chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: Patient called into PCP clinic to report adverse vaccine reaction, immunizations administered at local pharmacy. Patient self reports that he woke up early this morning (9/19/2024) to widespread itching. Upon further investigation he noticed that he had a widespread rash, which he describes as "red raised welts", primarily on trunk, genitals and thighs but diffuse throughout the rest of his body. Patient states this reaction occurred about 30 hours after receiving his vaccines. Denied any initial rash or itching at either injection site, fever, wheezing, SOB. Patient has taken Benadryl and noticed that hives are reducing and less itchy.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Depressed level of consciousness, Dizziness, Feeling hot, Hyperhidrosis, Mydriasis
Clinical narrative: Shortly after vaccination was administered patient started feeling faint, per patient started seeing  stars, ringing in ears, and feeling hot. When assessing the patient, she was pale, pupils dilated, sweaty, and left leg was uncontrollably shaking. Patient unable to answer questions until becoming fully conscious again. Patient fainted for approximately 2 minutes. Rapid response was initiated. Patient monitored for 15 minutes. Vitals assessed and stable. Ice packs and sprite were given to help cool off patient and help with glucose levels. Patient stable and sent home with mother.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pallor, Photopsia, Syncope, Tinnitus, Tremor
Clinical narrative: Shortly after vaccination was administered patient started feeling faint, per patient started seeing  stars, ringing in ears, and feeling hot. When assessing the patient, she was pale, pupils dilated, sweaty, and left leg was uncontrollably shaking. Patient unable to answer questions until becoming fully conscious again. Patient fainted for approximately 2 minutes. Rapid response was initiated. Patient monitored for 15 minutes. Vitals assessed and stable. Ice packs and sprite were given to help cool off patient and help with glucose levels. Patient stable and sent home with mother.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first dose of Shingrix in January 25th 2020 and received their second dose on 04 September 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number TF9HE) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th January 2020, lot number 453S4).   On 04-SEP-2024, the patient received the 2nd dose of Shingrix. On 04-SEP-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received first dose of Shingrix in January 25th 2020 and received their second dose on 04 September 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-SEP-2024 The pharmacy technician requested for the information about how to proceed after a patient received their second dose of Shingrix well beyond the six months. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: LARGE SWELLING, REDNESS OF ARM 2 DAYS LATER
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Cardioversion, Electrocardiogram, Palpitations
Clinical narrative: I woke up at 2am shaking uncontrollably and violently which I was able to stop by taking a very long hot shower. But, when I woke up this morning, my heart was racing and was arrhythmic. Turns out I was in AFIB, which I have never experienced before. I have a history of PVC's but not AFIB.  They almost had to shock me in the ambulance to restore normal heart rhythm... but we made it to the ER and with the help of three doses of metoprolol, was able to revert to normal heart rhythm.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, X-ray
Clinical narrative: I woke up at 2am shaking uncontrollably and violently which I was able to stop by taking a very long hot shower. But, when I woke up this morning, my heart was racing and was arrhythmic. Turns out I was in AFIB, which I have never experienced before. I have a history of PVC's but not AFIB.  They almost had to shock me in the ambulance to restore normal heart rhythm... but we made it to the ER and with the help of three doses of metoprolol, was able to revert to normal heart rhythm.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin swelling, Swelling
Clinical narrative: localized swelling, erythema, swelling palpated below the skin
Age: 14.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Pt had Vasovagal syncope episode following vaccination. Immediate safety measures assessment and intervention done with the pt. Pt mom and RN assisted pt to lie down, and elevated legs. Monitor VSS WNL. Pt was given OJ, water and crackers, tolerated well. Observed x 30 min, felt better. Pt discharged in stable condition. ER precaution reviewed with pt and pt mom.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Widespread hives throughout body with itching.
