chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hyperhidrosis, Nasopharyngitis
Clinical narrative: sweat profusely; feeling really weak; gets cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 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: HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweat profusely"; ASTHENIA (non-serious), outcome "unknown", described as "feeling really weak"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "gets cold".  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: Fall, Gait disturbance
Clinical narrative: having difficulty walking; falling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 27Sep2023, this case now contains all required information to be considered valid.  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 male patient received bnt162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 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: FALL (non-serious) with onset 2021, 1 day after the suspect product(s) administration, outcome "recovering", described as "falling"; GAIT DISTURBANCE (non-serious) with onset 2021, 1 day after the suspect product(s) administration, outcome "recovering", described as "having difficulty walking". Additional information: He had taken the Covid booster two years ago and had a bad effect on him. Additionally, on 27Sep2023, it was reported that two years ago after getting a Pfizer COVID-19 booster he started having difficulty walking and started falling. He has had many falls since then. This problem has been going on for two years. He was getting better with the walking issues. Previous to the vaccine, he used to walk three miles a day and one day after the vaccine his issues started. He wanted to know if there was anything he could do to get over it. He also asked if there was someone currently studying the side effects of the vaccine as he was willing to volunteer.  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-202300312109 same reporter/patient, different event;
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Diarrhea; Headache; Lightheadedness; Sluggish feeling; In general he feels off; Chest pain; Little bit of nausea; Tired; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 7 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single; lot number: unknown), for COVID-19 immunization; Bnt162b2 (dose 2, single; lot number: unknown), for COVID-19 immunization; Bnt162b2 (dose 3 (booster), single; lot number: unknown), for COVID-19 immunization; Bnt162b2 (dose 4 (booster), single; lot number: unknown), for COVID-19 immunization; Bnt162b2 (dose 5 (booster), single; lot number: unknown), for COVID-19 immunization; Bnt162b2 (dose 6 (booster), single; lot number: unknown), for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset Sep2023, outcome "unknown"; DIARRHOEA (non-serious) with onset Sep2023, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown"; MALAISE (non-serious) with onset Sep2023, outcome "unknown", described as "In general he feels off"; DIZZINESS (non-serious) with onset Sep2023, outcome "unknown", described as "Lightheadedness"; NAUSEA (non-serious) with onset Sep2023, outcome "unknown", described as "Little bit of nausea"; SLUGGISHNESS (non-serious) with onset Sep2023, outcome "unknown", described as "Sluggish feeling"; FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "Tired". The event "chest pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient received the new Pfizer COVID-19 vaccine on 25Sep2023. He experienced a series of symptoms; mentioned diarrhea most of the week, headache, a little bit of nausea, lightheadedness, sluggish feeling, tired, and feels off. The patient was asking if these were expected with the vaccine. This was his 7th vaccine, he also had Pfizer for the previous 6 vaccines. The patient mentioned that the whole week he was totally off and thrown for a loop since he came back from vacation. He went to the gym as he does every morning and towards the end of a spinning class which gets the heart pumping, he experienced chest pain and went to the hospital. He does not know if it was tied to the vaccine. The doctors did not state that it was the cause, but it was weird and made it seemed like it was. He had an EKG and blood work and they were negative. He also had to do stress test. The patient stated that he was not going to complain but just wanted to verify why he's feeling these.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling cold, Feeling hot, Headache
Clinical narrative: 24 hours later, fever of 103; Sweating; extreme fatigue; muscle aches; muscle tightness; Hard to move; Bad headache; Hot in the face and head; freezing through rest of my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 15:00 as dose 1, single (Lot number: HF9275) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing); "Allergy to cipro" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX QUAD taken for influenza immunisation, on 18Sep2023 as dose 1, single, 2023-2024 syr by seqiris. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "24 hours later, fever of 103"; HEADACHE (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Bad headache"; MOVEMENT DISORDER (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Hard to move"; FEELING HOT (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Hot in the face and head"; HYPERHIDROSIS (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Sweating"; FATIGUE (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "extreme fatigue"; FEELING COLD (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "freezing through rest of my body"; MYALGIA (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "muscle aches"; MUSCLE TIGHTNESS (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient received Advil/tylenol to reduce fever. Only down to 101.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Movement disorder, Muscle tightness, Myalgia, Pyrexia
Clinical narrative: 24 hours later, fever of 103; Sweating; extreme fatigue; muscle aches; muscle tightness; Hard to move; Bad headache; Hot in the face and head; freezing through rest of my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 15:00 as dose 1, single (Lot number: HF9275) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing); "Allergy to cipro" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX QUAD taken for influenza immunisation, on 18Sep2023 as dose 1, single, 2023-2024 syr by seqiris. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "24 hours later, fever of 103"; HEADACHE (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Bad headache"; MOVEMENT DISORDER (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Hard to move"; FEELING HOT (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Hot in the face and head"; HYPERHIDROSIS (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Sweating"; FATIGUE (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "extreme fatigue"; FEELING COLD (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "freezing through rest of my body"; MYALGIA (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "muscle aches"; MUSCLE TIGHTNESS (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient received Advil/tylenol to reduce fever. Only down to 101.
