chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered FLUZONE HD to a 59-year-old patient with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 59 years old female patient who was inadvertently administered influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, 59-year-old patient received an unknown dose of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with strength- high dose (lot U8515EA and expiry date- 30-Jun-2025) once via unknown route in unknown administration site as prophylactic vaccination with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given a 3rd dose of MENQUADFI, with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 17 years old female patient to whom had administered a 3rd dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza vaccine inact split 3v (Flulaval) for Immunisation; and HPV vaccine VLP rL1 4v (yeast) (Gardasil) for Immunisation.  On 09-Oct-2024, the patient received a 0.5 ml (dose 3) dose of suspect A-C-Y-W135 (T Conj) Vaccine Solution for injection (strength: standard, frequency: once and expiry date: 31-Jul-2026, lot U8113BA via intramuscular route in the right arm as immunization (extra dose administered) (latency; same day)   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Sender's Comment: Reporter can be contacted by Sanofi: Yes
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Patient contacted office at 4:32 pm on 10/22/24 via online chart message stating that their right arm, shoulder, neck and hand were all very painful. Patient asked which vaccine was given in arm.  Responded to patient on 10/23/24 to see if they were still experiencing symptoms on 3:21 pm, and asked if they would like to discuss further with triage nurse team.
Age: 78.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site rash, Injection site warmth, Rash
Clinical narrative: PATIENT IS EXPERIENCING A RASH AROUND THE INJECTION SITE  AND SLIGHTLY BELOW AND A LITTLE ON THE UPPER BACK. THE RASH IS NOT PAINFUL AND DOES NOT ITCH.  THE AREA AROUND THE INJECTION SITE IS WARM.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received duplicate Abrysvo vaccine at clinic on 10/17/24. Patient already received Abrysvo in 11/01/2023. There is no adverse event occurs.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site bruising, Rash erythematous, Rash papular
Clinical narrative: Patient reported to pharmacy 10/21 and was asking for advice regarding left arm following vaccination. Left arm had a red rash that was raised and approximately the size of an orange. The patient told me that redness and size of the rash area had not decreased since vaccination. Patient was also noted to have a bruise on right arm where flu vaccination was given. I suggested patient seek urgent care. Patient's APNP contacted me to verify that I was aware of post-vaccine outcome. APNP prescribed cephalexin for cellulitis.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Fall, Loss of consciousness
Clinical narrative: Patient received Spikevax, and went grocery shopping afterwards. She was found unconscious (she fell face down causing a severe nosebleed). She regained consciousness and agreed to call the paramedics to be evaluated at the hospital. She remembers feeling dizzy immediately before the event.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Anal incontinence, Balance disorder, Blindness, Fatigue, Hyperhidrosis
Clinical narrative: Migraine type headache, sensitivity to light, nausea, sweating, loss of balance, vision loss, fainting, loss of bladder and bowel control, freezing cold hands, temperature, fatigue, muscle and nerve pain
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Migraine, Myalgia, Nausea, Neuralgia, Peripheral coldness
Clinical narrative: Migraine type headache, sensitivity to light, nausea, sweating, loss of balance, vision loss, fainting, loss of bladder and bowel control, freezing cold hands, temperature, fatigue, muscle and nerve pain
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Photophobia, Syncope, Urinary incontinence
Clinical narrative: Migraine type headache, sensitivity to light, nausea, sweating, loss of balance, vision loss, fainting, loss of bladder and bowel control, freezing cold hands, temperature, fatigue, muscle and nerve pain
Age: 64.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient stated when filling out Vaccine Consent form that his last Covid-19 vaccination had been > 1 year ago. After administration it was discovered that the patient had received a Pfizer Covid-19 booster on 8/29/24 (27 days ago). The vaccination given was not a Pfizer 24-25 vaccination, so the patient was indicated for the most recent Spikevax 24-25 vaccination but since it was given within 8 weeks a VAERS report is being filed. The patient has been contacted and is aware of the administration error and that this report is being filed. He has been counseled on possible adverse reaction and has been asked to call the pharmacy if he has any further questions or issues.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haematoma, Patient uncooperative
Clinical narrative: Child jolted out of seat when needle was still in arm, resulting in needle moving around in arm before sliding out. No vaccine was administered in first attempt. Replaced needle and rewiped area of arm with alcohol swab, administering in area next to previous area. Noticed a hematoma forming due to the injury from the first attempt.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Cough, Sleep disorder
