chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Flushing, Headache, Hypoaesthesia
Clinical narrative: Flush feeling in her face; Shaky; Weak; She has felt sick to her stomach; She also has some numbness in her face; Has been vomiting; Felt a headache coming on; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Flush feeling in her face), TREMOR (Shaky), ASTHENIA (Weak), ABDOMINAL DISCOMFORT (She has felt sick to her stomach) and HYPOAESTHESIA (She also has some numbness in her face) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal and Blood sugar abnormal.    On 05-Dec-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Dec-2023, the patient experienced FLUSHING (Flush feeling in her face), TREMOR (Shaky), ASTHENIA (Weak), ABDOMINAL DISCOMFORT (She has felt sick to her stomach), HYPOAESTHESIA (She also has some numbness in her face), VOMITING (Has been vomiting) and HEADACHE (Felt a headache coming on). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FLUSHING (Flush feeling in her face), TREMOR (Shaky), ASTHENIA (Weak), ABDOMINAL DISCOMFORT (She has felt sick to her stomach), HYPOAESTHESIA (She also has some numbness in her face), VOMITING (Has been vomiting) and HEADACHE (Felt a headache coming on) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient was on regular blood pressure and blood sugar medications.   This case was linked to US-MODERNATX, INC.-MOD-2023-752966 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752966:Same Patient (Bivalent case)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Flush feeling in her face; Shaky; Weak; She has felt sick to her stomach; She also has some numbness in her face; Has been vomiting; Felt a headache coming on; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Flush feeling in her face), TREMOR (Shaky), ASTHENIA (Weak), ABDOMINAL DISCOMFORT (She has felt sick to her stomach) and HYPOAESTHESIA (She also has some numbness in her face) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal and Blood sugar abnormal.    On 05-Dec-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Dec-2023, the patient experienced FLUSHING (Flush feeling in her face), TREMOR (Shaky), ASTHENIA (Weak), ABDOMINAL DISCOMFORT (She has felt sick to her stomach), HYPOAESTHESIA (She also has some numbness in her face), VOMITING (Has been vomiting) and HEADACHE (Felt a headache coming on). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FLUSHING (Flush feeling in her face), TREMOR (Shaky), ASTHENIA (Weak), ABDOMINAL DISCOMFORT (She has felt sick to her stomach), HYPOAESTHESIA (She also has some numbness in her face), VOMITING (Has been vomiting) and HEADACHE (Felt a headache coming on) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient was on regular blood pressure and blood sugar medications.   This case was linked to US-MODERNATX, INC.-MOD-2023-752966 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752966:Same Patient (Bivalent case)
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body aches.; Like fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches.), PYREXIA (Like fever) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Patient had 4 Pfizer shot.). Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches.), PYREXIA (Like fever) and CHILLS (Chills). At the time of the report, PAIN (body aches.), PYREXIA (Like fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that patient was out of work for several days. And this was literally the day after patient got the Moderna vaccine. And like patient said, when patient got the Pfizer vaccine, and got four of them total and patient never had any symptoms.  The treatment medication was not reported by reporter.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site scar
