chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: I kept the bandaid on but noticed the area surrounding it became red, hot, and a little swollen like a rash. The next day I took off the bandaid and it was very red and a little blister or bubble that was clear but yellowish in color appeared.  The area was still extremely warm especially the little bubble. The next day I began having a strong itching sensation at the rash and bubble. I had been touching it quite a bit but nothing more than putting my hand over it to temporarily relieve the itching sensation. The bubble has gone down a little bit and is a little wrinkly now but still very warm. I took an allergy pill today but I think it?s just been an allergic reaction that I had to this booster specifically. I had a sore arm and a little bit of red last booster but nothing like this bubble
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: I kept the bandaid on but noticed the area surrounding it became red, hot, and a little swollen like a rash. The next day I took off the bandaid and it was very red and a little blister or bubble that was clear but yellowish in color appeared.  The area was still extremely warm especially the little bubble. The next day I began having a strong itching sensation at the rash and bubble. I had been touching it quite a bit but nothing more than putting my hand over it to temporarily relieve the itching sensation. The bubble has gone down a little bit and is a little wrinkly now but still very warm. I took an allergy pill today but I think it?s just been an allergic reaction that I had to this booster specifically. I had a sore arm and a little bit of red last booster but nothing like this bubble
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received first dose of Shingrix (herpes zoster vaccination) on May 19, 2023. The second dose was administered too early on June 7, 2023. The patient has been notified that their dose is invalid being that it is less than 4 weeks following the first administration. He has agreed to return in August 2023 to receive a valid second dose.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Angiogram cerebral, Arteriogram carotid, Bell's palsy, Blindness, Facial paralysis
Clinical narrative: Body aches, fever transient vision loss (rule out TIA) left hemifacial paralysis (Bell's Palsy)
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging head, Pain, Pyrexia
Clinical narrative: Body aches, fever transient vision loss (rule out TIA) left hemifacial paralysis (Bell's Palsy)
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Infant received Moderna Bivalent booster dose given as shot #1 in Primary Series for Moderna Bivalent vaccine in error rather than new bivalent vaccine designed for primary series.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; 1st dose (monovalent) was administered on 19-Aug-2022 and 2nd dose on 14-Oct-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose (monovalent) was administered on 19-Aug-2022 and 2nd dose on 14-Oct-2022) and NO ADVERSE EVENT (no adverse event) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Oct-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose (monovalent) was administered on 19-Aug-2022 and 2nd dose on 14-Oct-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose (monovalent) was administered on 19-Aug-2022 and 2nd dose on 14-Oct-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose (monovalent) was administered on 19-Aug-2022 and 2nd dose on 14-Oct-2022).    It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  The patient received an expired Moderna bivalent vaccine (lot-015H22A) on 02-June-2023. No treatment information was reported.   This case was linked to MOD-2023-727537 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Condition aggravated, Headache
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 52-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Headache (1 to no more than 4 headaches per month that were always easily resolved with Excedrin (two Extra Strength tablets)). Concomitant products included CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   On 12-MAR-2021, patient received Moderna COVID-19 Vaccine Dose 1, batch lot number 030A21A.  On 09-APR-2021, patient received Moderna COVID-19 Vaccine Dose 2, batch lot number 031B21A.  After the first course of Moderna vaccinations patient experience very significant change in both frequency and intensity of headaches.  No treatment medication was reported.   This case was linked to MOD-2023-724443 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2023: Follow up received that contains significant information includes updated medical history and narrative.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccine 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.).    Concomitant product use was not provided by the reporter. Suspect product dosage text was reported as unknown. It was reported that date of administration was unknown, but this was last week. The pharmacist reports that the 4 patients did not experienced any adverse reaction. One of the patients did come back and get the other half of the dose. The pharmacist did not know the patient COVID19 vaccination history. All 4 of the patients were adults over 18 years old.  Treatment information was not provided.  This case contains information about patient 3rd out of 4 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-727606 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727606:Patient 1 out of 4 patients
