chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller stated that she received 5 Pfizer immunization shots and the last one the omicron booster shot on 05Nov2022 (Lot number GJ6796), she was diagnosed covid positive; Caller stated that she received 5 Pfizer immunization shots and the last one the omicron booster shot on 05Nov2022 (Lot number GJ6796), she was diagnosed covid positive; 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 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: GJ6796) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, and all described as "Caller stated that she received 5 Pfizer immunization shots and the last one the omicron booster shot on 05Nov2022 (Lot number GJ6796), she was diagnosed covid positive". The patient stated that she received five Pfizer immunization shots. On Saturday, Nov2022, the patient was diagnosed COVID positive shortly after receiving the last Pfizer COVID shot. The patient wanted to know if the COVID vaccine has an interaction with Paxlovid. The patient also asked if there are reports of contracting the COVID virus even though five COVID-19 shots were received, considering that the last shot was the omicron shot. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: she was diagnosed covid positive on Saturday. Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment was Paxlovid from 01Nov2022 to 05Nov2022. On 10Nov2022, recurrence of covid symptoms (GI disruption, cold symptoms). No fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Poor quality sleep
Clinical narrative: We can not fall asleep; we were not sleepy; we were awake all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 90-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 3 (booster), single (Lot number: GH9697) at the age of 90 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: CANDESARTAN [CANDESARTAN CILEXETIL] taken for hypertension. Vaccination history included: flu shot, administration date: 07Oct2022, when the patient was 90-year-old, for Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: POOR QUALITY SLEEP (non-serious) with onset 11Nov2022, outcome "unknown", described as "We can not fall asleep; we were not sleepy; we were awake all night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that, he just wants to report and sort of curious. He could not find anything on the computer about side effects and one that he would like to pursue was ability to fall asleep. Last night, his wife and he had some time and they haven't had their third booster yet, so they had the first two and now they wanted to get the third one for the Pfizer. So, they made an appointment at pharmacy for 7:15 and 7:30 and went there and they both had shots. They did not see the shot getting drawn up out of the bottle it came already in syringe and they asked him if it came from a bottle and he said yes and he didn't get about 6 of the bottles (Further not clarified, hence event captured as per the verbatim) and that's what they knew about it. He did not see if it came from refrigeration or anything. He didn't particularly want that kind of shot because those often to have a protection called some kind of a, he did not know the word. Basically, they could not fall asleep. He and his wife had this shot, they were awake all night. She had a very little high blood pressure, its only 132 extremely not high but she took a tremendous number of ocular medications, her problem was Glaucoma.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201300388 Same product/event; different patient;
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swollen up and it still kind of hard so; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GH9694) 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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen up and it still kind of hard so".  Additional information: Consumer stated that when the patient got the injection, her arm swelled up real bad and it had not gone away at the time of report. It was still swollen and she had it 20Oct2022. She got the Pfizer (Confirmed as COVID-19 vaccine), number 4. Reporter stated that it was in the muscle when she got it but it was still swollen up and it still kind of hard so, it was probably since 20Sep and it was swollen up hard. Reporter asked what they could regarding the event. Reporter stated that Pfizer 30 mcg/0D 3 ml Inj Pfizer. It came through on the shot when she got it (not clarified further)."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An 18-year-old 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: MYOCARDITIS (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Pyrexia, Wrong product administered
Clinical narrative: "mild symptoms including fever"; Pfizer Bivalent - Dose Number: 1; Flucelvax Quad Flu vaccine Seqirus: 04Oct2022 ...Pfizer Bivalent: 04Oct2022; Flucelvax Quad Flu vaccine Seqirus: 04Oct2022 ...Pfizer Bivalent: 04Oct2022; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 1, single (Lot number: GJ6742) at the age of 44 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 04Oct2022 as dose number unknown, single (Lot number: 942381), in left deltoid for immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 04Oct2022, outcome "recovered", described as ""mild symptoms including fever""; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Oct2022, outcome "unknown" and all described as "Flucelvax Quad Flu vaccine Seqirus: 04Oct2022 ...Pfizer Bivalent: 04Oct2022"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 04Oct2022, outcome "unknown", described as "Pfizer Bivalent - Dose Number: 1". It was unknown if therapeutic measures were taken as a result of pyrexia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Deafness, Diplopia, Ear discomfort, Gait disturbance
Clinical narrative: Hearing loss in ears; Severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times; severe vertigo; Walking sideways; Confusion; Double vision; Ear Fullness; Severe vomiting; Headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eosinophils esophagitis" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 03:45 PM), administration date: 14Sep2021, when the patient was 36-year-old, for Covid-19 Immunization. The following information was reported: CONFUSIONAL STATE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Confusion"; DIPLOPIA (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Double vision"; EAR DISCOMFORT (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Ear Fullness"; HEADACHE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Headaches"; DEAFNESS (disability, medically significant) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Hearing loss in ears"; TINNITUS (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times"; VOMITING (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Severe vomiting"; GAIT DISTURBANCE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Walking sideways"; VERTIGO (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "severe vertigo". The events "hearing loss in ears", "severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times", "severe vertigo", "walking sideways", "confusion", "double vision", "ear fullness", "severe vomiting" and "headaches" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Negative, notes: Covid test: Nasal swab. Therapeutic measures were taken as a result of deafness, tinnitus, vertigo, gait disturbance, confusional state, diplopia, ear discomfort, vomiting, headache. Clinical course: Multiple ENT visits, PCP visits, new med pres. Prior to vaccination, the patient was not diagnosed with covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, SARS-CoV-2 test, Tinnitus, Vertigo
Clinical narrative: Hearing loss in ears; Severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times; severe vertigo; Walking sideways; Confusion; Double vision; Ear Fullness; Severe vomiting; Headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eosinophils esophagitis" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 03:45 PM), administration date: 14Sep2021, when the patient was 36-year-old, for Covid-19 Immunization. The following information was reported: CONFUSIONAL STATE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Confusion"; DIPLOPIA (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Double vision"; EAR DISCOMFORT (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Ear Fullness"; HEADACHE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Headaches"; DEAFNESS (disability, medically significant) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Hearing loss in ears"; TINNITUS (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times"; VOMITING (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Severe vomiting"; GAIT DISTURBANCE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Walking sideways"; VERTIGO (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "severe vertigo". The events "hearing loss in ears", "severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times", "severe vertigo", "walking sideways", "confusion", "double vision", "ear fullness", "severe vomiting" and "headaches" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Negative, notes: Covid test: Nasal swab. Therapeutic measures were taken as a result of deafness, tinnitus, vertigo, gait disturbance, confusional state, diplopia, ear discomfort, vomiting, headache. Clinical course: Multiple ENT visits, PCP visits, new med pres. Prior to vaccination, the patient was not diagnosed with covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Hearing loss in ears; Severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times; severe vertigo; Walking sideways; Confusion; Double vision; Ear Fullness; Severe vomiting; Headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eosinophils esophagitis" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 03:45 PM), administration date: 14Sep2021, when the patient was 36-year-old, for Covid-19 Immunization. The following information was reported: CONFUSIONAL STATE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Confusion"; DIPLOPIA (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Double vision"; EAR DISCOMFORT (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Ear Fullness"; HEADACHE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Headaches"; DEAFNESS (disability, medically significant) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Hearing loss in ears"; TINNITUS (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times"; VOMITING (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Severe vomiting"; GAIT DISTURBANCE (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "Walking sideways"; VERTIGO (disability) with onset 22Oct2021 at 07:00, outcome "not recovered", described as "severe vertigo". The events "hearing loss in ears", "severe high pitched ringing in ears/ ear fullness and roaring that lasts for weeks/month at times", "severe vertigo", "walking sideways", "confusion", "double vision", "ear fullness", "severe vomiting" and "headaches" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Negative, notes: Covid test: Nasal swab. Therapeutic measures were taken as a result of deafness, tinnitus, vertigo, gait disturbance, confusional state, diplopia, ear discomfort, vomiting, headache. Clinical course: Multiple ENT visits, PCP visits, new med pres. Prior to vaccination, the patient was not diagnosed with covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: came down with COVID; came down with COVID; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6204), on 30Mar2021 as dose 2, single (Lot number: EW0150), on 05Nov2021 as dose 3 (booster), single (Lot number: FF2590) and on 22Apr2022 as dose 4 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 62 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy induced asthma" (unspecified if ongoing), notes: Comments: Allergy induced asthma She has a history of allergy induced asthma and over 60 so that was why she thinks she was prescribed medications for COVID. She had a rescue inhaler that expired and her doctor sent a rescue inhaler and have used a couple times since she got sick. Albuterol rescue inhaler.; "Allergy induced asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Nov2022, outcome "recovering" and all described as "came down with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received concomitant medications as Multivitamins. Nurse is the patient who had completed primary series of COVID-19 Vaccines and the week she was planning to get Omicron booster she came down with COVID and treated with Paxlovid. Caller confirms details provided by transfer agent. Her physician is not going to know anything as she did a virtual care visit to get medications for the COVID. She took her last dose of Paxlovid this morning and finishes steroids tomorrow. Patient did not received other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Patient did not visit Emergency room.   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 known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19 and the suspect drug BNT162B2.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: shoulder is killing her, the muscle around the whole shoulder is sore.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 3 (booster), single (Lot number: GJ2524, Expiration Date: 30Jun2023) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "shoulder where she had the replacement" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Lot: FJ6369 in right arm as dose 1, single), administration date: 14Feb2022, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "no adverse event"; BNT162b2 (Lot: FK9893 in right arm as dose 2, single), administration date: 07Mar2022, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "no adverse event". The following information was reported: MYALGIA (non-serious) with onset 15Nov2022, outcome "not recovered", described as "shoulder is killing her, the muscle around the whole shoulder is sore.".  Additional information: Patient was calling about the Pfizer Covid-19 Bivalent vaccine for 12 years and up. She just had the shot yesterday in the left arm. She had a shoulder replacement and they gave her the vaccine in the shoulder where she had the replacement. Her shoulder is killing her today. The muscle around the whole shoulder is sore. She did not realize that she gave them at that arm and was not thinking that it was the shoulder where she had the replacement. Patient woke up with the pain today (day of report). It was reported that she had no problems with the other 2 injections. Patient vaccination facility type was pharmacy. Patient has no prior vaccination. No relevant family medical history to adverse event. Patient was asking if is it okay that they gave her the shot in the replacement shoulder and she was having pain.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; 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 84-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergic to Polyethylene glycol (PEG)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: Patient age was reported as almost 85 years old. Patient mentioned that she called like year and a half ago regarding the ingredients of the vaccine. She's allergic to Polyethylene glycol (PEG) and remembered that when she called, someone told her that it contains 53 mg. She said she's allergic to PEG on quantities greater than 1000mg. She stated that she never had an adverse event when she received her first doses of the Pfizer-BioNTech COVID-19 Vaccine. Later, she mentioned that she only had a sore arm but that's all. She waited between 4 to 5 months to receive her next dose of the Covid Vaccine, but in her area someone told her that the new formulation is only available. It was further reported that she took three shots of the COVID-19 vaccine and would like to know more regarding the new booster vaccine because she had an allergic reaction with one of the ingredients in it. She got information and found out it was safe for her to take the vaccines which she had. She didn't have any problem with the vaccines she took. Patient wanted to know if the new bivalent formulation contains the same amount of PEG (53 mg) as the monovalent formulation. Patient would like more information regarding the new vaccines and is there any side effects to look out for.  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-202201304677 Same reporter/patient/vaccine/events, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Confusional state, Eating disorder, Seizure, Speech disorder
Clinical narrative: He has collapsed on site; seizures; memory loss; confusion; difficulty talking, eating; difficulty talking, eating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  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 included: "hashimotos" (unspecified if ongoing), notes: Caller provided previous history for patient of hashimotos. The patient's concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "He has collapsed on site"; SEIZURE (medically significant), outcome "not recovered", described as "seizures"; AMNESIA (non-serious), outcome "not recovered", described as "memory loss"; CONFUSIONAL STATE (non-serious), outcome "not recovered", described as "confusion"; SPEECH DISORDER (non-serious), EATING DISORDER (non-serious), outcome "not recovered" and all described as "difficulty talking, eating". The events "he has collapsed on site", "seizures", "memory loss", "confusion" and "difficulty talking, eating" required physician office visit.  Clinical course: Reporter Inquired that there brother in law had been ill since he took the covid shots. He had memory loss, confusion, seizures, difficulty talking, eating, and many other symptoms. No doctor can pinpoint what was wrong. He was not getting better. Is there any study or program he can join to help him and my sister figure out what is going on? He had seen cardiologists, endocrinologists, neurologist s, and others. Caller provided previous history for patient of hashimotos and stated patient did not want to get the vaccine but was required by his workplace. Caller stated this had been happening for the excess of a year he can barely work and when driving to work one day, stated patient had a seizure behind the wheel of a car. He has collapsed on site, he stands up and it was a mess. Caller also stated kept a log everything he has eaten for the past 11 months.  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: Syncope
Clinical narrative: He has collapsed on site; seizures; memory loss; confusion; difficulty talking, eating; difficulty talking, eating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  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 included: "hashimotos" (unspecified if ongoing), notes: Caller provided previous history for patient of hashimotos. The patient's concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "He has collapsed on site"; SEIZURE (medically significant), outcome "not recovered", described as "seizures"; AMNESIA (non-serious), outcome "not recovered", described as "memory loss"; CONFUSIONAL STATE (non-serious), outcome "not recovered", described as "confusion"; SPEECH DISORDER (non-serious), EATING DISORDER (non-serious), outcome "not recovered" and all described as "difficulty talking, eating". The events "he has collapsed on site", "seizures", "memory loss", "confusion" and "difficulty talking, eating" required physician office visit.  Clinical course: Reporter Inquired that there brother in law had been ill since he took the covid shots. He had memory loss, confusion, seizures, difficulty talking, eating, and many other symptoms. No doctor can pinpoint what was wrong. He was not getting better. Is there any study or program he can join to help him and my sister figure out what is going on? He had seen cardiologists, endocrinologists, neurologist s, and others. Caller provided previous history for patient of hashimotos and stated patient did not want to get the vaccine but was required by his workplace. Caller stated this had been happening for the excess of a year he can barely work and when driving to work one day, stated patient had a seizure behind the wheel of a car. He has collapsed on site, he stands up and it was a mess. Caller also stated kept a log everything he has eaten for the past 11 months.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Heart rate, Heart rate increased, Nausea
Clinical narrative: racing resting heart rate; dizzy; sore arm; chills; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 14:30 as dose 4 (booster), single (Lot number: GJ6665) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic neck pain" (unspecified if ongoing), notes: other medical history: Chronic neck pain. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, in Sep2022 as dose number unknown, single; LYRICA. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 3rd, Manufacturer unknown), for Covid-19 immunization. The following information was reported: CHILLS (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown"; DIZZINESS (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "dizzy"; NAUSEA (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "nauseous"; HEART RATE INCREASED (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "racing resting heart rate"; PAIN IN EXTREMITY (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "sore arm". The events "racing resting heart rate", "dizzy", "sore arm", "chills" and "nauseous" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: (29Oct2022) racing resting. Therapeutic measures were taken as a result of heart rate increased, dizziness, pain in extremity, chills, nausea. Clinical course: Other medications in two weeks: Lyrica, Mounjaro 5 mg. Within 10 hours post vaccine she experienced a sore arm, chills, and a racing resting heart rate that was picked up 6 times by (name withheld) watch. She was unable to get her heart rate to lower and began to feel nauseous and dizzy. She then went to the ER. AE treatment: IV fluids and Tylenol. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: racing resting heart rate; dizzy; sore arm; chills; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 14:30 as dose 4 (booster), single (Lot number: GJ6665) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic neck pain" (unspecified if ongoing), notes: other medical history: Chronic neck pain. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, in Sep2022 as dose number unknown, single; LYRICA. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 3rd, Manufacturer unknown), for Covid-19 immunization. The following information was reported: CHILLS (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown"; DIZZINESS (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "dizzy"; NAUSEA (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "nauseous"; HEART RATE INCREASED (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "racing resting heart rate"; PAIN IN EXTREMITY (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "sore arm". The events "racing resting heart rate", "dizzy", "sore arm", "chills" and "nauseous" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: (29Oct2022) racing resting. Therapeutic measures were taken as a result of heart rate increased, dizziness, pain in extremity, chills, nausea. Clinical course: Other medications in two weeks: Lyrica, Mounjaro 5 mg. Within 10 hours post vaccine she experienced a sore arm, chills, and a racing resting heart rate that was picked up 6 times by (name withheld) watch. She was unable to get her heart rate to lower and began to feel nauseous and dizzy. She then went to the ER. AE treatment: IV fluids and Tylenol. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Dizziness, Fatigue, Pain
Clinical narrative: Feels dizzy; Achy; Tired; Having a runny nose; Sore left arm; dehydrated; His left shoulder felt sore; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. 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 14Nov2022 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left 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; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Zoster vaccine (DOSE 2), administration date: Jul2022, for immunisation; Zoster vaccine (DOSE 1), for immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 14Nov2022, outcome "not recovered", described as "His left shoulder felt sore"; PAIN (non-serious) with onset 15Nov2022, outcome "unknown", described as "Achy"; DIZZINESS (non-serious) with onset 15Nov2022, outcome "unknown", described as "Feels dizzy"; RHINORRHOEA (non-serious) with onset 15Nov2022, outcome "unknown", described as "Having a runny nose"; PAIN IN EXTREMITY (non-serious) with onset 15Nov2022, outcome "not recovered", described as "Sore left arm"; FATIGUE (non-serious) with onset 15Nov2022, outcome "unknown", described as "Tired"; DEHYDRATION (non-serious) with onset 15Nov2022, outcome "unknown", described as "dehydrated".  Additional information: the patient was not sure if the events were delayed vaccine side effects after 24 hours. He can't remember if the side effects started a few hours after or 24 hours after. He never had COVID. He had his second shingles vaccine in Jul2022, by that night around 9 pm, he started getting side effects, they were bad but COVID vaccine was nothing like that. He asked if these side effects were normal or these were something he should get checked out. His sore left arm was reported to worsened. It was progressive similar to any vaccination he has got. It was not terrible and he was outside moving garden hoses. He clarified the dizziness, a little dehydrated and was feeling out of it, and started about an hour ago before the call and it might pass. He called to find out the progression of the side effects.He was just trying to find out if what he was experiencing was normal. Since timing was coincidental that it would be because of the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: Feels dizzy; Achy; Tired; Having a runny nose; Sore left arm; dehydrated; His left shoulder felt sore; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. 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 14Nov2022 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left 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; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Zoster vaccine (DOSE 2), administration date: Jul2022, for immunisation; Zoster vaccine (DOSE 1), for immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 14Nov2022, outcome "not recovered", described as "His left shoulder felt sore"; PAIN (non-serious) with onset 15Nov2022, outcome "unknown", described as "Achy"; DIZZINESS (non-serious) with onset 15Nov2022, outcome "unknown", described as "Feels dizzy"; RHINORRHOEA (non-serious) with onset 15Nov2022, outcome "unknown", described as "Having a runny nose"; PAIN IN EXTREMITY (non-serious) with onset 15Nov2022, outcome "not recovered", described as "Sore left arm"; FATIGUE (non-serious) with onset 15Nov2022, outcome "unknown", described as "Tired"; DEHYDRATION (non-serious) with onset 15Nov2022, outcome "unknown", described as "dehydrated".  Additional information: the patient was not sure if the events were delayed vaccine side effects after 24 hours. He can't remember if the side effects started a few hours after or 24 hours after. He never had COVID. He had his second shingles vaccine in Jul2022, by that night around 9 pm, he started getting side effects, they were bad but COVID vaccine was nothing like that. He asked if these side effects were normal or these were something he should get checked out. His sore left arm was reported to worsened. It was progressive similar to any vaccination he has got. It was not terrible and he was outside moving garden hoses. He clarified the dizziness, a little dehydrated and was feeling out of it, and started about an hour ago before the call and it might pass. He called to find out the progression of the side effects.He was just trying to find out if what he was experiencing was normal. Since timing was coincidental that it would be because of the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Feeling abnormal, Suspected COVID-19
Clinical narrative: COVID/She does believe that she got COVID; COVID/She does believe that she got COVID; foggy head/Feels like she has 2 heads, 1 inside of the other; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, 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; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "COVID/She does believe that she got COVID"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "foggy head/Feels like she has 2 heads, 1 inside of the other". The patient reported foggy head after getting the booster shot and wanted to know any suggestions on what to do for this fogginess. She reported that she had COVID past year, and now she's ok. The patient reported that a friend of hers got COVID-19 and received Paxlovid. On the paper it mentioned that one of the possible side effects was 'foggy head' (sic)". She had the booster and she's been having that for quite some time. She asked the doctors, and they didn't know what she was talking about. It comes and goes, so it's not there all the time. The patient reported that she received the Pfizer COVID-19 Vaccine Booster and ever since she got it, she has had some foggy head. She has been having it for quite some time; it comes and goes, it's not there all the time. She clarified she was  not sure when the onset of the foggy head was. She does believe that she got COVID, but if so, it was long time ago. This foggy head she still has from time to time but lately it has occurred a little bit more often than ever. When she saw the side effects that were listed in some of the drug which has to do with COVID there was one called foggy head; so she thought that would fit the way to describe her head. Before then she couldn't think of how to describe her head and no one paid any attention anyway. It occurred to her that maybe if she called Pfizer someone could tell her what do you mean by 'foggy head' and if there anything to suggest that can do for it. She guessed Pfizer either didn't know or did not want to say without more information yet when caller queried if these inquiries were addressed with agent. She feels like she has 2 heads, 1 inside of the other.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: Severe whole body hives; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 08:45 as dose 1, single (Lot number: Gj6738) at the age of 67 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 11Nov2022 as dose 1, single (Lot number: Uj934aa), in left arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient has no known allergies and no covid prior vaccination or other vaccine in four weeks. The following information was reported: URTICARIA (medically significant) with onset 13Nov2022 at 20:00, outcome "not recovered", described as "Severe whole body hives". The event "severe whole body hives" required physician office visit. Therapeutic measures were taken as a result of urticaria including Prednisone 40 mg per day. The patient was not tested for covid-19 post vaccination.; Sender's Comments: As per the available information the causality of the event urticaria with the suspect BNT162b2, BNT162b2 omi ba.4-5 can not be ruled out completely. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, Ethics committees, and Investigators, as appropriate.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: ER8734), on 01May2021 as dose 2, single (Lot number: ER8736) and on 15Jan2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (Nov2022) Result unknown; Oxygen saturation: (Nov2022) Result unknown; SARS-CoV-2 test: (13Nov2022) Positive; Vital signs measurement: (unspecified date) Unknown.  Clinical course: Reporter States that he took his mom to the hospital on Saturday, 12Nov2022, and found out that she was positive for Covid. Saturday night he had a sore throat and a cough. He did a self test on Sunday, 13Nov2022 and it was positive for COVID-19. He called his transplant team and he went in for monoclonal antibodies yesterday. His symptoms are mild. He has a runny nose and today his body hurts. States that he monitors his vital signs 4 times a day anyway and sends his temperature and oxygen levels to the hospital via an app on his phone. His mom is normally his caretaker, so he is doing a lot more activity than he would normally due, so he is having hip issues which is probably from using different muscles to hold himself up with a walker. He thinks his body aches are because he is being more active.