Clinical narrative: Severe, breath taking coughs. No mucus with them.  I started taking Dayquil, Nitequil, cough medicine and cough drops. I have no allergies, no fever and do not feel bad.  I cough all day and all night.  I try to sleep with two propped up pillows because laying down makes the coughing worse.  I finally called my doctor who examined and questioned me and gave me some samples of Mucinex  and Delsym and ordered a chest xray.  These did not help.  She also prescribed Benzonatate capsules which I just started taking.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Anti-ganglioside antibody, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Arthralgia
Clinical narrative: I have had Pfizer COVID19 vaccines in past without any issues in past (mRNA vac 1/7/21, 1/28/21, 1/10/22; bivalent 12+ 11/2/22) prior to receiving the Moderna Spikevax COVID19 vaccine on 11/27/23.   At the time of this vaccination, I was an otherwise healthy 36 yo F, with pertinent past medical history of R ulnar neuropathy in 2019 (severe acute-onset motor and sensory R ulnar neuropathy starting 3/15/19 with 3 months of maximal symptoms [severe pain, swelling, and 3/5 motor weakness] and significant functional impairments, followed by gradual improvements and recovery by 3/15/20). This condition was thought to have been immunologic (autoimmune vs sequelae of a prior viral URI), and it has remained completely stable following remission in 2020, with very mild residual pain and mild motor weakness (5-/5) in the R ulnar distribution and no functional impairments.   Within 1 week of the Moderna Spikevax COVID19 vaccination on 11/27/23, I developed a new sensory neuropathy of L hand with pain, tingling, and numbness on the dorsal aspect of left thumb and first webspace, accompanied by intermittent red, purple, and bluish discoloration in the same areas at different days/times. The pain, tingling, and discoloration resolved within 2 weeks, but the partial sensory loss has persisted.  Within 3 weeks of the Moderna Spikevax COVID19 vaccination on 11/27/23, I developed a new sensory neuropathy of R medial knee and calf without foot involvement, with pain, tingling and dysesthesia, as well as functional impairments (i.e., reduced activities due to pain). It has gradually improved over 3 months thereafter, with residual symptoms being partial sensory deficits since then.   I had an urgent visit with my neurologist 12/19/23 who evaluated the new neuropathies with extensive laboratory workup as well as an EMG and NCS. His impression was that the new neuropathies were likely to be immune-mediated and may have been provoked by the COVID19 vaccination given the temporal course. It is possible that the new symptoms were part of a pre-existing multifocal neuropathy that had relapsed but given that my R ulnar neuropathy had been completely stable after remission since 2019-2020 as well as the temporal course of symptoms following the vaccination, he felt that they were more likely to have been a reaction to the vaccination. Since then, I have had several other neurologist visits, as well as extensive physical therapy, with gradual symptomatic improvements without other interventions. As of 10/23/24, the residual sensory deficits of R knee and calf, as well as L hand, remains, though quite mild in severity compared to when they first started, and not impairing my functionality at work or life.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Condition aggravated, Cryoglobulins, Dysaesthesia, Electromyogram
Clinical narrative: I have had Pfizer COVID19 vaccines in past without any issues in past (mRNA vac 1/7/21, 1/28/21, 1/10/22; bivalent 12+ 11/2/22) prior to receiving the Moderna Spikevax COVID19 vaccine on 11/27/23.   At the time of this vaccination, I was an otherwise healthy 36 yo F, with pertinent past medical history of R ulnar neuropathy in 2019 (severe acute-onset motor and sensory R ulnar neuropathy starting 3/15/19 with 3 months of maximal symptoms [severe pain, swelling, and 3/5 motor weakness] and significant functional impairments, followed by gradual improvements and recovery by 3/15/20). This condition was thought to have been immunologic (autoimmune vs sequelae of a prior viral URI), and it has remained completely stable following remission in 2020, with very mild residual pain and mild motor weakness (5-/5) in the R ulnar distribution and no functional impairments.   Within 1 week of the Moderna Spikevax COVID19 vaccination on 11/27/23, I developed a new sensory neuropathy of L hand with pain, tingling, and numbness on the dorsal aspect of left thumb and first webspace, accompanied by intermittent red, purple, and bluish discoloration in the same areas at different days/times. The pain, tingling, and discoloration resolved within 2 weeks, but the partial sensory loss has persisted.  Within 3 weeks of the Moderna Spikevax COVID19 vaccination on 11/27/23, I developed a new sensory neuropathy of R medial knee and calf without foot involvement, with pain, tingling and dysesthesia, as well as functional impairments (i.e., reduced activities due to pain). It has gradually improved over 3 months thereafter, with residual symptoms being partial sensory deficits since then.   