Sex: M
Vaccine: VARZOS
Symptoms: Retinal detachment
Clinical narrative: he developed retinal detachment 2 months after receiving the first dose of Shingrix.; This serious case was reported by a consumer via call center representative and described the occurrence of retinal detachment in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced retinal detachment (Verbatim: he developed retinal detachment 2 months after receiving the first dose of Shingrix.) (serious criteria GSK medically significant). The outcome of the retinal detachment was unknown.   It was unknown if the reporter considered the retinal detachment to be related to Shingrix.     The company considered the retinal detachment to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 13-SEP-2024 The patient was the reporter. The reporter reported that he developed retinal detachment 2 months after receiving the first dose of Shingrix. The reporter did not consent to follow-up.; Sender's Comments: Retinal detachment is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: JEV1
Symptoms: Cognitive disorder, Malaise, Mental disorder
Clinical narrative: She really got sick; She was out of her mind; She started losing comprehension and realized something was going on in her head; Two vaccinations were administered in one arm and two in the other arm; The following information was received from a consumer via distributor on 06 Sep 2024.  A 78 year old female received one dose of Japanese encephalitis vaccine, batch number not reported, i.m. on 12 Aug 2024.  Co-suspect vaccination included Rabavert (Rabies vaccine), Tetanus vaccine and Typhoid vaccine on the same day.  Two were administered in one arm and two in the other arm [constitutes a lack of vaccination site rotation].  The vaccinee reported that after vaccination she got really sick. She was hospitalised a week and a half later.  She was out of mind and slowly a couple of days before she lost comprehension and realised something was going on in her head.  Outcome was reported as ongoing.; Sender's Comments: Causality assessed as possibly related as time to onset is plausible (within 1.5 weeks after vaccination) and as general sick feeling is known to IXIARO, indicative of a systemic vaccination reaction. Mental disorders are not listed for IXIARO but might be seen as  symptoms of the general impaired health status of the vaccinee and the psychic and physical stressful situation. Nevertheless, co-suspect vaccinations with Rabavert, Tetanus vaccine and Typhoid vaccine on the same day should be taken into consideration, too.  Causality for the event Lack of vaccination site rotation is not applicable as this is no adverse event.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He mentioned that he had all of the COVID vaccinations so far and usually have arm pain for about 24 hours; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (He mentioned that he had all of the COVID vaccinations so far and usually have arm pain for about 24 hours) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (He mentioned that he had all of the COVID vaccinations so far and usually have arm pain for about 24 hours). At the time of the report, PAIN IN EXTREMITY (He mentioned that he had all of the COVID vaccinations so far and usually have arm pain for about 24 hours) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-773997 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773997:Same patient with different dose
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I have had five other Moderna vaccines (Unspecified vaccines) and never had a side effect other than a sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I have had five other Moderna vaccines (Unspecified vaccines) and never had a side effect other than a sore arm) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I have had five other Moderna vaccines (Unspecified vaccines) and never had a side effect other than a sore arm). At the time of the report, PAIN IN EXTREMITY (I have had five other Moderna vaccines (Unspecified vaccines) and never had a side effect other than a sore arm) outcome was unknown.      Concomitant medications were not reported.  Patient got a Covid booster clarified as Pfizer Covid-19 vaccine 2024-2025, lot number was reported as LM2222. That was patient's first Pfizer vaccine. Patient had got a side effect from it. Patient had five other Moderna vaccines (unspecified vaccines) and never had a side effect other than a sore arm. On day 3, patient still had 99 fever. Patient received the Pfizer covid 19 booster shot three days ago and she wants to know if the fever and body ache she was experiencing are normal and will last for how long.   Patient received the Pfizer vaccine on the left arm and the flus hot was on the other. Patient felt an irritating tickle cough that kept her up all night, but it was subsided. She had a fever that went up to 99 degrees, body aches, she couldn't eat, she did not feel good. Patient felt a little bit metter in the morning, but it was overall, malaise.  Treatment information was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19, FLUX, RVX, COVID19, FLUX, RVX
Symptoms: Ulcer
Clinical narrative: Ulceration of the smallpox scar; This spontaneous case was reported by a patient and describes the occurrence of ULCER (Ulceration of the smallpox scar) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect products included non-company products INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication and RSV VACCINE for an unknown indication.    The patient's past medical history included COVID-19 on 11-Aug-2022. Previously administered products included for Product used for unknown indication: smallpox vaccination (Smallpox scar was result of smallpox vaccination in 1960's). Past adverse reactions to the above products included Scar with smallpox vaccination.   On 28-Aug-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form, dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. On 01-Sep-2024, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ULCER (Ulceration of the smallpox scar). On 08-Sep-2024, ULCER (Ulceration of the smallpox scar) had resolved.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had no risk factor.  Concomitant product use was not provided by the reporter.  It is unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Malaise, Nausea
