chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Scab, Urticaria
Clinical narrative: hives, itching, scabbing, shedding, all over entire body; hives, itching, scabbing, shedding, all over entire body; hives, itching, scabbing, shedding, all over entire body; 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 right, administration date 17Oct2021 (Lot number: FF2593) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product: Covid-19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: FF2587, Prev dose lot unknown: False, Prev dose administration date: 23Sep2021, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 26Sep2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious), URTICARIA (non-serious), SCAB (non-serious) all with onset 18Oct2021, outcome "not recovered" and all described as "hives, itching, scabbing, shedding, all over entire body". The event "hives, itching, scabbing, shedding, all over entire body", "hives, itching, scabbing, shedding, all over entire body" and "hives, itching, scabbing, shedding, all over entire body" was evaluated at the physician office visit. Therapeutic measures were taken as a result of angioedema, pruritus, urticaria, scab. Adverse event reported was vaccination Shedding: hives, itching, scabbing, shedding, all over entire upper and lower body. Doctor consulted and prescribed antibiotics for 7 days, symptoms did not abate. Adverse event start date was 18Oct2021. Adverse event country was   . Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient was not recovered. Patient received adverse event treatment of oral antibiotics for 7 days. Covid was not there prior vaccination. No covid tested post vaccination. Known allergies and other medical history were not reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood lactic acid, Blood potassium, COVID-19 pneumonia, Chest X-ray, Drug ineffective
Clinical narrative: COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; This is a literature report.  Case Report TOPIC: Chest Infections INTRODUCTION: COVID-19 vaccination while on immunosuppressive therapy response may be "weakened" compared to the general population. CASE PRESENTATION: A 69 y/o F with DM2, hypertension, and psoriatic arthritis-on methotrexate/folinic acid and tofacitinib, presented with progressive cough, dyspnea, and fever x 3 days. She had a known exposure to COVID-19. She received two doses of Comirnaty vaccine (Pfizer), and the last dose was a day before admission. On admission, she was tachypneic and hypoxiemic with O2 satt 75% on room air. Chest x-ray showed diffuse patchy opacities, COVID RT-PCR positive. Due to acute hypoxemic respiratory failure, dexamethasone IV and remdesivir IV were given with improvement. On 4th day of admission, she was found unresponsive, bradycardic and pulseless. ACLS protocol was followed, and ROSC was achieved in 3 minutes. Her course was complicated with septic shock requiring pressors, acute kidney failure, shock liver injury, severe lactic acidosis, metabolic acidosis and hyperkalemia. She was found asystolic on the 5th day of admission but she was not coded because she was made DNR. DISCUSSION: Immunogenicity and efficacy of COVID vaccines are uncertain in rheumatic patients who are immunosuppressed. It is known that they are at higher risk for COVID-19 infection with more complications. Therefore, new guidelines emphasize the need of holding immunosuppressive medications for a certain time to increase the efficacy of vaccination.  CONCLUSION(S): Patient would have benefit from withholding immunosuppressive medications before and after COVID vaccine administration.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 pneumonia and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.; Reported Cause(s) of Death: COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; This is a literature report.  Case Report TOPIC: Chest Infections INTRODUCTION: COVID-19 vaccination while on immunosuppressive therapy response may be "weakened" compared to the general population. CASE PRESENTATION: A 69 y/o F with DM2, hypertension, and psoriatic arthritis-on methotrexate/folinic acid and tofacitinib, presented with progressive cough, dyspnea, and fever x 3 days. She had a known exposure to COVID-19. She received two doses of Comirnaty vaccine (Pfizer), and the last dose was a day before admission. On admission, she was tachypneic and hypoxiemic with O2 satt 75% on room air. Chest x-ray showed diffuse patchy opacities, COVID RT-PCR positive. Due to acute hypoxemic respiratory failure, dexamethasone IV and remdesivir IV were given with improvement. On 4th day of admission, she was found unresponsive, bradycardic and pulseless. ACLS protocol was followed, and ROSC was achieved in 3 minutes. Her course was complicated with septic shock requiring pressors, acute kidney failure, shock liver injury, severe lactic acidosis, metabolic acidosis and hyperkalemia. She was found asystolic on the 5th day of admission but she was not coded because she was made DNR. DISCUSSION: Immunogenicity and efficacy of COVID vaccines are uncertain in rheumatic patients who are immunosuppressed. It is known that they are at higher risk for COVID-19 infection with more complications. Therefore, new guidelines emphasize the need of holding immunosuppressive medications for a certain time to increase the efficacy of vaccination.  CONCLUSION(S): Patient would have benefit from withholding immunosuppressive medications before and after COVID vaccine administration.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 pneumonia and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.; Reported Cause(s) of Death: COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Confirmed clinical vaccination failure/Confirmed covid-19 Infection; Confirmed covid-19 Infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20211263449(0) (Janssen Research & Development, LLC).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administered in arm right, administration date 05Apr2021 (Lot number: 043A21A, Expiration Date: 10Sep2021) as dose 1, single for immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Confirmed clinical vaccination failure/Confirmed covid-19 Infection"; COVID-19 (medically significant) with onset 27Dec2021, outcome "unknown", described as "Confirmed covid-19 Infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Dyspnoea, SARS-CoV-2 test positive, Sinusitis, Suspected COVID-19
