chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Blood culture negative, C-reactive protein increased, Endotracheal intubation, Mechanical ventilation, Positive expiratory pressure therapy
Clinical narrative: Patient is a 2 month old male born at 29 weeks and 1 day complcated by bronchopulmonary dysplasia and pulmonary artery stenosis. Patient had been intubated multiple times for hypoxic and hypercapnic respiratory failure. Patient was extubated on 09/16/23 had had been doing well per mothers report. Patient received his two month vaccination on 09/28/23. Two hours after receiving vaccines  patient developed respiratory distress requiring intubation. Patient was unable to be oxygenated on mechanical ventilation and was transitioned to oscillation. He is a current candidate for ECMO as of 10/2/23
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Procalcitonin, Respiratory distress
Clinical narrative: Patient is a 2 month old male born at 29 weeks and 1 day complcated by bronchopulmonary dysplasia and pulmonary artery stenosis. Patient had been intubated multiple times for hypoxic and hypercapnic respiratory failure. Patient was extubated on 09/16/23 had had been doing well per mothers report. Patient received his two month vaccination on 09/28/23. Two hours after receiving vaccines  patient developed respiratory distress requiring intubation. Patient was unable to be oxygenated on mechanical ventilation and was transitioned to oscillation. He is a current candidate for ECMO as of 10/2/23
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 12.0
Sex: M
Vaccine: FLUR4
Symptoms: Headache, Product administered to patient of inappropriate age
Clinical narrative: Patient is 12 years old and was given Flublok which is recommended for 18 and over. Spoke with the mom on 10/2 and she stated he had a headache afterwards, but wasn't sure if that was related to the vaccination.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Dysstasia, Feeling hot, Nausea, Pyrexia
Clinical narrative: She got her vaccine, at the grocery store everything was fine, she shopped and left.  She had dinner, but the next morning she woke up and felt a little bit feverish.  She wasn't too sure, but didn't officially notice it until the next morning.  She woke up at 6:30 the next morning and she felt a little warm, she took her temperature, it was above normal arrow on the glass thermometer.   On the 30th she woke up to use the restroom around 6:30 and she was so dizzy, and got up 4 hours prior, and at that time she could not even stand up, she had to lie back down.  She had to hold onto the wall to use the bathroom.  She went back to bed, laid down and her head was spinning and felt like she was being swung around the  room and felt nauseous and wondered if she was going to throw up.  This would get up a few times to get something to drink, and had constant spinning of her head, and if she stood up she would spin around and fall back on her bed.  It gradually wore off and does not think that it was anything she did, just sort of ran it's course.  She is doing better today.  She went out, ran out an errand and did things around the house and everything is fine today.    She did not call her doctor as it was slightly easing up and so she assumed it was just a reaction and did not call, but she would have called her doctor if it had continued.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Vertigo
Clinical narrative: She got her vaccine, at the grocery store everything was fine, she shopped and left.  She had dinner, but the next morning she woke up and felt a little bit feverish.  She wasn't too sure, but didn't officially notice it until the next morning.  She woke up at 6:30 the next morning and she felt a little warm, she took her temperature, it was above normal arrow on the glass thermometer.   On the 30th she woke up to use the restroom around 6:30 and she was so dizzy, and got up 4 hours prior, and at that time she could not even stand up, she had to lie back down.  She had to hold onto the wall to use the bathroom.  She went back to bed, laid down and her head was spinning and felt like she was being swung around the  room and felt nauseous and wondered if she was going to throw up.  This would get up a few times to get something to drink, and had constant spinning of her head, and if she stood up she would spin around and fall back on her bed.  It gradually wore off and does not think that it was anything she did, just sort of ran it's course.  She is doing better today.  She went out, ran out an errand and did things around the house and everything is fine today.    She did not call her doctor as it was slightly easing up and so she assumed it was just a reaction and did not call, but she would have called her doctor if it had continued.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Patient received the vaccine and passed out in the waiting room about 5 minutes after; EMS was called, vitals taken, and patient cleared to go home by EMT
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination site erythema, Vaccination site inflammation
Clinical narrative: About two days after getting the Arexvy Vaccine, patient came to the pharmacy and reported redness and inflammation at  the vaccine injection site.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Mobility decreased, Pain in extremity
Clinical narrative: The patient's husband visited the pharmacy and stated the patient was having trouble moving/raising her arm due to soreness. He also presented a picture of a near-circular bruise approximately an 1.5 inches in diameter light brown in color in the center of the left deltoid.
Age: 77.0
Sex: M
Vaccine: FLUA4
Symptoms: Exposure via skin contact, Needle issue
Clinical narrative: Needle malfunctioned and dose completely leaked out onto patient's arm.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Blood iron, Loss of consciousness
Clinical narrative: Patient passed out about 5-10 min after vaccine was given. Patient came to and was evaluated by Provider.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Diarrhoea, Immediate post-injection reaction, Nausea, Pain
Clinical narrative: PATIENT STATED SHE HAD IMMEDIATE BACK PAIN FOLLOWED BY ACHES AND PAINS ALL OVER HER BODY. SHE ALSO HAD NAUSEA AND DIARRHEA. PATIENT REPORTED SHE WENT TO THE ER AT 5PM SAME DAY DUE TO HER REACTION.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema of eyelid, Eyelid ptosis, Insomnia, Pyrexia
Clinical narrative: INSOMNIA,  FEVER  AND CHILLS  ARM SORE, RED AND SWOLLEN LEFT EYELID DROOP ALL TREATED AT HOME, NO MEDICAL DR VISIT, PATIENT WANTED ME TO REPORT
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: INSOMNIA,  FEVER  AND CHILLS  ARM SORE, RED AND SWOLLEN LEFT EYELID DROOP ALL TREATED AT HOME, NO MEDICAL DR VISIT, PATIENT WANTED ME TO REPORT
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Fatigue, Gait disturbance, Inflammation
Clinical narrative: Severe bilateral hip pain that started less than a week post injection. Now requiring 2 anti-inflammatory meds that temporarily relieve symptoms. Work and exercise routine have not changed. Difficult to walk without a limp at times. Other symptoms are fatigue and weakness. Also had tooth pain develop about a week after vaccination. Saw a dentist on 10/02/2023 and x-rays looked OK. Dentist stated it was probably inflammation.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Toothache, X-ray dental normal
Clinical narrative: Severe bilateral hip pain that started less than a week post injection. Now requiring 2 anti-inflammatory meds that temporarily relieve symptoms. Work and exercise routine have not changed. Difficult to walk without a limp at times. Other symptoms are fatigue and weakness. Also had tooth pain develop about a week after vaccination. Saw a dentist on 10/02/2023 and x-rays looked OK. Dentist stated it was probably inflammation.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Erythema, Injection site swelling, Paraesthesia
Clinical narrative: Pt came into pharmacy on 10/2/23  and showed me his left arm which was red at inner bicep level and swollen at injection site. I told him to watch it and if does not improve seek medical attention. Pt then called 5 hrs later and said left arm is tingling and he is going to his physician to be check over
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Immediate post-injection reaction, Neck pain, Pain in extremity, Wrong technique in product usage process
Clinical narrative: I GOT THE VACCINE ON MONDAY  THE PAIN STARTED IMMIDIATLEY OF THE TIME OF INJECTION BUT THE SEVERITY INCREASE BY FRIDAY AND I HAD TO CALL THE NURSE FOR MEDICAL ADVICE AND WAS INSTRCTED TO TAKE TYLENOL . TODAY MONDAY I WENT TO THE CLINIC TO HAVE THEM LOOK AT IT AND WAS TOLD BY THE DOCTOR THAT MY TENDON WAS MORE THEM LIKLY HIT. THE PAIN IS SO BAD IT IS FROM MY ARM , NECK AND TO MY HEAD.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray
Clinical narrative: I GOT THE VACCINE ON MONDAY  THE PAIN STARTED IMMIDIATLEY OF THE TIME OF INJECTION BUT THE SEVERITY INCREASE BY FRIDAY AND I HAD TO CALL THE NURSE FOR MEDICAL ADVICE AND WAS INSTRCTED TO TAKE TYLENOL . TODAY MONDAY I WENT TO THE CLINIC TO HAVE THEM LOOK AT IT AND WAS TOLD BY THE DOCTOR THAT MY TENDON WAS MORE THEM LIKLY HIT. THE PAIN IS SO BAD IT IS FROM MY ARM , NECK AND TO MY HEAD.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Malaise, Pyrexia, Vomiting
Clinical narrative: 3 days of fever and malaise, redness at injection site, vomiting
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 25.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Swelling face
Clinical narrative: Swelling of the face, hot, red, rash, itching about 20 minutes after the vaccinations were given.  Patient called the pharmacy explaining her reaction that she was having. Patient was advised to take a benadryl and watch for worsening of symptoms and to go to the ER if anything worsens.
