chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Headache, Immunisation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 03Nov2021 (Lot number: Eluo317 also reported as Elu0217) at the age of 56 years as dose 3 (booster), single, administered in arm left, administration date 01Jul2021 09:45 (Lot number: El3247) as dose 2, single and administered in arm left, administration date 23Feb2021 10:30 (Lot number: El3247) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. There were no concomitant medications, and no other vaccines within four weeks. The patient did not have COVID prior to vaccination. The patient experienced runny nose, scratchy throat, headaches, "toughed and week." The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022 14:30, outcome "recovering" and all described as "Nasal Swab: Positive"; IMMUNISATION (non-serious), outcome "unknown", described as "booster"; THROAT IRRITATION (non-serious) with onset 02Jan2022 14:30, outcome "recovering", described as "scratchy throat"; HEADACHE (non-serious) with onset 02Jan2022 14:30, outcome "recovering", described as "headaches"; ASTHENIA (non-serious) with onset 02Jan2022 14:30, outcome "recovering", described as "week"; RHINORRHOEA (non-serious) with onset 02Jan2022 14:30, outcome "recovering", described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) negative, notes: Nasal Swab; (03Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, Covid-19, throat irritation, headache, dyspnoea, asthenia, rhinorrhoea. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Throat irritation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 03Nov2021 (Lot number: Eluo317 also reported as Elu0217) at the age of 56 years as dose 3 (booster), single, administered in arm left, administration date 01Jul2021 09:45 (Lot number: El3247) as dose 2, single and administered in arm left, administration date 23Feb2021 10:30 (Lot number: El3247) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. There were no concomitant medications, and no other vaccines within four weeks. The patient did not have COVID prior to vaccination. The patient experienced runny nose, scratchy throat, headaches, "toughed and week." The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022 14:30, outcome "recovering" and all described as "Nasal Swab: Positive"; IMMUNISATION (non-serious), outcome "unknown", described as "booster"; THROAT IRRITATION (non-serious) with onset 02Jan2022 14:30, outcome "recovering", described as "scratchy throat"; HEADACHE (non-serious) with onset 02Jan2022 14:30, outcome "recovering", described as "headaches"; ASTHENIA (non-serious) with onset 02Jan2022 14:30, outcome "recovering", described as "week"; RHINORRHOEA (non-serious) with onset 02Jan2022 14:30, outcome "recovering", described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) negative, notes: Nasal Swab; (03Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, Covid-19, throat irritation, headache, dyspnoea, asthenia, rhinorrhoea. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Tinnitus
Clinical narrative: Ringing in the ears; had low grade tinnitus for about ten years/ became more prominent and is still present now; Pfizer booster; Pfizer booster; Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 17:00 (Lot number: FL3197) at the age of 40 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "low vitamin D" (unspecified if ongoing); "low range B12" (unspecified if ongoing); "low grade tinnitus" (unspecified if ongoing), notes: Verbatim: had low grade tinnitus for about ten years/ became more prominent and is still present now. Concomitant medication(s) included: ATIVAN; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: J&j (prev dose product: COVID 19, prev dose brand: J&J, prev dose brand unknown: False, prev dose lot number: 1805029, prev dose lot unknown: False, prev dose administration date: 15Mar2021, prev dose administration time: 01:00PM , prev dose dose number: 1, prev dose vaccine location: Right arm), administration date: 15Mar2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 21Dec2021 17:00, outcome "unknown" and all described as "Pfizer booster"; TINNITUS (non-serious) with onset 24Dec2021 19:00, outcome "not recovered", described as "Ringing in the ears"; TINNITUS (non-serious) with onset 24Dec2021 19:00, outcome "not recovered", described as "had low grade tinnitus for about ten years/ became more prominent and is still present now". Therapeutic measures were not taken as a result of tinnitus, tinnitus.  Additional information: Patient had not received any other vaccine in four weeks. Patient was not tested positive before covid vaccination and not tested positive post vaccination. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Hot flush, Immunisation