Clinical narrative: I got COVID after I got two of the COVID shots; I got COVID after I got two of the COVID shots; had a sinus infection; Hard time breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Polio vaccine (When I was a kid I got polio vaccine.), for Immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID after I got two of the COVID shots"; SINUSITIS (non-serious), outcome "unknown", described as "had a sinus infection"; DYSPNOEA (non-serious), outcome "unknown", described as "Hard time breathing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: i got covid after i got two of the covid shots, notes: I got COVID after I got two of the COVID shots. Clinical Course: The patient stated I got COVID after I got two of the COVID shots, I was four days away from getting my booster and on the top of that I got the sinus infection." When I was a kid I got polio vaccine then none of us got polio.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient has Covid confirmed via two positive tests yesterday/runny nose/tired/unable to focus; Patient has Covid confirmed via two positive tests yesterday/runny nose/tired/unable to focus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Patient has Covid confirmed via two positive tests yesterday/runny nose/tired/unable to focus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) positive, notes: Covid confirmed via two positive tests Yesterday; (19Jan2022) positive, notes: Covid confirmed via two positive tests Yesterday. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Maternal exposure during pregnancy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result=Positive; covid test result=Positive; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jul2021 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Date of last menstrual period: 07Aug2021. The patient is expected to deliver a baby(s) on 14May2022. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 21Jun2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant) with onset 04Jan2022, outcome "unknown", COVID-19 (hospitalization, medically significant) with onset 04Jan2022, outcome "recovered with sequelae" (2022) and all described as "covid test result=Positive"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 21Jul2021, outcome "unknown", described as "Maternal Exposure During Pregnancy, second trimester". The patient was hospitalized for vaccination failure, covid-19 (hospitalization duration: 2 day(s)). The event "covid test result=positive" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (03Jan2022) fever; sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of covid-19.  Clinical course: Facility type vaccine was reported in Workplace clinic. Patient received no other vaccine in four weeks. Patient received no other medications in two weeks. The patient had covid prior vaccination. The patient was tested covid post vaccination. Adverse events included hard time breathing and hospitalized, headache with fever, cough, muscle aches, fatigue. AE treatment included albuteral inhaler.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: exposed to wife who was positive for covid and then he had HA and fever and runny nose 1/19 and did a home Ag test was positive; exposed to wife who was positive for covid and then he had HA and fever and runny nose 1/19 and did a home Ag test was positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Lot number: EL3247) at the age of 29 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: EL3247), administration date: 03Feb2021, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "recovering" and all described as "exposed to wife who was positive for covid and then he had HA and fever and runny nose 1/19 and did a home Ag test was positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.Clinical course: Patient exposed to wife who was positive for covid and then he had HA and fever and runny nose 1/19 and did a home Ag test and test was positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events vaccination failure, covid-19 and the administration of the vaccine cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Mensuration started within 48 hours of her first two vaccine doses even though her cycle was due 10-15 days later; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 49-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "recovered", described as "Mensuration started within 48 hours of her first two vaccine doses even though her cycle was due 10-15 days later". Therapeutic measures were not taken as a result of menstruation irregular.  Additional Information: Mensuration started within 48 hours of her first two vaccine doses even though her cycle was due 10-15 days later. That was unusual for her. It was unknown if the patient had other vaccine in four weeks and other medications in two weeks. No treatment was received for adverse events. The patient did not have COVID-19 prior to vaccination and was tested for COVID-19 post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID infection; Breakthrough COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "had COVID", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Breakthrough COVID infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive.  Clinical information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, SARS-CoV-2 test