Age: 90.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Dyspnoea, Pain in extremity
Clinical narrative: I had typical soreness in the arm about 6 hours later. Its lessening today. I was short of breath 24 hours after receiving the vaccine and I have been getting dizzy 48 hours after receiving the shot.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: headache, body aches, fatigue which increased to severe muscle cramps, utter exhaustion, weakness, chills, body shakes, inability to sleep all night due to pain
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV
Symptoms: Pain, Sleep disorder, Tremor
Clinical narrative: headache, body aches, fatigue which increased to severe muscle cramps, utter exhaustion, weakness, chills, body shakes, inability to sleep all night due to pain
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching and rash which was severe enough that the next day, I sought treatment at the Physicians Immediate Care.  I was prescribed 20 mg of Prednisone, Benadryl
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was asked name, DOB and age and they responded with name, 8/15/XX and 65, was asked a second time about age and confirmed 65. NP administered the high dose flu vaccine, based on patient report of age and did not confirm age in chart. Miscommunication about age and birth year led to error.
Sex: U
Vaccine: RSV
Symptoms: Device issue
Clinical narrative: System of the Abrysvo that works for it broke/despite of using that correctly it broke for ABRYSVO SFDPO 5X0.5ML; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group, Program ID.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5019, Expiration Date: Feb2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "System of the Abrysvo that works for it broke/despite of using that correctly it broke for ABRYSVO SFDPO 5X0.5ML".  Causality for "system of the abrysvo that works for it broke/despite of using that correctly it broke for abrysvo sfdpo 5x0.5ml" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: The pharmacist tried to pull up a shot of Abrysvo today and the system of the Abrysvo that works for it broke and it was not yet administered but the pharmacist is asking for a replacement about it. The pharmacist would like to ask for information about this, about the packaging of this. Reportability Determination: This is Medical Device Related. This complaint for The caller is a Pharmacist calling because they tried to pull up a shot of Abrysvo today and the system of the Abrysvo that works for it broke and it was not yet administered but the caller is asking for a replacement about it. The caller would like to ask for information about this, about the packaging of this. It did not happen multiple times, it happens once and because we know how to try it up, we know we are supposed to put it down and how to use the equipment and despite of using that correctly it broke for ABRYSVO SFDPO 5X0.5ML GVL+SYR is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury. This event is NOT a reportable malfunction for ROW since the deficiency of the device was found prior to use on the patient and the deficiency would always be detected.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Nausea
Clinical narrative: Pain at injection site; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX, on 26Sep2023 as dose 1, single; ATENOLOL; AMLODIPINE. The following information was reported: NAUSEA (non-serious) with onset 27Sep2023 at 12:00, outcome "recovering"; INJECTION SITE PAIN (non-serious) with onset 27Sep2023 at 12:00, outcome "recovering", described as "Pain at injection site". Therapeutic measures were not taken as a result of injection site pain, nausea. Additional information: Patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since vaccination.  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: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15May2023 as dose 5 (booster), single (Lot number: Gj3270) at the age of 75 years, in left arm for COVID-19 immunization; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Degenerative arthritis" (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 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient has no known allergies. Treatment of COVID-19 was Paxlovid from 16Sep2023 to 20Sep2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 4 (booster), single), second regimen (Batch/Lot number: unknown) at single (dose 3 (booster), single), third regimen (Batch/Lot number: unknown) at single (dose 2, single) and fourth regimen (Batch/Lot number: unknown) at single (dose 1, single) for COVID-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "Shellfish allergy" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Day 0, with symptoms; Negative, notes: Day 7, on 2 antigen tests, symptoms gone; Positive, notes: Day 8, on antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional infromation: On day 0, the patient tested positive for COVID with symptoms. The patient started Paxlovid. On day 7, the patient tested negative on 2 antigen tests, symptoms gone. On day 8, the patient tested positive on antigen test. On days 9,10 and 11, mild symptoms were reported.  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.
