chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: We have had limited cases of the monovalent Moderna vaccine being administered past the beyond use date; The vaccine was not expired, but was given after it was at refrigeration for more than 30 days; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have had limited cases of the monovalent Moderna vaccine being administered past the beyond use date), PRODUCT STORAGE ERROR (The vaccine was not expired, but was given after it was at refrigeration for more than 30 days) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have had limited cases of the monovalent Moderna vaccine being administered past the beyond use date), PRODUCT STORAGE ERROR (The vaccine was not expired, but was given after it was at refrigeration for more than 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have had limited cases of the monovalent Moderna vaccine being administered past the beyond use date), PRODUCT STORAGE ERROR (The vaccine was not expired, but was given after it was at refrigeration for more than 30 days) 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 EXPIRED PRODUCT ADMINISTERED (We have had limited cases of the monovalent Moderna vaccine being administered past the beyond use date) and PRODUCT STORAGE ERROR (The vaccine was not expired, but was given after it was at refrigeration for more than 30 days).    No concomitant medication information was provided.  The vaccine was not expired, but was given after it was at kept at refrigeration for more than 30 days.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered, No adverse event
Clinical narrative: they have used the refrigerated unpunctured Moderna COVID-19 vaccine beyond 30 days in the refrigerator; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they have used the refrigerated unpunctured Moderna COVID-19 vaccine beyond 30 days in the refrigerator), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (they have used the refrigerated unpunctured Moderna COVID-19 vaccine beyond 30 days in the refrigerator), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they have used the refrigerated unpunctured Moderna COVID-19 vaccine beyond 30 days in the refrigerator), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) 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 EXPIRED PRODUCT ADMINISTERED (they have used the refrigerated unpunctured Moderna COVID-19 vaccine beyond 30 days in the refrigerator) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    Concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2023-699020 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-699020:Bivalent Product
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; The patient received vaccine after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021.  The patient did not report any side effects.  No treatment information was provided by the reporter.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    Concomitant product use was not provider by the reporter.  The vaccines were stored in the fridge on 30-Jun-2021. Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  Treatment information was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 30Jun2021 and administer on 09-Aug-2021.; No adverse event; patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 09-Aug-2021.) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 09-Aug-2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 09-Aug-2021.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 09-Aug-2021.).    No concomitant was reported. 40 patients received the Moderna monovalent vaccines (1st and  2nd doses) after being more than 30 days stored in the fridge. Vaccines were stored in the fridge on 30Jun2021, there were different administration dates, starting on 02Aug2021 until 20Sep2021 being the last one. Patients did not report any side effects.  The case reported for 6 of 31 patient.  No treatment detain was reported.   This case was linked to MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698994:Master case
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 30Jun2021 and administer on 30-Aug-2021.; No adverse event; patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 30-Aug-2021.) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 30-Aug-2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 30-Aug-2021.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 30-Aug-2021.).    No concomitant was reported. 40 patients received the Moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge. Vaccines were stored in the fridge on 30Jun2021, there are different administration dates, starting on 02Aug2021 until 20Sep2021 being the last one. Patients did not report any side effects.  The case reported for 21 of 31 patient.  No treatment detain was reported.   This case was linked to MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-698994:Master case
