chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 1 dose of Moderna bivalent vaccine was administered BUD./Bivalent vaccine of lot number 0215K22A was administer to patient past its thawed out expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent vaccine was administered BUD./Bivalent vaccine of lot number 0215K22A was administer to patient past its thawed out expiration date.) and NO ADVERSE EVENT (No adverse event) in a 5-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 0215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Mar-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent vaccine was administered BUD./Bivalent vaccine of lot number 0215K22A was administer to patient past its thawed out expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent vaccine was administered BUD./Bivalent vaccine of lot number 0215K22A was administer to patient past its thawed out expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent vaccine was administered BUD./Bivalent vaccine of lot number 0215K22A was administer to patient past its thawed out expiration date.).    No concomitant information was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2023: Live follow up information received age group ,vaccination start date ,event start date and narrative was updated.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: TE-00023958 in response to clarification regarding temperature excursion where liquid vaccine was exposed to temperatures greater than 46F for greater than 24 hours; No adverse event; Poor quality vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (TE-00023958 in response to clarification regarding temperature excursion where liquid vaccine was exposed to temperatures greater than 46F for greater than 24 hours), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 11-Apr-2023 at 10:11 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Apr-2023 at 10:11 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (TE-00023958 in response to clarification regarding temperature excursion where liquid vaccine was exposed to temperatures greater than 46F for greater than 24 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (TE-00023958 in response to clarification regarding temperature excursion where liquid vaccine was exposed to temperatures greater than 46F for greater than 24 hours), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (TE-00023958 in response to clarification regarding temperature excursion where liquid vaccine was exposed to temperatures greater than 46F for greater than 24 hours) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medications was provided. No treatment medications was provided. Product temperature excursion issue was happened on 9-APR-2023.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2023: Live non significant follow up
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted, Product availability issue
Clinical narrative: first dose of the Moderna Covid 19 vaccine on December 17, 2022/Patient has not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series; Product availability issue; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (first dose of the Moderna Covid 19 vaccine on December 17, 2022/Patient has not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (first dose of the Moderna Covid 19 vaccine on December 17, 2022/Patient has not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (first dose of the Moderna Covid 19 vaccine on December 17, 2022/Patient has not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION INTERRUPTED (first dose of the Moderna Covid 19 vaccine on December 17, 2022/Patient has not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series) and PRODUCT AVAILABILITY ISSUE (Product availability issue).    No concomitant medications was reported. Patient reports no side effects after the first dose. No treatment medications was reported.  Patient had not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series The patient cannot find a vaccination provider to give him his second dose of the Moderna Covid-19 vaccine series. Patient was also told by a Pharmacy that he could receive the Pfizer vaccine for his second Covid-19 vaccine dose.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: no adverse event; Product temperature excursion issue; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (no adverse event) in a 47-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Apr-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant product was reported. The patient received Moderna booster before the 15 min thaw time. No treatment information was reported. It was unknown if the patient experienced any additional symptoms.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Nurse stated that a patient called and stated that she received a Moderna Bivalent and never received the primary dose; no adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Nurse stated that a patient called and stated that she received a Moderna Bivalent and never received the primary dose) and NO ADVERSE EVENT (no adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Nurse stated that a patient called and stated that she received a Moderna Bivalent and never received the primary dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Nurse stated that a patient called and stated that she received a Moderna Bivalent and never received the primary dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Nurse stated that a patient called and stated that she received a Moderna Bivalent and never received the primary dose).    No concomitant medications were reported.     The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   No treatment medications were reported.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; inadvertently administered the bivalent booster dose to a patient who came in today, 17Apr2023, for the 2nd dose of the primary series; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (inadvertently administered the bivalent booster dose to a patient who came in today, 17Apr2023, for the 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (inadvertently administered the bivalent booster dose to a patient who came in today, 17Apr2023, for the 2nd dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (inadvertently administered the bivalent booster dose to a patient who came in today, 17Apr2023, for the 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (inadvertently administered the bivalent booster dose to a patient who came in today, 17Apr2023, for the 2nd dose of the primary series).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.  The patient had 1st dose on 30-Jun-2022, Lot number AS1414B expiration date 13-Feb-2023. No adverse evet was reported after the administration. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: received Moderna Covid-19 vaccine that was past the 30 day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Moderna Covid-19 vaccine that was past the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Moderna Covid-19 vaccine that was past the 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received Moderna Covid-19 vaccine that was past the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received Moderna Covid-19 vaccine that was past the 30 day use by date).    No concomitant medications was reported. No additional information was provided by the Pharmacist. No treatment drug details was reported.   Reporter did not allow further contact
