chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Oropharyngeal pain
Clinical narrative: sore throat; headache; chills; 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 rsv vaccine prot.subunit pref 2v (ABRYSVO), in 2023 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: CHILLS (non-serious) with onset 2023, outcome "unknown"; HEADACHE (non-serious) with onset 2023, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 2023, outcome "unknown", described as "sore throat". Additional information: Patient stated she received Abrysvo vaccine on Monday. Patient asked if sore throat, headache and chills have been reported as side effects from the vaccine. Patient stated, no fever, runny nose and no positive covid test so far.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: lost her sense of taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 90-year-old female patient received bnt162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 88 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for thyroid disorder, start date: 1958. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 25Jan2021, for Covid-19 immunisation. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "lost her sense of taste".  Additional information: Reporter, a consumer calling about her second shot that she had with Covid-19 vaccine. She lost her taste buds. She was wondering if there was anything we had found out that they had a problem. She was wondering what she could do. She had all the shots up to the 5th shot and she had that couple of days ago, Sunday. she had it in (Shopping mall name withheld) everything was fine no complains about any now. but the second shot she had, she lost her taste buds came and they kind of came and went, came and went and now it was getting to the point she had not been able to taste anything. Patient lost her taste buds after the 2nd shot. Some people experience a little discomfort and can continue to go about their day. Others had side effects that affect their ability to do daily activities. She had all the Pfizer COVID vaccine, her latest shot was last Sunday and she just want to know recommendations from Pfizer and how we get back her taste buds. But it was been off and on and she might had in the morning and then she might had been able to taste at noon. It just was not like that all the time but the last two weeks she had not had that it was if she not had any taste at all, so she just thought she need to call to see if there is something that could be done, that may they had. Consumer stated, the date was 25Jan2021 and the next one was 24Feb2021, 14Oct2021, 30Mar2022 and 05Apr2023. The last one would have been on 15Oct2023. That was the dates she got the shots. She got one of the shots, because her husband had a shot on same day but it did not bother him. Patient took other medication, but it was for thyroid medication. Not had any lab test done.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Axillary pain, Extra dose administered, Injection site pain
Clinical narrative: pain at the injection site; pain at the injection site and also the armpit near the injection site.; Caller received Prevnar 20 vaccine when he was 65 y/o then another dose when he turned 66 y/o, would like to know if getting a 2nd dose is correct.; 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 66-year-old male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 20 (DOSE 1, SINGLE), when the patient was 65 years old, for immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site"; AXILLARY PAIN (non-serious), outcome "unknown", described as "pain at the injection site and also the armpit near the injection site."; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Caller received Prevnar 20 vaccine when he was 65 y/o then another dose when he turned 66 y/o, would like to know if getting a 2nd dose is correct.".  Additional information: The caller received Prevnar 20 vaccine when he was 65 y/o then another dose when he turned 66 y/o, would like to know if getting a 2nd dose is correct. Caller also mentioned having pain at the injection site and also the armpit near the injection site  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.
Age: 30.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Headache, Pain, Sensitive skin, Vaccination site pain
Clinical narrative: light achiness; Light headache; sensitive skin (all over); light fatigue; light soreness at injection site; Date of start of drug: 17Oct2023. Pfizer/BioNTech Bivalent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2023 at 14:15 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 17Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 17Oct2023, outcome "unknown", described as "Date of start of drug: 17Oct2023. Pfizer/BioNTech Bivalent"; HEADACHE (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "Light headache"; PAIN (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "light achiness"; FATIGUE (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "light fatigue"; VACCINATION SITE PAIN (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "light soreness at injection site"; SENSITIVE SKIN (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "sensitive skin (all over)". Therapeutic measures were taken as a result of headache.  Additional information: Ibuprofen used for headache.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 30.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Wrong product administered
Clinical narrative: light achiness; Light headache; sensitive skin (all over); light fatigue; light soreness at injection site; Date of start of drug: 17Oct2023. Pfizer/BioNTech Bivalent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2023 at 14:15 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 17Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 17Oct2023, outcome "unknown", described as "Date of start of drug: 17Oct2023. Pfizer/BioNTech Bivalent"; HEADACHE (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "Light headache"; PAIN (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "light achiness"; FATIGUE (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "light fatigue"; VACCINATION SITE PAIN (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "light soreness at injection site"; SENSITIVE SKIN (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "sensitive skin (all over)". Therapeutic measures were taken as a result of headache.  Additional information: Ibuprofen used for headache.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: I had extremely debilitating generalized pain throughout my entire body.; pain was constant in my right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received bnt162b2 (BNT162B2), on 12Aug2021 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE , Anatomical location: Arm Left, Vaccine Administration Time: 11:00 am), administration date: 15Jul2021, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Aug2021, outcome "recovering", described as "I had extremely debilitating generalized pain throughout my entire body."; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "not recovered", described as "pain was constant in my right arm". The events "i had extremely debilitating generalized pain throughout my entire body." and "pain was constant in my right arm" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, pain in extremity.  Additional information: Patient was forced by his command staff to take the second vaccine shot or be fired. Within one week of receiving the second vaccine, he had extremely debilitating generalized pain throughout his entire body. The pain was worse at night after working throughout the day pain was constant in his right arm. He would have to take 4 Ibuprofen every night to make the pain go away. After a month the pain in the rest of his body dissipated but the pain in his right arm was still present to this day. He had seen an orthopedic doctor, who believed the pain was not related to any muscular skeletal injuries. He consulted his primary care provider about seeing a rheumatologist, she recommended him to make this report of an adverse reaction first. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment/caught Covid January 8, 2022 after starting the vaccination process; COVID 19 Treatment/caught Covid January 8, 2022 after starting the vaccination process; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), on 16Mar2021 at 11:00 as dose 1, single (Lot number: EN6208), in right arm and on 06Apr2021 at 12:15 as dose 2, single (Lot number: ER8734) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Pneumococcal 20-Val Conj Vaccine, Vancomycin, Cortisone Base And Pcn Penicillins" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "COVID 19 Treatment/caught Covid January 8, 2022 after starting the vaccination process". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 07Oct2023 to 12Oct2023. Clinical course: Patient also received bnt162b2 (BNT162B2), on 22Feb2022 at 03:15 as dose 3 (booster), single (Lot number: FM0698), in right arm for covid-19 immunisation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334047 Same patient, different product, different dose/event;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness
Clinical narrative: Muscle weakness; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 12:00 as dose 1, single (Lot number: HF9275) at the age of 43 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for influenza immunisation, on 19Sep2023 as dose number unknown, single; CLARITIN [LORATADINE]; ADDERALL; WELLBUTRIN; IBUPROFEN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 18Oct2023 at 16:00, outcome "not recovered", described as "Muscle weakness"; ARTHRALGIA (non-serious) with onset 18Oct2023 at 16:00, outcome "not recovered", described as "joint pain". Therapeutic measures were not taken as a result of muscular weakness, arthralgia.  Additional information: Patient reported that Muscle weakness and joint pain to the point where simple tasks were difficult and even typing was difficult. No covid prior vaccination and no covid tested post vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Headache, Oropharyngeal pain, Pain, Upper-airway cough syndrome
Clinical narrative: Excessive chills; body aches; post nasal drip; headache; sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 00:45 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (AFLURIA), on 16Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for influenza immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 07Feb2023; CLARITIN [LORATADINE]. The following information was reported: CHILLS (non-serious) with onset 16Oct2023 at 23:00, outcome "not recovered", described as "Excessive chills"; PAIN (non-serious) with onset 16Oct2023 at 23:00, outcome "not recovered", described as "body aches"; HEADACHE (non-serious) with onset 16Oct2023 at 23:00, outcome "not recovered"; UPPER-AIRWAY COUGH SYNDROME (non-serious) with onset 16Oct2023 at 23:00, outcome "not recovered", described as "post nasal drip"; OROPHARYNGEAL PAIN (non-serious) with onset 16Oct2023 at 23:00, outcome "not recovered", described as "sore throat". Therapeutic measures were taken as a result of chills, pain, upper-airway cough syndrome, headache, oropharyngeal pain.  Additional information: The patient had no known allergies and took the Ibuprofen 400 mg every 4-5 hours.  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: 50.0
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) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Imitrex, reaction(s): "known allergies: Imitrex"; Azithromycin, reaction(s): "known allergies: azithromycin"; Levofloxacin, reaction(s): "known allergies: levofloxacin". Vaccination history included: Covid-19 vaccine (DOSE 4, SINGLE, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE , Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid for Covid-19 treatment from 09Oct2023 to 13Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 15Jul2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchopulmonary aspergillosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient received Paxlovid as treatment. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334580 same reporter/patient/product, different AE;US-PFIZER INC-202300334579 same reporter/patient/product, different AE;
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Felt dizzy; Very tired, little fatigue; Headache; This is a spontaneous report received from a 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 14Oct2023 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: DIZZINESS (non-serious) with onset Oct2023, outcome "unknown", described as "Felt dizzy"; HEADACHE (non-serious) with onset Oct2023, outcome "recovered" (Oct2023); FATIGUE (non-serious) with onset Oct2023, outcome "unknown", described as "Very tired, little fatigue".  Additional information: Caller stated her daughter felt really dizzy immediately but caller had same experience with hers. She stayed home with headache. After about a day went away. Caller stated that it felt like very much not that much, a little fatigue. It was mild symptoms, and she didn't have headache. Stated that it was herself and caller's sister that had headache on 1st day. Caller stated that they all Pfizer Covid vaccines. Caller was very tired but nothing out of the ordinary.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300333483 same reporter/drug, different patient/AE;US-PFIZER INC-202300334599 same reporter/drug, different patient/AE;
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 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: HEADACHE (non-serious) with onset Oct2023, outcome "recovered" (Oct2023).  Additional information: Reporter stated her daughter was vaccinated on Saturday 14Oct2023. During report while doing supplemental form caller stated she stayed home with headache. Caller's sister also. After about a day went away. Caller's sister had headache on 1st day.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334595 same reporter/drug, different patient/AE.;US-PFIZER INC-202300333483 same reporter/drug, different patient/AE.;
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 36-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 7 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient received Paxlovid from 09Oct2023 to 13Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Pain
Clinical narrative: pain/ hurts; 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 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: PAIN (non-serious), outcome "unknown", described as "pain/ hurts". Additional information included: The patient was calling about Abrysvo and was originally calling to find out if it was ok to take Excedrin for pain. She reported that she hurt and said that she may have gotten side effects from the Abrysvo. The patient didn't feel that the pain is related to the Abrysvo. 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.; Sender's Comments: Pain/ hurts occurred following the administration with ABRYSVO might be related to the vaccine use given the known adverse event profile of the vaccine.
Age: 64.0
Sex: M
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 65-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Feb2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Sep2023) Negative, notes: By day six I tested negative for Covid; (27Sep2023) Positive, notes: I tested positive on day 9; (04Oct2023) Positive, notes: still positive on day 16; (06Oct2023) Negative, notes: before testing negative on days 18 and 20; (08Oct2023) Negative, notes: before testing negative on days 18 and 20.  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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Peripheral swelling, Pruritus
Clinical narrative: My left upper arm was itchy and swollen; My left upper arm was itchy and swollen; lethargic; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Generalised anxiety disorder" (unspecified if ongoing); "known allergies: Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLUOXETINE; PRENATAL VITAMINS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE]. Vaccination history included: Covid-19 vaccine (Dose:1, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:2, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:3, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:4, unknown manufacture), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 14Oct2023, outcome "recovered" (17Oct2023) and all described as "My left upper arm was itchy and swollen"; LETHARGY (non-serious) with onset 14Oct2023, outcome "recovered" (Oct2023), described as "lethargic". Therapeutic measures were not taken as a result of pruritus, peripheral swelling, lethargy. Additional information: Patient reported, "My left upper arm was itchy and swollen starting the day after I received the vaccine and the swelling and itching lasted for four days. I also felt very lethargic the day after receiving the vaccine, which happened with the other doses but the arm swelling and itching was new this time".  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: RSV
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID. The reporter is the patient.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Sep2023, 2 weeks after the suspect product(s) administration, outcome "not recovered", described as "allergic reaction".  Additional information: The specialty of patient (the reporting physician) was allergy and Immunology. He was administered Abrysvo, after 2 weeks he experienced an allergic reaction, and had this now for a month. He asked how long will the reaction 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Upper respiratory tract congestion
Clinical narrative: sore throat; congestion in throat; This is a spontaneous report received from 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 18Oct2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 20Sep2023 as dose 1, single; IBUPROFEN; ACETAMINOPHEN; FLUORIDE [SODIUM FLUORIDE]. The following information was reported: UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 19Oct2023 at 06:30, outcome "recovering", described as "congestion in throat"; OROPHARYNGEAL PAIN (non-serious) with onset 19Oct2023 at 06:30, outcome "recovering", described as "sore throat". Therapeutic measures were not taken as a result of oropharyngeal pain, upper respiratory tract congestion. Additional information: No known allergies. It was also reported the patient experienced sore throat, congestion in throat at "14hrs" after vaccine.  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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 31-year-old female patient (pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. Date of last menstrual period: Mar2023. The patient is expected to deliver a baby(s) on 10Dec2023. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Oct2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  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-202300334811 Same patient, different event;
Sex: U
Vaccine: COVID19
Symptoms: Illness, Overdose, Product administered to patient of inappropriate age, Vomiting
Clinical narrative: Dose number: 2/The patient was 6-7 years old, and received the gray cap formulation of the COVID-19 Vaccine (the formulation for patients 12 plus); Dose number: 2/The patient was 6-7 years old, and received the gray cap formulation of the COVID-19 Vaccine (the formulation for patients 12 plus); sick with vomiting; sick with vomiting; This is a spontaneous report received from contactable reporter(s) (Physician).  A child patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 2, 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 (DOSE 1, lot number unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), VOMITING (non-serious) all with onset Oct2023, outcome "unknown" and all described as "sick with vomiting"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 18Oct2023, outcome "unknown" and all described as "Dose number: 2/The patient was 6-7 years old, and received the gray cap formulation of the COVID-19 Vaccine (the formulation for patients 12 plus)". It was unknown if therapeutic measures were taken as a result of illness, vomiting.  Additional information: The pharmacy administered the wrong formulation to the patient. The patient was 6-7 years old and received the gray cap formulation of the COVID-19 Vaccine (the formulation for patients 12 plus). After receiving the vaccine, the patient became sick with vomiting.  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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 83-year-old male patient received bnt162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6203), in left arm and on 31Mar2021 as dose 2, single (Lot number: EP7534) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "COPD" (unspecified if ongoing), notes: COPD; "Known allergies: No/egg" (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 11Oct2023 to 16Oct2023.  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: Cerebrovascular accident
Clinical narrative: A 60 year old male had a stroke 21 days after the bivalent dose was administered; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 60-year-old male 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. The patient's relevant medical history included: "Inflammation of the heart 10 years ago due to virus", start date: 2013 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown.), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, life threatening), 21 days after the suspect product(s) administration, outcome "recovered with sequelae", described as "A 60 year old male had a stroke 21 days after the bivalent dose was administered". Therapeutic measures were taken as a result of cerebrovascular accident. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, the event stroke is not considered possibly related to the suspect vaccine bnt162b2, bnt162b2 omi ba.4-5 in this elderly patient with medical history of inflammation of the heart 10 years ago due to virus. The event is more likely related to the underlying medical conditions in this patient. 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: PPV, RSV
Symptoms: Urticaria
Clinical narrative: broke out in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 16Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; pneumococcal vaccine conj (PNEUMOCOCCAL CONJUGATE VACCINE), on 16Oct2023 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: Influenza virus vaccine (got a flu shot then broke out with hives), for immunisation, reaction(s): "hives". The following information was reported: URTICARIA (non-serious) with onset Oct2023, outcome "unknown", described as "broke out in hives". Additional information: Just got RSV and Pneumonia shots yesterday (16Oct2023) broke out in hives again. Patient wondered if there is a common ingredient in all of these shots that may be causing this reaction.  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: RSV
Symptoms: Asthma, Cardiac disorder, Visual impairment
Clinical narrative: vision is severely impaired; asthma; heart trouble; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 70-year-old female patient 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 included: "Kidney cancer" (unspecified if ongoing), notes: Patient has had kidney cancer; "breast cancer" (unspecified if ongoing), notes: just getting over breast cancer; "auto immune deficiency disorders" (unspecified if ongoing), notes: her auto immune system doesn't even work right. The patient's concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "vision is severely impaired"; ASTHMA (non-serious), outcome "unknown"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart trouble". Additional information: Her vision is severely impaired. Patient later stated that she had serious health issues, she was just getting over breast cancer, she has had kidney cancer, she have auto immune deficiency disorders that her auto immune system doesn't even work right. She has asthma, she has heart trouble.  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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Polychondritis
Clinical narrative: Relapsing polychondritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Polychondritis" (unspecified if ongoing). The patient's concomitant medications were not reported. 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. The following information was reported: POLYCHONDRITIS (medically significant) with onset 2021, 1 month after the suspect product(s) administration, outcome "unknown", described as "Relapsing polychondritis". The event "relapsing polychondritis" required physician office visit. Clinical Course: After she received her 3rd Pfizer vaccination she was diagnosed with relapsing polychondritis a month later. She was wondering if the vaccine had anything to do with it. Her doctor said there was not enough research on the side effects of Covid-19 vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300299978 same patient, different drug/event;US-PFIZER INC-202300300744 same patient/vaccine, different dose number/event;
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID:.  A 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: DEATH (death, medically significant) with onset 2022, outcome "fatal", described as "Passed away". The patient date of death was 2022. The reported cause of death was unknown. It was not reported if an autopsy was performed. Additional information: The reporter said that she keeps receiving a notification card that is from Pfizer Biontech, and they sent this card in her aunt's name (patient). She doesn't understand why they're continuing to send her anything because the patient passed away last year (2022), and she called Pfizer and told them she passed away, and she thought that they had taken care of it. She mentioned that she has nothing to do with Pfizer.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Passed away
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: accidentally received 2 doses of FLUZONE HD QIV with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 85 years old female patient who accidentally received 2 doses of Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rsv Vaccine (Rsv Vaccine) for Immunisation.  On 14-Oct-2023, the patient received a dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine and on 16-Oct-2023 she also received another dose of the same vaccine (form, strength: unknown) (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.   On 16-OCT-2023 the patient accidentally received 2 doses of Influenza Quadrival A-B High Dose Hv Vaccine, with no reported adverse event (extra dose administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.