Clinical narrative: Red area with heat; Irregular boarders at/near injection site; Slightly itchy approximately 2-3 inches; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Slightly itchy approximately 2-3 inches), ERYTHEMA (Red area with heat) and VACCINATION SITE SCAR (Irregular boarders at/near injection site) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058876) for COVID-19 vaccination.     Heart disease, hypertension.  Concurrent medical conditions included Heart disease, unspecified and Hypertension.    On 14-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 16-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PRURITUS (Slightly itchy approximately 2-3 inches). On an unknown date, the patient experienced ERYTHEMA (Red area with heat) and VACCINATION SITE SCAR (Irregular boarders at/near injection site). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at an unspecified dose and frequency. At the time of the report, PRURITUS (Slightly itchy approximately 2-3 inches) had not resolved and ERYTHEMA (Red area with heat) and VACCINATION SITE SCAR (Irregular boarders at/near injection site) outcome was unknown.        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.   No concomitant and treatment medications were reported.  The patient had red area with heat and slightly itchy approximately 2-3 inches, irregular boarders at/near injection site. It was unknown if the patient experienced any additional symptoms/events. The patient had ice pack to affected area.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hot flush, Lethargy, Malaise
Clinical narrative: body aches; hot flashes; lethargy; general feeling of being unwell; dizziness/light headedness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HOT FLUSH (hot flashes), LETHARGY (lethargy), MALAISE (general feeling of being unwell) and DIZZINESS (dizziness/light headedness) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8059071) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 16-Dec-2023, the patient experienced PAIN (body aches), HOT FLUSH (hot flashes), LETHARGY (lethargy), MALAISE (general feeling of being unwell), DIZZINESS (dizziness/light headedness) and HEADACHE (headache). At the time of the report, PAIN (body aches), HOT FLUSH (hot flashes), LETHARGY (lethargy), MALAISE (general feeling of being unwell), DIZZINESS (dizziness/light headedness) and HEADACHE (headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient had headache, light headedness, dizziness, body aches, hot flashes, cold flashes, lethargy, general feeling of being unwell (I was fine before the shot) It is unknown if the patient experienced any additional symptoms/events.   Treatment information was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches; hot flashes; lethargy; general feeling of being unwell; dizziness/light headedness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HOT FLUSH (hot flashes), LETHARGY (lethargy), MALAISE (general feeling of being unwell) and DIZZINESS (dizziness/light headedness) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8059071) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 16-Dec-2023, the patient experienced PAIN (body aches), HOT FLUSH (hot flashes), LETHARGY (lethargy), MALAISE (general feeling of being unwell), DIZZINESS (dizziness/light headedness) and HEADACHE (headache). At the time of the report, PAIN (body aches), HOT FLUSH (hot flashes), LETHARGY (lethargy), MALAISE (general feeling of being unwell), DIZZINESS (dizziness/light headedness) and HEADACHE (headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient had headache, light headedness, dizziness, body aches, hot flashes, cold flashes, lethargy, general feeling of being unwell (I was fine before the shot) It is unknown if the patient experienced any additional symptoms/events.   Treatment information was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Musculoskeletal stiffness, Polymyalgia rheumatica
Clinical narrative: Since then she has struggled with fatigue, polymyalgia rheumatica, and stiffness.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Cellulitis
Clinical narrative: Patient ended up with cellulitis after his vaccination. He was put on a course of Bactrim DS and it is clearing up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects from the vaccine, however the patient had previously received her first and second dose at other facilities.   At the time of the vaccination, she stated she had never received a dose of Shingrix.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain, Muscular weakness, Myalgia, Sleep disorder
Clinical narrative: Burning aggravating pain in my shoulder injection site that runs down to my elbow. Muscle weakness.  I can not sleep on my left side.  Muscle soreness to the touch .