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; The patient received vaccine after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021.  The patient did not report any side effects.  No treatment information was provided by the reporter.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    Concomitant product use was not provider by the reporter.  The vaccines were stored in the fridge on 30-Jun-2021. Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    Concomitant product use was not provider by the reporter.  The vaccines were stored in the fridge on 30-Jun-2021. Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: didn't feel good; The initial case was missing the following minimum criteria: Other-info not qualifying for AE reporting- Medical information. Upon receipt of follow-up information on 17Jan2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jul2022 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: Covid-19 vaccine (Dose:1, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "didn't feel good".  Additional Information: She already took the first and second dose of the vaccine. She took the second dose she didn't feel good. Caller was asking where she can get the third shot for covid 19 booster shot around her area in [City and state name withheld]. Caller was asking about the availability of the third shot around her area in (city state withheld). She wanted to get the original Pfizer COVID-19 Vaccine instead of the new one. Her last dose was in Jul2022. Her pharmacist told her not to take the Bivalent COVID-19 Vaccine since it's not yet fully developed.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Product physical issue
Clinical narrative: Particulates were found in the prefilled syringe for Prevnar 20/ Prevnar 20- syringe has particulate in the syringe and patient was unable to get vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EJ4559, Expiration Date: Jun2023) for immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2607, Expiration Date: 31Aug2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PHYSICAL ISSUE (non-serious), described as "Particulates were found in the prefilled syringe for Prevnar 20/ Prevnar 20- syringe has particulate in the syringe and patient was unable to get vaccine".  Additional information: Medical assistant requesting stability information on a temperature excursion for Prevnar 13 that went above temperature range for around 30 minutes. Caller was unsure of specific temperature vaccine had reached. First excursion. Unknown if patients received Prenvar 13 and Prevnar 20 after 30 minute lapse in temperature. Reporter confirmed he does not know the temperature reached. Reporter later added in regards to Prevnar 20 it looks like something separate in the the mixture. There were particulates in the prefilled syringe. He shook it like it says too and he still sees the particle. When probed if any patients received the Prevnar 20 with this particulate, initially stated none that he knows of. Later added, he saw it when getting ready to give to a patient. He looked at a couple more of them and saw they all had them. He told the patient he did not feel comfortable to give the vaccine today. They all came from the same lot. He caught it before giving to a patient and this one was not given.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Got a headache for 4-5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "Just had some tiredness"; Bnt162b2 (Dose 2, Single), for COVID-19 immunization, reaction(s): "Just had some tiredness". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Got a headache for 4-5 days".  Additional Information: Reported as, he took the Pfizer-BioNTech COVID-19 Vaccine primary series 1 and 2. He states he just had some tiredness and then received his first Pfizer booster dose and got a headache for 4-5 days, 2nd booster had no side effects.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202300024481 same patient and reporter, different dose and event;
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: taking Paxlovid / covid right now; taking Paxlovid / covid right now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6200, Expiration Date: 30Jun2021) and on 25Mar2021 as dose 2, single (Lot number: EN6204, Expiration Date: Jun2021) at the age of 81 years, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "taking Paxlovid / covid right now". The event "taking paxlovid / covid right now" required emergency room visit. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient had covid right now and wants to treat it with Paxlovid, but she wants to know if this could cause a bad reaction in body. Caller is calling about the pills taken 3 in the morning 3 at night, Paxlovid. She is scared of the pill and doesn't know if will affect her or loose her words again. She knows there is so many things that can go wrong and she does take 3-4 other drugs. She asks is this drug going to hurt her to take Paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026462 Same patient, same product, different dose, different event;US-PFIZER INC-202300026488 Same patient, same product, different dose, different event;
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Dysarthria
Clinical narrative: taking Paxlovid / covid right now; taking Paxlovid / covid right now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6200, Expiration Date: 30Jun2021) and on 25Mar2021 as dose 2, single (Lot number: EN6204, Expiration Date: Jun2021) at the age of 81 years, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "taking Paxlovid / covid right now". The event "taking paxlovid / covid right now" required emergency room visit. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient had covid right now and wants to treat it with Paxlovid, but she wants to know if this could cause a bad reaction in body. Caller is calling about the pills taken 3 in the morning 3 at night, Paxlovid. She is scared of the pill and doesn't know if will affect her or loose her words again. She knows there is so many things that can go wrong and she does take 3-4 other drugs. She asks is this drug going to hurt her to take Paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026462 Same patient, same product, different dose, different event;US-PFIZER INC-202300026488 Same patient, same product, different dose, different event;