Clinical narrative: mensural cramps again after her third; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product =COVID 19,, Prev dose brand=Pfizer/Biontech,, Prev dose brand unknown=False,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Prev dose administrator route=Intramuscular,, Prev dose dose number=2,), for COVID-19 Immunization, reaction(s): "Menstruation started within 48 hours of her first two vaccine doses"; Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer/Biontech,, Prev dose brand unknown=False,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Prev dose administrator route=Intramuscular,, Prev dose dose number=1), for COVID-19 Immunization, reaction(s): "Menstruation started within 48 hours of her first two vaccine doses".The following information was reported: DYSMENORRHOEA (non-serious), outcome "recovered", described as "mensural cramps again after her third". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysmenorrhoea.  Additional information:  No treatment was received in response to the adverse event. Patient was no covid prior to the vaccination and Since the vaccination, patient was tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Costochondritis, Lymphadenopathy
Clinical narrative: costochondritis; pain in right part of chest; After first shot, I had swollen lymph nodes under right armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Lot number: EC6818) at the age of 50 years as dose 2, single and administered in arm left, administration date 26Mar2021 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. Relevant medical history included: "osteoarthritis" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Spinal stenosis" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; LEVOCETIRIZINE. The following information was reported: COSTOCHONDRITIS (non-serious) with onset 2021, outcome "not recovered", described as "costochondritis"; CHEST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain in right part of chest"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "After first shot, I had swollen lymph nodes under right armpit". The events "costochondritis" and "pain in right part of chest" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of costochondritis, chest pain.  Additional information: The patient not received 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 was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cancer recurrent
Clinical narrative: recurring ovarian cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVARIAN CANCER RECURRENT (medically significant) with onset Jan2021, outcome "unknown", described as "recurring ovarian cancer". Therapeutic measures were taken as a result of ovarian cancer recurrent.  Clinical course: Patient received Covid Pfizer series Jan/Feb2021. In Antibody study she was enrolled showed no antibodies Jun2021. On her own, she went and got third shot Pfizer Jul2021. She had 6 rounds of chemotherapy Jan-Jun 2021 for recurring ovarian cancer. Dec2021 withheld Covid antibody test results were positive for IgG antibodies. Her question was when she should consider getting a booster, it has been 6 months since the third shot in Jul2021 and received reply as "There was no information about a fourth dose or a booster in immunocompromised patients and refer to HCP". She reported that her antibody test for March, April, and May 2021 showed antibodies. In Jun2021 there were no antibodies. She decided to get another dose. She states that she "got caught after". She tested positive for antibodies since then in Dec2021. She has spoken with her HCP who relayed to let her know when she would want to get another dose. Her question was that for an immune compromised patient has there been any data on essentially a 4th dose being needed or being effective and asked that does it protect against the Omicron variant and received response "To discuss with HCP potential risks verses benefit from another dose with her health history. Relayed that Pfizer cannot suggest or recommend the used of the product outside of the Regulatory Authority approvals. "A third dose was not to be confused with a booster dose. Please see the definitions below on this. A booster dose was an additional dose of a vaccine that was given at least 6 months after completing the primary series because the immune response to the primary series wanes over time. 2, 5 An additional (third dose) of the vaccine was given at least 4 weeks after the second dose to people who were determined to have certain kinds of immunocompromise and did not get an adequate immune response to the primary series. 2, 5. "The early results show that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant. Two doses of vaccine showed decreased antibody response".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I currently have tested positive for covid; I currently have tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I currently have tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Respiratory tract congestion
Clinical narrative: anaphylactic reaction; difficulty in breathing; chest congestion; coughing; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program. The reporter is the parent.  A 6 year-old female patient received bnt162b2 (BNT162B2), administration date 13Jan2022 16:00 (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 14Jan2022 01:26, outcome "recovered" (14Jan2022 01:40), described as "anaphylactic reaction"; DYSPNOEA (non-serious) with onset 14Jan2022 01:26, outcome "recovered" (14Jan2022 01:40), described as "difficulty in breathing"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 14Jan2022 01:26, outcome "recovered" (14Jan2022 01:40), described as "chest congestion"; COUGH (non-serious) with onset 14Jan2022 01:26, outcome "recovered" (14Jan2022 01:40), described as "coughing". Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, respiratory tract congestion, cough.  Clinical course: My daughter withheld 6yrs took Pfizer Covid19 vaccine on thursday 13Jan2022 from withheld at 4.00pm.She started anaphylactic reaction at 1.26am at night including difficulty in breathing chestcongestion,coughing etc.I am a Physician graduated from outside the country.I gave her an medicine called Punarnavasavam immediately. At 1.40 am the symptoms relieved completely.If we can do studies more.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event anaphylactic reaction and the administration of the vaccine cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had both shots and tested positive on 25Dec2021 & 26Dec2021; had both shots and tested positive on 25Dec2021 & 26Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2021, outcome "unknown" and all described as "had both shots and tested positive on 25Dec2021 & 26Dec2021". The event "had both shots and tested positive on 25dec2021 & 26dec2021" and "had both shots and tested positive on 25dec2021 & 26dec2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) positive; (26Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: patient had both shots and tested positive on 25Dec & 26Dec. The 28Dec patient went to the hospital and had the monoclonal antibodies infusion done. patient wanted to know how long must patient wait to have the booster shot , or can patient even get it done?  The lot number for bnt162b2 was not provided and will be requested during follow up.     .
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Gait inability, Immunisation, Pain, Sciatica
Clinical narrative: had my booster shot last Friday; woke up with severe pain in my lower back and in my sciatica; woke up with severe pain in my lower back and in my sciatica; in excruciating pain; Can't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 14Jan2022 (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 (Manufacturer Unknown, Dose number 1 and 2), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Jan2022, outcome "unknown", described as "had my booster shot last Friday"; BACK PAIN (non-serious), SCIATICA (non-serious) all with onset Jan2022, outcome "unknown" and all described as "woke up with severe pain in my lower back and in my sciatica"; PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "in excruciating pain"; GAIT INABILITY (non-serious) with onset Jan2022, outcome "unknown", described as "Can't walk". The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: I just had my booster shot last Friday and now I have the worst side effect. Had to call EMS just to get me out of bed. They told me they have seen alot of this with the booster shot.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Body temperature, COVID-19, Cough, Diarrhoea
Clinical narrative: terrible cough; Diarrhea; couldn't eat or drink anything; couldn't eat or drink anything; Low grade fever; lost a little bit of my sense of smell; In between, I came down with Covid.; In between, I came down with Covid.; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 73 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYNTHROID; FLUTICASONE + SALMETEROL; LETROZOLE; CLOBETASOL; IRON; LOSARTAN POTASSIUM; MECLIZINE HCL; BIOTIN; CALCIUM; AMLODIPINE BESYLATE; XARELTO; TYLENOL; XGEVA; KEFLEX [CEFALEXIN MONOHYDRATE]; METHOTREXATE. Past drug history included: Sulfamethoxazole, reaction(s): "Allergies". Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "In between, I came down with Covid."; DIARRHOEA (non-serious) with onset 24Dec2021, outcome "unknown", described as "Diarrhea"; FEEDING DISORDER (non-serious), DYSPHAGIA (non-serious) all with onset 24Dec2021, outcome "unknown" and all described as "couldn't eat or drink anything"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Low grade fever"; ANOSMIA (non-serious) with onset 2021, outcome "unknown", described as "lost a little bit of my sense of smell"; COUGH (non-serious), outcome "unknown", described as "terrible cough". The patient underwent the following laboratory tests and procedures: body temperature: low grade. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Dysphagia, Feeding disorder, Pyrexia
Clinical narrative: terrible cough; Diarrhea; couldn't eat or drink anything; couldn't eat or drink anything; Low grade fever; lost a little bit of my sense of smell; In between, I came down with Covid.; In between, I came down with Covid.; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 73 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYNTHROID; FLUTICASONE + SALMETEROL; LETROZOLE; CLOBETASOL; IRON; LOSARTAN POTASSIUM; MECLIZINE HCL; BIOTIN; CALCIUM; AMLODIPINE BESYLATE; XARELTO; TYLENOL; XGEVA; KEFLEX [CEFALEXIN MONOHYDRATE]; METHOTREXATE. Past drug history included: Sulfamethoxazole, reaction(s): "Allergies". Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "In between, I came down with Covid."; DIARRHOEA (non-serious) with onset 24Dec2021, outcome "unknown", described as "Diarrhea"; FEEDING DISORDER (non-serious), DYSPHAGIA (non-serious) all with onset 24Dec2021, outcome "unknown" and all described as "couldn't eat or drink anything"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Low grade fever"; ANOSMIA (non-serious) with onset 2021, outcome "unknown", described as "lost a little bit of my sense of smell"; COUGH (non-serious), outcome "unknown", described as "terrible cough". The patient underwent the following laboratory tests and procedures: body temperature: low grade. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, Nasal congestion
