chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: RSV, UNK
Symptoms: Chills, Cough, Diarrhoea, Myalgia, Pain
Clinical narrative: 104 degree fever; chills to the point where he was violently shaking; shakes; muscle aches; massive diarrhea; vomiting; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received pf-06928316 (ABRYSVO), on 19Sep2023 at 09:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in right deltoid for immunisation; fluconazole (FLUZONE [FLUCONAZOLE]), on 19Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (medically significant) with onset 19Sep2023 at 22:00, outcome "unknown", described as "104 degree fever"; CHILLS (non-serious) with onset 19Sep2023 at 22:00, outcome "unknown", described as "chills to the point where he was violently shaking"; COUGH (non-serious) with onset 19Sep2023 at 22:00, outcome "not recovered"; DIARRHOEA (non-serious) with onset 19Sep2023 at 22:00, outcome "not recovered", described as "massive diarrhea"; MYALGIA (non-serious) with onset 19Sep2023 at 22:00, outcome "not recovered", described as "muscle aches"; TREMOR (non-serious) with onset 19Sep2023 at 22:00, outcome "unknown", described as "shakes"; VOMITING (non-serious) with onset 19Sep2023 at 22:00, outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: (19Sep2023) 104 degree. Therapeutic measures were taken as a result of pyrexia, myalgia, cough. Clinical course: He was calling about the RSV Vaccine, Abrysvo vial with diluent. He had a reaction to it and the reaction was somewhat severe. He never had a reaction to any vaccine. Describes the reaction as him having a 104 degree fever, shakes, chills to the point where he was violently shaking, massive diarrhea, vomiting, muscle aches. Everything mentioned above started on the night of 19Sep2023. He took Tylenol for treatment. He still has a little bit of aching and a cough, still a little bit of diarrhea but not as bad as it was. His fever broke. Patient got Flu vaccine, Fluzone once a year.  The information on the batch/lot number for pf-06928316 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: RSV, UNK
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: 104 degree fever; chills to the point where he was violently shaking; shakes; muscle aches; massive diarrhea; vomiting; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received pf-06928316 (ABRYSVO), on 19Sep2023 at 09:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in right deltoid for immunisation; fluconazole (FLUZONE [FLUCONAZOLE]), on 19Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (medically significant) with onset 19Sep2023 at 22:00, outcome "unknown", described as "104 degree fever"; CHILLS (non-serious) with onset 19Sep2023 at 22:00, outcome "unknown", described as "chills to the point where he was violently shaking"; COUGH (non-serious) with onset 19Sep2023 at 22:00, outcome "not recovered"; DIARRHOEA (non-serious) with onset 19Sep2023 at 22:00, outcome "not recovered", described as "massive diarrhea"; MYALGIA (non-serious) with onset 19Sep2023 at 22:00, outcome "not recovered", described as "muscle aches"; TREMOR (non-serious) with onset 19Sep2023 at 22:00, outcome "unknown", described as "shakes"; VOMITING (non-serious) with onset 19Sep2023 at 22:00, outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: (19Sep2023) 104 degree. Therapeutic measures were taken as a result of pyrexia, myalgia, cough. Clinical course: He was calling about the RSV Vaccine, Abrysvo vial with diluent. He had a reaction to it and the reaction was somewhat severe. He never had a reaction to any vaccine. Describes the reaction as him having a 104 degree fever, shakes, chills to the point where he was violently shaking, massive diarrhea, vomiting, muscle aches. Everything mentioned above started on the night of 19Sep2023. He took Tylenol for treatment. He still has a little bit of aching and a cough, still a little bit of diarrhea but not as bad as it was. His fever broke. Patient got Flu vaccine, Fluzone once a year.  The information on the batch/lot number for pf-06928316 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: I suffered with severe tachycardia about 9 hrs after dose. Tachycardia lasted about 15 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "CHF" (unspecified if ongoing); "HTN" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; METOPROLOL; HCTZ. Past drug history included: Augmentin, reaction(s): "Drug allergy: Augmentin". Vaccination history included: Covid-19 vaccine (Dose number: 3 Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose number: 2 Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose number: 1 Unknown manufacturer), for Covid-19 immunization. The following information was reported: TACHYCARDIA (non-serious) with onset 21Sep2023 at 20:00, outcome "unknown", described as "I suffered with severe tachycardia about 9 hrs after dose. Tachycardia lasted about 15 minutes". Therapeutic measures were not taken as a result of tachycardia.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Scab
