chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, SARS-CoV-2 test, Sinusitis
Clinical narrative: I have only had one prior to this/sinus/ear infections; I have only had one prior to this/sinus/ear infections; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma, controlled" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer: Unknown), administration date: 17Feb2021, when the patient was 52-year-old, for COVID-19 Immunization. The following information was reported: SINUSITIS (non-serious), EAR INFECTION (non-serious) all with onset 2021, outcome "unknown" and all described as "I have only had one prior to this/sinus/ear infections". The event "i have only had one prior to this/sinus/ear infections" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinusitis, ear infection.  Additional information: Reported that, Patient had no known allergies. The patient later received dose 3, BNT162B2 (Lot number: ff8841) in right arm on 09Oct2021 at 12:00. Patient has had 8 major sinus/ ear infections since taking the vaccine and has only had one prior to 3rd vaccine. The treatment taken for adverse events was reported as antibiotics every time. The patient has not taken other vaccines in four weeks. The patient had no COVID prior vaccination and has not been tested for COVID prior to vaccination.  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-202300146065 Same patient, same reporter, same vaccine, different dose, different events;
Sex: U
Vaccine: PNC20
Symptoms: Hypersensitivity, Pruritus, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: my upper arm itched like crazy; some swelling and pain at the injection site; some swelling and pain at the injection site; still warm to the touch; mild allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30Mar2023 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: PRURITUS (non-serious) with onset 31Mar2023, outcome "recovering", described as "my upper arm itched like crazy"; HYPERSENSITIVITY (non-serious) with onset 2023, outcome "recovering", described as "mild allergic reaction"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2023, outcome "recovering" and all described as "some swelling and pain at the injection site"; VACCINATION SITE WARMTH (non-serious) with onset 2023, outcome "recovering", described as "still warm to the touch".  Additional information: The patient reported that 'In the late afternoon on Friday, throughout Saturday (31Mar2023), and lessening on Sunday, my upper arm itched like crazy. And due to some swelling and pain at the injection site, when the itch was close to the site, I uttered things like, "gaaahhhh, not fun." This morning it's better, but still warm to the touch. Was this a mild allergic reaction and should I be made aware of ingredients for future reference?'.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Menstrual disorder
Clinical narrative: got Covid; got Covid; changes in her cycles; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 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), 2 months after the suspect product(s) administration, outcome "unknown", described as "got Covid"; COVID-19 (medically significant), 2 months after the suspect product(s) administration, outcome "unknown", described as "got Covid "; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "changes in her cycles".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events drug ineffective, Covid-19 and the suspect  product BNT162b2.(COMIRNATY).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown". Clinical course: Patient got fully vaccinated then she got boosted twice and she still wound up got covid-19 twice so as of this moment she do not saw the point and got another booster, all honesty was God almighty means for her to get sick with covid again she was going to get sick with covid again whether or not she had boosted herself with getting one of the shots from her doctor.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An adult 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), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown". Clinical course: Patient had covid after being vaccinated  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: Atrial fibrillation; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): MOD-2023-718093 (Moderna).  An adult male patient received BNT162b2 (BNT162B2), on 03Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, her husband has received 2 doses the Pfizer COVID 19 vaccine for the primary series), for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 2, SINGLE, her husband has received 2 doses the Pfizer COVID 19 vaccine for the primary series), for COVID-19 IMMUNIZATION. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2022, outcome "unknown". The event "atrial fibrillation" required physician office visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: his heart is still not right per a cardiogram. Therapeutic measures were taken as a result of atrial fibrillation. Clinical course: Caller states that she is calling on behalf of her husband who is the patient. She says that her husband has received 2 doses the Pfizer COVID 19 vaccine for the primary series as well as one booster dose of Pfizer. His last booster was on 03Mar2022. She mentions that approximately 8 months after received the Pfizer booster, his husband developed atrial fibrillation. Caller states that she does not think there is any correlation of the a-fib with the Pfizer vaccine. They met with the cardiologist today who is advocating receiving the Moderna COVID-19 bivalent booster dose for the patient at this time as his heart is still not right per a cardiogram that was done today. The patient is having a hard time breathing all the way in deeply due to the atrial fibrillation. Patient has been put on Eliquis and Metoprolol for the a-fib.  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-202300145124 same paitent, different drug/event.;
