chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Deafness neurosensory
Clinical narrative: Sudden sensorineural hearing loss; This is a spontaneous report received from an Other HCP.  A 48-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Dec2024 at 10:00 as dose 1, single (Lot number: LN0588) at the age of 48 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 06Dec2024 as dose number unknown, single (Lot number: 946638), in left arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 8 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 9 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 10 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization. The following information was reported: DEAFNESS NEUROSENSORY (medically significant) with onset 18Dec2024 at 20:00, outcome "not recovered", described as "Sudden sensorineural hearing loss". Therapeutic measures were taken as a result of deafness neurosensory.  Clinical course: No other vaccine in four weeks. No other medications in two weeks. Patient received high dose of steroid as treatment for the event. No known allergies.; Sender's Comments: The event deafness neurosensory is conservatively assessed as related to the suspect drug BNT162B2 OMICRON (KP.2) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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: 77.0
Sex: F
Vaccine: 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, Program ID.  A 77-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "Stage 4 breast cancer" (unspecified if ongoing), notes: Small nodules in her lungs, lymphs glands, and in her bones. The patient was taking Ibrance. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2025, outcome "recovering" and all described as "COVID-19".
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Dad tested positive for COVID / dad picked up COVID; Dad tested positive for COVID / dad picked up COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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) all with onset 07Jan2025, outcome "recovering" and all described as "Dad tested positive for COVID / dad picked up COVID". The clinical course was reported as follows: Patient's daughter stated that her dad tested positive for COVID on 07Jan2025 morning and hadn't had it in all five years, right first time, went to the doctor and got nirmatrelvir/ritonavir. Reporter's mom wasn't feeling good, didn't look good on 09Jan2025 night, so she tested her. Sure enough, she was positive, got the prescription for nirmatrelvir/ritonavir on 10Jan2025 teleconference with the doctor. Reporter's dad picked up COVID and he got kicked in the butt, but he was on the renal dose. Patient stated that he didn't think he would have survived this if he hadn't had the vaccine and if he hadn't had the nirmatrelvir/ritonavir. Reporter stated that patient was doing better; he spent 2 days in bed he was doing better, and of course, then he gave it to her mom. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jan2025) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 16.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Pain in extremity, Rash
Clinical narrative: right arm soreness; Patient states right arm soreness and rash; This is a spontaneous report received from an Other HCP.  A 16-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 09Jan2025 at 15:00 as dose 1, single (Lot number: LF5308) at the age of 16 years, in right arm for immunisation; meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), on 09Jan2025 as dose 2, single (Lot number: U8256AB), in left arm. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 09Jan2025, outcome "recovering", described as "Patient states right arm soreness and rash"; VACCINATION SITE PAIN (non-serious) with onset 09Jan2025, outcome "recovering", described as "right arm soreness". It was unknown if therapeutic measures were taken as a result of vaccination site pain, vaccination site rash.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the Trumenba vaccine. Patient taking any other medications within 2 weeks of the event starting was unknown. Patient states right arm soreness and rash.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: fever/has a fever of 101 degrees.; 1 year old received the pfizer vaccine 12 and plus/was administered Pfizer vaccine for age 12 and older; 1 year old received the pfizer vaccine 12 and plus/was administered Pfizer vaccine for age 12 and older; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 1-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 1 year for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever/has a fever of 101 degrees."; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "1 year old received the pfizer vaccine 12 and plus/was administered Pfizer vaccine for age 12 and older".  Additional information: Two children (3 year old and 1 year old) received the Pfizer vaccine 12 and plus and they are having a fever. The reporter is the children's parent. They went to the doctor to get the vaccine, and they received a call that the vaccine that was administered to both patients is the Pfizer vaccine for age 12 and older. The patients have fevers at the time of the report. The reporter was asking if the children should be taken to the ER/hospital.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500008598 same drug/event; different patient;
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: A 62-year-old female patient had a period for 2 months; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 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: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "A 62-year-old female patient had a period for 2 months". The clinical course was reported as follows: The patient stated that she had the shot when Pfizer first introduced it out. When they were supposed to take it, but the side effect that she had with this shot was, she is 62, and had a period for 2 months. The patient asked if that was normal.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Chills, Fatigue, Pyrexia
