chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: UNK
Symptoms: Chills, Cold sweat, Injection site bruising, Injection site pain, Insomnia
Clinical narrative: cold sweat; Bruise-like soreness at the injection site; chills; trouble sleeping which lasted for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping which lasted for 2 days), COLD SWEAT (cold sweat), VACCINATION SITE PAIN (Bruise-like soreness at the injection site) and CHILLS (chills) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 29-Sep-2023, the patient experienced COLD SWEAT (cold sweat), VACCINATION SITE PAIN (Bruise-like soreness at the injection site) and CHILLS (chills). On an unknown date, the patient experienced INSOMNIA (trouble sleeping which lasted for 2 days). On 02-Oct-2023, COLD SWEAT (cold sweat), VACCINATION SITE PAIN (Bruise-like soreness at the injection site) and CHILLS (chills) had resolved. At the time of the report, INSOMNIA (trouble sleeping which lasted for 2 days) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had no concomitant disease or risk factor. Treatment information was not provided.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given the 5-11 dosing of the 23/24 Covid Vaccine when she was supposed to receive the 12+ dosing. No adverse reactions from vaccine.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Dizziness, Feeling abnormal, Hallucination, Mobility decreased
Clinical narrative: I started feeling nauseated about 8 hours after I got the shot. around 10-11 hours after the shot I started having extreme and violent chills that came on every minute or 2. I had fever. I was dizzy and I was hallucinating. I felt like my brain was in 2 parts trying to do many different things. I couldn't get up to go to the bathroom and found that I had wet myself. I was alone but didn't know where my phone was so I didn't call for help.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Nausea, Pyrexia, Urinary incontinence
Clinical narrative: I started feeling nauseated about 8 hours after I got the shot. around 10-11 hours after the shot I started having extreme and violent chills that came on every minute or 2. I had fever. I was dizzy and I was hallucinating. I felt like my brain was in 2 parts trying to do many different things. I couldn't get up to go to the bathroom and found that I had wet myself. I was alone but didn't know where my phone was so I didn't call for help.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given the 5-11 dosing of the 23/24 Covid vaccine instead of the 12+ dosing. There have been no adverse reactions at this time.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Mild Flu like symptoms. Fever 100.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 88.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient approached flu shot table event and asked for flu vaccine for over 65yo, patient said she had not received the flu vaccine yet this season.  The tabling event ran from 10 am to 130pm and forms were processed after that.  Upon checking Shots, patient received the HD flu vaccine at pharmacy on Aug 2023.  Patient was contacted and has no adverse events
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Dermatitis acneiform, Rash, Rash pruritic
Clinical narrative: The patient stated she had a rash develop on the right arm, and a zit like bump on the palm of her left hand. She stated they were both itchy.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Mobility decreased
Clinical narrative: pt unable to lift arm and pain 48 hours following vaccine; limited range of motion
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: TIREDNESS, MUSCLE PAIN , CHILLS, NAUSEA, AND A LITTLE JOINT PAIN
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Back pain, Dyspnoea, Dyspnoea exertional, Feeling hot
Clinical narrative: Patient became short of breath when walking out to the car. He came back to the pharmacy and sat down. Reported being hot, short of breath, and having back pain for about 5 minutes. We alerted an ambulance, but the patient refused and stated he felt better after about 5 minutes of sitting with water and a cold cloth on the neck.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: PATIENT ADMINISTERED TWO DOSES IN ERROR.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU4, PNC20, VARZOS
Symptoms: Laboratory test, Syncope
Clinical narrative: After administering the 4 vaccines, the patient fainted. She was always breathing, EMS was called and they took her to the hospital.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Large 15 cm x 18 cm wheal on left arm, swollen, warm to touch, indurated, non-tender.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and  Swollen left on the anterolateral thigh on the side of the injection pain on the area
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Cold sweat, Dyspnoea, Swollen tongue
