chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Consumer also mentioned that from the previous Moderna shots she got, she was really sick for a few days; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Consumer also mentioned that from the previous Moderna shots she got, she was really sick for a few days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A, 017B21A, 037C21A and 001M21A) for COVID-19 prophylaxis.     The patient's past medical history included Yeast infection (fungal/yeast infection). Previously administered products included for Product used for unknown indication: flu shots in 2005 and flu shots in 2006. Past adverse reactions to the above products included Hearing loss unilateral with flu shots and flu shots. Concurrent medical conditions included Pre-diabetic and Lyme disease (fungal/yeast infection that is related to having a long history of having Lyme disease).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Consumer also mentioned that from the previous Moderna shots she got, she was really sick for a few days). At the time of the report, ILLNESS (Consumer also mentioned that from the previous Moderna shots she got, she was really sick for a few days) had resolved.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2024-756646 (Patient Link).
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Fear of injection, Product administered to patient of inappropriate age
Clinical narrative: they were more traumatized by getting the shot and the needle; She reports that 2 pediatric patients (4-years-old Paternal Twins) received 0.25 ml doses of Spikevax 12 plus SDV ( 2 different vials were used) on 11JAN2024; This spontaneous case was reported by a nurse and describes the occurrence of FEAR OF INJECTION (they were more traumatized by getting the shot and the needle) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She reports that 2 pediatric patients (4-years-old Paternal Twins) received 0.25 ml doses of Spikevax 12 plus SDV ( 2 different vials were used) on 11JAN2024) in a 4-year-old patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 11-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .25 milliliter. On 11-Jan-2024, the patient experienced FEAR OF INJECTION (they were more traumatized by getting the shot and the needle) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She reports that 2 pediatric patients (4-years-old Paternal Twins) received 0.25 ml doses of Spikevax 12 plus SDV ( 2 different vials were used) on 11JAN2024). At the time of the report, FEAR OF INJECTION (they were more traumatized by getting the shot and the needle) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She reports that 2 pediatric patients (4-years-old Paternal Twins) received 0.25 ml doses of Spikevax 12 plus SDV ( 2 different vials were used) on 11JAN2024) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. The patient did not receive any other vaccines within the last 4 months. So far there were no side effect reported. They were in the clinic for sometime afterwards, and they were more traumatized by getting the shot and the needle. No treatment medication was reported. This case is reported for patient 2out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-756658 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756658:Master case (Patient 1)
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Patient had a fever of 99.1 degrees to 99.9 degrees. Patient developed a fever of 99.1 degrees Fahrenheit the day after the vaccination.; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Patient had a fever of 99.1 degrees to 99.9 degrees. Patient developed a fever of 99.1 degrees Fahrenheit the day after the vaccination.) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 4) in 2022, Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 09-Jan-2024, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PYREXIA (Patient had a fever of 99.1 degrees to 99.9 degrees. Patient developed a fever of 99.1 degrees Fahrenheit the day after the vaccination.). At the time of the report, PYREXIA (Patient had a fever of 99.1 degrees to 99.9 degrees. Patient developed a fever of 99.1 degrees Fahrenheit the day after the vaccination.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2024, Body temperature: 99.1 degrees to 99.9 degrees Fahrenheit.         It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient received Spikevax vaccine 2023 2024 lot number was not available. Expiration date was not available.  Patient reports no other adverse events.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria, Vaccination site reaction
Clinical narrative: she had a local reaction (she does not know exactly when it started) on the injection site (left upper arm); She had a 2 x 4 inch welt which was warm to hot, hard and itchy.; headache; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (she had a local reaction (she does not know exactly when it started) on the injection site (left upper arm)), URTICARIA (She had a 2 x 4 inch welt which was warm to hot, hard and itchy.) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032680) for COVID-19 prophylaxis.     The patient's past medical history included Lyme disease (having a long history of having Lyme disease) and Fungal infection (fungal/yeast infection). Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 5) on 01-Oct-2022. Past adverse reactions to the above products included No adverse event with Pfizer vaccine. Concurrent medical conditions included Pre-diabetic.    On 03-Jan-2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 03-Jan-2024, the patient experienced VACCINATION SITE REACTION (she had a local reaction (she does not know exactly when it started) on the injection site (left upper arm)), URTICARIA (She had a 2 x 4 inch welt which was warm to hot, hard and itchy.) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In January 2024, VACCINATION SITE REACTION (she had a local reaction (she does not know exactly when it started) on the injection site (left upper arm)), URTICARIA (She had a 2 x 4 inch welt which was warm to hot, hard and itchy.) and HEADACHE (headache) had resolved.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The concomitant medication was not reported by reporter.   The patient had every Moderna shot except one. She had the last dose on 03 Jan 2024, and she had a local reaction (she did not know exactly when it started) on the injection site that was left upper arm. She had a 2 x 4-inch welt which was warm to hot, hard, and itchy. This resolved in 3-4 days which she managed with Benadryl. She also had a headache.   This case was linked to MOD-2024-756653 (Patient Link).
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Fear of injection, Product administered to patient of inappropriate age
Clinical narrative: they were more traumatized by getting the shot and the needle; She reports that 2 pediatric patients (4-years-old Paternal Twins) received 0.25 ml doses of Spikevax 12+ SDV ( 2 different vials were used) on 11JAN2024 (Lot# 8057456 & Exp. Date: MAR2024); This spontaneous case was reported by a nurse and describes the occurrence of FEAR OF INJECTION (they were more traumatized by getting the shot and the needle) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She reports that 2 pediatric patients (4-years-old Paternal Twins) received 0.25 ml doses of Spikevax 12+ SDV ( 2 different vials were used) on 11JAN2024 (Lot# 8057456 & Exp. Date: MAR2024)) in a 4-year-old patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .25 milliliter. On 11-Jan-2024, the patient experienced FEAR OF INJECTION (they were more traumatized by getting the shot and the needle) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She reports that 2 pediatric patients (4-years-old Paternal Twins) received 0.25 ml doses of Spikevax 12+ SDV ( 2 different vials were used) on 11JAN2024 (Lot# 8057456 & Exp. Date: MAR2024)). At the time of the report, FEAR OF INJECTION (they were more traumatized by getting the shot and the needle) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She reports that 2 pediatric patients (4-years-old Paternal Twins) received 0.25 ml doses of Spikevax 12+ SDV ( 2 different vials were used) on 11JAN2024 (Lot# 8057456 & Exp. Date: MAR2024)) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patients did not receive any other vaccines within the last 4 months.  Concomitant product use was not provided by the reporter.  Suspect vaccine was reported as unknown. Expiry date was reported as Mar-2024. It was reported that they were in the clinic for sometime afterwards, and they were more traumatized by getting the shot and the needle.  Treatment information was not provided.  This case contains information about patient 1st out of 2 child patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-756662 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756662:Patient 2
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Device leakage
Clinical narrative: tried to reconstitute 2 syringes and something went wrong when they were trying to reconstitute; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 05Jan2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5023, Expiration Date: 28Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "tried to reconstitute 2 syringes and something went wrong when they were trying to reconstitute".  Additional information: The reporter reported that they tried to reconstitute 2 syringes and something went wrong when they were trying to reconstitute. It happened on 2 separate occasions. She would like to get a credit or replacement. They did not keep the syringes and it was disposed of. There was no patient involvement. Caller clarified that she was not the pharmacist that was trying to reconstitute the Abrysvo. The pharmacist said that when the pressure in the vial was not equalized and it kept pushing the syringe out and would not lock. Because of that, when they tried to push the diluent, it did not go into the vial and shot out and the diluent was expelled.  The follow-up report from a Product Quality Group stated the pharmacy received a letter and mailer requesting product return but the product has already been discarded. Both vials were disposed of as both vials of Abrysvo were broken. Because there were two Abrysvo vaccines that had, seem like there was like a manufacturer like malfunction. So, it did not reconstitute and it just ended up spilling everywhere. So, at the time when both incidents happened, the pharmacist disposed of the broken pieces in the sharp container. The reporter stated, it happened at two separate times when they received unopened packages on 08Dec2023 and 14Dec2023.  The reporter causality and causality as determined was considered "tried to reconstitute 2 syringes and something went wrong when they were trying to reconstitute" not related to rsv vaccine prot.subunit pref 2v. Causality for "tried to reconstitute 2 syringes and something went wrong when they were trying to reconstitute" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: RSV
Symptoms: Product container issue