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Words started to slur- after 2nd COVID-19 Vaccine; after 5 days came home and took another Pfizer shot and lost her voice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: EN6204, Expiration Date: Jun2021) at the age of 81 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "blood thinner" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose Pfizer COVID-19 Vaccine:, Date Received: 24Feb2021, Lot number: EN6200, Expiration Date: 30Jun2021), administration date: 24Feb2021, when the patient was 81-year-old, for Covid-19 immunization, reaction(s): "brain bleed after 1st COVID-19 Vaccine". The following information was reported: DYSARTHRIA (medically significant), outcome "unknown", described as "Words started to slur- after 2nd COVID-19 Vaccine"; APHONIA (medically significant), outcome "unknown", described as "after 5 days came home and took another Pfizer shot and lost her voice". The events "words started to slur- after 2nd covid-19 vaccine" and "after 5 days came home and took another pfizer shot and lost her voice" required emergency room visit. Clinical course: The pills taken 3 in the morning 3 at night, Paxlovid. She was wondering because she had the Pfizer shots for COVID and had the one and had a brain bleed and after 5 days came home and took another Pfizer shot and lost her voice and had to take to Emergency Room. She was scared of the pill and doesn't know if will affect her or loose her words again. She knows there was so many things that can go wrong and she does take 3-4 other drugs. She asks was this drug going to hurt her to take Paxlovid. The flu shot was after she got home from the brain bleed. The cause of her brain bleed was Eliquis. She had the Pfizer shot a while before the brain bleed and brain bleed was due to her blood thinner. She took next Pfizer shot and her words started to slur. She doesn't want to get her doctor in trouble but she was worried about taking this medication. She received the 2nd vaccine at a hospital and might have been in the Emergency Room where the facility was administering the vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026448 Same patient, same product, different dose, different event;US-PFIZER INC-202300026462 Same patient, same product, different dose, different event;US-PFIZER INC-202300026448 Same patient, same product, different dose, different event;
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Dysarthria
Clinical narrative: Words started to slur- after 2nd COVID-19 Vaccine; after 5 days came home and took another Pfizer shot and lost her voice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: EN6204, Expiration Date: Jun2021) at the age of 81 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "blood thinner" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose Pfizer COVID-19 Vaccine:, Date Received: 24Feb2021, Lot number: EN6200, Expiration Date: 30Jun2021), administration date: 24Feb2021, when the patient was 81-year-old, for Covid-19 immunization, reaction(s): "brain bleed after 1st COVID-19 Vaccine". The following information was reported: DYSARTHRIA (medically significant), outcome "unknown", described as "Words started to slur- after 2nd COVID-19 Vaccine"; APHONIA (medically significant), outcome "unknown", described as "after 5 days came home and took another Pfizer shot and lost her voice". The events "words started to slur- after 2nd covid-19 vaccine" and "after 5 days came home and took another pfizer shot and lost her voice" required emergency room visit. Clinical course: The pills taken 3 in the morning 3 at night, Paxlovid. She was wondering because she had the Pfizer shots for COVID and had the one and had a brain bleed and after 5 days came home and took another Pfizer shot and lost her voice and had to take to Emergency Room. She was scared of the pill and doesn't know if will affect her or loose her words again. She knows there was so many things that can go wrong and she does take 3-4 other drugs. She asks was this drug going to hurt her to take Paxlovid. The flu shot was after she got home from the brain bleed. The cause of her brain bleed was Eliquis. She had the Pfizer shot a while before the brain bleed and brain bleed was due to her blood thinner. She took next Pfizer shot and her words started to slur. She doesn't want to get her doctor in trouble but she was worried about taking this medication. She received the 2nd vaccine at a hospital and might have been in the Emergency Room where the facility was administering the vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026448 Same patient, same product, different dose, different event;US-PFIZER INC-202300026462 Same patient, same product, different dose, different event;US-PFIZER INC-202300026448 Same patient, same product, different dose, different event;
Age: 75.0
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). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Stroke", start date: 2018 (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 "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: still testing positive; Positive, notes: initial positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, Heart rate, Interchange of vaccine products