Clinical narrative: The pt came into the flu vaccine clinic today at 1435 to receive her annual influenza vaccine. The writer administered the pt's vaccine in her right deltoid. The pt stated she felt good and thanked the writer for her vaccine and started to walk back to her office. Five to six minutes later the pt returned with a coworker stating that she had chest pain, SOB and a swollen tongue feeling in the back of her throat. The writer took the pt's BP, O2, Temp, pulse and respirations. The pt's blood pressure at 2:47PM was 151/108, her pulse was 78, respirations were 20, temperature was 98.7 and O2 was 98%. The pt was still clearing her throat and appeared cool and clammy. The pt respirations were labored but WNL at 20 respirations per min. The pt stated that her chest was tighter then before. The writer was trying to find the PO Benadryl, but none was available. Therefore, the writer had to administer 50mg/ml of Diphenhydramine via IM injection in the pt's left deltoid. The pt tolerated the injection well. The writer waited 10 mins later to take another set of vitals. The pt's BP was 161/113, respirations were 20, pulse was 72 and O2 level was 98%. The pt stated she was starting to feel woozy from the Benadryl but that her SOB felt better. The writer also gave the pt two apple juice boxes and a small bottle of water. The pt drank all of these liquids. The writer took the pt's vitals again 15 mins later at 1514. The pt's BP was 128/88, respirations were 18, pulse was 68 and O2 level was 99%. The pt stated that her SOB and chest pain was a lot better. The pt stated that she felt tired from the Benadryl but overall felt better. The writer suggested that the pt go to the emergency room to be seen in case anything else were to occur. The pt stated that she would just like to go home and rest and stated she will go in if anything changes. The writer told her to call if anything else changes or if she has any further questions. The pt agrees with this plan and communicated with her manager that she would be leaving for the day. The pt will not be taking the influenza vaccine next year through clinic. If the pt would like her vaccine she will need to go to her PCP or an allergist.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Throat clearing
Clinical narrative: The pt came into the flu vaccine clinic today at 1435 to receive her annual influenza vaccine. The writer administered the pt's vaccine in her right deltoid. The pt stated she felt good and thanked the writer for her vaccine and started to walk back to her office. Five to six minutes later the pt returned with a coworker stating that she had chest pain, SOB and a swollen tongue feeling in the back of her throat. The writer took the pt's BP, O2, Temp, pulse and respirations. The pt's blood pressure at 2:47PM was 151/108, her pulse was 78, respirations were 20, temperature was 98.7 and O2 was 98%. The pt was still clearing her throat and appeared cool and clammy. The pt respirations were labored but WNL at 20 respirations per min. The pt stated that her chest was tighter then before. The writer was trying to find the PO Benadryl, but none was available. Therefore, the writer had to administer 50mg/ml of Diphenhydramine via IM injection in the pt's left deltoid. The pt tolerated the injection well. The writer waited 10 mins later to take another set of vitals. The pt's BP was 161/113, respirations were 20, pulse was 72 and O2 level was 98%. The pt stated she was starting to feel woozy from the Benadryl but that her SOB felt better. The writer also gave the pt two apple juice boxes and a small bottle of water. The pt drank all of these liquids. The writer took the pt's vitals again 15 mins later at 1514. The pt's BP was 128/88, respirations were 18, pulse was 68 and O2 level was 99%. The pt stated that her SOB and chest pain was a lot better. The pt stated that she felt tired from the Benadryl but overall felt better. The writer suggested that the pt go to the emergency room to be seen in case anything else were to occur. The pt stated that she would just like to go home and rest and stated she will go in if anything changes. The writer told her to call if anything else changes or if she has any further questions. The pt agrees with this plan and communicated with her manager that she would be leaving for the day. The pt will not be taking the influenza vaccine next year through clinic. If the pt would like her vaccine she will need to go to her PCP or an allergist.
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event. She had already got a flu shot 9/30/23 at her doctor's office. She asked for flu shot but wanted covid shot. We eill give her covid shot
Age: 93.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses of this at the same time. Patient was monitored and will be followed up with via telephone call.