Clinical narrative: head fog; chills; fever; tired and not feeling like doing anything; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient 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: BRAIN FOG (non-serious), outcome "not recovered", described as "head fog"; CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever"; FATIGUE (non-serious), outcome "recovering", described as "tired and not feeling like doing anything".  Additional information: the patient got the latest COVID-19 vaccine and he was looking for help with head fog he had after a month of having the vaccine. At first he had chills and fever that subsided and then a head fog, a really bad one; he was tired and not feeling like doing anything and it was slowly going away but not really going away. The patient had been taking water and keeping hydrated, but he was looking for recommendations on things to do to make him feel better.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: UNK
Symptoms: Chills, Cough, Ear pain, Fatigue, Influenza
Clinical narrative: Tested positive for Flu Strain A; Vaccination failure; Aches; Chills; Congestion; Severe cough; Tiredness; Pain in ears; This spontaneous case, initially received on 07-Jan-2025, was reported by a health professional and concerns a female patient.  Administration of company suspect drug: On 22-Oct-2024, the patient received Flucelvax (TIV) for Influenza Immunization, Dose regimen: 0.5 ml. Route of administration: Not reported. Anatomical location: Left Deltoid. Lot number: 946624. Expiration 30-Jun-2025, CSL Seqirus batch number 946624.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 03-Jan-2025, the patient experienced Vaccination failure (Medically Significant, outcome: Unknown). On 03-Jan-2025, the patient experienced Tested positive for Flu Strain A (Medically Significant, outcome: Unknown). Associated symptoms included: Aches, Chills, Congestion, Severe cough, Tiredness, Pain in ears.  On 03-Jan-2025, after visiting for the week, patient had returned home with aches and chills. Over the weekend, congestion, and a severe cough continued. Other symptoms consisted of tiredness, and pain in ears. Finally, after going to a local urgent care on 06-Jan-2025 she tested positive for Flu Strain A. She has been to the doctor to confirm the diagnosis, but it was not known if she has received any treatment.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the events as non-serious and causality assessment was not reported. The event Tested positive for Flu Strain A and Vaccination failure upgraded to serious considering event's clinical significance.; Reporter's Comments: Casuality: Related. Due to the spontaneous nature of the case, it is considered related for reporting purposes. Vaccination failure and Influenza is assessed as related due to provided approximate time frame from the date of vaccine which is plausible.
Sex: F
Vaccine: UNK
Symptoms: Influenza A virus test positive, Pain, Respiratory tract congestion, Vaccination failure
Clinical narrative: Tested positive for Flu Strain A; Vaccination failure; Aches; Chills; Congestion; Severe cough; Tiredness; Pain in ears; This spontaneous case, initially received on 07-Jan-2025, was reported by a health professional and concerns a female patient.  Administration of company suspect drug: On 22-Oct-2024, the patient received Flucelvax (TIV) for Influenza Immunization, Dose regimen: 0.5 ml. Route of administration: Not reported. Anatomical location: Left Deltoid. Lot number: 946624. Expiration 30-Jun-2025, CSL Seqirus batch number 946624.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 03-Jan-2025, the patient experienced Vaccination failure (Medically Significant, outcome: Unknown). On 03-Jan-2025, the patient experienced Tested positive for Flu Strain A (Medically Significant, outcome: Unknown). Associated symptoms included: Aches, Chills, Congestion, Severe cough, Tiredness, Pain in ears.  On 03-Jan-2025, after visiting for the week, patient had returned home with aches and chills. Over the weekend, congestion, and a severe cough continued. Other symptoms consisted of tiredness, and pain in ears. Finally, after going to a local urgent care on 06-Jan-2025 she tested positive for Flu Strain A. She has been to the doctor to confirm the diagnosis, but it was not known if she has received any treatment.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the events as non-serious and causality assessment was not reported. The event Tested positive for Flu Strain A and Vaccination failure upgraded to serious considering event's clinical significance.; Reporter's Comments: Casuality: Related. Due to the spontaneous nature of the case, it is considered related for reporting purposes. Vaccination failure and Influenza is assessed as related due to provided approximate time frame from the date of vaccine which is plausible.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Developed afib 2 days after receiving the 2nd dose of Shingrix
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Additional Details: Patient reported feeling extremely tired for a day after getting the shot
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Additional Details: Patient reported feeling extremely tired
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Dermatitis allergic, Injection site erythema, Injection site pain, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Upset stomach-Medium, Additional Details: Patient reported that she feels upset stomach and light headed after receiving all vaccines, Other Vaccines:  VaccineTypeBrand: PREVNAR 20; Manufacturer: PFIZER; LotNumber: ; Route: ; BodySite: ; Dose: 1; VaxDate: 04/04/2024
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Lethargy, Nausea
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Nausea-Medium, Additional Details: got on the same day as boostrix but that was given in the right deltoid muscle
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Pruritus, Pruritus allergic
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Just a few minutes following vaccine administration, patient began to stand up from chair and fainted (fell backwards into privacy wall, knocking it over). Pt quickly regained consciousness and face/lips looked pale. Pt was helped back into seated position where he remained for approximately 15-20 minutes. EMS was not needed and pt walked out of pharmacy recovered. Pt did indicate on questionaire/consent form that he has gotten dizzy or fainted before, during or after immunization., Other Vaccines:  VaccineTypeBrand: Influenza seasonal Flucelvax Trivalent; Manufacturer: Seqirus, INC.; LotNumber: 946606; Route: intramuscular; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient stated burning, itchiness, redness and swelling started about 5 to 6 hours after injection. Patient went to urgent care and was given prednisone and cephalexin.