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, COVID-19, Computerised tomogram thorax, Dyspnoea, Pyrexia
Clinical narrative: Date of Admission:  11/14/2023    Date of Discharge:  11/16/2023    Primary Care Physician:   MD   Pending Study Results at Discharge: none   Issues to be Addressed in Follow-up: 1. Resolution of COVID-19   Reason for Hospital Admission (Admitting Diagnosis):  COVID    HPI on admission:  Per DR. note  This is a 84-year-old female with history of chronic respiratory failure on 2 L of home oxygen at baseline due to COPD and CHF.  Presents by ambulance to the ED due to shortness of breath for the last couple of weeks. However her daughter tells me her symptoms worsened the last couple of days.  In the ED patient was febrile and tachypneic.  Tested positive for COVID.  Otherwise Labs unremarkable except for elevated creatinine and UA with trace leukocytes.  Imaging including CT of the lungs
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Tachypnoea, White blood cells urine positive
Clinical narrative: Date of Admission:  11/14/2023    Date of Discharge:  11/16/2023    Primary Care Physician:   MD   Pending Study Results at Discharge: none   Issues to be Addressed in Follow-up: 1. Resolution of COVID-19   Reason for Hospital Admission (Admitting Diagnosis):  COVID    HPI on admission:  Per DR. note  This is a 84-year-old female with history of chronic respiratory failure on 2 L of home oxygen at baseline due to COPD and CHF.  Presents by ambulance to the ED due to shortness of breath for the last couple of weeks. However her daughter tells me her symptoms worsened the last couple of days.  In the ED patient was febrile and tachypneic.  Tested positive for COVID.  Otherwise Labs unremarkable except for elevated creatinine and UA with trace leukocytes.  Imaging including CT of the lungs
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was given 5 days past the Must Use Before Date, Dec 13, 2023
Age: 59.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: The patient is experiencing arm stiffness and can't life arm past shoulder
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Lung disorder, Muscle spasms, Sleep disorder
Clinical narrative: could not breath at all for like 1min or 2; Felt like lungs spasming; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 79-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 30Nov2023 at 12:00 as dose number unknown, single (Lot number: HF5021, Expiration Date: Feb2025) at the age of 79 years intramuscular, in left arm for immunisation, Device Lot Number: HA3217, Device Expiration Date: Mar2025. The patient's relevant medical history included: "Blood pressure high" (ongoing), notes: Blood pressure high. Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single. The following information was reported: MUSCLE SPASMS (life threatening) with onset 02Dec2023, outcome "recovered with sequelae", described as "Felt like lungs spasming"; RESPIRATORY ARREST (medically significant, life threatening), outcome "recovered with sequelae", described as "could not breath at all for like 1min or 2". Clinical course: more like over 24 hours from injection, the reaction occurred. The patient felt like her lungs spasming and when woke up while was asleep, could not take a breath.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Sex: U
Vaccine: RSV
Symptoms: Device breakage
Clinical narrative: went to insert diluent into vaccine, it basically spilled over vial; no patients involved; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Dec2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM7647, Expiration Date: Mar2025) and as dose number unknown, single (Lot number: HG1755, Expiration Date: May2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "went to insert diluent into vaccine, it basically spilled over vial; no patients involved".  Causality for "went to insert diluent into vaccine, it basically spilled over vial; no patients involved" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: Faulty product. Had issue with diluent when went to insert diluent into vaccine, it basically spilled over vial, outside of vial. Agent asked caller if user error or faulty product, caller believed product issue. Was faulty when pressed to place cap on before diluent. When pulled vial adapter off a piece of plastic broke off, puncture went sideways, the sharp edge, still had that piece but piece did detach from actual puncture mechanism, like it was broken, didn't think ever punctured vial, did not go through. just went to side. Vaccine came in box of 5 kits total, confirmed 1 vaccine with issue. Had clear plastic thing over top of it, nothing written on it as far as knows, no markings on vial adapter. It all comes in a kit, then pulled plastic off, nothing was labeled on vial adapter. Confirmed no patients involved with the vaccine. The sample of product was available to be returned. The packaging was sealed & intact. Abrysvo diluent syringe: NDC: 00690250-01, lot: HG1755. Abrysvo antigen vial: NDC: 00690207-01, lot: HM7647.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Product container issue
Clinical narrative: her technician was reconstituting Abrysvo, a small piece of glass snapped inside of the vial and she is looking to have it replaced; This initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 06Dec2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from a Pharmacist from product quality group, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM0167, Expiration Date: Mar2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT CONTAINER ISSUE (non-serious), outcome "unknown", described as "her technician was reconstituting Abrysvo, a small piece of glass snapped inside of the vial and she is looking to have it replaced". Additional information: Transferring agent stated, "I have a pharmacist on the other line and she mentioned that while her technician was reconstituting Abrysvo, a small piece of glass snapped inside of the vial and she is looking to have it replaced. It snapped up from the vial. So, the glass was from the vial." When probed if first time called in Pfizer Drug Safety for this concern, reporter stated, "It's the first time I have, I had a pharmacist at my store called once before but it was for a different concern but it was about reconstituting Abrysvo as well." When probed if product administered to patient, reporter stated, "No, we did not administer it to them."   Causality for "her technician was reconstituting abrysvo, a small piece of glass snapped inside of the vial and she is looking to have it replaced" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: pt in hospital bed also showing NOT Vaccinated in immunization record 12/13/2023