Age: 41.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Throat tightness
Clinical narrative: Patient was received vaccine at about 11:00 am, and was instructed to hangout for 15 minutes after for routine monitoring. He left before those 15 minutes were up. No history of allergy or anaphylaxis to previous vaccines, or any ingredients in the vaccines. ALERT shows both vaccines have been administered in the past, patient stated he has had no issues either with previous vaccines. Patient returned about 20 minutes later complaining of waves of severe lightheadedness, no other signs of allergic reactions or symptoms (example: difficulty breathing, nausea, swelling, etc.). Patient stated he may be dehydrated, gave him some water and had him sit down for a little bit to see if symptoms subside. About 5 minutes later patient said while drinking water he felt that his throat was feeling a little bit tighter but no difficulty breathing or facial swelling, or injection site swelling . We advised patient to go to urgent care across the street. Patient agreed, and pharmacist phoned urgent care to confirm patient had arrived, was admitted, and was getting care.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Started running a fever 6 hrs after injection and 54 hrs later it?s getting higher not lower.  Was running 99.5 on Tuesday and hit 101 at 3:00 today, Thursday.
Age: 64.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain in extremity
Clinical narrative: The patient was administered the High Dose Fluad vaccination at age 64 and 10 months.  The patient should have received the Flucelvax vaccine.  I contacted the patient to inform her of the higher dose flu vaccine.  She stated that she was not experiencing any adverse reactions.  She only felt some soreness in her left arm.  The patient did not voice any other complaint.  I educated the patient regarding side effects and if escalted to contact the clinic and her physician.  She stated 'I don't think that will be necessary."
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Pallor, Vomiting
Clinical narrative: Administered with no reports of concern or symptoms at 0945 on 10/5/2023. Sent back to class. Per school nurse, child became sweaty, pale, felt hot, dizzy and vomited at approximately 1030 on 10/5/2023 and she sent him home. She did not obtain vital signs prior to sending home.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest discomfort, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Pressure in center of chest;
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Erythema, Pruritus
Clinical narrative: redness and itchiness intense for 14-12 hrs. Patient took Claritin 10mg  to decrease itching
Age: 28.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Pain in extremity
Clinical narrative: 7~48 hours post vaccination: fever, chills, headache, sore arm that is red and itchy at injection site 7~80+ hours post vaccination: sore arm that is red and itchy at injection site continued
Age: 28.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pyrexia
Clinical narrative: 7~48 hours post vaccination: fever, chills, headache, sore arm that is red and itchy at injection site 7~80+ hours post vaccination: sore arm that is red and itchy at injection site continued
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Left shoulder swelling, severe pain. Improving swelling but NOT resolved and still limiting function.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Euphoric mood, Hangover, Hyperhidrosis, Photopsia
Clinical narrative: Pt had a flu vaccine on 09/27/23 @ 16:00.  Approx. an hour after vaccine staff member stated to feel euphoric, experienced intense dizziness, and visions of bright trailing lights,   when turning his focus from (R) side to (L) side at 04:00 experienced severe diaphoresis clothing and bed were completely saturated. He then vomited x2. Feeling as if he had the worst hangover he has ever had. The next 24 hours consisted of elevated temperatures instantly following any consumption of food. Staff member had been educated at time of vaccine re: reporting adverse s/s.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Pt had a flu vaccine on 09/27/23 @ 16:00.  Approx. an hour after vaccine staff member stated to feel euphoric, experienced intense dizziness, and visions of bright trailing lights,   when turning his focus from (R) side to (L) side at 04:00 experienced severe diaphoresis clothing and bed were completely saturated. He then vomited x2. Feeling as if he had the worst hangover he has ever had. The next 24 hours consisted of elevated temperatures instantly following any consumption of food. Staff member had been educated at time of vaccine re: reporting adverse s/s.