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block right, Chest X-ray normal, Chest pain, Chills, Computerised tomogram thorax normal
Clinical narrative: Prior history of vaccine assosiated myocarditis after SPV in 2009. CP began 1 day after 2nd dose of Moderna vaccine. Presented to the ED on 3/7/2021 with CP. No radiation, constant, aching. Worsened by movement and deep breathing, but constant at rest No N/V or SOB. Also had fever to 103 and chills. HR 120. EKG original 3/7/2021: ST. :COVID-19 PCR: neg x 2 3/7 and 3/8/2021. CT Chest: normal 3/8/2021. Trop I: max 0.094 (0-0.034) 3/7/2021. ECHO: normal (50-55%) 3/8/2021.  EKG repeat: NSR, rate 80. Incomplete RBBB and non specific ST-T wave changes on 3/8/2021.  CXR: neg 3/7/2021.  CP resolved within 4-5 days of onset. Went on to receive a booster dose (Pfizer) in December 2021 without recurrence of cardiac symptoms. Troponin trended down to normal range prior to discharge from hospital.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pain, Painful respiration, Pyrexia
Clinical narrative: Prior history of vaccine assosiated myocarditis after SPV in 2009. CP began 1 day after 2nd dose of Moderna vaccine. Presented to the ED on 3/7/2021 with CP. No radiation, constant, aching. Worsened by movement and deep breathing, but constant at rest No N/V or SOB. Also had fever to 103 and chills. HR 120. EKG original 3/7/2021: ST. :COVID-19 PCR: neg x 2 3/7 and 3/8/2021. CT Chest: normal 3/8/2021. Trop I: max 0.094 (0-0.034) 3/7/2021. ECHO: normal (50-55%) 3/8/2021.  EKG repeat: NSR, rate 80. Incomplete RBBB and non specific ST-T wave changes on 3/8/2021.  CXR: neg 3/7/2021.  CP resolved within 4-5 days of onset. Went on to receive a booster dose (Pfizer) in December 2021 without recurrence of cardiac symptoms. Troponin trended down to normal range prior to discharge from hospital.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Troponin I increased
Clinical narrative: Prior history of vaccine assosiated myocarditis after SPV in 2009. CP began 1 day after 2nd dose of Moderna vaccine. Presented to the ED on 3/7/2021 with CP. No radiation, constant, aching. Worsened by movement and deep breathing, but constant at rest No N/V or SOB. Also had fever to 103 and chills. HR 120. EKG original 3/7/2021: ST. :COVID-19 PCR: neg x 2 3/7 and 3/8/2021. CT Chest: normal 3/8/2021. Trop I: max 0.094 (0-0.034) 3/7/2021. ECHO: normal (50-55%) 3/8/2021.  EKG repeat: NSR, rate 80. Incomplete RBBB and non specific ST-T wave changes on 3/8/2021.  CXR: neg 3/7/2021.  CP resolved within 4-5 days of onset. Went on to receive a booster dose (Pfizer) in December 2021 without recurrence of cardiac symptoms. Troponin trended down to normal range prior to discharge from hospital.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Computerised tomogram thorax abnormal, Cough, Epistaxis
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 4/27/21 lot# 017B21A; Moderna 5/25/21 lot# 040B21A
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2, Haemoglobin decreased, Lung infiltration, Pain, Platelet count decreased
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 4/27/21 lot# 017B21A; Moderna 5/25/21 lot# 040B21A
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 4/27/21 lot# 017B21A; Moderna 5/25/21 lot# 040B21A
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 4/27/21 lot# 017B21A; Moderna 5/25/21 lot# 040B21A
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Medical assistant reported that patient received an extra dose of GARDASIL 9. Patient started the GARDASIL 9 series at age 11 and was only suppose to receive two doses of GARDASIL 9 but was mistakenly administered a third dose of GARDASIL 9 on May 4,; Patient received first dose of GARDASIL 9 at age 11 on Jun 3, 2017. Patient received second dose of GARDASIL 9 at age 13 on Jun 14, 2019. Patient received third dose of GARDASIL 9 at age 17 on May 4, 2023.; This spontaneous report was received from a medical assistant and refers to a 17-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-JUN-2017, the patient was vaccinated with the first dose of human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, valid lot #M040412, expiration date: 30-JUN-2019, administered for prophylaxis (dose, frequency, strength, anatomical location, and route of administration were not provided) at age of 11. On 14-JUN-2019, he received the second dose HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, valid lot #R023607, expiration date: 06-MAY-2021, administered for prophylaxis (dose, frequency, strength, anatomical location, and route of administration were not provided) (Inappropriate schedule of product administration) at age of 13. Later, on 04-MAY-2023, the patient was vaccinated with an extra dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, valid lot #W002614, expiration date: 15-SEP-2024, administered for prophylaxis (dose, frequency, strength, anatomical location, and route of administration were not provided) (Extra dose administered). No additional information or adverse event was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Angiopathy, Bell's palsy, Tooth loss