I had an urgent visit with my neurologist 12/19/23 who evaluated the new neuropathies with extensive laboratory workup as well as an EMG and NCS. His impression was that the new neuropathies were likely to be immune-mediated and may have been provoked by the COVID19 vaccination given the temporal course. It is possible that the new symptoms were part of a pre-existing multifocal neuropathy that had relapsed but given that my R ulnar neuropathy had been completely stable after remission since 2019-2020 as well as the temporal course of symptoms following the vaccination, he felt that they were more likely to have been a reaction to the vaccination. Since then, I have had several other neurologist visits, as well as extensive physical therapy, with gradual symptomatic improvements without other interventions. As of 10/23/24, the residual sensory deficits of R knee and calf, as well as L hand, remains, though quite mild in severity compared to when they first started, and not impairing my functionality at work or life.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Electrophoresis protein, Hypoaesthesia, Light chain analysis, Nerve conduction studies, Pain in extremity
Clinical narrative: I have had Pfizer COVID19 vaccines in past without any issues in past (mRNA vac 1/7/21, 1/28/21, 1/10/22; bivalent 12+ 11/2/22) prior to receiving the Moderna Spikevax COVID19 vaccine on 11/27/23.   At the time of this vaccination, I was an otherwise healthy 36 yo F, with pertinent past medical history of R ulnar neuropathy in 2019 (severe acute-onset motor and sensory R ulnar neuropathy starting 3/15/19 with 3 months of maximal symptoms [severe pain, swelling, and 3/5 motor weakness] and significant functional impairments, followed by gradual improvements and recovery by 3/15/20). This condition was thought to have been immunologic (autoimmune vs sequelae of a prior viral URI), and it has remained completely stable following remission in 2020, with very mild residual pain and mild motor weakness (5-/5) in the R ulnar distribution and no functional impairments.   Within 1 week of the Moderna Spikevax COVID19 vaccination on 11/27/23, I developed a new sensory neuropathy of L hand with pain, tingling, and numbness on the dorsal aspect of left thumb and first webspace, accompanied by intermittent red, purple, and bluish discoloration in the same areas at different days/times. The pain, tingling, and discoloration resolved within 2 weeks, but the partial sensory loss has persisted.  Within 3 weeks of the Moderna Spikevax COVID19 vaccination on 11/27/23, I developed a new sensory neuropathy of R medial knee and calf without foot involvement, with pain, tingling and dysesthesia, as well as functional impairments (i.e., reduced activities due to pain). It has gradually improved over 3 months thereafter, with residual symptoms being partial sensory deficits since then.   I had an urgent visit with my neurologist 12/19/23 who evaluated the new neuropathies with extensive laboratory workup as well as an EMG and NCS. His impression was that the new neuropathies were likely to be immune-mediated and may have been provoked by the COVID19 vaccination given the temporal course. It is possible that the new symptoms were part of a pre-existing multifocal neuropathy that had relapsed but given that my R ulnar neuropathy had been completely stable after remission since 2019-2020 as well as the temporal course of symptoms following the vaccination, he felt that they were more likely to have been a reaction to the vaccination. Since then, I have had several other neurologist visits, as well as extensive physical therapy, with gradual symptomatic improvements without other interventions. As of 10/23/24, the residual sensory deficits of R knee and calf, as well as L hand, remains, though quite mild in severity compared to when they first started, and not impairing my functionality at work or life.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral sensory neuropathy, Red blood cell sedimentation rate, Rheumatoid factor, Skin discolouration
Clinical narrative: I have had Pfizer COVID19 vaccines in past without any issues in past (mRNA vac 1/7/21, 1/28/21, 1/10/22; bivalent 12+ 11/2/22) prior to receiving the Moderna Spikevax COVID19 vaccine on 11/27/23.   At the time of this vaccination, I was an otherwise healthy 36 yo F, with pertinent past medical history of R ulnar neuropathy in 2019 (severe acute-onset motor and sensory R ulnar neuropathy starting 3/15/19 with 3 months of maximal symptoms [severe pain, swelling, and 3/5 motor weakness] and significant functional impairments, followed by gradual improvements and recovery by 3/15/20). This condition was thought to have been immunologic (autoimmune vs sequelae of a prior viral URI), and it has remained completely stable following remission in 2020, with very mild residual pain and mild motor weakness (5-/5) in the R ulnar distribution and no functional impairments.   Within 1 week of the Moderna Spikevax COVID19 vaccination on 11/27/23, I developed a new sensory neuropathy of L hand with pain, tingling, and numbness on the dorsal aspect of left thumb and first webspace, accompanied by intermittent red, purple, and bluish discoloration in the same areas at different days/times. The pain, tingling, and discoloration resolved within 2 weeks, but the partial sensory loss has persisted.  