chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: She is starting to feel like some slight chest pain; soreness in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 16 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 14Oct2023, outcome "unknown", described as "She is starting to feel like some slight chest pain"; PAIN IN EXTREMITY (non-serious) with onset 14Oct2023, outcome "unknown", described as "soreness in her arm". Therapeutic measures were taken as a result of chest pain, pain in extremity.  Additional information: The reporter stated, "I just want to call if I can get more information? My daughter received the updated covid vaccine yesterday afternoon and she felt some soreness in her arm, but she is normal. But right now, she is starting to feel like some slight chest pain."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious) with onset 08Oct2023, outcome "unknown", described as "Hot flashes". The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: I could barely walk because my pain in my hip; am still limping a little bit now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 13Oct2023, outcome "not recovered", described as "I could barely walk because my pain in my hip"; GAIT DISTURBANCE (non-serious) with onset 13Oct2023, outcome "not recovered", described as "am still limping a little bit now". Therapeutic measures were taken as a result of arthralgia, gait disturbance.  Additional information: Patient could barely walk because patient's pain in the hip and that went all night when patient finally took a muscles relaxer (Intent: Treatment). Patient asked if that is one of the side effects. Patient was still limping a little bit now.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Limb discomfort, Movement disorder, Musculoskeletal stiffness
Clinical narrative: Severe Headache; my arms to my shoulder down my hand, felt numbness; arms just feel very heavy/my arms to my shoulder down my hand, felt heavy; my arms to my shoulder down my hand, felt very-very tingly; stiffness; Movement disorder/hard to pick things up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Lot number: HD9876) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing). Concomitant medication(s) included: ENAPRIL taken for hypertension, start date: 2003. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation; Bnt162b2 nos (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 13Oct2023, outcome "unknown", described as "Severe Headache"; MOVEMENT DISORDER (non-serious) with onset Oct2023, outcome "unknown", described as "Movement disorder/hard to pick things up"; LIMB DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "arms just feel very heavy/my arms to my shoulder down my hand, felt heavy"; HYPOAESTHESIA (non-serious) with onset Oct2023, outcome "unknown", described as "my arms to my shoulder down my hand, felt numbness"; PARAESTHESIA (non-serious) with onset Oct2023, outcome "unknown", described as "my arms to my shoulder down my hand, felt very-very tingly"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Oct2023, outcome "unknown", described as "stiffness". Therapeutic measures were not taken as a result of headache, hypoaesthesia, limb discomfort, paraesthesia, musculoskeletal stiffness, movement disorder.  Additional information: Patient stated, she was feeling she had gotten COVID 19 shot this Thursday 12Oct2023 at (facility name withheld) and on Friday, she had a headache and this Saturday and Sunday today 14Oct, her arms to shoulder down her hand, she felt very-very tingly, numbness and heavy. She meant, she probably it was like hard to pick things up, her arms just feel very heavy. That seems like it got stretched to her arm. So, she was wondering  it as side effect from the vaccine, She had all her COVID shot (Clarified as Pfizer COVID-19 Shot) and that was the first time that had ever happened to her after the shot, so she was wondering that was side effect. She got it Thursday and Friday she had severe Headache and stiffness but Saturday and today she felt that numbness and tingling in my arms and she was heavy. She could hardly in her arms.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Severe Headache; my arms to my shoulder down my hand, felt numbness; arms just feel very heavy/my arms to my shoulder down my hand, felt heavy; my arms to my shoulder down my hand, felt very-very tingly; stiffness; Movement disorder/hard to pick things up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Lot number: HD9876) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing). Concomitant medication(s) included: ENAPRIL taken for hypertension, start date: 2003. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation; Bnt162b2 nos (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 13Oct2023, outcome "unknown", described as "Severe Headache"; MOVEMENT DISORDER (non-serious) with onset Oct2023, outcome "unknown", described as "Movement disorder/hard to pick things up"; LIMB DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "arms just feel very heavy/my arms to my shoulder down my hand, felt heavy"; HYPOAESTHESIA (non-serious) with onset Oct2023, outcome "unknown", described as "my arms to my shoulder down my hand, felt numbness"; PARAESTHESIA (non-serious) with onset Oct2023, outcome "unknown", described as "my arms to my shoulder down my hand, felt very-very tingly"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Oct2023, outcome "unknown", described as "stiffness". Therapeutic measures were not taken as a result of headache, hypoaesthesia, limb discomfort, paraesthesia, musculoskeletal stiffness, movement disorder.  Additional information: Patient stated, she was feeling she had gotten COVID 19 shot this Thursday 12Oct2023 at (facility name withheld) and on Friday, she had a headache and this Saturday and Sunday today 14Oct, her arms to shoulder down her hand, she felt very-very tingly, numbness and heavy. She meant, she probably it was like hard to pick things up, her arms just feel very heavy. That seems like it got stretched to her arm. So, she was wondering  it as side effect from the vaccine, She had all her COVID shot (Clarified as Pfizer COVID-19 Shot) and that was the first time that had ever happened to her after the shot, so she was wondering that was side effect. She got it Thursday and Friday she had severe Headache and stiffness but Saturday and today she felt that numbness and tingling in my arms and she was heavy. She could hardly in her arms.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: dizzy; Not feeling that well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 14Oct2023, outcome "unknown", described as "Not feeling that well"; DIZZINESS (non-serious) with onset 14Oct2023, outcome "unknown", described as "dizzy". Additional information: Patient woke up dizzy that she went flying across the room and mostly if she try to look down or if she get up too fast. The patient also reported not feeling that well. Patient don't have any heart conditions.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache
Clinical narrative: Headache; chills; pain in  joints (shoulders, elbows, hips); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: otherwise good health. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 13Oct2023 at 18:00, outcome "recovered" (14Oct2023 at 06:00); CHILLS (non-serious) with onset 13Oct2023 at 18:00, outcome "recovered" (14Oct2023 at 06:00); ARTHRALGIA (non-serious) with onset 13Oct2023 at 18:00, outcome "recovered" (14Oct2023 at 06:00), described as "pain in  joints (shoulders, elbows, hips)". Therapeutic measures were not taken as a result of headache, chills, arthralgia. Additional information: No other vaccine in four weeks. The patient experienced headache; chills; pain in joints (shoulders, elbows, hips), all lasted about 12 hours post-vaccine injection. No covid prior to vaccination. Not tested for covid post vaccination. No known allergies.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX, RSV
Symptoms: Diarrhoea, Faeces discoloured, Malaise
Clinical narrative: Having Diarrhea pretty bad really dark; I am not feeling good; Having Diarrhea pretty bad really dark; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU VACCINE VII), 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: DIARRHOEA (non-serious), FAECES DISCOLOURED (non-serious), outcome "unknown" and all described as "Having Diarrhea pretty bad really dark"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), on 05Mar2021 at 13:00 as dose 1, single (Lot number: En6199), in right arm, on 26Mar2021 at 14:00 as dose 2, single (Lot number: Ep7533), in left arm, on 19Dec2021 at 15:00 as dose 3 (booster), single (Lot number: 33025bd), in left arm and on 13May2022 at 14:00 as dose 4 (booster), single (Lot number: Fm9992) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Nov2022 at 11:00 as dose 5 (booster), single (Lot number: 049d22a), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; ASCORBIC ACID; CHOLECALCIFEROL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Nov2022 at 11:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details included Paxlovid for COVID 19 Treatment (treatment start date=02Oct2023, treatment stop date=07Oct2023; lot number=Gj0891). Other medication in 2weeks product included vitamins: multi, c, d, calcium, airborne dietary supplement (Other medication in 2weeks start date=01Jan2023; Other medication in 2weeks stop date=29Sep2023). None known known allergies, none known Other medical history.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Patient was vaccinated in clinic and waited with mother for 15 minutes, no adverse reactions were noted. Patient's mother came back to the clinic one week later for a separate appointment and stated that patient had redness, swelling and a bump at the injection site on patient's left arm the day following the injection.  Patient did not have a fever. Mother gave patient heat pack, ice pack and Tylenol on Thursday.  Patient's mother gave  Benadryl on Friday (10/13/23.)  On 10/18/23, patient still had a bump at the injection site but no redness or swelling.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: pruritic full body papular rash
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Feeling hot, Hyperhidrosis, Malaise, Throat irritation
Clinical narrative: Patient returned in 30 minutes complaining of scratchy throat, feeling hot/sweaty, and generally unwell.  Was not having difficulty swallowing or breathing.  Offered patient diphenhydramine for mild allergic-type reaction.  Patient reported feeling better 45 minutes later.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9
Symptoms: Chest pain, Electrocardiogram normal
Clinical narrative: pt stated chest pain
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: The patient was at our pharmacy on 10/17/23 to receive the newest COVID vaccine by Pfizer, Comirnaty.  A few hours after he received a dose, he felt a sudden pain on his stomach.  He said it was very painful.  He took over-the-counter pain medications he had at home and the medications did help.  The next day he felt better.
