chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL. Past drug history included: Salicylic acid, reaction(s): "Drug Allergy", notes: Known allergies: Salicylic acid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Negative, notes: positive tests after 2 days of negative tests; (Oct2022) Positive, notes: Indication=Treatment of COVID-19; (21Oct2022) Positive, notes: positive tests after 2 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received vaccine and other medication in 2 weeks. COVID 19 treatment start date 13Oct2022 and stop date reported as 18Oct2022. Reoccurrence of symptoms & positive tests was found after 2 days of negative tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lip blister, Oral herpes, Urticaria
Clinical narrative: hives; fever blister; blister on top lip; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 at 17:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 05Oct2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: LIP BLISTER (non-serious) with onset 19Oct2022, outcome "recovering", described as "blister on top lip"; ORAL HERPES (non-serious) with onset 19Oct2022, outcome "recovering", described as "fever blister"; URTICARIA (non-serious) with onset 23Oct2022, outcome "recovering", described as "hives". The events "fever blister", "blister on top lip" and "hives" required physician office visit. Therapeutic measures were taken as a result of oral herpes, lip blister, urticaria.  Additional Information: The patient had received Influenza vaccine within four weeks of covid-19 vaccine. After receiving the 4th bivalent vaccine, he developed a fever blister on top lip which appeared to be similar to hsv1 type lesion (no personal history of fevers blister or any previous lip lesions) and on 23Oct after eating out at a restaurant (grits, shrimp, bacon, mushroom, onion, coffee, white potato) within 30 minutes broke out in hives. The patient had no previous history of food allergies or similar type reactions and had no medical history. The patient was treated with Abreva, Claritin 10 mg Benadryl 50 mg famotidine 40 mg for adverse events. The patient had Covid-19 prior to vaccination and was not tested for Covid-19 post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes/ almost all lymph nodes were swollen for the first few days, then only my neck and left underarm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2021 as dose 2, single (Lot number: EW0170) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Shellfish" (unspecified if ongoing); "Heart palpitations" (unspecified if ongoing); "Heart palpitations (SVT)" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; NAPROXEN; AMBEREN; BIOTIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0150, Anatomical location: Left arm, Time of administration: 13.15), administration date: 10Apr2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "For the first 2 shots the swollen lymph nodes", "some joint pain", "the morning after: some joint pain, severe pain in spine", "about 24 hours after shot: swollen hands and feet", "About 48 hours after shot: sore, swollen lymph nodes". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "swollen lymph nodes/ almost all lymph nodes were swollen for the first few days, then only my neck and left underarm".  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have Covid prior to vaccination. For the first 2 shots, the swollen lymph nodes lasted 3 weeks but almost all lymph nodes were swollen for the first few days, then only neck and left underarm. The patient was not tested positive for Covid post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 10Apr2021 as dose 2, single (Lot number: ER8731), in left arm, on 22Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 01Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment Treatment start date- 05Oct2022; (11Oct2022) Negative, notes: Rebound of symptoms and positive test eight days after negative test; (19Oct2022) Positive, notes: Rebound of symptoms and positive test eight days after negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19.The patient was treated with COVID 19 Treatment from 05Oct2022 to 10Oct2022.  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: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Oct2022, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Oct2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: 99, notes: 99 temp; SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment Brand: Paxlovid. Treatment start date was14Oct2022 and treatment stop date was 18Oct2022. No other medication in 2 weeks and no allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Arthritis, Back pain, Off label use, Product use issue