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: achy and tired 24 hours; achy and tired 24 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient 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: FATIGUE (non-serious), PAIN (non-serious), outcome "recovered" and all described as "achy and tired 24 hours".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema, Scratch, Wound haemorrhage
Clinical narrative: was scratching my legs until they bleed again; Again began having moderate to severe eczema; was scratching my legs until they bleed again; Condition aggravated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 19Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SNGLE), administration date: 12Mar2021, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 23Oct2021, for COVID-19 immunization, reaction(s): "moderate to severe itching on my lower legs/moderate to severe eczema/began by presenting in my lower legs and on my scalp, and has now started presenting in my forearms and my buttocks", "Scratching my legs until they bleed", "Scratching my legs until they bleed"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 16Apr2022, for COVID-19 immunization. The following information was reported: ECZEMA (non-serious) with onset Mar2023, outcome "not recovered", described as "Again began having moderate to severe eczema"; CONDITION AGGRAVATED (non-serious) with onset Mar2023, outcome "not recovered"; WOUND HAEMORRHAGE (non-serious), SCRATCH (non-serious) all with onset Mar2023, outcome "not recovered" and all described as "was scratching my legs until they bleed again". Therapeutic measures were taken as a result of wound haemorrhage, eczema, scratch, condition aggravated.  Additional information: Approximately 6 months (Mar2023) after third Pfizer Booster, Patient again began having moderate to severe eczema, and was scratching my legs until they bleed again. She decided to use Benadryl ACI 25mg tablets this time (Over the Counter), taking 2 at night, but these proved ineffective for her problem. She researched hydroxyzine HCL and discovered that another over the counter alternative was Zyrtec (cetirizine), a second-generation antihistamine, which was chemically similar to hydroxyzine, but has much less of a sedative effect. She had taken one 10mg tablet at night, as needed, and had had relief from the eczema. She had never suffer from eczema in her life, until after the Pfizer vaccinations and boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200112487 same reporter/drug/patient, different dose (Dose 3);
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got COVID even though I was vaccinated; I got COVID even though I was vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An elderly 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID even though I was vaccinated". Clinical course: Unknown Title: Creative Spark Testing 2023. Unknown name: Covid-19 Patient Community for 2023. Vendor name (privacy). Patient identifier: Respondent Serial private. Age group: Elderly (greater and equals to 65 years). Age was unknown. Reported that got covid after vaccine. About her own covid journey and the fact that she got covid even though she was vaccinated and praised God for the vaccine because without it, she believed she wouldn't be here. It was unknown if the reporter considered 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.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I did eventually still get COVID in spite of all the COVID vaccines I've gotten; I did eventually still get COVID in spite of all the COVID vaccines I've gotten; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (had several doses of various Pfizer COVID vaccines), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I did eventually still get COVID in spite of all the COVID vaccines I've gotten". Clinical course: It was reported that the patient already had several doses of various Pfizer COVID vaccines so she didn't need to be sold on the efficacy of the current booster. She would probably try to get further COVID vaccine boosters (when they appear) from Pfizer. However she did eventually still get COVID in spite of all the COVID vaccines she had gotten; so they're not foolproof; nor did she agree with everything Pfizer does as a company.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: i got deep blood clots in my leg 10 days after getting the booster shot.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Unknown Manufacturer), for COVID-19 IMMUNIZATION. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "i got deep blood clots in my leg 10 days after getting the booster shot.". Therapeutic measures were taken as a result of thrombosis.  Clinical course: The patient got deep blood clots in her leg 10 days after getting the booster shot. It was reported that If she had any of these ailments she was at a higher risk of being sicker with covid. She was very much for the vaccines until a friend had a heart attack after one of her vaccine shots, Dr said she had long thick big blood clots that caused her to have the heart attack, she too had big block clots in her leg. Patient also stated that "Had to pay a lot of money for ELIQUIS Med, on it for 3 months. I was blessed to not have had an a bad heart or lung complication that could have been fatal".