Clinical narrative: bells palsy on side of face; bells palsy on side of face, broken blood vessels around eye; loss of 2 teeth; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (bells palsy on side of face) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (bells palsy on side of face) (seriousness criterion medically significant), ANGIOPATHY (bells palsy on side of face, broken blood vessels around eye) and TOOTH LOSS (loss of 2 teeth). At the time of the report, BELL'S PALSY (bells palsy on side of face), ANGIOPATHY (bells palsy on side of face, broken blood vessels around eye) and TOOTH LOSS (loss of 2 teeth) outcome was unknown.            No concomitant drugs were reported. It is unknown if the patient experienced any additional symptoms/events. Treatment drugs were not provided.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Bell´s palsy, which occurred on an unknown date related to mRNA-1273.222 vaccine, administered as second dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Rash erythematous, Rash pruritic, SARS-CoV-2 test
Clinical narrative: Tested Covid positive through at least the first two months of the rash; Tested Covid positive through at least the first two months of the rash; About 2weeks after the mild first symptoms passed I broke out in an all body red, itchy rash; About 2weeks after the mild first symptoms passed I broke out in an all body red, itchy rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Sep2022 at 13:00 as dose 1, single (Lot number: GM9694) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). There were no concomitant medications. No other vaccine in four weeks were reported. No Known allergies were reported.  The following information was reported: RASH ERYTHEMATOUS (non-serious), RASH PRURITIC (non-serious) all with onset 21Sep2022, outcome "recovered" and all described as "About 2weeks after the mild first symptoms passed I broke out in an all body red, itchy rash"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "recovered" and all described as "Tested Covid positive through at least the first two months of the rash". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of rash erythematous, rash pruritic.  Clinical course: About 2weeks after the mild first symptoms passed the patient broke out in an all body red, itchy rash which lasted 3 months. She treated it with aloe and skin cream moisteners. She tested Covid positive through at least the first two months of the rash. No one else that she knew of got this rash.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: E89262), in right arm, on 05Mar2021 as dose 2, single (Lot number: EN6205), in right arm, on 27Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 30155887), in right arm and in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No adverse reactions to COVID injections/boosters. Paxlovid treatment start date was 23May2023 and treatment stop date was 27May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162b2, BNT162b2 omi ba.4-5 , and the events covid-19, drug ineffective cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300210419 Same patient, different vaccine doses and different events.;
Age: 25.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment with Paxlovid, Treatment start date: 21May2023, Treatment stop date: 25May2023. No Other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test, Wrong product administered
Clinical narrative: COVID-19; COVID-19; Dose Number: 1 Batch/Lot No: GH9694; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:00 as dose 1, single (Lot number: GH9694) at the age of 45 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Dose Number: 1 Batch/Lot No: GH9694". The patient underwent the following laboratory tests and procedures: Body temperature: low grade fever, notes: low grade fever; SARS-CoV-2 test: Negative, notes: Tested negative on 2 different antigen test; Negative, notes: Tested negative on 2 different antigen test; Positive, notes: Two days later tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid as treatment for covid-19. Tested negative on 2 different antigen test. Two days later tested positive along with low grade fever, headache and runny nose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as treatment of COVID-19. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GT5342), in left arm and on 09May2023 as dose 6 (booster), single (Lot number: WAG#TU308) at the age of 78 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 02Feb2021 as dose 2, single (Lot number: EL9262), in left arm, on 21Sep2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 14Jun2022 as dose 4 (booster), single (Lot number: fm9992), in right arm for covid-19 immunisation. The patient had no relevant medical history. Patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of 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 vaccination failure, covid-19 which included PAXLOVID treatment from 30May2023 to 03Jun2023.