Age: 23.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Underdose, Wrong product administered
Clinical narrative: Patient received the incorrect vaccine.  He received Pfizer Covid-19 vaccine intended for 5-12 yr old patients.  I contacted the patient and he received the correct Moderna Spikevax vaccine later the same day at 7:10pm.  No adverse effects were reported by patient.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pruritus, Urticaria
Clinical narrative: Patient states she received spikevax vaccine  on 10/1/2023. By tuesday morning 10/3/23 she started getting low blood pressure symptoms and welts that started growing over her body roughly 48 hours after being vaccinated with spikevax. The welts started small and started to spread and she felt very itchy. She is since feeling much better.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 55.0
Sex: F
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received the incorrect vaccine.  She received Pfizer Covid-19 vaccine intended for 5-12 yr old patients.  I contacted the patient and she received the correct Moderna Spikevax vaccine later the same day at 7:10pm.  No adverse effects were reported by patient.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Brain fog, Headache, Impaired driving ability, Memory impairment, Vision blurred
Clinical narrative: Severe headache, blurry vision (unable to drive), brain fog, poor memory
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Eyelids pruritus, Swelling of eyelid
Clinical narrative: The patient states the next morning her right upper eye lid became swollen.  She has a small elongated itchy patch on the inner eyelid corner.  She reports no pain.  Her biggest complaint is itching.   She plans to take an oral antihistamine (loratadine) to help with the itch.  She may follow up with her provider.
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Underdose, Wrong product administered
Clinical narrative: Patient received the incorrect vaccine.  He received Pfizer Covid-19 vaccine intended for 5-12 yr old patients.  I contacted the patient and he understands that he needs to be revaccinated with the correct vaccine.  No adverse effects were reported by patient.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Disturbance in attention, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fatigue, muscle pain, can not concentrate, low-grade fever,  joint pain
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient came in to get a flu shot on 10/18. However, after the shot was given, it was noted that she already got the flu shot on 10/5. We immediately contacted the patient and told her that she already had a flu shot. She said that she thought she only had Arexvy and not the flu shot. We told her to watch for any untoward side effects and let us know.
Age: 64.0
Sex: F
Vaccine: COVID19, PNC15
Symptoms: Immediate post-injection reaction, Urticaria, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Site of vaccines turned red and welted within 30 seconds of poke. Patient had no other symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Underdose, Wrong product administered
Clinical narrative: Patient received the incorrect vaccine.  She received Pfizer Covid-19 vaccine intended for 5-12 yr old patients.  I contacted the patient and she understands that she will need revaccinated with the correct vaccine.  No adverse effects were reported by patient.
Age: 64.0
Sex: F
Vaccine: FLUA4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient came in to get a flu shot at a vaccine clinic at her employment. When she signed up, she put her age on the form as 74 thus we gave Fluad. On data entry at the pharmacy, actual patient's age is 64.  Patient was contacted and notified that she was given the dose that is intended for 65+. We told her to let us know if there are unusual side effects from the vaccine that she will notice.
Age: 46.0
Sex: F
Vaccine: DT
Symptoms: Axillary pain, Injection site erythema, Injection site pruritus, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Redness & warm to touch below site. Itchy at and bellow site. Tingling / pins & needles and pain left arm and armpit. Shoulder, arm feel tight/ swollen. Bump / induration apx 5+ cm across.