Clinical narrative: had a very very sore stomach; fever/low grade fever; chills; Nausea; overall sick feeling; runny nose; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (had a very very sore stomach), MALAISE (overall sick feeling), RHINORRHOEA (runny nose), PYREXIA (fever/low grade fever) and CHILLS (chills) in a 71-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer vaccine.    On 09-Sep-2024 at 2:00 PM, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 10-Sep-2024,  after starting , the patient experienced PYREXIA (fever/low grade fever). On 11-Sep-2024, the patient experienced ABDOMINAL PAIN UPPER (had a very very sore stomach). In September 2024, the patient experienced MALAISE (overall sick feeling), RHINORRHOEA (runny nose), CHILLS (chills) and NAUSEA (Nausea). On 12-Sep-2024, PYREXIA (fever/low grade fever) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (had a very very sore stomach), MALAISE (overall sick feeling), RHINORRHOEA (runny nose), CHILLS (chills) and NAUSEA (Nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2024, Body temperature: 99.9. On 11-Sep-2024, Body temperature: 99.1.         Patient received all Moderna vaccines except 1 Pfizer. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Patient stated that after every past Moderna vaccine he experienced the symptoms that he was reporting expecting for the stomach symptoms. He has never experienced stomach-related symptoms. Patient was planning on getting influenza vaccine in next few weeks. He stated the stomach issue was barely getting better.  No treatment information was reported.   This case was linked to MOD-2024-773995 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: had a very very sore stomach; fever/low grade fever; chills; Nausea; overall sick feeling; runny nose; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (had a very very sore stomach), MALAISE (overall sick feeling), RHINORRHOEA (runny nose), PYREXIA (fever/low grade fever) and CHILLS (chills) in a 71-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer vaccine.    On 09-Sep-2024 at 2:00 PM, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 10-Sep-2024,  after starting , the patient experienced PYREXIA (fever/low grade fever). On 11-Sep-2024, the patient experienced ABDOMINAL PAIN UPPER (had a very very sore stomach). In September 2024, the patient experienced MALAISE (overall sick feeling), RHINORRHOEA (runny nose), CHILLS (chills) and NAUSEA (Nausea). On 12-Sep-2024, PYREXIA (fever/low grade fever) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (had a very very sore stomach), MALAISE (overall sick feeling), RHINORRHOEA (runny nose), CHILLS (chills) and NAUSEA (Nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2024, Body temperature: 99.9. On 11-Sep-2024, Body temperature: 99.1.         Patient received all Moderna vaccines except 1 Pfizer. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Patient stated that after every past Moderna vaccine he experienced the symptoms that he was reporting expecting for the stomach symptoms. He has never experienced stomach-related symptoms. Patient was planning on getting influenza vaccine in next few weeks. He stated the stomach issue was barely getting better.  No treatment information was reported.   This case was linked to MOD-2024-773995 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: an area of inflammation on the upper arm and it grew; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLAMMATION (an area of inflammation on the upper arm and it grew) in an elderly male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (dose 1), COVID-19 vaccine (dose 2), COVID-19 vaccine (dose 3), COVID-19 vaccine (dose 7), COVID-19 vaccine (dose 5), COVID-19 vaccine (dose 6) and COVID-19 vaccine (dose 4). Past adverse reactions to the above products included No adverse effect with COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 11-Sep-2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 11-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced INFLAMMATION (an area of inflammation on the upper arm and it grew). At the time of the report, INFLAMMATION (an area of inflammation on the upper arm and it grew) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect vaccine dosage text was reported as unknown. Caller stated that her husband also had the vaccine shot that day (September 11,2024) and noticed that evening an area of inflammation on the upper arm and it grew. Reporter causality was not reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-774093 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774093:Wife case
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dry throat, Fatigue, Migraine, Pain
Clinical narrative: Fever of 102 F; Feeling fatigued; Kind of like migraine style, pounding on the side of head; Feel like has a tiny bit of an irritation in her throat; Feel like has a tiny bit of dryness in her throat; Aches, like an intermittent, very severe pain; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Kind of like migraine style, pounding on the side of head), THROAT IRRITATION (Feel like has a tiny bit of an irritation in her throat), DRY THROAT (Feel like has a tiny bit of dryness in her throat), PAIN (Aches, like an intermittent, very severe pain) and PYREXIA (Fever of 102 F) in a 52-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042879) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Sep-2024 at 4:00 PM, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 16-Sep-2024, the patient experienced MIGRAINE (Kind of like migraine style, pounding on the side of head), THROAT IRRITATION (Feel like has a tiny bit of an irritation in her throat), DRY THROAT (Feel like has a tiny bit of dryness in her throat), PAIN (Aches, like an intermittent, very severe pain) and FATIGUE (Feeling fatigued). On 17-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PYREXIA (Fever of 102 F). At the time of the report, MIGRAINE (Kind of like migraine style, pounding on the side of head), THROAT IRRITATION (Feel like has a tiny bit of an irritation in her throat), DRY THROAT (Feel like has a tiny bit of dryness in her throat), PAIN (Aches, like an intermittent, very severe pain), PYREXIA (Fever of 102 F) and FATIGUE (Feeling fatigued) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2024, Body temperature: 102 F.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2024: Live follow up received and updated references.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Fever of 102 F; Feeling fatigued; Kind of like migraine style, pounding on the side of head; Feel like has a tiny bit of an irritation in her throat; Feel like has a tiny bit of dryness in her throat; Aches, like an intermittent, very severe pain; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Kind of like migraine style, pounding on the side of head), THROAT IRRITATION (Feel like has a tiny bit of an irritation in her throat), DRY THROAT (Feel like has a tiny bit of dryness in her throat), PAIN (Aches, like an intermittent, very severe pain) and PYREXIA (Fever of 102 F) in a 52-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042879) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Sep-2024 at 4:00 PM, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 16-Sep-2024, the patient experienced MIGRAINE (Kind of like migraine style, pounding on the side of head), THROAT IRRITATION (Feel like has a tiny bit of an irritation in her throat), DRY THROAT (Feel like has a tiny bit of dryness in her throat), PAIN (Aches, like an intermittent, very severe pain) and FATIGUE (Feeling fatigued). On 17-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PYREXIA (Fever of 102 F). At the time of the report, MIGRAINE (Kind of like migraine style, pounding on the side of head), THROAT IRRITATION (Feel like has a tiny bit of an irritation in her throat), DRY THROAT (Feel like has a tiny bit of dryness in her throat), PAIN (Aches, like an intermittent, very severe pain), PYREXIA (Fever of 102 F) and FATIGUE (Feeling fatigued) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2024, Body temperature: 102 F.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2024: Live follow up received and updated references.
Sex: U
Vaccine: RSV
Symptoms: Device material issue
Clinical narrative: Vial adapter broke; Dysfunctional product; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 17Sep2024, 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: HP1193, Expiration Date: Apr2025) for immunisation, Device Lot Number: H790, Device Expiration Date: 01Aug2028. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MATERIAL ISSUE (non-serious), outcome "unknown", described as "Vial adapter broke; Dysfunctional product".  Causality for "vial adapter broke; dysfunctional product" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: A product, Abrysvo that the vial adapter broke, dysfunctional product. Little plastic couplet, nipple, in the middle, that goes onto pre filled sterile syringe, when going to insert, was kind of bent to side, piece of plastic broke off the tip. Piece snapped off, edges were sharp but not in shards for Abrysvo. It was not given to a patient. Abrysvo Diluent Syringe: LOT: HC3598, EXP: May2025, NDC: 0069-0250-01. Abrysvo Antigen Vial, Powder in unopened vial: NDC: 0069020701. The product was available to be returned. They were saving it to keep it to be returned and for a replacement.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Ear pain, Gastrooesophageal reflux disease, Influenza like illness
Clinical narrative: Felt a little sick from them (Covid vaccine) like the flu; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Covid", start date: 2021 (unspecified if ongoing), notes: I had Covid in 2021, it first came out the alpha strain and was very very sick., I had to be hospitalized (Later clarified due to Covid).; "pacemaker", start date: 1999 (unspecified if ongoing), notes: I am a pacemaker patient., I have had pacemakers for 25 years.; "Bradycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Felt a little sick from them (Covid vaccine) like the flu".  Additional information: Patient always felt a little sick from them (Covid vaccine) like the flu but nothing like this.  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-202400256951 same patient and reporter, different dose number and event;US-PFIZER INC-202400256965 same patient and reporter, different dose number and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw
Clinical narrative: Felt a little sick from them (Covid vaccine) like the flu; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Covid", start date: 2021 (unspecified if ongoing), notes: I had Covid in 2021, it first came out the alpha strain and was very very sick., I had to be hospitalized (Later clarified due to Covid).; "pacemaker", start date: 1999 (unspecified if ongoing), notes: I am a pacemaker patient., I have had pacemakers for 25 years.; "Bradycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Felt a little sick from them (Covid vaccine) like the flu".  Additional information: Patient always felt a little sick from them (Covid vaccine) like the flu but nothing like this.  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-202400256951 same patient and reporter, different dose number and event;US-PFIZER INC-202400256965 same patient and reporter, different dose number and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: Felt a little sick from them (Covid vaccine) like the flu; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Covid", start date: 2021 (unspecified if ongoing), notes: I had Covid in 2021, it first came out the alpha strain and was very very sick., I had to be hospitalized (Later clarified due to Covid).; "pacemaker", start date: 1999 (unspecified if ongoing), notes: I am a pacemaker patient., I have had pacemakers for 25 years.; "Bradycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Felt a little sick from them (Covid vaccine) like the flu".  Additional information: Patient always felt a little sick from them (Covid vaccine) like the flu but nothing like this.  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-202400256951 same patient and reporter, different dose number and event;US-PFIZER INC-202400256965 same patient and reporter, different dose number and event;
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: I always felt a little sick from them (Covid vaccine) like the flu but nothing like this.; I always felt a little sick from them (Covid vaccine) like the flu but nothing like this.; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) intramuscular for COVID-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing), notes: taking Levothyroxine 88 milligrams, once a day; "Covid", start date: 2021 (unspecified if ongoing), notes: did not stay in the hospital, I just went to the ER; "pacemaker", start date: 1999 (unspecified if ongoing), notes: I am a pacemaker patient., I have had pacemakers for 25 years.; "Bradycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Manufacturer: Pfizer), administration date: 2021, for Covid-19 immunization, reaction: "felt a little sick from them (Covid vaccine) like the flu"; Bnt162b2, administration date: 2021, for Covid-19 immunization, reaction: "felt a little sick from them (Covid vaccine) like the flu". The following information was reported: MALAISE (non-serious), INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown" and all described as "I always felt a little sick from them (Covid vaccine) like the flu but nothing like this.". Additional information: The patient and her husband got the Pfizer first, second, third, fourth, all of the shots up until this year. She always felt a little sick from them (Covid vaccine) like the flu but nothing like this. The patient took only Pfizer for all of her shots.  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-202400256951 same patient and reporter, different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After first Covid-19 shot developed dizziness.; This is a spontaneous report received from a Physician from a sales representative.  A male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WARFARIN. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "After first Covid-19 shot developed dizziness.". It was unknown if therapeutic measures were taken as a result of dizziness.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400257049 same patient, different doses/events.;US-PFIZER INC-202400257050 same patient, different doses/events.;
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: hypertension; This is a spontaneous report received from a Physician from a sales representative.  A male patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WARFARIN. Vaccination history included: Comirnaty (Dose 1), for Covid-19 immunisation, reaction(s): "dizziness". The following information was reported: HYPERTENSION (non-serious), outcome "unknown". It was unknown if therapeutic measures were taken as a result of hypertension.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400256984 same patient, different doses/events.;US-PFIZER INC-202400257050 same patient, different doses/events.;
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: soreness in the armpit which she indicated as swollen lymph nodes; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "soreness in the armpit which she indicated as swollen lymph nodes".  Additional information: Patient had soreness in her armpit which was lymph and she was asking how far in advance she should get the shot before getting breast imaging because she was due for MRI in November. Patient stated that she had got 2 or 3 shots of the Pfizer Covid vaccine before and experienced soreness in the armpit which she indicated as swollen lymph nodes. She said that she was planning to get the new Pfizer Covid19 vaccine in the fall and had a scheduled MRI for her breast. She asked how long after getting the vaccine can she get her MRI. She asked as a follow up, if she were to get the MRI first before taking the covid vaccine, how long will the protection of the vaccine take effect.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feel a little weird; This is a spontaneous report received from a Consumer or other non HCP.  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. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feel a little weird".  Additional information: consumer stated, patient just got a shot half an hour ago and patient was just wondered what was and patient ripped up the piece of paper which patient should not had ripped up and then patient was wondered, what patient looking at it said, and patient was wondered what side effects can patient get. There was dizzying, there was vomiting, there was swollen limb, there was injection, fainting. When clarified if consumer was experienced any of the side effects that was mentioned, consumer stated no. When probed for shot name, consumer stated that some kind of Covid, that might had been it. When clarified manufacturer as Pfizer for the shot, consumer stated, patient think so. Yes. Patient just got it and thought it was the new one and consumer got it at the Redacted. Consumer was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the concerned department to answer the question. Consumer stated, could you give any advice, could you tell anything. Consumer was informed to contact Pfizer Medical Information. Consumer stated, well look, act like patient was your best friend or act like patient was your mother or father and tell what the effects were could patient get, as if patient was your best friend. Consumer was requested to contact the nearest Healthcare professional. Consumer stated, ok. Patient had got a feeling, everything was going to work out. Patient do feel a little weird but of course patient had been walking too but the thing was when you get a shot you do feel feelings, Right. In response to further probing consumer stated, no because patient want to call out because patient want to also find out what was going on with me because this was dizziness and weakness and bad rash and are you going ask me anything like that or chest pain or feeling of having a fast(Incomplete sentence). Consumer further stated, patient going to pass.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a Consumer or other non HCP.  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. The following information was reported: DEATH (death), outcome "fatal", described as "died". The reporter stated that he/she knew six people who lost loved ones directly to the shot, and the reporter knew two more personally who died. The reporter stated, "That's eight people I know in my circle who died directly from it. If I know eight, there are millions." The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200104641 same reporter/drug/event, different patient;; Reported Cause(s) of Death: died
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm/pain in the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Moderna (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2024, outcome "unknown", described as "sore arm/pain in the injection site".  Additional information: AE due to pain in the injection site. Patient just had her 4th booster of COVID-19 vaccine, she started with Pfizer then last year she had Moderna and went back to Pfizer again. Caller had no reaction that she's aware of other than the sore arm.  Batch/lot number is not provided, and it cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Enlarged uvula, Headache, Hypoaesthesia, Neuropathy peripheral, Oropharyngeal pain
Clinical narrative: neuropathy; numbness and tingling from the scalp to the tongue; numbness and tingling from the scalp to the tongue; swelling of the uvula; throat pain; headache; This is a spontaneous report received from a Physician from medical information team.  A 66-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunization; Moderna (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 13Sep2024, outcome "unknown"; ENLARGED UVULA (non-serious) with onset 14Sep2024, outcome "unknown", described as "swelling of the uvula"; OROPHARYNGEAL PAIN (non-serious) with onset 14Sep2024, outcome "unknown", described as "throat pain"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 15Sep2024, outcome "not recovered" and all described as "numbness and tingling from the scalp to the tongue"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy". Therapeutic measures were taken as a result of neuropathy peripheral. Clinical course: The patient self-administered prednisone (40 mg) on Sunday, suspecting neuropathy as the underlying cause. Caller clarifies that he took Prednisone 40mg; 20mg BID on Sunday, Monday and today. States that is a moderate dose and he is 120 pounds. There were no indications of GBS, reflux deficit, or changes in bladder function. The patient has no prior medical conditions, history of systemic disease, or lumbar spinal stenosis.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: neuropathy; numbness and tingling from the scalp to the tongue; numbness and tingling from the scalp to the tongue; swelling of the uvula; throat pain; headache; This is a spontaneous report received from a Physician from medical information team.  A 66-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunization; Moderna (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 13Sep2024, outcome "unknown"; ENLARGED UVULA (non-serious) with onset 14Sep2024, outcome "unknown", described as "swelling of the uvula"; OROPHARYNGEAL PAIN (non-serious) with onset 14Sep2024, outcome "unknown", described as "throat pain"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 15Sep2024, outcome "not recovered" and all described as "numbness and tingling from the scalp to the tongue"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy". Therapeutic measures were taken as a result of neuropathy peripheral. Clinical course: The patient self-administered prednisone (40 mg) on Sunday, suspecting neuropathy as the underlying cause. Caller clarifies that he took Prednisone 40mg; 20mg BID on Sunday, Monday and today. States that is a moderate dose and he is 120 pounds. There were no indications of GBS, reflux deficit, or changes in bladder function. The patient has no prior medical conditions, history of systemic disease, or lumbar spinal stenosis.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Took Paxlovid medication, I have Pfizer vaccines; Took Paxlovid medication, I have Pfizer vaccines; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Took Paxlovid medication, I have Pfizer vaccines". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: The patient was calling for Paxlovid medication. She took three tablets from an expired pack of Paxlovid medication, that was the only information they had here. Initial consultant said that the patient's Paxlovid which expired Sep2024 was good for another 24 months, then she transferred her to another person who said that they saw her Lot number and Expiration date that her Paxlovid expired. So, she was getting two different answers, and she was a bit confused. So, she still doubted. She further stated, because she had Pfizer vaccines. So, she did not know it was kind of worrisome. She wanted to speak to someone that can set it straight. She wanted to get transferred to whoever could help. Further probing could not be done as consumer hung up the call abruptly.   Batch/lot number is not provided, and it cannot be obtained.