chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: other medical history: Hashimotos, EDS, Meiges Syndrome; "wheat" (unspecified if ongoing), notes: known allergies: Peanuts, legumes, wheat; "Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts, legumes, wheat; "legumes" (unspecified if ongoing), notes: known allergies: Peanuts, legumes, wheat; "EDS" (unspecified if ongoing), notes: other medical history: Hashimotos, EDS, Meiges Syndrome; "Meige's Syndrome" (unspecified if ongoing), notes: other medical history: Hashimotos, EDS, Meiges Syndrome. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 25Sep2023 to 29Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number 3 (boster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 completed, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2 completed, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Covid positive day #4 after finishing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine bnt162b2 omi xbb.1.5 administration.
Sex: F
Vaccine: 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 a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "ITP (remission)" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "Splenectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Toridol, reaction(s): "Known Allergies: Toridol." The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.  The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: strawberries" (unspecified if ongoing); "known allergies: apples" (unspecified if ongoing); "known allergies: nectarines" (unspecified if ongoing); "known allergies: peaches" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Nirmatrelvir, ritonavir (PAXLOVID) was given as treatment of COVID-19 from 19Sep2023 to 24Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: other medical history: hypothyroid; "Frozen shoulder" (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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (01Oct2023) Negative, notes: I tested negative on 01Oct; (06Oct2023) Positive, notes: tested positive again today after a day of sniffles yesterday. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 27Sep2023 to 01Oct2023. The patient had no known allergies.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: She developed the fluttering heart 2 weeks later; 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 72-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, lot number: EK4176), administration date: 15Jan2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Allergic reaction of numbness and swelling of her lips", "numbness and swelling of her lips", "Allergic reaction of numbness and swelling of her lips"; bnt162b2 (DOSE 2, lot number: E8982/ K8982, ), administration date: 10Feb2021, when the patient was 70-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3, lot number: 301US8A), administration date: 29Sep2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "fluttering heart"; bnt162b2 (DOSE 4, lot number: FJ9943), administration date: 01Apr2022, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "fluttering heart". The following information was reported: CARDIAC FLUTTER (medically significant) with onset Sep2022, outcome "unknown", described as "She developed the fluttering heart 2 weeks later". Therapeutic measures were not taken as a result of cardiac flutter. Clinical course: The patient develops fluttering of the heart two weeks later. She developed a fluttering heart two weeks later, on all of three of her last doses.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321100 same patient/vaccine, different dose number/event;US-PFIZER INC-202300321099 same patient/vaccine, different dose number/event;US-PFIZER INC-202300321098 same patient/vaccine, different dose number/event;
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Influenza like illness, Sneezing
Clinical narrative: Flu-like symptoms; Sneezing; Cough; Tiredness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 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: COUGH (non-serious) with onset 03Oct2023, outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Oct2023, outcome "unknown", described as "Flu-like symptoms"; SNEEZING (non-serious) with onset 03Oct2023, outcome "unknown"; FATIGUE (non-serious) with onset 03Oct2023, outcome "unknown", described as "Tiredness". Therapeutic measures were taken as a result of influenza like illness, sneezing, cough, fatigue. Additional information: The patient reported on she got the Pfizer COVID-19 vaccine, 2023-2024 on a Friday prior to the time of the report (29Sep2023). On Tuesday (03Oct2023), she started to experience sneezing, cough, and tiredness. She had been taking Tylenol and cold medicine. The patient asked if it was normal to have flu-like symptoms after getting the 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling, Vaccination site pruritus, Vaccination site rash
Clinical narrative: arm swelled up a little bit; little tired; a small rash in the shape of a circle about 6 hours later that was itchy/ she got a rash at the site; a small rash in the shape of a circle about 6 hours later that was itchy/ she got a rash at the site; 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.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm 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 immunization, reaction(s): "she had no issues"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "she had no issues"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "she had no issues"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "she had no issues"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "rash". The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 03Oct2023, outcome "recovered" and all described as "a small rash in the shape of a circle about 6 hours later that was itchy/ she got a rash at the site"; PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "arm swelled up a little bit"; FATIGUE (non-serious), outcome "recovered", described as "little tired".  Additional Information:  Reporter stated that all of her Covid 19 vaccines have been Pfizer products. She was uncertain how many doses she's had. On her first 3-4 doses she had no issues. She got Pfizer Comirnaty 2023/2024 for adults on Tuesday morning (03Oct2023) in her right arm and she  developed a small rash in the shape of a circle about 6 hours later that was itchy and was going away. Her arm swelled up a little bit but was going down. Rash color was fading and was less itchy. Its topical and she didn't have any issues with breathing. The reaction was mild with no fever or other symptoms, other than maybe a little tired, but she didn't noticed much at all this time. She also had a rash with the previous dose she receive which was the bivalent. Reporter asked if anyone else reported this and asked if one face can swell up. She asked that if she got a rash at the site, does that mean she will get the same reaction with future doses or get worse. Further mentioned that if she had it Tuesday and its already Friday, she is feeling fine, she asked if it is to assume that she won't get any other side effects later. Caller also asked how long does it take for the vaccine to be effective - 10 days or how long.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: She developed the fluttering heart 2 weeks later; 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 71-year-old female patient received bnt162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: 301US8A) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Lot number: EK4176), administration date: 15Jan2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Allergic reaction of numbness and swelling of her lips", "Allergic reaction of numbness and swelling of her lips", "Allergic reaction of numbness and swelling of her lips"; bnt162b2 (Lot number: E, not sure if it's a K or a C, not sure its like they wrote something on the top of the something but the number is 8982), administration date: 10Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "no reaction". The following information was reported: CARDIAC FLUTTER (medically significant) with onset Oct2021, 2 weeks after the suspect product(s) administration, outcome "unknown", described as "She developed the fluttering heart 2 weeks later". Clinical course: Patient had her shot last year and had a fluttering heart 2 weeks after getting the vaccine. She would like to know what to do if she got the same with the latest vaccine. All of her COVID-19 vaccines have been Pfizer products. She has had a total of 5 doses. When she had the first dose, she started to get the allergic reaction of numbness and swelling of her lips. She was at the hospital, so they gave her an antihistamine and observed her for an hour. The second dose she had no reaction. On her last three shots she took an antihistamine prior to getting them and did not have an allergic reaction, however she developed the fluttering heart 2 weeks later after each of the doses. She was concerned about what she should do if she is alone and develops the fluttering heart again. Therapeutic measures were not taken as a result of cardiac flutter. She was calling to ask what to do when she feels that flutter. The report was considered as non-serious by the patient.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320687 same patient/vaccine, different dose number/event;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: DRUG INEFFECTIVE (death), SUSPECTED COVID-19 (death), outcome "fatal" and all described as "Covid". The patient date of death was Mar2023. Reported cause of death: "Covid". It was not reported if an autopsy was performed.  Clinical course: the reporter's wife (patient) was living in a rehab hospital and nurse that gave her and the reporter COVID but the reporter had a very mild case because of the fact that he had been inoculated and unfortunately his wife (patient) passed away on the march of this year (Mar2023).   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: Covid; Covid
Age: 68.0
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 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2023 at 12:00 as dose 6 (booster), single (Lot number: GK0928) at the age of 68 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: two days after testing negative for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had the latest Pfizer vaccine; after 7 days of having the vaccine I got the Covid; I had the latest Pfizer vaccine; after 7 days of having the vaccine I got the Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 03:30 as dose 6 (booster), single (Lot number: HH7595) at the age of 69 years for covid-19 immunisation; bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing). Concomitant medication(s) included: OLMESARTAN MEDOXOMIL taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Oct2023 at 03:30, outcome "not recovered" and all described as "I had the latest Pfizer vaccine; after 7 days of having the vaccine I got the Covid". The event "i had the latest pfizer vaccine; after 7 days of having the vaccine i got the covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive, notes: I woke up with Covid which I now got tested today and confirmed. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course was reported as follows: patient reported symptoms occurred 7 and half days after vaccination. On Wednesday, when she woke up she only had a cold that got worsened, in the day of the report she reported it got worse and she woke up in the middle of night sick and in the morning was sick and she went to urgent care where she got all kinds of medicines. Azithromycin 250 mg tablet, 6 pack normally Z pack 2 that day and then she took one by mouth each day for the next 4 days, altogether it was 6 tablets. Other medication was Prednisone 20 milligrams, 2 that day and 2 tablets each morning for 3 days and they told she to take Advil if she need it. She reported she got all the vaccines 1,2,3,4,5, 6 all Pfizer and she had Covid 3 times.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: She also had a rash with the previous dose she receive which was the bivalent.; 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 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: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "She also had a rash with the previous dose she receive which was the bivalent.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: somewhat more uncomfortable post-vaccine time; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 06Oct2023, 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. An adult female patient received bnt162b2 (BNT162B2), on 22Feb2021 as dose 2, single (Lot number: EN6201) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "graves' disease" (unspecified if ongoing), notes: in remission; "Multiple chemical sensitivities" (unspecified if ongoing); "Over reactive immune system in general" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 01Feb2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "immune system issues", "somewhat more uncomfortable post-vaccine time". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "somewhat more uncomfortable post-vaccine time".  Additional Information: Regarding family medical history relevant to adverse events (AES), it was reported that "nothing other than slightly heightened (for a few days) immune system reactions-no follow-up care needed from any medical facility or physician". The patient had MCS (Multiple chemical sensitivities) and Graves' disease (in remission from graves' disease), over reactive immune system in general that probably contributed to a somewhat more uncomfortable post vaccine time. She commented that she doesn't know why the form was sent to her, she had normal post-vaccine reactions (a few days only each time) each of the 4 times she was vaccinated against COVID. She had the 2 initial vaccines for the first course, and then 2 booster, a year apart.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
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 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 19Sep2023 at 10:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left 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 Immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (BOOSTER); Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (BOOSTER); Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 5 (BOOSTER); Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient was treated with COVID 19 antiviral treatment from 27Sep2023 to 02Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient was treated with COVID 19 anti viral treatment with Paxlovid from 22Sep2023 to 27Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: In Aug I had the Delta variant couldn't get out of bed, 2022 covid, 2023 covid/ Long Covid is killing me; In Aug I had the Delta variant couldn't get out of bed, 2022 covid, 2023 covid/ Long Covid is killing me; In Aug I had the Delta variant couldn't get out of bed, 2022 covid, 2023 covid/ Long Covid is killing me; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Jan2021 as dose 2, single (Batch/Lot number: unknown), in right 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), SUSPECTED COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "In Aug I had the Delta variant couldn't get out of bed, 2022 covid, 2023 covid/ Long Covid is killing me"; DISEASE RECURRENCE (medically significant) with onset 2022, outcome "unknown", described as "In Aug I had the Delta variant couldn't get out of bed, 2022 covid, 2023 covid/ Long Covid is killing me". Additional information: The patient received the first round of double Covid vaccine back in Jan2021, the patient had a reaction to it in the left arm and that night the right hand started trembling, so when the patient went for the second the on-hand pharmacist had the patient get it in the right arm. In Aug2021, the patient had the Delta variant and couldn't get out of bed, 2022 COVID, 2023 COVID. It's like the patient have no immune system anymore thanks to the vaccine and the patient's body just keeps getting weaker and weaker. Doctors are no help. Long Covid was killing the patient.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 (Drug ineffective); COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 11:00 as dose 5 (booster), single (Lot number: 6J2524) at the age of 64 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 08Mar2021 at 15:30 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 at 14:00 as dose 2, single (Lot number: ER8733), in left arm, on 08Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 03May2022 at 11:30 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "MGUS" (unspecified if ongoing); "Coronary artery disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN, start date: 01Jun2017, stop date: 22Sep2023. The following information was reported: COVID-19 (medically significant) with onset Sep2023, outcome "recovering", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset Sep2023, outcome "recovering", described as "COVID 19 (Drug ineffective)". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Aug2023 at 15:00 as dose 5 (booster), single (Lot number: GK0928) at the age of 76 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's relevant medical history included: "Benign prostatic hyperplasia" (unspecified if ongoing); "diverticulitis" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN, start date: 01Jan2018; CLIMAX, start date: 01Jan2018. Past drug history included: Nsaids, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Therapeutic measures were taken as a result of covid-19, drug ineffective, the patient received paxlovid from 27Sep2023 to 01Oct2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 cannot be completely excluded.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling, Pruritus, Skin warm, Urticaria
Clinical narrative: Itchiness and hives appeared first on my back the evening of the shot. Took Benadryl. Next day, itchiness was worse and all over. Hives on neck, back, stomach, legs, ears, scalp, and arms. Hives are hot to the touch. Taking benedyrl twice a day but hives keep appearing new places. Lips became swollen Tuesday evening, and began breaking out on my face Tuesday during the day.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, Laboratory test abnormal, Renal cancer, Ureteric cancer
Clinical narrative: Patient has sudden hematuria,  work up revealed kidney /ureteral cancer
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Bradycardia, Hypotension, Syncope
Clinical narrative: Brief episode (< 5 min) syncope, bradycardia, hypotension
Age: 75.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: Sore and itchy arm and red rash still remain.  Never had this reaction before with Covid or flu shots
Age: 85.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Pain in extremity
Clinical narrative: Patient came in on 10102023 at approximately 04:50 PM  to let us know  at the pharmacy what  he had been feeling after getting both his RSV and Flu Vaccination(s). Patient stated that he felt mild pain on the back of his left hand after  getting the vaccination and didn't think too much about it. When asking how he felt today, 10/10/2023, patient had stated that he felt fine overall but would like this to be documented.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Induration, Limb mass, Pruritus, Rash macular, Sensitive skin
Clinical narrative: The day after the shot I got like a baseball-size lump in my arm, nontender, but very firm and warm. It slowly went down over the course of 2 weeks but also became more and more itchy. A small irregular patchy colored area was left. That has also faded now. But the skin in the area is super sensitive now to light touch. The sensation of my shirt rubbing on my shoulder feels like there's thorns sticking into my skin or something. I've tried lidocaine cream but it doesn't really help. Now I'm wearing Tegaderms over the area so that nothing rubs on the skin because it's so sensitive.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Skin warm
Clinical narrative: The day after the shot I got like a baseball-size lump in my arm, nontender, but very firm and warm. It slowly went down over the course of 2 weeks but also became more and more itchy. A small irregular patchy colored area was left. That has also faded now. But the skin in the area is super sensitive now to light touch. The sensation of my shirt rubbing on my shoulder feels like there's thorns sticking into my skin or something. I've tried lidocaine cream but it doesn't really help. Now I'm wearing Tegaderms over the area so that nothing rubs on the skin because it's so sensitive.
Age: 63.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Abdominal discomfort, Blood pressure increased, Eye pain, Headache, Injection site pain
Clinical narrative: Patient reports sharp frontal lobe pain on right side initially, then progressed to pain on left temple and left eye and left shoulder pain . She also reporst abdominal upset and high blood pressure reading  177/111
Age: 26.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Seizure, Syncope
Clinical narrative: patient fainted following administration of each vaccine. Following the second vaccination (fluzone influenza) into the left arm, patient began to seize for about 6 seconds. Patient stated prior to vaccines that he passes out every time he get a vaccine. Following the seizure, patients parents stated that he has had seizures in the past but never following a vaccine. I, the administering pharmacist, offered to call 911 and made sure patient was safely positioned. Parents declined my offer to call 911 and stated that he was fine. Monitored patient after the administration until he was okay to leave. Parents took him and he walked out of the store about 5 minutes following  the following.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Balance disorder, Dizziness, Fatigue, Headache
Clinical narrative: My first vaccine was on 16 Jan. 2021. I had bad headaches for two weeks.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Confusional state, Dizziness, Hemiparesis, Hypoaesthesia, Mobility decreased
Clinical narrative: After a few minutes after receiving vaccine, patient complained of dizziness, blurred vision and numbness on left arm. She was brought to a room and assessed, and vital signs were stable and right after she started having a seizure that lasted for less than a minute. She felt confused and all her left side felt weak, and she could not move limbs. EMS was called and she was transferred to the emergency room by paramedics.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Seizure, Vision blurred
Clinical narrative: After a few minutes after receiving vaccine, patient complained of dizziness, blurred vision and numbness on left arm. She was brought to a room and assessed, and vital signs were stable and right after she started having a seizure that lasted for less than a minute. She felt confused and all her left side felt weak, and she could not move limbs. EMS was called and she was transferred to the emergency room by paramedics.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Electric shock sensation, Fatigue, Feeling cold
Clinical narrative: After the injection was given during the mid-day, at nighttime the symptoms began. The symptoms included chills, sweats, bodily fatigue, headache, nausea, electric-shock-like sensations throughout the entire body (being the most notable due to it being an odd symptom), tingling sensitive skin, and dizziness. These symptoms went on for a week and a half. The electric-shock-like sensations that occur in the entire body in forms of pulses would happen occasionally, some strands being hours apart and some being months apart. No known triggers as of right now cause these shocks. These shocks happen quickly (like a pulse) and  occur through the entire body, causing fatigue and bodily distress sometimes paired with sweating or dizziness as well as sensitive tingling skin. The shocks do not occur in a specific area of the body, but is body-wide. I was hospitalized on October 23rd, 2022 for these shock symptoms that only increased in intensity until it became so debilitating that it became a medical emergency. The symptoms apparent that hospital trip were sweats, chills, sensitive tingly skin, the shocks, fatigue, headache, nausea, and dizziness. There are no known triggers thus far. Throughout the past two and a half years, these electric shocks come in occasional strands, some strands being worse than others. No medical professionals have been able to deduce where these electric shocks come from or why they happen. No known treatment or preventatives keep these shocks at bay.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Paraesthesia, Sensitive skin
Clinical narrative: After the injection was given during the mid-day, at nighttime the symptoms began. The symptoms included chills, sweats, bodily fatigue, headache, nausea, electric-shock-like sensations throughout the entire body (being the most notable due to it being an odd symptom), tingling sensitive skin, and dizziness. These symptoms went on for a week and a half. The electric-shock-like sensations that occur in the entire body in forms of pulses would happen occasionally, some strands being hours apart and some being months apart. No known triggers as of right now cause these shocks. These shocks happen quickly (like a pulse) and  occur through the entire body, causing fatigue and bodily distress sometimes paired with sweating or dizziness as well as sensitive tingling skin. The shocks do not occur in a specific area of the body, but is body-wide. I was hospitalized on October 23rd, 2022 for these shock symptoms that only increased in intensity until it became so debilitating that it became a medical emergency. The symptoms apparent that hospital trip were sweats, chills, sensitive tingly skin, the shocks, fatigue, headache, nausea, and dizziness. There are no known triggers thus far. Throughout the past two and a half years, these electric shocks come in occasional strands, some strands being worse than others. No medical professionals have been able to deduce where these electric shocks come from or why they happen. No known treatment or preventatives keep these shocks at bay.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Swelling
Clinical narrative: pain in arm lasting for 3 weeks following vaccine, mild swelling
Age: 22.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Injection site rash
Clinical narrative: I had a rash on my arm around the injection site of the COVID vaccine starting on 1/10/23. The rash got bigger on 1/11/23. I took pictures so I know the rash started on the tenth and that it had grown on the eleventh. I think it cleared up within the week, and I don't think it got worse after the eleventh, otherwise I would have taken more pictures. It might have been itchy, but it's hard to remember. Apologies for not reporting sooner.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Condition aggravated, Disability, Magnetic resonance imaging, Seizure
Clinical narrative: Worsening of seizures, permanent disability
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Nasal disorder, Nasopharyngitis, Respiratory disorder, Upper respiratory tract infection
Clinical narrative: Received vaccine on Sept 30 ,2023  Several days later came down with a cold which eventually got worse and had temp and upper respiratory issues. Had to go to hospital on 10-08-2023 to be treated for Upper respiratory infection given antibiotics. Still recovering and in addition have Nasal issues now.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Injection site scab
Clinical narrative: Approx 4 days after immunization developed painful round scab like sore at site of injection (R upper arm)
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: pityriasis rosea
Age: 25.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Exposure during pregnancy, Influenza virus test positive, Injection site erythema, Pain, Peripheral swelling
Clinical narrative: Patient indicated at 27 weeks and 2 days. Patient indicated they had redness at injection site. Swelling, fever of 100.4, soreness and significant rash. Tested positive for flu in addition to rash and swelling o f left arm
Age: 25.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: Patient indicated at 27 weeks and 2 days. Patient indicated they had redness at injection site. Swelling, fever of 100.4, soreness and significant rash. Tested positive for flu in addition to rash and swelling o f left arm
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Contusion, Immunisation reaction, Swelling
Clinical narrative: The patient has bruise and constant shoulder pain. The swollen, bruise and pain remains after three weeks of vaccinations. The patient consulted her primary doctor. The doctor diagnosis that this was from vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema of eyelid, Eyelid oedema, Injection site erythema
Clinical narrative: Eyelid edema and erythema; redness at injection site
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Severe shoulder pain for over a month, worsening not getting better
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Heart rate increased, Pyrexia, Skin warm
Clinical narrative: 102 heart rate. 101.9 fever. 24 hours after injection Took tylenol at 5:00pmTylenol reduced fever to 99at  8:20 pm. Heart rate 79. Duration of high heart rate and high fever approximately 2 hours.  Skin feels hot chills
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Diarrhoea, Myalgia, Peripheral swelling
Clinical narrative: Severe stomach cramping and diarrhea. Severe muscle and bone pain  Swelling of arm
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient stated that she experienced pain, redness, swelling and itching at the injection site
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Pt developed localized redness, warmth, swelling, pain, headache, fatigue and has ongoing pain in (R) arm
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Skin warm, Swelling
Clinical narrative: Pt developed localized redness, warmth, swelling, pain, headache, fatigue and has ongoing pain in (R) arm
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site irritation, Urticaria
Clinical narrative: Injection site irritation Hives disseminating across entire body, more upper trunk, limbs than lower limbs
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT