chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Movement disorder, Pain in extremity
Clinical narrative: The patient experienced a very sore arm the day after the injection.; She mentioned that it was very hard to move her arm. She continues to move it and gets getting better.; Feels like she has a big bruise on the arm.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Jan2022 (Lot number: unknown) as dose 1, single for COVID-19 immunisation. It was unknown whether the patient had any relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Jan2022, outcome "recovering", described as "The patient experienced a very sore arm the day after the injection"; MOVEMENT DISORDER (non-serious) with onset 07Jan2022, outcome "recovering", described as "She mentioned that it was very hard to move her arm. She continues to move it and gets getting better"; CONTUSION (non-serious) with onset 07Jan2022, outcome "recovering", described as "Feels like she has a big bruise on the arm". Therapeutic measures were not taken as a result of pain in extremity, movement disorder and contusion.  Additional Information: It was unknown whether the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: showing symptoms of COVID-19; showing symptoms of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Exposed to COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "showing symptoms of COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results. Clinical course: The reporter had the primary series and a booster dose of the Pfizer COVID-19 vaccine. She recently tested positive for COVID-19 and her daughters (includes the patient) were exposed to COVID-19 after they received their first dose of the Pfizer COVID-19 vaccine pediatric formulation. Both of her daughters are showing symptoms of COVID-19 and they have been tested but have not received their test results yet. The patient was scheduled to take the second dose at the time of report.  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-202200027211 same reporter, different patient, same product, same events; US-PFIZER INC-202200027212 same reporter, different patient, same product, similar events
Sex: M
Vaccine: COVID19
Symptoms: Asthma, SARS-CoV-2 antibody test
Clinical narrative: Asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 11 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 11 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "Asthma". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: What happens with the kids that were part of the clinical trial when it has been 6 months after their last dose, Caller agreed to transfer to, but disconnected during hold. E-transmitting possible duplicate AE info. Consumer states that here 11 year old son was participating in the Pfizer clinical trials for the COVID 19 vaccine. It has been more than 6 months since his last dose. We did an antibody test and his levels are declining. He has asthma. Response was received that Per VR, referred caller to the clinical trial investigator that they have been working with. No information at . The reporter stating the events as non serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for Covid on 26Dec2021; I tested positive for Covid on 26Dec2021; dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Nov2021 09:30 (Lot number: EW0217) at the age of 54 years as dose 3 (booster), single, administered in arm left, administration date 16Mar2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 24Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "dose_number=3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovered" and all described as "I tested positive for Covid on 26Dec2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19,vaccination failure, booster.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysphagia, Head discomfort, Investigation, Malaise
Clinical narrative: vaginal bleeding; felt head pressure; swallowing issues; felt terrible; pain in her right thigh, arm and knee; pain in her right thigh, arm and knee; pain in her right thigh, arm and knee; lost 20 pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: VAGINAL HAEMORRHAGE (medically significant), outcome "unknown", described as "vaginal bleeding"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "felt head pressure"; DYSPHAGIA (non-serious), outcome "unknown", described as "swallowing issues"; MALAISE (non-serious), outcome "unknown", described as "felt terrible"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "pain in her right thigh, arm and knee"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 20 pounds". The patient underwent the following laboratory tests and procedures: investigation: everything was negative; weight: lost 20 pounds. It was reported that, she got the call from (withheld) in patient assistance program CEP 5570. The caller was a consumer who according to DSU agent stated that, after her second dose of the Pfizer BioNTech COVID-19 vaccine she felt terrible for about four months, she had vaginal bleeding, pain in her right thigh, arm and knee, lost 20 pounds, she felt head pressure and had swallowing issues. Stated that, she got follow up testing and everything was negative. She was due for her booster dose and her doctor told her to hold off, she was nervous to get it because of all that she experienced after her second dose. Asked whether they had additional reports of this side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaginal haemorrhage, Weight, Weight decreased