Within 3 weeks of the Moderna Spikevax COVID19 vaccination on 11/27/23, I developed a new sensory neuropathy of R medial knee and calf without foot involvement, with pain, tingling and dysesthesia, as well as functional impairments (i.e., reduced activities due to pain). It has gradually improved over 3 months thereafter, with residual symptoms being partial sensory deficits since then.   I had an urgent visit with my neurologist 12/19/23 who evaluated the new neuropathies with extensive laboratory workup as well as an EMG and NCS. His impression was that the new neuropathies were likely to be immune-mediated and may have been provoked by the COVID19 vaccination given the temporal course. It is possible that the new symptoms were part of a pre-existing multifocal neuropathy that had relapsed but given that my R ulnar neuropathy had been completely stable after remission since 2019-2020 as well as the temporal course of symptoms following the vaccination, he felt that they were more likely to have been a reaction to the vaccination. Since then, I have had several other neurologist visits, as well as extensive physical therapy, with gradual symptomatic improvements without other interventions. As of 10/23/24, the residual sensory deficits of R knee and calf, as well as L hand, remains, though quite mild in severity compared to when they first started, and not impairing my functionality at work or life.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received duplicate Fuad vaccine within 10 days at flu clinic
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Same vaccine was given twice for a resident
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Tonsillar erythema, Tonsillar hypertrophy
Clinical narrative: Only the Right side of my tonsil is swollen and red.
Age: 41.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy
Clinical narrative: Rsv vaccine that i was given  is. Not approved for pregnancy and was documented incorrectly
Age: 41.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Pyrexia
Clinical narrative: Rsv vaccine that i was given  is. Not approved for pregnancy and was documented incorrectly
Age: 71.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Dyspnoea, Fatigue, Pyrexia
Clinical narrative: 100 degree Fahrenheit fever over 2 days, extreme tiredness, difficulty breathing for 2 days
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Client received a flu vaccination without consent from parent.   Mother stated child was very sleepy all afternoon including falling to sleep during shopping a local grocery store - very
Age: 73.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Back pain
Clinical narrative: Pt saw PCP on 10/23/24 and was prescribed prednisone 20mg tablets (2 tabs po QD x5d) for pain in his back.
Age: 73.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Arthralgia, Atrial fibrillation, Chills, Condition aggravated, Echocardiogram
Clinical narrative: Pt saw PCP on 10/23/24 and was prescribed prednisone 20mg tablets (2 tabs po QD x5d) for pain in his back.
Age: 73.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered, Immediate post-injection reaction, Injection site pain, Migraine, Myalgia
Clinical narrative: Pt saw PCP on 10/23/24 and was prescribed prednisone 20mg tablets (2 tabs po QD x5d) for pain in his back.
Age: 73.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Palpitations, Viral infection, White blood cell count increased
Clinical narrative: Pt saw PCP on 10/23/24 and was prescribed prednisone 20mg tablets (2 tabs po QD x5d) for pain in his back.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Fatigue, Guillain-Barre syndrome, Paraesthesia, Vision blurred
Clinical narrative: Patient believes she is experiencing guillain-barre syndrom.  States she has blurred and double vision, tingling in her extremities and chronic fatigue.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Rash erythematous, Rash papular, Skin warm
Clinical narrative: Red rash with raised edges and warm to touch within 8 hours of vaccine, headache, body aches, all within 12 hours of vaccine
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest pain, Heart rate increased
Clinical narrative: Patient was given both Flublok and Comirnaty vaccines on 10/21/24. Patient stated that she started experiencing symptoms of chest pain and high heart rate that same night. The following day, 10/22/24, patient went to the ER to get checked out. She says that she no longer has symptoms of chest pain but is still experiencing high heart rate (current heart rate was in the 90s). Patient was consulted to continue to monitor her symptoms and keep track of her heart rate daily. Advised her to contact her doctor or go to ER if her symptoms get worst.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was accidentally administered two doses of flucelvax on the same day at the same time. Patient was made aware of the error and expressed understanding.
Age: 42.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Brain fog, Fatigue, Headache, Injection site pain
Clinical narrative: Injection sites pain, headache, fatigue, brain fog
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient got a vaccine on the 19th and has come in complaining of a rash. I could see a slight rash across her body. She states no real rash around where vaccine was administered. Told patient to take some benadryl and use hydrocortisone cream. If the rash gets worse or she starts to swell I informed patient to go seek medical help.
Age: 35.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient lost consciousness after vaccine administration
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Moderate Neck stiffness and it's very hot on the neck area, Slight headache, Severe Joint Pain, Nausea and Fatigue
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: SARS-CoV-2 test negative, Skin warm
Clinical narrative: Moderate Neck stiffness and it's very hot on the neck area, Slight headache, Severe Joint Pain, Nausea and Fatigue
Age: 59.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: Patient's first time receiving 2 vaccine on the same visit and same arm.  She got Spikevax (moderna) and  Flublok (flu shot)  on the same arm (Left deltoid muscle).  Upon getting home she put an icepack on the injection site since it was sore.  A few hours later she noticed redness few/several inches below the vaccine site.  She started to ice that area which then turned into a blister filled with fluid.. It ended up popping next day when she was applying icepack on it again.  It drained fluid and she started applying Neosporin to it.  the blister has healed but left darker skin color in the area.  She did not have any fever with the blister but the area was warm to touch per patient.  Patient never contacted pharmacy or other healthcare provider but husband was at the pharmacy and mentioned this so documenting after speaking with the patient herself
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen injection site. Red, and warm to touch
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test normal, Brain fog, Chest X-ray normal
Clinical narrative: I am on day eight of side effects. My side effects include constant headache (radiating back to front, sometimes to face and jaw), constant pain in my neck and traps, stiffness in my neck and traps, constant back pain (especially lower back), brain fog, joint pain, shortness of breath, fatigue, muscle weakness, poor sleep, shooting pains in my limbs, nausea, sensitivity to light. I did have a slight fever for the first 24 hours after my booster.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Facial pain, Fatigue, Headache
Clinical narrative: I am on day eight of side effects. My side effects include constant headache (radiating back to front, sometimes to face and jaw), constant pain in my neck and traps, stiffness in my neck and traps, constant back pain (especially lower back), brain fog, joint pain, shortness of breath, fatigue, muscle weakness, poor sleep, shooting pains in my limbs, nausea, sensitivity to light. I did have a slight fever for the first 24 hours after my booster.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza A virus test negative, Influenza B virus test negative, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: I am on day eight of side effects. My side effects include constant headache (radiating back to front, sometimes to face and jaw), constant pain in my neck and traps, stiffness in my neck and traps, constant back pain (especially lower back), brain fog, joint pain, shortness of breath, fatigue, muscle weakness, poor sleep, shooting pains in my limbs, nausea, sensitivity to light. I did have a slight fever for the first 24 hours after my booster.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Pain in jaw
Clinical narrative: I am on day eight of side effects. My side effects include constant headache (radiating back to front, sometimes to face and jaw), constant pain in my neck and traps, stiffness in my neck and traps, constant back pain (especially lower back), brain fog, joint pain, shortness of breath, fatigue, muscle weakness, poor sleep, shooting pains in my limbs, nausea, sensitivity to light. I did have a slight fever for the first 24 hours after my booster.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Poor quality sleep, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: I am on day eight of side effects. My side effects include constant headache (radiating back to front, sometimes to face and jaw), constant pain in my neck and traps, stiffness in my neck and traps, constant back pain (especially lower back), brain fog, joint pain, shortness of breath, fatigue, muscle weakness, poor sleep, shooting pains in my limbs, nausea, sensitivity to light. I did have a slight fever for the first 24 hours after my booster.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis normal
Clinical narrative: I am on day eight of side effects. My side effects include constant headache (radiating back to front, sometimes to face and jaw), constant pain in my neck and traps, stiffness in my neck and traps, constant back pain (especially lower back), brain fog, joint pain, shortness of breath, fatigue, muscle weakness, poor sleep, shooting pains in my limbs, nausea, sensitivity to light. I did have a slight fever for the first 24 hours after my booster.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Erythema, Perioral dermatitis, Rash, Respiratory tract congestion
Clinical narrative: Mother called clinic on 10/23/2024 to report an adverse reaction to vaccines received on 10/16/2024. Per mom, child developed an itchy throat evening of 10/16/2024 at home, but had no further complaints of an itchy throat afterwards. No medications taken at that time. Later in the week, specific date not provided by mother, child developed a rash on her neck and around her mouth. Rash resolved with use of Zyrtec prescribed during visit for allergies. "Cough and congestion" worsened after receiving vaccines per mother. Child has remained afebrile. No adverse reactions at injection sites per mother. Mother stated on 10/23/2024 patient came home from school with "large red spots on her thighs and calves," mother describes them as "they look like chicken pox, they're size of pepperonis." Provider informed, provider advised for child to be taken to ED for further evaluation.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Throat irritation
Clinical narrative: Mother called clinic on 10/23/2024 to report an adverse reaction to vaccines received on 10/16/2024. Per mom, child developed an itchy throat evening of 10/16/2024 at home, but had no further complaints of an itchy throat afterwards. No medications taken at that time. Later in the week, specific date not provided by mother, child developed a rash on her neck and around her mouth. Rash resolved with use of Zyrtec prescribed during visit for allergies. "Cough and congestion" worsened after receiving vaccines per mother. Child has remained afebrile. No adverse reactions at injection sites per mother. Mother stated on 10/23/2024 patient came home from school with "large red spots on her thighs and calves," mother describes them as "they look like chicken pox, they're size of pepperonis." Provider informed, provider advised for child to be taken to ED for further evaluation.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test normal, Impaired driving ability, Loss of personal independence in daily activities
Clinical narrative: On Saturday, October 19, 2024, I began to experience pain at my hip, both upper hip (which feels like lower back pain) and lower hip (pain in the buttocks). This pain came on suddenly and the pain was intense from the start. It has affected my daily mundane tasks such as putting on my shoes and driving. The pain has been constant since it began on 10/19/2024.  Tylenol did not relieve the pain whatsoever. This pain was not a result of an accident, a fall, lifting or exercising or any impact whatsoever to my body. I was healthy and active up until this pain began. The pain is unusual, out of the ordinary, and sudden with no other viable explanation or reason.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Renal function test normal
Clinical narrative: On Saturday, October 19, 2024, I began to experience pain at my hip, both upper hip (which feels like lower back pain) and lower hip (pain in the buttocks). This pain came on suddenly and the pain was intense from the start. It has affected my daily mundane tasks such as putting on my shoes and driving. The pain has been constant since it began on 10/19/2024.  Tylenol did not relieve the pain whatsoever. This pain was not a result of an accident, a fall, lifting or exercising or any impact whatsoever to my body. I was healthy and active up until this pain began. The pain is unusual, out of the ordinary, and sudden with no other viable explanation or reason.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Allergy test, Anxiety, Autoantibody test
Clinical narrative: 1 week after first dose in 2021: Tachycardia, heart palpitations, chest pain, fatigue, brain fog, concentration issues, anxiety, and severe dizziness. 1 week after 2nd dose in 2021: Dry eyes and mouth, burning abdominal pain, itchy skin throughout body, increased urination/urgency, diarrhea/constipation, food intolerances, and histamine intolerance. I was diagnosed with dysautonomia in 2024 and am working on treating my symptoms with supplements and lifestyle changes. My symptoms have not improved much, and they make it hard for me to function on a daily basis. I have not been able to work after graduating college.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autonomic nervous system imbalance, Brain fog, Cardiac monitoring, Chest X-ray, Chest pain
Clinical narrative: 1 week after first dose in 2021: Tachycardia, heart palpitations, chest pain, fatigue, brain fog, concentration issues, anxiety, and severe dizziness. 1 week after 2nd dose in 2021: Dry eyes and mouth, burning abdominal pain, itchy skin throughout body, increased urination/urgency, diarrhea/constipation, food intolerances, and histamine intolerance. I was diagnosed with dysautonomia in 2024 and am working on treating my symptoms with supplements and lifestyle changes. My symptoms have not improved much, and they make it hard for me to function on a daily basis. I have not been able to work after graduating college.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Constipation, Diarrhoea, Disturbance in attention, Dizziness
Clinical narrative: 1 week after first dose in 2021: Tachycardia, heart palpitations, chest pain, fatigue, brain fog, concentration issues, anxiety, and severe dizziness. 1 week after 2nd dose in 2021: Dry eyes and mouth, burning abdominal pain, itchy skin throughout body, increased urination/urgency, diarrhea/constipation, food intolerances, and histamine intolerance. I was diagnosed with dysautonomia in 2024 and am working on treating my symptoms with supplements and lifestyle changes. My symptoms have not improved much, and they make it hard for me to function on a daily basis. I have not been able to work after graduating college.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry eye, Dry mouth, Echocardiogram, Electrocardiogram, Endoscopy