Sex: F
Vaccine: 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) (Other HCP). The reporter is the patient.  A 32-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid on 16Sep2023 to 20Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test date=Nov2021, covid test result=Positive; covid test date=Nov2021, covid test result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 28Apr2021 as dose 1, single (Lot number: EW0176) and on 19May2021 as dose 2, single (Lot number: EW0179) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL; FLECAINIDE; ZOLOFT. Past drug history included: Midrin, reaction(s): "Known allergies: midrin"; Dilaudid, reaction(s): "Known allergies: Dilaudid"; Tramadol, reaction(s): "Known allergies: tramadol".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "covid test date=Nov2021, covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2021) Positive.  Additional information: It was reported that patient had positive COVID test on Nov2021. It was also that patient received dose 3 on 13Aug2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2 cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300312003 same patient and different drug dose/events.;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: start taking Paxlovid two weeks ago; start taking Paxlovid two weeks ago; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "start taking Paxlovid two weeks ago". Therapeutic measures were taken as a result of drug ineffective, covid-19.Patient states he had taken the Covid booster two years ago and had a bad effect on him. Started taking Paxlovid two weeks ago and is feeling very weak and not well. Therapeutic measures were taken as a result of drug ineffective, covid-19. Eight (8) months ago he came down with COVID-19 and was prescribed Paxlovid. Two years ago after getting a Pfizer COVID-19 booster he started having difficulty walking and started falling.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312112 same reporter/patient, different event;
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Headache, Hyperhidrosis
Clinical narrative: Mild soreness at injection site; fever; chills; muscle pain; joint pain; nausea; vomiting; headache; sweats; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 12:00 as dose: 1, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Terbinafine and related corticosteroids, penicillins, prednisone, sulfa antibiotics" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "Mild soreness at injection site"; CHILLS (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; PYREXIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; ARTHRALGIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "joint pain"; MYALGIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "muscle pain"; NAUSEA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; HYPERHIDROSIS (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "sweats"; VOMITING (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; ASTHENIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "weakness". Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, chills, myalgia, arthralgia, nausea, vomiting, headache, hyperhidrosis, asthenia. Additional information: No other vaccine in four weeks. No other medications in two weeks. Mild soreness at injection site. Less than 24 hrs later, fever, chills, muscle pain, joint pain, nausea, vomiting, headache, sweats, weakness. Lasting two full days. No covid prior vaccination. Not covid tested post vaccination.  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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Mild soreness at injection site; fever; chills; muscle pain; joint pain; nausea; vomiting; headache; sweats; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 12:00 as dose: 1, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Terbinafine and related corticosteroids, penicillins, prednisone, sulfa antibiotics" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "Mild soreness at injection site"; CHILLS (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; PYREXIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; ARTHRALGIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "joint pain"; MYALGIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "muscle pain"; NAUSEA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; HYPERHIDROSIS (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "sweats"; VOMITING (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering"; ASTHENIA (non-serious) with onset 25Sep2023 at 01:00, outcome "recovering", described as "weakness". Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, chills, myalgia, arthralgia, nausea, vomiting, headache, hyperhidrosis, asthenia. Additional information: No other vaccine in four weeks. No other medications in two weeks. Mild soreness at injection site. Less than 24 hrs later, fever, chills, muscle pain, joint pain, nausea, vomiting, headache, sweats, weakness. Lasting two full days. No covid prior vaccination. Not covid tested post vaccination.  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: U
Vaccine: COVID19, FLUX
Symptoms: Rash erythematous, Vaccination site erythema, Vaccination site pain
Clinical narrative: red mark and very sore after the shot; red mark and very sore after the shot; red rashes; 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 patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 as dose number unknown (booster), single (Lot number: HF9375) intramuscular for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 24Sep2023 as dose number unknown , single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Sep2023, outcome "recovering" and all described as "red mark and very sore after the shot"; RASH ERYTHEMATOUS (non-serious) with onset Sep2023, outcome "recovering", described as "red rashes".