Clinical narrative: vaginal bleeding; felt head pressure; swallowing issues; felt terrible; pain in her right thigh, arm and knee; pain in her right thigh, arm and knee; pain in her right thigh, arm and knee; lost 20 pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: VAGINAL HAEMORRHAGE (medically significant), outcome "unknown", described as "vaginal bleeding"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "felt head pressure"; DYSPHAGIA (non-serious), outcome "unknown", described as "swallowing issues"; MALAISE (non-serious), outcome "unknown", described as "felt terrible"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "pain in her right thigh, arm and knee"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 20 pounds". The patient underwent the following laboratory tests and procedures: investigation: everything was negative; weight: lost 20 pounds. It was reported that, she got the call from (withheld) in patient assistance program CEP 5570. The caller was a consumer who according to DSU agent stated that, after her second dose of the Pfizer BioNTech COVID-19 vaccine she felt terrible for about four months, she had vaginal bleeding, pain in her right thigh, arm and knee, lost 20 pounds, she felt head pressure and had swallowing issues. Stated that, she got follow up testing and everything was negative. She was due for her booster dose and her doctor told her to hold off, she was nervous to get it because of all that she experienced after her second dose. Asked whether they had additional reports of this side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lower limb fracture
Clinical narrative: She broke her leg severely in September; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, for COVID-19 immunization. The following information was reported: LOWER LIMB FRACTURE (medically significant) with onset Sep2021, outcome "unknown", described as "She broke her leg severely in September". Therapeutic measures were taken as a result of lower limb fracture. Patient was taking a muscle relaxer, VALIUM, and gabapentin for her leg. She stated she has not had a reaction in the past so she was not sure if she should take those medications that day. She asked if they should apply heat or cold to it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Herpes simplex, Hypersensitivity, Immunisation
Clinical narrative: Agressive cold sore; herpes simplex; Covid arm; Chills; Nausea; Headache; Dose received: 3; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 05Jan2022 at 17:45 (Lot number: 33036BD)at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Cold sores" (unspecified if ongoing), notes: History of cold dore (last one 1 year ago). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number:EN6201, Anatomical Location: Right arm, Administration Time: 13:00, Route of Administration: Unspecified), administration date: 19Mar2021, when the patient was 48 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8734, Anatomical Location: Right arm, Administration Time: 14:00, Route of Administration: Unspecified), administration date: 09Apr2021, when the patient was 48 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 at 17:45, outcome "unknown", described as "Dose received: 3"; ORAL HERPES (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Agressive cold sore"; HERPES SIMPLEX (non-serious) with onset 07Jan2022 , outcome "not recovered", described as "herpes simplex"; HYPERSENSITIVITY (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Covid arm"; CHILLS (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Chills"; NAUSEA (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of oral herpes, herpes simplex, hypersensitivity, chills, nausea and headache.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received Valacyclovir as the treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral herpes
Clinical narrative: Agressive cold sore; herpes simplex; Covid arm; Chills; Nausea; Headache; Dose received: 3; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 05Jan2022 at 17:45 (Lot number: 33036BD)at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Cold sores" (unspecified if ongoing), notes: History of cold dore (last one 1 year ago). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number:EN6201, Anatomical Location: Right arm, Administration Time: 13:00, Route of Administration: Unspecified), administration date: 19Mar2021, when the patient was 48 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8734, Anatomical Location: Right arm, Administration Time: 14:00, Route of Administration: Unspecified), administration date: 09Apr2021, when the patient was 48 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 at 17:45, outcome "unknown", described as "Dose received: 3"; ORAL HERPES (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Agressive cold sore"; HERPES SIMPLEX (non-serious) with onset 07Jan2022 , outcome "not recovered", described as "herpes simplex"; HYPERSENSITIVITY (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Covid arm"; CHILLS (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Chills"; NAUSEA (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of oral herpes, herpes simplex, hypersensitivity, chills, nausea and headache.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received Valacyclovir as the treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19.