Clinical narrative: It was the size of a quarter and now is smaller the size of a dime, it does not itch or hurt, but it is scabby; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pf-06928316 (ABRYSVO), on 06Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SCAB (non-serious) with onset 08Sep2023, outcome "unknown", described as "It was the size of a quarter and now is smaller the size of a dime, it does not itch or hurt, but it is scabby". Additional information: Patient received Abrysvo vaccine on 06Sep2023, it didn't itch or hurt, she noticed it in the mirror two days later on the 08Sep2023. It was the size of a quarter and now is smaller the size of a dime, it does not itch or hurt, but it is scabby.   The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Dizziness, Photosensitivity reaction, Vaccination site pain, Vomiting
Clinical narrative: 24 hours after administration the patient developed dizziness, lightheaded, photosensitivity, arm pain around injection site, and vomiting.; 24 hours after administration the patient developed dizziness, lightheaded, photosensitivity, arm pain around injection site, and vomiting.; 24 hours after administration the patient developed dizziness, lightheaded, photosensitivity, arm pain around injection site, and vomiting.; 24 hours after administration the patient developed dizziness, lightheaded, photosensitivity, arm pain around injection site, and vomiting.; This is a spontaneous report received from non-contactable reporter (Pharmacist).  A 42-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 11:00 as dose 1, single (Lot number: HH7595) intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 19Sep2023 as dose 1, single (Lot number: 944458), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), DIZZINESS (non-serious), PHOTOSENSITIVITY REACTION (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 20Sep2023 at 08:00, outcome "recovered" and all described as "24 hours after administration the patient developed dizziness, lightheaded, photosensitivity, arm pain around injection site, and vomiting.". Therapeutic measures were not taken as a result of vomiting, dizziness, photosensitivity reaction, vaccination site pain. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Discomfort, Dizziness, Nausea, Pallor, Tremor
Clinical narrative: The patient started complaining of dizziness and nausea a couple of minutes after the vaccine was given. Said he felt how the medication was going in the muscle and he didn't feel comfortable. Called Dr. and then he started getting pale and started shaking as if he had a seizure. Dr. stayed with the patient and he started to get some color back and began to feel better after about 10 minutes. The patient was observed in the room and released after 15 mins. He was able to walk out and advised his mom to keep an eye on him at home. Let us know if there are any questions.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Swelling face
Clinical narrative: Swelling of r side of face and lower lip lasted 48 hours.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Dysphonia, Productive cough
Clinical narrative: The day after dose, pt stated that she experienced a dry cough and hoarseness. She stated that her cough became more wet/phlegm in nature a few days later
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Muscular weakness, Pain
Clinical narrative: At the time of the injection I noticed it bled more than normal. Within a couple hours I had developed a visible bruise that took 2.5 weeks to go away. My arm hurt which is to be expected but now it?s been 6.5 weeks and it hurts to lift or twist my arm, feels weak and painful. Some days worse than others.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: At the time of the injection I noticed it bled more than normal. Within a couple hours I had developed a visible bruise that took 2.5 weeks to go away. My arm hurt which is to be expected but now it?s been 6.5 weeks and it hurts to lift or twist my arm, feels weak and painful. Some days worse than others.
Age: 71.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blood test, Platelet count, Thrombocytopenia
Clinical narrative: Pt admitted to hospital on 9/5/23 for thrombocytopenia from COVID vaccine and discharged on 9/11/23 from Hospital. Pt still getting blood work done weekly to check platelets and if they don't go down then pt will be put on meds.