Clinical narrative: Dose received: 3; sore arm; temp 101; body aches; chills; night sweats; hot flashes; my period is always on time and started 5 days late; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 05:00 (Lot number: FE3594) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: shell fish" (unspecified if ongoing), notes: known allergies: shell fish; "known allergies:cow dairy milk" (unspecified if ongoing), notes: known allergies: cow dairy milk; "known allergies: gluten" (unspecified if ongoing), notes: known allergies: gluten. Concomitant medication(s) included: SYNTHROID; LIOTHYRONIN; CALCIUM. Vaccination history included: Bnt162b2 (dose number=1,, lot number=EW0158,, vaccine location=Left arm, Shots 1 & 2 only gave me sore arm), administration date: 12Apr2021, when the patient was 44 years old, for Covid-19 Immunization, reaction(s): "Sore arm"; Bnt162b2 (dose number=2,, lot number=EW0173,, vaccine location=Left arm, Shots 1 & 2 only gave me sore arm), administration date: 01May2021, when the patient was 44 years old, for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021 05:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "sore arm"; BODY TEMPERATURE INCREASED (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "temp 101"; PAIN (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "body aches"; CHILLS (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "chills"; MENSTRUATION DELAYED (non-serious) with onset Dec2021, outcome "unknown", described as "my period is always on time and started 5 days late"; NIGHT SWEATS (non-serious) with onset 18Dec2021, outcome "unknown", described as "night sweats"; HOT FLUSH (non-serious) with onset 18Dec2021, outcome "unknown", described as "hot flashes". The events "sore arm", "temp 101", "body aches", "chills", "my period is always on time and started 5 days late", "night sweats" and "hot flashes" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, body temperature increased, pain, chills, menstruation delayed, night sweats, hot flush.  Additional information; The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Night sweats, Pain, Pain in extremity
Clinical narrative: Dose received: 3; sore arm; temp 101; body aches; chills; night sweats; hot flashes; my period is always on time and started 5 days late; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 05:00 (Lot number: FE3594) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: shell fish" (unspecified if ongoing), notes: known allergies: shell fish; "known allergies:cow dairy milk" (unspecified if ongoing), notes: known allergies: cow dairy milk; "known allergies: gluten" (unspecified if ongoing), notes: known allergies: gluten. Concomitant medication(s) included: SYNTHROID; LIOTHYRONIN; CALCIUM. Vaccination history included: Bnt162b2 (dose number=1,, lot number=EW0158,, vaccine location=Left arm, Shots 1 & 2 only gave me sore arm), administration date: 12Apr2021, when the patient was 44 years old, for Covid-19 Immunization, reaction(s): "Sore arm"; Bnt162b2 (dose number=2,, lot number=EW0173,, vaccine location=Left arm, Shots 1 & 2 only gave me sore arm), administration date: 01May2021, when the patient was 44 years old, for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021 05:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "sore arm"; BODY TEMPERATURE INCREASED (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "temp 101"; PAIN (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "body aches"; CHILLS (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "chills"; MENSTRUATION DELAYED (non-serious) with onset Dec2021, outcome "unknown", described as "my period is always on time and started 5 days late"; NIGHT SWEATS (non-serious) with onset 18Dec2021, outcome "unknown", described as "night sweats"; HOT FLUSH (non-serious) with onset 18Dec2021, outcome "unknown", described as "hot flashes". The events "sore arm", "temp 101", "body aches", "chills", "my period is always on time and started 5 days late", "night sweats" and "hot flashes" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, body temperature increased, pain, chills, menstruation delayed, night sweats, hot flush.  Additional information; The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Photopsia
Clinical narrative: Colorful flashes of vision/ she seen in both eyes different colored flashes okay some are like a line or zig zag; I got the Johnson and Johnson in April/ I had a Pfizer booster shot; I got the Johnson and Johnson in April/ I had a Pfizer booster shot; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 30Dec2021 (Lot number: SD7218) at the age of 45 years as dose 2 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Johnson and johnson (DOSE 1), administration date: 28Apr2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 30Dec2021, outcome "unknown" and all described as "I got the Johnson and Johnson in April/ I had a Pfizer booster shot"; IMMUNISATION (non-serious) with onset 30Dec2021, outcome "unknown", described as "booster"; PHOTOPSIA (non-serious) with onset 02Jan2022, outcome "unknown", described as "Colorful flashes of vision/ she seen in both eyes different colored flashes okay some are like a line or zig zag". Therapeutic measures were taken as a result of photopsia.   Additional information: The anatomical site of vaccination was right side. The patient had ibuprofen in response to adverse event as treatment. The patient had only one shot dose on 28Apr2021 before booster. The patient seen in both eyes different colored flashes, some are like a line or zig zag. The patient had no event like this before vaccination. The patient developed on Sunday which is just about 2 and half or 2 days after the shot. Reporter seriousness for Colorful flashes of vision; she seen in both eyes different colored flashes; some are like a line or zig zag: Unspecified  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Antibody test, COVID-19 pneumonia, Vaccination failure
