chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Transient ischaemic attack, Weight decreased
Clinical narrative: we were heavier when we got the shot; GERD; ministroke; lost vision in 1/2 right eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 2, single (Lot number: EL9266, Expiration Date: 31Mar2021) at the age of 75 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Breathing" (unspecified if ongoing), notes: He is on Breo Ellipta inhaler for breathing; "Rt side carotid artery-100% blocked", start date: Nov2020 (ongoing), notes: cardiac stress test and echocardiogram both normal, collateral circulation present so not new. Concomitant medication(s) included: CRESTOR taken for blood cholesterol; BREO ELLIPTA taken for dyspnoea. Vaccination history included: BNT162b2 (Anatomical location: Lt arm, Route: intramuscular, Batch/lot number: EL3249, Time: AM), administration date: 19Jan2021, when the patient was 75-year-old, for COVID-19 immunization. The following information was reported: BLINDNESS (medically significant) with onset 17Sep2021, outcome "unknown", described as "lost vision in 1/2 right eye"; TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 17Sep2021, outcome "recovered" (18Sep2021), described as "ministroke"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "we were heavier when we got the shot"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "GERD". The patient underwent the following laboratory tests and procedures: Blood test: (17Sep2021) Mini stroke; Cardiac stress test: (Nov2020) Normal; Computerised tomogram: (17Sep2021) Mini stroke; Echocardiogram: (Nov2020) Normal; Magnetic resonance imaging: (17Sep2021) Mini stroke. Therapeutic measures were taken as a result of transient ischaemic attack, blindness, gastrooesophageal reflux disease. The patient was 6' and was 188 pound. That's what they currently are, and they were heavier when got the shot. He was on a heart tablet twice a day for Metoprolol Tartrate and he has GERD and he's on Nexium (Treatment). He had ministroke on 17Sep2021 and Retina doctor said not an ocular stroke. On 26Jul2021, Rt eye lens replaced and on 17Sep2021, lost vision in 1/2 of Rt eye-horizontally. On 09Aug2021, Lt eye lens replaced and Retina Doctor said Not an ocular Stroke.  Follow-Up (12May2022): Follow-up attempts are completed. No further information is expected.  Follow-up (24May2022): This is a spontaneous follow-up report received from a contactable consumer (patient's wife). Updated information: Age, medical history, lab data, historical vaccine, suspect drug details, new event and clinical information.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200687387 as same reporter/drug/event, different patient.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myosclerosis, Peripheral swelling, Pruritus
Clinical narrative: Right arm red, swollen, muscle hard, itching. Slowly got better with time. At this time back to normal
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Pericarditis
Clinical narrative: Chest pain,  shortness of breath headache,  developed into pericarditis treated with non-steroidal oral medication X 5 days
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Swelling at injection site, sore arm few days. Used ice compress.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Pain in extremity, Ultrasound Doppler abnormal
Clinical narrative: I started feeling leg pain (in my left leg) three days after receiving my Pfizer booster shot. The pain got increasingly worse over the next couple days. I called my hematologist and he ordered me an ultrasound. The ultrasound confirmed I had a DVT in my left leg, and I started on 120mg of generic Lovenox asap for 3 months. I went in for another ultrasound after the three months had past and the technician confirmed that the clot was gone. However, two days after the ultrasound (and after stopping blood thinners) I started feeling leg pain again. I went in for another ultrasound and the technician confirmed another DVT. I started on 120mg of generic Lovenox again, and I've been on this dose ever since.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID (developing mild congestion, a mild headache, and diarrhea); tested positive for COVID (developing mild congestion, a mild headache, and diarrhea); mild congestion; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 46-year-old female patient received BNT162b2 (COMIRNATY), on 18Feb2021 as dose 1, single (Lot number: EL3247, Expiration Date: May2021), on 11Mar2021 as dose 2, single (Lot number: EN6203, Expiration Date: Jun2022) and on 01Dec2021 as dose 3 (booster), single (Lot number: FH8027) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious) with onset 25May2022, outcome "unknown", described as "mild congestion"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "tested positive for COVID (developing mild congestion, a mild headache, and diarrhea)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Oct2021) Positive, notes: previously tested positive for COVID; (25May2022) Positive, notes: at approximately 10:30 p.m. Clinical details: On 25May2022, she began developing mild congestion, a mild headache, and diarrhea. She took a BinaxNow home test at approximately 10:30 p.m. and it showed a positive result. She mentioned that she previously tested positive for COVID on 05Oct2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101326549 same patient/suspect drug, different dose, similar events (previous LOE)
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: severe joint pain ,Particularly in left ankle and foot making it painful to walk or stand for periods of time; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (severe joint pain ,Particularly in left ankle and foot making it painful to walk or stand for periods of time) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (severe joint pain ,Particularly in left ankle and foot making it painful to walk or stand for periods of time). The patient was treated with TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (severe joint pain ,Particularly in left ankle and foot making it painful to walk or stand for periods of time) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: inflammation of the synovial fluid in the ankle (abnormal) inflammation of the synovial fluid in the ankle joint area.         Concomitant medications details were not reported by the reporter.  Reportedly,Since the beginning of Jan 2022, Patient visited  foot/ankle doctor ,he gave her 2 shots into that area.The triaminicolone acetonide shots helped for a limited time, but did not resolve the problem.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, X-ray
Clinical narrative: severe joint pain ,Particularly in left ankle and foot making it painful to walk or stand for periods of time; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (severe joint pain ,Particularly in left ankle and foot making it painful to walk or stand for periods of time) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (severe joint pain ,Particularly in left ankle and foot making it painful to walk or stand for periods of time). The patient was treated with TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (severe joint pain ,Particularly in left ankle and foot making it painful to walk or stand for periods of time) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: inflammation of the synovial fluid in the ankle (abnormal) inflammation of the synovial fluid in the ankle joint area.         Concomitant medications details were not reported by the reporter.  Reportedly,Since the beginning of Jan 2022, Patient visited  foot/ankle doctor ,he gave her 2 shots into that area.The triaminicolone acetonide shots helped for a limited time, but did not resolve the problem.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Intervertebral disc protrusion
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), 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: INTERVERTEBRAL DISC PROTRUSION (non-serious), outcome "unknown", described as "The adverse  was reported as a herniated vertebral disc".   Additional information: Consumer reported himself having an adverse reaction three days after receiving Comirmaty. The adverse  was reported as a herniated vertebral disc. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intervertebral disc protrusion
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), 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: INTERVERTEBRAL DISC PROTRUSION (non-serious), outcome "unknown", described as "The adverse  was reported as a herniated vertebral disc".   Additional information: Consumer reported himself having an adverse reaction three days after receiving Comirmaty. The adverse  was reported as a herniated vertebral disc. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 91.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Back pain, Mobility decreased, Movement disorder, Sleep disorder
Clinical narrative: My first 3 injections (2 regular; lst booster), after effects were minimal (slight chills, of short duration).  The second booster, had extreme problems.  At 2:30 AM, woke (as normal for me, to go to bathroom).  However, had extreme pain in back and legs--unable to get out of bed, no matter how hard I tried.  through repeated attempts, finally got my legs partially over the side of bed---but, still could not get out of bed + severe pain continued.  Remained in this position until approximately 7:30 AM. I was then able to get out of bed and stood (very weakly). Rested throughout the day and body returned to normal state---no pain and able to move. Was extremely frightening.  I now have to decide whether to take future booster shots.  Please study and advise.  Thank you
Age: 91.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Back pain, Chills, Dysstasia, Mobility decreased
Clinical narrative: My first 3 injections (2 regular; lst booster), after effects were minimal (slight chills, of short duration).  The second booster, had extreme problems.  At 2:30 AM, woke (as normal for me, to go to bathroom).  However, had extreme pain in back and legs--unable to get out of bed, no matter how hard I tried.  through repeated attempts, finally got my legs partially over the side of bed---but, still could not get out of bed + severe pain continued.  Remained in this position until approximately 7:30 AM. I was then able to get out of bed and stood (very weakly). Rested throughout the day and body returned to normal state---no pain and able to move. Was extremely frightening.  I now have to decide whether to take future booster shots.  Please study and advise.  Thank you
Age: 91.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: My first 3 injections (2 regular; lst booster), after effects were minimal (slight chills, of short duration).  The second booster, had extreme problems.  At 2:30 AM, woke (as normal for me, to go to bathroom).  However, had extreme pain in back and legs--unable to get out of bed, no matter how hard I tried.  through repeated attempts, finally got my legs partially over the side of bed---but, still could not get out of bed + severe pain continued.  Remained in this position until approximately 7:30 AM. I was then able to get out of bed and stood (very weakly). Rested throughout the day and body returned to normal state---no pain and able to move. Was extremely frightening.  I now have to decide whether to take future booster shots.  Please study and advise.  Thank you
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Malaise, Nausea
Clinical narrative: Pain at injection site; Fatigue; She also had nausea; Chills; Body aches; Has an auto immune gastritis history/after receiving 1st dose had a horrible flare up that still experiencing; Skin sensitivity over stomach area; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune gastritis.   On 8th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, fatigue, nausea, chills, general body pain, gastritis aggravated and sensitive skin. On an unknown date, the outcome of the injection site pain, fatigue, chills and general body pain were unknown and the outcome of the nausea, gastritis aggravated and sensitive skin were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, nausea, chills, general body pain, gastritis aggravated and sensitive skin to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-MAY-2022 Reporter's Comments: The case was self-reported by the patient. The patient reported that she received the dose of Shingrix vaccine into right arm and experienced pain at injection site and fatigue also she had nausea, chills and body aches. The patient reported that she had an auto immune gastritis history but after receiving first dose of Shingrix and patient had a horrible flare up that she was still experiencing.  The patient reported that she had skin sensitivity on stomach area, nausea still.  The patient reported that both HCP's (health care professional) stated she should not get second dose of Shingrix.  Referred to HCP (health care professional).  Spoke per content.  Adverse events filed for the patient. The reporter consented to follow up. This case had been linked with case US2022086535, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022086535:Same Reporter
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain at injection site; Fatigue; She also had nausea; Chills; Body aches; Has an auto immune gastritis history/after receiving 1st dose had a horrible flare up that still experiencing; Skin sensitivity over stomach area; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune gastritis.   On 8th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, fatigue, nausea, chills, general body pain, gastritis aggravated and sensitive skin. On an unknown date, the outcome of the injection site pain, fatigue, chills and general body pain were unknown and the outcome of the nausea, gastritis aggravated and sensitive skin were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, nausea, chills, general body pain, gastritis aggravated and sensitive skin to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-MAY-2022 Reporter's Comments: The case was self-reported by the patient. The patient reported that she received the dose of Shingrix vaccine into right arm and experienced pain at injection site and fatigue also she had nausea, chills and body aches. The patient reported that she had an auto immune gastritis history but after receiving first dose of Shingrix and patient had a horrible flare up that she was still experiencing.  The patient reported that she had skin sensitivity on stomach area, nausea still.  The patient reported that both HCP's (health care professional) stated she should not get second dose of Shingrix.  Referred to HCP (health care professional).  Spoke per content.  Adverse events filed for the patient. The reporter consented to follow up. This case had been linked with case US2022086535, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022086535:Same Reporter
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Condition aggravated, Fatigue, Gastritis, Injection site pain
Clinical narrative: Pain at injection site; Fatigue; She also had nausea; Chills; Body aches; Has an auto immune gastritis history/after receiving 1st dose had a horrible flare up that still experiencing; Skin sensitivity over stomach area; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune gastritis.   On 8th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, fatigue, nausea, chills, general body pain, gastritis aggravated and sensitive skin. On an unknown date, the outcome of the injection site pain, fatigue, chills and general body pain were unknown and the outcome of the nausea, gastritis aggravated and sensitive skin were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, nausea, chills, general body pain, gastritis aggravated and sensitive skin to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-MAY-2022 Reporter's Comments: The case was self-reported by the patient. The patient reported that she received the dose of Shingrix vaccine into right arm and experienced pain at injection site and fatigue also she had nausea, chills and body aches. The patient reported that she had an auto immune gastritis history but after receiving first dose of Shingrix and patient had a horrible flare up that she was still experiencing.  The patient reported that she had skin sensitivity on stomach area, nausea still.  The patient reported that both HCP's (health care professional) stated she should not get second dose of Shingrix.  Referred to HCP (health care professional).  Spoke per content.  Adverse events filed for the patient. The reporter consented to follow up. This case had been linked with case US2022086535, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022086535:Same Reporter
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Sensitive skin
Clinical narrative: Pain at injection site; Fatigue; She also had nausea; Chills; Body aches; Has an auto immune gastritis history/after receiving 1st dose had a horrible flare up that still experiencing; Skin sensitivity over stomach area; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune gastritis.   On 8th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, fatigue, nausea, chills, general body pain, gastritis aggravated and sensitive skin. On an unknown date, the outcome of the injection site pain, fatigue, chills and general body pain were unknown and the outcome of the nausea, gastritis aggravated and sensitive skin were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, nausea, chills, general body pain, gastritis aggravated and sensitive skin to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-MAY-2022 Reporter's Comments: The case was self-reported by the patient. The patient reported that she received the dose of Shingrix vaccine into right arm and experienced pain at injection site and fatigue also she had nausea, chills and body aches. The patient reported that she had an auto immune gastritis history but after receiving first dose of Shingrix and patient had a horrible flare up that she was still experiencing.  The patient reported that she had skin sensitivity on stomach area, nausea still.  The patient reported that both HCP's (health care professional) stated she should not get second dose of Shingrix.  Referred to HCP (health care professional).  Spoke per content.  Adverse events filed for the patient. The reporter consented to follow up. This case had been linked with case US2022086535, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022086535:Same Reporter
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure, Syncope, Urinary incontinence, Vomiting
Clinical narrative: patient started sweating and passed out about 1-2 minutes after receiving the vaccine. He urinated when he passed out. He came to and sat in the chair for 30 minutes afterward. He was given an ice pack and water and juice. He stated he was diabetic and had not eaten that  day.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Urinary incontinence
Clinical narrative: patient started sweating and passed out about 1-2 minutes after receiving the vaccine. He urinated when he passed out. He came to and sat in the chair for 30 minutes afterward. He was given an ice pack and water and juice. He stated he was diabetic and had not eaten that  day.
Age: 31.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain
Clinical narrative: Pt. reports that she felt immediate pain in her left deltoid when the vaccine was administered.  She has had continued left deltoid pain since, limiting her ROM.  She was treated with naproxen 500 mg bid and referred to Physical Therapy (first appt. is 6/3/2022).  She reports persistent pain.
Age: 31.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Pt. reports that she felt immediate pain in her left deltoid when the vaccine was administered.  She has had continued left deltoid pain since, limiting her ROM.  She was treated with naproxen 500 mg bid and referred to Physical Therapy (first appt. is 6/3/2022).  She reports persistent pain.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Tinnitus
Clinical narrative: TINNITUS WHICH STARTED OFF AND ON BUT IS NOW CONSTANT,WAITING TO SEE SPECIALIST LARYNGITIS WHICH LASTED 2 WEEKS.ANTIBIOTICS MULTISYSTEM/JOINT PAIN AND INFLAMMATION.ICE PACKS
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Laryngitis, Tinnitus
Clinical narrative: TINNITUS WHICH STARTED OFF AND ON BUT IS NOW CONSTANT,WAITING TO SEE SPECIALIST LARYNGITIS WHICH LASTED 2 WEEKS.ANTIBIOTICS MULTISYSTEM/JOINT PAIN AND INFLAMMATION.ICE PACKS
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer, Inc.) concerned a 60 year old female. Initial information was processed along with the additional information received on 01-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy (unspecified). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 07-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included celecoxib, and pantoprazole. The patient received additionally non-company suspect Pfizer Biontech Covid-19 Vaccine (tozinameran), (dose number in series 2), (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on 04-NOV-2021 to left arm for prophylactic vaccination.  On an unspecified date, after both doses of vaccination, the patient experienced suspected covid-19 infection (dose number in series 2) and had suspected clinical vaccination failure (dose number in series 1). The patient started treatment with Paxlovid for suspected covid-19 infection on 8-MAY-2022 and continued till 12-MAY-2022. On 17-MAY-2022, after end of treatment, patient had experienced a resurgence of symptoms as well as positive antigen test. The treatment drug Paxlovid was also considered as non-company suspect. The action taken with covid-19 vaccine ad26.cov2.s, Pfizer Biontech Covid-19 Vaccine (tozinameran) was not applicable and with Paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000233655.; Sender's Comments: V0: 20220562331-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer, Inc.) concerned a 60 year old female. Initial information was processed along with the additional information received on 01-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy (unspecified). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 07-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included celecoxib, and pantoprazole. The patient received additionally non-company suspect Pfizer Biontech Covid-19 Vaccine (tozinameran), (dose number in series 2), (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on 04-NOV-2021 to left arm for prophylactic vaccination.  On an unspecified date, after both doses of vaccination, the patient experienced suspected covid-19 infection (dose number in series 2) and had suspected clinical vaccination failure (dose number in series 1). The patient started treatment with Paxlovid for suspected covid-19 infection on 8-MAY-2022 and continued till 12-MAY-2022. On 17-MAY-2022, after end of treatment, patient had experienced a resurgence of symptoms as well as positive antigen test. The treatment drug Paxlovid was also considered as non-company suspect. The action taken with covid-19 vaccine ad26.cov2.s, Pfizer Biontech Covid-19 Vaccine (tozinameran) was not applicable and with Paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000233655.; Sender's Comments: V0: 20220562331-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total administered to right arm on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 60 years old. No concomitant medications were reported. The patient additionally received non-company suspect vaccine Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered to right arm on 01-DEC-2021 for prophylactic vaccination. On 29-APR-2022, the patient experienced confirmed clinical vaccination failure (dose number in series 1), laboratory data included: COVID-19 virus test (NR: not provided) positive and confirmed covid-19 infection (diagnosed with covid-19 infection) (dose number in series 2). On same day, patient's physician prescribed Paxlovid which patient took for 5 days (till 03-MAY-2022) for treatment of Covid-19. The patient visited to physician office. On 20-MAY-2022, day 21 after the diagnosis, patient still tested (COVID-19 virus test) positive for Covid-19 infection.  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000233654.; Sender's Comments: V0: 20220562310-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total administered to right arm on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 60 years old. No concomitant medications were reported. The patient additionally received non-company suspect vaccine Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered to right arm on 01-DEC-2021 for prophylactic vaccination. On 29-APR-2022, the patient experienced confirmed clinical vaccination failure (dose number in series 1), laboratory data included: COVID-19 virus test (NR: not provided) positive and confirmed covid-19 infection (diagnosed with covid-19 infection) (dose number in series 2). On same day, patient's physician prescribed Paxlovid which patient took for 5 days (till 03-MAY-2022) for treatment of Covid-19. The patient visited to physician office. On 20-MAY-2022, day 21 after the diagnosis, patient still tested (COVID-19 virus test) positive for Covid-19 infection.  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000233654.; Sender's Comments: V0: 20220562310-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm after second vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm after second vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site arm after second vaccine). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm after second vaccine) outcome was unknown.    No concomitant drug was reported. No treatment medications were reported. Patient provides permission for Safety to contact the patient via e-mail. This case was linked to MOD-2022-580197, MOD-2022-580188 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm injection site after the first booster dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm injection site after the first booster dose of the Moderna Covid-19 vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left arm injection site after the first booster dose of the Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Sore left arm injection site after the first booster dose of the Moderna Covid-19 vaccine) outcome was unknown.  No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2022-580188, MOD-2022-580196 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: shaking; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking), CHILLS (chills) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced TREMOR (shaking), CHILLS (chills) and PYREXIA (fever). In March 2021, TREMOR (shaking), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant products were reported. It was reported that 8-9 days after the second dose of the vaccine, patient woke up with chills, shaking, and with a fever that went away after 2 days. No treatment drugs were reported.   This case was linked to MOD-2022-580241, MOD-2022-580248 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: shaking; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking), CHILLS (chills) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced TREMOR (shaking), CHILLS (chills) and PYREXIA (fever). In March 2021, TREMOR (shaking), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant products were reported. It was reported that 8-9 days after the second dose of the vaccine, patient woke up with chills, shaking, and with a fever that went away after 2 days. No treatment drugs were reported.   This case was linked to MOD-2022-580241, MOD-2022-580248 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: pains; muscle aches; elevated temperature/ fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains), MYALGIA (muscle aches), PYREXIA (elevated temperature/ fever) and FATIGUE (fatigue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PAIN (pains), MYALGIA (muscle aches), PYREXIA (elevated temperature/ fever) and FATIGUE (fatigue). At the time of the report, PAIN (pains), MYALGIA (muscle aches), PYREXIA (elevated temperature/ fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated (High) elevated temperature.         Concomitant product use was not provided by the reporter.  Patient had no COVID-19 in past or diagnosed with COVID-19. Patient received a Tetanus shot in her right arm on 5 MAY 2022 as an IM injection.  Treatment information was not provided.   This case was linked to MOD-2022-580253, MOD-2022-580258, MOD-2022-580194 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Feeling hot, Immunisation reaction, Vaccination site pain, Vaccination site swelling
Clinical narrative: pains; muscle aches; elevated temperature/ fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains), MYALGIA (muscle aches), PYREXIA (elevated temperature/ fever) and FATIGUE (fatigue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PAIN (pains), MYALGIA (muscle aches), PYREXIA (elevated temperature/ fever) and FATIGUE (fatigue). At the time of the report, PAIN (pains), MYALGIA (muscle aches), PYREXIA (elevated temperature/ fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated (High) elevated temperature.         Concomitant product use was not provided by the reporter.  Patient had no COVID-19 in past or diagnosed with COVID-19. Patient received a Tetanus shot in her right arm on 5 MAY 2022 as an IM injection.  Treatment information was not provided.   This case was linked to MOD-2022-580253, MOD-2022-580258, MOD-2022-580194 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: pains; muscle aches; elevated temperature/ fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains), MYALGIA (muscle aches), PYREXIA (elevated temperature/ fever) and FATIGUE (fatigue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PAIN (pains), MYALGIA (muscle aches), PYREXIA (elevated temperature/ fever) and FATIGUE (fatigue). At the time of the report, PAIN (pains), MYALGIA (muscle aches), PYREXIA (elevated temperature/ fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated (High) elevated temperature.         Concomitant product use was not provided by the reporter.  Patient had no COVID-19 in past or diagnosed with COVID-19. Patient received a Tetanus shot in her right arm on 5 MAY 2022 as an IM injection.  Treatment information was not provided.   This case was linked to MOD-2022-580253, MOD-2022-580258, MOD-2022-580194 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had been traveling and was concerned that I may have been exposed to the COVID-19 virus. I had mild fatigue the day before I tested positive this was the only symptom I experienced; I called the COVID-19 telemedicine line the day the home test came back positive. I was prescribed PAXLOVID.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: I had been traveling and was concerned that I may have been exposed to the COVID-19 virus. I had mild fatigue the day before I tested positive this was the only symptom I experienced; I called the COVID-19 telemedicine line the day the home test came back positive. I was prescribed PAXLOVID.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test positive
Clinical narrative: I had been traveling and was concerned that I may have been exposed to the COVID-19 virus. I had mild fatigue the day before I tested positive this was the only symptom I experienced; I called the COVID-19 telemedicine line the day the home test came back positive. I was prescribed PAXLOVID.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Computerised tomogram head, Laboratory test, Migraine, Oedema peripheral
Clinical narrative: On 5/16/2022, I began to experience edema in my lower right and left legs along with a migraine headache on the left side of my head. The swelling increased significantly in both legs on 5/17/2022, warranting a visit with my doctor on 5/18/2022. The edema continues to be a problem in both legs as well as swelling my in my lower abdomen and a swollen feeling under my left underarm.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling, Ultrasound Doppler
Clinical narrative: On 5/16/2022, I began to experience edema in my lower right and left legs along with a migraine headache on the left side of my head. The swelling increased significantly in both legs on 5/17/2022, warranting a visit with my doctor on 5/18/2022. The edema continues to be a problem in both legs as well as swelling my in my lower abdomen and a swollen feeling under my left underarm.