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: That I got COVID anyway after getting the vaccination. The vax made me sick as well.; That I got COVID anyway after getting the vaccination. The vax made me sick as well.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An adult male 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "That I got COVID anyway after getting the vaccination. The vax made me sick as well."  Clinical course: it was reported That I got covid anyway after getting the vaccination. The vax made me sick as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain in the left arm; left shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 05May2021 as dose 2, single (Lot number: EW0182) at the age of 47 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Site: Arm left, Route of administration: Intramuscular, Batch/Lot number: Pfizer/er8731), administration date: 14Apr2021, when the patient was 47-year-old, for Covid-19 immunization, reaction(s): "I get really sick", "I could not move for two days". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in the left arm"; ARTHRALGIA (non-serious), outcome "not recovered", described as "left shoulder pain". The events "pain in the left arm" and "left shoulder pain" required emergency room visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: After dose 2, the patient felt pain in the left arm, after a few months it got worse with left shoulder pain and he  ended up going to the urgent care and they gave him medication it help him a little bit and he still have (as reported) arm and shoulder pain. There was no relevant tests, no concomitant drugs, no prior vaccinations, no medical history. Specific Relevant Test For Thromboembolic Events with Thrombocytopenia : None; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107482 same patient, different dose/event;
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death/Passed away at home after having a COVID shot; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP).  An 80-year-old female patient received BNT162b2 (BNT162B2 NOS), on 04Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation; treprostinil sodium (TYVASO), since 03Nov2022 (Lot number: 000321P, Expiration Date: 30Apr2024) at 64 ug 4x/day, nasal for pulmonary arterial hypertension; treprostinil (TREPROSTINIL), first regimen (Batch/Lot number: unknown) at 64 ug 4x/day and second regimen since 03Nov2022 (Batch/Lot number: unknown), all nasal for pulmonary arterial hypertension. The patient's relevant medical history included: "Pulmonary arterial hypertension" (ongoing), notes: Current Condition. Concomitant medication(s) included: OPSUMIT. The following information was reported: DEATH (death, medically significant) with onset 2023, outcome "fatal", described as "death/Passed away at home after having a COVID shot". The patient date of death was 2023. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: Report received from a consumer's spouse from a patient support program via (pharmacy name). Passed away at home after having a COVID shot.  The reporter did not provide causality for the event of death. Case Comment/Senders Comment: The company has assessed the serious adverse event of death as not related to treprostinil inhalation powder and Tyvaso DPI inhaler. The event was likely due to progressive and life limiting nature of underlying PAH (Pulmonary hypertension).  The reporter's assessment of the causal relationship of "death/passed away at home after having a covid shot" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information the causal role of suspect product cannot be excluded for reported event. Case will be reviewed on receipt of FU information The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: started spotting every week with her menstrual cycle, and then eventually one night bled so much that she felt as though she was hemorrhaging; started spotting every week with her menstrual cycle; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient in her 40's (unknown if pregnant) received BNT162b2 (BNT162B2), in 2021 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: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "started spotting every week with her menstrual cycle, and then eventually one night bled so much that she felt as though she was hemorrhaging"; INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "started spotting every week with her menstrual cycle".  Additional information: Description of Event: The doctor was a female patient in her 40s. She states that after receiving the primary series in 2021 that she started spotting every week with her menstrual cycle, and then eventually one night bled so much that she felt as though she was hemorrhaging. It occurred one month after she completed the primary series. Stated that she was completely regular prior to this and prior to receiving the primary series. She said a lot of female doctors she talked to noticed the same.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have Covid-19/Symptoms are mild. Dry throat runny nose a little cough. A bit lethargic; I have Covid-19/Symptoms are mild. Dry throat runny nose a little cough. A bit lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have Covid-19/Symptoms are mild. Dry throat runny nose a little cough. A bit lethargic".  Clinical information: The patient reported that she learned yesterday that he has Covid-19. Symptoms are mild. Dry throat runny nose a little cough. A bit lethargic. She received Pfizer Covid vaccine and all boosters shortly after CDC announced use for my age group.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247783 same patient, different dose/event;US-PFIZER INC-PV202200060088 same patient, different dose/event;
Age: 79.0
Sex: F
Vaccine: DT
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was administered DT today instead of Td, with no reported adverse evet; Initial information received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 79 years old female patient who was administered DIPHTHERIA-25/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE today instead of td, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-APR-2023 (latency: same day) the reporter reported a non-serious patient was administered dt today instead of td, with no reported adverse evet (wrong product administered) in the right deltoid (with lot C5864AA, dose 0.5 mL, 1X, expiry date 07-APR-2023, unknown strength, formulation, route) for wound treatment.  No relevant lab data was reported.  Action taken: Not Applicable.  Outcome: Unknown.     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: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently gave a two-year-old the Quadracel vaccine with no reported adverse event; Initial information was received on 05-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient to whom nurse inadvertently gave DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] vaccine 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 HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 30-Mar-2023, the patient received 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, suspension for injection (lot C6002BAand expiry 18-May-2024) (strength,: unknown) via intramuscular route in the left thigh prophylactic vaccination (immunization).  On 30-MAR-2023 the patient developed a non-serious inadvertently gave a two-year-old the quadracel vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency same day)  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently gave a two-year-old the quadracel vaccine 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 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: 14.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: daptacel was given to 14 year old with no reported adverse event; Initial information received on 05-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 years old and unknown gender patient who was given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] to 14 year old 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 reporter reported a non-serious DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE was given to 14 year old with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) (with dose, strength, formulation, lot number and expiry date not reported) via unknown route in unknown administration site for immunization.   No relevant lab data was reported.  Action taken: Not Applicable.  Outcome: Unknown     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: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient being administered YF-VAX that was not reconstituted with supplied diluent and a different sodium chloride diluent was used instead with no reported adverse event; Initial information received on 05-Apr-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered yellow fever vaccine - [YF-VAX] that was not reconstituted with supplied diluent and a different sodium chloride diluent was used instead 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 administered unknown dose of suspect yellow fever vaccine, solution for injection (strength; unknown) (Lot number:UJ683AA,Expiration Date :15-Sep-2023) via unknown route in unknown administration site for immunization that was not reconstituted with supplied diluent and a different sodium chloride diluent was used instead with no reported adverse event (product preparation error) (latency; on same day).  Action taken : not applicable.  Outcome: Unknown.   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: 10.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Per vaccinator administered 1.5 mL of Pedi pfizer Bivalent vaccine. Per vaccinator administered incorrect dose of Pedi pfizer Bivalent.  According to the manufacture the Pedi Pfizer Bivalent dose is 0.2ml after diluent reconstitution. No adverse reaction noted while in postvaccination.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid 19 positive antigen test on Jan 1,2023.   This was 86 days after vaccination.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Chills, Fatigue, Headache, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Shakiness-Severe
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling, Lethargy, Pain, Pyrexia
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Shakiness-Severe
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Tremor
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Shakiness-Severe
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Phobia, Suspiciousness
