chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Paraesthesia
Clinical narrative: The next day i also have swelling in my left lymph node and it still hurts; The next day i also have swelling in my left lymph node and it still hurts; tingling; numbness in both my legs and feet for several hours; booster; booster; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 43-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 07Nov2021 at 12:00 (Batch/Lot Number: FH8020) as DOSE 3 (BOOSTER), SINGLE (at the age of 43-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination. Historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 01Mar2021 (at the age of 42-year-old) as dose 1, single and second dose of bnt162b2 PFIZER BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 22Mar2021 (at the age of 42-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive other vaccine in four weeks. On 07Nov2021, the patient got all the same symptoms reported from first shot and adverse event plus tingling and numbness in both my legs and feet for several hours. The next day on 08Nov2021, the patient had swelling in left lymph node and it still hurts, that was patient observing. It was unknown if Covid tested post vaccination or not. The patient underwent lab tests and procedures which included blood test: unknown result on an unspecified date. The outcome of events reported as recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralyzed; This is a spontaneous report from contactable Other Health Care Professional (HCP). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (unknown age at time of vaccination) at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The HCP mentioned several people she knows that have had serious AE's after receiving the vaccine. She mentioned "2 other girls that are paralyzed". The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event paralysis and the suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Limb injury, Malaise
Clinical narrative: couldn't even breath, this sucked; he didn't feel good; It was a kind of hard of breathe too; arm blowing up like crazy, arm was blowing up/ it was hurting; didn't feel good; This is spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration, administered in right arm on 09Nov2021 as dose number unknown, single for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient experienced couldn't even breath, this sucked; he didn't feel good; It was a kind of hard of breathe too on 09Nov2021, arm blowing up like crazy, arm was blowing up/ it was hurting on 09Nov2021, didn't feel good on 09Nov2021. The patient stated that he got the COVID shot, he got the vaccine shot at the time of the report and his arm blowing up like crazy and he got nobody talk to his, yeah his arm was blowing up but he couldn't go back to the doctor because they won't see him again. And it was hurting he didn't feel good, it was really crazy. He couldn't even breath, this sucked. He was sorry, he didn't feel good. It was a kind of hard of breathe too. No treatment received for the events. The outcome of the events was not recovered.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunodeficiency, Psoriasis, Vaccination site pain
Clinical narrative: Immunocompromised; Psoriasis on feet and face; Got sore on the first covid vaccine from Pfizer; This is a solicited report from a non-interventional (FACILITATED COLLECT) based on the information received by Pfizer manufacture number (21K-163-4144547-00).   This is a non-interventional study report from the marketing program facilitated collect received from a contactable consumer or other non hcp.   A 70-years-old female patient received Tozinameran (BNT162B2), dose 1 intramuscular on 29Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number was not reported) and ongoing, at unspecified dose for plaque psoriasis.  Medical history included Could hardly walk from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. On an unspecified date, the patient experienced got sore on the first covid vaccine from Pfizer, immunocompromised and psoriasis on feet and face with Humira (Adalimumab).  The action taken in response to the events for adalimumab was dose not changed.  On May 2021, patient received second dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown.  Causality for Humira (adalimumab): The reporter's causality for the event of got sore on the first covid vaccine from Pfizer with Humira (adalimumab) was no reasonable possibility. the reporter's causality for the events of immunocompromised and psoriasis on feet and face was not provided.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on the information available in narrative the reported  event of  Vaccination site pain is assessed as related to suspected vaccine BNT162B2, However the reported event of Psoriasis, and immunocompromised is assessed as unrelated to vaccine and more likely due to on going condition of Psoriasis and concomitant medication   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Wrong technique in product usage process
