chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Illness, Vomiting
Clinical narrative: has been sick; throwing up for two weeks; having diarrhea; in a daze; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. A male 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: Covid-19 vaccine (Primary Immunization series complete; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (first Booster, manufacturer unknown), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "has been sick"; VOMITING (non-serious), outcome "unknown", described as "throwing up for two weeks"; DIARRHOEA (non-serious), outcome "unknown", described as "having diarrhea"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "in a daze".  Additional information: Agent with the Pfizer Call Center has a reporter on the line calling to report after he took the Pfizer COVID booster shot, he had been sick and throwing up for two weeks. Reporter verified the information provided by the transferring agent and clarified it was his second booster dose and he was in a daze for a week throwing up and having diarrhea and thought this was not a live virus asks if it is a live virus and how is he sick like this. He was fine with the first shots. He was sick and missed work and this is two weeks and asks if there is help for him being sick and out of work regarding compensation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (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 Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid started from 19Sep2022 to 24Sep2022 as a Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events drug ineffective, COVID-19  and the use of suspect product cannot be fully excluded.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 16:00 as dose number unknown (booster), single (Lot number: GH9694) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19; Positive, notes: Positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: If vaccine received: Yes, Other medication in 2weeks: No. Anti viral details: Paxlovid for COVID 19 Treatment,Treatment start date was 21Sep2022 and stop date was 25Sep2022.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
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 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 04Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Beta blockers" (unspecified if ongoing); "Optical migraines" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Vitamin D and vitamin B12 deficiency" (unspecified if ongoing); "Vitamin D and vitamin B12 deficiency" (unspecified if ongoing); "IBS" (unspecified if ongoing); "constipation" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "nausea" (unspecified if ongoing); "abdominal pain" (unspecified if ongoing); "Postural orthostatic tachycardia" (unspecified if ongoing); "low blood pressure" (unspecified if ongoing); "dizziness" (unspecified if ongoing). Concomitant medication(s) included: XANAX; LEXAPRO; GABAPENTIN. Past drug history included: Neomycin, reaction(s): "Known allergies: neomycin"; Melatonin, reaction(s): "Known allergies: melatonin". The patient also received Birth control medication in 2 weeks product. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (20Sep2022) 101.4 Fahrenheit; SARS-CoV-2 test: (20Sep2022) Positive; (25Sep2022) Negative; (29Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient positive on 20Sep2022 with 101.4 F fever, back pain, nausea, chills, sore throat, headache, dizziness, cough, postnasal drip, chest pain, increased heart rate, started Paxlovid on 20Sep2022 and completed full course 24Sep2022. Tested negative on 25Sep2022 and feeling better. Patient was tested positive 29Sep2022 with low grade fever, sore throat, back pain, nausea, postnasal drip.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Ear discomfort, Eustachian tube disorder, Feeling abnormal, Headache
Clinical narrative: My ear Eustachian tube bulges and I feel pressure in the evening; My ear Eustachian tube bulges and I feel pressure in the evening; fogginess; confusion; Both of our second toe feels numb; headaches in the back of my head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset 01Mar2022, outcome "recovering", described as "Both of our second toe feels numb"; EUSTACHIAN TUBE DISORDER (non-serious), EAR DISCOMFORT (non-serious) all with onset 01Mar2022, outcome "recovering" and all described as "My ear Eustachian tube bulges and I feel pressure in the evening"; CONFUSIONAL STATE (non-serious) with onset 01Mar2022, outcome "recovering", described as "confusion"; FEELING ABNORMAL (non-serious) with onset 01Mar2022, outcome "recovering", described as "fogginess"; HEADACHE (non-serious) with onset 01Mar2022, outcome "recovering", described as "headaches in the back of my head". The events "my ear eustachian tube bulges and i feel pressure in the evening", "fogginess", "confusion", "both of our second toe feels numb" and "headaches in the back of my head" required physician office visit. Therapeutic measures were not taken as a result of eustachian tube disorder, ear discomfort, feeling abnormal, confusional state, hypoaesthesia, headache.  Additional information: Patient didn't received other vaccine in four weeks and other medications in two weeks. My ear Eustachian tube bulges and I feel pressure in the evening , fogginess and confusion, my husband and I have toes that are numb. Both of our second toe feels numb. He also received a Pfizer shot. I also have headaches in the back of my head. No covid prior vaccination. Patient was covid tested post vaccination. No known allergies. Covid test post vaccination: covid test type post vaccination Nasal Swab,covid test result was Positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: My ear Eustachian tube bulges and I feel pressure in the evening; My ear Eustachian tube bulges and I feel pressure in the evening; fogginess; confusion; Both of our second toe feels numb; headaches in the back of my head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset 01Mar2022, outcome "recovering", described as "Both of our second toe feels numb"; EUSTACHIAN TUBE DISORDER (non-serious), EAR DISCOMFORT (non-serious) all with onset 01Mar2022, outcome "recovering" and all described as "My ear Eustachian tube bulges and I feel pressure in the evening"; CONFUSIONAL STATE (non-serious) with onset 01Mar2022, outcome "recovering", described as "confusion"; FEELING ABNORMAL (non-serious) with onset 01Mar2022, outcome "recovering", described as "fogginess"; HEADACHE (non-serious) with onset 01Mar2022, outcome "recovering", described as "headaches in the back of my head". The events "my ear eustachian tube bulges and i feel pressure in the evening", "fogginess", "confusion", "both of our second toe feels numb" and "headaches in the back of my head" required physician office visit. Therapeutic measures were not taken as a result of eustachian tube disorder, ear discomfort, feeling abnormal, confusional state, hypoaesthesia, headache.  Additional information: Patient didn't received other vaccine in four weeks and other medications in two weeks. My ear Eustachian tube bulges and I feel pressure in the evening , fogginess and confusion, my husband and I have toes that are numb. Both of our second toe feels numb. He also received a Pfizer shot. I also have headaches in the back of my head. No covid prior vaccination. Patient was covid tested post vaccination. No known allergies. Covid test post vaccination: covid test type post vaccination Nasal Swab,covid test result was Positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5, Vaccine brand: Pfizer / BioNTech, Vaccine brand unknown: False, Vaccine lot unknown AND Vaccine dose number unknown: False), on 10Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Jan2021 as dose 1, single (Lot number: 026620A), in left arm, on 22Feb2021 as dose 2, single (Lot number: 011M20A), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: 014F21A), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: 056A22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included [Other medication in 2weeks product]: VITAMIN D3 (Other medication in 2weeks brand); OMEGA 3 FATTY ACID (Other medication in 2weeks brand); CALCIUM supplement (Other medication in 2weeks brand). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Sep2022 at 12:00, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Report about COVID treatment: Yes. Anti viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 11Jul2022, Treatment stop date: 16Jul2022, Indication: Treatment of COVID-19. Known allergies: No. Other medical history: None.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
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 a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. 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: (unspecified date) Positive, notes: COVID 19 Treatment; (Sep2022) Negative, notes: Rebound Covid after 10 days of testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 13Sep2022 to 17Sep2022. The patient had Rebound Covid after 10 days of testing negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test result Positive; COVID test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) and on 16Mar2022 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient had no relevant medical history or known allergies. There were no concomitant medications or other medications in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab. The facility where the most recent vaccine was administered was other. The patient did not receive any other vaccine in four weeks. The patient did not have COVID-19 prior to vaccination. The patient had tested for COVID-19 post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Both of our second toe feels numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Both of our second toe feels numb".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old 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) at the age of 72 years for covid-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart attack" (unspecified if ongoing), notes: Heart attack; "Congestive heart failure" (unspecified if ongoing), notes: Congestive heart failure; "problems with my bronchial tubes" (unspecified if ongoing); "Diarrhea " (unspecified if ongoing), notes: this medicine they give me diarrhea . The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I got COVID and I get check and they give me the Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient stated, I got the pack yesterday. I got COVID and I get check and they give me the Paxlovid and I took Wednesday, I took it morning and night and today I took it this morning but twice today now the pain in my leg is so bad, I have legs not on the floor, I mean it is killer pain. It is the whole thing from the thigh down to the ankle, it is just I mean it is actual joint pain and it is kind of scares me and I do not know, is that normal. I tell you I have had, a Pfizer is the way I go. I have had Pfizer, all the COVID shot and the booster shot from Pfizer (further clarification unknown hence captured as Unspecified shots). I am on other medication and I have had a heart attack and I have got congestive heart failure and I am having problems with my bronchial tubes. I haven't got bronchitis. I got a disease in the bronchial tubes. And I do have that, this medicine they give me diarrhea but you know what, that does not bother me too much because diarrhea I call mother natures cleanse and I can deal with that. I do not know if it made my blood pressure go up or down, do not know about that.  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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 at 10:30 as dose 1, single (Batch/Lot number: unknown), in right arm and on 26Dec2021 at 19:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent laboratory test: SARS-CoV-2 test: Positive. 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: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested for positive for COVID today; tested for positive for COVID today; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Sep2022, outcome "not recovered" and all described as "tested for positive for COVID today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Sep2022) Positive, notes: just tested positive today, 29Sep on a home rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient tested for positive for COVID today. Patient received the updated COVID Pfizer booster early September. Patient has had symptoms since Monday 26Sep202 but just tested positive today, 29Sep2022 on a home rapid test. His doctor prescribed Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: still got very sick 6 weeks after last boost; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, My healthy dad had, 4 of your shots and still got very sick 6 weeks), for Covid-19 Immunization, reaction(s): "Covid"; Bnt162b2 (Dose:02, My healthy dad had, 4 of your shots and still got very sick 6 weeks), for Covid-19 Immunization, reaction(s): "Covid"; Bnt162b2 (Dose:03, My healthy dad had, 4 of your shots and still got very sick 6 weeks), for Covid-19 Immunization, reaction(s): "Covid". The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "still got very sick 6 weeks after last boost". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: My healthy dad had 4 of your shots and still got very sick 6 weeks after last boost. Would have been hospitalized but hospital too full. Took Paxlovid yet remained positive for 17-18 days. He's still symptomatic. Week 4/5. It was unknown if patient took other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Incorrect dose administered, SARS-CoV-2 test
Clinical narrative: had 4 of your shots; had 4 of your shots; Inappropriate dose of Vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "had 4 of your shots"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Inappropriate dose of Vaccine administered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Took Paxlovid yet remained positive for 17-18 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: My healthy dad had 4 of your shots and still got very sick 6 weeks after last boost. Would have been hospitalized but hospital too full. Took Paxlovid yet remained positive for 17-18 days. He's still symptomatic. Week 4/5. It was unknown if patient took other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Illness, Pain, Pain in extremity
Clinical narrative: rash; metallic taste; terribly sick; fever; headache; body aches; could hardly move her limbs because it hurt so bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8733) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (ongoing). There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 29Mar2021, outcome "recovered", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 29Mar2021, outcome "recovered", described as "could hardly move her limbs because it hurt so bad"; PYREXIA (non-serious) with onset 29Mar2021, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 29Mar2021, outcome "recovered"; DYSGEUSIA (non-serious) with onset 29Mar2021, outcome "recovered" (29Mar2021), described as "metallic taste"; RASH (non-serious) with onset 29Mar2021, outcome "recovering"; ILLNESS (non-serious) with onset 29Mar2021, outcome "recovered", described as "terribly sick". The events "rash", "metallic taste", "terribly sick", "fever", "headache", "body aches" and "could hardly move her limbs because it hurt so bad" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: rash; metallic taste; terribly sick; fever; headache; body aches; could hardly move her limbs because it hurt so bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8733) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (ongoing). There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 29Mar2021, outcome "recovered", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 29Mar2021, outcome "recovered", described as "could hardly move her limbs because it hurt so bad"; PYREXIA (non-serious) with onset 29Mar2021, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 29Mar2021, outcome "recovered"; DYSGEUSIA (non-serious) with onset 29Mar2021, outcome "recovered" (29Mar2021), described as "metallic taste"; RASH (non-serious) with onset 29Mar2021, outcome "recovering"; ILLNESS (non-serious) with onset 29Mar2021, outcome "recovered", described as "terribly sick". The events "rash", "metallic taste", "terribly sick", "fever", "headache", "body aches" and "could hardly move her limbs because it hurt so bad" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Condition aggravated, Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: he had fatigue; pain in his arm; pain in his arm at the injection site; pain was worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 17:30 as dose 4 (booster), single (Lot number: GJ2524) at the age of 55 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 28Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "past MI" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; CARVEDILOL; LISINOPRIL; ATORVASTATIN; EZETIMIBE; ASPRIN. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (booster); Unknown manufacturer), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 29Sep2022, outcome "recovering", described as "he had fatigue"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2022, outcome "recovering", described as "pain in his arm"; VACCINATION SITE PAIN (non-serious) with onset 29Sep2022, outcome "recovering", described as "pain in his arm at the injection site"; CONDITION AGGRAVATED (non-serious) with onset 29Sep2022, outcome "not recovered", described as "pain was worse". Therapeutic measures were not taken as a result of fatigue, pain in extremity, vaccination site pain, condition aggravated.  Additional information: The patient received his vaccine on 28Sep2022 at approximately 5:30 pm. At approximately midnight on 29Sep2022 he said he had pain in his arm at the injection site. Therefore 29Sep2022 is the date for Pfizer first awareness as reporter was Pfizer employee. At approximately 8:00 am on 29Sep2022 he said the pain was worse and he had fatigue. No other adverse events were reported to him. Patient had covid prior vaccination and was not tested for covid post vaccination. Patient had no known allergies. Patient was taking unspecified vitamins.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Extreme headache, aches & pains the day following the vaccine. Headache has persisted off and on for one week.; ache and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 14:15 as dose 4 (booster), single (Lot number: GH9693) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. 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. The following information was reported: HEADACHE (non-serious) with onset 23Sep2022 at 05:00, outcome "recovering", described as "Extreme headache, aches & pains the day following the vaccine. Headache has persisted off and on for one week."; PAIN (non-serious) with onset 23Sep2022 at 05:00, outcome "recovering", described as "ache and pains". Therapeutic measures were taken as a result of headache, pain.  Additional information: the patient had no other vaccines in four weeks and no other medications in two weeks. The events were treated with Advil.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Brain operation, Cerebral haemorrhage, Craniotomy, Haematoma
Clinical narrative: brain bleed; brain surgery; craniotomy; Hematoma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but Manufacture unknown), for covid-19 immunization. The following information was reported: CEREBRAL HAEMORRHAGE (hospitalization, medically significant), outcome "unknown", described as "brain bleed"; BRAIN OPERATION (hospitalization), outcome "unknown", described as "brain surgery"; CRANIOTOMY (hospitalization), outcome "unknown"; HAEMATOMA (non-serious), outcome "unknown", described as "Hematoma". The events "brain bleed", "brain surgery", "craniotomy" and "hematoma" required emergency room visit. Therapeutic measures were taken as a result of cerebral haemorrhage. Clinical course: Callers husband had brain surgery, hematoma, and brain bleed 6 weeks after booster shot of Covid vaccine. Can he still get another booster shot? They don't know if it was caused by the booster shot, but her husband had the shot 6 weeks before the brain bleed was detected. The doctor in the ER saw old blood and asked them what occurred 6 weeks prior. Caller and her husband couldn't think of anything. Her husband never fell or hurt himself. They had to transfer him from that hospital because they were not qualified or set up to do a brain surgery. They transferred him to [name withheld] Hospital where that is the specialty. Then caller heard from different people that Pfizer's had caused brain bleeds. Caller and her husband believe in science and [name withheld]. Caller and her husband got the shot after comparing shots and deciding to get Pfizer. Then to hear it was causing brain bleeds was astounding. The doctor said there was no proof of that. Caller and her husband didn't know to believe that.  2 days before Christmas in 2021, 23Dec2021, her husband had first brain surgery and had blood drained from brain. Then had to have 2 subsequent surgeries. He developed infection and had to have craniotomy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Vaccination site pain
Clinical narrative: I experienced some pain at the injection site in the left arm. It began in the evening of the day of injection and resolved by the early afternoon of the following day.; BNT162B2, BNT162B2 OMI BA.4-5; 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 female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 12:45 as dose 4 (booster), single (Lot number: GJ6742) at the age of 50 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: seasonal" (unspecified if ongoing), notes: Known allergies: seasonal; "Known allergies: Pet" (unspecified if ongoing), notes: Known allergies: pet; "food allergies" (unspecified if ongoing), notes: Known allergies: food allergies. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 13Sep2022 as dose 1, single; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; NASACORT; VITAMIN D [COLECALCIFEROL]; FISH OIL. Past drug history included: Robitussin, reaction(s): "Known allergies: Robitussin", notes: Known allergies: Robitussin. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 01Dec2021, when the patient was 49-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EK3248, Location of injection: Arm Left, Route of Administration: Intramuscular, administration time:02:00 PM), administration date: 10Mar2021, when the patient was 48-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular, administration time:02:00 PM), administration date: 19Feb2021, when the patient was 48-year-old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 29Sep2022 at 19:30, outcome "unknown", described as "BNT162B2, BNT162B2 OMI BA.4-5"; VACCINATION SITE PAIN (non-serious) with onset 29Sep2022 at 19:30, outcome "recovered" (30Sep2022), described as "I experienced some pain at the injection site in the left arm. It began in the evening of the day of injection and resolved by the early afternoon of the following day.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: Other vaccine in four weeks: Seasonal influenza vaccine, vaccine date:13Sep2022, dose number:1, vaccine location:Left arm. Other medications in two week were allegra, nasacort, vitamin D, fish oil, multivitamin. Covid prior vaccination was no. Covid tested post vaccination was no.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 84-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197140 Same Patient, different drug/AE;
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2021 at 09:30 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Sep2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown results, notes: Experienced rebound COVID symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received any other medication with in 2 weeks of the vaccination. The patient received Paxlovid from 18Sep2022 to 22Sep2022 for the treatment COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events COVID-19, DRUG INEFFECTIVE, Interchange of vaccine products  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Cough, Decreased appetite, Irritability, Nasal congestion
Clinical narrative: Developed a temperature of 100.4 along with nasal congestion and cough on 9/1.  Was given Tylenol 3.75 ml every 4-6 hrs when awake.  Temperature decreased to 98 degrees with Tylenol but fever keep returning  on 9/2-9/4 with highest temperature of 101.3.  He also developed decreased appetite and increased fussiness on 9/2.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Developed a temperature of 100.4 along with nasal congestion and cough on 9/1.  Was given Tylenol 3.75 ml every 4-6 hrs when awake.  Temperature decreased to 98 degrees with Tylenol but fever keep returning  on 9/2-9/4 with highest temperature of 101.3.  He also developed decreased appetite and increased fussiness on 9/2.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Illness
Clinical narrative: This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), 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: "Long haulers" (unspecified if ongoing), notes: She mentioned that she was one of the "long haulers". The patient's concomitant medications were not reported. The following information was reported: BEDRIDDEN (medically significant), outcome "not recovered", described as "Had been bedridden"; ILLNESS (medically significant), outcome "not recovered", described as "She'd been extremely sick from it".  She had the Pfizer primary series and a booster shot. She added that after the doses she'd been extremely sick from it and had been bedridden and getting a lot of therapy.  Therapeutic measures were taken as a result of bedridden, illness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer) and only lasted 48 hours; not feeling well; not feeling normal; feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-024693 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa" (unspecified if ongoing), notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine; "cipro antibiotics" (unspecified if ongoing), notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine; "kidney-pancreas transplant" (unspecified if ongoing), notes: kidney-pancreas transplant; "kidney-pancreas transplant" (unspecified if ongoing), notes: kidney-pancreas transplant. The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Allergies: morphine", notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine. The following information was reported: PYREXIA (non-serious), outcome "not recovered", described as "running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer) and only lasted 48 hours"; MALAISE (non-serious), outcome "not recovered", described as "not feeling well"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "not feeling normal"; FATIGUE (non-serious), outcome "not recovered", described as "feeling tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, malaise, feeling abnormal, fatigue.  Additional information: Caller received her fall booster on 09Sep2022 two weeks and 2 days ago. Patient was still running a low grade with temperatures below 100-degree F since the day after receiving the Moderna shot on 10Sep2022.Caller stated she was not feeling well, not feeling normal and feeling tired about having fever. The symptoms were ongoing. When reading list of expected side effects with the bivalent booster caller stated that she experienced all of them with her previous vaccines (Pfizer) and only lasted 48 hours.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.