov2022.The patient was going to go get the updated version of the vaccine booster, whatever it is, but then noticed this knot on her left arm so thought the patient should find out if its ok to get another dose with her having the knot on her left arm before doing that; There were no other conditions. There were no investigations.There were no relevant tests