chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Loss of consciousness, Myocardial infarction, Pneumonia pseudomonal
Clinical narrative: Heart attack; lost consciousness; acute hypoxic respiratory failure due to or as a consequence of pseudomonas pneumonia; acute hypoxic respiratory failure due to or as a consequence of pseudomas pneumonia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EN61989, Expiration Date: 30Jun2021) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MYOCARDIAL INFARCTION (death, hospitalization, medically significant) with onset 01Mar2021, outcome "fatal", described as "Heart attack"; PNEUMONIA PSEUDOMONAL (death) with onset 2021, outcome "fatal", described as "acute hypoxic respiratory failure due to or as a consequence of pseudomonas pneumonia"; ACUTE RESPIRATORY FAILURE (death) with onset 2021, outcome "fatal", described as "acute hypoxic respiratory failure due to or as a consequence of pseudomas pneumonia"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset Mar2021, outcome "unknown", described as "lost consciousness". The patient was hospitalized for myocardial infarction, loss of consciousness (start date: 01Mar2021, discharge date: 31Mar2021, hospitalization duration: 30 day(s)). The event "heart attack" was evaluated at the emergency room visit. The patient date of death was 21Apr2021. The reported cause of death was acute respiratory failure, myocardial infarction, pneumonia pseudomonal. No autopsy was performed. Clinical course: States she is a widower, states her husband withheld took the first dose of the Pfizer Covid vaccine and 4 days later is when he had an attack and went to the emergency room, doctors at this time they said it was too early in the Covid 19 stuff they did not really know what caused it, states the thing she has heard later is that it was a form of the heart attack caused by the vaccines. States he got the first dose on 25Feb2021, states on 01Mar2021 he had a heart attack, states they were able to revive him and everything, states he was in the hospital for a while trying to see if he could recover because he had lost consciousness, states he was discharged to rehab on 01Apr2021 and he passed away on 21Apr2021.  No follow-up attempts are possible. No further information is expected; Reported Cause(s) of Death: acute hypoxic respiratory failure due to or as a consequence of pseudomonas pneumonia; Heart attack; acute hypoxic respiratory failure due to or as a consequence of pseudomonas pneumonia
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive with Covid-19; tested positive with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive with Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had Paxlovid a little more than a month ago because he tested positive with Covid-19. Patient already had the first 2 shots of the vaccine and got the booster 7 months ago. He would like to get another booster as soon as possible and he would like to know if there was a waiting period after taking Paxlovid to get a booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Ever since I took your 2 shots I have been suffering with anxiety 4 times over now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "Ever since I took your 2 shots I have been suffering with anxiety 4 times over now".  Additional Information: Patient heart sometimes started beating fast for no reason that patient have no idea how that happened. All patient know was that his/her anxiety kicked 10000 times since I took your shot. Patient was writing this asking for help but soon I will look for legal obligations.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Palpitations
Clinical narrative: we all are now experiencing heart palpitations and anxiety.; we all are now experiencing heart palpitations and anxiety.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), ANXIETY (non-serious), outcome "unknown" and all described as "we all are now experiencing heart palpitations and anxiety.".  Additional information: The reporter reported that he along with his brother and several friends have gotten the Covid shot and all were experiencing heart palpitations and anxiety. He wanted to know If this was something aware he wanted to know what was the solution as he was spending a lot of money trying to figure how to stop this and have not been able to work.  The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200458383 same reporter/drug/AE, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: all caught Covid-19; all caught Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "all caught Covid-19".  Additional information: It was reported, Recently, despite receiving the three shots, daughter, son-in-law, and the patient all caught Covid-19 from unvaccinated 2 year old granddaughter. Fortunately it was very mild for all and recovered quickly.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200460245 same reporter/drug/event, different patient;US-PFIZER INC-202200460246 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: All caught Covid-19; All caught Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "All caught Covid-19".  Clinical information: Thank you for developing the Covid-19 vaccine. Recently, despite receiving the three shots, my daughter, son-in-law, and myself all caught Covid-19 from my unvaccinated 2-year-old granddaughter. Fortunately it was very mild for all of us and we recovered quickly. Thank You. I honestly believe that without the vaccine we might have been hospitalized or worse. You literally saved our lives as well as millions of others. Kudos to Pfizer.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200460138 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Gait disturbance, Heart rate