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was given 6 days past the Must Use Before Date, Dec 13, 2023. Patient did  not want to take the re vaccinate offer.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was given 6 days past the Must Use Before Date, Dec 13, 2023. Patient did not want to take the re vaccinate offer.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose, Condition aggravated, Electrocardiogram, Erythema, Haemoglobin
Clinical narrative: Left arm redness and swelling and worsening vertigo that is spreading shortly after receiving injection on 12/17/2023
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Vertigo
Clinical narrative: Left arm redness and swelling and worsening vertigo that is spreading shortly after receiving injection on 12/17/2023
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient came in a month after receiving the injection reporting continued soreness/stiffness in the injection arm. There is no swelling/redness/bruising.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was given 6 days past the Must Use Before Date.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states she had severe redness, swelling, and pain at injection site and down arm.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was given 6 days past the Must Use Before Date, Dec 13, 2023
Age: 49.0
Sex: M
Vaccine: PNC20
Symptoms: Brain fog, Gaze palsy, Hallucination, Musculoskeletal chest pain, Pain
Clinical narrative: Pt states after the injection his ribs and thighs began to ache, then whole body aching. For 48 hours he had the achiness and hallucinations. I believe he said he considered going to ER, but was so sick and the hallucinations caused him to feel staying home may have been the best decision at the time. After the 48 hours, the hallucinations stopped, but for the following 24 hours he had "brain fog" and a headache. Things eventually resolved at the 72 hour time frame post Prevnar 20 injection given at his local pharmacy.
Age: 49.0
Sex: M
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: Pt states after the injection his ribs and thighs began to ache, then whole body aching. For 48 hours he had the achiness and hallucinations. I believe he said he considered going to ER, but was so sick and the hallucinations caused him to feel staying home may have been the best decision at the time. After the 48 hours, the hallucinations stopped, but for the following 24 hours he had "brain fog" and a headache. Things eventually resolved at the 72 hour time frame post Prevnar 20 injection given at his local pharmacy.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Chills, Electric shock sensation, Mobility decreased, Tremor
Clinical narrative: Patient experienced teeth chattering that she described as electrical sensations one to two days after she got the vaccine. She also experienced hand quivering one to two days after she got the vaccine. She says these symptoms have resolved as of 12/19. She also had extreme knee pain that prevented her from getting up or using the bathroom as normal. She rates the pain on 12/17 a 10 and on 12/19 her knee pain is a 3. She has used Tylenol to manage the pain.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Chills
Clinical narrative: Shivering chills overnight for two nights following the injection. No treatment sought.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Mass, Pain, Pruritus, Somnolence
Clinical narrative: Large swollen lump. Itchy/painful. Size was 4inches by 2 inches. Child was very difficult to wake up at daycare. Reported irritability. appeared over an hour
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: Large swollen lump. Itchy/painful. Size was 4inches by 2 inches. Child was very difficult to wake up at daycare. Reported irritability. appeared over an hour
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Dizziness, Hyperhidrosis, Vomiting
Clinical narrative: The patient out of nowhere became extremely dizzy 30-45 minutes after the vaccination. He became sweaty and needed to sit down from the extreme dizziness. I got up some water to drink, which he drank very fast and then threw some of it up. We then spent some time just relaxing as he sat in a motorized cart seat and he gradually started to feel better. I offered to call ambulance but he did not want to do that. He very quickly started to feel better once he relaxed and slowly drank a little more water. I got him some cookies and he slowly ate them as he was concerned his sugar might be low. He stated this has happened before due to low blood sugar. We spent about 30 minutes together and he gradually got better and better. We walked around the store together and he felt much better. His daughter was coming to the facility to check on him as well and they met up outside. He stated he did not feel dizzy at all anymore, I gave him some water to take with him along with a few more cookies.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Full blood count normal, Influenza virus test negative, Muscular weakness, SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: Severe musculoskeletal weakness. Taking ibuprofen. 48 hours after injection, seeing slight improvement?