Clinical narrative: Bottom of the glass vial kind of broke out; This is a spontaneous report received from a Pharmacist from product quality group.  The rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9849) for immunisation. The relevant medical history and concomitant medications were not reported.The following information was reported: PRODUCT CONTAINER ISSUE (non-serious), outcome "unknown", described as "Bottom of the glass vial kind of broke out".  Causality for "bottom of the glass vial kind of broke out" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: Pharmacist (Reporter) stated, they had an Abrysvo vaccine that he/she was giving and went to go reconstitute it and like the bottom of the glass vial kind of broke out so, seeing if we could, trying to let us know about that and see if they could get a credit or replacement for it. The reporter just took like,  didn't even got that far,  just was taking everything out of the packaging like the bottom broke out of the glass vial. When clarified if the vial was already broken or it happened by mistake: Pharmacist stated, "No, it was like, I wasn't even tapping it like free the powder or anything, it's packaged in that plastic so you just turn that upside down, just kind of poke everything out of it and that was enough to shatter the bottom out of it. We have given quite a few of these and it wasn't treated any poorly than the others that we have given so, just a random broken one and the other four that were in the package were fine, it was just that one." No patient was involved.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: Two Abrysvo RSV vaccines that broke, the syringe broke while they were removing the actual dose from the vial; This is a spontaneous report received from a Nurse from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9849) for immunisation, Device Lot Number: HG1756 . 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 "Two Abrysvo RSV vaccines that broke, the syringe broke while they were removing the actual dose from the vial". Additional information: Two separate dosages from the same batch of the Pfizer Abrysvo that they ordered. the NDC number of Abrysvo was 0069020701, the NDC number of syringe was 0069025001. There was a sample of the product available to be returned, the packaging sealed and intact.  Causality for "two abrysvo rsv vaccines that broke, the syringe broke while they were removing the actual dose from the vial" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Syringe issue
Clinical narrative: two missed doses; When she connects the two mechanisms it will create the burst or explode; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (03Jan2024), this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9849, Expiration Date: Mar2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG DOSE OMISSION BY DEVICE (non-serious), described as "two missed doses"; DEVICE BREAKAGE (non-serious), described as "When she connects the two mechanisms it will create the burst or explode".  Additional information: NDC number of Abrysvo: 0069034405. UPC number of Abrysvo: 30069034405. The caller informed that when she connects the two mechanisms it will create a burst or explode. So, she is looking for a replacement for two doses. When paraphrased the above concern, transferring agent stated, "Yes, for two doses." When paraphrased the above concern, reporter stated, "Yes, we have two missed doses." Later clarified no vaccine is given to patient. The sample of the product is not available to be returned. Reporter stated, "I only have the empty box. I don't have like anything else to return." The packaging was sealed and intact.   Causality for "two missed doses" and "when she connects the two mechanisms it will create the burst or explode" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 01Jan2024 to 06Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2022 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lipitor, reaction(s): "known allergies lipitor". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2024) Negative; (06Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid start date: 28Dec2023, treatment stop date: 01Jan2024. After testing negative for Covid on 03Jan I tested positive on 06Jan and  had severe symptoms of congestion  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got a very mild covid infection; got a very mild covid infection; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "got a very mild covid infection". Clinical course: the patient stated she will be getting her 6th Covid vaccine that week- a Pfizer Covid vaccine and was asking how long it will protect her. Confirms she is an adult and had received her last Covid vaccine (Pfizer) in Dec2022 but got a very mild Covid infection in Feb2023. States she is not sure whether to wait a bit longer to get the Covid vaccine as the variants may change. States she is 68 years of age.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna dose 6 and Vaccine brand=Pfizer / BioNTech dose 5; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 48 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 27Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 17Aug2021 as dose 3 (booster), single (Lot number: EW0181), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Sep2023 as dose 6 (booster), single (Lot number: 8057965), in right arm for covid-19 immunisation. The patient's relevant medical history included: "CHFpEF (Chronic heart failure with preserved ejection fraction)" (unspecified if ongoing); "asthma" (unspecified if ongoing); "diabetes type 2" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Sulfa medications" (unspecified if ongoing); "Known allergies: NSAIDS (Non-steroidal anti-inflammatory drugs)" (unspecified if ongoing); "Known allergies: macrolide antibiotics/tetracycline" (unspecified if ongoing); "Known allergies: steroids" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2023, outcome "unknown", described as "Vaccine brand other=Moderna dose 6 and Vaccine brand=Pfizer / BioNTech dose 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The patient received Paxlovid as treatment of COVID-19 from 01Jan2024 to 06Jan2024.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Psoriasis, Rash, Reaction to excipient