Clinical narrative: COVID-19 pneumonia; ARDS; COVID-19 pneumonia; This is a literature report for a Pfizer sponsored program.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "heart failure with reduced ejection fraction" (unspecified if ongoing); "multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ocrelizumab, notes: received last dose four months prior. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "unknown" and all described as "COVID-19 pneumonia"; ACUTE RESPIRATORY DISTRESS SYNDROME (hospitalization, medically significant), outcome "unknown", described as "ARDS". The patient underwent the following laboratory tests and procedures: antibody test: negative result for sars-cov-2 igm spike and cov-2, notes: lgG nucleocapsid. Therapeutic measures were taken as a result of covid-19 pneumonia, acute respiratory distress syndrome.; Sender's Comments: As there is limited information in the case provided, the causal association between the events acute respiratory distress syndrome, vaccination failure and covid-19 pneumonia with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : PFIZER_INC-202200011017 same article/reporter, different patient; PFIZER_INC-202200011018 same article/reporter, different patient
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, CSF test, Investigation, Magnetic resonance imaging head, Magnetic resonance imaging neck
Clinical narrative: systemic autoimmune conditions with serum testing, MS was diagnosed;   A 29-year-old female patient received bnt162b2 (Formulation: Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (hospitalization, medically significant), outcome "recovering", described as "systemic autoimmune conditions with serum testing, MS was diagnosed". The event "systemic autoimmune conditions with serum testing, ms was diagnosed" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: 0.71; csf test: pleocytosis (8 leukocytes/ul), an elevated igg, notes: index (0.71), and 10 oligoclonal unmatched bands in the CSF; investigation: negative diagnostics for systemic autoimmune, notes: conditions; investigation (normal high range 5): 5, notes: with positive orbiting sign and mild pronator drift; 4; magnetic resonance imaging head: multiple brain lesions, including several, notes: periventricular and juxtacortical white matter lesions with one enhancing lesion in the right centrum semiovale; magnetic resonance imaging neck: multiple brain lesions, including several, notes: periventricular and juxtacortical white matter lesions with one enhancing lesion in the right centrum semiovale; neurological examination: noted to have weakness in, notes: her left arm (power 5/5 per scale), with positive orbiting sign and mild pronator drift), and left leg (power 4/5 per MRC scale); white blood cell count: 8, notes: /uL. Therapeutic measures were taken as a result of multiple sclerosis.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported multiple sclerosis and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202200012202 Same article/drug/event and different patient;PFIZER INC-202200012201 Same article/drug/event and different patient
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis, Neurological examination, White blood cell count
Clinical narrative: systemic autoimmune conditions with serum testing, MS was diagnosed;   A 29-year-old female patient received bnt162b2 (Formulation: Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (hospitalization, medically significant), outcome "recovering", described as "systemic autoimmune conditions with serum testing, MS was diagnosed". The event "systemic autoimmune conditions with serum testing, ms was diagnosed" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: 0.71; csf test: pleocytosis (8 leukocytes/ul), an elevated igg, notes: index (0.71), and 10 oligoclonal unmatched bands in the CSF; investigation: negative diagnostics for systemic autoimmune, notes: conditions; investigation (normal high range 5): 5, notes: with positive orbiting sign and mild pronator drift; 4; magnetic resonance imaging head: multiple brain lesions, including several, notes: periventricular and juxtacortical white matter lesions with one enhancing lesion in the right centrum semiovale; magnetic resonance imaging neck: multiple brain lesions, including several, notes: periventricular and juxtacortical white matter lesions with one enhancing lesion in the right centrum semiovale; neurological examination: noted to have weakness in, notes: her left arm (power 5/5 per scale), with positive orbiting sign and mild pronator drift), and left leg (power 4/5 per MRC scale); white blood cell count: 8, notes: /uL. Therapeutic measures were taken as a result of multiple sclerosis.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported multiple sclerosis and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202200012202 Same article/drug/event and different patient;PFIZER INC-202200012201 Same article/drug/event and different patient
