chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Incorrect dose administered, Product availability issue, Wrong product administered
Clinical narrative: An order for Infanrix (DTAP) was placed by PA-C on 8/10/23. The patient arrived with her father on 8/15/23. The medical assistant collected ordered vaccines including PCV13 and Hep A. The MA grabbed Adacel (Tdap) without realizing the difference between DTAP and TDAP. The correct vaccine, Infanrix (DTAP) was not available at the time of incident. The patient was brought into the medical lab with her father for vaccine administration. After administering one vaccine, the MA came to the provider for assistance administering the other two vaccines. The provider inadvertently administered Adacel (TDAP) to the patient's right deltoid while the patient sat on her father's lap. The MA was also present in the lab at time of administration. The vaccine was partially administered as some of the vaccine was left in the syringe upon the patient pulling away. The mistake was realized when documenting the vaccines in the chart. The refrigerator was checked for the correct vaccine at which time the correct vaccine was not available. The provider informed the parent that the incorrect vaccine was administered and that the patient will need subsequent doses to complete the DTAP  series. The parent and the provider agreed to administer the correct, needed vaccine at time of next visit after patient turns 4 years old.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV, MMRV
Symptoms: Incorrect dose administered, Injection site mass
Clinical narrative: 08/11/23 Patient was given a kinrix (which has Dtap and polio)and a IPV opposite legs.  patients parents were informed immediately and provider was informed and spoke with the mother about possible side effects and if needed ice to injection sites and tylenol for pain.   08/16/23 I spoke with mother and she states child had no adverse effects.  Was acting normal and small lumps under Kinrix site on left and proquad site on right.  Which is normal she states.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: Customer tolerated vaccination well (given at 1:30pm).  Advised customer to wait 15 minutes for observation and to inform Pharmacy any changes in condition. Customer drunk water during observation time. Customer complained of nausea and headache symptoms at 1:40 p.m. Had her wait additional time to monitor condition. Customer felt better after 2:21p.m. and left store with no further reactions.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix instead of Kinrix; 4 year old female kid received by error Boostrix instead of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number J7749, expiry date 03-NOV-2024) for prophylaxis.   Previously administered products included Dtap (previously patient had 4 Dtap the last one was taken 1 year and 8 months ago).   On 04-AUG-2023, the patient received Boostrix. On 04-AUG-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix instead of Kinrix) and inappropriate age at vaccine administration (Verbatim: 4 year old female kid received by error Boostrix instead of Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 08-AUG-2023 The patient received Boostrix instead of Kinrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.            The reporter consented to follow up via email.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Product storage error, Wrong product administered
Clinical narrative: Product storage error; Bexsero instead of Menquadfi; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number E74MY, expiry date 31-JUL-2024) for prophylaxis.   On 08-AUG-2023, the patient received Bexsero. On 08-AUG-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero instead of Menquadfi). On an unknown date, the patient experienced product storage error (Verbatim: Product storage error). The outcome of the wrong vaccine administered and product storage error were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 08-Aug-2023 The healthcare professional called to inform that a prefilled syringe was activated (needle attached) on 25th July 2023 and such dose was administered until 08th August 2023 to a patient, which led to product storage error. The caller stated that such patient should had received Menquadfi instead of Bexsero, which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hallucination, Incomplete course of vaccination, Malaise
Clinical narrative: not feeling well and went home and went straight to bed.; will now have her second dose of Shingrix administered; Later that night she started hallucinating and saw two different people; This serious case was reported by a consumer via call center representative and described the occurrence of hallucination in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In DEC-2022, the patient received the 1st dose of Shingrix. In DEC-2022, not applicable after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced hallucination (Verbatim: Later that night she started hallucinating and saw two different people) (serious criteria GSK medically significant). On an unknown date, the patient experienced feeling unwell (Verbatim: not feeling well and went home and went straight to bed.) and incomplete course of vaccination (Verbatim: will now have her second dose of Shingrix administered). The outcome of the hallucination and feeling unwell were not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the hallucination and feeling unwell to be related to Shingrix.     It was unknown if the company considered the hallucination and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt date: 08-AUG-2023 The reporter was the patient. The patient went home and went straight to bed. The patient reported later that night she started hallucinating and saw two different people. The patient states she lives alone. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 43.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose August 9th 2023; 2nd dose in their facility on June 2023; 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 a 43-year-old male patient who received HBV (Engerix B) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 09-AUG-2023, the patient received the 3rd dose of Engerix B. In JUN-2023, the patient received the 2nd dose of Engerix B. In JUN-2023, not applicable after receiving Engerix B, an unknown time after receiving Engerix B and an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose in their facility on June 2023). On 09-AUG-2023, the patient experienced drug dose administration interval too short (Verbatim: 3rd dose August 9th 2023). The outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 09-AUG-2023 The reporter reported on reporting day that patient was administered Engerix B. The reporter reported that first dose was administered in unknown facility and the second dose in their facility. The reporter asked question that should the 3rd dose be repeated. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. The patient received 2nd dose of Engerix-B, later than the recommended interval, which led to lengthening of vaccinations schedule. The patient received 3rd dose of Engerix-B vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient not received the 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 adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 4th November 2022 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: Patient not received the 2nd dose.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 09-AUG-2023 The patient self-reported this case. The patient reported that he got the first shot at a pharmacy that was referred by his doctor. The patient asked about insurance coverage and locations where Shingrix was administered. One organization advised them, they could only go to his doctor to get the second shot. Not to a pharmacy. Per policy.  They paid for first shot because they advised the patient wrong the first time, according to them.  The patient stated that his doctor did not carry the shot, so he had not gotten the second shot as of this date and the organization stated the patient could not go to a pharmacy to get the shot.  Today their doctor handed them a coupon/advertisement to go to their local pharmacy.  The reporter did not think this was going to work. The reporter wanted to know what he should do. Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the liquid portion of Menveo to a patient; Administered only the liquid portion of Menveo to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA938A, expiry date 31-JUL-2024) for prophylaxis.   On 08-AUG-2023, the patient received Menveo. On 08-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administered only the liquid portion of Menveo to a patient) and inappropriate dose of vaccine administered (Verbatim: Administered only the liquid portion of Menveo to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt Date: 09-AUG-2023 The reporter reported that she administered only liquid portion of Menveo vaccine to the patient, 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 did consent to follow up via postal.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero exposed to RT 22 C (72 F) for 53 hrs, 12 min and administered to a patient; 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 a 17-year-old female patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis.   On 04-AUG-2023, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero exposed to RT 22 C (72 F) for 53 hrs, 12 min and administered to a patient). The outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 10-Aug-2023 Clinical director assistant stated that Bexsero dose was exposed to room temperature 22 C (72 F) for 53 hours, 12 min and administered to a patient. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up via email. The patient received a dose of Bexsero after temperature excursion, which led to incorrect storage of drug.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold sores in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 10-AUG-2023, 1 days after receiving Shingrix, the patient experienced cold sores (Verbatim: cold sore). The outcome of the cold sores was not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.     It was unknown if the company considered the cold sores to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-AUG-2023 The patient self-reported this case. She inquired if she could use Valtrex for the cold sore after the vaccine. She was concerned about a potential interaction. The reporter did not consent to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Overdose
Clinical narrative: patient received 1 dose on Kinrix vaccine in the AM and a 2nd dose of Kinrix in the afternoon.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number SAY2J, expiry date 10-JUN-2024) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS TOXOID, POLIO VACCINE, TETANUS VACCINE TOXOID (KINRIX).   On 07-AUG-2023, the patient received the 2nd dose of Kinrix (intramuscular). On 07-AUG-2023, an unknown time after receiving Kinrix, the patient experienced overdose (Verbatim: patient received 1 dose on Kinrix vaccine in the AM and a 2nd dose of Kinrix in the afternoon.). The outcome of the overdose was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 10-AUG-2023 The reporter reported that the patient received 1st dose of Kinrix vaccine in AM and 2nd dose of Kinrix in the afternoon of the same day. The reporter did consent to follow up. The reporter reported that the patient received 2 doses of Kinrix on same day, which led to overdose.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the 2nd 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 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In October 2020, received first 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: never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 10-AUG-2023 The reporter reported that the patient never got the 2nd dose of Shingrix  after receiving the 1st dose. The reporter did consent to follow up via email. The reporter reported that till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which lead to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vial of Menveo mixed with "generic diluent".; Vial of Menveo mixed with "generic diluent".; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Vial of Menveo mixed with "generic diluent". ) and inappropriate dose of vaccine administered (Verbatim: Vial of Menveo mixed with "generic diluent".). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-AUG-2023 The reporter stated that vial of Menveo was mixed with generic diluent. The vaccine administration facility is the same as primary reporter. No other adverse event (AE) details available.  The patient received Menveo which was mixed with generic diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication information were provided. Patient had COVID-19 disease by the end of Oct2022 after receiving COVID-19 vaccine on 22Sep2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-735421 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735421:Patient 1