Age: 28.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Immunisation, Product use issue, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID-19 after vaccination; Contracted COVID-19 after vaccination; dose number=3; other vaccine same date product=Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Lot number: 301558A) at the age of 28 years as dose 3 (booster), single, administration date 18Mar2021 (Lot number: ER2613) as dose 2, single and administration date 25Feb2021 (Lot number: EN6200) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administration date 06Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included: "Asthma" (unspecified if ongoing); "overweight" (unspecified if ongoing); "known allergies Sulfa based medications" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUPROPION received within two weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant) with onset 31Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 31Dec2021, outcome "recovering" and all described as "Contracted COVID-19 after vaccination"; IMMUNISATION (non-serious) with onset 06Oct2021, outcome "unknown", described as "dose number=3"; PRODUCT USE ISSUE (non-serious) with onset 06Oct2021, outcome "unknown", described as "other vaccine same date product=Flu". Awareness Date was 31Dec2021. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) unknown results, notes: Nasal Swab covid test result=Pending; (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Pain, Pain assessment, Pain in extremity
Clinical narrative: Dose received: 3; My cousin let me know that she had itchiness on both forearms (gone the second day); Pain on the left arm and left armpit; Pain on the left arm and left armpit; Also had left body ache; This is a spontaneous report from a contactable reporter (consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 07Jan2022 at 13:00 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were reported as unknown. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 13:00, outcome "unknown", described as "Dose received: 3"; PRURITUS (non-serious) with onset 07Jan2022, outcome "recovered" (08Jan2022), described as "My cousin let me know that she had itchiness on both forearms (gone the second day)"; PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious), all with onset 07Jan2022, outcome "recovering", and all described as "Pain on the left arm and left armpit"; PAIN (non-serious) with onset 07Jan2022, outcome "recovering", described as "Also had left body ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, pain in extremity, axillary pain and pain.  Additional Information: It was unknown, whether the patient had any known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported pain level about 5 on a scale of 1-10. Less pain on the 3rd day (09Jan2022). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Dose received: 3; My cousin let me know that she had itchiness on both forearms (gone the second day); Pain on the left arm and left armpit; Pain on the left arm and left armpit; Also had left body ache; This is a spontaneous report from a contactable reporter (consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 07Jan2022 at 13:00 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were reported as unknown. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 13:00, outcome "unknown", described as "Dose received: 3"; PRURITUS (non-serious) with onset 07Jan2022, outcome "recovered" (08Jan2022), described as "My cousin let me know that she had itchiness on both forearms (gone the second day)"; PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious), all with onset 07Jan2022, outcome "recovering", and all described as "Pain on the left arm and left armpit"; PAIN (non-serious) with onset 07Jan2022, outcome "recovering", described as "Also had left body ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, pain in extremity, axillary pain and pain.  Additional Information: It was unknown, whether the patient had any known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported pain level about 5 on a scale of 1-10. Less pain on the 3rd day (09Jan2022). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had Covid; had Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "wrestles with anxiety" (unspecified if ongoing), notes: other medical history: wrestles with anxiety, otherwise unknown. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "had Covid". Clinical comment: It was unknown if patient received any other vaccine in four weeks or took any other medications in two weeks. Adverse events: (Withheld) said on Thursday evening that they had Covid. They did not provide other details. Likely took a test to confirm but did not explicitly say so. Age 23 or 24 years old, and do not believe pregnant but cannot confirm. Not sure dates of vaccination for each dose, but individual was a nurse so likely had access earlier. May have had at least two doses by June, but cannot confirm. Cannot remember which vaccine received, but believe could have been Pfizer from when originally told me (at least for first two doses). It is unknown if patient had covid prior vaccination. Known allergies: Unknown. Had told individual that they started not feeling well prior to an event that was held on 02Jan2022-03Jan2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information provided, a causal association between reported events drug ineffective, covid-19 and the suspect BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pain, Vaccination site pain
Clinical narrative: booster; having minor body aches and pains; minor injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- Unknown, dose 1, single), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN (non-serious), outcome "unknown", described as "having minor body aches and pains"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "minor injection site pain".  Additional information: It was reported that, the patient having minor body aches and pains along with minor injection site pain after administration of Pfizer Covid 19 booster. Stated that, the events took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Polymerase chain reaction, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient developed positive covid (confirmed by symptoms: Sore throat, headache, overall weakness); Patient developed positive covid (confirmed by symptoms: Sore throat, headache, overall weakness); booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 61 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Nov2021 (Lot number: FH8028) at the age of 61 years as dose 3, (booster) single, intramuscular, administration date 04Feb2021 08:15 (Lot number: EL0140) as dose 1, single and administration date 25Feb2021 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cochlea implant" (unspecified if ongoing). Concomitant medication(s) included: MOTRIN [IBUPROFEN]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: IMMUNISATION (medically significant) with onset 09Nov2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 06Jan2022, outcome "not recovered", COVID-19 (medically significant) with onset 06Jan2022, outcome "not recovered" and all described as "Patient developed positive covid (confirmed by symptoms: Sore throat, headache, overall weakness)". Clinical course details: Patient developed positive Covid-19 (2 home tests confirmed by symptoms. Had a PCR test 07Jan2022. Sore throat, headache, overall weakness for first 2 days. The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (07Jan2022) unknown results, notes: Covid test type post vaccination: Nasal Swab; sars-cov-2 test: (06Jan2022) positive, notes: home tests; (06Jan2022) positive, notes: home tests. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Pyrexia, Vaccination site swelling
Clinical narrative: booster of vaccine; injection site swelling; muscle aches in arm pit area and across chest; feverish symptoms; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster of vaccine"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "injection site swelling"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches in arm pit area and across chest"; PYREXIA (non-serious), outcome "unknown", described as "feverish symptoms". Additional information: Patient was healthy. Symptoms include injection site swelling, muscle aches in arm pit area and across chest, and feverish symptoms 12 hours after taking 3rd booster of vaccine. Event took place after use of product. No underlying conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: I have a son in law who took the Vaccine and almost died from it; This is a spontaneous report received from contactable Consumer or other non HCP for a Pfizer sponsored program (149602).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant, life threatening), outcome "unknown", described as "I have a son in law who took the Vaccine and almost died from it".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Female developed symptoms and then tested positive for Covid-19 despite having 3 shots of the vaccine.; Female developed symptoms and then tested positive for Covid-19 despite having 3 shots of the vaccine.; Female developed symptoms and then tested positive for Covid-19 despite having 3 shots of the vaccine.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative and product quality group.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: On a medication for high blood pressure; "Cholesterol" (unspecified if ongoing), notes: Maybe on something for cholesterol. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Female developed symptoms and then tested positive for Covid-19 despite having 3 shots of the vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The patient was fairly healthy overall. She has had a mild case and has not needed to go to the hospital. The event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Injection site pain, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from a sales representative. A 13-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: MULTIVITAMIN [VITAMINS NOS]. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID-19 Vaccine booster dose"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site"; PYREXIA (non-serious), outcome "recovered", described as "mild fever"; MALAISE (non-serious), outcome "unknown", described as "general malaise". Therapeutic measures were taken as a result of pyrexia. The lot number for bnt162b2 was not provided and will be requested during follow up. Additional information: The patient was 98 lbs. and 5 ft 4in. The patient experienced some expected side effects from her booster dose, pain at the injection site, mild fever, and general malaise. Treated fever with Advil and it resolved. The patient was a healthy 13-year-old with no underlying conditions. She takes a daily multivitamin (when she remembers). Event took place after use of product.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Home AG-Positive; Home AG-Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Jan2021 (Lot number: EL3247) as dose 2, single and administration date 05Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "Home AG-Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) negative, notes: covid test type post vaccination=Other; (06Jan2022) positive, notes: covid test type post vaccination=Other. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: the patient never got booster but was exposed to someone on 25Dec2021 who was positive COVID and then she developed cough on 30Dec2021, tested neg Ag Home test and then continued to cough and tested on 06Jan2022 mild HA and cough.The patient was not diagnosed with COVID-19 prior to vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Peripheral swelling, Swelling