Clinical narrative: Areas of mild arthritis (hands and feet) flared; Significant musculoskeletal pain in back; Location of injection for vaccine received same date Flu - right; Location of injection for vaccine received same date Flu - right; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 61 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 29Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: BNT162b2 (DOSE 3 (BOOTSER), SINGLE; Lot number: EK9893; Administration time: 09:00; Anatomical location: Right arm), administration date: 18Apr2022, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "Vaccination failure", "COVID-19"; BNT162b2 (DOSE 2, SINGLE; Lot number: EN8736; administration time: 09:00; anatomical location: right arm), administration date: 22Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Vaccination failure", "COVID-19"; BNT162b2 (DOSE 1, SINGLE; Lot number: EP7533; administration time: 09:00; anatomical location: right arm), administration date: 01Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Vaccination failure", "COVID-19". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 29Sep2022, outcome "unknown" and all described as "Location of injection for vaccine received same date Flu - right"; ARTHRITIS (non-serious) with onset 01Oct2022, outcome "recovered with sequelae", described as "Areas of mild arthritis (hands and feet) flared"; BACK PAIN (non-serious) with onset 01Oct2022, outcome "recovered with sequelae", described as "Significant musculoskeletal pain in back". Therapeutic measures were not taken as a result of arthritis, back pain.  Additional Information: It was reported that significant musculoskeletal pain in back. Areas of mild arthritis (hands and feet) flared for about 9 days following injection. The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. The events did not resulted 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. Prior to vaccination, the patient was diagnosed with COVID-19 and no other medical history.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253368 same product, patient, different adverse events and dose.;
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: pain in upper arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Oct2022, outcome "recovering", described as "pain in upper arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The treatment included Ibuprofen. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: pain in upper arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Oct2022, outcome "recovering", described as "pain in upper arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The treatment included Ibuprofen. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: flu shot on same date vaccine; flu shot on same date vaccine; paint in upper left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 54 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 23Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "chronic migraines" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing), notes: known allergies: PCN; "known allergies: latex" (unspecified if ongoing), notes: known allergies: latex. Concomitant medication(s) included: IBUPROFEN; NYSTATIN; VIT D [COLECALCIFEROL]; VIT B12. Past drug history included: Amoxicllin, reaction(s): "known allergies: amoxicllin", notes: known allergies: amoxicllin. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 23Oct2022, outcome "unknown" and all described as "flu shot on same date vaccine"; PAIN IN EXTREMITY (non-serious) with onset 23Oct2022, outcome "recovering", described as "paint in upper left arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: flu shot on same date vaccine; flu shot on same date vaccine; paint in upper left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 54 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 23Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "chronic migraines" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing), notes: known allergies: PCN; "known allergies: latex" (unspecified if ongoing), notes: known allergies: latex. Concomitant medication(s) included: IBUPROFEN; NYSTATIN; VIT D [COLECALCIFEROL]; VIT B12. Past drug history included: Amoxicllin, reaction(s): "known allergies: amoxicllin", notes: known allergies: amoxicllin. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 23Oct2022, outcome "unknown" and all described as "flu shot on same date vaccine"; PAIN IN EXTREMITY (non-serious) with onset 23Oct2022, outcome "recovering", described as "paint in upper left arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: was semi-okay; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "was semi-okay".  Additional information: It was reported that they got the Omicron shot, here it says shot at 09:00. She woke up having serious reactions right now. Right now her fever only about 100 but she was shivering and freezing and it has been since last few hours and vomiting too. The reporter stated, she had 4 of your shots, the first one she was semi-okay with it but the other three shot she got pretty bad high fever, chills, really not well. This is her 5th shot, with Pfizer, yes with the Omicron variant (Hence, suspect product name captured as COVID-19 Vaccine) but want to know what the best thing to do but can't get anything for her."When informed to contact nearest emergency room or health care provider in case of emergency, reporter stated, She was having vomiting now and have to go.  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-202201252978 same product, patient, different AEs, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pyrexia