Age: 28.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered at inappropriate site
Clinical narrative: patient states vaccine was administered too high in arm (shoulder joint instead of deltoid)
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was too old to receive the first dose of oral rotateq. No noted adverse symptoms at time of error.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Pyrexia
Clinical narrative: Fever Day 1 - then intense itching for 5 days
Age: 74.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Head discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Patient reported possible side effect with vaccine.  She noticed a large red swollen round spot on left bicep below where the shot was given . Patient took Alieve. It got a bit smaller today. Her head felt heavy the other day after getting the vaccine and she had to lie down at home. Patient has had flu and the first dose of shingles vaccines in the past without reaction but the only difference is that she both two vaccines in one day this time.  Recommended patient to apply ice and continue Alieve. If symptom gets worse, patient is to contact medical doctor.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: CHILD RECEIVED KINRIX  AND MMRV TODAY BUT HAD ALREADY RECEIVED THEM A YEAR AGO.  NO TREATMENT REQUIRED.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: She reports feeling severe shooting pain from the injection site down into the fingertips during vaccine administration.  Symptoms did not resolve promptly.  They did last for a while.  She reports that she was unable to sleep night.  Then she is had severe pain in the deltoid area.  She is unable to lift arm.  She does not report feeling weakness.  T
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Hypersensitivity, Rash
Clinical narrative: Patient developed an allergic reaction (skin rash on trunk). Given Benadryl 50mg orally. Symptoms and vital were monitored every 5 minutes for at least 40minutes and rechecked prior to discharge, more than an hour after his shots were given. The rash did not progress any further. He did not develop hypotension, wheezing, shortness of breath, or oral or throat swelling. EpiPen was not required.
Age: 65.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Rash
Clinical narrative: Rash on Chest
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills; fever; body aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), PYREXIA (fever) and MYALGIA (body aches) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145FB) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced CHILLS (chills) (seriousness criterion life threatening), PYREXIA (fever) (seriousness criterion life threatening) and MYALGIA (body aches) (seriousness criterion life threatening). On 20-Sep-2022, CHILLS (chills), PYREXIA (fever) and MYALGIA (body aches) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   On 29-Sep-2023 patient received SPIKEVAX 2023-2024. Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to MOD-2023-743044.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2023: Non-significant follow up received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: she developed bicipital tendinitis in her left arm; This is a spontaneous report received from contactable reporter (Consumer) from medical information team, Program ID. The reporter is the patient.  A 72-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2021 as dose 3 (booster), single (Lot number: EW0186), on 24Jun2022 as dose 4 (booster), single (Lot number: FM7553) and on 25Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "She has a history of osteoarthritis in her left shoulder", start date: 2004 (ongoing), notes: Bone on Bone Osteoarthritis; "Inflammatory arthritis", start date: 2019 (ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (Dose 1, Lot: EL3249, Primary Immunization series completed.), administration date: 21Jan2021, for Covid-19 Immunization, reaction(s): "had surgery in Mar2022 and had 3 lymph nodes removed", "After her covid primary series, she developed breast cancer"; bnt162b2 (Dose 2, Lot: EL8982, Primary Immunization series completed.), administration date: 11Feb2021, for Covid-19 Immunization, reaction(s): "had surgery in Mar2022 and had 3 lymph nodes removed", "After her covid primary series, she developed breast cancer". The following information was reported: TENDONITIS (non-serious) with onset Sep2022, outcome "recovering", described as "she developed bicipital tendinitis in her left arm".  Additional information: Inquiry: Patient wanted to know if she can inject the Pfizer covid 19 vaccines anywhere other than shoulder or muscles. After her last booster in Sep2022, she developed bicipital tendinitis in her left arm. She has a history of osteoarthritis in her left shoulder and last week, had a steroid shot in her shoulder joint.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Rash, SARS-CoV-2 test
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; itchy Body rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "AFib" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). No covid prior vaccination. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, in Sep2023 as dose number unknown, single, at Right arm; RSV VACCINE taken for immunisation, in Sep2023 as dose number unknown, single, at Right arm; ELIQUIS; METOPROLOL; WELLBUTRIN XL; COLLAGEN. The following information was reported: RASH (non-serious) with onset 22Sep2023 at 03:00, outcome "recovering", described as "itchy Body rash"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Sep2023, outcome "unknown" and all described as "Nasal Swab Positive". The event "itchy body rash" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Sep2023) Positive. Therapeutic measures were not taken as a result of rash. Clinical courses: Next day appearance of very itchy Body rash starting back of knees, spreading to thighs. Gradually over the week rash spread to buttocks then elbows.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in hands and lips; Numbness in hands and lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 13:15 as dose 1, single (Lot number: HD9876) at the age of 53 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: QUADRIVALENT INFLUENZA VACCINE taken for immunisation, on 30Sep2023 as dose 1, single. Past drug history included: Aspirin, reaction(s): "Allergies: Aspirin". The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset 01Oct2023 at 03:00, outcome "recovering" and all described as "Numbness in hands and lips". Therapeutic measures were not taken as a result of hypoaesthesia, hypoaesthesia oral.  Additional information: Other medications in two weeks included multiple vitamins.