Age: 46.0
Sex: F
Vaccine: DT
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Redness & warm to touch below site. Itchy at and bellow site. Tingling / pins & needles and pain left arm and armpit. Shoulder, arm feel tight/ swollen. Bump / induration apx 5+ cm across.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administer triple dose.  No immediate signs, symptoms or side effects noted.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Blister, Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Pt received vaccines on 10/9,  got IV contrast dye on 10/10, then called 10/11 to say that her right arm was red and swollen and also both thighs were red and swollen. She went to the hospital on 10/14 because her legs became blistered and was treated for an allergic reaction. The hospital was not able to determine the cause of the reaction.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired driving ability, Joint range of motion decreased, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: I was ordered by my employer to receive a flu shot. At the time off injection, I noticed that my injection was higher than where I've normally received them in the past- about two fingers width below the riding of my shoulder. Within hours of administration I began to experience severe pain and stiffness is my arm. Several days passed and the pain and lack of mobility remained. The intensity eventually subsidized, but I still experienced pain with motion. As time progressed, The pain began to increase. I started experiencing pain when dressing/undressing, turning my wheel while driving, and other basic tasks.  Nsaids and Tylenol had no effect when taken. On October 7th, I was in so much pain and experienced a decreased range of motion to the point I was unable to sweep my floor or open a jar. I went to urgent care that afternoon as I suspected that this was no longer within the realm of being a normal side effect.  I was advised that this may be a result of an improperly administered vaccine. I was also advised that this may be exacerbated by my Fibromyalgia.  I was prescribed Baclofen, given instructions to rotate with ice/heat, but to continue movement and do "spidercrawls" with my fingers. I did as instructed, but my condition not improve over the next week.  Today, October 18th, I saw PCP who acknowledged a likely improper administration and diagnosed me with a frozen shoulder. She has prescribed Meloxicam and referred me to physical therapy.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Periarthritis, Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: I was ordered by my employer to receive a flu shot. At the time off injection, I noticed that my injection was higher than where I've normally received them in the past- about two fingers width below the riding of my shoulder. Within hours of administration I began to experience severe pain and stiffness is my arm. Several days passed and the pain and lack of mobility remained. The intensity eventually subsidized, but I still experienced pain with motion. As time progressed, The pain began to increase. I started experiencing pain when dressing/undressing, turning my wheel while driving, and other basic tasks.  Nsaids and Tylenol had no effect when taken. On October 7th, I was in so much pain and experienced a decreased range of motion to the point I was unable to sweep my floor or open a jar. I went to urgent care that afternoon as I suspected that this was no longer within the realm of being a normal side effect.  I was advised that this may be a result of an improperly administered vaccine. I was also advised that this may be exacerbated by my Fibromyalgia.  I was prescribed Baclofen, given instructions to rotate with ice/heat, but to continue movement and do "spidercrawls" with my fingers. I did as instructed, but my condition not improve over the next week.  Today, October 18th, I saw PCP who acknowledged a likely improper administration and diagnosed me with a frozen shoulder. She has prescribed Meloxicam and referred me to physical therapy.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb
Clinical narrative: I was ordered by my employer to receive a flu shot. At the time off injection, I noticed that my injection was higher than where I've normally received them in the past- about two fingers width below the riding of my shoulder. Within hours of administration I began to experience severe pain and stiffness is my arm. Several days passed and the pain and lack of mobility remained. The intensity eventually subsidized, but I still experienced pain with motion. As time progressed, The pain began to increase. I started experiencing pain when dressing/undressing, turning my wheel while driving, and other basic tasks.  Nsaids and Tylenol had no effect when taken. On October 7th, I was in so much pain and experienced a decreased range of motion to the point I was unable to sweep my floor or open a jar. I went to urgent care that afternoon as I suspected that this was no longer within the realm of being a normal side effect.  I was advised that this may be a result of an improperly administered vaccine. I was also advised that this may be exacerbated by my Fibromyalgia.  I was prescribed Baclofen, given instructions to rotate with ice/heat, but to continue movement and do "spidercrawls" with my fingers. I did as instructed, but my condition not improve over the next week.  Today, October 18th, I saw PCP who acknowledged a likely improper administration and diagnosed me with a frozen shoulder. She has prescribed Meloxicam and referred me to physical therapy.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria, Scratch
