chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin disorder
Clinical narrative: Big dimple in her left arm; The dimple has a bunch of red dots that looks like a rash but is not a rash; 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 79-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISORDER (non-serious) with onset Feb2021, outcome "not recovered", described as "Big dimple in her left arm"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "The dimple has a bunch of red dots that looks like a rash but is not a rash".  Additional Information: Patient had a pretty big dimple in her left arm where she received the vaccines. She stated the dimple has a bunch of red dots that looks like a rash but is not a rash. She stated the dimple started out small and got bigger and has not gone away but has not gotten any bigger and the dimple started in Feb2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 96-year-old male patient received BNT162b2 (BNT162B2), on 19Sep2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 96 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medication in 2 weeks. COVID 19 Treatment: Paxlovid. Treatment start date: 05May2022 and stop date: 10May2022. Patient completed the medication. After 3 days of testing negative and was feeling fine, on 14May2022, patient's cold symptoms returned and tested positive again. Patient continued to test positive for 10 more days until finally testing negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid infection (fully vaccinated & boostered twice with Pfizer vaccine).; Covid infection (fully vaccinated & boostered twice with Pfizer vaccine).; 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), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid infection (fully vaccinated & boostered twice with Pfizer vaccine).". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had both my shot then I had the Pfizer booster shot. I had Pfizer all three shot/ tested positive for covid; I had both my shot then I had the Pfizer booster shot. I had Pfizer all three shot/ tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6206), on 07Apr2021 as dose 2, single (Lot number: ER8734) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: take Flonase which is nasal spray for allergy; "Type 1 diabetes mellitus" (unspecified if ongoing), notes: type 1 diabetic for 33 years; "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; IRBESARTAN taken for hypertension; FLONASE [FLUTICASONE PROPIONATE] taken for hypersensitivity; PRAVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had both my shot then I had the Pfizer booster shot. I had Pfizer all three shot/ tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive for COVID. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Pharmacist told and doctor gave patient paxlovid, as tested positive for COVID. Patient had Pfizer all three shot. Pharmacist told stop taking it because patient was type 1 diabetic for 33 years. Patient took irbesartan and amlodipine for high blood pressure. Patient took Pravastatin, but did not feel good so, did not take it the night, on the Thursday night and the pharmacist told not to take the pravastatin because it was a statin drug so just do not take it, and other than that just take vitamins and also take Flonase which was nasal spray for allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: little tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: ER8734) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: I also take Flonase which is nasal spray for allergy; "Diabetes" (unspecified if ongoing), notes: Diabetes, Consumer stated, "I am type 1 diabetic for 33 years."; "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure. Concomitant medication(s) included: IRBESARTAN taken for hypertension; AMLODIPINE taken for hypertension; FLONASE ALLERGY RELIEF taken for hypersensitivity; PRAVASTATIN. Vaccination history included: BNT162b2 (Dose:1, LOT# (first shot): EN6206., first one was nothing), administration date: 17Mar2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Nothing". The following information was reported: FATIGUE (non-serious) with onset 09Apr2021, outcome "unknown", described as "little tired". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID after testing negative at end of treatment; tested positive for COVID after testing negative at end of treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), on 02Mar2021 as dose 2, single (Lot number: EN6202) and on 09Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sulfur for Allergy. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive for COVID after testing negative at end of treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: testing negative at end of treatment; positive, notes: tested positive for COVID after testing negative at end of treatment. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Addition information: After being on paxlovid I relapsed with COVID symptoms again about 7-8 days after finishing treatment. Also, tested positive for COVID after testing negative at end of treatment.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have now tested positive again; I have now tested positive again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6200), in left arm and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunization. The patient's had no relevant medical history and no known allergies. Concomitant medication(s) included: TAMSULOSIN; FLONASE; TURMERIC and reported as patient taking other medications or products within 2 weeks of starting COVID-19 treatment. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "I have now tested positive again". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 12May2022 and stopped on 17May2022. Clinical course was reported as, After taking Paxlovid (which worked great) patient started having symptoms again 5 days after completing the series and after having tested negative for Covid. Patient have now tested positive again and in 3rd day of symptoms which are worse than originally had. Symptoms include congestion, coughing and feeling run down. Patient believe his wife was also experiencing the rebound but has not tested again yet. Rebound symptoms started on 22May2022. No treatment received for symptoms and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC
Symptoms: Product storage error
Clinical narrative: vaccine was accidentally left out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT STORAGE ERROR (non-serious), outcome "unknown", described as "vaccine was accidentally left out". Prevnar 13 or Prevnar 20 was unable to be verified as the suspect product as the caller disconnected the line prior to speaking to the call handler.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: EW0151), in left arm and on 03May2021 as dose 2, single (Lot number: EW0173) at the age of 26 years, in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 07Dec2021 as dose 3 (booster), single (Lot number: 029H21B), in left arm for covid-19 immunization. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "mast cell activation syndrome" (unspecified if ongoing); "postural orthostatic tachycardia syndrome" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "likely autoimmune condition" (unspecified if ongoing), notes: Other medical history: likely autoimmune condition; "ADHD" (unspecified if ongoing), notes: ADHD; "OCD" (unspecified if ongoing), notes: OCD; "obstructive sleep apnea" (unspecified if ongoing); "known allergies: Pineapple" (unspecified if ongoing), notes: known allergies: Pineapple. Concomitant medication(s) included: VYEPTI, start date: 17Dec2020; BOTOX, start date: 23Aug2021; TROKENDI XR, also reported as other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive; (16May2022) Negative; (21May2022) Negative; (23May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (start date: 11May2022, stop date: 15May2022). Clinical course was reported as, patient was tested positive for COVID on 10May2022; had symptoms started 09May2022 and started Paxlovid on 11May2022, took for 5 days (full course). She was tested negative on 16May2022, started having symptoms again on 21May2022; tested negative on 21May2022, Symptoms worsened; tested positive on 23May2022. Overall symptoms from COVID: chest pain, shortness of breath, cough, sneezing, congestion, chills, fever. Paxlovid eliminated chills and fever. Patient was not recovered from symptoms and no treatment received for symptoms.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, SARS-CoV-2 test, Vertigo
Clinical narrative: headache; Fogginess; weakness; Extreme Vertigo; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 at 11:00 as dose number unknown, single (Lot number: FM0698) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: known allergies: No, other medical history: No. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 18May2022 at 14:00, outcome "recovering", described as "Extreme Vertigo"; VOMITING (non-serious) with onset 18May2022 at 14:00, outcome "recovering"; FEELING ABNORMAL (non-serious) with onset 19May2022, outcome "recovering", described as "Fogginess"; HEADACHE (non-serious) with onset 19May2022, outcome "recovering"; ASTHENIA (non-serious) with onset 19May2022, outcome "recovering", described as "weakness". The events "extreme vertigo", "vomiting", "headache", "fogginess" and "weakness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, vomiting, headache, feeling abnormal, asthenia.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Extreme Vertigo causing vomiting approximately 2:00am Thursday 19May until approximately 8:00pm that night. Midnight 19May Extreme Vertigo subsided leaving headache and mild vertigo. Fogginess and weakness. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Meclizine and Ondansetron. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (as reported).  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: headache; Fogginess; weakness; Extreme Vertigo; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 at 11:00 as dose number unknown, single (Lot number: FM0698) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: known allergies: No, other medical history: No. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 18May2022 at 14:00, outcome "recovering", described as "Extreme Vertigo"; VOMITING (non-serious) with onset 18May2022 at 14:00, outcome "recovering"; FEELING ABNORMAL (non-serious) with onset 19May2022, outcome "recovering", described as "Fogginess"; HEADACHE (non-serious) with onset 19May2022, outcome "recovering"; ASTHENIA (non-serious) with onset 19May2022, outcome "recovering", described as "weakness". The events "extreme vertigo", "vomiting", "headache", "fogginess" and "weakness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, vomiting, headache, feeling abnormal, asthenia.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Extreme Vertigo causing vomiting approximately 2:00am Thursday 19May until approximately 8:00pm that night. Midnight 19May Extreme Vertigo subsided leaving headache and mild vertigo. Fogginess and weakness. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Meclizine and Ondansetron. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (as reported).  