Age: 71.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: Pt admitted to hospital on 9/5/23 for thrombocytopenia from COVID vaccine and discharged on 9/11/23 from Hospital. Pt still getting blood work done weekly to check platelets and if they don't go down then pt will be put on meds.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Pruritus, Swelling
Clinical narrative: patient called the pharmacy and said that she experienced redness, itching, swelling, and nausea the day after she received her vaccination.  Patient said she went to urgent care to receive treatment and was prescribed prednisone to help with her symptoms
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives (redness, itchy) that come with any contact. They come and go.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: fever/chills, swollen lymph node in left armpit, fatigue
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Cellulitis, redness at injection site, rash, hard, swollen, extremely  painful, rash, fever
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pyrexia, Rash
Clinical narrative: Cellulitis, redness at injection site, rash, hard, swollen, extremely  painful, rash, fever
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Heart rate irregular, Muscular weakness
Clinical narrative: Rapid and irregular heartbeat, shortness of breath, weakness in legs on 9/8/2023.  On 9/10/2023 & 9/11/2023 I had intermittent chest pain.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever  body ache  Chills Headache
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal distension, Arthralgia, Pain in extremity
Clinical narrative: Shoulder and arm pain, swelling for over 2 weeks after vaccination (not yet resolved)
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling cold, Pyrexia
Clinical narrative: Severe uncontrollable chills,  could not get warm. fever of 101.8.  Almost went to the E.R. Symptoms lasted about 5 hours,  from 6PM - 11PM
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Rash
Clinical narrative: muscle pain, tiredness, rashes
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Myalgia, Pyrexia
Clinical narrative: patient came back 4 days later stating that her lower part of her bicep was red and hurting. Stated she felt feverish every day but not currently.
Age: 48.0
Sex: F
Vaccine: FLUA4
Symptoms: Blister, Rash, Rash erythematous, Skin warm, White blood cell count normal
Clinical narrative: I got a flu shot on Saturday afternoon (9/23/23) and shortly after noticed a red rash that was warm. Sunday, the rash expanded, the rash was still warm to the touch, and a blister appeared on my skin. Monday, I went to the doctor. I had a white blood cell test performed (it's fine) and received a series of antibiotics - a shot in the urgent care office and an oral prescription for 7 days. I've had to mark my arm to monitor the growth of the rash and blister.
Age: 8.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Extra dose administered
Clinical narrative: Reporting system showed patient in need of FLU, Hep A, MMR, Varicella, Tdap, and IPV.  Post vaccine administration mother presented staff with written vaccine record to enter today's vaccines.  It was discovered patient had vaccines administered prior at a clinic never reported to the state immunization reporting system therefore did not show up in the reports pulled prior to vaccine administration.  Doses have been entered as historicals.  Parent aware of extraneous doses and advised to return to clinic for any reason or adverse reaction or to call Emergency.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Electrocardiogram normal
Clinical narrative: Episode of EKG device confirmed atrial fibrillation initiated 13 hours after vaccination. Treated with metoprolol and flecainide., resolved in 2 hours .
