chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: POSTMENOPAUSAL BLEEDING; This solicited report received from a health care professional via NON-COMPANY STUDY: No Description Available, concerned a female of unspecified age. This patient was also referenced in literature. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the women received Ad26.COV2-S COVID-19 vaccination. However, they developed postmenopausal bleeding secondary to Ad26.COV2-S vaccine. The action taken with covid-19 vaccine ad26.cov2.s (dose series 1) was not applicable. The outcome of postmenopausal bleeding was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s (dose series 1), and postmenopausal bleeding as related. company causality  was assessed as not related  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:- Postmenopausal haemorrhage. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related.
Sex: U
Vaccine: COVID19, COVID19, UNK
Symptoms: Illness
Clinical narrative: I took the vaccine, both the Moderna's and the Pfizer's and I got sick on all of them, but it only lasted a day and a half; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I took the vaccine, both the Moderna's and the Pfizer's and I got sick on all of them, but it only lasted a day and a half) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I took the vaccine, both the Moderna's and the Pfizer's and I got sick on all of them, but it only lasted a day and a half). At the time of the report, ILLNESS (I took the vaccine, both the Moderna's and the Pfizer's and I got sick on all of them, but it only lasted a day and a half) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   No concomitant medication was reported.  No treatment medication was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Aug-2024 and was forwarded to Moderna on 20-Aug-2024.      This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer vaccine.    In August 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In August 2024, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2024, SARS-CoV-2 test: Positive.         No concomitant medication was reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Dermatitis, Eczema
Clinical narrative: Patient was diagnosed with dermatitis or eczema; Patient was diagnosed with dermatitis or eczema; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Patient was diagnosed with dermatitis or eczema) and DERMATITIS (Patient was diagnosed with dermatitis or eczema) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced ECZEMA (Patient was diagnosed with dermatitis or eczema) and DERMATITIS (Patient was diagnosed with dermatitis or eczema). At the time of the report, ECZEMA (Patient was diagnosed with dermatitis or eczema) and DERMATITIS (Patient was diagnosed with dermatitis or eczema) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Consumer reported that, had a reaction to the Moderna Spikevax booster shot in Aug-2022, as red spots appeared and then spread. Consumer was diagnosed with dermatitis or eczema. Since the treatment did not work, consumer went to naturopaths, medicine practitioners, herbalists. All of these had varying results.  Consumer also mentioned that he/she had never had Eczema, Rashes or any skin condition, but at the end of the day after the Moderna shot he/she still had Eczema.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Patient had a reaction on her arm in December of 2023; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Patient had a reaction on her arm in December of 2023) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058492) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: moderna Covid-19 vaccine (Dose 2) in 2021, moderna Covid-19 vaccine (Dose 1) in 2021, moderna Covid-19 vaccine (Dose 4) in 2022, moderna Covid-19 vaccine (Dose 3) in 2022 and moderna Covid-19 vaccine (Dose 5) in 2023; for Drug use for unknown indication: AMOXICILLIN (every inch of my body had purple spots and urticaria on top of it itchy), AMOXICILLIN (every inch of my body had purple spots and urticaria on top of it itchy), AMOXICILLIN, prednisone and AMOXICILLIN. Past adverse reactions to the above products included Itchy with AMOXICILLIN; No adverse effect with moderna Covid-19 vaccine, moderna Covid-19 vaccine, moderna Covid-19 vaccine, moderna Covid-19 vaccine and moderna Covid-19 vaccine; Tachycardia with prednisone; Tingling feet/hands with AMOXICILLIN; and Urticaria with AMOXICILLIN and AMOXICILLIN.    In 2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE REACTION (Patient had a reaction on her arm in December of 2023). At the time of the report, VACCINATION SITE REACTION (Patient had a reaction on her arm in December of 2023) outcome was unknown.            Patient had a really bad allergic reaction to amoxicillin several decades ago. It was a disaster, head to toe. And then they gave me prednisone to calm It. she was with my husband on his business trip and because she took some vacation time from work to go down and when they were driving home, head to toe, she woke up one morning, every inch of my body had purple spots and urticaria on top of it itchy. Her feet were tingling.  Concomitant product use was not provided by the reporter.  Patient had itchy and it had almost like little kind of like bumps, just a couple on it. Mine was on her arm only with no other symptomatology. it's not systemic. In December it was not systemic means it goes over your whole body but what's to say that my next exposure won't result in a more severe reaction. He said it won't because this is an injection site reaction.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-772979 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-772979:Same patient, different product
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Nodule, Rash
Clinical narrative: bumps on her arm; rashes similar to eczema.; she experienced rashes on her arms, legs, and a few other spots/like rashes on her arms and fingers.; This spontaneous case was reported by a patient and describes the occurrence of NODULE (bumps on her arm), ECZEMA (rashes similar to eczema.) and RASH (she experienced rashes on her arms, legs, and a few other spots/like rashes on her arms and fingers.) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NODULE (bumps on her arm), ECZEMA (rashes similar to eczema.) and RASH (she experienced rashes on her arms, legs, and a few other spots/like rashes on her arms and fingers.). At the time of the report, NODULE (bumps on her arm) and ECZEMA (rashes similar to eczema.) outcome was unknown and RASH (she experienced rashes on her arms, legs, and a few other spots/like rashes on her arms and fingers.) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Dosage text was reported as unknown. Suspect vaccine dosage text was reported as unknown. After getting the booster shot, the patient experienced rashes on her arms, legs, and a few other spots. She had the 1st shot in April. When returned home she noticed bumps on her arm, like rashes on her arms and fingers. The rash had gone after a few hours. Occasionally she had noticed rashes similar to eczema. Reporter causality was not reported.  Treatment information was not provided.
