chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: hives/wheals; rash and red all over; rash and red all over; itchy lasting longer; eczema; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives/wheals), ECZEMA (eczema), RASH (rash and red all over), ERYTHEMA (rash and red all over) and PRURITUS (itchy lasting longer) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 041C21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Pneumocystis pneumonia, Interstitial plasma cell pneumonia and Pneumocystis jiroveci pneumonia.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced URTICARIA (hives/wheals), RASH (rash and red all over), ERYTHEMA (rash and red all over) and PRURITUS (itchy lasting longer). In 2021, the patient experienced ECZEMA (eczema). The patient was treated with Diphenhydramine hydrochloride (Benadryl) at an unspecified dose and frequency; Loratadine (Claritin) at a dose of daily; Fexofenadine, Pseudoephedrine hydrochloride (Allegra d) (oral use) at a dose of daily and Cetirizine hydrochloride (Zyrtec) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives/wheals), ECZEMA (eczema), RASH (rash and red all over) and PRURITUS (itchy lasting longer) had not resolved and ERYTHEMA (rash and red all over) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that dermatologist thought it was eczema, but patient never had problems till covid shot which caused patient to itch mostly daily. One topical was given which helped with getting rid of red around mouth and the worse of the plaque like skin growth on lip and body but it was very itchy and it won't go away fully, so patient tried other topicals and with use of oral medication as well it did not seemed to go away and had itching every day since patient started receiving the Covid shot but patient never had reactions directly after the shot, it developed later by end of day after shot or within a day.  Patient never had problem till covid shot and each time it got worse.  Patient had tried and was using itch creams over the counter and daily.   This case was linked to US-MODERNATX, INC.-MOD-2024-776074 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: feeling absolutely miserable; she is still "running a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (feeling absolutely miserable) and PYREXIA (she is still "running a fever) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling absolutely miserable) and PYREXIA (she is still "running a fever). At the time of the report, FEELING ABNORMAL (feeling absolutely miserable) and PYREXIA (she is still "running a fever) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No relevant medical history or conditions, allergy, concomitant diseases and risk factor. No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD may have been inadvertently administered to multiple patients after the TE occurred. Nurse reports TE occurred on 08/26/24 and could have been administered from 08/26/24 until today 9/17/24; Product administration error (Indicate at which point in the process the medication error ocurred: administration); This spontaneous report was received from a Nurse and refers to a 4-year-old male patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and Concomitant therapies were not reported.  On 26-AUG-2024, measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) vaccines, lot #Y008885, expiration date: 03-NOV-2025 experienced a temperature excursion (TE) of -12.7 degrees Celsius (C) during a time frame of 30 minutes.   On 06-SEP-2024, the patient was inadvertently vaccinated with improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, lot #Y008885, expiration date: 03-NOV-2025, administered intramuscularly at public health clinic/ hospital purchased with public funds as prophylaxis (strength, exact dose and anatomical locations were not provided) (Product storage error). The point in the process the medication error occurred was reported as administration (Product administration error). No treatment was prescribed for the adverse events. Operator of vaccine /device was a trained healthcare professional. The outcome of Product storage error and Product administration error was reported as recovered.  No additional adverse event (AE) was reported. It was reported that from 26-AUG-2024 until 17-SEP-2024, 5 measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), lot #Y008885, expiration date: 03-NOV-2025, were administered. Temperature excursion checked with the company; vaccines were still viable.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA013461:Original Case : 2409USA006137 US-009507513-2410USA013458:Original Case : 2409USA006137 US-009507513-2409USA006137:Original Case : 2409USA006137 US-009507513-2410USA013460:Original Case : 2409USA006137
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD may have been inadvertently administered to multiple patients after the TE occurred. Nurse reports TE occurred on 08/26/24 and could have been administered from 08/26/24 until today 9/17/24; Product administration error (Indicate at which point in the process the medication error ocurred: administration); This spontaneous report was received from a Nurse and refers to a 5-year-old male patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 26-AUG-2024, measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) vaccines, lot #Y008885, expiration date: 03-NOV-2025 experienced a temperature excursion (TE) of -12.7 degrees Celsius (C) during a time frame of 30 minutes.   On 10-SEP-2024, the patient was inadvertently vaccinated with improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, lot #Y008885, expiration date: 03-NOV-2025, administered intramuscularly at public health clinic/ hospital purchased with public funds as prophylaxis (strength, exact dose and anatomical locations were not provided) (Product storage error). The point in the process the medication error occurred was reported as administration (Product administration error). No treatment was prescribed for the adverse events. Operator of vaccine /device was a trained healthcare professional. The outcome of Product storage error and Product administration error was reported as recovered.  No additional adverse event (AE) was reported. It was reported that from 26-AUG-2024 until 17-SEP-2024, 5 measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), lot #Y008885, expiration date: 03-NOV-2025, were administered. Temperature excursion checked with the company; vaccines were still viable.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA013461:Original Case : 2409USA006137 US-009507513-2410USA013458:Original Case : 2409USA006137 US-009507513-2410USA013459:Original Case : 2409USA006137 US-009507513-2409USA006137:Original Case : 2409USA006137
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD may have been inadvertently administered to multiple patients after the TE occurred. Nurse reports TE occurred on 08/26/24 and could have been administered from 08/26/24 until today 9/17/24; Product administration error (Indicate at which point in the process the medication error ocurred: administration); This spontaneous report was received from a Nurse and refers to a 4-year-old female patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 26-AUG-2024, measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) vaccines, lot #Y008885, expiration date: 03-NOV-2025 experienced a temperature excursion (TE) of -12.7 degrees Celsius (C) during a time frame of 30 minutes.   On 10-SEP-2024, the patient was inadvertently vaccinated with improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, lot #Y008885, expiration date: 03-NOV-2025, administered intramuscularly at public health clinic/ hospital purchased with public funds as prophylaxis (strength, exact dose and anatomical locations were not provided) (Product storage error). The point in the process the medication error occurred was reported as administration (Product administration error). No treatment was prescribed for the adverse events. Operator of vaccine /device was a trained healthcare professional. The outcome of Product storage error and Product administration error was reported as recovered.  No additional adverse event (AE) was reported.  It was reported that from 26-AUG-2024 until 17-SEP-2024, 5 measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), lot #Y008885, expiration date: 03-NOV-2025, were administered. Temperature excursion checked with the company; vaccines were still viable.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2409USA006137:Original Case : 2409USA006137 US-009507513-2410USA013458:Original Case : 2409USA006137 US-009507513-2410USA013459:Original Case : 2409USA006137 US-009507513-2410USA013460:Original Case : 2409USA006137
Sex: U
Vaccine: PNC20
Symptoms: Product quality issue
Clinical narrative: Prevnar 20 and cloudiness did not go away, has particles in it and is also orange tinged wanted to know if those would be still viable; The initial case was missing the following minimum criteria: product complaint only. Upon receipt of follow-up information on 22Oct2024 this case now contains all required information to be considered valid.  This is a spontaneous report received from a Nurse 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: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "Prevnar 20 and cloudiness did not go away, has particles in it and is also orange tinged wanted to know if those would be still viable". Additional information: Calling about Prevnar 20 and has two boxes and both boxes have lot number HL3889. They have the two boxes of the Prevnar 20 and apparently they say on the box that you are supposed to shake it before you give it and the caregiver went to shake it and instead of having the cloudiness go away, they shook it and it did not go away and is still cloudy and has particles in it and is orange tinged which did not happened with other ones and she wanted to ask if it is still viable. Thinks they were both brand new boxes and she is not sure how many are in the box and this says 10 so she is thinking that both boxes had 10 in them and that nobody used any of them. The expiry date is May2025, NDC 0005-2000-10 and it is the same lot, expiry date, NDC for all of the syringes involved but she does not know the number of syringes that had the reported issue.  Caller clarified that it looks like there is only one box and she thought it was two but it is only one box. Caller states no patients were administered the vaccines. Seen the vaccine before and this time looked different, did not look the same. Agent relays he has a caller on the line that had spoken to someone in drug safety earlier. Caller called back for further information and had requested replacement or credit for defective product. Agent relays she probably gave her address wrong and wants to correct that information. Product is Prevnar 20. Reason for the original transfer is the caller found vaccines to be cloudy with particles after preparation. The reason for her call now is to confirm the address. Caller states she did not provide an address originally. She had to figure out what clinic to send this to. No patient involvement. Device available for evaluation.  Causality for "prevnar 20 and cloudiness did not go away, has particles in it and is also orange tinged wanted to know if those would be still viable" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Sex: U
Vaccine: RSV
Symptoms: No adverse event, Syringe issue