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Fatigue, Headache, Immune system disorder, Immunisation reaction
Clinical narrative: Sep20: Receive vaccination Sep21-22: Slight prickly sensation like previously experienced with boosters plus normal injection site soreness, began to notice being a bit sniffly. Sep23: Very runny nose, periodic cough, increased prickly sensation, temp 99-100. Fitful sleep Sep24: Temp 101-102, increased sinus congestion and headache, still frequent runny nose and periodic cough. Went to urgent case - lungs and heart sounded fine, ears and throat clear, nasal passages inflamed, but nothing that indicated an infection. Practitioner recommended symptomatic relief with ibuprofen and acetaminophen and to follow up with primary care if not feeling better by Wed 27Sep. The ibuprofen and acetaminophen helped. Sep25: Runny nose and period cough continued, temp 99 with the ibuprofen/acetaminophen regimen. Very tired - slept much of afternoon. Through the night developed sore throat. Sep26: Sore throat throughout the day, but it did not look like strep from my personal experience. Fatigued. Temp 99. Sinuses still tender, but began feeling a little better overall in the evening, so discontinued ibuprofen/acetaminophen. Sep27: Throat less sore, nose not running as much, not coughing as much. Temp 98.6-99 without ibuprofen/acetaminophen. Had online visit with primary case - assessment is that this is immune response to vaccination rather than other infection. Still fatigued ? slept in the afternoon. Mild sinus headache this evening.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain, Nasal inflammation, Oropharyngeal pain, Paraesthesia, Poor quality sleep
Clinical narrative: Sep20: Receive vaccination Sep21-22: Slight prickly sensation like previously experienced with boosters plus normal injection site soreness, began to notice being a bit sniffly. Sep23: Very runny nose, periodic cough, increased prickly sensation, temp 99-100. Fitful sleep Sep24: Temp 101-102, increased sinus congestion and headache, still frequent runny nose and periodic cough. Went to urgent case - lungs and heart sounded fine, ears and throat clear, nasal passages inflamed, but nothing that indicated an infection. Practitioner recommended symptomatic relief with ibuprofen and acetaminophen and to follow up with primary care if not feeling better by Wed 27Sep. The ibuprofen and acetaminophen helped. Sep25: Runny nose and period cough continued, temp 99 with the ibuprofen/acetaminophen regimen. Very tired - slept much of afternoon. Through the night developed sore throat. Sep26: Sore throat throughout the day, but it did not look like strep from my personal experience. Fatigued. Temp 99. Sinuses still tender, but began feeling a little better overall in the evening, so discontinued ibuprofen/acetaminophen. Sep27: Throat less sore, nose not running as much, not coughing as much. Temp 98.6-99 without ibuprofen/acetaminophen. Had online visit with primary case - assessment is that this is immune response to vaccination rather than other infection. Still fatigued ? slept in the afternoon. Mild sinus headache this evening.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, Sinus congestion, Sinus headache, Sinus pain, Somnolence
Clinical narrative: Sep20: Receive vaccination Sep21-22: Slight prickly sensation like previously experienced with boosters plus normal injection site soreness, began to notice being a bit sniffly. Sep23: Very runny nose, periodic cough, increased prickly sensation, temp 99-100. Fitful sleep Sep24: Temp 101-102, increased sinus congestion and headache, still frequent runny nose and periodic cough. Went to urgent case - lungs and heart sounded fine, ears and throat clear, nasal passages inflamed, but nothing that indicated an infection. Practitioner recommended symptomatic relief with ibuprofen and acetaminophen and to follow up with primary care if not feeling better by Wed 27Sep. The ibuprofen and acetaminophen helped. Sep25: Runny nose and period cough continued, temp 99 with the ibuprofen/acetaminophen regimen. Very tired - slept much of afternoon. Through the night developed sore throat. Sep26: Sore throat throughout the day, but it did not look like strep from my personal experience. Fatigued. Temp 99. Sinuses still tender, but began feeling a little better overall in the evening, so discontinued ibuprofen/acetaminophen. Sep27: Throat less sore, nose not running as much, not coughing as much. Temp 98.6-99 without ibuprofen/acetaminophen. Had online visit with primary case - assessment is that this is immune response to vaccination rather than other infection. Still fatigued ? slept in the afternoon. Mild sinus headache this evening.
Age: 65.0
Sex: M
Vaccine: COVID19, FLUA4, RSV
Symptoms: Wrong product administered
Clinical narrative: Patient was given RSV vaccine in error, patient is of age and recommended group but didn't request.  Patient was not upset.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Ear discomfort, Gaze palsy
Clinical narrative: Headaches, chills, ear pressurenone
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Came down with covid even after booster.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Injection site discolouration, Injection site pain, Pruritus, Skin warm
Clinical narrative: Pt reporting, swelling, itching redness and hot to touch however she said there is discoloration at site of injection looking similar to a tan on that part of the body and has been that way for 1 week. She reported tenderness but no pain or other accompanying symptoms. Told patient to contact provider as it sounds like possible capillary puncture and bruising but due to her transplant history I told her to contact MD for f/u.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Swelling
Clinical narrative: Pt reporting, swelling, itching redness and hot to touch however she said there is discoloration at site of injection looking similar to a tan on that part of the body and has been that way for 1 week. She reported tenderness but no pain or other accompanying symptoms. Told patient to contact provider as it sounds like possible capillary puncture and bruising but due to her transplant history I told her to contact MD for f/u.
Age: 42.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Pt reported feeling lightheaded and nauseous after vaccination. Recorded BP and BP was in normal range. Pt was pallor and sweating. After resting for ~5 minutes and drinking water, pt felt better. Monitored patient for 30 minutes
Age: 53.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Dizziness, Vision blurred, Vomiting
Clinical narrative: 5-10 min after vaccination patient came back  complain of COB, lightheadness , blurred vision monitor with team. pulls was ok patient did not need EpiPen inject. patient was send to ER after EMT arrival, also before EMT arrival she vomited
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient presented to vaccination clinic the facility requested a Shingles vaccine for the patient. The patient presented an incorrect DOB on consent form. Upon searching database, no history of shingles vaccine was found. When billing to the patient's insurance, it was discovered that he had already had 2 previous doses of SHINGRIX.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site rash
Clinical narrative: patient states developed rash and bumps at the site of injection and spread throughout the deltoid. When she came in to report the reaction only had a few bumps at site of injection
Age: 75.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Headache, Injection site pain
Clinical narrative: Pain at both injection sites , both upper arms, headache, shivering
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site reaction, Injection site swelling
Clinical narrative: Migraine, extreme fatigue, nausea, fever, chills, aches, joint pain, shot site swelling and sensitivity.  Basically, I felt like crap for around a day. My wife and I have received the same vaccines and experienced identical, terrible side effects every time. This was the first time that I felt so terrible I thought I?d have to go to urgent care if my Tylenol and advil combo didn?t help my migraine.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: Migraine, extreme fatigue, nausea, fever, chills, aches, joint pain, shot site swelling and sensitivity.  Basically, I felt like crap for around a day. My wife and I have received the same vaccines and experienced identical, terrible side effects every time. This was the first time that I felt so terrible I thought I?d have to go to urgent care if my Tylenol and advil combo didn?t help my migraine.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: Migraine, extreme fatigue, nausea, fever, chills, aches, joint pain, shot site swelling and sensitivity.  Basically, I felt like crap for around a day. My wife and I have received the same vaccines and experienced identical, terrible side effects every time. This was the first time that I felt so terrible I thought I?d have to go to urgent care if my Tylenol and advil combo didn?t help my migraine.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Limb injury, Musculoskeletal disorder, Pain
Clinical narrative: Right after the vaccination my left arm did not function like it used to. Since I received the vaccine and until now (70 days after) I?m experiencing pain in my left arm and limited range of motion. It hurts to do certain movements that I had no problem doing before the vaccine. The injection was done in the wrong place (too low) and damaged something in my arm.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Right after the vaccination my left arm did not function like it used to. Since I received the vaccine and until now (70 days after) I?m experiencing pain in my left arm and limited range of motion. It hurts to do certain movements that I had no problem doing before the vaccine. The injection was done in the wrong place (too low) and damaged something in my arm.
Age: 25.0
Sex: F
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Pt. was given PCV13 and should have been given PCV20.  Pt. previously received PCV23 vaccine.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Child experienced a seizure lasting about 2-3 minutes the morning after getting vaccinated; Had a fever of 104 or higher; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2608322-1. The original narrative from the sender is as follows:  Child experienced a seizure lasting about 2-3 minutes the morning after getting vaccinated. Had a fever of 104 or higher.  No further information is expected.
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLU4, PNC15, RV5, COVID19, DTPPVHBHPB, FLU3, PNC15, RV5
Symptoms: Expired product administered
Clinical narrative: I realized the Moderna 6 mo.-5 yr primary series vaccine expired on 04/13/2023; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2617600-1. The original narrative from the sender is as follows:  The patient presented today (14-APR-2023) for routine six-month well childcare and vaccines/flu and covid vaccine as well. After the immunizations were administered and documentation was being completed, it was realized the Moderna 6 month-5 year primary series vaccine expired on 13-APR-2023. The patient and mother left the clinic when this error was discovered.    Due to the nature of the event the causal relationship between Vaxelis and the events, "I realized the Moderna 6 mo.-5 yr primary series vaccine expired on 04/13/2023" is not applicable.  No further information is not expected.  MAH notes: Based on the available information, the event was not related to Vaxelis but to Covid-19 vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Started having diarrhea up to 7 episodes daily on 5/12 and has been ongoing since; Vomiting, multiple episodes started 7 hours after injection lasted 12 hours to put us at hour 19 after injection; Intermittent fever for first 48 hours, TMAX 102F; This spontaneous safety report, with reference number 2307USA002364 (VAERS ID 2632505-1), was received by the partner on 06-JUL-2023 and forwarded on 10-JUL-2023, from a health professional.  Non-significant additional information was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2632505-1.  The reporter did not provide an assessment of causal relationship between Vaxelis and the events "Started having diarrhea up to 7 episodes daily on 5/12 and has been ongoing since"," Vomiting, multiple episodes started 7 hours after injection lasted 12 hours to put us at hour 19 after injection " and " Intermittent fever for first 48 hours, TMAX 102F".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Started having diarrhea up to 7 episodes daily on 5/12 and has been ongoing since; Vomiting, multiple episodes started 7 hours after injection lasted 12 hours to put us at hour 19 after injection; Intermittent fever for first 48 hours, TMAX 102F; This spontaneous safety report, with reference number 2307USA002364 (VAERS ID 2632505-1), was received by the partner on 06-JUL-2023 and forwarded on 10-JUL-2023, from a health professional.  Non-significant additional information was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2632505-1.  The reporter did not provide an assessment of causal relationship between Vaxelis and the events "Started having diarrhea up to 7 episodes daily on 5/12 and has been ongoing since"," Vomiting, multiple episodes started 7 hours after injection lasted 12 hours to put us at hour 19 after injection " and " Intermittent fever for first 48 hours, TMAX 102F".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever; Vomiting; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2635429-1. The original narrative from the sender is the following:  Fever and vomiting  The causal relationship between Vaxelis and the events " Fever and vomiting" was not assessed.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: Patient was to receive VAQTA (hep A) but instead grabbed the Vaxelis and gave in error. CDC Immunization hotline contacted and states no harm to patient- need to administer Hep A; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2649850-1. The original narrative from the sender is the following:  Concomitant medication included Miralax (macrogol) for an unknown indication.  "Patient was to rece VAQTA (hep A) but instead grabbed the Vaxelis and gave in error. CDC Immunization hotline contacted and states no harm to patient- need to administer Hep A".  The causal relationship between Vaxelis and the event "Patient was to rece VAQTA (hep A) but instead grabbed the Vaxelis and gave in error. CDC Immunization hotline contacted and states no harm to patient- need to administer Hep A" was assessed as not applicable due to the nature of the reported event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Product administration error, Wrong product administered
Clinical narrative: Patient was to receive VAQTA (hep A) but instead grabbed the Vaxelis and gave in error. CDC Immunization hotline contacted and states no harm to patient- need to administer Hep A; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2649850-1. The original narrative from the sender is the following:  Concomitant medication included Miralax (macrogol) for an unknown indication.  "Patient was to rece VAQTA (hep A) but instead grabbed the Vaxelis and gave in error. CDC Immunization hotline contacted and states no harm to patient- need to administer Hep A".  The causal relationship between Vaxelis and the event "Patient was to rece VAQTA (hep A) but instead grabbed the Vaxelis and gave in error. CDC Immunization hotline contacted and states no harm to patient- need to administer Hep A" was assessed as not applicable due to the nature of the reported event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Erythema, Swelling
