chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023; No adverse event; She states they administered the Moderna bivalent 2 days after the 30-day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She states they administered the Moderna bivalent 2 days after the 30-day BUD), PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Aug-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (She states they administered the Moderna bivalent 2 days after the 30-day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She states they administered the Moderna bivalent 2 days after the 30-day BUD), PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) 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 EXPIRED PRODUCT ADMINISTERED (She states they administered the Moderna bivalent 2 days after the 30-day BUD) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023).    The patient had Monovalent Moderna vaccine in 2021. It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  The vial did not undergo temperature excursions.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737986 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737986:Same Reporter
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu, Shingles (Shingles), COVID-19 Vaccine (Past vaccines), Prevnar and HEP B. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, Flu, HEP B, Prevnar and Shingles.    In November 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In August 2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: Injection itself was almost sheared; glass part of the vial was sheared off between that and the hub where you would screw the needle on to; it was just this one vial that was broken...It was not administered to a patient; The initial case was missing the following minimum criteria: Product complaint only. Upon receipt of follow-up information on 15Aug2023, this case now contains all the required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), (Lot number: GT6702, Expiration Date: Oct2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Injection itself was almost sheared; glass part of the vial was sheared off between that and the hub where you would screw the needle on to; it was just this one vial that was broken...It was not administered to a patient".  Additional information: The clinic received an order of PREVNAR 20 and when the reporter was opening the package of medication to put into their hands on bin, she noticed that one of the injections, the injection itself was almost sheared, the glass part of the vial was sheared off between that and the hub where you would screw the needle on to. There was nothing wrong with the package itself, but it was like the glass itself was broken at that time. The nurse stated it was not administered to a patient. It was just taken out of the box. All the packages received were intact, but it was just this one vial that was broken. Product Quality Group provided investigation results. Reportability Determination: This is Medical Device Related. Reportability Determination: This complaint for I noticed that one of the injections, the injection itself was almost sheared, the glass part of the vial was sheared off between that and the hub where you would screw the needle on to. There was nothing wrong with the package itself, but as I said it was like the glass itself was broken at that time. for PREVNAR 20V PFS SUSPENSION 0.5MLX10 is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: I became so short of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 at 12:00 as dose 1, single (Lot number: FF8839) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset 09Dec2021, outcome "not recovered", described as "I became so short of breath". The event "i became so short of breath" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnea. Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient walking to her gate at airport, she became so short of breath she had to take a wheelchair for the rest of her trip. Prior to vaccination, patient was not diagnosed with COVID-19.
Sex: M
Vaccine: 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 non-contactable reporter (Physician).  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "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.  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: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Influenza like illness, Somnolence, Vertigo
Clinical narrative: Vertigo; sleepy/feeling sleepy; flu like thing/flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID. The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, single), for COVID-19 Immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy"; Bnt162b2 (Dose: 02, single), for COVID-19 Immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy"; Bnt162b2 (Dose: 03, single), for COVID-19 Immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy"; Bnt162b2 (Dose: 04, single), for COVID-19 Immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 18Aug2023, outcome "recovered" (Aug2023), described as "flu like thing/flu like symptoms"; SOMNOLENCE (non-serious) with onset 18Aug2023, outcome "unknown", described as "sleepy/feeling sleepy"; VERTIGO (non-serious) with onset 21Aug2023, outcome "not recovered". Therapeutic measures were not taken as a result of somnolence, influenza like illness, vertigo.  Additional information: patient had a Pfizer booster on Thursday of last week which is about the seventeenth. The day following that patient was kind of sleepy and with a flu like thing for a little while which is pretty typical, patient've had that before with some of your earlier Pfizer vaccines. But yesterday morning, three days plus later, patient woke up with vertigo which patient still have, patient read online that maybe there is an association. Have you seen that reaction or not? Flu like symptoms: Started about 12 hours after the vaccine, the day after vaccine. Got vaccine 17Aug2023, symptoms started 18Aug2023. Outcome of event: Not still experiencing these symptoms, dissipated pretty quickly, in less than 12 hours. Vertigo: Started yesterday morning, 21Aug2023, when he woke up.  Outcome of event: Has stayed about the same.  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.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Influenza like illness, Somnolence, Vertigo
Clinical narrative: woke up with vertigo; sleepy/feeling sleepy; flu like thing/flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID. The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Aug2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy"; Bnt162b2 (DOSE: 2, SINGLE), for COVID-19 immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy"; Bnt162b2 (DOSE: 1, SINGLE), for COVID-19 immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 18Aug2023, outcome "recovered" (18Aug2023), described as "flu like thing/flu like symptoms"; SOMNOLENCE (non-serious) with onset 18Aug2023, outcome "unknown", described as "sleepy/feeling sleepy"; VERTIGO (non-serious) with onset 21Aug2023, outcome "not recovered", described as "woke up with vertigo". Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient has been administered with Pfizer BioNTech Covid-19 Bivalent booster vaccine on 17Aug2023.  After getting vaccine, patient was feeling sleepy and had flu like symptoms on 18Aug2023 (Started about 12 hours after the vaccine, a day after), and wants to talk to someone with a medical background. The day following that (18Aug2023), patient was kind of sleepy and with a flu like thing for a little while which is pretty typical, Patient had that before with some of the earlier Pfizer vaccines. Outcome of flu like symptoms was reported as not still experiencing these symptoms, dissipated pretty quickly, in less than 12 hours. On 21Aug2023 (yesterday morning, three days plus later), patient woke up with vertigo which he still had it currently. Patient read online that there might be an association and wanted to know whether they have seen that reaction or not.  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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: shellfish (vomit)" (unspecified if ongoing); "Known allergies: shellfish (vomit)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pencillin, reaction(s): "Rash", notes: Known allergies: Penicillin (rash); Percocet, reaction(s): "vomit", notes: Known allergies: Percocet (vomit). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had received Paxlovid as a treatment of COVID-19 on 11Aug2023 to 15Aug2023".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300282577 Same patient, different drug, different event;