Clinical narrative: The vaccine was diluted properly but the entire vial was administered to the patient; She did not use a flashpoint needle, but a regular needle and syringe.  She diluted the purple cap Pfizer BioNTech Covid-19 vaccine vial with 1.8 mL of diluent, then drew up the entire vial; The overdose only happened yesterday, and the patient has only reported a sore arm so far; This is a spontaneous report from a contactable Registered Nurse via Medical Information Team. This Nurse reported for a 65-years-old male patient who received bnt162b2 (Pfizer COVID 19 Vaccine, Solution for injection, Batch/Lot Number: EW0217, NDC number, Expiry Date: Unknown) via an unspecified route of administration in right arm on 10Nov2021 (age at vaccination: 65-years-old) as dose 3 (booster), 1.8 ml single for COVID-19 immunisation. No medical history (The patient denied medical conditions) and no other products were reported. Historical vaccine included bnt162b2 (Pfizer COVID 19 Vaccine) on 11Feb2021 as dose 1, single and dose 2 taken on 11Mar2021; both doses taken for COVID-19 immunisation. Reporter did not have any information about the patient's other two doses of the vaccines except for the dates. Reporter stated that she had never drawn up the vaccine before and did not read the instructions carefully. She did not use a flashpoint needle, but a regular needle and syringe. She diluted the purple cap Pfizer BioNTech Covid-19 vaccine vial with 1.8 mL of diluent, then drew up the entire vial and administered it as the booster dose to the patient. Stated that the patient was a 65-year-old male, and it was his booster dose of the vaccine. Reporter further stated that they had never drawn up a vaccine on their own and did not use a flash point needle to do so. The vaccine was diluted properly but the entire vial was administered to the patient. The overdose only happened yesterday (10Nov2021), and the patient has only reported a sore arm (on an unspecified date in 2021) so far. She was asking for information on that administration error. Reporter declined to provide patient's initials, name, date of birth, height, weight, or ethnicity, she was not comfortable providing any patient information. Reporter also declined to provide her mailing address, alternative phone number, or fax number. When probed for specific seriousness criteria for the patient receiving the entire vial of the vaccine the reporter replied only with no. The reporter was not comfortable providing more specific patient details or practice address, and provided her manager contact information to speak to for future follow up. Reporter denied labs, testing, No Investigation Assessment was there, and she denied treatments taken by the patient for these events. The outcome of the event "The overdose only happened yesterday, and the patient has only reported a sore arm so far" was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Crohn's disease, Depression, Weight, Weight decreased
Clinical narrative: Crohns disease aggravated; Weight loss; Depression; output of feces was more than what was input for food; This is a solicited report from a non-Pfizer sponsored marketing program (FACILITATED COLLECT) based on information received by Pfizer from AbbVie (manufacturer control number: 21K-163-4146567-00.   A contactable 79-year-old female consumer (patient) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 13Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE , dose 2 intramuscular on 13Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, for covid-19 immunization at age of 79 years old; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe adult crohn's disease. The patient medical history and concomitant medications were not reported. In 2021, the patient experienced crohns disease aggravated, weight loss, depression, output of feces was more than what was input for food, and adalimumab was not working. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included weight: 105 pounds on an unspecified date.  The action taken in response to the events for adalimumab was unknown. The outcome of events crohns disease aggravated, weight loss, depression was not resolved, for other events was unknown.   The reporter's causality for the events of weight loss, crohn's disease symptoms worsened, humira was not working and output of feces was more than what was input for food with adalimumab was not provided, the reporter's causality for the event of depression with adalimumab was a reasonable possibility.   The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and a possible contributory role of the suspect product BNT162B2 to the development of events crohn's disease aggravation, weight loss, depression and abnormal faeces cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Pain; This is a solicited report based on the information received by Pfizer from Abbvie (Mfr. Control No.: 21K-163-4141389-00) from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular in Jan2021 (Batch/Lot number was not reported) and second dose via intramuscular in Feb2021 (Batch/Lot number was not reported) both at age of 57 years old and as single dose for Covid-19 Vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, as citrate free for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced aches/pain. In Aug2021, the patient experienced COVID-19. In 2021, the COVID-19 resolved. On an unknown date in 2021, aches/pain resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient underwent lab tests and procedures which included COVID-19: covid-19 in Aug2021. The action taken in response to the events for adalimumab was unknown. The outcome of events was recovered in 2021.  