Clinical narrative: Systemic: pt said he's now having phobias and suspicions and other symptoms but would not clarify further-Severe, Additional Details: Pt was very angry when he called on 4/3/23 and said after he received the vaccine on 6/18/2022 he went home and took a nap and after he woke up is when the symptoms began and they have continued since then. He said his symptoms include phobias and being suspicious. He said there are other symptoms, but when I asked for more details he said no.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Eye pruritus, Hypoaesthesia oral, Paraesthesia oral, Pruritus
Clinical narrative: At approximately 2:10pm, staff member received his second dose of Hepatitis B vaccine Heplisav B 0.5mL in his left deltoid.   At approximately 230pm, I was notified client was having a reaction in the bathroom. When I walked in and observed him, he had redness on his body had removed most of his clothing. He complained of itchiness all over his body,  Gave client two 25mg of Diphenhydramine HCl capsules.  After 10 mins, he was not getting any relief and started to shake from his ?itchiness? and urticaria presented on his chest, back, and arms.   911 was called   While waiting for EMS, client complained that his lips were starting to tingle and were going numb. He also stated he was having some irritation in his throat and his eyes were itching uncontrollably.   Administered one 0.3 Mg of Epinephrine via auto-inject pen.   EMS arrived and at 3pm,  client  was transported him to Hospital ER for observation.   Approximately 2 hours later, client was released from the ER observation. No additional follow-up was needed or recommended.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Throat irritation, Tremor, Urticaria
Clinical narrative: At approximately 2:10pm, staff member received his second dose of Hepatitis B vaccine Heplisav B 0.5mL in his left deltoid.   At approximately 230pm, I was notified client was having a reaction in the bathroom. When I walked in and observed him, he had redness on his body had removed most of his clothing. He complained of itchiness all over his body,  Gave client two 25mg of Diphenhydramine HCl capsules.  After 10 mins, he was not getting any relief and started to shake from his ?itchiness? and urticaria presented on his chest, back, and arms.   911 was called   While waiting for EMS, client complained that his lips were starting to tingle and were going numb. He also stated he was having some irritation in his throat and his eyes were itching uncontrollably.   Administered one 0.3 Mg of Epinephrine via auto-inject pen.   EMS arrived and at 3pm,  client  was transported him to Hospital ER for observation.   Approximately 2 hours later, client was released from the ER observation. No additional follow-up was needed or recommended.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: Patient was administered an over diluted dose of Pfizer covid vaccine. No signs or symptoms of reaction reported, patient is due to be boosted.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There was no adverse outcome. The patient received an unnecessary dose of polio vaccine along with the intended Dtap. Mother denied that pt had fever, H/A, fussiness or other symptoms when I called her the next day.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Feeling abnormal, Insomnia, Lethargy, Pyrexia, Rash erythematous
Clinical narrative: On 4/6/23 Pt. woke up covered in red spots, slightly raised,  no heads/swelling/peeling, and he had a 101.1 fever.  He would only take formula and some water.  We did not administer any medicine.  That night, he was really hot, had trouble sleeping, and a temp of 100.4.  The morning of 4/7/23, his spots turned into large patches of red all over his body, including face, tops of hands, and tops of feet, still slightly raised, and very hot to touch.  He barely had any areas that weren?t red.  His fever peaked at 102.7 and he was very lethargic, wouldn?t nap, and obviously felt bad .  I gave Tylenol once that evening and a cool bath.  He slept a little better that night.  This morning, 4/8/23, his fever is gone, he?s acting a bit better, and most of the redness is lightened and no longer raised or hot.  The doctor was closed during this because of holiday/weekend; we almost went to the ER.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash papular, Skin warm
Clinical narrative: On 4/6/23 Pt. woke up covered in red spots, slightly raised,  no heads/swelling/peeling, and he had a 101.1 fever.  He would only take formula and some water.  We did not administer any medicine.  That night, he was really hot, had trouble sleeping, and a temp of 100.4.  The morning of 4/7/23, his spots turned into large patches of red all over his body, including face, tops of hands, and tops of feet, still slightly raised, and very hot to touch.  He barely had any areas that weren?t red.  His fever peaked at 102.7 and he was very lethargic, wouldn?t nap, and obviously felt bad .  I gave Tylenol once that evening and a cool bath.  He slept a little better that night.  This morning, 4/8/23, his fever is gone, he?s acting a bit better, and most of the redness is lightened and no longer raised or hot.  The doctor was closed during this because of holiday/weekend; we almost went to the ER.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Discharge, Fatigue, Hypersensitivity, Mobility decreased