Sex: U
Vaccine: UNK
Symptoms: Drug interaction
Clinical narrative: I had a Pfizer Covid  booster yesterday Plus I had a Flu shot plus (unspecified Flu shot) I had a an RSV shot(unspecified RSV shot), three shots; I had a reaction; I have a flu and I've experienced it; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 27Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Sep2023 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: Bnt162b2 (Primary Immunization series complete., I've had Pfizer shots, all the shots, all the boosters, I've never had a reaction and now I had a reaction and I have had other shots with my Pfizer booster shots and my Pfizer Covid shots and I never had a reaction.), for COVID-19 immunization, reaction(s): "I've never had a reaction"; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, I've had Pfizer shots, all the shots, all the boosters, I've never had a reaction and now I had a reaction and I have had other shots with my Pfizer booster shots and my Pfizer Covid shots and I never had a reaction.), for COVID-19 immunization, reaction(s): "I've never had a reaction". The following information was reported: DRUG INTERACTION (non-serious) with onset 27Sep2023, outcome "unknown", described as "I had a Pfizer Covid  booster yesterday Plus I had a Flu shot plus (unspecified Flu shot) I had a an RSV shot(unspecified RSV shot), three shots"; INFLUENZA (non-serious) with onset 27Sep2023, outcome "recovering", described as "I had a reaction; I have a flu and I've experienced it". Additional information: Consumer stated, he/she had a Pfizer Covid booster yesterday Plus had a Flu shot plus (unspecified Flu shot) and had an RSV shot (unspecified RSV shot) three shots and had a reaction. Patient just felt like he/she kind of have the flu. Patient was feeling like he/she has a flu and experienced it yesterday which was Wednesday, today is Thursday. Patient was still recovering from it but just wondered, what he/she was trying to do is find out if he/she could get a test kit for home testing for COVID and he/she was fully insured, that's not a problem. Patient stated, he/she just feel like he/she has. He/she never had a reaction. He/she had Pfizer shots, all the shots, all the boosters, he/she never had a reaction and now he/she had a reaction and had other shots with his/her Pfizer booster shots, with his/her Pfizer Covid shots, he/she never had a reaction.  The information on the batch/lot number for bnt162b2 omi xbb.1.5, 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: Malaise, Pain
Clinical narrative: each of them feeling sick; aching all over for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), 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: MALAISE (non-serious), outcome "unknown", described as "each of them feeling sick"; PAIN (non-serious), outcome "recovered", described as "aching all over for a day or two".  Additional information: Caller reports receiving 6 Pfizer COVID-19 vaccine injections in the past (dates and formulations not provided) and after each of them felt sick and aching all over for a day or two.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312955 Same patient/vaccine/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: each of them feeling sick; aching all over for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2 (Dose 2, Single), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 3 (Booster), Single), for COVID-19 immunisation, reaction(s): "each of them feeling sick"; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 3 (Booster), Single), for COVID-19 Immunization, reaction(s): "aching all over for a day or two". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "each of them feeling sick"; PAIN (non-serious), outcome "recovered", described as "aching all over for a day or two".  Additional Information: Caller reports receiving 6 Pfizer COVID--19 vaccine injections in the past (dates and formulations not provided) and after each of them feeling sick and aching all over for a day or two.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312955 Same patient/vaccine/event, different dose (Dose 6);
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Poor quality sleep, Pyrexia, Vaccination site swelling
Clinical narrative: Poor sleep; swelling at injection site; light fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 11:15 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: POOR QUALITY SLEEP (non-serious) with onset 27Sep2023 at 23:00, outcome "recovering", described as "Poor sleep"; HEADACHE (non-serious) with onset 27Sep2023 at 23:00, outcome "recovering"; PYREXIA (non-serious) with onset 27Sep2023 at 23:00, outcome "recovering", described as "light fever"; VACCINATION SITE SWELLING (non-serious) with onset 27Sep2023 at 23:00, outcome "recovering", described as "swelling at injection site". Therapeutic measures were not taken as a result of poor quality sleep, vaccination site swelling, pyrexia, headache.  Additional information: Patient does not get covid prior vaccination. Patent not tested positive for COVID 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: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: run down; very sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 15:00 as dose 1, single (Lot number: HG4677) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Sep2023 at 15:00, outcome "recovered", described as "run down"; SOMNOLENCE (non-serious) with onset Sep2023 at 15:00, outcome "recovered", described as "very sleepy". Therapeutic measures were not taken as a result of fatigue, somnolence.  Additional information: The patient received no other vaccine in four weeks, Patient was very sleepy and run down 1 day post vaccination. Patient did not have covid prior vaccination and was not covid tested post vaccination.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: run down; very sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 15:00 as dose 1, single (Lot number: HG4677) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Sep2023 at 15:00, outcome "recovered", described as "run down"; SOMNOLENCE (non-serious) with onset Sep2023 at 15:00, outcome "recovered", described as "very sleepy". Therapeutic measures were not taken as a result of fatigue, somnolence.  Additional information: The patient received no other vaccine in four weeks, Patient was very sleepy and run down 1 day post vaccination. Patient did not have covid prior vaccination and was not covid tested post vaccination.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Chills; pain in arm; sore aching body; headache; 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 male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 11:45 as dose 6 (booster), single (Lot number: HF9275) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "AFIB" (unspecified if ongoing); "Bees" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ciprofloxacin, reaction(s): "Drug Allergy"; Flu for Influenza Immunization, notes: DOSE NUMBER UNKNOWN, SINGLE; MANUFACTURER UNKNOWN. Vaccination history included: bnt162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: FH8027; Anatomical Location: Arm Left), administration date: 07Apr2022, for COVID-19 immunization, reaction(s): "Nausea", "Aches", "sore arm"; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE; Lot number: GJ6742, Route of Administration: Intramuscular; Anatomical Location: Arm Right), administration date: 26Oct2022, for COVID-19 immunization, reaction(s): "Body aches", "hot and cold", "knot in arm", "arm twitching", "Headache", "Nausea"; Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 28Sep2023, outcome "recovering"; HEADACHE (non-serious) with onset 28Sep2023, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 28Sep2023, outcome "recovering", described as "pain in arm"; PAIN (non-serious) with onset 28Sep2023, outcome "recovering", described as "sore aching body". Therapeutic measures were not taken as a result of chills, pain in extremity, pain, headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The upper left arm where the COVID vaccine was administered was very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 11:45 as dose 1, single, (Lot number: HF9275) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for influenza immunisation as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Sep2023 at 19:00, outcome "recovered", described as "The upper left arm where the COVID vaccine was administered was very sore". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: Patient recevied vaccine at PRIVACY Clinic. Pateint took over the counter pain killer (Ibuprofen).
Sex: F
Vaccine: COVID19, RSV
Symptoms: Lung disorder
Clinical narrative: lung problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient. A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: LUNG DISORDER (non-serious), outcome "unknown", described as "lung problems". Additional information: The caller wanted to verify the RSV vaccine Abrysvo because it depends on her life. She said she spoke to her doctor and with the pharmacy needed to get some information about the vaccine for she has a lot of lung problems. She said her doctor gave her the RSV vaccine Abrysvo, Pfizer COVID vaccine and booster all three of them. She wanted to know information about the RSV vaccine, Abrysvo because she said don't want to die but she did need something in her lungs because this is really bad.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: fever; chills; her hands were shaking; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Bnt162b2 (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), administration date: Apr2022, for COVID-19 Immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: CHILLS (non-serious) with onset 27Sep2023, outcome "unknown"; PYREXIA (non-serious) with onset 27Sep2023, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 27Sep2023, outcome "unknown"; TREMOR (non-serious) with onset 27Sep2023, outcome "unknown", described as "her hands were shaking".  Additional information: The caller said that she got the new vaccine yesterday afternoon. The caller mentioned that this was her fourth booster. The caller stated that she had a bad reaction last night. The caller said that she had a fever, chills, and her hands were shaking. She also had a headache. The caller said that she noticed that she had those bad reactions after taking her second booster shot in Apr2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300313905 same reporter/patient/AE, different dose number (dose 4);
Age: 52.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Fatigue, Headache, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Left arm: swelling, lump, and redness surrounding injection area beginning 12 hours post injection and continuing with a broader redness area by 48 hrs. At 17 hours post injection: severe headache and general malaise and fatigue, lasting 24 hours. 48 hrs post injection, swelling and a painful lump in left clavicle region noted. Currently at 56 hours post injection: still swollen painful left arm with a knot and redness; still painful lump and swelling in left clavicle region
Age: 52.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Malaise, Mass, Pain
Clinical narrative: Left arm: swelling, lump, and redness surrounding injection area beginning 12 hours post injection and continuing with a broader redness area by 48 hrs. At 17 hours post injection: severe headache and general malaise and fatigue, lasting 24 hours. 48 hrs post injection, swelling and a painful lump in left clavicle region noted. Currently at 56 hours post injection: still swollen painful left arm with a knot and redness; still painful lump and swelling in left clavicle region
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Diarrhea and abdominal pain
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Imaging procedure, Laboratory test normal, Paraesthesia
Clinical narrative: Right arm tingling. Patient reports it has been going on and off all day on 10/3/23.  Tingling from right mid bicep down to both sides of hands. No other symptoms.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Chest X-ray, Laboratory test, Tremor
Clinical narrative: Patient presented to our ED with complaint of bad shakes started on evening of 10/3/23.  These shakes where whole body shakes that started ~2000 and lasted 30 minutes and were resolved on arrival to ED.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: VERY BAD REACTION; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid, and concurrent conditions included: diabetes, and cancer, and other pre-existing medical conditions included: Patient was a nurse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-JUL-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced very bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very bad reaction. This report was non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE/PQC reported; HCP reported that an adult patient was administered the pediatric dose of the RECOMBIVAX HB vaccine.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 28-SEP-2023, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (incorrect dose administered) (lot number W038864 has been determined to be valid for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), with an expiration date established as 16-JUL-2025), administered for prophylaxis (strength, and anatomical site of administration were not provided). No adverse events were reported for this patient.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue
Clinical narrative: episodes of pain in the joints; episodes of fatigue; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-SEP-2023, the patient received the 2nd dose of Shingrix. In SEP-2023, an unknown time after receiving Shingrix, the patient experienced joint pain (Verbatim: episodes of pain in the joints) and fatigue (Verbatim: episodes of fatigue). In SEP-2023, the outcome of the joint pain and fatigue were resolved.   It was unknown if the reporter considered the joint pain and fatigue to be related to Shingrix.     It was unknown if the company considered the joint pain and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-SEP-2023 The pharmacist reported after the administration of Shingrix 2nd dose the patient experienced episodes of joint pain as well as episodes of fatigue. These episodes of joint pain and fatigue lasted for hour or two hours. These episodes were not every day. The reporter consented to follow up.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a 25-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot on 28-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included CETIRIZINE HCL for an unknown indication.    On 28-Sep-2023 at 1:00 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 29-Sep-2023, the patient experienced HEADACHE (headache) and PYREXIA (fever). On 30-Sep-2023, HEADACHE (headache) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Rhinorrhoea
Clinical narrative: nose is running like crazy; head cold; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose is running like crazy), NASOPHARYNGITIS (head cold) and PAIN IN EXTREMITY (sore arm) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced RHINORRHOEA (nose is running like crazy), NASOPHARYNGITIS (head cold) and PAIN IN EXTREMITY (sore arm). On 26-Sep-2023, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, RHINORRHOEA (nose is running like crazy) and NASOPHARYNGITIS (head cold) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Patient recently received Spikevax vaccine and was asking how many days it will take to be fully protected after getting the vaccine. Patient had head cold, nose was running like crazy and asked if she could take antihistamine after taking the Spikevax vaccine. She will have a dentist appointment soon, and asked if she could take antibiotics. After getting the Moderna vaccine on 25-Sep-2023 she had sore arm during a day and a half after getting Spikevax.  No treatment drug was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Laboratory test, Urine ketone body absent
Clinical narrative: In less than 24 hours of receiving the Spikevax vaccine I began to experience very high glycemic excursions, despite having been stable on my insulin pump and Metformin. My blood sugar would go over 325 and remain there for several hours without warning or cause. No ketones developed. This has been persisting over the past 10 days since receiving the vaccine.  The increases in blood sugar occur randomly and are not related to food intake, insulin bolus, or activity levels.
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Chest pain, Insomnia, Pain in extremity, Sleep disorder
Clinical narrative: Received a Prevnar-20 injection on 25 Sept 2023 in my left shoulder. On 27 Sept started feeling pain in my left arm and let chest that made sleeping difficult and interrupted. Pain has been increasing and spreading since then. Sleep is now very difficult.
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Axillary pain, Musculoskeletal chest pain, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Received a Prevnar-20 injection on 25 Sept 2023 in my left shoulder. On 27 Sept started feeling pain in my left arm and let chest that made sleeping difficult and interrupted. Pain has been increasing and spreading since then. Sleep is now very difficult.
Sex: U
Vaccine: FLU4
Symptoms: Product appearance confusion, Product design issue
Clinical narrative: A near miss occurred whereby an RN administering vaccines affixed a high-dose Fluzone vaccine syringe to the vial containing lyophilized RSV vaccine. On review, it was observed that the pre-filled syringes of high-dose Fluzone and the pre-filled sterile water diluent to reconstitute the RSV vaccine look very similar and have the same (interchangeable) connector system. In high-volume vaccine clinic settings where both vaccines are stored, there is a risk for inadvertent co-mingling of flu vaccine and RSV diluent. (photos attached). Note, this was caught prior to incorrect administration; no harm done.
Sex: M
Vaccine: FLUN4
Symptoms: Ear pain, Headache, Pain
Clinical narrative: Severe body aches, ear pain, headache.
Sex: M
Vaccine: COVID19-2
Symptoms: Blood sodium decreased, Blood test abnormal, CSF test abnormal, Confusional state, Encephalitis autoimmune
Clinical narrative: I was a physically fit, 67 year old male who enjoyed roding a bicycle several thousand miles a year as well as backpacking and skiing. I received a COVID-19 vaccination at the pharmacy on 2023-05-10. On 2023-5-31 my wife took me to the ED due to Altered Mental State due to confusion and memory problems. I was evaluated, they found I had low sodium (125), I was given a saline infusion and sent home with 1 L of saline to take, which I did. The next day my condition continued to decline, so my wife tok me again to ED where I was admitted to the hospital. A few days later I was moved to another hospital where I stayed until 2023-06-14 while clinicians attempted to diagnose my problem. They determined I suffered from sub-clinical seizures in addition to the symptoms described above. I had several blood and cerebral spinal fluid samples taken with no positive results while I was in the hospital. I was released on June14 with no definitive diagnosis. On June 22 I received a diagnosis autoimmune encephalitis mediated by LGI-1 antibodies by a test result from the clinic. Since then I have received two infusions of Retuximab as well as taking other drugs to control seizures and control other aspects of this condition. I seem to be recovering well from this condition as a result of our quick action and good care teams, but I now have to consider myself immuno-compromized. As a result, I and my wife have to take measures (avoiding enncclosed places many peoples, wearing masks in public, etc.) to prevent infections from common viruses circulating in the general population, such as colds, flu, etc. I have been on leave and extended leave from my employer since this started. I'm due to return to work next week. I'm glad I have good medical insurance from my employer, otherwise I do know how I would have afforded treatment. I do not know whether this is an adverse event due to the vaccination, but both events involve my immune system and the timing is suspicious to me. This is the first time I can recall having a serious health issue since I was hospitalized a few days in late 1963. I also have questions about whether I should take the new COVID-19 vaccination due to this experience.
Sex: M
Vaccine: COVID19-2
Symptoms: Impaired work ability, Infusion, Memory impairment, Mental status changes, Seizure
Clinical narrative: I was a physically fit, 67 year old male who enjoyed roding a bicycle several thousand miles a year as well as backpacking and skiing. I received a COVID-19 vaccination at the pharmacy on 2023-05-10. On 2023-5-31 my wife took me to the ED due to Altered Mental State due to confusion and memory problems. I was evaluated, they found I had low sodium (125), I was given a saline infusion and sent home with 1 L of saline to take, which I did. The next day my condition continued to decline, so my wife tok me again to ED where I was admitted to the hospital. A few days later I was moved to another hospital where I stayed until 2023-06-14 while clinicians attempted to diagnose my problem. They determined I suffered from sub-clinical seizures in addition to the symptoms described above. I had several blood and cerebral spinal fluid samples taken with no positive results while I was in the hospital. I was released on June14 with no definitive diagnosis. On June 22 I received a diagnosis autoimmune encephalitis mediated by LGI-1 antibodies by a test result from the clinic. Since then I have received two infusions of Retuximab as well as taking other drugs to control seizures and control other aspects of this condition. I seem to be recovering well from this condition as a result of our quick action and good care teams, but I now have to consider myself immuno-compromized. As a result, I and my wife have to take measures (avoiding enncclosed places many peoples, wearing masks in public, etc.) to prevent infections from common viruses circulating in the general population, such as colds, flu, etc. I have been on leave and extended leave from my employer since this started. I'm due to return to work next week. I'm glad I have good medical insurance from my employer, otherwise I do know how I would have afforded treatment. I do not know whether this is an adverse event due to the vaccination, but both events involve my immune system and the timing is suspicious to me. This is the first time I can recall having a serious health issue since I was hospitalized a few days in late 1963. I also have questions about whether I should take the new COVID-19 vaccination due to this experience.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Pain in extremity, Palpitations
Clinical narrative: Adverse reaction to Spikevax covid age12+ vaccine 12 hours after the shot had, fever, difficulty breathing, headache, chills, very sore arm, some palpitations.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Adverse reaction to Spikevax covid age12+ vaccine 12 hours after the shot had, fever, difficulty breathing, headache, chills, very sore arm, some palpitations.
Sex: M
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Patient reports rash and seeking emergency medical services after receiving Arexvy.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Muscle disorder, Nausea, Neurological symptom
Clinical narrative: Severe reaction to the SPIKEVAX 12+ manufactured by Moderna. Some of the severe adverse effects included comatose-like effects, nausea, extreme weakness, some loss of muscular functions. I have been around people that were under chemotherapy and this comes as close to chemotherapy as I imagine it to be. I have taken all 5 previous COVID vaccines, all made by Pfizer (2 original and 3 boosters) with some weakness and sleepiness reactions, but this immunization of SPIKEVAX by Moderna was far worse. Due to the unavailability of the Pfizer vaccine, I agree to take the Moderna vaccine with the CDC states is interchangeable with the Pfizer vaccine but based on my experience this does not mean equivalency in every respect, including adverse reaction. My conclusion after this experience is either never take a COVID vaccine in the future or stick to the Pfizer vaccines exclusively. The equivalency stated between the Pfizer and Moderna vaccines is overstated especially in adverse reactions.
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Chest pain, Dyspnoea, Heart rate increased, Muscle spasms
Clinical narrative: On September 28, 2023 I received a recommended pneumonia vaccine advised by my new primary doctor. I was given the shot by the nurse around 2:30pm at the doctors office. Around approximately 4:15pm this same day, out of no where I began having severe chest pains and my heart began to race at an alarm rate, to the point I dropped to the floor. My girlfriend wound up rushing me to Hospital, where I was immediately admitted to the ER and had numerous devices placed on me, as well as IVs and such to help me. During my time in the ER initially which was around 5pm, my throat began to close up, I couldn't breath and every muscle in my body began to spasm. I repeatedly told each doctor and nurse that asked me that I've never had this happen before nor do I have medical history of heart problems, and that this was a direct side effect of the pneumonia vaccine. Those statements were ignored constantly. Eventually, my heart rate slowed down and everything went back to normal as if nothing happened. I discharged myself from the ER since I was fine, and was prescribed medication to lower my blood pressure and heart rate, by a doctor at the hospital who has no knowledge of my medical history. I vehemently believe that the pneumonia vaccine caused my issue, as each issue I had was listed as a rare side effect on the Clinic website. This vaccine almost lead to me having a heart attack and needs to be studied more before being administered further.
Sex: M
Vaccine: PPV
Symptoms: Palpitations, Throat tightness
Clinical narrative: On September 28, 2023 I received a recommended pneumonia vaccine advised by my new primary doctor. I was given the shot by the nurse around 2:30pm at the doctors office. Around approximately 4:15pm this same day, out of no where I began having severe chest pains and my heart began to race at an alarm rate, to the point I dropped to the floor. My girlfriend wound up rushing me to Hospital, where I was immediately admitted to the ER and had numerous devices placed on me, as well as IVs and such to help me. During my time in the ER initially which was around 5pm, my throat began to close up, I couldn't breath and every muscle in my body began to spasm. I repeatedly told each doctor and nurse that asked me that I've never had this happen before nor do I have medical history of heart problems, and that this was a direct side effect of the pneumonia vaccine. Those statements were ignored constantly. Eventually, my heart rate slowed down and everything went back to normal as if nothing happened. I discharged myself from the ER since I was fine, and was prescribed medication to lower my blood pressure and heart rate, by a doctor at the hospital who has no knowledge of my medical history. I vehemently believe that the pneumonia vaccine caused my issue, as each issue I had was listed as a rare side effect on the Clinic website. This vaccine almost lead to me having a heart attack and needs to be studied more before being administered further.