chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Computerised tomogram, Lymphadenopathy, Pyrexia
Clinical narrative: Weight was less; lump in his shoulder, mentioning that his lymph node was inflamed/One of lymph nodes was swollen near the shoulder; fever; 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 52-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 2, single (Lot number: EN6206) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Lot: EN6200, route of administration: left arm , Dose: Adult dose caller guesses.), administration date: 18Feb2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "Fever". The following information was reported: PYREXIA (non-serious) with onset 11Mar2021, outcome "recovered" (2021), described as "fever"; LYMPHADENOPATHY (non-serious) with onset 01May2021, outcome "recovered" (May2021), described as "lump in his shoulder, mentioning that his lymph node was inflamed/One of lymph nodes was swollen near the shoulder"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Weight was less". The event "fever" required physician office visit. The event "lump in his shoulder, mentioning that his lymph node was inflamed/one of lymph nodes was swollen near the shoulder" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The seriousness of the events was reported as non-serious. Everything began with fever. Had fever right away after receiving second dose Pfizer Covid 19 Vaccine and then after 5 weeks had 9 days of fever. In first day of fever, went to doctor and doctor did blood test to see if had infection. Did not have any infection. One of lymph nodes was swollen near the shoulder. When went to doctor for that lump, went to emergency room was discharged from the emergency room. Did a CT scan right away. Went away, doesn't know date went away, was going away slowly, it maybe lasted 4 or 5 days.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Weight was less; lump in his shoulder, mentioning that his lymph node was inflamed/One of lymph nodes was swollen near the shoulder; fever; 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 52-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 2, single (Lot number: EN6206) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Lot: EN6200, route of administration: left arm , Dose: Adult dose caller guesses.), administration date: 18Feb2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "Fever". The following information was reported: PYREXIA (non-serious) with onset 11Mar2021, outcome "recovered" (2021), described as "fever"; LYMPHADENOPATHY (non-serious) with onset 01May2021, outcome "recovered" (May2021), described as "lump in his shoulder, mentioning that his lymph node was inflamed/One of lymph nodes was swollen near the shoulder"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Weight was less". The event "fever" required physician office visit. The event "lump in his shoulder, mentioning that his lymph node was inflamed/one of lymph nodes was swollen near the shoulder" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The seriousness of the events was reported as non-serious. Everything began with fever. Had fever right away after receiving second dose Pfizer Covid 19 Vaccine and then after 5 weeks had 9 days of fever. In first day of fever, went to doctor and doctor did blood test to see if had infection. Did not have any infection. One of lymph nodes was swollen near the shoulder. When went to doctor for that lump, went to emergency room was discharged from the emergency room. Did a CT scan right away. Went away, doesn't know date went away, was going away slowly, it maybe lasted 4 or 5 days.