Clinical narrative: This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 05Jan2022 at 13:15 (Lot number: unknown) at the age of 64 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: high blood pressure; "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? : Yes. The patient received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6208, Anatomical site: Left arm, Administration time: 13:15, Route of administration: Unspecified), administration date: 16Mar2021, when the patient was 63 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EN6206, Anatomical site: Left arm, Administration time: 12:15, Route of administration: Unspecified), administration date: 06Apr2021, when the patient was 63 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 at 13:15, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 07Jan2022 at 08:00, outcome "not recovered", and all described as "Swelling underarm and below arm where shot was given". Therapeutic measures were not taken as a result of swelling and peripheral swelling. Additional information:  Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough Covid-19 infection: at least 5 symptoms including high grade fever; Breakthrough Covid-19 infection: at least 5 symptoms including high grade fever; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 24-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 28May2021 17:00 (Batch/Lot number: unknown) at the age of 24 years as dose 2, single and intramuscular, administration date 07May2021 17:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported that the patient had breakthrough Covid-19 infection at least 5 symptoms including high grade fever (medically significant) with onset of 03Jan2022 at 20:00 and outcome of recovering. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: Nasal Swab (NAAT). Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: the patient did not receive other vaccines in the last four weeks. The patient was not diagnosed with covid-19 prior to vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Heart rate, Heart rate increased
Clinical narrative: Dose received: 3; Largely Swollen lymph nodes under left arm; Elevated heart rate; Chills; Bad back pain; Muscle aches; Fever; Headache; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 16-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 07Jan2022 at 12:00 (Lot number: FJ8762) at the age of 16 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". The patient did not take any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0173, Route of Administration: unspecified, Anatomical site: Left Arm), administration date: 13May2021, when the patient was 15 year(s) old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0191, Route of Administration: unspecified, Anatomical site: Left Arm), administration date: 03Jun2021, when the patient was 15 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 12:00, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset 07Jan2022, outcome "recovering", described as "Largely Swollen lymph nodes under left arm"; HEART RATE INCREASED (non-serious) with onset 07Jan2022, outcome "recovering", described as "Elevated heart rate"; CHILLS (non-serious) with onset 07Jan2022, outcome "recovering", described as "Chills"; BACK PAIN (non-serious) with onset 07Jan2022, outcome "recovering", described as "Bad back pain"; MYALGIA (non-serious) with onset 07Jan2022, outcome "recovering", described as "Muscle aches"; PYREXIA (non-serious) with onset 07Jan2022, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 07Jan2022, outcome "recovering", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown whether any therapeutic measures were taken as a result of the events.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Dose received: 3; Largely Swollen lymph nodes under left arm; Elevated heart rate; Chills; Bad back pain; Muscle aches; Fever; Headache; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 16-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 07Jan2022 at 12:00 (Lot number: FJ8762) at the age of 16 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". The patient did not take any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0173, Route of Administration: unspecified, Anatomical site: Left Arm), administration date: 13May2021, when the patient was 15 year(s) old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0191, Route of Administration: unspecified, Anatomical site: Left Arm), administration date: 03Jun2021, when the patient was 15 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 12:00, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset 07Jan2022, outcome "recovering", described as "Largely Swollen lymph nodes under left arm"; HEART RATE INCREASED (non-serious) with onset 07Jan2022, outcome "recovering", described as "Elevated heart rate"; CHILLS (non-serious) with onset 07Jan2022, outcome "recovering", described as "Chills"; BACK PAIN (non-serious) with onset 07Jan2022, outcome "recovering", described as "Bad back pain"; MYALGIA (non-serious) with onset 07Jan2022, outcome "recovering", described as "Muscle aches"; PYREXIA (non-serious) with onset 07Jan2022, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 07Jan2022, outcome "recovering", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown whether any therapeutic measures were taken as a result of the events.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: Rash; Dose received: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 08Jan2022 at 14:45 (Lot number: unknown) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical Location: Right arm, Administration time: 14:45), administration date: 03May2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Anatomical Location: Right arm, Administration time: 14:30), administration date: 28May2021, when the patient was 49 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 08Jan2022 at 14:45, outcome "unknown", described as "Dose received: 3"; RASH (non-serious) with onset 09Jan2022 at 09:00, outcome "not recovered", described as "Rash". Therapeutic measures were not taken as a result of rash.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.