Age: 32.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; HCP administered a single dose of Moderna Covid-19 bivalent vail that exceeded thawing out date.Vails thaw out date expired on 5-Apr-23 administered a single dose of Moderna Covid-19 bivalent-23 vaccine was administered on and 12-Apr-23.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered a single dose of Moderna Covid-19 bivalent vail that exceeded thawing out date.Vails thaw out date expired on 5-Apr-23 administered a single dose of Moderna Covid-19 bivalent-23 vaccine was administered on and 12-Apr-23.) and NO ADVERSE EVENT (No Adverse Event) in a 32-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered a single dose of Moderna Covid-19 bivalent vail that exceeded thawing out date.Vails thaw out date expired on 5-Apr-23 administered a single dose of Moderna Covid-19 bivalent-23 vaccine was administered on and 12-Apr-23.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered a single dose of Moderna Covid-19 bivalent vail that exceeded thawing out date.Vails thaw out date expired on 5-Apr-23 administered a single dose of Moderna Covid-19 bivalent-23 vaccine was administered on and 12-Apr-23.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP administered a single dose of Moderna Covid-19 bivalent vail that exceeded thawing out date.Vails thaw out date expired on 5-Apr-23 administered a single dose of Moderna Covid-19 bivalent-23 vaccine was administered on and 12-Apr-23.).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: No adverse event; The last dose was December 2021. Did patient need to start it again or did patient get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (The last dose was December 2021. Did patient need to start it again or did patient get the second dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.   No Medical History information was reported.    In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (The last dose was December 2021. Did patient need to start it again or did patient get the second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (The last dose was December 2021. Did patient need to start it again or did patient get the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (The last dose was December 2021. Did patient need to start it again or did patient get the second dose).    No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 3 boosters prior to getting bivalent in September; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (3 boosters prior to getting bivalent in September) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was reported that patient had all types of health issues.  Concurrent medical conditions included Diabetes and Hypercholesterolemia.   On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (3 boosters prior to getting bivalent in September) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (3 boosters prior to getting bivalent in September) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (3 boosters prior to getting bivalent in September).    Concomitant drugs were not reported. It was reported that patient had 2 primary doses and 3 booster doses prior to getting bivalent in September. Treatment medications were not provided.   Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), in Apr2020 as dose 2, single (Lot number: Er8735), in left arm and in Apr2020 as dose 3 (booster), single (Lot number: Ep6955) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Plaxovid from 02Apr2023 to 07Apr2023 for the treatment of COVID-19. The patient had no known allergies.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Blood test normal, Chest pain, Fatigue, Malaise
Clinical narrative: joint aches; Chest pain; body aches; fatigue; general not feeling well; 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 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for immunisation. The patient's relevant medical history included: "allergy related asthma" (unspecified if ongoing), notes: since she was a child. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 01Apr2023, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 01Apr2023, outcome "not recovered"; MALAISE (non-serious) with onset 01Apr2023, outcome "not recovered", described as "general not feeling well"; CHEST PAIN (non-serious) with onset 05Apr2023, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 05Apr2023, outcome "not recovered", described as "joint aches". The events "body aches", "joint aches", "fatigue", "general not feeling well" and "chest pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, arthralgia. Therapeutic measures were not taken as a result of fatigue, malaise, chest pain. Additional information: the patient had asthma and used an inhaler and allergist and primary care doctor thought that she should get pneumococcal 20-val conj vac (dipht CRM197 protein). She had the vaccine on 31Mar2023 ever since then had body aches, joint aches, fatigue and just like the general not feeling well since had it for 2 weeks. Went to the doctor. Had blood work done that was normal. She didn't read anything about side effects lasting more than 2-3 days. The patient had this for two weeks. Did not know if other people have reported this same problem. Had chest pain that went with the joint aches. For the body and joint aches, the patient took TYLENOL. When the patient took TYLENOL, the joint aches were a little better and then they got worse again. The fatigue had been pretty much consistent (was persisting).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pain
Clinical narrative: joint aches; Chest pain; body aches; fatigue; general not feeling well; 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 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for immunisation. The patient's relevant medical history included: "allergy related asthma" (unspecified if ongoing), notes: since she was a child. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 01Apr2023, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 01Apr2023, outcome "not recovered"; MALAISE (non-serious) with onset 01Apr2023, outcome "not recovered", described as "general not feeling well"; CHEST PAIN (non-serious) with onset 05Apr2023, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 05Apr2023, outcome "not recovered", described as "joint aches". The events "body aches", "joint aches", "fatigue", "general not feeling well" and "chest pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, arthralgia. Therapeutic measures were not taken as a result of fatigue, malaise, chest pain. Additional information: the patient had asthma and used an inhaler and allergist and primary care doctor thought that she should get pneumococcal 20-val conj vac (dipht CRM197 protein). She had the vaccine on 31Mar2023 ever since then had body aches, joint aches, fatigue and just like the general not feeling well since had it for 2 weeks. Went to the doctor. Had blood work done that was normal. She didn't read anything about side effects lasting more than 2-3 days. The patient had this for two weeks. Did not know if other people have reported this same problem. Had chest pain that went with the joint aches. For the body and joint aches, the patient took TYLENOL. When the patient took TYLENOL, the joint aches were a little better and then they got worse again. The fatigue had been pretty much consistent (was persisting).