Clinical narrative: Vaccine was 10-1-22, event was 3-1-23, is this really relavent? 2 days dry annoying cough, day 3 added sore throat and cough is getting more frequent and wetter added mucinex cold and flu liquid, day 3-5 gradually more coughing and somewhat productive, throat more sore, feeling gradually worse like 75%, Day 5 really tired and not want to get out of bed and seek out doctor, day 5 given zpack and steroid for 7 days continued mucinex as needed.  after med dose over, continued mucinex and added Allegra 24 hour to handle allergy type symptoms, after 4 more days went back to urgent care with more sinusitis symptoms and given a bigger antibiotic for 7 days.  after med does much better.  after 5 weeks still drainage and some light cough, back to 99%
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Productive cough, SARS-CoV-2 test negative, Sinusitis
Clinical narrative: Vaccine was 10-1-22, event was 3-1-23, is this really relavent? 2 days dry annoying cough, day 3 added sore throat and cough is getting more frequent and wetter added mucinex cold and flu liquid, day 3-5 gradually more coughing and somewhat productive, throat more sore, feeling gradually worse like 75%, Day 5 really tired and not want to get out of bed and seek out doctor, day 5 given zpack and steroid for 7 days continued mucinex as needed.  after med dose over, continued mucinex and added Allegra 24 hour to handle allergy type symptoms, after 4 more days went back to urgent care with more sinusitis symptoms and given a bigger antibiotic for 7 days.  after med does much better.  after 5 weeks still drainage and some light cough, back to 99%
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Back pain, Vaginal haemorrhage
Clinical narrative: Constant spotting from viginia since vaccination.  Pain in ovaries and lower back.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Respiration abnormal, Syncope, Vomiting
Clinical narrative: Patient fainted 5 minutes after vaccine administration. When patient fainted, I got him down to the floor and got his legs elevated on a chair. I brought him a paper bag to breathe in to until his breathing slowed and then checked his blood pressure until it came back up to normal. I then helped him back up into a chair and get him some water and a snack. Patient then vomited about 5 minutes later, we got that cleaned up, he waited his 15 minutes, felt better and went home. I called him this morning to see how he was doing and he said he felt just fine and thanked me for checking in on him
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria physical
Clinical narrative: Urticaria related to heat and exercise appeared a few days after bivalent booster shot.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Confusional state, Memory impairment, Pyrexia
Clinical narrative: Patient states that on 4/16 she became very confused and was unable to even remember her name or DOB. She also reports a fever. She said the symptoms resolved within 24 hours. She does remember this happening with the initial covid vaccine but she didnt report. She also had this occur with a live flu vaccine many years ago.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Myocarditis, Peripheral swelling, Thrombosis, Ventricular tachycardia
Clinical narrative: Myocarditis, sudden weight gain, blood clot, left leg swelling
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Myocarditis, sudden weight gain, blood clot, left leg swelling
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac monitoring, Echocardiogram, Supraventricular tachycardia
Clinical narrative: Supra ventricular tachycardia occurring during intense exercise like hiking and shoveling snow
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Acute left MCA stroke.  1 week hospitalization at a local Medical Center. 10 days acute rehabilitation at a local Rehab Hospital. Currently, outpatient rehabilitation at another local Hospital.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The next day, another Rph noticed Moderna bivalent vaccine vials in the fridge was expired. That vail along with the whole package that was in there was thaw on 2/19/23 in the refrigerator and should be expired on 3/9/23 but it was given on 3/15/23 to one patient.  Moderna lot 016h22a manufacturer expiration at freezing is 5/2/23.    Rph reached out to Moderna to consult and got an email on 3/27/23 stating, " Use of an expired vaccine or a vaccine that has undergone a   storage excursion  that is determined to be invalid constitutes a vaccine administration error/deviation. Moderna does not provide any specific recommendations in the event of a vaccine administration error or deviation except to instruct vaccination providers to report these events to the Vaccine Adverse Event Reporting System (VAERS). Safety and efficacy data are not available to support administration of an additional dose to patients who received vaccine impacted by storage and handling errors. The management of these patients is at the discretion of the healthcare provider."  Rph got a hold of patient on 3/30/23 and she stated she is doing fine with no reaction.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antiphospholipid antibodies, Antiphospholipid syndrome, Cardiac failure, Deep vein thrombosis, Iritis
Clinical narrative: DVT, Antiphosilipid syndrome, lupus anticoagulant, heart failure, iritis, nerve problems
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nervous system disorder
Clinical narrative: DVT, Antiphosilipid syndrome, lupus anticoagulant, heart failure, iritis, nerve problems
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient had already received bivalent booster on 09/03/2022. Received a second bivalent booster in error on 11/09/2022.