Clinical narrative: 6 cm x 6 cm area of induration and redness with wheels/scratches on right lateral thigh
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: Shot was given too high in right arm.  Nearly on top of shoulder. The pain in my shoulder is getting worse by the day. I cannot move my arm without severe pain
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Disorientation, Dysstasia, Feeling abnormal, Hypersomnia
Clinical narrative: After receiving the 2nd dose I felt like death later that afternoon, I couldn?t think straight was very disoriented and immediately passed out and slept from 7pm until 7am I didn?t move that entire time. Then a week after my lower back was inflamed I was unable to stand up from a sitting position with out  feeling tremendous pain to my lower back.  My spinal nerves were inflamed and my lower lumber was compressing the nerves
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Loss of consciousness, Magnetic resonance imaging spinal abnormal, Pain, Radiculopathy
Clinical narrative: After receiving the 2nd dose I felt like death later that afternoon, I couldn?t think straight was very disoriented and immediately passed out and slept from 7pm until 7am I didn?t move that entire time. Then a week after my lower back was inflamed I was unable to stand up from a sitting position with out  feeling tremendous pain to my lower back.  My spinal nerves were inflamed and my lower lumber was compressing the nerves
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Spinal decompression, Thinking abnormal
Clinical narrative: After receiving the 2nd dose I felt like death later that afternoon, I couldn?t think straight was very disoriented and immediately passed out and slept from 7pm until 7am I didn?t move that entire time. Then a week after my lower back was inflamed I was unable to stand up from a sitting position with out  feeling tremendous pain to my lower back.  My spinal nerves were inflamed and my lower lumber was compressing the nerves
Age: 7.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Dizziness
Clinical narrative: Five minutes after being administered the vaccine, the patient stated not knowing where she was and also stated to feel dizzy, but did not faint. The parent became concerned, and a bystander called emergency services. EMS arrived, after which the patient stated to start feeling better. Parent refused EMS services. Both parent and patient left without further incident. No history of adverse reactions to vaccines listed on the intake form. Unclear if this was a true adverse reaction to the vaccine or whether this was due to other circumstances.
Age: 69.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Abdominal pain, Diarrhoea, Haematochezia, Headache, Nasal congestion
Clinical narrative: Within 12 hours had a headache and stuffy nose. About 12 hours later experienced intense itching in four areas on body, mostly hands and foot. Another 12 hours later and after a small breakfast had very loose stools with extreme abdominal pain off and on for about 90 minutes and ending with bloody stool. This time frame also included vomiting
Age: 69.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Pruritus, Vomiting
Clinical narrative: Within 12 hours had a headache and stuffy nose. About 12 hours later experienced intense itching in four areas on body, mostly hands and foot. Another 12 hours later and after a small breakfast had very loose stools with extreme abdominal pain off and on for about 90 minutes and ending with bloody stool. This time frame also included vomiting
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain, Sleep disorder
Clinical narrative: PT received Moderna Spikevax on 10/14 from our pharmacy. Pt called in on 10/18 to report the issue. The patient said that the vaccinating pharmacist had said that the initial needle that he was planning to use was too short, and that he was going to get a longer needle. Immediately after the vaccine was administered, the patient said "It hurt as bad as when I tore my rotator cuff." She reported asking the pharmacist about it being given too high, and they responded that it was given in the correct place. That whole day, the pain did not subside, and she was awake all night taking Tylenol and Advil for pain, but it has provided little to no help. She reports that she has been unable to move her arm/shoulder until today, but that the movement is still limited and painful.