Causality for Humira(adalimumab): The reporter's causality for the events of aches/pain and COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility. Causality for Pfizer Biontech Covid-19 Vaccine: The reporter's causality for the events of aches/pain and COVID-19 with Pfizer Biontech Covid-19 Vaccine was not reported. The reporter's assessment of the causal relationship of the events with the suspect vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    The lot number for the vaccine was not provided and will be requested during follow-up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Face injury, Haemoglobin, Haemoglobin decreased, Infection
Clinical narrative: Hemoglobin low; Infection; SMALL ULCERATIVE COLITIS FLARE UP AFTER COVID SHOT; Face injury; Laceration; This is a solicited report based on information received by Pfizer from Regulatory Authority (Mfr. Control No.: 21K-163-3860847-00).   Solicited report from the RA by a consumer of a 71 year old male with events of small ulcerative colitis flare up after covid shot squirrel hitting patient in face, cut arm, hemoglobin low and infection with Humira (adalimumab) for moderate to severe ulcerative colitis. There was no reported medical history. Concomitant medication included prednisone. On an unknown date, the patient experienced hemoglobin low. In 2021, the patient experienced small ulcerative colitis flare up after covid shot squirrel hitting patient in face and cut arm/laceration. In Jun2021, the patient experienced small ulcerative colitis flare up after covid shot squirrel hitting patient in face and infection. In 2021, the infection resolved. Pfizer bioNtech covid-19 vaccine (BNT162B2) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer/BioNTech. The action taken in response to the events for adalimumab was unknown. The outcome of event infection was recovered in 2021, outcome of event hemoglobin low was not recovered, outcome of event small ulcerative colitis flare up after covid shot squirrel hitting patient in face and cut arm/laceration was recovering.   Causality for adalimumab (HUMIRA) The reporter's causality for the event(s) of small ulcerative colitis flare up after covid shot squirrel hitting patient in face onset in 2021, hemoglobin low and small ulcerative colitis flare up after covid shot squirrel hitting patient in face onset in Jun2021 was not provided. The reporter's causality for the event(s) of cut arm and infection with humira (Adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Ulcerative colitis, Face injury, Laceration, Haemoglobin low, Infection  and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Skin laceration
Clinical narrative: Hemoglobin low; Infection; SMALL ULCERATIVE COLITIS FLARE UP AFTER COVID SHOT; Face injury; Laceration; This is a solicited report based on information received by Pfizer from Regulatory Authority (Mfr. Control No.: 21K-163-3860847-00).   Solicited report from the RA by a consumer of a 71 year old male with events of small ulcerative colitis flare up after covid shot squirrel hitting patient in face, cut arm, hemoglobin low and infection with Humira (adalimumab) for moderate to severe ulcerative colitis. There was no reported medical history. Concomitant medication included prednisone. On an unknown date, the patient experienced hemoglobin low. In 2021, the patient experienced small ulcerative colitis flare up after covid shot squirrel hitting patient in face and cut arm/laceration. In Jun2021, the patient experienced small ulcerative colitis flare up after covid shot squirrel hitting patient in face and infection. In 2021, the infection resolved. Pfizer bioNtech covid-19 vaccine (BNT162B2) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer/BioNTech. The action taken in response to the events for adalimumab was unknown. The outcome of event infection was recovered in 2021, outcome of event hemoglobin low was not recovered, outcome of event small ulcerative colitis flare up after covid shot squirrel hitting patient in face and cut arm/laceration was recovering.   Causality for adalimumab (HUMIRA) The reporter's causality for the event(s) of small ulcerative colitis flare up after covid shot squirrel hitting patient in face onset in 2021, hemoglobin low and small ulcerative colitis flare up after covid shot squirrel hitting patient in face onset in Jun2021 was not provided. The reporter's causality for the event(s) of cut arm and infection with humira (Adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Ulcerative colitis, Face injury, Laceration, Haemoglobin low, Infection  and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Groin abscess, Hidradenitis, Pain in extremity, Subcutaneous abscess