Clinical narrative: pretty bad high fever; chills; really not well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "was semi-okay". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "pretty bad high fever"; CHILLS (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "really not well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated, that "Okay, well it's not me, it's concerning my girlfriend. Yesterday, we got the Omicron, my girlfriend and I got the Omicron shot, here it says shot at 9am. She woke up having serious reactions right now. Right now her fever only about 100 but she is shivering and freezing and it has been since last few hours and vomiting too." When paraphrased the concern reporter stated, "Okay, she has had 4 of your shots, the first one she was semi-okay with it but the other three shot she got pretty bad high fever, chills, really not well." When probed to clarify the concern with Pfizer COVID-19 Vaccine, reporter stated, "This is her 5th shot, with Pfizer, it's Pfizer, it was the Pfizer, yes with the Omicron variant (Hence, suspect product name captured as COVID-19 Vaccine)." When probed to clarify the concern, reporter stated, "No, but I want to know what the best thing for me to do but I can't get anything for her.  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-202201252978 same product, patient, different AEs, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pyrexia
Clinical narrative: prettybad high fever; chills; really not well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 3), for Covid-19 immunization, reaction(s): "really not well", "pretty bad high fever"; Bnt162b2 (Dose: 3), for COVID-19 Immunization, reaction(s): "Chills"; Bnt162b2 (Dose: 2), for Covid-19 immunization, reaction(s): "pretty bad high fever"; Bnt162b2 (Dose: 2), for COVID-19 Immunization, reaction(s): "Chills", "really not well"; Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "was semi-okay".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "prettybad high fever"; CHILLS (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "really not well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information :Reporter stated that it was not for him, it's concerning about his girlfriend. Yesterday, both of them got the Omicron, shot, at around 9am. She woke up having serious reactions right now. Right now her fever only about 100 but she was shivering and freezing and it has been since last few hours and vomiting too.When paraphrased the concern reporter stated, "Okay, she has had 4 of your shots, the first one she was semi-okay with it but the other three shot she got pretty bad high fever, chills, really not well.When probed to clarify the concern with Pfizer COVID-19 Vaccine, reporter stated, "This was her 5th shot, with Pfizer, it's Pfizer, it was the Pfizer, yes with the Omicron variant (Hence, suspect product name captured as COVID-19 Vaccine).When probed to clarify the concern, reporter stated, "No, but he want to know what the best thing for him to do but he can't get anything for her.When informed to contact nearest emergency room or health care provider in case of emergency, reporter stated, she was vomitting and he would call later.  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-202201252978 same product, patient, different AEs, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Gait disturbance
Clinical narrative: Bone pain in both legs; Was "debilitating" and she could barely walk for a couple of days afterwards; Was "debilitating" and she could barely walk for a couple of days afterwards; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Bone pain in both legs"; GAIT DISTURBANCE (non-serious), ASTHENIA (non-serious) all with onset Mar2021, outcome "recovered" and all described as "Was "debilitating" and she could barely walk for a couple of days afterwards". It was unknown if therapeutic measures were taken as a result of bone pain, gait disturbance, asthenia.  Additional information: The patient also received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. It was unknown, whether the patient received any other vaccine in four weeks. It was unknown, whether the patient was diagnosed with COVID prior vaccination. It was unknown, whether the patient tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), on 20Apr2021 as dose 2, single (Lot number: EW0170) and on 05Feb2022 as dose 3 (booster), single (Lot number: FJ1614) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "adhesives" (unspecified if ongoing); "Environmental allergy" (unspecified if ongoing); "Known allergies: potatoes, tomatoes, almonds, pecans" (unspecified if ongoing), notes: Known allergies: potatoes, tomatoes, almonds, pecans; "ADHD" (unspecified if ongoing), notes: Other medical history: ADHD; "reactive hypoglycemia" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "gall bladder removed" (unspecified if ongoing), notes: Other medical history: gall bladder removed; "inguinal hernia repaired" (unspecified if ongoing), notes: Other medical history: inguinal hernia repaired; "Known allergies: potatoes, tomatoes, almonds, pecans" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; FEXOFENADINE HCL, stop date: 19Oct2022; ZINC. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin"; Prednisone, reaction(s): "Known allergies: prednisone"; Biaxin, reaction(s): "Known allergies: Biaxin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: Adverse event: Patient had a strong metallic taste in her mouth within a few hours of the first dose, like a mouthful of dirty pennies with overtones of brass keys. It continued pretty much the entire course of medicine. It powered through most food tastes. The things that banished the taste (for 5 minutes to an hour) were chewing crystallized ginger and drinking a honey/apple cider vinegar shrub. Patient took her last dose of Paxlovid in the morning and hope the taste will go away within a day or so. Con-med drug 'NatraBio', 'Welby' were unable to code due to Argus limitation and 'Raw garlic more than 2 cloves' not coded as it taken more than 2 weeks of dose 3 was updated in narrative.