Age: 61.0
Sex: M
Vaccine: RSV
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Pallor
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: wife noticed patient's face went pale after the second shot was given (Abrysvo in right arm), and recognized signs of syncope and vasovagal response which patient has a hx of in response to pain.  Pt became confused, & non responsive verbally.  Rx tech and wife assisted patient to the floor for safety.  A instant cold pack was given to put on back of his neck (trick that worked for family during previous episodes).  After about 15 min patient pt became verbal, but still confused,  called EMS., Other Vaccines:  VaccineTypeBrand: Prevnar; Manufacturer: Pfizer; LotNumber: LG5579; Route: IM; BodySite: Left Arm; Dose: 0; VaxDate: UNKNOWN
Age: 61.0
Sex: M
Vaccine: RSV
Symptoms: Presyncope, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: wife noticed patient's face went pale after the second shot was given (Abrysvo in right arm), and recognized signs of syncope and vasovagal response which patient has a hx of in response to pain.  Pt became confused, & non responsive verbally.  Rx tech and wife assisted patient to the floor for safety.  A instant cold pack was given to put on back of his neck (trick that worked for family during previous episodes).  After about 15 min patient pt became verbal, but still confused,  called EMS., Other Vaccines:  VaccineTypeBrand: Prevnar; Manufacturer: Pfizer; LotNumber: LG5579; Route: IM; BodySite: Left Arm; Dose: 0; VaxDate: UNKNOWN
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Systemic: Fever-Mild, Additional Details: patient stated she always gets sick for a few days after taking the vaccine.
Age: 34.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Pharm. D gave Patient pfizer comirnaty and flublock influenza vaccine. When patient recieved vaccinations, the rph hand shook while administering the vaccine. Patient still recieved both vaccinations in the correct location of the left deltioid.  , Other Vaccines:  VaccineTypeBrand: comirnaty; Manufacturer: pfizer; LotNumber: ln0589; Route: im; BodySite: left; Dose: ; VaxDate: UNKNOWN
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Received a call from the mother (2:06pm) several hrs after pt received the vaccine, stating that his son's elbow has a rash and pt's arm and hands are numb. Informed the mother to take pt to the ER or urgent care. I called at 4:55pm to see the condition of the pt, but mother states that they just arrived to ER and pt's symptoms are still the same. Informed mother to keep us informed or I will call back the following day.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Lethargy, Pain
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Butterfly rash, Injection site pruritus, Lyme disease, Rash pruritic, Systemic lupus erythematosus
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Butterfly rash, itchy - was told lyme then lupus-Medium
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Deafness unilateral
Clinical narrative: Systemic: Hearing loss in right ear (about 10% hearing)-Medium
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site necrosis, Injection site nodule, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: local swelling, knot, necrosis - likely to leave a scar
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: local swelling, knot, necrosis - likely to leave a scar
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Systemic: Chills-Severe, Systemic: Fever-Severe, Additional Details: Date is approximate because patient stated it was the 4th or 5th dose of the Covid vaccine that caused her symptoms. Patient reports also not feeling well after her recent (8/26/24) Fluzone High Dose Triv but could not provide any details other than she felt "sick"
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lethargy, Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Patient states similar effects for the last 3 Covid vaccinations received
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Mouth swelling, Rash, Rash pruritic
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient stated start having swelling of eyes and rash on face. She came in the pharmacy today and said gotten better but wanted cream to relieve the itching and benadryl since doctor told patient to go to the pharmacy to get OTC meds. No more swelling but redness on face is still present.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient stated start having swelling of eyes and rash on face. She came in the pharmacy today and said gotten better but wanted cream to relieve the itching and benadryl since doctor told patient to go to the pharmacy to get OTC meds. No more swelling but redness on face is still present.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Systemic: Chills-Medium, Systemic: Fever-Medium, Additional Details: Flu-like symptoms