Age: 0.75
Sex: U
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: administered 0.2ml of the Moderna bivalent vaccine to a peaditric patient of 9 months old who had never been vaccinated before; no adverse event; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (administered 0.2ml of the Moderna bivalent vaccine to a pediatric patient of 9 months old who had never been vaccinated before) and NO ADVERSE EVENT (no adverse event) in a 9-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (administered 0.2ml of the Moderna bivalent vaccine to a pediatric patient of 9 months old who had never been vaccinated before) and NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (administered 0.2ml of the Moderna bivalent vaccine to a pediatric patient of 9 months old who had never been vaccinated before) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (administered 0.2ml of the Moderna bivalent vaccine to a pediatric patient of 9 months old who had never been vaccinated before).    No concomitant medication was reported.  No treatment medication was reported.   Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Pericarditis, SARS-CoV-2 test
Clinical narrative: Pericarditis; Covid-19; This spontaneous case was reported by a patient and describes the occurrence of PERICARDITIS (Pericarditis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral use) from 02-May-2023 to 07-May-2023 for COVID-19 treatment, at a dose of UNK, bid. On 19-May-2023, COVID-19 (Covid-19) had resolved. At the time of the report, PERICARDITIS (Pericarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2023, SARS-CoV-2 test: Positive. On 19-May-2023, SARS-CoV-2 test: Negative.         Concomitant medication was not reported.  Patient started taking Paxlovid and felt better. Then on 11-May-2023 patient became very ill again for seven days and developed pink eye in right eye and stated covid-19 rebound. On 19-May-2023, patient felt better. It was reported patient had pericarditis symptoms after Moderna doses and thought it was a heart attack and went to ER. It was reported that patient didn't receive Pfizer vaccine.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of Pericarditis and non-serious event of Pericarditis and the non-serious event of COVID-19. The event pericarditis is reported in relationship with the administration of mRNA-1273 vaccine. The patient received three doses in a correct schedule. About 2 years later, the patient had COVID-19 and was treated with Paxlovid. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2023: Significant follow-up received: Suspect drug and events were updated.
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram head, Echocardiogram, Magnetic resonance imaging, Thrombosis
Clinical narrative: Thrombosis Development After mRNA COVID-19 Vaccine Administration: A Case Series; This is a literature report.  A 40-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Thrombosis Development After mRNA COVID-19 Vaccine Administration: A Case Series". The patient underwent the following laboratory tests and procedures: White blood cell count: 12.9 x103, notes: 12.9 x103 uL (Ref: 4.4-11.0 x103 uL); Computerised tomogram head: showed no signs of an acute bleed; Magnetic resonance imaging: bilateral thalamic ischemic infarcts; Echocardiogram: showed an intracardiac shunt with patent foramen o; Angiogram: multiple pulmonary emboli in the right lung; Ultrasound testes: a right brachial vein deep vein thrombosis. Therapeutic measures were taken as a result of thrombosis.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202300137572 Same article/drug/event or different patient;
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound testes, White blood cell count
Clinical narrative: Thrombosis Development After mRNA COVID-19 Vaccine Administration: A Case Series; This is a literature report.  A 40-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Thrombosis Development After mRNA COVID-19 Vaccine Administration: A Case Series". The patient underwent the following laboratory tests and procedures: White blood cell count: 12.9 x103, notes: 12.9 x103 uL (Ref: 4.4-11.0 x103 uL); Computerised tomogram head: showed no signs of an acute bleed; Magnetic resonance imaging: bilateral thalamic ischemic infarcts; Echocardiogram: showed an intracardiac shunt with patent foramen o; Angiogram: multiple pulmonary emboli in the right lung; Ultrasound testes: a right brachial vein deep vein thrombosis. Therapeutic measures were taken as a result of thrombosis.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202300137572 Same article/drug/event or different patient;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Psoriasis, Rash erythematous, SARS-CoV-2 test
Clinical narrative: Psoriasis; red rash; burning stinging; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obstuctive Sleep Apnea" (unspecified if ongoing); "Anti-Body Thyroid Disease" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "severe pain" (unspecified if ongoing), notes: Jan2021 /Feb2021. The patient took concomitant medications which included thyroid medications and a statin. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, lot number: EW0172, vaccine location: Right arm), administration date: 24Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "patch of discolored skin on right ankle area/left lower leg area"; BNT162b2 (DOSE 1, SINGLE, lot number: ER8737,, vaccine location: Right arm), administration date: 02Apr2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: PSORIASIS (disability) with onset 2021, outcome "not recovered"; PAIN (disability) with onset 2021, outcome "not recovered", described as "burning stinging"; RASH ERYTHEMATOUS (disability) with onset 2021, outcome "not recovered", described as "red rash". The events "psoriasis", "red rash" and "burning stinging" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Negative. Therapeutic measures were taken as a result of psoriasis, rash erythematous, pain which included ointments, steroid shots, photo light therapy.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30May2023 as dose 6 (booster), single (Lot number: GJ3270) at the age of 76 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing); "Elevated cholesterol" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: LEVOTHYROXINE, start date: Oct1988. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered with sequelae" (2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ritonavir (PAXLOVID: Lot Number: 1925343A) from 04Aug2023 to 09Aug2023.
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: pulmonary problems; 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 73-year-old female patient received BNT162b2 (BNT162B2), on 08Sep2021 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: LUNG DISORDER (hospitalization) with onset 2022, outcome "unknown", described as "pulmonary problems". The patient was hospitalized for lung disorder (start date: 2022). The event "pulmonary problems" required emergency room visit.  Additional information: The patient stated she was supposed to have booster doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022. However, she had pulmonary problems and other health problems during 2022 and early 2023; she was hospitalized 5 times and wasn't able to get her boosters shots. She was in urgent care in Mar2023.  The last dose she received was on 08Sep2021. She wanted to know if she should receive a dose of the Bivalent vaccine.  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: Death
Clinical narrative: 7 people had  died from Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly (reported as "50-99" and "Age Group: Elderly (greater than equal to 65 years)") male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "7 people had  died from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Age + years/months/days: 50-99. Age Group: Elderly (greater than equal to 65 years). Moderna has proven to be effective against COVID-19; Pfizer is not that effective when the reporter first heard about it. 7 people had died from Pfizer; So that made a change in mind about taking Moderna. Plus, the Primary Care doctor suggested Moderna based of these stories that the reporter heard. The reporter considers the event as caused by the suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300139954 Same reporter/event/drug, different patient;; Reported Cause(s) of Death: 7 people had  died from Pfizer
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 7 people had died from Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly (reported as "50-99" and "Age Group: Elderly (greater than equal to 65 years)") male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "7 people had died from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Age + years/months/days: 50-99. Age Group: Elderly (greater than equal to 65 years). Moderna has proven to be effective against COVID-19; Pfizer is not that effective when the reporter first heard about it. 7 people had died from Pfizer; So that made a change in mind about taking Moderna. Plus, the Primary Care doctor suggested Moderna based of these stories that the reporter heard. The reporter considers the event as caused by the suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300139954 Same reporter/event/drug, different patient;; Reported Cause(s) of Death: 7 people had died from Pfizer
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 7 people had died from Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An elderly (reported as "50-99" and "Age Group: Elderly (greater than equal to 65 years)") male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "7 people had died from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Age + years/months/days: 50-99. Age Group: Elderly (greater than equal to 65 years). Moderna has proven to be effective against COVID-19; Pfizer is not that effective when the reporter first heard about it. 7 people had died from Pfizer; So that made a change in mind about taking Moderna. Plus, the Primary Care doctor suggested Moderna based of these stories that the reporter heard. The reporter considers the event as caused by the suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300139954 Same reporter/event/drug, different patient;; Reported Cause(s) of Death: 7 people had died from Pfizer
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 7 people had  died from Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An elderly (reported as "50-99" and "Age Group: Elderly (greater than equal to 65 years)") male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "7 people had  died from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Age + years/months/days: 50-99. Age Group: Elderly (greater than equal to 65 years). Moderna has proven to be effective against COVID-19; Pfizer is not that effective when the reporter first heard about it. 7 people had died from Pfizer; So that made a change in mind about taking Moderna. Plus, the Primary Care doctor suggested Moderna based of these stories that the reporter heard. The reporter considers the event as caused by the suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300139954 Same reporter/event/drug, different patient;; Reported Cause(s) of Death: 7 people had  died from Pfizer
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dose 1/Dose 2/ Dose 3: Pfizer / BioNTech; Dose 4: Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex sensitivity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1/Dose 2/ Dose 3: Pfizer / BioNTech; Dose 4: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive, notes: initial positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was so grateful she was able to get paxlovid while abroad in France. She tested negative on day 5 of treatment and remained negative (have been testing for rebound) until today, one week after completing the course, and 13 days after her initial positive test. So far she just had cold symptoms. When she first tested positive she had a very unpleasant sore throat, fatigue, lack of appetite, mild fever, and beginnings of a painful cough. Paxlovid stopped all of those things.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Illness
Clinical narrative: Very sick/keeps getting sick; Power level low and limited/no strength; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 at 14:00 as dose 2, single (Lot number: FH8020) at the age of 36 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "he is allergic to PCN" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose on 04Oct2021. lot FF2589, got it on arm at approximately 2pm.), administration date: 04Oct2021, when the patient was 36-year-old, for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "Power level low and limited/no strength"; ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "Very sick/keeps getting sick". Therapeutic measures were taken as a result of illness.  Additional information: Was never sick and didn't get Covid 19 before. Got them 1.5-2 years after pandemic because of jobs forcing into vaccination shot. He was worried about losing job. Now aftermath, he wasn't in danger of losing his job. Was completely abused by work making him get vaccination shot. Ever since taking vaccination keeps getting sick. His level of power is not all the way there since he was vaccinated. Got Covid 19 he thinks 3 weeks after vaccinated like 2-3 times. Went to color to get tested and tested positive for Covid 19 directly 3 weeks after 2nd dose. Very sick after that. Has got Covid 19 on record 2 times. Keeps getting sick. Hasn't gotten power back, no strength after vaccinated. Power level low and limited. Noted after Covid 19 twice. Severely sick since 2nd dose. Didn't go back for booster. Severely sick. Scared of getting more shots or boosters. Worked through pandemic and never got vaccinated for couple years or 1-1.5 years, right after he got vaccinated has been ill since. He is very healthy might take Tylenol or Robitussin if sick but very healthy.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Very sick/keeps getting sick; Power level low and limited/no strength; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 at 14:00 as dose 2, single (Lot number: FH8020) at the age of 36 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "he is allergic to PCN" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose on 04Oct2021. lot FF2589, got it on arm at approximately 2pm.), administration date: 04Oct2021, when the patient was 36-year-old, for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "Power level low and limited/no strength"; ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "Very sick/keeps getting sick". Therapeutic measures were taken as a result of illness.  Additional information: Was never sick and didn't get Covid 19 before. Got them 1.5-2 years after pandemic because of jobs forcing into vaccination shot. He was worried about losing job. Now aftermath, he wasn't in danger of losing his job. Was completely abused by work making him get vaccination shot. Ever since taking vaccination keeps getting sick. His level of power is not all the way there since he was vaccinated. Got Covid 19 he thinks 3 weeks after vaccinated like 2-3 times. Went to color to get tested and tested positive for Covid 19 directly 3 weeks after 2nd dose. Very sick after that. Has got Covid 19 on record 2 times. Keeps getting sick. Hasn't gotten power back, no strength after vaccinated. Power level low and limited. Noted after Covid 19 twice. Severely sick since 2nd dose. Didn't go back for booster. Severely sick. Scared of getting more shots or boosters. Worked through pandemic and never got vaccinated for couple years or 1-1.5 years, right after he got vaccinated has been ill since. He is very healthy might take Tylenol or Robitussin if sick but very healthy.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Illness
Clinical narrative: tested positive for COVID-19 directly 3 weeks after 2nd dose/got COVID-19 on record 2 times; tested positive for COVID-19 directly 3 weeks after 2nd dose/got COVID-19 on record 2 times; 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 04Oct2021 at 14:00 as dose 1, single (Lot number: FF2589), in arm and on 25Oct2021 at 14:00 as dose 2, single (Lot number: FH8020) at the age of 36 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "allergic to PCN" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "tested positive for COVID-19 directly 3 weeks after 2nd dose/got COVID-19 on record 2 times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2021) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient wanted to report experience with Pfizer vaccine shot. After got vaccinated, he got COVID-19 several times. Ever since taking vaccination keeps getting sick. He was never sick and didn't get COVID-19 before. Got them 1.5-2 years after pandemic because of jobs forcing into vaccination shot. He was worried about losing job. Now aftermath, he wasn't in danger of losing his job. Was completely abused by work making him get vaccination shot. Continues to be sick. His level of power is not all the way there since he was vaccinated. Anything he can do or paperwork to fill out to make this on report. Got COVID-19 he thinks 3 weeks after vaccinated like 2-3 times. Went to get tested and tested positive for COVID-19 directly 3 weeks after 2nd dose. Very sick after that. Has got COVID-19 on record 2 times. Keeps getting sick. Hasn't gotten power back, no strength after vaccinated. Power level low and limited. Noted after COVID-19 twice. Severely sick since 2nd dose. Didn't go back for booster. Scared of getting more shots or boosters. Worked through pandemic and never got vaccinated for couple years or 1-1.5 years, right after he got vaccinated has been ill since. He is very healthy might take Tylenol or Robitussin if sick but very healthy. The patient did not get vaccinated or did not have medication before any of this.