Clinical narrative: mom called and reported redness and localized swelling; mom called and reported redness and localized swelling; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2649954-1. The original narrative from the sender is the following:  "mom called and reported redness and localized swelling".  The reporter did not provide an assessment of causal relationship between Vaxelis and the event, " mom called and reported redness and localized swelling".  No further information is expected.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bell's palsy, Facial paralysis, Tongue paralysis
Clinical narrative: Facial paralysis; pain; numbess; vacccin eadmisnisned fo runaprobed indication; This serious case was reported by a consumer and described the occurrence of facial paralysis in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number T5J32) for bell's palsy and prophylaxis.   On 31-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 31-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: vacccin eadmisnisned fo runaprobed indication). On 07-SEP-2023, the patient experienced facial paralysis (Verbatim: Facial paralysis) (serious criteria GSK medically significant), pain (Verbatim: pain) and numbness (Verbatim: numbess).  The outcome of the facial paralysis, pain and numbness were not resolved and the outcome of the drug use for unapproved indication was unknown.   It was unknown if the reporter considered the facial paralysis, pain and numbness to be related to Shingrix.     It was unknown if the company considered the facial paralysis, pain and numbness to be related to Shingrix.   Additional Information: GSK receipt date: 21-SEP-2023 The patient had vaccine and had facial paralysis, pain, numbness The patient was continuing with the Anti-viral, steroid. No disclosure provided by prescribing physician, pharmacy or Shingrix labeling concerning reported association of facial paralysis as possible Shingrix related risk profile. The patient received Shingrix for bell's palsy, which led to drug use for unknown indication. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis, Hypoaesthesia, Pain, Product use in unapproved indication
Clinical narrative: Facial paralysis; pain; numbess; vacccin eadmisnisned fo runaprobed indication; This serious case was reported by a consumer and described the occurrence of facial paralysis in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number T5J32) for bell's palsy and prophylaxis.   On 31-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 31-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: vacccin eadmisnisned fo runaprobed indication). On 07-SEP-2023, the patient experienced facial paralysis (Verbatim: Facial paralysis) (serious criteria GSK medically significant), pain (Verbatim: pain) and numbness (Verbatim: numbess).  The outcome of the facial paralysis, pain and numbness were not resolved and the outcome of the drug use for unapproved indication was unknown.   It was unknown if the reporter considered the facial paralysis, pain and numbness to be related to Shingrix.     It was unknown if the company considered the facial paralysis, pain and numbness to be related to Shingrix.   Additional Information: GSK receipt date: 21-SEP-2023 The patient had vaccine and had facial paralysis, pain, numbness The patient was continuing with the Anti-viral, steroid. No disclosure provided by prescribing physician, pharmacy or Shingrix labeling concerning reported association of facial paralysis as possible Shingrix related risk profile. The patient received Shingrix for bell's palsy, which led to drug use for unknown indication. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Red patch on arm at location of injection that is rectangle in shape; This red patch is swollen and painful; This red patch is swollen and painful; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE JOINT ERYTHEMA (Red patch on arm at location of injection that is rectangle in shape), INJECTION SITE PAIN (This red patch is swollen and painful) and INJECTION SITE SWELLING (This red patch is swollen and painful) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030368) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 21-Sep-2023, the patient experienced INJECTION SITE JOINT ERYTHEMA (Red patch on arm at location of injection that is rectangle in shape), INJECTION SITE PAIN (This red patch is swollen and painful) and INJECTION SITE SWELLING (This red patch is swollen and painful). At the time of the report, INJECTION SITE JOINT ERYTHEMA (Red patch on arm at location of injection that is rectangle in shape), INJECTION SITE PAIN (This red patch is swollen and painful) and INJECTION SITE SWELLING (This red patch is swollen and painful) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were reported. No treatment medications were provided. It is unknown if the patient experienced any additional symptoms/events.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site joint erythema, Injection site pain, Injection site swelling