Age: 29.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: 6 days after negative rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies: None; Other medical history: None. Other medication in 2weeks product is Umcka (Nature's Way), start date 06Oct2022, stop date 09Oct2022.  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-202201252936 Same patient, different product and event;
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Vaccination site pain
Clinical narrative: injection side pain; felt sick; she was sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2021 as dose 1, single (Lot number: FF2588) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "She got covid a year ago", start date: 05May2021 (unspecified if ongoing), notes: She got covid a year ago and almost died in the hospital. That was 05May2021. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection side pain"; MALAISE (non-serious), outcome "unknown", described as "felt sick"; ILLNESS (non-serious), outcome "recovered", described as "she was sick".  Additional information: The reporter reported that with her initial vaccines she had injection side pain and felt sick but no other symptoms. After her first vaccine in the series she was sick for a day and then she was fine. She got covid a year ago and almost died in the hospital. That was 05May2021, before her primary series. But she did not have swelling or other symptoms. Other conditions and investigations were not reported. Other products were not provided. Vaccination facility type reported as medicine mart. Vaccine administered at a facility were reported as no. None of the AE(s) required a visit to emergency room or physician office. No prior vaccinations reported within 4 weeks. List of other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI) were reported as no.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Vaccination site pain
Clinical narrative: injection side pain; felt sick; she was sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 22Sep2021 as dose 2, single (Lot number: FF8839) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "She got covid a year ago", start date: 05May2021 (unspecified if ongoing); "almost died in the hospital" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot: FF2588), administration date: 01Sep2021, when the patient was 53-year-old, for COVID-19 Immunization, reaction(s): "injection side pain", "felt sick", "she was sick". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection side pain"; MALAISE (non-serious), outcome "unknown", described as "felt sick"; ILLNESS (non-serious), outcome "unknown", described as "she was sick".  Additional information: She stated that with her initial vaccines she has injection side pain and felt sick but no other symptoms. On her Initial vaccine she got, she got sick and had injection site pain. But she did not have swelling or other symptoms. After her first vaccine in the series she was sick for a day and then she was fine. She got covid a year ago and almost died in the hospital. That was 5May2021, before her primary series. Vaccination facility type reported as medicine mart. Vaccine administered at military facility were reported as no. Did any AE(s) require a visit to emergency room was reported as no. Physician office reported as no. Prior Vaccinations (within 4 weeks) reported as no. Relevant tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI) were reported as no.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Lymphadenopathy, Off label use, Product use issue
Clinical narrative: left swollen axillary lymph node; INFLUENZA VACCINE was given to the patient on the same day as BNT162B2, BNT162B2 OMI BA.4-5; INFLUENZA VACCINE was given to the patient on the same day as BNT162B2, BNT162B2 OMI BA.4-5; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 18:45 as dose 4 (booster), single (Lot number: GJ6665) at the age of 54 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 21Oct2022 as dose number unknown, single (Lot number: 942415), in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COLACE; FAMOTIDINE; UMCKA A; VITAMIN D [COLECALCIFEROL]; PROBIOTICS. 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; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 21Oct2022, outcome "unknown" and all described as "INFLUENZA VACCINE was given to the patient on the same day as BNT162B2, BNT162B2 OMI BA.4-5"; LYMPHADENOPATHY (non-serious) with onset 23Oct2022, outcome "recovering", described as "left swollen axillary lymph node". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: The patient had no known allergies. The patient did not receive any other vaccine within the four weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: other medical history: RA; "Panuveitis" (unspecified if ongoing); "GAD" (unspecified if ongoing), notes: Other medical history: GAD; "Depression" (unspecified if ongoing). Concomitant medication(s) included: INFLECTRA [INFLIXIMAB]; CELEXA [CELECOXIB]. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin", notes: Known allergies: Clindamycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association the causal association of suspect drug BNT162b2 and for reported events- Drug Ineffective and COVID-19 cannot be excluded .