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Decreased appetite, Paraesthesia, Sensation of foreign body
Clinical narrative: still very sick; joint pain; skin feels weird (like pins); doesn't feel like eating; feels something like a lump in her throat; This is a spontaneous report received from a contactable reporter (consumer) from Medical Information Team. The reporter is the patient. A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 25Sep2023 as dose number unknown, single (lot number unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DECREASED APPETITE (non-serious) with onset Sep2023, outcome "not recovered", described as "doesn't feel like eating"; SENSATION OF FOREIGN BODY (non-serious) with onset Sep2023, outcome "not recovered", described as "feels something like a lump in her throat"; ARTHRALGIA (non-serious) with onset Sep2023, outcome "not recovered", described as "joint pain"; PARAESTHESIA (non-serious) with onset Sep2023, outcome "not recovered", described as "skin feels weird (like pins)"; ILLNESS (non-serious) with onset Sep2023, outcome "not recovered", described as "still very sick".  Additional Information: The patient got the RSV vaccine on Monday and was still sick; not as sick as she was, but still very sick. She had joint pain, skin feels weird (like pins), she doesn't feel like eating, and she feels something like a lump in her throat. The patient would like to know how long these symptoms will last.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; 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 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa-based medications allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lortab [loratadine], reaction(s): "Allergy"; Morphine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received treatment with Paxlovid from 15Sep2023 to 20Sep2023 for COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: Flu vaccine 29Sep2023; Flu vaccine 29Sep2023; Arm soreness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 32-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 10:30 as dose 1, single (Lot number: HH7595) at the age of 32 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Sep2023, outcome "recovering", described as "Arm soreness"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 29Sep2023, outcome "unknown" and all described as "Flu vaccine 29Sep2023". Therapeutic measures were not taken as a result of pain in extremity. Additional information: No covid prior vaccination and has not been tested for COVID post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Idiopathic inflammatory myopathy
Clinical narrative: One respondent (3%) reported JIIM flare after the 2nd dose of the Pfizer BioNTech COVID-19 vaccine; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Covid-19 vaccine for COVID-19 immunisation, notes: DOSE 1,SINGLE, UNKNOWN MANUFACTURER. The following information was reported: IDIOPATHIC INFLAMMATORY MYOPATHY (medically significant), outcome "unknown", described as "One respondent (3%) reported JIIM flare after the 2nd dose of the Pfizer BioNTech COVID-19 vaccine".  The reporter considered "one respondent (3%) reported jiim flare after the 2nd dose of the pfizer biontech covid-19 vaccine" related to bnt162b2.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: U
Vaccine: RSV
Symptoms: Device breakage, Device leakage, Poor quality product administered
Clinical narrative: Upon mixing the product and attempting to draw up, the neck of the syringe must have been cracked or breached because it leaked all over out of the side of the neck of the syringe.; Upon mixing the product and attempting to draw up, the neck of the syringe must have been cracked or breached because it leaked all over out of the side of the neck of the syringe.; Upon mixing the product and attempting to draw up, the neck of the syringe must have been cracked or breached because it leaked all over out of the side of the neck of the syringe.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: POOR QUALITY PRODUCT ADMINISTERED (non-serious), DEVICE BREAKAGE (non-serious), DEVICE LEAKAGE (non-serious) and all described as "Upon mixing the product and attempting to draw up, the neck of the syringe must have been cracked or breached because it leaked all over out of the side of the neck of the syringe.". Additional information: The reporter had two syringes fail from the Abrysvo. Upon mixing the product and attempting to draw up, the neck of the syringe must have been cracked or breached because it leaked all over out of the side of the neck of the syringe. Causality for "upon mixing the product and attempting to draw up, the neck of the syringe must have been cracked or breached because it leaked all over out of the side of the neck of the syringe." was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: FLUC3
Symptoms: Blood pressure increased, Ear discomfort, Headache, Hypertension, Hypoaesthesia