Clinical narrative: I have got really sick; horrible tinnitus, 'sizzling' and ringing in my ear; inability to want to eat; 'excess' fatigue; small fiber neuropathy; I have just been barely able to walk; intense brain fog; I started to get racing heart; 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), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I have got really sick"; TINNITUS (non-serious), outcome "unknown", described as "horrible tinnitus, 'sizzling' and ringing in my ear"; DECREASED APPETITE (non-serious), outcome "unknown", described as "inability to want to eat"; FATIGUE (non-serious), outcome "unknown", described as "'excess' fatigue"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "small fiber neuropathy"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I have just been barely able to walk"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "intense brain fog"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "I started to get racing heart". The patient underwent the following laboratory tests and procedures: heart rate: racing heart.  Additional information: reporter stated that got the first 2 COVID vaccine, patient was fine with them and got the booster 23Dec (Not clarified) and from the day patient got that booster, I have got really sick, horrible tinnitus, 'sizzling' (not clarified) and ringing in my ear which patient never had before and started to get racing heart, inability to want to eat, 'excess' fatigue, and had small fiber neuropathy (further clarifications unknown) which had been managed and patient had just been barely able to walk and intense brain fog and was hoping that actually go away but it's been few months now and Patient was trying to investigate what could have happened from the booster since it happened that same night.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Illness, Small fibre neuropathy, Tinnitus
Clinical narrative: I have got really sick; horrible tinnitus, 'sizzling' and ringing in my ear; inability to want to eat; 'excess' fatigue; small fiber neuropathy; I have just been barely able to walk; intense brain fog; I started to get racing heart; 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), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I have got really sick"; TINNITUS (non-serious), outcome "unknown", described as "horrible tinnitus, 'sizzling' and ringing in my ear"; DECREASED APPETITE (non-serious), outcome "unknown", described as "inability to want to eat"; FATIGUE (non-serious), outcome "unknown", described as "'excess' fatigue"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "small fiber neuropathy"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I have just been barely able to walk"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "intense brain fog"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "I started to get racing heart". The patient underwent the following laboratory tests and procedures: heart rate: racing heart.  Additional information: reporter stated that got the first 2 COVID vaccine, patient was fine with them and got the booster 23Dec (Not clarified) and from the day patient got that booster, I have got really sick, horrible tinnitus, 'sizzling' (not clarified) and ringing in my ear which patient never had before and started to get racing heart, inability to want to eat, 'excess' fatigue, and had small fiber neuropathy (further clarifications unknown) which had been managed and patient had just been barely able to walk and intense brain fog and was hoping that actually go away but it's been few months now and Patient was trying to investigate what could have happened from the booster since it happened that same night.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: even though I had all my shots, I develop the COVID Virus; even though I had all my shots, I develop the COVID Virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "even though I had all my shots, I develop the COVID Virus". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Reaction event as reported by primary source for translation: taking the Paxlovid; I see on the list that may be a reaction, it says something about simvastatin; Unknown if patient is taking both medications  Additional Context: Concern: Consumer stated, "I was prescribed the Paxlovid by my doctor because I develop, even though I had all my shots (Further clarifications unknown hence captured as Unspecified Shot), I develop the COVID Virus. I am 87 years old (Not clarified hence not captured) and I have been taking the Paxlovid but one of the medication I see on the list that may be a reaction, it says something about simvastatin (Further clarifications unknown if patient is taking both the medications hence Paxlovid and Simvastatin captured as suspect conservatively), Am I correct?" Consumer was informed about role of Pfizer Drug Safety. Consumer was informed about the Pfizer Medical Information department and telephone# was shared as withheld, option 3, 8 AM to 9 PM, Monday to Friday, as per EST. Further Questions: Consumer stated, "Right now I have some company here and I have just (incomplete sentence)." Product details (Expiration date, NDC# UPC# and Treatment) and Pharmacy details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call.QR Comment: Reporter type  could not be probed hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia areata, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Started losing hair from Dec but in January 2022 we noticed patchy hair loss; BNT162B2 was administered after 42 days of primary dose; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 14-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 at 19:00 (Lot number: 32030BD) at the age of 13 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: N/A. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0181, Anatomical site: left arm), administration date: 26Jun2021, when the patient was 13 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Nov2021 at 19:00, outcome "unknown", described as "BNT162B2 was administered after 42 days of primary dose"; ALOPECIA AREATA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Started losing hair from Dec but in January 2022 we noticed patchy hair loss". The event "Started losing hair from Dec but in January 2022 we noticed patchy hair loss" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that one of the spots got bigger and got an appointment with her pediatrician and also with a dermatologist. Her pediatrician noted it as Alopecia. Dermatologist confirmed it as Alopecia areata. They had started the treatment for the patient. Note no one in the family had any history of Alopecia. The patient had thick and full hair but the vaccine had caused the autoimmune attacking hair follicle. Treatment for alopecia included steroid shots on her scalp where she had lost hair. Since the vaccination, the patient had been tested for COVID-19.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Alopecia areata, Blood test normal
Clinical narrative: Started losing hair from Dec but in January 2022 we noticed patchy hair loss; BNT162B2 was administered after 42 days of primary dose; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 14-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 at 19:00 (Lot number: 32030BD) at the age of 13 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: N/A. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0181, Anatomical site: left arm), administration date: 26Jun2021, when the patient was 13 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Nov2021 at 19:00, outcome "unknown", described as "BNT162B2 was administered after 42 days of primary dose"; ALOPECIA AREATA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Started losing hair from Dec but in January 2022 we noticed patchy hair loss". The event "Started losing hair from Dec but in January 2022 we noticed patchy hair loss" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that one of the spots got bigger and got an appointment with her pediatrician and also with a dermatologist. Her pediatrician noted it as Alopecia. Dermatologist confirmed it as Alopecia areata. They had started the treatment for the patient. Note no one in the family had any history of Alopecia. The patient had thick and full hair but the vaccine had caused the autoimmune attacking hair follicle. Treatment for alopecia included steroid shots on her scalp where she had lost hair. Since the vaccination, the patient had been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Face injury, Fall
Clinical narrative: was in the shower and fell and bashed her face; was in the shower and fell and bashed her face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURE UNKNOWN). The following information was reported: FALL (non-serious), FACE INJURY (non-serious) and all described as "was in the shower and fell and bashed her face".  Additional Context: The report is cross referenced to report ID: QLX7E9PJ Caller is calling about the COVID-19 vaccine that Pfizer gives kids under 18. She is calling about her now 16-year-old son that now has a heart condition. She states people are suing for this. Caller reports her son got the COVID-19 vaccine and now has a heart condition. Caller states she is so angry.  She reports this person was a 14-year-old girl who was in the shower and fell twice and bashed her face a week after the booster COVID-19 vaccine.  Caller states let me talk to the attorney about whether she can complete a safety report. She states she is unsure of what she can and cannot say. She states she will call back are file a report once she speaks to her attorney.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: I experienced irregular period afterwards my first dose; after I received that dose in the month of November, I did not have a menstrual cycle; my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine; my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 (Lot number: FF2589) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE taken for asthma; CHELATED IRON taken for anaemia. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "I experienced irregular period afterwards my first dose; after I received that dose in the month of November, I did not have a menstrual cycle"; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding, dysmenorrhoea.  Additional information: No Prior Vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: I received the second dose on 19Nov2021 and I did not receive a cycle in December; my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine; my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 (Lot number: 330268D) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing); "Asthama" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE taken for asthma; CHELATED IRON taken for anaemia. Vaccination history included: Bnt162b2 (Dose 1, Batch/ Lot Number: FF2589, Anatomical site of administration: Right Arm), administration date: 23Oct2021, when the patient was 32 years old, for covid 19 immunization, reaction(s): "my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine", "I experienced irregular period afterwards my first dose", "cycles are irregular, I have more bleeding", "my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine". The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "I received the second dose on 19Nov2021 and I did not receive a cycle in December"; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious), outcome "unknown" and all described as "my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding, dysmenorrhoea. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Confirmed Positive for COVID; Confirmed Positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Lot number: FF2540) at the age of 50 years as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient received no other vaccine in four weeks, no other medications in two weeks. The patient had no covid prior vaccination. The patient was covid tested post vaccination. The patient had no known allergies and none other medical history. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Mar2022, outcome "recovering" and all described as "Confirmed Positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Mar2022) positive, notes: Nasal Swab; (22Mar2022) positive, notes: Confirmed Positive for COVID via PCR test on 22Mar2022 at 6:25pm. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient confirmed Positive for COVID via PCR test on 22Mar2022 at 6:25 PM.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Herpes zoster, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Her chin, cheek, lips, it sort of feels numb, like it's dead; Her chin, cheek, lips, it sort of feels numb, like it's dead; Shingles; COVID-19 virus; COVID-19 virus; tingling in the face, hand, torso and feet; 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 78-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: ER8731) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jan2022, outcome "unknown" and all described as "COVID-19 virus"; HERPES ZOSTER (non-serious) with onset 03Feb2022, outcome "recovered", described as "Shingles"; PARAESTHESIA (non-serious) with onset May2021, outcome "unknown", described as "tingling in the face, hand, torso and feet"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious), outcome "unknown" and all described as "Her chin, cheek, lips, it sort of feels numb, like it's dead". Clinical course was reported as follows. She's had tingling in the face, hand, torso and feet. She took the shot on her left arm, hanging out the window at the drive through and within less than 3 weeks she had tingling in her head, face, on her left side, all on her left side, same side she was injected on 30Apr2021. She has had this problem ever since May2021, tingling face, scalp, hand, feet, torso, but her leg, even run down her leg to her knee. Only on the left side. She never had it before getting the COVID-19 shot. She is home alone, her husband passed away 3-year-ago. This really worries her, she has never been sick, but since this time, she has had COVID-19 virus, she went and had the test on 22Jan2022, results were positive. On 03Feb2022, she got shingles and just got over them and the tingling is back. And the tingling back on the left side of her face. Her chin, cheek, lips, it sort of feels numb, like it's dead. She went to NP and MD 5 times, back and forth, they had not a clue and of course it's all over the internet that it could be Guillain-Barre Syndrome or it could be MS. It says it is a symptom from covid 19 vaccine. The article says it's Pfizer covid 19 vaccine. It's on withheld, it's not just Pfizer vaccine, but that is the one that she took. It will be a year in May.  The articles, say they have gone to neurologists and they say it is from the vaccine. All summer long she was paranoid. Reports say it can give shingles.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Her chin, cheek, lips, it sort of feels numb, like it's dead; Her chin, cheek, lips, it sort of feels numb, like it's dead; Shingles; COVID-19 virus; COVID-19 virus; tingling in the face, hand, torso and feet; 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 78-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: ER8731) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jan2022, outcome "unknown" and all described as "COVID-19 virus"; HERPES ZOSTER (non-serious) with onset 03Feb2022, outcome "recovered", described as "Shingles"; PARAESTHESIA (non-serious) with onset May2021, outcome "unknown", described as "tingling in the face, hand, torso and feet"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious), outcome "unknown" and all described as "Her chin, cheek, lips, it sort of feels numb, like it's dead". Clinical course was reported as follows. She's had tingling in the face, hand, torso and feet. She took the shot on her left arm, hanging out the window at the drive through and within less than 3 weeks she had tingling in her head, face, on her left side, all on her left side, same side she was injected on 30Apr2021. She has had this problem ever since May2021, tingling face, scalp, hand, feet, torso, but her leg, even run down her leg to her knee. Only on the left side. She never had it before getting the COVID-19 shot. She is home alone, her husband passed away 3-year-ago. This really worries her, she has never been sick, but since this time, she has had COVID-19 virus, she went and had the test on 22Jan2022, results were positive. On 03Feb2022, she got shingles and just got over them and the tingling is back. And the tingling back on the left side of her face. Her chin, cheek, lips, it sort of feels numb, like it's dead. She went to NP and MD 5 times, back and forth, they had not a clue and of course it's all over the internet that it could be Guillain-Barre Syndrome or it could be MS. It says it is a symptom from covid 19 vaccine. The article says it's Pfizer covid 19 vaccine. It's on withheld, it's not just Pfizer vaccine, but that is the one that she took. It will be a year in May.  The articles, say they have gone to neurologists and they say it is from the vaccine. All summer long she was paranoid. Reports say it can give shingles.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease progression, Herpes zoster, Illness anxiety disorder, Paraesthesia
Clinical narrative: Her chin, cheek, lips, it sort of feels numb, like it's dead; Her chin, cheek, lips, it sort of feels numb, like it's dead; Shingles; COVID-19 virus; COVID-19 virus; tingling in the face, hand, torso and feet; 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 78-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: ER8731) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jan2022, outcome "unknown" and all described as "COVID-19 virus"; HERPES ZOSTER (non-serious) with onset 03Feb2022, outcome "recovered", described as "Shingles"; PARAESTHESIA (non-serious) with onset May2021, outcome "unknown", described as "tingling in the face, hand, torso and feet"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious), outcome "unknown" and all described as "Her chin, cheek, lips, it sort of feels numb, like it's dead". Clinical course was reported as follows. She's had tingling in the face, hand, torso and feet. She took the shot on her left arm, hanging out the window at the drive through and within less than 3 weeks she had tingling in her head, face, on her left side, all on her left side, same side she was injected on 30Apr2021. She has had this problem ever since May2021, tingling face, scalp, hand, feet, torso, but her leg, even run down her leg to her knee. Only on the left side. She never had it before getting the COVID-19 shot. She is home alone, her husband passed away 3-year-ago. This really worries her, she has never been sick, but since this time, she has had COVID-19 virus, she went and had the test on 22Jan2022, results were positive. On 03Feb2022, she got shingles and just got over them and the tingling is back. And the tingling back on the left side of her face. Her chin, cheek, lips, it sort of feels numb, like it's dead. She went to NP and MD 5 times, back and forth, they had not a clue and of course it's all over the internet that it could be Guillain-Barre Syndrome or it could be MS. It says it is a symptom from covid 19 vaccine. The article says it's Pfizer covid 19 vaccine. It's on withheld, it's not just Pfizer vaccine, but that is the one that she took. It will be a year in May.  