Clinical narrative: abscesses in the left groin; Hidradenitis suppurativa flare in the Groin area and the Rear End area; abscesses in the left arm pit; sore arm; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-3991430-00). A contactable consumer (patient) reported that a 66-year-old male patient received bnt162b2, intramuscular on 15Apr2021 (Batch/Lot number was not reported) as dose 1, single at the age of 66-year-old, intramuscular on 21May2021 (Batch/Lot number was not reported) as dose 2, single at the age of 66-year-old, both for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for moderate to severe Hidradenitis suppurativa. The patient's medical history and concomitant medications were not reported. The patient experienced abscesses in the left groin in May2021 with outcome of recovered in May2021, hidradenitis suppurativa flare in the groin area and the rear end area in May2021 with outcome of recovering, abscesses in the left arm pit in May2021 with outcome of recovered in Jun2021, sore arm in 2021 with outcome of unknown. The action taken in response to the events for adalimumab was unknown. Therapeutic measures were taken as a result of all events. The patient was treated with Cortisone. The case was reported as non-serious.    Causality for Humira (Adalimumab): The reporter's causality for the events of hidradenitis suppurativa flare in the groin area and the rare end area, abscesses in the left groin, abscesses in the left arm pit and sore arm was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the events of hidradenitis suppurativa flare in the groin area and the rare end area, abscesses in the left groin, abscesses in the left arm pit and sore arm was not related.    No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known mechanism of action of the drugs, the events of groin abscess, hidradenitis, subcutaneous abscess, pain in extremity are assessed as not related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Vaccination site swelling
Clinical narrative: shortness of breath; chest pain; injection site swelling; This is a spontaneous report from a non-contactable consumer (patient).   A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 10Nov2021 (Batch/Lot number was not reported) as single dose (at the age of 33) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination, or covid tested post vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced shortness of breath on 11Nov2021, chest pain on 11Nov2021, injection site swelling on 11Nov2021. The events resulted in Emergency room/department or urgent care. The events were not treated. The events outcome was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia
Clinical narrative: Dyspnea and hypoxia that required a 4 day hospitalization for the hypoxia; Dyspnea and hypoxia that required a 4 day hospitalization for the hypoxia; This is a spontaneous report from a contactable physician.   A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 15Sep2021 (Batch/Lot Number: FC3180) as single dose (at the age of 49) for covid-19 immunisation. Patient received the first dose of Intramuscular BNT162B2 (lot number=FA7484) left arm on 08Aug2021 (at the age of 49). Medical history was none. There were no concomitant medications. The patient experienced dyspnea and hypoxia that required a 4 day hospitalization for the hypoxia on 17Sep2021. Patient was treated with Oxygen. The events recovered in 2021.; Sender's Comments: Based on the current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events Hypoxia, Dyspnoea .The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Paraesthesia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Intermittent parenthesis of right cheek; covid test date Sep2021, covid test result Positive; covid test date Sep2021, covid test result Positive; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 70-years-old non-pregnant female patient bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, via an unspecified route of administration, administered in Left Arm on 23Mar2021 at 12:00 AM (Batch/Lot Number: ER2613) as Dose 2, Single (age at vaccination:70-Years-old), via an unspecified route of administration administered in Left Arm on 26Feb2021 (Batch/Lot Number: EN6198) as Dose 1, Single, both doses for Covid-19 immunisation. The patient medical history was not reported. Other medications in two weeks as Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; meloxicam (MELOXICAM) taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine hydrochloride (CYCLOBENZAPRIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously took bnt162b2 for covid-19 immunisation, amoxicillin and experienced hypersensitivity. The patient was not diagnosed with covid-19 before and tested post vaccination. On an unspecific date in Sep2021 the patient experienced covid test date sep2021, covid test result positive (vaccination failure). On 10Jun2021 patient experienced intermittent parenthesis of right cheek. On unspecific date in Sep2021 the patient underwent lab tests and procedures which included sars-cov-2 test as positive. The patient had not received treatment for the intermittent parenthesis of right cheek. The outcome of the Intermittent parenthesis of right cheek was not recovered, and unknown for the other event.  