Clinical narrative: 1 week after first dose in 2021: Tachycardia, heart palpitations, chest pain, fatigue, brain fog, concentration issues, anxiety, and severe dizziness. 1 week after 2nd dose in 2021: Dry eyes and mouth, burning abdominal pain, itchy skin throughout body, increased urination/urgency, diarrhea/constipation, food intolerances, and histamine intolerance. I was diagnosed with dysautonomia in 2024 and am working on treating my symptoms with supplements and lifestyle changes. My symptoms have not improved much, and they make it hard for me to function on a daily basis. I have not been able to work after graduating college.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Faecal calprotectin, Fatigue, Food intolerance, Histamine intolerance, Hormone analysis
Clinical narrative: 1 week after first dose in 2021: Tachycardia, heart palpitations, chest pain, fatigue, brain fog, concentration issues, anxiety, and severe dizziness. 1 week after 2nd dose in 2021: Dry eyes and mouth, burning abdominal pain, itchy skin throughout body, increased urination/urgency, diarrhea/constipation, food intolerances, and histamine intolerance. I was diagnosed with dysautonomia in 2024 and am working on treating my symptoms with supplements and lifestyle changes. My symptoms have not improved much, and they make it hard for me to function on a daily basis. I have not been able to work after graduating college.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Laboratory test, Loss of personal independence in daily activities, Micturition urgency, Palpitations
Clinical narrative: 1 week after first dose in 2021: Tachycardia, heart palpitations, chest pain, fatigue, brain fog, concentration issues, anxiety, and severe dizziness. 1 week after 2nd dose in 2021: Dry eyes and mouth, burning abdominal pain, itchy skin throughout body, increased urination/urgency, diarrhea/constipation, food intolerances, and histamine intolerance. I was diagnosed with dysautonomia in 2024 and am working on treating my symptoms with supplements and lifestyle changes. My symptoms have not improved much, and they make it hard for me to function on a daily basis. I have not been able to work after graduating college.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pollakiuria, Pruritus, Tachycardia
Clinical narrative: 1 week after first dose in 2021: Tachycardia, heart palpitations, chest pain, fatigue, brain fog, concentration issues, anxiety, and severe dizziness. 1 week after 2nd dose in 2021: Dry eyes and mouth, burning abdominal pain, itchy skin throughout body, increased urination/urgency, diarrhea/constipation, food intolerances, and histamine intolerance. I was diagnosed with dysautonomia in 2024 and am working on treating my symptoms with supplements and lifestyle changes. My symptoms have not improved much, and they make it hard for me to function on a daily basis. I have not been able to work after graduating college.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Tendonitis
Clinical narrative: acute onset right shoulder pain most consistent with rotator cuff tendonitis within 2 days of flu vaccine in the right deltoid
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Noticed raised red spots on chest first and now on both arms.  They are not itching.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Electrocardiogram normal, Electroencephalogram normal, Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: Unsure of which brand/manufacturer I received- was an MMR  booster at post partum check up.  9 days later I returned to clinic complaining of new onset scary neurological symptoms - weakness in both legs, left hand, and groin.  Was referred to neurologist for further testing- followed up diligently with multiple specialist with no answers. Weakness in legs is still present- never returned to normal sensation.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Muscular weakness, Neurological symptom
Clinical narrative: Unsure of which brand/manufacturer I received- was an MMR  booster at post partum check up.  9 days later I returned to clinic complaining of new onset scary neurological symptoms - weakness in both legs, left hand, and groin.  Was referred to neurologist for further testing- followed up diligently with multiple specialist with no answers. Weakness in legs is still present- never returned to normal sensation.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reported adverse effect as of now, patient was given incorrect hep-B according to age (patient is 13 yo and given heplislav which is 18 and up)
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Arthralgia, Fall, Joint injury, Joint swelling, Pyrexia
Clinical narrative: Following morning after vaccine, patient developed fever, knee swelling, and hives on left knee and thigh. overnight he was running and fell hitting the left knee so knee pain may be unrelated to vaccine.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Soft tissue swelling, Urticaria, X-ray limb abnormal
Clinical narrative: Following morning after vaccine, patient developed fever, knee swelling, and hives on left knee and thigh. overnight he was running and fell hitting the left knee so knee pain may be unrelated to vaccine.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong patient received product
Clinical narrative: Pharmacist counseling the patient about her adult son's vaccine choices and accidentally gave the patient her son's dose of flu vaccine instead of the ordered Spikevax. Later the Spikevax was administered to the patient on the opposite arm.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: FLU VACCINE RECEIVED 9/18/2024 AT PCP OFFICE,  FLU VACCINE GIVEN AGAIN 10/22/2024
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Arthralgia, Back pain, Chest discomfort, Feeling abnormal, Pain