Clinical narrative: Feel ear clogged; Elevated blood pressure; Numbness on the left side; Headache; This spontaneous case was received on 18-Sep-2023 from a non-healthcare professional (patient's wife) (reference number SEQW23-02379) and concerned a 60-years-old male patient.   The patient's medical history and concomitant medications were not reported.  On 08-Sep-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number was not reported.  On the same date, 'since that day', the patient started to feel ear clogged, headache, elevated blood pressure and numbness on the left side.  The outcome of the events was unknown.  This case was assessed as non-serious.  Company comment: A 60-year-old male patient complained of ear discomfort, hypertension, hypoaesthesia and headache, on the same date, after the vaccination with Flucelvax Quadrivalent. Medical history, concomitant medication and relevant diagnostic findings were not provided. Based on suggestive temporal relationship, causality for all reported events is assessed as possibly related.; Sender's Comments: A 60-year-old male patient complained of ear discomfort, hypertension, hypoaesthesia and headache, on the same date, after the vaccination with Flucelvax Quadrivalent. Medical history, concomitant medication and relevant diagnostic findings were not provided. Based on suggestive temporal relationship, causality for all reported events is assessed as possibly related.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP called to report inadvertent administration of VARIVAX to a patient after a temperature excursion that occurred on 08/31/2023. No additional AE/PQC.         ?    Names of vaccines involved (including lot/exp): VARIVAX 12/13/2024 W039688; HCP called to report inadvertent administration of VARIVAX to a patient after a temperature excursion that occurred on 08/31/2023. No additional AE/PQC.         ?    Names of vaccines involved (including lot/exp): VARIVAX 12/13/2024 W039688; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 31-AUG-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number W039688 with an expiration date of 13-DEC-2024). The administered dose of the vaccine experienced a temperature excursion at 6.1 degrees Fahrenheit (F) for 6 minutes. It was not mentioned if the information was recorded by a data logger or not. There was no adverse effect reported.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took Vivotif capsule after temperature excursion; A spontaneous report was received from a 26-year-old female on 20SEP2023 along with the additional information received on 22SEP2023 who "took Vivotif capsule after temperature excursion" (PT: Product storage error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003852) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient placed the Vivotif capsules in the cold packs when she was out for four hours. She believed that the first cold pack lasted for one hour and another cold pack was applied until the Vivotif capsules were kept in the refrigerator, few hours later. Reportedly, the capsules were at room temperature possibly that was in between 70-74 degrees Fahrenheit (with AC on) for about 1 to 2 hours, potentially 2.5 hours. On 20SEP2023, morning, the patient administered the first dose of Vivotif on an empty stomach followed by the second dose on 22SEP2023, morning.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif capsule after temperature excursion (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif capsule after temperature excursion (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Aug2023 as dose 4 (booster), single (Lot number: GK0928) at the age of 37 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Shellfish allergy". The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid from 06Sep2023 to 10Sep2023.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 50 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6203), on 17Mar2021 as dose 2, single (Lot number: EN6208), on 12Oct2021 as dose 3 (booster), single (Lot number: FD0810) and on 22Apr2022 as dose 4 (booster), single (Lot number: FT4989) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "Known allergies: kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metformin, reaction(s): "Known allergies: Metformin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Sep2023) Negative; (27Sep2023) Positive, notes: tested positive on 27Sep. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient. A 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 65 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertrophic cardiomyopathy" (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 "recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Sep2023 to 21Sep2023. Additional information: Covid "rebound" symptoms 5 days after last dose Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cyst, Heavy menstrual bleeding, Polyp, Vertigo
Clinical narrative: severe asthma; Vertigo; increased heavy menstrual bleeding; polyps; cysts; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 28Apr2021 as dose 1, single (Lot number: EW0176) at the age of 36 years and on 19May2021 as dose 2, single (Lot number: EW0179) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL; FLECAINIDE; ZOLOFT. Past drug history included: Midrin, reaction(s): "known allergies: midrin"; Dialuadid, reaction(s): "known allergies: Dilaudid"; Tramadol, reaction(s): "known allergies: tramadol". The following information was reported: VERTIGO (hospitalization) with onset May2021, outcome "not recovered"; CYST (hospitalization) with onset May2021, outcome "not recovered", described as "cysts"; HEAVY MENSTRUAL BLEEDING (hospitalization) with onset May2021, outcome "not recovered", described as "increased heavy menstrual bleeding"; POLYP (hospitalization) with onset May2021, outcome "not recovered", described as "polyps"; ASTHMA (hospitalization) with onset May2021, outcome "not recovered", described as "severe asthma". The patient was hospitalized for asthma, vertigo, heavy menstrual bleeding, polyp, cyst (hospitalization duration: 2 day(s)). The events "severe asthma", "vertigo", "increased heavy menstrual bleeding", "polyps" and "cysts" required physician office visit and emergency room visit. Additional information: No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of vertigo, heavy menstrual bleeding and severe asthma might not be fully excluded, considering the temporal relationship.  Polyp and cyst more likely represent intercurrent medical conditions.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate