chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 1st October 2023 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not yet received 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 04-JUN-2024 A reporter reported that her husband received his first Shingrix vaccine on 01 October 2019 and he was 75 years old at the time.  He forgot to go back for the second shot, today, the pharmacist stated that he can still (5 years later) get his second shot.  The reporter wanted to know was that correct, will his coverage with the second shot being given 5 years after the first make the protection effective. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurt very much; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm hurt very much). The outcome of the pain in arm was not reported.   The reporter considered the pain in arm to be possibly related to Shingrix.     The company considered the pain in arm to be possibly related to Shingrix.   Additional Information: GSK receipt date: 29-MAY-2024 This case was reported the patient via interactive digital media. It was offered to all patients who turn 50 years old.  The vaccine made the patient arm hurt very much, but it was much better than the pain of having shingles.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient came late for a second dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patient's who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On an unknown date, the patients received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient came late for a second dose of Twinrix). The outcome of the drug dose administration interval too long was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 28-MAY-2024 The pharmacist explained in the past they had cases where patient came late for a second dose of Twinrix, instead of month 1 they received it at month 2. They were not sure in cases like this if third dose should be delayed.  The reporter did not had any patient demographics, lot number or expiration of the vaccine used, since she was not calling on behalf of a specific patient, it was more like a general inquiry.  Agent did not ask for consent to follow up with Safety team. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not get her second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first Shingrix shot on 09-DEC-2022).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not get her second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-MAY-2024 The pharmacist had a patient that got her first Shingrix shot but did not get her second dose yet which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not recived 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 21-FEB-2024, batch number:797F9).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not recived 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA receipt date: 28-MAY-2024 The reporter said that they need to know the minimum amount of time between the 2nd dose and the 3rd dose of Twinrix. The Vaccine Administration Facility was the same as Primary Reporter. They had the schedule to provide the 2nd dose of Twinrix at the time of reporting. As this dose would be a late dose, they were wondering when to administrate the 3rd dose of Twinrix.  At the moment of the call, the patient was not vaccinating with the 2nd dose of Twinrix. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEP, TDAP
Symptoms: Product storage error
Clinical narrative: vaccines with temperature excursions administered to patients; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Boostrix and Engerix B. On an unknown date, an unknown time after receiving Boostrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: vaccines with temperature excursions administered to patients). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 28-MAY-2024 The reporter reported that they had temperature excursion, they had lowest it got was 1.15 degree C which led to incorrect storage of drug. The reporter reported that their safety lady wants to know if they need to contact the patients who had the vaccines since it's not viable or if they were ok with what they were given. The reporter reported that they did not know for sure which patients was given too, that they had to go to whole list. Did not had way of telling and how many affected.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product supply issue
Clinical narrative: She was late in getting her second dose due to supply issue; This non-serious case was reported by a consumer via call center representative and described the occurrence of product supply issue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29-MAR-2018).   On 13-NOV-2018, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced product supply issue (Verbatim: She was late in getting her second dose due to supply issue). The outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 28-MAY-2024 The patient self-reported this case. She received her first dose of Shingrix and was late in getting her second dose due to supply issues, which led to product supply issue.  She received her second dose of Shingrix 8.5 months after the 1st dose outlined by the prescribing information and her pharmacy advised that it was not an issue but she wanted to bring it to our attention.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: accidentally administer Infanrix instead of Pentacel to a patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa (Infanrix) (batch number Z53J4, expiry date 07-JUN-2025) for prophylaxis.   Concomitant products included Pentacel.   On 28-MAY-2024, the patient received Infanrix. On 28-MAY-2024, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: accidentally administer Infanrix instead of Pentacel to a patient.). The outcome of the wrong vaccine administered was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 28-MAY-2024 The nurse reported that they accidentally administered Infanrix instead of Pentacel to a patient which led to wrong vaccine administered. The reporter consent to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Device connection issue, No adverse event
Clinical narrative: Potential adverse event Hiberix with luer lock issues administered; the luer lock does not stay into the syringe, the whole luer lock comes off of the syringe; Product Complaint; No adverse event /Pure PQC.
Age: 1.08
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: administered to a patient only the diluent part of the Hiberix vaccine; they administered to a patient only the diluent part of the Hiberix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 13-month-old male patient who received Hib (Hiberix) (batch number 9E3BH) for prophylaxis.   On 29-MAY-2024, the patient received Hiberix. On 29-MAY-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate dose of vaccine administered (Verbatim: they administered to a patient only the diluent part of the Hiberix vaccine). On an unknown date, the patient experienced inappropriate preparation of medication (Verbatim: administered to a patient only the diluent part of the Hiberix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-MAY-2024 An other health professional reported that they administered to a patient only the diluent part of the Hiberix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: got vaccinated yesterday (May 28th 2024) with Engerix-B which was expired; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HBV (Engerix B) (batch number 7B2YL, expiry date 25-FEB-2024) for prophylaxis.   On 28-MAY-2024, the patient received Engerix B. On 28-MAY-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: got vaccinated yesterday (May 28th 2024) with Engerix-B which was expired). The outcome of the expired vaccine used was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 29-MAY-2024 The patient got vaccinated with Engerix-B which was expired, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site discomfort
Clinical narrative: Injection site discomfort; fatigue/felt very tired; didn't have alot of energy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 12 hrs after receiving Shingrix, the patient experienced injection site discomfort (Verbatim: Injection site discomfort), fatigue (Verbatim: fatigue/felt very tired) and loss of energy (Verbatim: didn't have alot of energy). The outcome of the injection site discomfort, fatigue and loss of energy were resolved (duration 2 days).   It was unknown if the reporter considered the injection site discomfort, fatigue and loss of energy to be related to Shingrix.     It was unknown if the company considered the injection site discomfort, fatigue and loss of energy to be related to Shingrix.   Linked case(s) involving the same patient: US2024AMR069766   Additional Information: GSK Receipt Date: 29-MAY-2024 The pharmacist was a patient who received Shingrix and experienced fatigue, injection site discomfort, he felt tired and need to rest and he did not had a lot of energy. The fatigue was significant. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR069586:WIFE CASe Same reporter US-GSK-US2024AMR069766:2nd dose MALE PATIENT US-GSK-US2024AMR070956:subgroup case
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash under her arm (armpit) and under breast; This non-serious case was reported by a other health professional via call center representative and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 7992N, expiry date 16-MAY-2026) for prophylaxis.   On 29-MAY-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 30-MAY-2024, 1 days after receiving Shingrix, the patient experienced rash (Verbatim: rash under her arm (armpit) and under breast). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAY-2024 The pharmacy intern stated that a patient received Shingrix vaccine and woke up with a rash under arm (armpit) and under breast on the same side the vaccine was administered. There was no rash at the injection site. The patient called reporter on the day of reporting and according to the reporter, the way patient described the rash they did not think it was hives but sounded more like a heat rash. It did not sound like a herpes zoster rash but caller said that anything was possible since they did not saw it and were not in a position to diagnose.
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: pain all over; fever; could barely get out of bed all day; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-MAY-2024, the patient received the 2nd dose of Shingrix. On 29-MAY-2024, 1 days after receiving Shingrix, the patient experienced general body pain (Verbatim: pain all over), fever (Verbatim: fever) and bedridden (Verbatim: could barely get out of bed all day). The outcome of the general body pain, fever and bedridden were not resolved.   It was unknown if the reporter considered the general body pain, fever and bedridden to be related to Shingrix.     It was unknown if the company considered the general body pain, fever and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAY-2024 The patient's mother reported that, the patient received his Shingrix dose 2 days before reporting. The patient was experiencing fever, pain all over and could barely get out of bed all day.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: she had a sore arm/pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site pain (Verbatim: she had a sore arm/pain at injection site). The outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAY-2024 The patient reported that the when she received her dose of Shingrix vaccine several years ago and she had developed sore arm at injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received one in 2021 and she never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received one in 2021 and she never got the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-MAY-2024 The pharmacist called and reported that he/she had the patient who never got the second one from the 2 dose series. The reporter said that the patient's doctor said to restart it but as far as reporter was concerned they were not supposed to. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: RSV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: mistakenly did not reconstitute; Diluent only administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EA4RB, expiry date 01-FEB-2025) for prophylaxis.   On 03-JUN-2024, the patient received Arexvy. On 03-JUN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: mistakenly did not reconstitute) and inappropriate dose of vaccine administered (Verbatim: Diluent only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 03-JUN-2024 Reporter administered the Arexvy vaccine to patient and reporter mistakenly did not reconstitute it. Reporter just injected the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Reporter asked a question that was there any serious reaction to monitor. The patient was fine afterwards. The reporter consented to follow-up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: The following day her tongue began tingling; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tingling tongue in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-JUN-2024, the patient received the 2nd dose of Shingrix. On 02-JUN-2024, 1 days after receiving Shingrix, the patient experienced tingling tongue (Verbatim: The following day her tongue began tingling). The outcome of the tingling tongue was not resolved.   It was unknown if the reporter considered the tingling tongue to be related to Shingrix.     It was unknown if the company considered the tingling tongue to be related to Shingrix.   Additional Information: GSK receipt date: 04-JUN-2024 The reporter was the pharmacist at the pharmacy where the vaccine was given.  She reported that the patient had her 2nd dose of Shingrix on Saturday and following day her tongue began tingling.   It had not yet subsided (at the time of reporting). Did not consent to follow-up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: 2nd dose administered.; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number L7373, expiry date 30-NOV-2024) for prophylaxis.   Previously administered products included Menveo (received 1st dose on October 2023).   On 05-JUN-2024, the patient received the 2nd dose of Menveo. On 05-JUN-2024, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 2nd dose administered.). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 05-JUN-2024 The reporter had one patient that we gave her the Menveo vaccine, and after we administered it, we realized that (that the patient had already received one dose), which led to extra dose administered. Reporter mentioned that patient was 17 years old, and that the 1st dose was received in October 2023.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix - Administration of the diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix - Administration of the diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 05-JUN-2024 The health care professional (HCP) requested information on appropriate next steps when a patient only received the diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case is linked with US2024069982, by same reporter.; Sender's Comments:  US-GSK-US2024069982:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: had 15 blood clots in her lung; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2), in 2021 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: PULMONARY THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "had 15 blood clots in her lung". Additional information: reporter would like a list of all the ingredients in the Pfizer Covid 19 vaccine. Reporter's daughter's doctor wants to know exactly what is in this Pfizer vaccine. Reporter's daughter had 15 blood clots in her lung and it happened shortly after the vaccine. It is not the current one but the 'earlier' or older one, and that's the one where everybody is having problems. She got it in 2021 so whatever one was in 2021 is what reporter need the list of ingredients. There is an issue with the old one.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Got sick with a high fever; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (hospitalization), outcome "unknown", described as "Got sick with a high fever". The patient was hospitalized for pyrexia (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: Body temperature: high fever. Clinical course: Reporter stated that patient got sick with a high fever and then hospitalized after receiving the Pfizer COVID Vaccine and was in hospital for 4 days.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400074150 same reporter/product, different patient/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug Ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EN5318), on 23Feb2021 as dose 2, single (Lot number: EN6201) and on 25Jan2022 as dose 3 (booster), single (Lot number: FL3198), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11May2024 to 16May2024.  No follow-up attempts are possible.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Malaise, Migraine
Clinical narrative: Uncontrolled blood pressure; My blood pressure is 170 over 110; Seizures; Heart muscle got damaged; Severe headache; I am not feeling well; Migraine; Sinus tachycardia; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EN6201) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INJURY (medically significant) with onset 2021, outcome "not recovered", described as "Heart muscle got damaged"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "I am not feeling well"; MIGRAINE (non-serious) with onset 2021, outcome "not recovered"; SEIZURE (medically significant) with onset 2021, outcome "not recovered", described as "Seizures"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Severe headache"; SINUS TACHYCARDIA (non-serious) with onset 2021, outcome "not recovered"; HYPERTENSION (medically significant) with onset 2021, outcome "not recovered", described as "Uncontrolled blood pressure; My blood pressure is 170 over 110". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 170 over 110, notes: reporter stated, "My blood pressure is 170 over 110.". Therapeutic measures were taken as a result of headache, migraine. Clinical course: Patient reported she was healthy three years ago until she got the vaccine. Patient reported it all started in the year 2021. After taking Pfizer COVID-19 Vaccine (on right shoulder, in right arm), she experiences some health problem such as uncontrolled blood pressure. She also exp seizures. Her heart got damaged. She also experiences headache that is not going anywhere. She had seizures for 15 times in three years now from the time they received the vaccine. In three years, the seizures and she mentioned as well that before she got the vaccine before vaccine, she undergoes medical checkups, and she was perfectly healthy. She experiences everything after she got vaccine. She mentioned that the vaccine damaged her body. The patient was fine before that. She is suffering from uncontrolled blood pressure, sinus tachycardia and daily migraine, headache, severe headache. She have been on 10 different medications trying to stop these headaches. Patient stated they were all just told to go get the vaccine, they all went and got the vaccine. There was no doctor involved. No doctors told anyone to go get the vaccine. They were all told by the news and our government to go get the vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial injury, Seizure, Sinus tachycardia
Clinical narrative: Uncontrolled blood pressure; My blood pressure is 170 over 110; Seizures; Heart muscle got damaged; Severe headache; I am not feeling well; Migraine; Sinus tachycardia; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EN6201) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INJURY (medically significant) with onset 2021, outcome "not recovered", described as "Heart muscle got damaged"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "I am not feeling well"; MIGRAINE (non-serious) with onset 2021, outcome "not recovered"; SEIZURE (medically significant) with onset 2021, outcome "not recovered", described as "Seizures"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Severe headache"; SINUS TACHYCARDIA (non-serious) with onset 2021, outcome "not recovered"; HYPERTENSION (medically significant) with onset 2021, outcome "not recovered", described as "Uncontrolled blood pressure; My blood pressure is 170 over 110". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 170 over 110, notes: reporter stated, "My blood pressure is 170 over 110.". Therapeutic measures were taken as a result of headache, migraine. Clinical course: Patient reported she was healthy three years ago until she got the vaccine. Patient reported it all started in the year 2021. After taking Pfizer COVID-19 Vaccine (on right shoulder, in right arm), she experiences some health problem such as uncontrolled blood pressure. She also exp seizures. Her heart got damaged. She also experiences headache that is not going anywhere. She had seizures for 15 times in three years now from the time they received the vaccine. In three years, the seizures and she mentioned as well that before she got the vaccine before vaccine, she undergoes medical checkups, and she was perfectly healthy. She experiences everything after she got vaccine. She mentioned that the vaccine damaged her body. The patient was fine before that. She is suffering from uncontrolled blood pressure, sinus tachycardia and daily migraine, headache, severe headache. She have been on 10 different medications trying to stop these headaches. Patient stated they were all just told to go get the vaccine, they all went and got the vaccine. There was no doctor involved. No doctors told anyone to go get the vaccine. They were all told by the news and our government to go get the vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GJ2524), in left arm and on 02Jun2023 as dose 6 (booster), single (Lot number: GJ3270) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 16May2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracyline, reaction(s): "known allergies: Tetracyline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken with Paxlovid from 16May2024 to 21May2024 as a result of drug ineffective, covid-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Lot number: HD9876) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "NED breast cancer" (unspecified if ongoing); "Allergy: mango" (unspecified if ongoing); "Allergy: cashew" (unspecified if ongoing); "Allergy: pistachio" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN, start date: Apr2018. Past drug history included: Nsaids, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 30May2024 to 04Jun2024.
Sex: U
Vaccine: PNC20
Symptoms: Injection site pain
Clinical narrative: Patient had pain at the injection site after vaccination; This is a spontaneous report received from a Physician from a sales representative.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Drug Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Patient had pain at the injection site after vaccination".  Additional information: Patient had pain at the injection site after vaccination. It was unknown if the patient received any other vaccines on the same date as the vaccine for which you are reporting. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccine for which you are reporting. It was unknown if the patient taking any other medications within 2 weeks of the event starting.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I developed mild  congestion and tested positive for COVID; I developed mild  congestion and tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myalgic encephalomyelitis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "inflammatory arthritis" (unspecified if ongoing); "Low IgM" (unspecified if ongoing); "possible rheumatoid arthritis or ankylosis spondylitis" (unspecified if ongoing); "possible rheumatoid arthritis or ankylosis spondylitis" (unspecified if ongoing); "nickel allergy" (unspecified if ongoing); "red dye allergy" (unspecified if ongoing); "artificial sweetners allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Formaldehyde, reaction(s): "Drug allergy: Formaldehyde"; Morphine, reaction(s): "Drug allergy: morphine"; Neomycin, reaction(s): "Drug allergy: neomycin". Vaccination history included: pfizer / biontech (Dose 4, single, vaccine location: Right arm), administration date: 16Jul2022, when the patient was 64-year-old, for COVID-19 immunization; pfizer / biontech (Dose 3, single, vaccine location: Right arm), administration date: 13Dec2021, when the patient was 63-year-old, for COVID-19 immunization; pfizer / biontech (Dose 2, single, vaccine location: Right arm), administration date: 11Jul2021, when the patient was 63-year-old, for COVID-19 immunization; pfizer / biontech (Dose 1, single, vaccine location: Right arm), administration date: 20May2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2024, outcome "recovering" and all described as "I developed mild congestion and tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2024) Positive, notes: tested positive for  COVID. The patient started Paxlovid within a few hours on 24May2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many factors. The association between the event lack of effect (COVID-19) with COMIRNATY (2023-2024 FORMULA) can not be fully excluded.,Linked Report(s) : US-PFIZER INC-202400188273 same reporter/product/ patient, different dose/event;
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Feeling of despair, Head discomfort, Headache, Tinnitus
Clinical narrative: pressure in the head started; headache, pulse pounding in the head; Tinnitus; started losing balance; Feeling of despair; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 09Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, Batch/Lot No: EL3249, Location of injection: Arm Left), administration date: 20Jan2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "lost taste and smell", "lost taste and smell". The following information was reported: FEELING OF DESPAIR (non-serious) with onset 02Jan2022, outcome "unknown"; TINNITUS (non-serious) with onset 02Jan2022, outcome "not recovered"; HEADACHE (non-serious) with onset 02Jan2022, outcome "not recovered", described as "headache, pulse pounding in the head"; HEAD DISCOMFORT (non-serious) with onset 02Jan2022, outcome "not recovered", described as "pressure in the head started"; BALANCE DISORDER (non-serious) with onset 02Jan2022, outcome "not recovered", described as "started losing balance". The events "pressure in the head started", "headache, pulse pounding in the head", "tinnitus" and "started losing balance" required physician office visit. Therapeutic measures were taken as a result of head discomfort, headache, tinnitus, balance disorder.  Additional information: After the 3rd shot pressure in the head started, headache, pulse pounding in the head, Tinnitus and started losing balance. Patient was on his 4th Neurologist seeking help. He asked, "What help do you have for people that set in a darkened room and pray that their head explodes?" It was reported that the adverse events resulted in: Doctor or other healthcare professional office/clinic visit. Treatment was received for the events (10 different medications that did not work). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (no info on result).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400188430 same patient and product, different dose number (DOSE 1) and different event;
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost taste and smell; lost taste and smell; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3249) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Allergy". The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "not recovered" and all described as "lost taste and smell".  Additional information: The patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 2, single (Lot number: EN6201), in left arm for covid-19 immunisation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400188316 same patient and product, different dose number and different event;
Age: 61.0
Sex: F
Vaccine: DTAP
Symptoms: Antinuclear antibody positive, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: pain at injection site; swelling at injection site; induration at injection site; There was minimal redness; slight warmth; Initial information received on 01-Jun-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 61 years old female patient who experienced pain, swelling, induration at injection site, there was minimal redness and slight warmth after receiving Diphtheria, Tetanus and Acellular Pertussis vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Hypersensitivity.  On an unknown date in May 2024, the patient received an unknown dose of suspect Diphtheria, Tetanus and Acellular Pertussis vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry: not reported) via intramuscular route in the left upper arm as prophylactic vaccination (immunization). Information on batch number was requested.  On an unknown date in MAY-2024, the patient developed pain at injection site (vaccination site pain), swelling at injection site (vaccination site swelling), induration at injection site (vaccination site induration), there was minimal redness (vaccination site erythema) and slight warmth (vaccination site warmth) (latency: few days approximately) following the administration of Diphtheria and Tetanus and Acellular Pertussis vaccine.  Reportedly, Person received Tdap vaccination (brand unknown) 1-2 weeks earlier. Complained of pain, swelling, induration at injection site that still was present on the day of contact. Induration, swelling and pain had decreased but was still present on June 1st. Person had residual 2-3 cm indurated area on L upper arm. There was minimal redness and slight warmth.  Relevant laboratory test results included:  Antinuclear antibody - On an unknown date: Positive  Physical examination - On an unknown date:  [Person had residual 2-3 cm indurated area on L upper arm]  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for the events.
Age: 61.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: pain at injection site; swelling at injection site; induration at injection site; There was minimal redness; slight warmth; Initial information received on 01-Jun-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 61 years old female patient who experienced pain, swelling, induration at injection site, there was minimal redness and slight warmth after receiving Diphtheria, Tetanus and Acellular Pertussis vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Hypersensitivity.  On an unknown date in May 2024, the patient received an unknown dose of suspect Diphtheria, Tetanus and Acellular Pertussis vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry: not reported) via intramuscular route in the left upper arm as prophylactic vaccination (immunization). Information on batch number was requested.  On an unknown date in MAY-2024, the patient developed pain at injection site (vaccination site pain), swelling at injection site (vaccination site swelling), induration at injection site (vaccination site induration), there was minimal redness (vaccination site erythema) and slight warmth (vaccination site warmth) (latency: few days approximately) following the administration of Diphtheria and Tetanus and Acellular Pertussis vaccine.  Reportedly, Person received Tdap vaccination (brand unknown) 1-2 weeks earlier. Complained of pain, swelling, induration at injection site that still was present on the day of contact. Induration, swelling and pain had decreased but was still present on June 1st. Person had residual 2-3 cm indurated area on L upper arm. There was minimal redness and slight warmth.  Relevant laboratory test results included:  Antinuclear antibody - On an unknown date: Positive  Physical examination - On an unknown date:  [Person had residual 2-3 cm indurated area on L upper arm]  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for the events.