Sex: U
Vaccine: PNC20
Symptoms: Device connection issue
Clinical narrative: Prevnar 20 prefilled syringe (PFS) breaking at the point where the needle attaches to the syringe; The initial case was missing the following minimum  criteria: no adverse event, product complaint only. Upon receipt of follow-up information on 16Aug2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Nurse and a Consumer or other non HCP from medical information team and product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HL3889, Expiration Date: 31May2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE CONNECTION ISSUE (non-serious), outcome "unknown", described as "Prevnar 20 prefilled syringe (PFS) breaking at the point where the needle attaches to the syringe".  The reporter considered "prevnar 20 prefilled syringe (pfs) breaking at the point where the needle attaches to the syringe" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "prevnar 20 prefilled syringe (pfs) breaking at the point where the needle attaches to the syringe" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Sex: M
Vaccine: PNC20
Symptoms: Asthma, Cough, Drug ineffective, Dyspnoea, Malaise
Clinical narrative: pneumonia; pneumonia; asthma; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 80-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE SODIUM taken for rheumatoid arthritis. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "pneumonia"; ASTHMA (non-serious), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, pneumonia, asthma. Clinical course: The husband got Prevnar 20 vaccine about a year ago. He is 80 years old and recently came down with pneumonia.  Caller clarifies the shot was a little over a year ago. They were very surprised; it was in one of the lower parts of the lung and he was put on a powerful drug.  He does also have asthma and was put on high levels of cortisone to undo it all. He still coughs some. States this was about 2 months ago. Caller clarifies it was the first part of Aug.  He was pretty sick; she was worried about him. He was coughing to the point he couldn't get his breath anymore. He went to urgent care twice and then his pulmonologist. He does take methotrexate which is an immune suppressant for rheumatoid arthritis.  His father died in his 80's of multiple pneumonias and she wants to make sure. States that the day he got the shot from his doctor after a visit the doctor said he needed the pneumonia shot. Normally when he gets shots, he stops the methotrexate for a week or so to get his immune system back up and she doesn't think he did that this time. Asking should he get another shot or are they only effective for say 80% cases or what happened here.  She got the shot and didn't get it and was around him and cleaning. States he didn't have a reaction to the shot.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Pneumonia
Clinical narrative: pneumonia; pneumonia; asthma; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 80-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE SODIUM taken for rheumatoid arthritis. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "pneumonia"; ASTHMA (non-serious), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, pneumonia, asthma. Clinical course: The husband got Prevnar 20 vaccine about a year ago. He is 80 years old and recently came down with pneumonia.  Caller clarifies the shot was a little over a year ago. They were very surprised; it was in one of the lower parts of the lung and he was put on a powerful drug.  He does also have asthma and was put on high levels of cortisone to undo it all. He still coughs some. States this was about 2 months ago. Caller clarifies it was the first part of Aug.  He was pretty sick; she was worried about him. He was coughing to the point he couldn't get his breath anymore. He went to urgent care twice and then his pulmonologist. He does take methotrexate which is an immune suppressant for rheumatoid arthritis.  His father died in his 80's of multiple pneumonias and she wants to make sure. States that the day he got the shot from his doctor after a visit the doctor said he needed the pneumonia shot. Normally when he gets shots, he stops the methotrexate for a week or so to get his immune system back up and she doesn't think he did that this time. Asking should he get another shot or are they only effective for say 80% cases or what happened here.  She got the shot and didn't get it and was around him and cleaning. States he didn't have a reaction to the shot.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: headache; administered dose 1 on 11Jan2021 and dose2 on 02Dec2021; This is a spontaneous report received from a Consumer or other non HCP.  A 28-year-old female patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 2, single (Lot number: 33030BD) at the age of 26 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, lot number: FH8030 and expiration date: 30Apr2021 in the right arm), administration date: 11Jan2021, when the patient was 25-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "administered dose 1 on 11Jan2021 and dose2 on 02Dec2021".
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 81-year-old female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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 following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that the Caller had a question regarding the Pfizer Covid19 vaccine latest booster. She wanted to know, how soon after getting a covid infection could she get the next booster shot. She mentioned during the call that she got 5 shots of the covid vaccine (did not indicate the manufacturer), but she had covid, maybe because she had not received a booster dose yet.   Batch/lot number is not provided, and it cannot be obtained.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: dry component (acthib) of the pentacel was mixed with saline solution and given to a patient with no reported adverse event; Initial information received on 16-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 months old male patient for whom  dry component (acthib) of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was mixed with saline solution and given to a patient 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 PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination.  On 15-Aug-2024, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, 0.5 ml TOTAL, Powder and suspension for suspension for injection, expiry- 14-MAR-2025, lot UJ994AA via intramuscular route in the right vastus lateralis for Prophylactic vaccination (Immunisation) (strength unknown) dry component (acthib) of the pentacel was mixed with saline solution and given to a patient with no reported adverse event (single component of a two-component product administered) (latency same day).   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.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Off label use
Clinical narrative: was told by their office manager to get 2 doses of Imovax Rabies vaccines and had off-label use as per local labelling with no reported adverse event; Initial information received on 19-Aug-2024 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who was told by their office manager to get 2 doses of rabies (hdc) vaccine [Imovax Rabies]vaccines and had off-label use as per local labelling with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was told by their office manager to get 2 doses of imovax rabies vaccine Powder and solvent for suspension for injection (Dose, strength, frequency, route, batch number, expiry date, administration site. was unknown) as immunization (off label use) (unknown latency).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was not requested.   Reportedly, She mentioned that she called last week to ask when to get her pre-exposure prophylaxis for IMOVAX RABIES. It has been cleared up and information was emailed to her. After getting off the phone, she was told by their office manager to get 2 doses of those vaccines. However, upon reading the information, she saw that it should be 3 doses in which the 3rd dose should be taken at Day 21 or 28. She called to confirm if IMOVAX RABIES is 3 doses and not 2 doses for pre-exposure prophylaxis.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: the top part of the actual syringe broke off/No patients were administered the Prevnar 20.; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 19Aug2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein)  (PREVNAR 20), as dose number unknown, single (Lot number: LA6406, Expiration Date: 31Dec2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "the top part of the actual syringe broke off/No patients were administered pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein).".  Additional information: The reporter stated that when they attempted to retrieve the dose from the refrigerator, they found the syringe was already broken into two pieces before its use. It was reported that the actual syringe broke off, for the blue cap and it was the actual part of the syringe where it twists into and both of those broke off. The reporter sent two photos of the broken pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein).   Causality for "the top part of the actual syringe broke off/no patients were administered pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein)." was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction).