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Dry eye, Ocular hyperaemia, Off label use, Product use issue
Clinical narrative: Left eye become blood shot and dry; Left eye become blood shot and dry; Trouble focusing on screens and devices; Left eye is still very dry and can become strained after long periods of focus.; vaccine received same date: Influenza - Right Arm; vaccine received same date: Influenza - Right Arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 25Nov2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DUPIXENT. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 25Nov2022, outcome "unknown" and all described as "vaccine received same date: Influenza - Right Arm"; OCULAR HYPERAEMIA (non-serious), DRY EYE (non-serious) all with onset 26Nov2022, outcome "recovering" and all described as "Left eye become blood shot and dry"; ASTHENOPIA (non-serious) with onset 26Nov2022, outcome "not recovered", described as "Left eye is still very dry and can become strained after long periods of focus."; VISION BLURRED (non-serious) with onset 26Nov2022, outcome "recovering", described as "Trouble focusing on screens and devices". Therapeutic measures were not taken as a result of ocular hyperaemia, dry eye, vision blurred, asthenopia.  Additional information: Left eye become blood shot and dry. Trouble focusing on screens and devices. No fluid discharge. Took 3 days to partially recover to light pink sclera. Left eye is still very dry and can become strained after long periods of focus. No COVID prior vaccination, No COVID tested post vaccination, No treatment adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Left eye become blood shot and dry; Left eye become blood shot and dry; Trouble focusing on screens and devices; Left eye is still very dry and can become strained after long periods of focus.; vaccine received same date: Influenza - Right Arm; vaccine received same date: Influenza - Right Arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 25Nov2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DUPIXENT. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 25Nov2022, outcome "unknown" and all described as "vaccine received same date: Influenza - Right Arm"; OCULAR HYPERAEMIA (non-serious), DRY EYE (non-serious) all with onset 26Nov2022, outcome "recovering" and all described as "Left eye become blood shot and dry"; ASTHENOPIA (non-serious) with onset 26Nov2022, outcome "not recovered", described as "Left eye is still very dry and can become strained after long periods of focus."; VISION BLURRED (non-serious) with onset 26Nov2022, outcome "recovering", described as "Trouble focusing on screens and devices". Therapeutic measures were not taken as a result of ocular hyperaemia, dry eye, vision blurred, asthenopia.  Additional information: Left eye become blood shot and dry. Trouble focusing on screens and devices. No fluid discharge. Took 3 days to partially recover to light pink sclera. Left eye is still very dry and can become strained after long periods of focus. No COVID prior vaccination, No COVID tested post vaccination, No treatment adverse event.  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: soreness in arm/Arm soreness; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "soreness in arm/Arm soreness".  Additional information: The reporter reported that reporting for herself, she mentioned that she had a coworker that had it last month. She only had soreness in arm and nothing that month. She did have a few days of soreness in arm and then it was better. She did not wish to complete report for her and unable to confirm which vaccine she received. This report was to capture information for her coworker.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201377871 same reporter/product, different patient/AE;
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Terrible rash on her whole body, and it itches; 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 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 but unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious), outcome "unknown", described as "Terrible rash on her whole body, and it itches".  Additional information: The patient states that she is calling about the Pfizer Product Covid Vaccine. The patient states that she got her booster shot on Monday afternoon and by Tuesday she had a terrible rash on her whole body, and it itches. The patient asks what she can do to get this to disappear. The patient would like to know how many people have experienced a rash similar to hers. The patient would like to know if there was anything Pfizer suggests or recommend in order to make this rash go away.  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: Body temperature abnormal, Macule, Nasopharyngitis
Clinical narrative: cold symptoms; a little temperature; spot on her arm may be red and the size of a quarter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), 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: NASOPHARYNGITIS (non-serious), outcome "recovered", described as "cold symptoms"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "recovered", described as "a little temperature"; MACULE (non-serious), outcome "recovered", described as "spot on her arm may be red and the size of a quarter".  Additional information: Reporter stated he and his wife both had three doses of the Pfizer BioNTech COVID-19 vaccine. Stated that he had no reactions but his wife had terrible reactions to all of them. Stated that it takes 2-3 days before she got over her reactions. The patient had cold symptoms and a little temperature for a day or two and it was gone. The patient had reactions as just kind of cold symptoms and the spot on her arm may be red and the size of quarter for a little while then eventually goes away. The spot was on her left arm but he was not sure and to just put it as unknown. Wanted to know was there anything a person taking these shots could to do to reduce or eliminate the reaction beforehand.   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-202201378898 same reporter/patient/event, different dose;US-PFIZER INC-202201378899 same reporter/patient/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Vomiting