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 22 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Known allergies: allergic to mushrooms" (unspecified if ongoing), notes: Known allergies allergic to mushrooms; "Known allergies: allergic to cats" (unspecified if ongoing), notes: Known allergies allergic to cats. Concomitant medication(s) included: SERTRALINE; BUPROPION; CLARITIN [LORATADINE]; also reported as other medication in 2 weeks. Past drug history included: Quinoa, reaction(s): "Known allergies: allergic to quinoa", notes: Known allergies: allergic to quinoa. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Apr2022, outcome "not recovered" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative, notes: Began to test negative on day 6; (22Apr2022) Positive; (22May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 22Apr2022 (took for 5 days) and stopped on 27Apr2022 (Began to test negative on day 6). Symptoms reoccurred, patient experienced rebound symptoms on 19May2022 and tested positive again on 22May2022. No treatment received for symptoms and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: tested positive for Covid after receiving 2 shots and a booster; tested positive for Covid after receiving 2 shots and a booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3247), on 09Feb2021 as dose 2, single (Lot number: EL9269) and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid after receiving 2 shots and a booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: a self test and it was positive; Weight: 181-182 lbs. Therapeutic measures were taken as a result of covid-19.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 16:00 as dose 4 (booster), single (Lot number: Fj6369) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. No other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Indication=Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Paxlovid, treatment start date: 12May2022, treatment stop date: 16May2022. Additional Information: This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in RA Q1215 and/or Q1252. Conclusion of Previously Completed Investigation: The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FP FJ6369 (SF: FJ6287). A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Arm -aim for 2 days (Arm-pain for 2 days); This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received meningococcal group b Rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm -aim for 2 days (Arm-pain for 2 days)".  Additional 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: Drug ineffective, Suspected COVID-19
Clinical narrative: she knows her friend received COVID after the booster dose; she knows her friend received COVID after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was reported as no additional vaccines administered on same date of the pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she knows her friend received COVID after the booster dose". Clinical course was reported as, reporter states her friend (patient) was 39 years old when she received the booster dose of COVID-19 Vaccine and is now 40 years old or was 40 years old when she received the booster and is 41 years old now. She states after the first 2 doses of the COVID-19 vaccine, her friend had a light change in her menstrual cycle. She states after her friend's booster dose of the COVID-19 Vaccine almost a year ago, her friend was suffering from horrible long strong cycles and visited physician office multiple times. Her friend believed the first 2 were preventing COVID but did not and states her friend felt coerced to receive the booster so that she would be able to fly. She knows her friend received COVID after the booster dose but she states her friend might have gotten COVID after the first 2 doses as well. Also reports she has a lot of friends who were pregnant. She states the friends took the Pfizer COVID-19 vaccine and got problems after the COVID-19 vaccine. She states serious issues with menstrual cycles and lost there babies. Agent reports the caller is pregnant. Reporter wants to know if the vaccine is safe to take for women. Agent reports the caller is quite afraid. The reporter confirms details provided by transfer agent. She states the previous agent already read her a long list of potential side effects. She thinks she is okay to do a report but states she is calling today as she was concerned for herself.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: after the first 2 doses of the COVID-19 vaccine, her friend had a light change in her menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "after the first 2 doses of the COVID-19 vaccine, her friend had a light change in her menstrual cycle". The event "after the first 2 doses of the covid-19 vaccine, her friend had a light change in her menstrual cycle" required physician office visit.  Additional Context: She stated after the first 2 doses of the COVID-19 vaccine, her friend had a light change in her menstrual cycle. She stated after her friend's booster dose of the COVID-19 Vaccine almost a year ago, her friend was suffering from horrible long strong cycles. Indication: Caller stated her friend believed the first 2 were preventing COVID but did not and stated her friend felt coerced to receive the booster so that she would be able to fly. Reporter stated her friend did not want the booster. Reporter stated she knows her friend received COVID after the booster dose but she stated her friend might have gotten COVID after the first 2 doses as well.