Clinical narrative: syringe seemed to break and he was not able to extract the medication; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 25Oct2024, this case now contains all the required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: Sep2025) 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 "syringe seemed to break and he was not able to extract the medication".  Additional information: The pharmacist called about a problem with an ABRYSVO vaccine that he was administering, and the syringe seemed to break and he was not able to extract the medication out of the vial and wanted to return it and get a replacement. Carton/box: lot number KC7884, expiry date Sep2025, NDC 0069034401. Antigen vial: lot number KC7884, expiry date Oct2025, for the NDC 0069020701. Vial Adaptor: the vial adaptor is on the vial when he was trying to administer it and he does not see the lot, expiry date, NDC or manufacturer on the vial adaptor. Diluent syringe: the lot number looks like HM8389, expiry date Sep2025, NDC 0069025001. The pharmacist verified that no patients were administered the vaccine.  The reporter considered "syringe seemed to break and he was not able to extract the medication" not related to rsv vaccine prot.subunit pref 2v. Causality for "syringe seemed to break and he was not able to extract the medication" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: M
Vaccine: FLUX, RSV
Symptoms: Myalgia
Clinical narrative: pretty bad muscle pain at the back muscle progressing downwards; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 83-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 19Oct2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA), on 19Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "back problems" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 21Oct2024, outcome "not recovered", described as "pretty bad muscle pain at the back muscle progressing downwards". Additional information: Reporter (patient) received a Flu vaccine and Abrysvo ten days ago. On the second and third day after vaccination he had a "pretty bad muscle pain at the back muscle progressing downwards" and its bothering him. patient was asking how long is the muscle pain will go away. Consumer stated, wanted to know, that is one of the side effects but it was probably been about last Thursday the pain got pretty bad and he was getting pretty concern. The patient walk with pain anyways. He had back problems, but the pain after he got that shot. It was not going away. The patient just want to, how long does it take me for a muscle pain goes away.   Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Patient lost taste and smell; Patient lost taste and smell; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 nos (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "Patient lost taste and smell", "Patient lost taste and smell". The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "not recovered" and all described as "Patient lost taste and smell".  Additional information: The patient have had six of Pfizer COVID-19 vaccine covid shots. After the third, patient lost taste and smell and still have none.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400140660 Same Reporter/Patient/Drug/AE, Vaccine Dose;US-PFIZER INC-202400291190 Same Reporter/Patient/Drug/AE, Vaccine Dose;US-PFIZER INC-202400291191 Same Reporter/Patient/Drug/AE, Vaccine Dose;
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: I lost taste and smell; I lost taste and smell; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), 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. Vaccination history included: Bnt162b2 nos (Dose 1, single), for COVID-19 immunisation; Bnt162b2 nos (Dose 2, single), for COVID-19 immunisation; Bnt162b2 nos (Dose 3 (booster), single), for COVID-19 immunisation, reaction(s): "lost taste", "lost smell"; Bnt162b2 nos (Dose 4 (booster), single), for COVID-19 immunisation, reaction(s): "lost taste", "lost smell". The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "not recovered" and all described as "I lost taste and smell". Additional information: After the third, patient lost taste and smell and still have none.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400140660 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202400291189 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202400291191 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: I lost taste and smell; I lost taste and smell; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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 nos (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 nos (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "Patient lost taste and smell", "Patient lost taste and smell"; Bnt162b2 nos (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "Patient lost taste and smell", "Patient lost taste and smell"; Bnt162b2 nos (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "Patient lost taste and smell", "Patient lost taste and smell". The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "not recovered" and all described as "I lost taste and smell".  Additional information: The patient had six of Pfizer COVID-19 vaccine covid shots. After the third, patient lost taste and smell and still have none.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400291190 Same Reporter/Patient/Drug/AE, Vaccine Dose;US-PFIZER INC-PV202400140660 Same Reporter/Patient/Drug/AE, Vaccine Dose;US-PFIZER INC-202400291189 Same Reporter/Patient/Drug/AE, Vaccine Dose;
Age: 34.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Ovulation delayed