Clinical narrative: Pulsing pain in her hips; Pain in lower back; Heavy weight on her chest; Something is wrong, she did not feel right; Pain; This spontaneous case, initially received on 08-Oct-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2791562-1), and concerns an elderly female patient.  Past medical history included heart disease. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 18-Sep-2024, the patient received Fluad (TIV) for not reported, dosing regimen: not reported, route of administration: not reported, Anatomical location: Right arm, Lot number: 388459. CSL Seqirus Batch number unable to be matched.  Non-company suspect drugs: Pfizer BioNTech COVID-19 vaccine (Tozinameran), Indication: not reported, , dosing regimen: not reported, route of administration: intramuscular.   Adverse reactions/events and outcomes: On 18-Sep-2024, the patient experienced Pulsing pain in her hips (outcome: Unknown), Pain in lower back (outcome: Unknown), Heavy weight on her chest (outcome: Unknown), Something is wrong, she did not feel right (outcome: Unknown), Pain (outcome: Unknown).  Patient experienced pulsing pain in her hips and lower back and what she described as a heavy weight on her chest. This occurred around 9:45-9:50, 911 was called Emergency Medical Services (EMS) arrived shortly after at about 10 am and checked patient's vitals then took her to hospital. Patient remained awake and was able to sit upright she just said something Is wrong, she did not feel right and pharmacy staff Immediately offered her a chair and called 911.   Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality assessment. In addition, the events were considered as non-serious.; Reporter's Comments: All events were considered related.
Sex: M
Vaccine: COVID19, FLUX, RVX, COVID19, FLUX, RVX
Symptoms: Ulcer
Clinical narrative: ULCER; This spontaneous case, initially received on 08-Oct-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2791932-1), and concerns an elderly male patient.  Past medical history included COVID 19.  Administration of company suspect drug(s): On 28-Aug-2024, the patient received Influenza virus vaccine for not reported., Lot number: No batch number available and will not requested, as case received from regulatory authority.  Non-company suspect drugs: Moderna COVID-19 vaccine (Elasomeran), Indication: COVID-19 prophylaxis. Rotavirus vaccine (Rotavirus vaccine), Indication: not reported.  Adverse reactions/events and outcomes: On 01-Sep-2024, the patient experienced ULCER (outcome: Recovered / Resolved, stop date: 08-Sep-2024).  Ulceration of the smallpox scar. This spontaneous case was reported by a patient and described the occurrence of ULCER (Ulceration of the smallpox scar) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Cosuspect products included non-company products INFLUENZA VACCINE (FW [INFLUENZA VACCINE]) for an unknown indication and RSV VACCINE for an unknown indication. The patient's past medical history included  COVID-19 on 11-Aug-2022. Previously administered products included for Product used for unknown indication: smallpox vaccination (Smallpox scar was result of smallpox vaccination In 1960's). Past adverse reactions to the above products Included Scar with smallpox vaccination. On 28-Aug-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form, dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form and dose of RSV VACCINE {unknown route) 1 dosage form. On 01-Sep- 2024, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ULCER (Ulceration of the smallpox scar). On 08- Sep-2024, ULCER (Ulceration of the smallpox scar) had resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments. The patient had no risk factor. Concomitant product use was not provided by the reporter. It is unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.  Influenza virus vaccine action taken: Not Applicable  Reporter's assessment: The reporter considered the event as non-serious and causality was not reported.; Reporter's Comments: All events were considered related.
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: She had antibody response to Pneumovax (5/23 serovars); Literature report.  This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 67-year-old female with primary immunodeficiency and hypercholesterolemia. Her medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (dose, vaccination scheme, strength, lot #, expiration date, vaccination site and route of administration were not provided).  On an unknown date, the patient's antibody response to Pneumovax showed 5/23 serovars (antibody test negative). The outcome of the event was not provided.  Per internal guidelines the event antibody test negative was determined to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report a TE. HCP also called yesterday for a TE and was mistakenly given supported outcomes for MMR II and VARIVAX. (Case 02685548). Due to this, MMR II and VARIVAX were administered to patients. No additional AE/No PQC.; This spontaneous report was received from a medical assistant referring a patient of unknown age or gender.  The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 08-OCT-2024, the patient was mistakenly vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, lot number: X018902 and expiration date: 12-JUL-2025 (strength, exact dose, anatomical location and route of administration were not reported) and with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot number: Y006582 and expiration date: 26-MAR-2026 (strength, exact dose, anatomical location and route of administration were not reported); both administered as prophylaxis. Those vaccines underwent temperature excursion (Product storage error) No additional adverse event was reported.