Sex: F
Vaccine: COVID19
Symptoms: CSF test, Investigation, Magnetic resonance imaging, Magnetic resonance imaging head, Multiple sclerosis
Clinical narrative: Multiple sclerosis; This is a literature report.  A 43 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (FIRST DOSE, SINGLE). The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "recovering", described as "Multiple sclerosis". The patient underwent the following laboratory tests and procedures: csf test: presence of 8 oligoclonal bands, otherwise not, notes: present in the serum, but normal cell counts (1 leukocyte/uL); investigation (normal high range 5): 4, notes: per scale; investigation: negative; 4, notes: per scale; magnetic resonance imaging: did not show any signal abnormalities; magnetic resonance imaging head: enhancing and non-enhancing temporal and callosal, notes: periventricular ovoid lesions, as well as enhancement of the proximal right trigeminal nerve. Therapeutic measures were taken as a result of multiple sclerosis.; Sender's Comments: Linked Report(s) : PFIZER INC-202200012186 Same article/drug and different patient/events
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Reduced facial expression, Toothache
Clinical narrative: Booster; top of my front tooth started, kind of slightly stinging; my face is just slightly feeling a little tight; 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 04Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VIRUS VACCINE) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Jan2022, outcome "unknown", described as "Booster"; TOOTHACHE (non-serious) with onset 04Jan2022, outcome "unknown", described as "top of my front tooth started, kind of slightly stinging"; REDUCED FACIAL EXPRESSION (non-serious) with onset 04Jan2022, outcome "unknown", described as "my face is just slightly feeling a little tight".  Additional information: Consumer reported that patient got the Pfizer COVID booster today and the minute patient got the shot the top of his front tooth started, kind of slightly stinging. It has 'concerned' patient ever since like face is just slightly feeling a little tight so  wanted to know if patient could take a Valium (Suspect captured for MI query only) because if patient ever had an allergic reaction in the past it always affects his face (Further clarification unknown).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site swelling
Clinical narrative: site of body where the vaccine booster was administered is ''somewhat'' puffy it is not solid like other side; booster; 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 Jan2022 (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, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization.The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "site of body where the vaccine booster was administered is ''somewhat'' puffy it is not solid like other side"; IMMUNISATION (non-serious) with onset Jan2022, outcome "unknown", described as "booster".  Additional information: As the patient is the reporter stated that question on COVID booster possible side effects that the patient experienced roughly four days ago and still experiencing some side effects namely the site of body where the vaccine booster was administered is 'somewhat' puffy it is not solid like other side, puffy is the best way like the stomach for example it jiggles on the one side of Pfizer shot was not administered side (Further clarifications unknown hence event captured as per verbatim)." reporter was informed about the role of Pfizer Drug Safety and Pfizer Medical Information department and offered the number. Further probing could not be done as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Gastric disorder, Suspected COVID-19
Clinical narrative: i was like having covid all over again; i was like having covid all over again; has had stomach issues ever since then and is dealing with that and its been a year; 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 75 year-old female patient received bnt162b2 (BNT162B2), administration date 24Jan2021 (Lot number: EL1283) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "i was like having covid all over again"; GASTRIC DISORDER (non-serious), outcome "unknown", described as "has had stomach issues ever since then and was dealing with that and its been a year". Patient history and investigation assessment was not provided. Clinical course The reporter had her first dose on 24Jan2021 but it was too close to after she had covid, so she had a bad reaction. At the time, the allergist said don't take the second shot and same with her Primary care provider. It was now one year later and the patient was wondering if she could have her second shot now because on her vaccination card it will not allow her to travel. The only thing that the patient wanted to add to her safety report was that she  had stomach issues ever since then and was dealing with that and its been a year. the patient stated "i was like having covid all over again i had the shot apparently too close to when i had covid and i am now one year later trying to have the second dose of the shot i'm hoping i won't have a reaction".  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product administered to patient of inappropriate age, SARS-CoV-2 test, Vaccination failure