Age: 32.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Loss of consciousness
Clinical narrative: PATIENT PASSED OUT AFTER RECEIVING A DOSE OF 23/24 COMIRNATY PFIZER COVID VACCINE AND A DOSE OF SEASONAL FLU VACCINE. AMBULANCE WAS CALLED. PATIENT REGAINED CONSIOUSNESS BY THE TIME ANMBULANCE ARRIVED. REFUSED FUTHER EVALUATION/RIDE IN AMBULANCE OFFERED BY THE EMERGENCY CREW AS A FOLLOW UP. PATIENT WAITED FOR ABOUT 15 MINUTES IN PHARMACY WAITING AREA AND GOT A FRIEND TO PICK HER UP
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blister rupture, Bloody discharge, Discharge, Erythema
Clinical narrative: Patient said his arm was red, swollen and developed a blister about the size of a quarter.  I was draining fluid and blood.  He went to urgent care and they cleaned it up and told him to use vaseline and bandaid until healed.  It was healed, but a red spot was still on his arm when he reported this on 10/11/2023
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Patient said his arm was red, swollen and developed a blister about the size of a quarter.  I was draining fluid and blood.  He went to urgent care and they cleaned it up and told him to use vaseline and bandaid until healed.  It was healed, but a red spot was still on his arm when he reported this on 10/11/2023
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia, Headache, Malaise, Oral pain, Pain in extremity
Clinical narrative: After shot, six hours later had  24 hours of general malaise which has occurred with each vaccine. Then 48 hours after shot, bucal mouth pain that eventually turned into mouth sore 4 days later. Off and on headache and loss taste. Upper left arm pain slowly decreasing, still sore 6 days later.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Stomatitis
Clinical narrative: After shot, six hours later had  24 hours of general malaise which has occurred with each vaccine. Then 48 hours after shot, bucal mouth pain that eventually turned into mouth sore 4 days later. Off and on headache and loss taste. Upper left arm pain slowly decreasing, still sore 6 days later.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection related reaction, Injection site swelling, Pruritus
Clinical narrative: The vaccine is Moderna Spikevax  Arm is itchy , hurts to the touch, and  is a little swollen
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is only 63 and was given a high dose flu shot for 65+ instead of the regular quadrivalent flu shot
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Low grade fever continues five days after injection; skin is red in a rectangular shape diagonally from the injection site (site was upper left arm near the shoulder and the shape is down and on the inner arm towards the body
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient came in for flu shot but administered moderna shot. There were 2 people with similar first names. When pharmacist called for Patient, patient stepped up ( she upset because she was waiting for 20 minutes ) Pharmacist told her that I am going to give you covid vaccine vaccine, she may be did not pay attention she was upset. Patient had 5 pfizer shorts in the past, but she said she was not going to get this new vaccine.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea
Clinical narrative: Patient reports diarrhea for 10 to 12 hours after vaccine. Started close to midnight.
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vial was not diluted. Entire vial was drawn and administered to patient. Two days later, medical assistant realized error and informed staff Called patient's parent, no obvious side effects noted since error. Pfizer called, advised not to repeat dose, continue schedule for subsequent doses
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Presyncope, Seizure, Syncope
Clinical narrative: Patient did not report history of adverse reaction to vaccines or fainting.  After receiving a flu and COVID vaccine at a clinic, she very quicky fainted and had some convulsions for approximately 2 seconds.  RPH held her head & arms so she would not fall out of chair.  We laid her down while calling campus EMS to respond - BP was 110/80.  She reported a headache & nausea.  RPH stayed to observe for 20 minutes - friend was also present.  After standing, patient reported to health services on campus for futher evaluation/observation.  EMS & campus health conclused vasovagal response to vaccine administration.  Patient later disclosed that she has fainted before.
Age: 23.0
Sex: F
Vaccine: FLUR4
Symptoms: Confusional state, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Patient reported history of vasovagal response to 2020 COVID dose - mother was present on 10/6 for flu vaccination just in case.  RPH advised to lay down for vaccine -patient and mother refused this advisement since she had not had any issue with a flu shot in the past.  Approximately 30 seconds after vaccine, patinet reported "feeling it coming" and was lightheaded, sweating, and fainted for about 30 seconds.  When she came to, she was confused, sweating, BP 120/84.  Campus EMS was called at mother's request, patient observed & went home with mother about 30 min later.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Presented to doctor's office on 10/2/23 with complaints of increased redness , swelling, and warmth at injection site. Reports that symptoms have been worsening but no fever or chills. At the time of presentation on 10/2, redness and swelling was moving all the way down to patient's elbow. Patient started on cefuroxime and reported symptoms began improving on 10/3.