Age: 55.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Body temperature, Chills, Headache, Heart rate, Heart rate increased
Clinical narrative: Extreme vomiting; Nausea; Fever (>101F); High heart rate (>110bpm even though sedentary); Muscle aches; Headache; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 17:00 as dose 5 (booster), single (Lot number: HG4629) at the age of 55 years, in left arm for covid-19 immunisation; for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 30Sep2023 as dose 1, single (Lot number: 9CE79), in left arm. The patient's relevant medical history included: "Long-COVID" (unspecified if ongoing), notes: Long-COVID; "RA" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "CFS" (unspecified if ongoing), notes: CFS; "IBS" (unspecified if ongoing), notes: IBS. The patient took concomitant medications. Vaccination history included: comirnaty (dose number=1, lot number=ER8732,, administration time=05:00 PM, vaccine location=Left arm), administration date: 06Mar2021, when the patient was 53-year-old, for COVID-19 immunization; comirnaty (dose number=2, lot number=ER8731, administration time=05:00 PM, vaccine location=Left arm), administration date: 16Apr2021, when the patient was 53-year-old, for COVID-19 immunization; comirnaty (dose number=3, lot number=FH8027, administration time=05:00 PM, vaccine location=Left arm), administration date: 28Oct2021, when the patient was 53-year-old, for COVID-19 immunization; comirnaty (dose number=4, lot number=GH9702,, administration time=05:00 PM, vaccine location=Left arm), administration date: 15Sep2022, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered"; VOMITING (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered", described as "Extreme vomiting"; PYREXIA (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered", described as "Fever (>101F)"; HEADACHE (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered", described as "High heart rate (>110bpm even though sedentary)"; MYALGIA (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered", described as "Muscle aches"; NAUSEA (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, nausea, pyrexia, heart rate increased, myalgia, headache, chills.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Extreme vomiting; Nausea; Fever (>101F); High heart rate (>110bpm even though sedentary); Muscle aches; Headache; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 17:00 as dose 5 (booster), single (Lot number: HG4629) at the age of 55 years, in left arm for covid-19 immunisation; for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 30Sep2023 as dose 1, single (Lot number: 9CE79), in left arm. The patient's relevant medical history included: "Long-COVID" (unspecified if ongoing), notes: Long-COVID; "RA" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "CFS" (unspecified if ongoing), notes: CFS; "IBS" (unspecified if ongoing), notes: IBS. The patient took concomitant medications. Vaccination history included: comirnaty (dose number=1, lot number=ER8732,, administration time=05:00 PM, vaccine location=Left arm), administration date: 06Mar2021, when the patient was 53-year-old, for COVID-19 immunization; comirnaty (dose number=2, lot number=ER8731, administration time=05:00 PM, vaccine location=Left arm), administration date: 16Apr2021, when the patient was 53-year-old, for COVID-19 immunization; comirnaty (dose number=3, lot number=FH8027, administration time=05:00 PM, vaccine location=Left arm), administration date: 28Oct2021, when the patient was 53-year-old, for COVID-19 immunization; comirnaty (dose number=4, lot number=GH9702,, administration time=05:00 PM, vaccine location=Left arm), administration date: 15Sep2022, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered"; VOMITING (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered", described as "Extreme vomiting"; PYREXIA (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered", described as "Fever (>101F)"; HEADACHE (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered", described as "High heart rate (>110bpm even though sedentary)"; MYALGIA (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered", described as "Muscle aches"; NAUSEA (non-serious) with onset 01Oct2023 at 07:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, nausea, pyrexia, heart rate increased, myalgia, headache, chills.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Vertigo
Clinical narrative: Vertigo; lightheadedness; Felt as though I would pass out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 11:00 as dose 1, single (Lot number: 2267330-04919) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPPV" (unspecified if ongoing); "balance problems" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 01Oct2023 at 09:00, outcome "recovering", described as "Felt as though I would pass out"; VERTIGO (non-serious), outcome "recovering"; DIZZINESS (non-serious), outcome "recovering", described as "lightheadedness". Therapeutic measures were not taken as a result of loss of consciousness, vertigo, dizziness.  Clinical information: Patient reported that 'Vertigo/lightheadedness. Had a little lightheadedness for several days. Today was the worse so far. Felt as though I would pass out twice today.' Prior vaccination, the patient did not get COVID and did not test covid post vaccination. Known allergies: None known. The patient did not receive any other vaccines within 4 weeks. The patient did not receive any other medications within 2 weeks.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Headache, Malaise, Pyrexia, Urinary incontinence