Clinical narrative: break through infection / covid test result=Positive; break through infection / covid test result=Positive; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Batch/Lot number: unknown) at the age of 9 years as dose 2, single and administration date 20Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.There were no other vaccine given in four weeks. The covid was not there prior vaccination. The covid tested positive post vaccination.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 03Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 03Jan2022, outcome "recovering" and all described as "break through infection / covid test result=Positive"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Inappropriate age at vaccine administration". The symptoms included coughing.The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: Test type: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: had received both doses of the Pfizer Covid vaccine as well as a booster dose and had recently been diagnosed with a Covid infection; had received both doses of the Pfizer Covid vaccine as well as a booster dose and had recently been diagnosed with a Covid infection; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 (Lot number: FF2590, Expiration Date: 30Dec2021) at the age of 51 years as dose 3 (booster), single, administered in arm left, administration date 07Feb2021 (Lot number: EL9269) as dose 2, single and administered in arm left, administration date 16Jan2021 (Lot number: EZ3249) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient history : No, Patient's medical history:None. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 09Oct2021, outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "had received both doses of the Pfizer Covid vaccine as well as a booster dose and had recently been diagnosed with a Covid infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. No follow-up attempts are possible. No further information is expected.  Additional Information: On 04Jan2022, the patient was diagnosed with covid. The patient was not sure which test he had that came up positive for covid.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Migraine
Clinical narrative: Booster; experienced their 6th day of a Migraine headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 60 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 2), for COVID-19 Immunization; Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; MIGRAINE (non-serious), outcome "unknown", described as "experienced their 6th day of a Migraine headache".  Additional details: Reporter and his 60 year old mother (patient) received Pfizer Covid-19 Booster Vaccine and both experienced their 6th day of a migraine headache. Reporter enquired how long it lasts. Reporter stated that he is missing work and commented not to get the booster, it doesn't work against Omicron.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single and (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Caller also has nasal polyps." (unspecified if ongoing); "spinal injury" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Additional Information: The reporter reported that, the day patient got her booster patient woke up with vertigo. Patient had a spinal injury and one of the things that could happen was vertigo. Patient was advised by her Doctor to receive the booster. Then about about a week later someone just tested positive. Patient mentioned that patient had an upcoming surgery and kept distance from people. Caller wants to know what happens if somebody gets their booster shot when they are COVID positive. Caller wished to stay anonymous. Caller wants to know if it is possible that her Vertigo would have been from Covid-19. What are the implications of that. Caller mentioned that Friday makes 10 days since she got vertigo. Caller wants to know whether or not the vaccine was effective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product administered to patient of inappropriate age, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of efficacyCovid + on 1/4; Lack of efficacyCovid + on 1/4; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in leg right, administration date 26Nov2021 10:30 (Lot number: FK-5127) at the age of 8 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK-5127, Vaccine Administration Time: 10:00 AM), administration date: 06Nov2021, when the patient was 8 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovering" and all described as "Lack of efficacyCovid + on 1/4"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 26-NOV-2021 10:30, outcome "unknown", described as "Inappropriate age at vaccine administration". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, product administered to patient of inappropriate age. The patient did not receive other vaccine in four weeks and did not have Covid prior vaccination.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Decreased appetite, Dizziness, Illness
Clinical narrative: 1st dose JANSSEN,2nd dose Pfizer; 1st dose JANSSEN,2nd dose Pfizer; really sick; Dizziness; No appetite; joint pain; nausea; in bed for 7 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20211229790(0) (JANSSEN).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Janssen Covid-19 vaccine (Covid-19 vaccine AD26. COV2.S) (Suspension for injection) (Covid-19 Vaccine)), for Prophylactic vaccination. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "1st dose JANSSEN,2nd dose Pfizer"; ILLNESS (non-serious), outcome "unknown", described as "really sick"; BEDRIDDEN (non-serious), outcome "recovered", described as "in bed for 7 days"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; DECREASED APPETITE (non-serious), outcome "unknown", described as "No appetite"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Additional information: It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov.s (dose number in series 1). The patient received non-company suspect booster vaccine: BNT162 (from of admin, route of admin, and batch number were not reported), 1 dose and total, start therapy date were not reported for prophylactic vaccination (dose number in series 2). On an unspecified date following BNT162 (Pfizer) vaccination, the patient got really sick. From the next day, the patient was in bed for 7 days with joint pain, Nausea, Dizziness and no appetite (Dose number in series 2). As per reporter relatedness between BNT162B2  and reported events was reported as unknow. As per reporter and manufacturer relatedness between BNT162B2  and reported events was reported as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Nausea, Off label use
Clinical narrative: 1st dose JANSSEN,2nd dose Pfizer; 1st dose JANSSEN,2nd dose Pfizer; really sick; Dizziness; No appetite; joint pain; nausea; in bed for 7 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20211229790(0) (JANSSEN).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Janssen Covid-19 vaccine (Covid-19 vaccine AD26. COV2.S) (Suspension for injection) (Covid-19 Vaccine)), for Prophylactic vaccination. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "1st dose JANSSEN,2nd dose Pfizer"; ILLNESS (non-serious), outcome "unknown", described as "really sick"; BEDRIDDEN (non-serious), outcome "recovered", described as "in bed for 7 days"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; DECREASED APPETITE (non-serious), outcome "unknown", described as "No appetite"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Additional information: It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov.s (dose number in series 1). The patient received non-company suspect booster vaccine: BNT162 (from of admin, route of admin, and batch number were not reported), 1 dose and total, start therapy date were not reported for prophylactic vaccination (dose number in series 2). On an unspecified date following BNT162 (Pfizer) vaccination, the patient got really sick. From the next day, the patient was in bed for 7 days with joint pain, Nausea, Dizziness and no appetite (Dose number in series 2). As per reporter relatedness between BNT162B2  and reported events was reported as unknow. As per reporter and manufacturer relatedness between BNT162B2  and reported events was reported as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Immunisation, Somnolence, Vomiting
Clinical narrative: booster; vomiting; headache; sleepiness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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; MANUFACTURER UNKNOWN), for COVID-19 Immnuization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; HEADACHE (non-serious), outcome "unknown", described as "headache"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepiness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Rash, Urticaria
Clinical narrative: I broke out around my neck and on my face; got a rash; booster shot; 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, Solution for injection), administration date 29Dec2021 (Lot number: 1834) 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 1 & DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "booster shot"; URTICARIA (non-serious) with onset Jan2022, outcome "unknown", described as "I broke out around my neck and on my face"; RASH (non-serious) with onset Jan2022, outcome "unknown", described as "got a rash".  Additional information: Patient stated, "Well today actually it was on the 29th I got a booster shot and after that I felt fine everything. Today or actually about 3 days ago I broke out around my neck and on my face and I don't know if that's from the shot I think it was cause I was fine before the shot. So was there something I can take to get rid of my rash or it can make me want to itch it." Patient stated don't know but I just got a rash. I don't know what to do, that's all, its on my face and on my neck. So I don't know what to do. Well I don't know what to take. Well It just goes away or what. Do I need to play it out let it role away or what. I don't know.