Sex: M
Vaccine: 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 (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Scleroderma" (unspecified if ongoing); "Pulmonary fibrosis" (unspecified if ongoing). There were no concomitant medications. 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. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 14Aug2023 to 18Aug2023.  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.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Somnolence
Clinical narrative: sleepy/feeling sleepy; flu like thing/flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy/feeling sleepy"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like thing/flu like symptoms". Additional information: After getting vaccine, had flu like symptoms day after, was feeling sleepy. These things pretty typical, has had this experience with Pfizer vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-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; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Hallucination, auditory, Headache, Pyrexia
Clinical narrative: She was hallucinating/having auditory hallucinations; She had a fever of 102.9; Headache; pain in her stomach and in her side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 17 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HALLUCINATION, AUDITORY (medically significant), outcome "recovered", described as "She was hallucinating/having auditory hallucinations"; PYREXIA (non-serious), outcome "recovered", described as "She had a fever of 102.9"; HEADACHE (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "pain in her stomach and in her side". The patient underwent the following laboratory tests and procedures: Body temperature: 102.9, notes: She had a fever of 102.9. Additional information: Reporter stated, "I am calling for (name withheld) (Patient). Well, I am calling to notify all the reaction that (name withheld) had so that the Pfizer Bivalent Vaccine (COVID-19 Bivalent Vaccine) that she received on 15Aug2023. A night she had a fever of 102.9. She was hallucinating, having auditory hallucinations and she had a headache and she started having stomach pain. Pain in her stomach, yes and in her side, normal side you know, but yeah. The fever lasted two days, might have lasted three days, but she got the day off and it lasted three days. I do not need any help. I do not need any help. I just want to let you know what her side effects are. Her fever is down, she is feeling better, but that was verified and she was hallucinating. She haven't been currently hallucinating and she is not experiencing fever."  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.
Age: 65.0
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 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13May2023 as dose 6 (booster), single (Lot number: 066H22A) at the age of 65 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 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had 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 given from 12Aug2023 to 17Aug2023. No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, 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 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GJ6665), in right arm and on 20May2023 at 14:00 as dose 6 (booster), single (Lot number: GJ3210) at the age of 79 years, in right 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 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2023) Positive; Body temperature: (11Aug2023) 102. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has no known allergies. Began Paxlovid upon testing positive (11Aug2023) with symptoms of 102 fever, aches, cough, headaches and congestion.
Sex: F
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 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown), in right 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 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, 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: first symptoms and positive test; Negative, notes: negative tests 5; Negative, notes: negative tests 5 and 7 days. Therapeutic measures were taken as a result of drug ineffective, covid-19 which Paxlovid treatment was provided from 12Aug2023 to 16Aug2023.  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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, single (Batch/Lot number: unknown) 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: "Hypothyroidism" (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 "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (19Aug2023) Negative, notes: Day 9; (21Aug2023) Positive, notes: Day 11. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 11Aug2023 to 15Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: wrist/ulnar nerve tenderness; This is a spontaneous report received from non-contactable reporter(s) (Physician).  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEURALGIA (non-serious), outcome "unknown", described as "wrist/ulnar nerve tenderness". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: clavicular nodules; This is a spontaneous report received from non-contactable reporter(s) (Physician).  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NODULE (non-serious), outcome "unknown", described as "clavicular nodules".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: clavicular nodules; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NODULE (non-serious), outcome "unknown", described as "clavicular nodules".  Additional information: dose received more than 3.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: cardiac issues.; This is a spontaneous report received from non-contactable reporter(s) (Physician).  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "cardiac issues.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: He said he did get Covid; He said he did get Covid; 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 male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He said he did get Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300283516 same patient, different vaccine dose number, different event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthma, Cough, Hyperhidrosis, Insomnia, Respiratory tract inflammation
Clinical narrative: He said he did get Covid; He said he did get Covid; 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 male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He said he did get Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300283516 same patient, different vaccine dose number, different event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Secretion discharge, Wheezing
Clinical narrative: He said he did get Covid; He said he did get Covid; 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 male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He said he did get Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300283516 same patient, different vaccine dose number, different event;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Moderna/ Dose 5: Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2023 as dose 4 (booster), single (Lot number: 001M21A), in left arm 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2023, outcome "unknown", described as "Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Moderna/ Dose 5: Pfizer."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measure such as Paxlovid from 11Aug2023 to 16Aug2023 was taken as a result of vaccination failure, covid-19. Additional information: The patient took other medication in 2weeks Levothyroxine and Gabapentin.  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, SARS-CoV-2 test
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 38-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: antigen tests and 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.
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: Shortness of Breath; allergy; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID.  A 72-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious) with onset 24Feb2022, outcome "unknown", described as "Shortness of Breath"; HYPERSENSITIVITY (non-serious) with onset 24Feb2022, outcome "unknown", described as "allergy".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Weight, Weight decreased
Clinical narrative: Did not feel well for a few days; lost 95 pounds; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL9267), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pre-diabetic" (not ongoing), notes: no longer a diabetic or pre. No medicine.; "diarrhea" (unspecified if ongoing); "migraine" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bystolic for high blood pressure; Colestipol for diarrhea; Metformin for pre-diabetic . The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Did not feel well for a few days"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost 95 pounds". Relevant laboratory tests and procedures are available in the appropriate section.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: a very serious allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant), outcome "not recovered", described as "a very serious allergic reaction". The patient received the bivalent Pfizer shot and had a very serious allergic reaction that still has not gone away fully. The patient was not sure if she trusts it to get another one. The reporter considers the event as caused by the suspect product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: acthib that was administered a week after the expiration date with no reported adverse event; Initial information received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 1 years old female patient to whom HIB (PRP/T) vaccine [ACT-HIB] that was administered a week after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination.  On 17-Aug-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Frequency: once; Strength: standard) (batch number: UJ739AAA; expiry date: 10-Aug-2023) via intramuscular route in the right thigh for Immunization a week after the expiration date with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event acthib that was administered a week after the expiration date with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administering an expired vaccine to a patient with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient to whom an expired Hib (Prp/T) Vaccine [Act-Hib] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine, Tetanus Vaccine Toxoid (Dtp); Rotavirus Vaccine (Rotavirus Vaccine); Polio Vaccine Inact (Ipv); And Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination.  On 16-Aug-2023, the patient received expired dose 3 at a dose of 0.5 ml of suspect Hib (Prp/T) Vaccine (Frequency: once, strength: standard, expiry date: 10-Aug-2023 and lot UJ739AB) via intramuscular route in the left thigh for immunization (expired product administered) (latency: same day).  It was reported "Medical assistant called saying she has questions on a vaccine that was administered but has already expired. She said that ACT-HIB which expired on 10Aug2023 was administered to a patient on 16Aug2023. She asked what are the guidance regarding this or what are the next steps following the situation? She also asked if they should re-administer the dose and where can they report the situation? This situation is reported as a medication error due to administering an expired vaccine to a patient."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: patient received two doses of Adacel one on 16aug2023 and on 10July 2019,less than 10 years apart with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 year old female patient who received two doses of diphtheria-2/tetanus/5 AC Pertussis Vaccine [Adacel] one on 16aug2023 and on 10july 2019,less than 10 years apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Jul-2019, the patient received a unknown (dose 1) dose of suspect diphtheria-2/tetanus/5 AC Pertussis Vaccine (strength, expiry date and lot number not reported) via unknown route in unknown administration site; On 16-Aug-2023 she also received a dose 2 at dose of 0.5 ml of the same vaccine (strength: standard, frequency: once, expiry date: 18-Aug-2025 and lot U7869AA) via intramuscular route in the left deltoid for immunization. Information on the batch number was requested.  On 16-Aug-2023 the patient received two doses of adacel with in less than 10 years apart with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: given a patient PENTACEL instead of PEDIARIX with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who was given diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/hib(PRP/T) vaccine [Pentacel (Vero)] instead of pediarix with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 05-Aug-2023, the patient received a dose 1 Primary dose 0.5 ml of suspect Suspension for injection of diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/hib(PRP/T) vaccine instead of pediarix (wrong product administered) (Latency: same day) (Batch number: UJ844AA, expiry date: 02-Mar-2024, strength: standard, Frequency: Once) via intramuscular route in the left arm as immunization. First time product used : Yes Still using product : No  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.