Clinical narrative: significant delayed ovulation; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), on 21Oct2024 at 06:30 as dose 1, single (Lot number: LN0588) at the age of 34 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 21Oct2024 as dose 1, single (Lot number: 388522), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVULATION DELAYED (non-serious) with onset 21Oct2024 at 18:30, outcome "not recovered", described as "significant delayed ovulation". Therapeutic measures were not taken as a result of ovulation delayed.  Additional information: Patient had no known allergy. Patient did not receive any other vaccines within 4 weeks prior to the vaccine. Patient was not taking any other medications within 2 weeks of the event starting. Patient had significant delayed ovulation. It was day 21 of her cycle and she still have not ovulated. She always ovulate around day 16 and the vaccine was the only factor that could have influenced this.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Diarrhoea, Fatigue, Nausea, Off label use, Product use issue
Clinical narrative: a little nausea; diarrhea/Loose stools; Tiredness; she got Comirnaty along with the extra strength flu shot; she got Comirnaty along with the extra strength flu shot; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "a little nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea/Loose stools"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "she got Comirnaty along with the extra strength flu shot".  Additional information; Transferring agent stated, "I have a patient reporting an adverse event with the Comirnaty. Patient was 75 years old and 11 days ago patient received Comirnaty and the extra strength flu shot (Hence, Suspect captured as Unspecified Flu Shot). Patient has had off and on diarrhea and little nausea." When paraphrased the above concern, patient stated, "Off and on nausea and loose stools not running diarrhea but very loose stool that comes on very quickly and tiredness too, a lot of tiredness." Patient further stated, "This was not working. Patient can't understand you. You were not understanding me. Patient was going to go." Further probing could not be done as the consumer hung up the call abruptly. Thus, product details and pharmacy details were unknown. Hence, limited information is available over the call. Country of incidence could not be clarified as the consumer hung up the call to answer the questions. Hence, by default.  Batch/lot number is not provided, and it cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 1, single (Lot number: FC3181), in left arm and on 03Sep2021 as dose 2, single (Lot number: FF2588) at the age of 29 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Clinical course: Patient whole family had Covid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400108765 same patient/product, different dose/event;US-PFIZER INC-PV202400124358 same patient/product, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus
Clinical narrative: gave the caller a second dose, and later in the day caller got even itchier; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-775783 (Moderna).  An elderly male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "his eye got itchy when they gave him the contrast media" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: EYE PRURITUS (non-serious), outcome "unknown", described as "gave the caller a second dose, and later in the day caller got even itchier".  Additional information: Reported as, patient wanted to shift from Pfizer which he has been taking all along to a Moderna booster shot. He wanted to switch because of evidence he found in professional publications that if you are over 65, which the patient is, if you shift from Pfizer to Moderna, there is a boost. He added he had a minor issue with Visipaque, a contrast media, which has those 2 ingredients in it. The amount of those 2 ingredients in the Pfizer shot was very small, so he went ahead and took the Pfizer shot and it did not bother him at all. He was guessing the amount in the Moderna shot will also be very small and it won't bother him either, but he wants to be cautious. Patient was asked to clarify if he experienced an allergy. He said no, but he had a CT scan. He had a CT scan many years ago, and his eye got itchy when they gave him the contrast media. Patient had a second dose, and later in the day he got even itchier. He added so he had some kind of reaction to the contrast media. So he checked it out before getting a booster shot. He asked when will he get a response, he's over 65 and wanted his booster shot soon and he wanted to switch to Moderna.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: UNK
Symptoms: Paraesthesia, Peripheral swelling, Pruritus, Rash
Clinical narrative: He developed a rash in his hands and his arms; His left foot is a little swollen,; Itchy; Tingling; This spontaneous case, initially received on 15-Oct-2024, was reported by a health professional and concerns a male patient.  Administration of company suspect drug(s): On 14-Oct-2024, the patient received Flucelvax (TIV) for Active immunization for the prevention of influenza vaccine, Dose regimen: 0.5 ml, Route of administration: Not reported, Lot number: 391248.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 15-Oct-2024, the patient experienced He developed a rash in his hands and his arms (outcome: not resolved), His left foot was a little swollen, (outcome: not resolved), Itchy (outcome: not resolved), Tingling (outcome: not resolved).  Patient said in morning he woke up developed and he developed a rash in his hands and his arms, and then he showed me his feet, and his let foot was a little swollen, and its itchy and tingling.   Flucelvax (TIV) action taken: Not Applicable Treatment medication: Hydrocortisone cream  Reporter assessment: The reporter considered the events as non-serious and did not provide the causality assessment.; Reporter's Comments: All the events considered as related.