Clinical narrative: broke out with those dots; common ingredient, something, he is allergic to; rash/broke out with those dots; allergic reaction; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2022 as dose 3 (booster), single (Lot number: 33025BD) at the age of 60 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "arthritis " (unspecified if ongoing); "psoriasis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL taken for arthritis, psoriasis. Vaccination history included: pfizer/biontech COVID-19 (Dose 2, Single lot EW0150), administration date: 02Apr2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "First and second Covid vaccines were fine"; pfizer/biontech COVID-19 (Dose 1, Single lot EP6955), administration date: 11Mar2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "First and second Covid vaccines were fine". The following information was reported: HYPERSENSITIVITY (non-serious) with onset Jan2022, outcome "unknown", described as "allergic reaction"; PSORIASIS (medically significant) with onset Jan2022, outcome "recovered" (2023), described as "broke out with those dots"; REACTION TO EXCIPIENT (non-serious) with onset Jan2022, outcome "unknown", described as "common ingredient, something, he is allergic to"; RASH (non-serious) with onset Jan2022, outcome "unknown", described as "rash/broke out with those dots".  Additional information: Goes back to Covid. Got first Pfizer vaccination on 11Mar2021, got second one 02Apr2021, got booster 18Jan2022 (Provided anatomical location as, 1 in right arm, 1 in left arm, 1 was back to other arm. Unable to clarify which arm he had which dose in). At that point, his entire body broke out, 1,000 small dots, from Pfizer medication. Has got to be something with Pfizer. Those 2 medications, from Covid vaccination, to Inflectra. There is some common ingredient, something, he is allergic to. Had same reaction to booster, that he is having now, with this rash. Came on almost within week after getting booster, 18Jan2022, broke out with those dots. Took a year for them to clear, to finally go away. Broke out (plaque psoriasis) after Covid booster: Can't remember exactly when it was. Was some type of reaction. Went to primary, who said he was having allergic reaction.  Was not getting another vaccination after that. Clarified, this reaction occurred only after booster dose, 18Jan2022. First and second Covid vaccines were fine. When asked for treatment the reporter stated that: Just Enbrel, at the time, took for arthritis and psoriasis. Clarified, he had been taking those prior to taking the vaccine. Had no reactions, nothing. When asked if the event required visit to: No, went to doctor, to see what was going on. Primary said he was having reaction, most likely to the medication.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP. A 37-year-old female patient received BNT162b2 (BNT162B2), in Jun2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 29Dec2023 to 04Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: killed my dad; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 09Jan2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (batch/lot number: EK4176) and as dose number unknown, single (batch/lot number: EN5318) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "killed my dad". The date and cause of death for the patient were unknown.  Follow-up attempts are completed.; Reported Cause(s) of Death: killed my dad
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: They contracted COVID-19 after they were vaccinated by Pfizer COVID-19 vaccines; They contracted COVID-19 after they were vaccinated by Pfizer COVID-19 vaccines; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, 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 "They contracted COVID-19 after they were vaccinated by Pfizer COVID-19 vaccines".  Clinical information : The caller (consumer) was wanting to get PAXLOVID for her mom who lived in (withheld), but was having issues with getting patient assistance for it. They contracted COVID-19 after they were vaccinated by Pfizer COVID-19 vaccines.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Lung neoplasm malignant, Pulmonary resection
Clinical narrative: lung removed due to cancer; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: LUNG NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "lung removed due to cancer". Therapeutic measures were taken as a result of lung neoplasm malignant. Additional information: Caller called in seeking assistance with the Abrysvo vaccine. During the call caller stated."I had part of my lung removed due to cancer".    The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Joint pain and no interference with activity; Mild injection site pain and no interference with activity; Mild injection site redness; Mild injection site swelling; Mild fatigue; Moderate muscle pain with some interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (COMIRNATY), in Dec2023 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: ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fatigue"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Joint pain and no interference with activity; Mild injection site pain and no interference with activity; Mild injection site redness; Mild injection site swelling; Mild fatigue; Moderate muscle pain with some interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (COMIRNATY), in Dec2023 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: ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fatigue"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Vaccination site swelling
Clinical narrative: Mild injection site swelling; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (COMIRNATY), in Dec2023 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) with onset Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity". Additional information: Record the worst reaction experienced anytime during the 2 days after your COVID-19 vaccination, which occurred on Monday, Dec 18, 2023 and Tuesday, Dec 19, 2023. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: brief tiredness; temporary deltoid muscled soreness; This is a spontaneous report received from a Physician. An 85-year-old male patient received BNT162b2 (COMIRNATY), on 11Jan2021 as dose 1, single (Lot number: FL3246) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Jan2021, outcome "recovered", described as "brief tiredness"; MYALGIA (non-serious) with onset Jan2021, outcome "recovered", described as "temporary deltoid muscled soreness". Additional information: Patient received Pfizer Covid19 vaccine at first availability, and have had four successive boosters, the latest was in late 2022. Total of five vaccine injections. No immediate reaction or symptoms, except for brief tiredness and temporary deltoid muscled soreness.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400004585 same patient/events/product, different dose (dose 2);US-PFIZER INC-PV202400004586 same patient/events/product, different dose (dose 3);US-PFIZER INC-PV202400004587 same patient/events/product, different dose (dose 4);US-PFIZER INC-202300295170 same patient/product, different events/dose (dose 5);
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: brief tiredness; temporary deltoid muscled soreness; This is a spontaneous report received from a Physician.  An 85-year-old male patient received BNT162b2 (COMIRNATY), on 01Feb2021 as dose 2, single (Lot number: EL9264) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pfizer-biontech (dose 1, lot number: FL3246), administration date: 11Jan2021, for COVID-19 immunisation, reaction(s): "brief tiredness", "temporary deltoid muscle soreness". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "brief tiredness"; MYALGIA (non-serious), outcome "unknown", described as "temporary deltoid muscled soreness".  Additional information: Patient received Pfizer Covid19 vaccine at first availability, and have had four successive boosters, the latest was in late 2022. Total of five injections. No immediate reaction or symptoms, except for brief tiredness and temporary deltoid muscle soreness.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: brief tiredness; temporary deltoid muscled soreness; This is a spontaneous report received from a Physician.  An 85-year-old male patient received BNT162b2 (COMIRNATY), on 15Aug2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pfizer-biontech (dose 2, single, lot# FL3246 85), administration date: 01Feb2021, when the patient was 85-year-old, for COVID-19 immunization, reaction(s): "temporary deltoid muscled sorenes", "Tiredness"; pfizer-biontech (dose 1, single, lot# FL3246 85), administration date: 11Jan2021, when the patient was 85-year-old, for COVID-19 immunization, reaction(s): "temporary deltoid muscled sorenes", "Tiredness". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "brief tiredness"; MYALGIA (non-serious), outcome "unknown", described as "temporary deltoid muscled soreness".  Additional information: The patient had no immediate reaction or symptoms except for brief tiredness and temporary deltoid muscled soreness.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400004584 same patient/events/product, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: temporary deltoid muscled soreness; brief tiredness; This is a spontaneous report received from a Physician. An 86-year-old male patient received BNT162b2 (COMIRNATY), on 15Feb2022 as dose 4 (booster), single (Lot number: FK9729) for covid-19 immunisation. The patient's relevant medical history included: "hereditary spastic paraplegia" (ongoing), notes: uses electric scooter; "uses electric scooter" (ongoing); "hyperactive DTR" (unspecified if ongoing), notes: in childhood; "ankle clonus" (unspecified if ongoing), notes: in childhood no physical limitations. The patient's concomitant medications were not reported. Vaccination history included: PFIZER-BIONTECH (DOSE 1, lot# FL3246), administration date: 11Jan2021, when the patient was 85-year-old, for COVID-19 immunization, reaction(s): "tiredness", "temporary deltoid muscled soreness"; PFIZER-BIONTECH (DOSE 2, lot#EL9264), administration date: 01Feb2021, when the patient was 85-year-old, for COVID-19 immunization, reaction(s): "tiredness", "temporary deltoid muscled soreness"; PFIZER-BIONTECH (DOSE 3, lot#FC 3180), administration date: 15Aug2021, when the patient was 85-year-old, for COVID-19 immunization, reaction(s): "tiredness", "temporary deltoid muscled soreness". The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "temporary deltoid muscled soreness"; FATIGUE (non-serious), outcome "unknown", described as "brief tiredness". Additional information: The patient had no immediate reaction or symptoms except for brief tiredness and temporary deltoid muscled soreness. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400004584 same patient/events/product, different dose number;
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Peripheral swelling, Rash
Clinical narrative: rash on her arm; swelling on her arm; flu shot gave her the flu; Initial information received on 05-Jan-2024 regarding an unsolicited valid non-serious case received from a patient.  This case involves Elderly female patient who had rash on her arm, swelling on her arm and flu shot gave her the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number, expiry date: unknown) via unknown route in unknown administration site for flu shot (Influenza).  On an unknown date the patient had rash on her arm (rash), swelling on her arm (peripheral swelling) and flu shot gave her the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Reportedly, patient reports most recent dose was 6 days late due to insurance issues.  It is unknown if the patient experienced any additional symptoms/events.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (rash on her arm, swelling on her arm, flu shot gave her the flu).  At time of reporting, the outcome was Unknown for all the events.
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: child was inadvertently given only the liquid component and not the dry component of the Pentacel with no reported adverse event; Initial information was received on 09-Jan-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age female child patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was inadvertently given only the liquid component and not the dry component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization and child was inadvertently given only the liquid component and not the dry component of the pentacel with no reported adverse event (single component of a two-component product administered) (latency: same day). The information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Pyrexia, Upper respiratory tract infection
Clinical narrative: Symptoms of an upper respiratory infection; Low grade fever; This spontaneous case was received on 05-Jan-2024 from other non-healthcare professional (consumer) via Communications (reference number: SEQW24-00069) and concerned a patient of unspecified age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, reported as Friday afternoon, the patient was vaccinated with the influenza vaccine (brand not specified; dose, route of administration, and anatomical location: not reported) for prevention of influenza virus. The batch number was not reported.  On an unspecified date, reported as Sunday, the patient had a low grade fever and symptoms of an upper respiratory infection.   The outcome of the events of low grade fever and 'upper respiratory infection' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A patient of unreported age and gender experienced low grade fever and symptoms of an upper respiratory infection an unknown amount of time after being vaccinated with Influenza vaccine. The patient's medical history, concomitant medication as well as relevant laboratory and diagnostic findings were not reported. Due to unclear temporal relationship and lack of above-mentioned information, causality for the events including pyrexia and upper respiratory tract infection is unassessable.; Sender's Comments: A patient of unreported age and gender experienced low grade fever and symptoms of an upper respiratory infection an unknown amount of time after being vaccinated with Influenza vaccine. The patient's medical history, concomitant medication as well as relevant laboratory and diagnostic findings were not reported. Due to unclear temporal relationship and lack of above-mentioned information, causality for the events including pyrexia and upper respiratory tract infection is unassessable.