Clinical narrative: had Covid, got original Covid shots from Pfizer/Caller is half way through Covid and, they gave him Paxlovid for it.; had Covid, got original Covid shots from Pfizer/Caller is half way through Covid and, they gave him Paxlovid for it.; Clarified that caller had 2 Pfizer Covid shots and 1 Moderna shot, probably the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 13Feb2021 as dose 2, single (Lot number: EL3249) at the age of 69 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "extreme peripheral neuropathy" (ongoing). Concomitant medication(s) included: GABAPENTIN taken for neuropathy peripheral (ongoing); TAMSULOSIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had Covid, got original Covid shots from Pfizer/Caller is half way through Covid and, they gave him Paxlovid for it."; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Clarified that caller had 2 Pfizer Covid shots and 1 Moderna shot, probably the booster". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 150/93, notes: it was just elevated; 130/74, notes: When he was at urgent care, they checked his blood pressure and it was 130/74; Unknown results, notes: It is just is loud enough to make him take his blood pressure in the middle of the night; Heart rate: 73; SARS-CoV-2 test: Unknown results, notes: Wife just came home sick with Covid, caller took self test; had Covid, got original Covid shots from Pfizer.  Clinical course: Stopped taking Flomax Saturday, was told not to take it while taking Paxlovid. Clarified that caller is taking Tamsulosin, which is generic for Flomax. Stopped taking it the same days he started the Paxlovid, Saturday, 14Jan2023. Concerned about this because he has 2 other packs of medication left, 4 doses. It said to take it for 5 days. Original Covid shots were Pfizer. Just had 1, couldnt get another one but got the next shot as the Moderna shot. Clarified that caller had 2 Pfizer Covid shots and 1 Moderna shot, Third Dose was Moderna  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
Symptoms: SARS-CoV-2 test
Clinical narrative: had Covid, got original Covid shots from Pfizer/Caller is half way through Covid and, they gave him Paxlovid for it.; had Covid, got original Covid shots from Pfizer/Caller is half way through Covid and, they gave him Paxlovid for it.; Clarified that caller had 2 Pfizer Covid shots and 1 Moderna shot, probably the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 13Feb2021 as dose 2, single (Lot number: EL3249) at the age of 69 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "extreme peripheral neuropathy" (ongoing). Concomitant medication(s) included: GABAPENTIN taken for neuropathy peripheral (ongoing); TAMSULOSIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had Covid, got original Covid shots from Pfizer/Caller is half way through Covid and, they gave him Paxlovid for it."; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Clarified that caller had 2 Pfizer Covid shots and 1 Moderna shot, probably the booster". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 150/93, notes: it was just elevated; 130/74, notes: When he was at urgent care, they checked his blood pressure and it was 130/74; Unknown results, notes: It is just is loud enough to make him take his blood pressure in the middle of the night; Heart rate: 73; SARS-CoV-2 test: Unknown results, notes: Wife just came home sick with Covid, caller took self test; had Covid, got original Covid shots from Pfizer.  Clinical course: Stopped taking Flomax Saturday, was told not to take it while taking Paxlovid. Clarified that caller is taking Tamsulosin, which is generic for Flomax. Stopped taking it the same days he started the Paxlovid, Saturday, 14Jan2023. Concerned about this because he has 2 other packs of medication left, 4 doses. It said to take it for 5 days. Original Covid shots were Pfizer. Just had 1, couldnt get another one but got the next shot as the Moderna shot. Clarified that caller had 2 Pfizer Covid shots and 1 Moderna shot, Third Dose was Moderna  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand=Pfizer / BioNTech/ vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Lot number: GJ665) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 4 (booster), single (Lot number: 005M21A), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Oct2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech/ vaccine brand other=Moderna"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: The patient had No known allergies. He received Paxlovid for COVID-19 treatment from 07Jan2023 to 12Jan2023.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; interchange of vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunization; BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: PF8841) for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 29Mar2021 as dose 1, single (Lot number: 021B21A) and on 26Apr2021 as dose 2, single (Lot number: 048B21A) for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reaction(s): "Known allergies: ampicillin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021, outcome "unknown", described as "interchange of vaccine"; 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: positive COVID test on day 8 of isolation; positive, notes: Treatment of COVID-19. 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.