Age: 75.0
Sex: F
Vaccine: 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 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 28Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 08Feb2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: P.E., High blood pressure; "Pulmonary embolism (PE)" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2023) Negative, notes: Tested Negative; (02Jun2023) positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started from 24May2023 to 29May2023, over the counter severe cold symptoms by Tylenol.  Clinical course: Patient had no known allergies. Adverse event reported as tested Negative on 31May2023 then on 02Jun2023 started with cold symptoms and tested positive for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2 NOS), on 17Oct2022 at 09:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Post-traumatic stress disorder (PTSD)" (unspecified if ongoing). Patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of 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 which included PAXLOVID from 16May2023 to 21May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Positive, notes: Treatment of COVID-19; (Jun2023) Positive, notes: Covid rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Pfizer Covid-19 treatment from 24May2023 to 28May2023. Covid rebound on 02Jun2023 at 02:00 PM. The patient had no other medication within 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300211387 same reporter/patient/product, different dose/event.;
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 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "chronic lyme" (unspecified if ongoing). Concomitant medication(s) included: TETRACYCLINE; BACTRIM DS; CANDESARTAN; AMLODIPINE. Past drug history included: Blueberries for allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" 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 drug ineffective, covid-19.  Clinical course: It was reported that patient received other medication in 2 weeks. COVID 19 Treatment start date was 22May2023 and treatment stop date was 26May2023,  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years 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: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (2023) Negative, notes: testing negative for the 2nd time within 48 hours; (2023) Negative, notes: testing negative for the 2nd time within 48 hours; (2023) Positive, notes: positive immediately with a high load within 2 days. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24May2023 to 29May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 4 (booster), single (Lot number: BH9694) at the age of 73 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL9265), in right arm, on 22Feb2021 as dose 2, single (Lot number: EL9266), in right arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3597), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: Jun2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2023) Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient got paxlovid from 23May2023 to 28May2023 as COVID-19 treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300210389 same reporter/patient, different product/ event.;
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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (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; Positive, notes: she tested positive for Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Got Covid in early Apr2023; Got Covid in early Apr2023; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 42 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "endometriosis" (unspecified if ongoing); "severe varicose veins with treatment" (unspecified if ongoing); "history of bell's palsy" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Jul2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Got Covid in early Apr2023". The event "got covid in early apr2023" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient had no prolonged hospitalization. It was unknown that patient received any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Seeking medical care by primary physician. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had any known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300211339 same patient and drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Lip swelling, Mouth swelling
Clinical narrative: Coughing; Tired; massive swelling of mouth/side of mouth looks like swollen  lips were like big and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 05Jun2023, outcome "unknown", described as "Coughing"; FATIGUE (non-serious) with onset 05Jun2023, outcome "unknown", described as "Tired"; LIP SWELLING (non-serious) with onset 05Jun2023, outcome "not recovered", described as "lips were like big and swollen"; MOUTH SWELLING (non-serious) with onset 05Jun2023, outcome "not recovered", described as "massive swelling of mouth/side of mouth looks like swollen . Additional information: Patient stated she had possible side effect. She called health care professional and was informed to call to see if any data on side effect she was experiencing. Friday afternoon (unspecified date), she had the shot; she had standard reaction and outcome. She was feeling like she was finally over it "last night". This morning (05Jun2023), she woke up to take blood pressure medication. She was coughing a little. She went back to bed because she was tired. She later got up and had massive swelling of mouth. Her lips were like big and swollen. The side of mouth looks like swollen . There was no pain or dental issues that she was aware. Has not reduced. Patient asked how long this would take as she was waiting for call from her doctor as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Rash, Respiratory distress, Wheezing
Clinical narrative: respiratory distress; rash on face; wheezing; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: 2023SA133327 (Sanofi).  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM 197 protein) (PREVNAR 13), as dose number unknown, single (batch/lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY DISTRESS (medically significant), outcome "unknown"; RASH (non-serious), outcome "unknown", described as "rash on face"; WHEEZING (non-serious), outcome "unknown".  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM 197 protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: Soreness at Injection Site/slightly more painful than anticipated-a longer pinch felt; couldn't lift my arm after; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID: The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (PREVNAR 20), on 19May2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19May2023 as dose number unknown, booster single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: prescribed therapy ; "Hyperlipidemia" (unspecified if ongoing), notes: prescribed therapy ; "Hypothyroid" (unspecified if ongoing), notes: prescribed therapy . The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, Single, Manufacturer Unknown), for Covid-19 Immunization.The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2023, outcome "unknown", described as "Soreness at Injection Site/slightly more painful than anticipated-a longer pinch felt"; MOBILITY DECREASED (non-serious) with onset 2023, outcome "unknown", described as "could't lift my arm after". Addition information: patient reported that "l received Prevnar 20 a few weeks ago and I couldn't lift my arm after", After probing, he explained that the soreness was on par with what you would expect following a shot. However, he did mention that the initial injection was slightly more painful than anticipated -a longer pinch felt. Received Prevnar 20 and COVID booster on the same day - different arms.  The information on the batch/lot number for pneumococcal 20-val conj vac, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Experienced COVID-19; Experienced COVID-19/Suspected COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Experienced COVID-19"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Experienced COVID-19/Suspected COVID-19".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Incorrect route of product administration
Clinical narrative: alopecia; route of administraion: intravenous; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) intravenous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "route of administraion: intravenous".  Additional Information: The reporter mentioned that both her and her father developed what appears to be alopecia after being vaccinated. Now Pfizer is introducing a new drug for alopecia. Just curious if anyone else developed this after being vaccinated.  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-202300213364 same reporter/drug/event, different patient;