Sex: F
Vaccine: COVID19
Symptoms: Body height, COVID-19, Drug ineffective, Dysstasia, SARS-CoV-2 test
Clinical narrative: she took 7 Pfizer vaccines/She had tested positive last night; she took 7 Pfizer vaccines/She had tested positive last night; the last one the day after she couldn't stand; This is a spontaneous report received from a Nurse.  A 66-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney stone" (unspecified if ongoing); "kidney stone surgery" (unspecified if ongoing), notes: they removed a big old stone that wouldn't move. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization; Bnt162b2 (Dose: 3 (BOOSTER)), for COVID-19 immunization; Bnt162b2 (Dose: 4 (BOOSTER)), for COVID-19 immunization; Bnt162b2 (Dose: 5 (BOOSTER)), for COVID-19 immunization; Bnt162b2 (Dose: 6 (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she took 7 Pfizer vaccines/She had tested positive last night"; DYSSTASIA (non-serious), outcome "unknown", described as "the last one the day after she couldn't stand". Clinical course: She has gone through in past week daughter getting married and on the way home found out her dear friends mother had passed away. Right before dinner she felt chilled and had fallen asleep in the sun and got sunburned and thought felt chilled. Her arms were bright pink. Around 7-8 she thought oh she has postnasal drip and a tad sore throat, she couldn't tell. She talked to her daughter and was told that others also tested positive for Covid that were at the wedding. Her husband is negative, and she was positive at 9. She goes into panic because she has 2 pregnant daughter in laws and one is high risk. States she has a lot of anxiety; she is an anxious person. She feels fine and he has been sneezing all day. States she took 7 Pfizer vaccines, the last one the day after she couldn't stand, and people said that was fine it was a good response. Caller did not clarify name of product. She is a fan of the vaccine. She has had all of them. Thinks that might be why she doesn't feel that horrible. She will be 67 in a couple of weeks. The patient underwent the following laboratory tests and procedures: Body height: 5 foot 4; SARS-CoV-2 test: Positive; Weight: 128-130 range. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid as treatment.; Sender's Comments: Based on the known drug safety profile, the reported events Drug ineffective, Covid 19 are assessed as related to suspect drug .
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: she took 7 Pfizer vaccines/She had tested positive last night; she took 7 Pfizer vaccines/She had tested positive last night; the last one the day after she couldn't stand; This is a spontaneous report received from a Nurse.  A 66-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney stone" (unspecified if ongoing); "kidney stone surgery" (unspecified if ongoing), notes: they removed a big old stone that wouldn't move. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization; Bnt162b2 (Dose: 3 (BOOSTER)), for COVID-19 immunization; Bnt162b2 (Dose: 4 (BOOSTER)), for COVID-19 immunization; Bnt162b2 (Dose: 5 (BOOSTER)), for COVID-19 immunization; Bnt162b2 (Dose: 6 (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she took 7 Pfizer vaccines/She had tested positive last night"; DYSSTASIA (non-serious), outcome "unknown", described as "the last one the day after she couldn't stand". Clinical course: She has gone through in past week daughter getting married and on the way home found out her dear friends mother had passed away. Right before dinner she felt chilled and had fallen asleep in the sun and got sunburned and thought felt chilled. Her arms were bright pink. Around 7-8 she thought oh she has postnasal drip and a tad sore throat, she couldn't tell. She talked to her daughter and was told that others also tested positive for Covid that were at the wedding. Her husband is negative, and she was positive at 9. She goes into panic because she has 2 pregnant daughter in laws and one is high risk. States she has a lot of anxiety; she is an anxious person. She feels fine and he has been sneezing all day. States she took 7 Pfizer vaccines, the last one the day after she couldn't stand, and people said that was fine it was a good response. Caller did not clarify name of product. She is a fan of the vaccine. She has had all of them. Thinks that might be why she doesn't feel that horrible. She will be 67 in a couple of weeks. The patient underwent the following laboratory tests and procedures: Body height: 5 foot 4; SARS-CoV-2 test: Positive; Weight: 128-130 range. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid as treatment.; Sender's Comments: Based on the known drug safety profile, the reported events Drug ineffective, Covid 19 are assessed as related to suspect drug .
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Adacel exposed to maximum 70F upto undetermined time due to human error with no reported adverse event; products been administered post excursion with no reported adverse event; Initial information received on 19-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to 2024SA248071.  This case involves Adult and unknown gender patient who received Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] exposed to maximum 70f upto undetermined time due to human error with no reported adverse event and products been administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) , Concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and adacel exposed to maximum 70f upto undetermined time due to human error with no reported adverse event (product storage error) (unknown latency) and products been administered post excursion with no reported adverse event (poor quality product administered) (latency: same day). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  Reportedly "MIS (abbreviation not known) discussed stability excursions, noting that both temperature and duration of excursion is needed to determine suitability for use. Discussed use of a vaccine not suitable for use. She states that they received a shipment of 2 boxes of ADACEL on Friday, 16aug2024 at 1601. It was delivered to the front desk. It was not immediately opened. When it was opened on 19aug2024, at 0800, the vaccines were "still cold" but the "dry ice" was melted. She states that shipments usually have a "temperature tracker" but this particular box did not contain one. Approximately 64 hours elapsed between delivery of shipment and vaccines being returned to refrigeration. She states that 2 patients received the vaccine this morning already. Have products been administered post excursion: Yes "   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.; Sender's Comments:  US-SA-2024SA248071:02186178
Sex: F
Vaccine: TYP, TYP
Symptoms: Medication error, No adverse event
Clinical narrative: ultimately decided that due to a travel deadline, it was more expedient to get the typhim vi vaccine instead with no reported adverse event; Initial information received on 20-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who ultimately decided that due to a travel deadline, it was more expedient to get the TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2024, the patient received TYPHOID VI POLYSACCHARIDE VACCINE Solution for injection via unknown route in unknown administration site for Immunization (strength, dose, batch number and expiry date unknown)ultimately decided that due to a travel deadline, it was more expedient to get the vaccine instead with no reported adverse event (wrong product administered) (latency same day).  Information on batch number corresponding to the one at time of event occurrence was requested.   Reportedly, Vivotif oral Typhoid vaccine had been out of refrigeration for 4 or 5 days. So in the interest of making sure patient was immunized prior to departure, consumer had gone in for the TYPHIM VI injection instead.  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: 75.0
Sex: F
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: Pentacel accidentally administered to an adult patient instead of Adacel with no reported adverse event; Initial information received on 20-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 75 years old female patient where diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] accidentally administered to an adult patient instead of diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Aug-2024, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Powder and suspension for suspension for injection (strength- standard) (lot- UK023AA and expiration date- 30-APR-2025) via unknown route in the right deltoid (route- not provided) for immunization and a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection in pre-filled syringe lot number not reported (dose, strength, lot/batch number and expiration date: not provided) for Immunisation (wrong product administered) (latency- same day).  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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: sterile water diluent instead of the 0.4% sodium chloride diluent to mix and immediately administer acthib with no reported adverse event; Initial information received on 20-Aug-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient where sterile water diluent was given instead of the 0.4% sodium chloride diluent to mix and immediately administer HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (product preparation error) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  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.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an Ipol shot using an Ipol MDV that was first punctured July 1, 2024 with no adverse event; Initial information received on 20-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age male patient who received an IPV (VERO) [IPOL] shot using an ipol mdv that was first punctured july 1, 2024 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received IPV (VERO), Suspension for injection, expiry-10-Feb-2025 lot W1A101M via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, dose unknown) using an ipol mdv that was first punctured july 1, 2024 with no adverse event (poor quality product administered) (same day latency).   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: M
Vaccine: HPV9, IPV, MNQ, TDAP
Symptoms: Confusional state, Dizziness, Immediate post-injection reaction, Loss of consciousness, Seizure
Clinical narrative: The patient received three vaccines in the Right Deltoid and I moved to the Left Deltoid to administer the last two.  He seemed fine and I gave the Meningitis B vaccine and then gave the Gardasil 9 vaccine.  He immediately fainted and started convulsing a little and slipped down in the chair a couple inches.  I caught him and he did not fall.  Less than 30 seconds later he regained consciousness and was a bit confused as to why I was holding him upright and why his mother was now in front of him looking worried.  He said water so I went to grab the cold water bottles we keep for such situations.  I returned with the water seconds later.  I asked if he would like to lay down.  He nodded and I guided him to the exam table.  I called the interpreter line to explain to the mom that it was a common reaction to getting the meningitis vaccines and the HPV vaccine.  Especially if they did not eat beforehand.  I did find out he did not eat yet today.  I relayed that he was going to be fine in a few minutes but that we were going to let him rest a bit.  He sat up a few minutes later and then laid down again and did this a couple times.  I asked what his other symptoms were and he said he was dizzy.  I asked if he would like something to nibble on and brought him some crackers.  He rested for a bit more until his answer to my checking up on him was that he thought he felt ok.  He ambulated on his own beside his mother at 12:32.
Age: 16.0
Sex: M
Vaccine: HPV9, IPV, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: The patient received three vaccines in the Right Deltoid and I moved to the Left Deltoid to administer the last two.  He seemed fine and I gave the Meningitis B vaccine and then gave the Gardasil 9 vaccine.  He immediately fainted and started convulsing a little and slipped down in the chair a couple inches.  I caught him and he did not fall.  Less than 30 seconds later he regained consciousness and was a bit confused as to why I was holding him upright and why his mother was now in front of him looking worried.  He said water so I went to grab the cold water bottles we keep for such situations.  I returned with the water seconds later.  I asked if he would like to lay down.  He nodded and I guided him to the exam table.  I called the interpreter line to explain to the mom that it was a common reaction to getting the meningitis vaccines and the HPV vaccine.  Especially if they did not eat beforehand.  I did find out he did not eat yet today.  I relayed that he was going to be fine in a few minutes but that we were going to let him rest a bit.  He sat up a few minutes later and then laid down again and did this a couple times.  I asked what his other symptoms were and he said he was dizzy.  I asked if he would like something to nibble on and brought him some crackers.  He rested for a bit more until his answer to my checking up on him was that he thought he felt ok.  He ambulated on his own beside his mother at 12:32.
Age: 44.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient requested covid vaccine, but received flu vaccine. Received same vaccine 8/24/2024 at pharmacy. No side effects reported at time of vaccination.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient requested covid vaccine, but received flu vaccine. Received same vaccine 8/24/2024 at pharmacy. No side effects reported at time of vaccination.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Influenza vaccine given inadvertently a second time in same season. No signs/symptoms
Age: 36.0
Sex: F
Vaccine: FLUR4
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: VACCINE GIVEN AROUND 2:20PM, PT REPORTED VOMITING, DIARRHEA, AND CHILLS AROUND 6:00 PM THE SAME DAY
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered too early. Not due until age 4. Child is 3 years old.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: At approximately 5:15 PM on 08/27/24, patient was inadvertently administered Tdap vaccine too early in catch up schedule. Vaccine should not have been administered until 01/15/25. Patient tolerated vaccine fine with no symptoms.
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Administered 0.5mL intradermally instead of 0.5mL SQ or 0.1mL intradermally as appropriate
Age: 1.08
Sex: M
Vaccine: HEPA
Symptoms: Rash, Rash papular
Clinical narrative: 24 HOURS AFTER ADMINISTRATION; MOTHER OF PATIENT STATES THAT THE PATIENT HAD TOTAL BODY RASH THAT WHERE RAISE AND SWOLLEN IN NATURE. MOP TOOK PT TO A LOCAL URGENT CARE WHERE BENADRILY WAS GIVEN AND IMPORVED. MOTHER OF PATIENT STATES THAT SHE F/U WITH DOCTOR AND WAS SSENT TO ALLERGIST BUT STATES THAT PT WAS TOO YOUNG START TESTING FOR HEP A ALLERGIES.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PT STATES THAT HIS ARM HAS BEEN ACHEY AT THE INJECTION SITE ON AN OFF SINCE HE RECEIVED THE VACCINE.  THE VACCINATION ITSELF DID NOT HURT BUT HIS ARM HAS ACHED ON AND OFF SINCE.
Age: 11.0
Sex: F
Vaccine: FLUC3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event double flu shot given
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Rash erythematous, Swelling
Clinical narrative: Patient received a flu and Moderna COVID vaccine. A few hours later patient reported an anaphylactic reaction that included throat swelling, and red bumps. The patient went to the ER for treatment. The patient has had Pfizer COVID vaccines before but not Moderna. He always get a flu vaccine.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Skin infection
Clinical narrative: Pt. recieved a flu shot and developed redness around injection site. it did not go away after a few days and she went to the doctor who said she had a skin infection cellulitis on the arm that she had the vaccine in.
Age: 5.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Grabbed HIB vaccine instead of Hep B by accident.  Pt did not experience any symptoms and the guardian of the pt did not see any unusual symptoms or reactions after administration. Provider also assessed the pt in office and advised guardian for signs and symptoms.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: Patient received flu immunization into the right deltoid from pharmacist on 8/8/2024. Said he had regular localized muscle pain from the shot for a few days but then it kept getting worse. Progressed to numbing all through arm into thumb. Cannot lift shoulder past 90 degrees without shaking/stablizing. Pain shoots into the right shoulder blade as well. Still tender at spot immunization was given.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: PATIENT ASKED TO GET A FLU SHOT TODAY SO WE PROCESSED AND ADMINISTERED. BUT THEN I REALIZED AFTER SHE GOT A FLU SHOT LAST MONTH ON 7/24. WHEN I SPOKE TO THE PT, SHE THOUGHT WHAT SHE HAD LAST MONTH WAS COVID. DUPLICATE SHOTS GIVEN
Age: 27.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Patient was not supposed to get his third Twinrix yet. IT has only been 60 days from his first dose, and was actually supposed to be due for a different vaccine at the time he came in. He was given another Twinirx at an inappropriate time interval.
Age: 51.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthropathy, Wrong technique in product usage process
Clinical narrative: The patient reports after having these immunizations, both shoulders stopped worked. They report the vaccine was administered incorrectly and spent nearly a year in physical therapy. The right shoulder remains to have lingering symptoms, although has improved.