Sex: F
Vaccine: UNK
Symptoms: Underdose
Clinical narrative: Few drops of the vaccine came out; The person giving it to her, squirted out the air bubble and a few drops of the vaccine came out; Few drops of the vaccine came out; This spontaneous case, initially received on 15-Oct-2024, was reported by a non health professional and concerns a female patient. Age group not reported.   Administration of company suspect drug(s): On an unknown date, the patient received Flucelvax (TIV) for Flu immunisation, Dose regimen: 0.5 ml, , route of administration: not reported. Lot number: No batch number available and would not be obtained due to no follow-up consent.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Few drops of the vaccine came out (outcome: Unknown), The person giving it to her, squirted out the air bubble and a few drops of the vaccine came out (outcome: Not Reported) and Few drops of the vaccine came out (outcome:  not reported).  Reporter was concerned that the daughter got a flu shot few days ago and the person giving it to her, squirted out the air bubble and a few drops of the vaccine came out.    It was reported 1 defective units. the defect discovered during use, when the drops of the vaccine came out The full dose administered was not administered. No complaint sample available. Unknown if there is a picture of the complaint sample available.  Unknown if plunger depressed or not depressed.  Unknown if the needle shield in place.  Unknown the location of the leak  Unknown if there are signs of damage on the syringe Unknown if leaking from the needle or syringe connection. Unknown what needle was used (manufacturer/model). Unknown if there are signs of damage on the needle Unknown if the needle appear tightly attached. Unknown if they try with a different needle.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter consider event as non-serious and causality assessment was not provided.; Reporter's Comments: The special situations are not related to Flucelvax (TIV)
Age: 54.0
Sex: U
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Headache most of the night afterwards.; Low grade fever (99-100); This spontaneous case, initially received on 16-Oct-2024, was reported by a non-health professional and concerns an adult patient.  Administration of company suspect drug: On 15-Oct-2024, the patient received Influenza virus vaccine for Indication not reported, Dosage regimen: not reported, Route of administration: Intramuscular, Lot number: 946578. Administration site: Left intramuscular injection  No additional suspect drugs.  Adverse reactions/events and outcomes: On 15-Oct-2024, the patient experienced Headache most of the night afterwards. (outcome: Not Reported), Low grade fever (99-100) (outcome: Not Reported).   Influenza virus vaccine action taken: Not Applicable  Reporter's assessment:  The reporter did not provide seriousness and causality assessment. ; Reporter's Comments: The events are considered as related
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth, Pain
Clinical narrative: Experiencing long-term symptoms at the injection site, soreness, warm to the touch, and the pain radiates throughout the arm as well.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Photopsia, Vision blurred, Vitreous detachment
Clinical narrative: Had severe headache and then noticed flashes in corner of left eye. As days went by was still getting flashes in left eye, seemed like a film was crossing my vision and the eye felt a little swollen or that something was in it.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in arm and hand
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: Patient states the next day after getting the vaccine, she had extreme redness,  a rash, and lump in the injection area.  The lump has subsided but the rash and redness still are there so she went to see a dr today who prescribed her an antibiotic and steroid.  The rash today was approximately a 2 in x 2 inch area.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states she's had chronic arm pain and limited range of motion. Symptoms began day of administration and still continue. She states she is going to make an appointment with her doctor for further evaluation.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Feeling cold, Headache
Clinical narrative: Nausea, headache, severe fatigue, body aches started late pm 10/17/24 - No relief with Tylenol 1500mg x2 doses - Slept off and on for approx 36 hours - unable to function fully for 48 hours - Then still fome fatigue and head ache but able to function. Also shivering, unable to warm up and then fever 100 degrees, frequent loose stools.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: Nausea, headache, severe fatigue, body aches started late pm 10/17/24 - No relief with Tylenol 1500mg x2 doses - Slept off and on for approx 36 hours - unable to function fully for 48 hours - Then still fome fatigue and head ache but able to function. Also shivering, unable to warm up and then fever 100 degrees, frequent loose stools.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Impaired work ability, Joint range of motion decreased, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: I did not have a local reaction to the vaccine.  The vaccine was given too high in my right arm.  Within 4 hrs, i was experiencing intense pain and not being able to lift or cross over with my arm.  