Clinical narrative: vomiting; diarrhea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2022 at 16:00 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "no side effects". The following information was reported: DIARRHOEA (non-serious) with onset 15Dec2022, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset 15Dec2022, outcome "unknown"; VOMITING (non-serious) with onset 15Dec2022, outcome "unknown". The events "vomiting", "diarrhea" and "headache" required emergency room visit. Therapeutic measures were taken as a result of vomiting, diarrhoea, headache.  Additional information: Caller mentioned it took more than a month for them to get the second dose because everybody only got the booster shot. Her son did not have a problem to the first shot. He received the second dose of the vaccine yesterday at 4 o'clock and had a reaction at about 12 o'clock got the diarrhea and headache. She also mentioned giving medication to her child for the side effects. Doctors are closed so she will be reaching out to a pharmacy or bring him to the ER. Caller mentioned towards the end of the call that she won not let her son get the booster anymore. Patient  reported other Conditions also. Investigations was not Provided. Caller states the patient has Asthma and he received his first Pfizer shot with no side effects. Caller stated her son was murdered before his son could get the second one, so she made sure his son got the second dose  yesterday at about 4:00 p.m. Caller reported the patient has diarrhea, he has vomited once and he has a headache. Caller asking, what should she do? Caller stated she has given him Tylenol for his headache and crackers and rice to deter the diarrhea. States if the patient was not feeling better, she was going to go to the ER. Caller states she has full custody of the patient, since his father, her son, was    The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever after in the night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EN6200) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset Feb2021, outcome "unknown", described as "fever after in the night".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201377857 same reporter/patient,different dose/AE;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Bronchitis, Depression, Fatigue, Feeling abnormal
Clinical narrative: bronchitis/inflammation in my bronchial tubes; brain fog; exhaustion; joint aches; general malaise; worsening depression & mental health; worsening depression & mental health; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female 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. The patient's relevant medical history included: "1st in Nov2020 before the vaccines", start date: Nov2020 (unspecified if ongoing); "being u thyroid since 2004", start date: 2004 (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization; Bnt162b2 (Dose 3), for COVID-19 Immunization. The following information was reported: BRONCHITIS (non-serious), outcome "unknown", described as "bronchitis/inflammation in my bronchial tubes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; FATIGUE (non-serious), outcome "unknown", described as "exhaustion"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint aches"; MALAISE (non-serious), outcome "unknown", described as "general malaise"; DEPRESSION (non-serious), MENTAL DISORDER (non-serious), outcome "unknown" and all described as "worsening depression & mental health".  Additional info: "I have had an acute COVID infection twice, both times contracted from work, as I work in healthcare as support staff, 1st in Nov2020 before the vaccines, the 2nd time after receiving both COVID Pfizer vaccines and 2 boosters; in Nov2022. The first time I had pneumonia in my left lung and the 2nd time I had bronchitis and inflammation in my bronchial tubes. I'm still experiencing brain fog, exhaustion, joint aches and general malaise; as well as worsening depression & mental health both times. The 2nd infection occurred while working in a cancer clinic as a Medical Assistant, where I still work. The 1st infection, I was working as a personal care aide at an assisted living home. I'm 47, a single mother of 3, have a somewhat weakened immune system from being u thyroid since 2004 & having Celiac disease as well as high blood pressure. My blood type is A+. Both infections I believe occurred due to other coworkers improperly wearing masks or not wearing them at all at work. I even lost time from work that I was not paid for-both times, the I practice safe hand hygiene, wear a mask at my job and stayed home and isolated from my own kids and to protect the patients I help care for."  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200125601 same reporter/patient  drug, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Mental disorder
Clinical narrative: bronchitis/inflammation in my bronchial tubes; brain fog; exhaustion; joint aches; general malaise; worsening depression & mental health; worsening depression & mental health; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female 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. The patient's relevant medical history included: "1st in Nov2020 before the vaccines", start date: Nov2020 (unspecified if ongoing); "being u thyroid since 2004", start date: 2004 (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization; Bnt162b2 (Dose 3), for COVID-19 Immunization. The following information was reported: BRONCHITIS (non-serious), outcome "unknown", described as "bronchitis/inflammation in my bronchial tubes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; FATIGUE (non-serious), outcome "unknown", described as "exhaustion"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint aches"; MALAISE (non-serious), outcome "unknown", described as "general malaise"; DEPRESSION (non-serious), MENTAL DISORDER (non-serious), outcome "unknown" and all described as "worsening depression & mental health".  Additional info: "I have had an acute COVID infection twice, both times contracted from work, as I work in healthcare as support staff, 1st in Nov2020 before the vaccines, the 2nd time after receiving both COVID Pfizer vaccines and 2 boosters; in Nov2022. The first time I had pneumonia in my left lung and the 2nd time I had bronchitis and inflammation in my bronchial tubes. I'm still experiencing brain fog, exhaustion, joint aches and general malaise; as well as worsening depression & mental health both times. The 2nd infection occurred while working in a cancer clinic as a Medical Assistant, where I still work. The 1st infection, I was working as a personal care aide at an assisted living home. I'm 47, a single mother of 3, have a somewhat weakened immune system from being u thyroid since 2004 & having Celiac disease as well as high blood pressure. My blood type is A+. Both infections I believe occurred due to other coworkers improperly wearing masks or not wearing them at all at work. I even lost time from work that I was not paid for-both times, the I practice safe hand hygiene, wear a mask at my job and stayed home and isolated from my own kids and to protect the patients I help care for."  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200125601 same reporter/patient  drug, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: bronchitis/inflammation in my bronchial tubes; brain fog; exhaustion; joint aches; general malaise; worsening depression & mental health; worsening depression & mental health; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female 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. The patient's relevant medical history included: "1st in Nov2020 before the vaccines", start date: Nov2020 (unspecified if ongoing); "being u thyroid since 2004", start date: 2004 (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization; Bnt162b2 (Dose 3), for COVID-19 Immunization. The following information was reported: BRONCHITIS (non-serious), outcome "unknown", described as "bronchitis/inflammation in my bronchial tubes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; FATIGUE (non-serious), outcome "unknown", described as "exhaustion"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint aches"; MALAISE (non-serious), outcome "unknown", described as "general malaise"; DEPRESSION (non-serious), MENTAL DISORDER (non-serious), outcome "unknown" and all described as "worsening depression & mental health".  Additional info: "I have had an acute COVID infection twice, both times contracted from work, as I work in healthcare as support staff, 1st in Nov2020 before the vaccines, the 2nd time after receiving both COVID Pfizer vaccines and 2 boosters; in Nov2022. The first time I had pneumonia in my left lung and the 2nd time I had bronchitis and inflammation in my bronchial tubes. I'm still experiencing brain fog, exhaustion, joint aches and general malaise; as well as worsening depression & mental health both times. The 2nd infection occurred while working in a cancer clinic as a Medical Assistant, where I still work. The 1st infection, I was working as a personal care aide at an assisted living home. I'm 47, a single mother of 3, have a somewhat weakened immune system from being u thyroid since 2004 & having Celiac disease as well as high blood pressure. My blood type is A+. Both infections I believe occurred due to other coworkers improperly wearing masks or not wearing them at all at work. I even lost time from work that I was not paid for-both times, the I practice safe hand hygiene, wear a mask at my job and stayed home and isolated from my own kids and to protect the patients I help care for."  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200125601 same reporter/patient  drug, different dose/event;
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: General Achiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 at 01:45 as dose 4 (booster), single (Lot number: GJ6742) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (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 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 14Dec2022 at 23:00, outcome "recovering", described as "General Achiness". Therapeutic measures were not taken as a result of pain.  Additional information: General Achiness starting at night through the next day. Prior to vaccination, the patient was 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. The patient did not have any known allergies or any other medical history.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Nasopharyngitis
Clinical narrative: cold symptoms; a little temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "a little temperature", "cold symptoms". The following information was reported: NASOPHARYNGITIS (non-serious), outcome "recovered", described as "cold symptoms"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "recovered", described as "a little temperature".  Additional information: Patient had three doses of the Pfizer BioNTech COVID-19 Vaccine, including the bivalent booster dose that they received three months ago (LOT: GJ3277) (form the day of this report). Patient had a terrible reaction to all of them. It took 2 or 3 days before she got over her reactions. Half the people they knew had the same thing: cold symptoms and a little temperature a day or two and it was gone. Reporter inquired for healthcare guidance for patient concerning past and future vaccinations, specifically how to lessen her symptoms. The case was reported as non-serious.  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): PFIZER INC-202201377994 same reporter/patient/event, different dose;PFIZER INC-202201378899 same reporter/patient/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Nasopharyngitis
Clinical narrative: Cold symptoms; A little temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 3 (booster), single (Lot number: GJ3277) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown), for COVID-19 immunization, reaction(s): "little temperature a day or two and it is gone", "spot on her arm may be red and the size of a quarter", "Cold symptoms"; Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown), for COVID-19 immunization, reaction(s): "little temperature a day or two and it is gone", "Cold symptoms". The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious) with onset 2022, outcome "recovered" (2022), described as "A little temperature"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "recovered" (2022), described as "Cold symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated he and his wife have had three doses of the Pfizer BioNTech COVID-19 Vaccine, including the bivalent booster dose that they received three months ago. Reporter stated, "his wife has a terrible reaction to all of them. It takes 2 or 3 days before she gets over her reactions. Half the people they know have the same thing: cold symptoms and a little temperature a day or two and it is gone. He never had any reaction. The reporter asked for guidance to lessen her symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201377994 same reporter/patient/event, different dose;US-PFIZER INC-202201378898 same reporter/patient/event, different dose;
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Very sore arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 14 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lactose intolerance" (unspecified if ongoing). Concomitant medication(s) included: HPV VACCINE taken for immunisation, on 05Dec2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Dose 1, Single, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Dec2022, outcome "recovering", described as "Very sore arm at injection site". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  Additional information: Patient had not received any other medications in two weeks. Patient had no covid prior vaccination and had not tested for Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Results of tests: Positive; Results of tests: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "chronic back pain" (unspecified if ongoing), notes: other medical history: chronic back pain; "asthma" (unspecified if ongoing), notes: other medical history: asthma; "allergies" (unspecified if ongoing), notes: other medical history: allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Dec2021, outcome "unknown" and all described as "Results of tests: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2021) Negative; (02Dec2021) Positive.  Clinical course: No other vaccine received within 4 weeks, No COVID-19 prior vaccination, Covid tested post vaccination.  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-202201372314 same product, patient, different AEs;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product leakage, Underdose
Clinical narrative: when giving vaccine it leaked out of the syringe; when giving vaccine it leaked out of the syringe; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose number unknown (booster), single (Lot number: GJ3274, Expiration Date: 31Jan2023) at the age of 68 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol takes medication for this. There were no concomitant medications. Vaccination history included: flu shot (had a flu shot 25Sep2022), administration date: 25Sep2022, when the patient was 68-year-old; Pfizer covid-19 vaccine (Dose number unknown), administration date: Oct2021, when the patient was 67 years old, for COVID-19 immunization; Pfizer covid-19 vaccine (Dose number unknown , lot FK9895), administration date: Apr2022, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: UNDERDOSE (non-serious), PRODUCT LEAKAGE (non-serious) all with onset 16Dec2022, outcome "unknown" and all described as "when giving vaccine it leaked out of the syringe".  Additional information: This hasn't happened before, and they have used these needles and syringes before with no issues. It leaked out where the needle meets the syringe at the luer-lock junction.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: he's had swollen lymph nodes in groin area for about 4 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 32 years 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: LYMPHADENOPATHY (non-serious) with onset Sep2022, outcome "not recovered", described as "he's had swollen lymph nodes in groin area for about 4 months". The event "he's had swollen lymph nodes in groin area for about 4 months" required physician office visit.  Additional information: Reporter reported that his brother was fairly private about his health. His mom told him about his brother that he told her in confidence that he's had swollen lymph nodes in groin area for about 4 months. He told her it started about the time he got a COVID booster and he was wondering if it could be related. Guessing this was about Sep so likely the Bi-valent booster but I can't confirm this. Apparently, he was following up with a doctor now. As her told her in confidence and reporter did not even know if this was 3rd dose, booster or even the Pfizer brand vaccine for sure reporter don't want to had cold call to his brother about it. When possible he will try to get more details and ask him to follow up and keep this reference number to not double report the case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Insomnia, Paraesthesia, Pruritus
Clinical narrative: Itching; Tingling; itching on my skin; it seems to be getting worse instead of better; I cannot sleep, all throughout the day and it has been driving me crazy; this is driving me crazy; 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), in Dec2022 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset Dec2022, outcome "unknown", described as "I cannot sleep, all throughout the day and it has been driving me crazy"; PRURITUS (non-serious) with onset Dec2022, outcome "unknown", described as "Itching"; PARAESTHESIA (non-serious) with onset Dec2022, outcome "unknown", described as "Tingling"; CONDITION AGGRAVATED (non-serious) with onset Dec2022, outcome "unknown", described as "it seems to be getting worse instead of better"; PRURITUS (non-serious) with onset Dec2022, outcome "unknown", described as "itching on my skin"; FEELING ABNORMAL (non-serious) with onset Dec2022, outcome "unknown", described as "this is driving me crazy".  Additional Information: It was reported that patient got the Pfizer Bivalent Booster (Clarified as COVID -19 Vaccine Bivalent Booster) 2 days ago and patient had a lot of itching, tingling, and itching on my skin and it seems to be getting worse instead of better. Well, who was somebody supposed to call than Pfizer. I mean because this was driving me crazy. Patient cannot sleep, all throughout the day and it has been driving me crazy. I mean I got the other three shots by Pfizer (Further name of the shots could not be clarified. Hence, captured as unspecified shots) and I had a little bit of pain, you know, a little bit of difficulty but nothing like this. This was the worst, and I must say that there is nobody to talk to at Pfizer at night-time.  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: Treatment of COVID-19; 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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2022, 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) Negative, notes: I tested negative for several days; (unspecified date) Positive, notes: I'm testing positive again; (16Dec2022) Positive, notes: I'm testing positive again. 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.
Age: 70.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2022 at 01:00 as dose 2, single (Lot number: BVGJ6739) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 took Paxlovid from 24Nov2022 to 29Nov2022.  Clinical course: The patient has no known allergies.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Pain in extremity
Clinical narrative: 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 78 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Potts" (unspecified if ongoing), notes: Potts. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left), administration date: 12Jan2021, when the patient was 77-year-old, for COVID-19 Immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs"; BNT162b2 (Dose Number: 2, Batch/Lot No: N9581, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 77-year-old, for COVID-19 Immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs"; Bnt162b2 (Dose Number: 3, Batch/Lot No: FK49894F, Location of injection: Arm Right), for COVID-19 Immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), HEADACHE (non-serious), COUGH (non-serious), FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Apr2022, outcome "unknown" and all described as "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201380992 same patient and different drug dose/events.;
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FK49894F), in right arm for covid-19 immunisation. The patient's relevant medical history included: "POTTS" (unspecified if ongoing), notes: POTTS. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left), administration date: 12Jan2021, when the patient was 77-year-old, for COVID-19 immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs"; BNT162b2 (Dose Number: 2, Batch/Lot No: N9581, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 77-year-old, for COVID-19 immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), HEADACHE (non-serious), COUGH (non-serious), FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs".  Additional Information: COVID prior vaccination reported as No. COVID tested post vaccination reported as yes. COVID test post vaccination, test date 30Nov2021. result positive. Known allergy reported as unknown. Device Date : 17Dec2022.; Sender's Comments: Linked Report(s) : PFIZER INC-202201380992 same patient and different drug dose/events.;