Follow-up (15Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: Breakthrough COVID case in Jul2021; Breakthrough COVID case in Jul2021; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (Lot Number: EN6201) as dose 2, single for COVID-19 immunization (at the age of 23-year-old). The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 19Jan2021 13:45 (Lot Number: EL3247) as dose 1, single for COVID-19 immunization (at the age of 23-year-old). It was unknown if patient diagnosed with COVID-19 and tested for COVID-19 since vaccination. On an unspecified date in Jul2021, the patient experienced breakthrough COVID case. On an unspecified date in Jul2021, the patient underwent lab tests and procedures which included breakthrough COVID case: unknown. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Blood test, Burning sensation, Electrocardiogram
Clinical narrative: severe burning pain in her arms; blurred vision; tingling; burning sensations throughout her body; cold legs which then feel very hot; muscle aches; joint pain; insomnia; anxiety; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 01Oct2021 as single dose for covid-19 immunisation. The patient was pregnant and/or nursing for over 7 consecutive years. She has medical history of Lyme disease & Fibromyalgia, both of which resolved over 10 years ago from unknown start and stop dates and DVT during pregnancy 5 years ago from unknown start date and unknown if ongoing. She gave birth to her 5th child on 25Aug2021. She received her first Pfizer COVID vaccine 3 days later, on 28Aug2021. The patient's concomitant medications include gabapentin and lorazepam for unspecified indication, start dates and stop dates were not reported. On 09Oct2021, she presented to the ER with severe burning pain in her arms. The following other symptoms have since developed: blurred vision, tingling, burning sensations throughout her body, cold legs which then feel very hot, muscle aches, and joint pain. She began feeling anxious about the symptoms and developed insomnia. She presented to the ER again on 16Oct2021 with anxiety. Concomitant medication started once the baby was weaned. Symptoms remain, although concomitant medications have helped reduce the severity. Patient underwent lab tests and procedures which include MRI, EMG, EKG, Lyme test and the findings were negative on unspecified date in 2021. She stated all blood work has come back with normal findings on unspecified date in 2021. She stated that her neurologist and obstetrician both felt these symptoms are related to the COVID vaccine. She has asked to be informed if there is a treatment that will help with her adverse events. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101639288 mother/baby
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Insomnia, Investigation, Magnetic resonance imaging, Myalgia
Clinical narrative: severe burning pain in her arms; blurred vision; tingling; burning sensations throughout her body; cold legs which then feel very hot; muscle aches; joint pain; insomnia; anxiety; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 01Oct2021 as single dose for covid-19 immunisation. The patient was pregnant and/or nursing for over 7 consecutive years. She has medical history of Lyme disease & Fibromyalgia, both of which resolved over 10 years ago from unknown start and stop dates and DVT during pregnancy 5 years ago from unknown start date and unknown if ongoing. She gave birth to her 5th child on 25Aug2021. She received her first Pfizer COVID vaccine 3 days later, on 28Aug2021. The patient's concomitant medications include gabapentin and lorazepam for unspecified indication, start dates and stop dates were not reported. On 09Oct2021, she presented to the ER with severe burning pain in her arms. The following other symptoms have since developed: blurred vision, tingling, burning sensations throughout her body, cold legs which then feel very hot, muscle aches, and joint pain. She began feeling anxious about the symptoms and developed insomnia. She presented to the ER again on 16Oct2021 with anxiety. Concomitant medication started once the baby was weaned. Symptoms remain, although concomitant medications have helped reduce the severity. Patient underwent lab tests and procedures which include MRI, EMG, EKG, Lyme test and the findings were negative on unspecified date in 2021. She stated all blood work has come back with normal findings on unspecified date in 2021. She stated that her neurologist and obstetrician both felt these symptoms are related to the COVID vaccine. She has asked to be informed if there is a treatment that will help with her adverse events. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101639288 mother/baby
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Peripheral coldness, Vision blurred
Clinical narrative: severe burning pain in her arms; blurred vision; tingling; burning sensations throughout her body; cold legs which then feel very hot; muscle aches; joint pain; insomnia; anxiety; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 01Oct2021 as single dose for covid-19 immunisation. The patient was pregnant and/or nursing for over 7 consecutive years. She has medical history of Lyme disease & Fibromyalgia, both of which resolved over 10 years ago from unknown start and stop dates and DVT during pregnancy 5 years ago from unknown start date and unknown if ongoing. She gave birth to her 5th child on 25Aug2021. She received her first Pfizer COVID vaccine 3 days later, on 28Aug2021. The patient's concomitant medications include gabapentin and lorazepam for unspecified indication, start dates and stop dates were not reported. On 09Oct2021, she presented to the ER with severe burning pain in her arms. The following other symptoms have since developed: blurred vision, tingling, burning sensations throughout her body, cold legs which then feel very hot, muscle aches, and joint pain. She began feeling anxious about the symptoms and developed insomnia. She presented to the ER again on 16Oct2021 with anxiety. Concomitant medication started once the baby was weaned. Symptoms remain, although concomitant medications have helped reduce the severity. Patient underwent lab tests and procedures which include MRI, EMG, EKG, Lyme test and the findings were negative on unspecified date in 2021. She stated all blood work has come back with normal findings on unspecified date in 2021. She stated that her neurologist and obstetrician both felt these symptoms are related to the COVID vaccine. She has asked to be informed if there is a treatment that will help with her adverse events. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101639288 mother/baby
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed with at-home rapid antigen self test; COVID-19 confirmed with at-home rapid antigen self test; This is a spontaneous report from a contactable pharmacist via Pfizer. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), dose 1 intramuscular, administered in Arm Left on 30Jan2021 (at the age of 29-years-old) as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266), dose 2 intramuscular, administered in Arm Left on 20Feb2021 (at the age of 29-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included exercise-induced asthma and sleep apnoea syndrome from an unknown date. There were no known allergies. Concomitant medications included cetirizine, esomeprazole (ESOMEPRAZOLE) and multivitamins taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccination within four weeks. On 12Nov2021, the patient experienced covid-19 which was confirmed with at-home rapid antigen self-test. On 12Nov2021, the patient underwent lab tests and procedures which included sars-cov-2 test/ Antigen self-test using nasal swab and tested positive. Therapeutic measures were taken as a result of the event of covid-19 with Ibuprofen Chlorpheniramine/phenylephrine. The outcome of the event covid-19 was not recovered.  No Follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Disease recurrence, Dizziness, Dyspnoea, Headache
Clinical narrative: There was something neurological that has been disturb; chest pain; Numbness on the right side of your body from her face, her right arm, her hand, her right leg; Tingling in her lips and tongue; Dizziness; Headache; shortness of breath; This is a spontaneous report from a contactable consumer. This consumer reported for a 38-year-old female patient (reporter's wife) that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FD8448, Expiry Date: not reported), via an unspecified route of administration on 31Aug2021 (at the age of 38 years) as dose 2, single for covid-19 immunisation. Medical history included something neurological (nervous system disorder) from an unknown date and unknown if ongoing. There was something neurological that had been disturb. Concomitant medication(s) included prednisone taken for nervous system disorder, start and stop date were not reported. She had been prescribed the steroids. She was on steroids prednisone at the time of vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180, Expiry Date: not reported), via an unspecified route of administration on 27Jul2021 (at the age of 38 years) as dose 1, single for covid-19 immunisation. Reporter stated that side effect include chest pain and shortness of breath, numbness on the right side of your body from her face, her right arm, her hand, her right leg, tingling in her lips and tongue, dizziness, headaches that discovered everything then initially diagnosed as neurological on 10Sep2021. There was something neurological that had been disturb so, they continued to seek treatment that the prednisone. She had not have side effects at the time of report. Patient's husband reported on behalf of his wife. had visited emergency room and physician visit office for the events. They both received the Pfizer Covid vaccine in August and in about 10 days or so after her vaccine she started experiencing some severe side effects so they had been to the emergency room 7 times since, then and seen a cardiologist, a neurologist and a neuro surgeon and her husband was reporting the side effects because they wont be able to find out any kind of treatment for these side effects. Reporter stated that it would have been approximately 10Sep2021 and she would be. Reporter wanted to know whether Pfizer provides any guidance on how to seek treatment for any of these side effects. Patient Therapeutic measures were taken as a result of all events. Other than trying to say Ibuprofen and Tylenol and just the steroid that she had been prescribed recently. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia oral
Clinical narrative: There was something neurological that has been disturb; chest pain; Numbness on the right side of your body from her face, her right arm, her hand, her right leg; Tingling in her lips and tongue; Dizziness; Headache; shortness of breath; This is a spontaneous report from a contactable consumer. This consumer reported for a 38-year-old female patient (reporter's wife) that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FD8448, Expiry Date: not reported), via an unspecified route of administration on 31Aug2021 (at the age of 38 years) as dose 2, single for covid-19 immunisation. Medical history included something neurological (nervous system disorder) from an unknown date and unknown if ongoing. There was something neurological that had been disturb. Concomitant medication(s) included prednisone taken for nervous system disorder, start and stop date were not reported. She had been prescribed the steroids. She was on steroids prednisone at the time of vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180, Expiry Date: not reported), via an unspecified route of administration on 27Jul2021 (at the age of 38 years) as dose 1, single for covid-19 immunisation. Reporter stated that side effect include chest pain and shortness of breath, numbness on the right side of your body from her face, her right arm, her hand, her right leg, tingling in her lips and tongue, dizziness, headaches that discovered everything then initially diagnosed as neurological on 10Sep2021. There was something neurological that had been disturb so, they continued to seek treatment that the prednisone. She had not have side effects at the time of report. Patient's husband reported on behalf of his wife. had visited emergency room and physician visit office for the events. They both received the Pfizer Covid vaccine in August and in about 10 days or so after her vaccine she started experiencing some severe side effects so they had been to the emergency room 7 times since, then and seen a cardiologist, a neurologist and a neuro surgeon and her husband was reporting the side effects because they wont be able to find out any kind of treatment for these side effects. Reporter stated that it would have been approximately 10Sep2021 and she would be. Reporter wanted to know whether Pfizer provides any guidance on how to seek treatment for any of these side effects. Patient Therapeutic measures were taken as a result of all events. Other than trying to say Ibuprofen and Tylenol and just the steroid that she had been prescribed recently. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dizziness, Eyelid margin crusting, Feeling abnormal
Clinical narrative: a foggy feeling in my head that made it hard to think; woke up with my eyes crusted shut; my whole body aching so severely that I could barely move; my whole body aching so severely that I could barely move; a foggy feeling in my head that made it hard to think; severe dizziness that affected my ability to drive; severe dizziness that affected my ability to drive; loss of appetite; I also experienced some bruising at the injection site; I experienced a fever of 101.1; This is a spontaneous report from a contactable consumer, the patient.  A 17-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: FF2587), via an unspecified route of administration, in arm left on an unspecified date at 10:00 as dose 2, single for COVID-19 immunisation. The patient's medical history included IBS, asthma, cholecystectomy since an unknown date. The patient did not have covid prior to the vaccination. The patient did not have any known allergies. Concomitant medication(s) included dicycloverine hydrochloride (BENTYL) and ferrous sulphate since an unknown date. The patient previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: 30145BA), via an unspecified route of administration, in arm left on an unspecified date at 10:00 as dose 1, single for COVID-19 immunisation and experienced moderate dizziness, low grade fever, arm aches, and mild swelling at the injection site. No other vaccine was taken in in four weeks. The patient experienced her symptoms the day after the shot. She woke up with her eyes crusted shut, her whole body aching so severely that she could barely move, loss of appetite, a foggy feeling in her head that made it hard to think, and she experienced a fever of 101.1 and severe dizziness that affected her ability to drive. She also experienced some bruising at the injection site but that was to be expected. These adverse effects however only lasted 1 to 3 days and afterward she was fine. The patient did not take any treatment for the events. The patient underwent lab tests and procedures which included body temperature as 101.1 on an unknown date. The patient was not tested for COVID-19 post vaccination. The outcome of all the events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.