I never had this happen before.  There was no redness or inflammation where it was given.  The pain was constant.  I could not sleep on my right side.  Kept me up majority of the night.  By day 2,  I had limited ROM, chronic pain.  OTC motrin and tylenol was not helping.  I tried ice and heat.  I was not able to reach across my body with assisting arm with my left hand,  not able to lift arm up from side, pull or pick things up.  Day 6  I called my PCP, reported what happened, showed her the pictures of my arm with the bandaid on and pulled back so she could see that it was administered incorrectly.  I have very little body fat, my BMI is 21%.  Small arms.  It was given almost in my joint.  She prescribed 12 days of oral Prednisone.  I finished course of therapy with zero effect.  I have had daily chronic pain that ranges from moderate to about a 8.  My arm feels "heavy" at times, my shoulder throbs at times, tender when palpated.  I can't use my arm the same since I had the vaccine.  I am scheduling an ortho consult and will find out what damage was done.  Never had an injury to my shoulder.  Never sought treatment for my shoulder.  It is seriously affecting my daily activities of living and also my worklife, as I am in EMS and nursing.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity, Product administered at inappropriate site, Sleep disorder, Tenderness
Clinical narrative: I did not have a local reaction to the vaccine.  The vaccine was given too high in my right arm.  Within 4 hrs, i was experiencing intense pain and not being able to lift or cross over with my arm.  I never had this happen before.  There was no redness or inflammation where it was given.  The pain was constant.  I could not sleep on my right side.  Kept me up majority of the night.  By day 2,  I had limited ROM, chronic pain.  OTC motrin and tylenol was not helping.  I tried ice and heat.  I was not able to reach across my body with assisting arm with my left hand,  not able to lift arm up from side, pull or pick things up.  Day 6  I called my PCP, reported what happened, showed her the pictures of my arm with the bandaid on and pulled back so she could see that it was administered incorrectly.  I have very little body fat, my BMI is 21%.  Small arms.  It was given almost in my joint.  She prescribed 12 days of oral Prednisone.  I finished course of therapy with zero effect.  I have had daily chronic pain that ranges from moderate to about a 8.  My arm feels "heavy" at times, my shoulder throbs at times, tender when palpated.  I can't use my arm the same since I had the vaccine.  I am scheduling an ortho consult and will find out what damage was done.  Never had an injury to my shoulder.  Never sought treatment for my shoulder.  It is seriously affecting my daily activities of living and also my worklife, as I am in EMS and nursing.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: redness (warm to touch) and itching
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient given fluzone HD under 65 years old
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: PTS GOT A DUPLICATE FLU SHOT
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased, Dyspnoea, Erythema, Exposure during pregnancy, Immediate post-injection reaction
Clinical narrative: Patient is a 37 year old pregnant female who presented for RVS vaccines. Patient reported having shortness of breath and elevated blood pressure immediately after receiving a single dose of Abrysvo. Her face also turned red and stayed that way for a few minutes after the shot.  Per patient, she was given 2 due dates for her pregnancy. One put her at 36 weeks and 5 days and another for 37 weeks.  Prior to giving the shot, I informed patient of CDC's  recommended pregnancy term for RSV (no later than 36 weeks and 6 days) due to having insufficient time for antibodies to develop and pass onto her baby. Patient decided to get the shot anyway as she was instructed my her physician to get RSV just before she hit 37 weeks. EMS was called and arrived shortly after. Patient stabilized after having water and sitting down for a few minutes. Patient refused to be transfer to the ER for further check-up
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse reaction at this time
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: patient has a large circular erythema around the injection site. no pain, just slightly itchy and warm to the touch. patient states erythema gas gotten progressively bigger over the 48 hours since injection
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was >65 years old and should have been given Boostrix NOT Adacel. Not necessarily an adverse event but an inappropriate vaccine administration.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt received two annual flu shots. (8/2/24, 10/30/24) Both were Fluad. Spoke with pt and adverse effect from second vaccine.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Headache, Hypotension
Clinical narrative: Patient came in got Gardasil -9 1st shot, around 4:31pm, then shopping inside store for 10-15 minutes.  Then around 4:50pm, the family walked out of store going home. Patient felt dizzy and fell on the ground. 911 was called and checked her vital signs, All were normal except low blood pressure .  Per patient, she felt dizzy and a light headache after the fall, but overall back to normal.
Age: 23.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Pallor, Posture abnormal, Syncope
Clinical narrative: Pt fainted immediately after administration of 2nd vaccine (covid) in left arm. He had minimal bleeding at that site but prev vaccine (flu administered in right arm) required an additional bandage. He was slumped over in chair with normal breathing and pulse. Upon awakening, pt was pale but was able to have conversation and stated that this had happened to him before.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: beginning ~2 days post vaccination patient experienced a rapid heartbeat and higher blood pressure that sustained until 11/03/2024 per patient report, and they believe was associated with the vaccine
Age: 84.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 flu vaccines. First dose on 08/07/2024 and 2nd dose on 10/31/2024. Patient states they did not experience any adverse events from 2nd shot.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Patient came back 2 days after the vaccine her arm was red and warm to touch
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Injection site pain, Mobility decreased, Neck pain
Clinical narrative: Patient came to the pharmacy on 10.15.2024 at 6:24pm and complaining about the pain at injection site , back of the neck, chest, and she can't move her arm since she got the vaccine on 10/11,2024
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Severe itching, rash, and hives that surfaced all over my body.  It was more painful around my heals and soles of my feet.  This occurred at the second and third booster but the worst has been this 4th booster, which has been 4 days of rashes, hives, and itching.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Oral mucosal eruption
Clinical narrative: The day after my vaccine, when I woke up, I noticed a rash on the palate and inside my mouth, but on the inside of my lips. After looking it up, I think it seems to be an oral herpes Zoster infection following the COVID vaccine.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Extreme arm pain/ache  5 weeks
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Pt was to receive Kinrix but received DTaP alone instead.
Age: 56.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: REDNESS, HARD TO TOUCH AND ITCHY
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Headache, Nausea, Palpitations
Clinical narrative: Painful circulation and dizzy. Symptoms are still occuring, fading on some days. Continuous headaches, racing heart and vascular pain, as well as, nausea. Swelling along venous lines
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Ultrasound scan, Vascular pain
Clinical narrative: Painful circulation and dizzy. Symptoms are still occuring, fading on some days. Continuous headaches, racing heart and vascular pain, as well as, nausea. Swelling along venous lines
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine increased, Blood lactic acid normal, Chest X-ray normal, Computerised tomogram abdomen abnormal, Cystitis
Clinical narrative: Cycstitis Date of Admission: 7/16/2024, Date of Discharge: 7/20/2024 Subject enrolled in the Janssen study received first dose of study medicatoin (Janssen ad26.CoV2.vaccine) on 8/29/2023 in Segment 1 low responder arm. Subject recently admitted 6/24-6/28 due to transplant pyelonephritis due to MDR. E. Coli, ID was consulted and it was recommended he be treated with 14 days of Ertapenem, which he completed on 7/8/24. A discussion was had about possible prophylactic antibiotics due to recurrent infections but it was not recommended at that time. He presented to Clinic ED on 7/16/24 with complaints of cloudy urine, dysuria, frequency, and urgency. Fever at home of 100.9F. In the ED, vitals were stabe. WBC 11.2. Lactate 0.73. Cr 3.39 (baseline 2.8-3.2). UA grossly abnormal. CXR negative. Renal US unremarkable. He received IV ertapenem and was admitted for further evaluation and treatment. Upon admission, ertapenem was continued. No changes were made to his immunosuppression regimen. Infectious disease was consulted; CT a/p and MR abd were completed to rule out abscess and/or infected stone. Transplant Nephrology was consulted for immunosuppression management. CT a/p showed fat stranding around RLQ renal allograft, slightly increased from prior on 6/14; mild perivesical fat stranding. 7/17 MR Pelvis -- Changes of acute pyelonephritis of the renal allograft; no evidence of renal or perinephric abscess. Multifocal small papillary lesions in the bladder with diffusion restriction, consistent with the patient's known bladder cancer Blood culture returned showing 1/2 positive for ESBL EColi. Infectious disease recommended Continue ertapenem x 4 weeks, renal equivalent of 1g q24h. ? Abx completion date expected 8/13. ? Recommend outpatient urology assessment of urodynamic studies Patient discharged 7/20/2024. Discharge diagnosis is Cystitis Study Prinicipal investigator has assessed the causality as not study related.