Clinical narrative: Tested positive for Covid- 19; Tested positive for Covid- 19; Mild congestion; Janssen dose number in serious 1/BNT162 dose number in serious 2; Janssen dose number in serious 1/BNT162 dose number in serious 2; This is a spontaneous report received from contactable reporters (Consumer or other non HCP). Other Case identifier(s): 20211260954 (Janssen).  A female patient received BNT162B2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose number: 1), administration date: Apr2021, for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Janssen dose number in serious 1/BNT162 dose number in serious 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "Tested positive for Covid- 19"; NASAL CONGESTION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Mild congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for Covid- 19; Tested positive for Covid- 19; Mild congestion; Janssen dose number in serious 1/BNT162 dose number in serious 2; Janssen dose number in serious 1/BNT162 dose number in serious 2; This is a spontaneous report received from contactable reporters (Consumer or other non HCP). Other Case identifier(s): 20211260954 (Janssen).  A female patient received BNT162B2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose number: 1), administration date: Apr2021, for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Janssen dose number in serious 1/BNT162 dose number in serious 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "Tested positive for Covid- 19"; NASAL CONGESTION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Mild congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Asthenia, Blood pressure abnormal, Disturbance in attention, Dizziness
Clinical narrative: has been diagnosed with Type II diabetes; Fatigue; Extreme Thirst; Frequent Urination; Lack of Energy; Dizziness; Difficulty Focusing; Unexplained Weight Loss; blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing), notes: Slightly overweight according to BMI. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer ), for COVID-19 Immunization. The following information was reported: TYPE 2 DIABETES MELLITUS (medically significant), outcome "unknown", described as "has been diagnosed with Type II diabetes"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; THIRST (non-serious), outcome "unknown", described as "Extreme Thirst"; POLLAKIURIA (non-serious), outcome "unknown", described as "Frequent Urination"; ASTHENIA (non-serious), outcome "unknown", described as "Lack of Energy"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "Difficulty Focusing"; ABNORMAL LOSS OF WEIGHT (non-serious), outcome "unknown", described as "Unexplained Weight Loss"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure". Therapeutic measures were taken as a result of type 2 diabetes mellitus, blood pressure abnormal. Clinical course: Patient was on blood pressure medications and insulin pills.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pollakiuria, Thirst, Type 2 diabetes mellitus
Clinical narrative: has been diagnosed with Type II diabetes; Fatigue; Extreme Thirst; Frequent Urination; Lack of Energy; Dizziness; Difficulty Focusing; Unexplained Weight Loss; blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing), notes: Slightly overweight according to BMI. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer ), for COVID-19 Immunization. The following information was reported: TYPE 2 DIABETES MELLITUS (medically significant), outcome "unknown", described as "has been diagnosed with Type II diabetes"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; THIRST (non-serious), outcome "unknown", described as "Extreme Thirst"; POLLAKIURIA (non-serious), outcome "unknown", described as "Frequent Urination"; ASTHENIA (non-serious), outcome "unknown", described as "Lack of Energy"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "Difficulty Focusing"; ABNORMAL LOSS OF WEIGHT (non-serious), outcome "unknown", described as "Unexplained Weight Loss"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure". Therapeutic measures were taken as a result of type 2 diabetes mellitus, blood pressure abnormal. Clinical course: Patient was on blood pressure medications and insulin pills.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; Drug ineffective; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "COVID-19"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2021 16:00 (Lot number: EL0142) 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 1, single, intramuscular in the left arm, Batch/Lot number: EJ1685, administration time: 16:00), administration date: 26Dec2020, for COVID-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset Mar2021, outcome "unknown", described as "Bell's Palsy".; Sender's Comments: Based on the available reported information, the causal association between the event Bell's palsy, and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal association. 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.