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Oropharyngeal pain, Wrong product administered
Clinical narrative: accidentally received a Pfizer Bivalent Orange Cap Covid vaccine without prior vaccination history; was complaining last night that his back hurt and throat was hurting; was complaining last night that his back hurt and throat was hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 5-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 1 (bivalent), single (Lot number: GK1657) at the age of 5 years for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Chronic insomnia" (unspecified if ongoing), notes: At some point, he saw a neurologist for chorionic insomnia and they had to give him melatonin. . There were no concomitant medications. Past drug history included: Melatonin for Chronic insomnia, notes: At some point, he saw a neurologist for chorionic insomnia and they had to give him melatonin.  The following information was reported: BACK PAIN (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset Oct2022, outcome "unknown" and all described as "was complaining last night that his back hurt and throat was hurting"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 20Oct2022, outcome "unknown", described as "accidentally received a Pfizer Bivalent Orange Cap Covid vaccine without prior vaccination history".  Additional information: The patient received the Covid-19 Bivalent booster, but he has never had any other Covid vaccine before. The patient's mother just wanted to ask if her son was fully vaccinated now. Just wanted him to be fully vaccinated at this point. The patient's mother wanted to know if it was safe enough for him to get that booster without getting the first two doses of the vaccine. The patient's mother reported that her son was complaining last night (at the time of reporting) that his back hurt and throat was hurting, but he didn't have a fever or anything like that.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Incorrect dose administered, Vaccination site pain
Clinical narrative: Headache; Chills; Sore in both arms; Received two doses at once; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID. The reporter is the parent.  A 14-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose number unknown (booster), single (Lot number: GH9693) at the age of 14 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: coviD-19 vaccine (1st booster, Unknown Manufacturer), administration date: 21Jan2022, when the patient was 13-year-old, for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 22Oct2022, outcome "unknown", described as "Received two doses at once"; HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore in both arms".  Additional Information: The patient was the caller's 14-year-old daughter who received two doses of the Pfizer BioNTech Covid 19 Bivalent Vaccine instead of one dose. Stated that the doses were given at the same time to her daughter, one dose in each arm.Caller stated that this wasn't her daughter's first Covid Vaccine though. Stated that her daughter had a booster, 21Jan2022. This was the first of the Bivalent Booster.Caller stated that she called her daughter's doctor and they said to just watch for tachycardia or other symptoms. Caller states that her daughter just had a headache and some chills, she was better today, just sore in both arms. Caller states that they were just worried about long term effects.Caller mentioned that she was calling on behalf of her daughter who had the Bivalent Vaccine last saturday and unfortunately they gave 2 doses of the bivalent. She has had Covid vaccines before, but instead of receiving one dose of the booster, she accidently was administered two doses of the bivalent. The pharmacist said to especially watch her the first 24 hours and be very careful, and signs of needing to go to the ER. Luckily she's been okay, just a headache, or something like that, sore arms, kind of like a flu shot. She was given double the dose.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: was the patient diagnosed with COVID-19?:Yes; was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 at 09:00 as dose 1, single (Lot number: EP7533), in right arm, on 22Apr2021 at 09:00 as dose 2, single (Lot number: EN8736), in right arm and on 18Apr2022 at 09:00 as dose 3 (booster), single (Lot number: EK9893) at the age of 61 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "was the patient diagnosed with COVID-19?:Yes".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201252981 same product, patient, different AEs, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Palmar-plantar erythrodysaesthesia syndrome
Clinical narrative: Palm Planter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE unknown manufacturer, Batch/lot number: Unknown, her received dose was last Mar2022 and with a monovalent dose.), administration date: Mar2022, for Covid-19 Immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Batch/lot number: Unknown), for Covid-19 Immunization. The following information was reported: PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (medically significant), outcome "unknown", described as "Palm Planter".  Clinical course: Caller also briefly mentioned that she experienced "Palm Planter" on her left hand after getting the second booster dose of the Pfizer BionTech Covid-19 Vaccines. Caller also stated that she is about to undergo surgery. Unable to obtain age information. Gender: Female. Caller wanted to know how long she will be protected after her Pfizer BionTech Covid-19 Monovalent booster vaccine shot. Caller wanted to know if she could get the PfizerBioNTech Covid-19 Bivalent Booster dose if her received dose was last Mar2022 and with a monovalent dose.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Echocardiogram, Ejection fraction, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: myocarditis; This is a literature report for the following literature source(s): "A report on short-term follow-up cardiac imaging and clinical outcomes of myocarditis after coronavirus disease 2019 vaccination".  A 12-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, unknown manufacturer), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: C-reactive protein: elevated; Echocardiogram: left ventricular ejection fraction 64 percent, notes: no regional wall motion abnormality, normal diastolic function; left ventricular ejection fraction 65 percent, notes: no regional wall motion abnormality, normal diastolic function; Ejection fraction: 64 %; 65 %; Electrocardiogram: ST elevations in inferior leads, notes: on presentation; Resolved ST-T wave, notes: changes; Electrocardiogram ambulatory: Normal; Exercise test: Normal; Magnetic resonance imaging heart: edema patchy subepicardial late gadolinium, notes: enhancement; Small focal late gadolinium, notes: enhancement; Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;