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Pyrexia
Clinical narrative: Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Cold-Mild, Additional Details: Patient reported having bad reaction such as a cold, fever, chills and it last for a couple of days.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Systemic: pt complained about severe muscle spasm and pharmacy called EMS-Severe, Additional Details: pt complained about severe muscle spasm throughout her body and she complained about feeling it the most in her throat and chest. Pharmacy called EMS with pt consent., Other Vaccines:  VaccineTypeBrand: influenza vaccine; Manufacturer: seqirus; LotNumber: 946619; Route: im; BodySite: right arm; Dose: 1; VaxDate: 01/10/2025
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: varvivax with diluent; Manufacturer: merck; LotNumber: Y011020; Route: subcutaneous; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Systemic: Vomiting-Mild, Additional Details: This was for the flucelevax trivalent-quadravalent was only formulation listed
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: Patient stated that symptoms just lasted a few hours
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Dermatitis contact, Injection site vesicles, Wound
Clinical narrative: Systemic: PATIENT REPORTED OPEN WOUND BLISTER FROM ADHESIVE FROM BANDAID USED-Medium, Additional Details: PATIENT REPORTED RX COMPLAINT IN MY CUSTOMER CONNECTION 01/10/2025 THAT HE EXPERIENCED AN OPEN WOUND BLISTER FROM ADHESIVE. I CALLED HIM AS A FOLLOW UP 01/13/2025 TO GET MORE DETAIL AND FIND OUT IF THERE WAS ANYTHING ELSE HE WOULD LIKE ME TO ADD TO ADVERSE EVENT REPORT. HE DID NOT SEEK ANY ADDITIONAL MEDICAL CARE OR REQUIRED ANY URGENT CARE VISIT. IN SPEAKING HE SAID IT WAS BETTER TODAY. I ASKED HIM IF IN THE FUTURE HE USES PHARMACY FOR ANY ADDITIONAL VACCINES TO PLEASE MAKE SURE WE ARE AWARE., Other Vaccines:  VaccineTypeBrand: COVID; Manufacturer: PFIZER; LotNumber: LN0588; Route: IM; BodySite: LEFT ARM; Dose: 1; VaxDate: 01/06/2025
Age: 50.0
Sex: M
Vaccine: PNC21
Symptoms: Dizziness, Malaise, Syncope
Clinical narrative: Patient received 2 vaccines Capvaxive and Flublok. Patient fainted and was not feeling well for about 15 minutes post vaccines. We gave patient a cold pack to put on his neck and gave him a soda to drink to increase blood sugar. We also had patient sit on floor after he started feeling dizzy and faint.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Pallor, Tremor
Clinical narrative: Pt was sitting in the upright position, prepared left deltoid, IM injection given, spot band-aid applied. pt was sitting calmly. I proceeded to prepare right deltoid area and pt stated she needed to lay back. Pt was directed to lay down, I proceeded to elevate her feet. I noticed pt became very pale, started to shake, gasping for breaths were noted. Mother was immediately by her side as I continued to talk to the patient. approximately 10 seconds passed and pt awoke startled, she tried to jump up to her feet, her mother and myself calmly held her and stopped her from standing. pt was able to understand us at that time and we were able to get her to lay down, provider was called immediately, mother remained next to her. provider came to the room, an ice pack was placed to the back of pt neck, cold wet towels placed to her forehead and abdomen area. pt slowly became aware of what had happened. pt remained laying as provider talked to her and mother. 2 4 ounce containers of juice were given to the pt. pt tolerated and was able to regain color back in her face. Pt mother, at that time declined/refused that she receive the Meningococcal B vaccine, which would have been #1 in the series. pt recovered approximately 15 min after vaccine administration, she ambulated on her own, with her mother nearby with no further concerns noted.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no none adverse reactions
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain
Clinical narrative: persistent musculoskeletal pain
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Lethargy, Myalgia
Clinical narrative: The patient's symptoms included myalgia, lethargy, and a loss of taste, which has persisted for seven weeks.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Butterfly rash, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Chills, headache, fatigue, diarrhea, soreness of butt and thighs, soreness at injection site
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Chills, headache, fatigue, diarrhea, soreness of butt and thighs, soreness at injection site
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Magnetic resonance imaging abnormal, Pain in extremity, Periarthritis, X-ray
Clinical narrative: left arm pain, reduced range of motion.  MRI in December revealed Adhesive Capsulitis.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient states her Left arm still hurts/aches  from time to time in the area where she received her Flu vaccine. She was given vaccine on October 23rd, 2024. She is able to move and use her Left arm.  She has not had another vaccine since in that arm. She has not contacted her doctor as of yet. She states vaccine was giving  lower than she is used to.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain, Pain in jaw
Clinical narrative: Patient reported Headaches,  Jaw pain,  and pains throughout body.   Patient took Fioricet, Ibuprofen, and Ajovy Injection to get pain to subside but will only last for a couple of hours before reoccurring.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bursitis, Hypoaesthesia, Immediate post-injection reaction, Joint range of motion decreased
Clinical narrative: Nurse administered the vaccine into subacromial space rather than the deltoid muscle. This caused immediate pain on administration and inability to move. Left shoulder within 20 minutes following the injection. Have experienced ongoing left shoulder pain, left arm numbness and tingling, and restricted range of motion due to pain since that time. Three weeks after initial injection, range of motion significantly worsened as well as the pain, which also affected ability to sleep. Was evaluated on 11/15/24, diagnosed with SIRVA, tendonitis, and bursitis. X-ray completed 11/15/24 was normal. Took Medrol dosepak at that time. Continued use of Aleve twice daily. Multiple visits with occupational medicine since then and physical therapy, and this has continued since that time.  Dry needling has been helpful in reducing the numbness and tingling in the arm. Continued pain deep in the shoulder joint and ligaments. Pain persists with flexion, extension, and external rotation of the shoulder. Evaluated by orthopedics 1/15/25, received Kenalog 80mg injection into shoulder joint. MRI to follow in a couple weeks. The influenza vaccine is not to blame for the injury, incorrect administration of the vaccine into the subacromial space is what caused the injury.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Ligament pain, Mobility decreased, Pain, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Nurse administered the vaccine into subacromial space rather than the deltoid muscle. This caused immediate pain on administration and inability to move. Left shoulder within 20 minutes following the injection. Have experienced ongoing left shoulder pain, left arm numbness and tingling, and restricted range of motion due to pain since that time. Three weeks after initial injection, range of motion significantly worsened as well as the pain, which also affected ability to sleep. Was evaluated on 11/15/24, diagnosed with SIRVA, tendonitis, and bursitis. X-ray completed 11/15/24 was normal. Took Medrol dosepak at that time. Continued use of Aleve twice daily. Multiple visits with occupational medicine since then and physical therapy, and this has continued since that time.  Dry needling has been helpful in reducing the numbness and tingling in the arm. Continued pain deep in the shoulder joint and ligaments. Pain persists with flexion, extension, and external rotation of the shoulder. Evaluated by orthopedics 1/15/25, received Kenalog 80mg injection into shoulder joint. MRI to follow in a couple weeks. The influenza vaccine is not to blame for the injury, incorrect administration of the vaccine into the subacromial space is what caused the injury.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Shoulder injury related to vaccine administration, Sleep disorder, Tendonitis, X-ray limb normal
Clinical narrative: Nurse administered the vaccine into subacromial space rather than the deltoid muscle. This caused immediate pain on administration and inability to move. Left shoulder within 20 minutes following the injection. Have experienced ongoing left shoulder pain, left arm numbness and tingling, and restricted range of motion due to pain since that time. Three weeks after initial injection, range of motion significantly worsened as well as the pain, which also affected ability to sleep. Was evaluated on 11/15/24, diagnosed with SIRVA, tendonitis, and bursitis. X-ray completed 11/15/24 was normal. Took Medrol dosepak at that time. Continued use of Aleve twice daily. Multiple visits with occupational medicine since then and physical therapy, and this has continued since that time.  Dry needling has been helpful in reducing the numbness and tingling in the arm. Continued pain deep in the shoulder joint and ligaments. Pain persists with flexion, extension, and external rotation of the shoulder. Evaluated by orthopedics 1/15/25, received Kenalog 80mg injection into shoulder joint. MRI to follow in a couple weeks. The influenza vaccine is not to blame for the injury, incorrect administration of the vaccine into the subacromial space is what caused the injury.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mom stated swelling and warmth noted on left arm almost down to the elbow the next day after receiving vaccine. Mom stated there was a circle of redness like an raised doughnut that spread down towards the elbow. Mom stated this redness and swelling was painful for the child and the child was given Motrin then in a few hours Tylenol. Mom stated today the area is slightly fading and there is less of a complaint from the child. Mom denies child having a bug or insect bite. Mom stated definitely from the shot.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was accidentally given a second dose of Arexvy, First dose was administered 4/25/2024
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: Cough, Hypersensitivity, Swelling face, Urticaria
Clinical narrative: Within hours of receiving polio vaccine patient "start cough, swelling face, hives generalized." Patient was seen at Urgent Care facility and urticarial rash was noted. Patient was treated for allergic reaction with signs concerning for evolving anaphylaxis per review of Urgent Care note. Patient was treated with prednisone, diphenhydramine, albuterol treatment. Symptoms resolved.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, HPV9, RV5
Symptoms: Infant irritability, Product administered to patient of inappropriate age, Pyrexia, Vomiting, Wrong product administered
Clinical narrative: was suppose to receive PCV20, instead received HPV9. had fever on vomiting the night of. was irritable for 2 days after. on 01/16/2025 was stable and better
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Rash, Rash macular, Urticaria
Clinical narrative: PATIENT EXPERIENCED NEAR ANAPHYLAXIS, HAD BLOTCHY NECK WITH RASH AND HIVES, BEGAN TO HAVE TROUBLE BREATHING AND TOOK BENADRYL IMMEDIATELY. REACTION OCCURED 3HRS POST IMMUNIZATION
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epistaxis
Clinical narrative: PATIENT REPORTED POSSIBLE ADVERSE REACTIONS FOLLOWING ADMINISTRATION OF COVID-19 VACCINE. HE STATES THAT IN OCTOBER 2024 HE EXPERIENCED NOSE BLEEDS ONCE WEEKLY LASTING A FEW SECONDS. IN NOVEMBER 2024 HE EXPERIENCED NOSE BLEEDS 2 TIMES WEEKLY, AND IN DECEMBER 2024 AND JANUARY 2025 HE EXPERIENCED NOSE BLEEDS 3-4 TIMES PER DAY ALSO LASTING A FEW SECONDS.   HE IS NOT DIZZY OR WEAK, NOR HAS HE STARTED ANY NEW MEDICTIONS.  I TOLD HIM TO CONSULT WITH HIS PHYSICIAN
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Vascular pain
Clinical narrative: PATIENT REPORTED POSSIBLE ADVERSE REACTIONS FOLLOWING ADMINISTRATION OF COVID-19 VACCINE. HE STATES THAT IN OCTOBER 2024 HE EXPERIENCED NOSE BLEEDS ONCE WEEKLY LASTING A FEW SECONDS. IN NOVEMBER 2024 HE EXPERIENCED NOSE BLEEDS 2 TIMES WEEKLY, AND IN DECEMBER 2024 AND JANUARY 2025 HE EXPERIENCED NOSE BLEEDS 3-4 TIMES PER DAY ALSO LASTING A FEW SECONDS.   HE IS NOT DIZZY OR WEAK, NOR HAS HE STARTED ANY NEW MEDICTIONS.  I TOLD HIM TO CONSULT WITH HIS PHYSICIAN
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site mass, Injection site pain, Pain
Clinical narrative: I received my COVID vaccine on 10/18/24 and on 10/19/24 I noted a hard area around the vaccination site. It was not red or warm to touch.  I then started to have pain in my right upper arm, I was just thinking it was soreness from the vaccine. The pain did not improve and started to increase with movement. I went to my PCP on 12/17/24 and she prescribed Voltaren gel. I tried the Voltaren gel for a few weeks with no improvement. I reached out to my PCP and she referred me to orthopedics. I saw orthopedics on 1/13/25 and they completed x-rays. X-rays were normal and they stated that my nerve in my shoulder/upper arm was irritated along with my rotator cuff muscle due to the vaccine. I was prescribed meloxicam and home exercises. I am to return if there is no improvement. At this time, there has been slight improvement, but I am still having pain.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Nervous system disorder, Pain, Vaccination site induration, X-ray normal
Clinical narrative: I received my COVID vaccine on 10/18/24 and on 10/19/24 I noted a hard area around the vaccination site. It was not red or warm to touch.  I then started to have pain in my right upper arm, I was just thinking it was soreness from the vaccine. The pain did not improve and started to increase with movement. I went to my PCP on 12/17/24 and she prescribed Voltaren gel. I tried the Voltaren gel for a few weeks with no improvement. I reached out to my PCP and she referred me to orthopedics. I saw orthopedics on 1/13/25 and they completed x-rays. X-rays were normal and they stated that my nerve in my shoulder/upper arm was irritated along with my rotator cuff muscle due to the vaccine. I was prescribed meloxicam and home exercises. I am to return if there is no improvement. At this time, there has been slight improvement, but I am still having pain.
Age: 58.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received vaccine on Thursday afternoon, by early Friday AM whole body was achy with a low-grade fever which is normal for me when I get shots. But by Saturday, I noticed the area below the injection site started getting redder and redder which is not normal. Red area spread across upper arm and got worse and worse each day, until by Wednesday, Jan 15, area was very swollen, bright red, and very hot. Visited nurse at work who recommended I immediately see a doctor (concerned about cellulitis). Made doc appointment but started finally improving so cancelled doc appointment. Still red on Friday, Jan 17, but getting better and not hot anymore.
Age: 58.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Received vaccine on Thursday afternoon, by early Friday AM whole body was achy with a low-grade fever which is normal for me when I get shots. But by Saturday, I noticed the area below the injection site started getting redder and redder which is not normal. Red area spread across upper arm and got worse and worse each day, until by Wednesday, Jan 15, area was very swollen, bright red, and very hot. Visited nurse at work who recommended I immediately see a doctor (concerned about cellulitis). Made doc appointment but started finally improving so cancelled doc appointment. Still red on Friday, Jan 17, but getting better and not hot anymore.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JAN-2025. This case was reported by a patient via interactive digital media. Patient had the vaccine and then got shingles.  Same with Covid, same with flu.  Not sure if patient believed in vaccines anymore. This case was considered as suspected vaccination failure as detail regarding completion of primary vaccination, laboratory test confirming shingles and time to onset were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Myalgia, Nasal congestion, Nausea
Clinical narrative: whole body myalgia; nasal congestion; The health professional administered the vaccine through a regular band aid, rather than an intended barrier bandage; burning pain at the injection site; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID vaccine (she took vaccine 3 weeks ago).   On 15-DEC-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 15-DEC-2024, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: burning pain at the injection site), nausea (Verbatim: nausea) and wrong technique in product usage process (Verbatim: The health professional administered the vaccine through a regular band aid, rather than an intended barrier bandage). On 16-DEC-2024, the patient experienced myalgia (Verbatim: whole body myalgia) and nasal congestion (Verbatim: nasal congestion). The patient was treated with ibuprofen (Advil). On 15-DEC-2024, the outcome of the nausea was resolved.  On 17-DEC-2024, the outcome of the myalgia was resolved (duration 1 day). The outcome of the injection site pain was not resolved and the outcome of the nasal congestion was resolved and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site pain, nausea, myalgia and nasal congestion to be related to Shingrix.     It was unknown if the company considered the injection site pain, nausea, myalgia and nasal congestion to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-DEC-2024 The health professional (pharmacist/vaccinator) administered the vaccine through a regular (opaque, gauze centered) band-Aid, rather than an intended barrier bandage, which led to wrong technique in product usage process. The patient immediately had burning pain at the injection site and immediately, briefly, had nausea. The patient believed the nausea may have been due to the intensity of the pain. The next day she had whole body myalgia and took Advil and the myalgia resolved after one day.  She had nasal congestion the day after vaccination. The patient did not know the batch number or expiration date. Nothing else was reported.