The articles, say they have gone to neurologists and they say it is from the vaccine. All summer long she was paranoid. Reports say it can give shingles.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test date=27/Nov/2021 / covid test result=Positive; covid test date=27/Nov/2021 / covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 16:00 (Lot number: FD0810) at the age of 66 years as dose 3 (booster), single, administered in arm left, administration date 08Mar2021 15:00 (Lot number: EN6203) as dose 2, single and administered in arm left, administration date 15Feb2021 16:00 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]. Past drug history included: Tetracycline, reaction(s): "Drug allergy"; Erythromycin, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Nov2021, outcome "not recovered" and all described as "covid test date=27/Nov/2021 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient stated that severe hives rash itching inflammation dry peeling skin located on my face eyes lips neck and the outside of both hands. Treatment received with : 4 rounds Steroids / Pepcid Zyrtec Allegra etc.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry skin, Inflammation, Rash pruritic, SARS-CoV-2 test, Skin exfoliation
Clinical narrative: covid test date=27/Nov/2021 / covid test result=Positive; covid test date=27/Nov/2021 / covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 16:00 (Lot number: FD0810) at the age of 66 years as dose 3 (booster), single, administered in arm left, administration date 08Mar2021 15:00 (Lot number: EN6203) as dose 2, single and administered in arm left, administration date 15Feb2021 16:00 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]. Past drug history included: Tetracycline, reaction(s): "Drug allergy"; Erythromycin, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Nov2021, outcome "not recovered" and all described as "covid test date=27/Nov/2021 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient stated that severe hives rash itching inflammation dry peeling skin located on my face eyes lips neck and the outside of both hands. Treatment received with : 4 rounds Steroids / Pepcid Zyrtec Allegra etc.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: covid test date=27/Nov/2021 / covid test result=Positive; covid test date=27/Nov/2021 / covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 16:00 (Lot number: FD0810) at the age of 66 years as dose 3 (booster), single, administered in arm left, administration date 08Mar2021 15:00 (Lot number: EN6203) as dose 2, single and administered in arm left, administration date 15Feb2021 16:00 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]. Past drug history included: Tetracycline, reaction(s): "Drug allergy"; Erythromycin, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Nov2021, outcome "not recovered" and all described as "covid test date=27/Nov/2021 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient stated that severe hives rash itching inflammation dry peeling skin located on my face eyes lips neck and the outside of both hands. Treatment received with : 4 rounds Steroids / Pepcid Zyrtec Allegra etc.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had some mild Covid symptoms and testes positive for Covid; had some mild Covid symptoms and testes positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Lot number: FF8839) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; FISH OIL; COQ 10; TURMERIC [CURCUMA LONGA]. Vaccination history included: Covid-19 vaccine (First dose, Lot No: EL3247), administration date: 25Feb2021, when the patient was 58 years old, for COVID-19 Immunization; Covid-19 vaccine (Second dose), administration date: 2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had some mild Covid symptoms and testes positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, LE cells, Neuropathy peripheral
Clinical narrative: she feels like her nerve sensation got activated or aggravated by the booster; 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 51 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "Tested positive for Lupus (they are still in the process of diagnosing her for it) and Sjogren Syndrome", "Pins and needles sensation to the left side of her face, in her fingertips, and in her toes that lasted for 3 weeks", "Pins and needles sensation to the left side of her face, in her fingertips, and in her toes that lasted for 3 weeks", "Pins and needles sensation to the left side of her face, in her fingertips, and in her toes that lasted for 3 weeks", "Sjogren Syndrome"; Bnt162b2 (Dose 2), administration date: Apr2021, for Covid-19 Immunization, reaction(s): "little pain/pressure sensation in her left ear", "little pain/pressure sensation in her left ear", "tested positive for lupus (they are still in the process of diagnosing her for it)", "spasms in the left side of her face, her left ear, left side of her mouth, and her left eye", "Sjogren's syndrome/antibodies for sjogren's were very low but they were positive". The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "she feels like her nerve sensation got activated or aggravated by the booster". The patient underwent the following laboratory tests and procedures: antibody test: positive, notes: antibodies for Sjogren's were very low but they were positive; le cells: positive, notes: Tested positive for Lupus (they are still in the process of diagnosing her for it) and Sjogren Syndrome.  The lot number for bnt162b2 was not provided and will be requested during follow up.