Clinical narrative: Red patch on arm at location of injection that is rectangle in shape; This red patch is swollen and painful; This red patch is swollen and painful; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE JOINT ERYTHEMA (Red patch on arm at location of injection that is rectangle in shape), INJECTION SITE PAIN (This red patch is swollen and painful) and INJECTION SITE SWELLING (This red patch is swollen and painful) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030368) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 21-Sep-2023, the patient experienced INJECTION SITE JOINT ERYTHEMA (Red patch on arm at location of injection that is rectangle in shape), INJECTION SITE PAIN (This red patch is swollen and painful) and INJECTION SITE SWELLING (This red patch is swollen and painful). At the time of the report, INJECTION SITE JOINT ERYTHEMA (Red patch on arm at location of injection that is rectangle in shape), INJECTION SITE PAIN (This red patch is swollen and painful) and INJECTION SITE SWELLING (This red patch is swollen and painful) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were reported. No treatment medications were provided. It is unknown if the patient experienced any additional symptoms/events.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Arthralgia, Chills, Listless, Musculoskeletal stiffness, Tremor
Clinical narrative: Stiffness; Chills; Tremors; Rash on upper body; Vomiting; Aches; Listlessness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 13:00 as dose 5 (booster), single (Lot number: HG4629) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing); "known allergies: Erythromycin tetracycline sulfate" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ROSUVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Aches"; CHILLS (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering"; LISTLESS (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Listlessness"; RASH (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Rash on upper body"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Stiffness"; TREMOR (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Tremors"; VOMITING (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of musculoskeletal stiffness, chills, tremor, rash, vomiting, pain, listless.  Additional information: Patient had not suffered from COVID prior to vaccination and not tested COVID post vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Chills, Listless, Musculoskeletal stiffness, Pain, Rash
Clinical narrative: Stiffness; Chills; Tremors; Rash on upper body; Vomiting; Aches; Listlessness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 13:00 as dose 5 (booster), single (Lot number: HG4629) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing); "known allergies: Erythromycin tetracycline sulfate" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ROSUVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Aches"; CHILLS (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering"; LISTLESS (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Listlessness"; RASH (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Rash on upper body"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Stiffness"; TREMOR (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Tremors"; VOMITING (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of musculoskeletal stiffness, chills, tremor, rash, vomiting, pain, listless.  Additional information: Patient had not suffered from COVID prior to vaccination and not tested COVID post vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: SARS-CoV-2 test, Tremor, Vomiting
Clinical narrative: Stiffness; Chills; Tremors; Rash on upper body; Vomiting; Aches; Listlessness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 13:00 as dose 5 (booster), single (Lot number: HG4629) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing); "known allergies: Erythromycin tetracycline sulfate" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ROSUVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Aches"; CHILLS (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering"; LISTLESS (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Listlessness"; RASH (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Rash on upper body"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Stiffness"; TREMOR (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering", described as "Tremors"; VOMITING (non-serious) with onset 24Sep2023 at 23:30, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of musculoskeletal stiffness, chills, tremor, rash, vomiting, pain, listless.  Additional information: Patient had not suffered from COVID prior to vaccination and not tested COVID post vaccination.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Palpitations
Clinical narrative: heart beat very hard; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: PALPITATIONS (non-serious), outcome "unknown", described as "heart beat very hard". Additional information: The patient reported, "I had a reaction to the last combination COVID vaccine. My heart beat very hard for several days after the shot. How can I avoid this with the Mono Vaccine that is now available."  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.