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair has been falling out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 88-year-old female patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FG3524) at the age of 88 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing). The patient's medical history, reported also as family history included: "high blood pressure" (unspecified if ongoing), notes: Been taking blood pressure medicine for years and never had any problems.; "Cancer" (unspecified if ongoing), notes: Cancer in her family and high blood pressure and thyroid. The patient's concomitant medications were not reported. Vaccination history included: pfizer covid vaccine (DOSE 1, Single, Lot number: EW0169, Expiration is unknown, Anatomical site: Injected in left arm), administration date: 14May2021, when the patient was 88-year-old, for COVID-19 immunization; pfizer covid vaccine (DOSE 2, Single, Lot number: EW01S3, Anatomical site: Injected in left arm, she said she cannot make it out.), administration date: 04Jun2021, when the patient was 88-year-old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset Nov2021, outcome "not recovered", described as "Hair has been falling out". Therapeutic measures were taken as a result of alopecia.  Additional information: Hair has been falling out was reported as worsened. No other Conditions. Received a call from consumer regarding booster shot 3rd one of Pfizer and reported her hair has been falling out. Within a week of getting the third booster shot is when she started noticing it. Just shampooed it and it comes out in her hands. No medical treatment. Just treated herself with oils and things to strengthen it and special shampoos and it just keeps breaking. She knows a lot of people are going through the same thing. No prior vaccinations taken (within 4 weeks). Time: morning. Vaccine was not administered at Facility. Vaccination Facility Type was Pharmacy. The patient had vaccine on 03Oct2022, Batch/lot number GH9703, Dosage text was Unknown dose injected in left arm.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 4 (booster), 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 included: "Long QT syndrome" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 06Apr2023 to 10Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: testing Positive on 23Mar2023; testing Positive on 23Mar2023; 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 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose 5 (booster), single (Lot number: GJ6742) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: ER8733), in right arm, on 29Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 15Jul2022 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies:shrimp" (unspecified if ongoing); "Known allergies: Iodine" (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 23Mar2023, outcome "unknown" and all described as "testing Positive on 23Mar2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Mar2023) positive. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot GJ6742, FE3593, FH8020, EW0151, ER8733 was investigated. The investigation included a review of manufacturing and packaging records, deviations, and the complaint history for in scope lots. The final scope was determined to be the finished goods lot GJ6742, bulk and fill lots GJ6729, and GJ6736. The final scope was determined to be the reported finished goods lot FP7135, fill lot FP7126, and the bulk formulated drug product lot FP6245. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. The final scope was determined to be the reported finished goods lot EW0151, fill lot EP8691, and the formulated drug product lot EP8588. The final scope was determined to be the reported finished goods lot ER8733, fill lot EP8685, and the bulk formulated drug product EP8572. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1686), in left arm, on 13Jan2021 as dose 2, single (Lot number: EJ1686), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Sulfa meds" (unspecified if ongoing), notes: Known allergies: Sulfa meds. Concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event VACCINATION FAILURE  and COVID 19 cannot be ruled out.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/Testing positive for covid; COVID 19 Treatment/Testing 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 70-year-old male patient received BNT162b2 (BNT162B2 NOS), on 24Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/Testing positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Testing positive for covid with headache. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 5 (booster), single (Lot number: GL6665) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 05Apr2023 to 10Apr2023. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 04Mar2021 as dose 2, single (Lot number: EN6202), on 30Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXIN (ongoing). Past drug history included: Codeine, reaction(s): "Known Allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (10Apr2023) Negative, notes: I had tested Negative on 10Apr2023; (16Apr2023) Positive, notes: I had rebound COVID that tested positive on 16Apr2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: On an unspecified date in Apr2023, patient started taking Paxlovid (Lot: GF9578) for COVID-19 treatment and stopped on 07Apr2023.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand: Pfizer / BioNTech; Vaccine dose number: 2 / Vaccine brand other: Moderna; Vaccine dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in right arm and on 01Apr2021 as dose 2, single (Lot number: ER8732) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 03Dec2021 as dose 3 (booster), single (Lot number: O5OH22B), in right arm and on 01Oct2022 as dose 4 (booster), single (Lot number: H35763B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Dec2021, outcome "unknown", described as "Vaccine brand: Pfizer / BioNTech; Vaccine dose number: 2 / Vaccine brand other: Moderna; Vaccine dose number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment from 08Apr2023 to 13Apr2023.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Vaccine brand=Pfizer / BioNTech; vaccine dose number=1/ vaccine brand other=Janssen/ vaccine dose number=2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 13May2021 as dose 2, single (Lot number: 1805020) and on 23Oct2021 as dose 3 (booster), single (Lot number: 1822809) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 016J21-2A) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 22Sep2022 as dose 5 (booster), single (Lot number: AS7162B) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13May2021, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech; vaccine dose number=1/ vaccine brand other=Janssen/ vaccine dose number=2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Pfizer / BioNTech Vaccine lot number was 1805020 (as reported). Known allergies: none.  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: COVID-19, Drug ineffective
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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 31Mar2023 to 05Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 06Apr2023 to 11Apr2023. The patient had no known allergy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.