Clinical narrative: Urinated 3 times on myself; It made me so sick; Headache; I thought my head would go split wide open; I have never had a headache like that before; Fever; No appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in Sep2023 as dose number unknown, single (Lot number: HG4629) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDRALAZINE; OMEGA 3 [FISH OIL]; ATORVASTATIN. The following information was reported: POLLAKIURIA (non-serious), outcome "unknown", described as "Urinated 3 times on myself"; ILLNESS (non-serious), outcome "unknown", described as "It made me so sick"; HEADACHE (non-serious), outcome "unknown", described as "Headache; I thought my head would go split wide open; I have never had a headache like that before"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; DECREASED APPETITE (non-serious), outcome "unknown", described as "No appetite". Additional Information: Concern: Consumer stated, "I took the COVID shot yesterday at 9 o'clock AM and during the night I could not hold my, I had urinated 3 times on myself and I had such a bad headache I thought my head would go split wide open, I have never had a headache like that before. I had fever and I am just kind of coming down now and it made me so sick." When clarified if the vaccine is Pfizer COVID-19 Vaccine, Consumer stated, "Yes." When paraphrased the concern, Consumer stated, "Yes, I mean I am just kind of coming up, I am just kind of getting myself together now. I did not have no appetite I have needed to take eat food some to take my medicine, so I ate a very, just a few bite to get the medicine down but I had no appetite. I don't see an expiration date, Nov2023 would that be it? It does not say expiration date." Other Medical conditions or concomitant medication: Consumer stated, "I am taking Hydralazine, Omega 3 and I am taking a Statin, it is a statin for cholesterol, the doctor says, I don't have a high cholesterol but they have given me because of my age, Atorvastatin." Prior Vaccinations (Within 4 weeks): Consumer stated, "Yes, I had got the Flu shot. No, I think it was last week or a week before last." When clarified if the patient got flu shot within 4 weeks of getting Pfizer COVID-19 Vaccine, Consumer stated, "No, it was not, last than 4 weeks".  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: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: blood clot; Incredibly excruciating pain in left thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: THROMBOSIS (medically significant), outcome "unknown", described as "blood clot"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Incredibly excruciating pain in left thigh". Clinical course: Reporter stated, her husband who is 77 got his fourth booster (clarified as COVID booster) yesterday and last night on here which both had that is not a problem but now he has an incredibly excruciating pain in left thigh. She was just wondering he is in good physical shape he is an athlete but just wondering if that is a complication or is normal like blood clot or something. Reporter was informed about the role of Safety and informed that Medical Information is the concerned department to answer the question. Reporter was provided with the number of Medical Information department as [withheld] followed by Option # with the timing 8am to7pm on Monday to Friday. Further probing could not be done as reporter hung up the call abruptly. Thus, product details (NDC#, UPC# and expiry date) and purchase details were unknown. Hence, limited information was available over the call.   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: COVID19
Symptoms: COVID-19, Gastrointestinal disorder, SARS-CoV-2 test
Clinical narrative: Tested positive/COVID 19 (fever and sore throat); intestinal issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 18:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 19Sep2023, outcome "unknown", described as "Tested positive/COVID 19 (fever and sore throat)"; GASTROINTESTINAL DISORDER (non-serious) with onset 19Sep2023, outcome "unknown", described as "intestinal issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19, gastrointestinal disorder. Additional information: Had covid vaccine on Monday 18Sep2023. On Tuesday 19Sep2023 began fever and sore throat plus intestinal issues, tested positive. Took Paxlovid for next five days (19Sep2023 to 23Sep2023). Better on 29Sep2023. Symptoms (fever, intestinal issues) returned today 30Sep2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 13 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: From 18Sep2023 to 22Sep2023 patient received Paxlovid as Covid-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Lymphadenopathy