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Insomnia; 1st dose 14Jul2021/ 2nd dose 15Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 15Oct2021 at 10:00 as dose 2, single (Lot number: FC3184) at the age of 39 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Time: 10 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular , Batch/Lot number: EW0176), administration date: 14Jul2021, when the patient was 39-year-old, for Covid-19 immunization, reaction(s): "Insomnia". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Oct2021, outcome "unknown", described as "1st dose 14Jul2021/ 2nd dose 15Oct2021"; INSOMNIA (disability, medically significant), outcome "recovering". The event "insomnia" required physician office visit. The patient underwent the following laboratory tests and procedures: Full blood count: Normal. Therapeutic measures were taken as a result of insomnia.  Clinical information: No Prior vaccination within four weeks. No specific relevant test for thromboembolic events with thrombocytopenia. The patient reported she was unable to fall/ stay asleep for several weeks. Was prescribed Sleeping pills but those didn't help. The lack of sleep caused muscle jerks and anxiety. The 1st 6 weeks after each shot were the worst and it slowly got better each week. It did flare up badly again right after my second shot. Now I am 5 month post my Second shot and feel 80percent recovered. I am able to sleep most nights with minimal meds.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: sister had reaction after 1st dose diagnosed with Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "sister had reaction after 1st dose diagnosed with Pericarditis".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: confirmed positive with self-antigen rapid testing on tuesday 24May; confirmed positive with self-antigen rapid testing on tuesday 24May; sore throat; Sniffles; 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 (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EL3247), on 23Mar2021 as dose 2, single (Lot number: EL3247) and on 09Dec2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious) with onset 23May2022, outcome "unknown", described as "Sniffles"; OROPHARYNGEAL PAIN (non-serious) with onset 23May2022, outcome "unknown", described as "sore throat"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "unknown" and all described as "confirmed positive with self-antigen rapid testing on tuesday 24May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: confirmed positive with self antigen rapid testing on Tuesday 24May; (24May2022) Positive, notes: confirmed positive with self antigen rapid testing on Tuesday 24May.  Adverse event: Sniffles and sore throat on Monday 23May; confirmed positive with self antigen rapid testing on Tuesday 24May. Patient did not have covid prior vaccination and patient did not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Regular chills, fatigue, fever etc. from the first dose in Feb; Regular chills, fatigue, fever etc. from the first dose in Feb; Regular chills, fatigue, fever etc. from the first dose in Feb; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: WN6201) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHILLS (non-serious), FATIGUE (non-serious), PYREXIA (non-serious) all with onset Feb2021, outcome "recovered with sequelae" and all described as "Regular chills, fatigue, fever etc. from the first dose in Feb". The event "regular chills, fatigue, fever etc. from the first dose in feb" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, fatigue, pyrexia.  Additional information: The patient not had other vaccine in four weeks. No other medications in two weeks. The patient not had COVID prior vaccination. The patient tested for COVID post vaccination. The patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: right armpit is swollen up like a half size baseball protruding out of her armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 23May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset May2022, outcome "unknown", described as "right armpit is swollen up like a half size baseball protruding out of her armpit".  Additional information: It was reported as serious: no, PQC present: no. Reporter declined a safety report. Reporter received her booster dose on Monday, and her right armpit was swollen up like a half size baseball protruding out of her armpit and she would like to know if this related to the vaccine or if there was a follow up medical care relative to it. Swollen lymph nodes (lymphadenopathy) were also reported and generally improved within 10 days. The report was not related to a study or programme. COVID-19 Booster manufacturer was unspecified. NDC number of COVID-19 Booster was unknownReason for no lot number: of COVID-19 Booster was reported as reporter unwilling to complete the report.Expiry Date of COVID-19 Booster was unknown.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I now have COVID-19 but thanks to the vaccines that I took earlier I will come through this with my life; now have COVID-19 but thanks to the vaccines that I took earlier I will come through this with my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart problem" (unspecified if ongoing), notes: I'm 65 with heart problems and controlled blood, pressure problems; "Blood Pressure" (unspecified if ongoing), notes: I'm 65 with heart problems and controlled blood, pressure problems. The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "I now have COVID-19 but thanks to the vaccines that I took earlier I will come through this with my life"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "now have COVID-19 but thanks to the vaccines that I took earlier I will come through this with my life". Clinical course: Patient would like to take this opportunity thank for what patient believed was a life-saving vaccine. The patient was 65 with heart problems and controlled blood pressure problems, patient believed patient would not have survived without wonderful vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: was exposed to temperatures out of labelled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FL8094, Expiration Date: 25Apr2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "was exposed to temperatures out of labelled".  Additional information: The product was subjected to storage conditions of 2 degree C to 8 degree C for a total of 80 days. Stability data does not support the use of this product following this deviation. Pfizer could not authorize storage of any product outside the approved labelled conditions. Additionally, Pfizer could not make any disposition decisions for product outside Pfizer's control. Any decision to release or dispose of the impacted products based on provided information or other information was the responsibility of Clinic.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: I only had a sore arm with  second booster dose of the Pfizer Covid 19 vaccine as well as the flu shot each 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 79-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU), (Batch/Lot number: unknown). The patient's relevant medical history included: "kidney failure" (unspecified if ongoing), notes: had third stage kidney failure; "overweight" (unspecified if ongoing), notes: 90 lbs overweight; "a-fib" (unspecified if ongoing), notes: a-fib. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary series immunization completed , unknown manufacturer, Booster Dose), for Covid-19 Immunization; Covid-19 vaccine (primary series immunization completed , unknown manufacturer), for Covid-19 Immunization; Flu shot (Flu shot, Stated that she gets the sore arm with her annual flu shot each year), reaction(s): "sore arm".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I only had a sore arm with  second booster dose of the Pfizer Covid 19 vaccine as well as the flu shot each year".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: Rebound from Paxlovid; Rebound from Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 06Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing); "valley fever", start date: Dec2019 (unspecified if ongoing), notes: valley fever in Dec2019; "known allergies sulfa" (unspecified if ongoing); "known allergies penicilin" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE, start date: 01Sep2020; METHIMAZOLE, start date: 08Feb2021. Past drug history included: Levaquin, reaction(s): "known allergies: levaquin". The following information was reported: VACCINATION FAILURE (medically significant) with onset 23May2022 at 19:00, outcome "recovering", SUSPECTED COVID-19 (medically significant) with onset 23May2022 at 19:00, outcome "recovering" and all described as "Rebound from Paxlovid". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Additional information: Report about covid treatment was Yes. If vaccine received reported as Yes. Other medication in 2weeks reported as Yes. Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 13May2022, Treatment stop date: 18May2022, Indication: Treatment of COVID-19. Adverse event: Rebound from Paxlovid. Known allergies: Sulfa penicillin Levaquin. Other medical history: Graves' disease, valley fever in Dec2019.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Antibody test, Antinuclear antibody, Investigation, Rash
Clinical narrative: had a rash 31 days after the first dose of the vaccine/she started breaking out in a rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; cetirizine (CETIRIZINE), (Batch/Lot number: unknown); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), (Batch/Lot number: unknown). The patient's relevant medical history included: "has reactions and sensitivities to a lot of medications" (unspecified if ongoing), notes: has reactions and sensitivities to a lot of medications; "has a lot of allergic reactions" (unspecified if ongoing), notes: has a lot of allergic reactions. The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "had a rash 31 days after the first dose of the vaccine/she started breaking out in a rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The reporter stated that based on the recommendation of her allergist and her Primary Care Provider she took a Zyrtec, Cetirizine, 2 hours before the vaccine. She stated she is I&I positive and ANA positive, sensitive to a lot of medications. She was fine for the first 30 days. States that the doctors recommended her to get the vaccines 45-60 days apart instead of the recommended 21 days apart. 30-45 days after the vaccines she started breaking out in a rash. She did an antibody test and her level was 7.92. Reporter stated that the nurse at her allergist office told the caller that the staff there who had received three doses of the vaccine had results of 2500. The patient reported that, there was no information, so how did you know the vaccine was effective, specially someone who was autoimmune positive, no one wanted to put something in the body that will be harming instead of helping. Allergist and all their staff took a test after the first, second and booster dose of the vaccine, they had Pfizer and they were within the 25,000 range, so my 7.92 after just one vaccine seems low, the patient was trying to learn if in fact the vaccine may work for me, regardless of what vaccine it was.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.