Sex: F
Vaccine: HEP, MMR, VARCEL, HEP, MMR, VARCEL
Symptoms: Fatigue, Maternal exposure before pregnancy, Nausea
Clinical narrative: Patient received vaccine on 14-AUG-2023 and learned she was pregnant on 16-SEP-2023; Patient reports no symptoms or side effects; This spontaneous prospective report was received from a nurse, referring to a currently 38-year-old female patient without known allergies. Her concurrent conditions included polycystic ovarian syndrome. The patient's medical history and concomitant therapies were not reported.  The patient's last menstrual period was on 25-JUL-2023. Later, on 14-AUG-2023, the patient presented to reporter's clinic to receive immigration vaccines and was vaccinated with: varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, first dose, lot #X006979 with expiration date on 07-MAR-2025, administered subcutaneously in left arm (dose not provided); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, first dose, lot # X005838 with expiration date on 03-JUN-2024, administered subcutaneously in left arm (dose not provided); and hepatitis b vaccine, lot # reported as NT9X3 with expiration date on 09-SEP-2024, administered intramuscularly in left arm (dose not provided). By that time, the patient was asked if she was planning on becoming pregnant or if she was pregnant, and answered no to both questions. No pregnancy tests were performed prior to vaccines administration.   On 22-AUG-2023, the patient noticed she missed her period and learned she became pregnant on 16-SEP-2023 (exposure during pregnancy). Therefore, on 19-SEP-2023, she presented to clinic and informed the reporter about pregnancy status. No treatment was given to the patient.  By the time of the report, pregancy outcome was pending and the fetal outcome was unknown. Additionally, she had not seen an obstetric provider, but was scheduled for first visit in December 2023. No symptoms, side effects or complaints were reported. The estimated date of delivery would be on 30-APR-2024.  Lot number X005838 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Sex: F
Vaccine: HEP, MMR, VARCEL, HEP, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient received vaccine on 14-AUG-2023 and learned she was pregnant on 16-SEP-2023; Patient reports no symptoms or side effects; This spontaneous prospective report was received from a nurse, referring to a currently 38-year-old female patient without known allergies. Her concurrent conditions included polycystic ovarian syndrome. The patient's medical history and concomitant therapies were not reported.  The patient's last menstrual period was on 25-JUL-2023. Later, on 14-AUG-2023, the patient presented to reporter's clinic to receive immigration vaccines and was vaccinated with: varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, first dose, lot #X006979 with expiration date on 07-MAR-2025, administered subcutaneously in left arm (dose not provided); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, first dose, lot # X005838 with expiration date on 03-JUN-2024, administered subcutaneously in left arm (dose not provided); and hepatitis b vaccine, lot # reported as NT9X3 with expiration date on 09-SEP-2024, administered intramuscularly in left arm (dose not provided). By that time, the patient was asked if she was planning on becoming pregnant or if she was pregnant, and answered no to both questions. No pregnancy tests were performed prior to vaccines administration.   On 22-AUG-2023, the patient noticed she missed her period and learned she became pregnant on 16-SEP-2023 (exposure during pregnancy). Therefore, on 19-SEP-2023, she presented to clinic and informed the reporter about pregnancy status. No treatment was given to the patient.  By the time of the report, pregancy outcome was pending and the fetal outcome was unknown. Additionally, she had not seen an obstetric provider, but was scheduled for first visit in December 2023. No symptoms, side effects or complaints were reported. The estimated date of delivery would be on 30-APR-2024.  Lot number X005838 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bipolar disorder, Condition aggravated
Clinical narrative: Significant and extensive worsening of Bipolar disorder.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 04Oct2023 at 21:30 as dose 1, single (Lot number: HG4665) at the age of 54 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: RISPERIDONE; LAMOTRIGINE; METOPROLOL; AMLODIPINE. Vaccination history included: Covid-19 vaccine (Dose 4), for Covid-19 immunization; Covid-19 vaccine (Dose 3), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 1), for Covid-19 immunization. The following information was reported: BIPOLAR DISORDER (medically significant) with onset 09Oct2023 at 11:00, outcome "not recovered", described as "Significant and extensive worsening of Bipolar disorder.". The events "significant and extensive worsening of bipolar disorder." required physician office visit. Therapeutic measures (increase of Risperidone and additional atypical an) were taken as a result of bipolar disorder.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disorders" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "Known allergies: Iodine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "Treatment of 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 vaccination failure, covid-19. Clinical course: Patient received COVID 19 anti viral treatment with Anti viral from 30Sep2023 to 05Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.