Clinical narrative: After her covid primary series, she developed breast cancer; Had surgery in Mar2022 and had 3 lymph nodes removed.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received bnt162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3249) and on 11Feb2021 as dose 2, single (Lot number: EL8982) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis in that left shoulder", start date: 2004 (ongoing), notes: bone on bone osteoarthritis; "Inflammatory Arthritis", start date: 2019 (ongoing). The patient's concomitant medications were not reported. The following information was reported: BREAST CANCER (medically significant) with onset Mar2022, outcome "recovered" (Apr2022), described as "After her covid primary series, she developed breast cancer"; LYMPHADENOPATHY (medically significant) with onset Mar2022, outcome "recovered" (Apr2022), described as "Had surgery in Mar2022 and had 3 lymph nodes removed.". Clinical course details: After her Covid primary series, she developed breast cancer and had surgery in Mar2022, and with that surgery she had 3 lymph nodes removed. Stated she had outpatient surgery and then radiation. She stated she is cancer free and in remission after completing the surgery and radiation. The patient clarified that this was after the primary series. The events "after her covid primary series, she developed breast cancer" and "had surgery in mar2022 and had 3 lymph nodes removed." required physician office visit. Therapeutic measures were taken as a result of lymphadenopathy.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Microscopic colitis" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19.  Clinical course: There were no other medications received in two weeks prior to COVID-19 vaccination. The patient received COVID-19 treatment with Paxlovid in Aug2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 24-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 20Sep2023 to 25Sep2023.  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.; Sender's Comments: The contributory role of BNT162B2, BNT162B2 OMI BA.4-5 to the reported drug ineffective cannot be excluded since a lack of effect can generally be expected for any medicinal product as a 100% success rate cannot be reasonably assumed in every patient treated.,Linked Report(s) : US-PFIZER INC-202300314704 same patient, different drug/events;
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Mastication disorder, Musculoskeletal stiffness, Pain in extremity, Pain in jaw
Clinical narrative: Hands are stiff and I can't use them regularly (ie, can't pick up baby); Extreme pain in opposite arm from injection site; almost like a phantom pain; Jaw pain to the point of not being able to chew regularly; Jaw pain to the point of not being able to chew regularly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing); "Gave birth", start date: 19Sep2023, stop date: 19Sep2023, notes: Note: Gave birth. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 22Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Sep2023, outcome "unknown", described as "Extreme pain in opposite arm from injection site; almost like a phantom pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 28Sep2023, outcome "unknown", described as "Hands are stiff and I can't use them regularly (ie, can't pick up baby)"; PAIN IN JAW (non-serious), MASTICATION DISORDER (non-serious) all with onset 28Sep2023, outcome "unknown" and all described as "Jaw pain to the point of not being able to chew regularly". The events "hands are stiff and i can't use them regularly (ie, can't pick up baby)", "extreme pain in opposite arm from injection site; almost like a phantom pain" and "jaw pain to the point of not being able to chew regularly" required physician office visit.  Additional information: Prior vaccination, patient didn't had COVID-19 while post vaccination, patient was not tested for COVID-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Chills; sweats; body aches; headache; arm hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing); "Gluten" (unspecified if ongoing), notes: known allergies: Gluten. The patient took concomitant medications. The following information was reported: CHILLS (non-serious) with onset 29Sep2023, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2023, outcome "recovering", described as "arm hurts"; PAIN (non-serious) with onset 29Sep2023, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 29Sep2023, outcome "recovering"; HYPERHIDROSIS (non-serious) with onset 29Sep2023, outcome "recovering", described as "sweats". Therapeutic measures were not taken as a result of chills, hyperhidrosis, pain, headache, pain in extremity.  Additional information: No other vaccine was received within four weeks but patient received other medications in two weeks. Prior vaccination, no COVID-19 and post-vaccination, no COVID-19 test was positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.