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash macular
Clinical narrative: Initially red rash near the injection site on the left shoulder, later followed by a blotchy rash on the back, both forearms and both legs
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Pain in arm. Can?t left arm, sensitive to touch, started within 1 hour of getting vaccine and increased pain with time
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Shoulder injury related to vaccine administration
Clinical narrative: Patient reports shoulder pain for two months following vaccine administration.  Based on her physical therapist visit last week, it has been evaluated as SIRVA.
Sex: M
Vaccine: HEP
Symptoms: Eczema, Food allergy, Hypersensitivity, Milk allergy, Multiple allergies
Clinical narrative: Allergic to all dairy. Couldn t consume Mother s breast milk without reaction. Believe this to be the beginning of multiple food and environmental allergies and severe eczema conditions. Could cause death if ingested
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Nystagmus
Clinical narrative: Nystagmus developed after well visit with vaccines given
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Carditis, Chest discomfort, Fatigue, Pain in extremity
Clinical narrative: Extreme tightening of the chest / heart muscle inflammation; mild increase in temperature; fatigue; mild soreness on arm
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient received flu vaccine (Fluad) and Spikevax (moderna) on the same arm (left arm). After vaccination, she developed allergic reaction including rash around neck area and it spread her entire body. She took 25mg of Benadryl within an hour and repeated another dose in 4 hours.  Next morning, rash has disappear.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Left arm started itching from sholder to Left wrist.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: "ERYTHEMA/HARD MASS TO INJECTION SITE" ((R) ARM) WHEN SEEN ON 8/9/23 = NOTED WITH ABOUT 2' X 2" DARK DISCOLORATION TO BACK OF (R) ARM. WITH ABOUT A NICKLE SIZE HARD AREA AT THE CENTER OF THE DISCOLORATION. APPLIED WARM COMPRESSES TO SITE THEN RESOLVED AFTER 1 MONTH
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Dysstasia, Muscular weakness, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: extreme muscle weakness and stiffness in legs, back and arms. Could barely walk and could not reach my feet toput on my socks
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Blood test, Electrocardiogram, Gait disturbance, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: extreme muscle weakness and stiffness in legs, back and arms. Could barely walk and could not reach my feet toput on my socks
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Atrial fibrillation, Chest X-ray normal, Condition aggravated, Electrocardiogram abnormal, Laboratory test normal
Clinical narrative: Atrial Fibrillation; condition aggravated; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2716878-1 (VAERS ID).  A 68-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Oct2023 as dose number unknown, single (Lot number: HF5014) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "a-fib" (unspecified if ongoing), notes: no episode since 2019. Concomitant medication(s) included: ELIQUIS; ATORVASTATIN; ESCITALOPRAM. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 19Nov2023, outcome "recovered" (22Nov2023); CONDITION AGGRAVATED (medically significant) with onset 19Nov2023, outcome "recovered" (22Nov2023). The events "atrial fibrillation" and "condition aggravated" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown results; Electrocardiogram: Unknown results. Therapeutic measures were taken as a result of atrial fibrillation, condition aggravated. The patient had an episode of a fib on 19Nov2023, was treated with diltiazem on 19Nov2023. It discontinued on 22Nov2023. The current illness and allergies was reported as none. The case was not reported as serious.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (04Dec2023): This case is being submitted to notify that the initial information for this case was first received by the company on 04Dec2023 and not on 05Dec2023 as previously reported.
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Atrial fibrillation, Chest X-ray, Condition aggravated, Electrocardiogram
Clinical narrative: Atrial Fibrillation; condition aggravated; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2716878-1 (VAERS ID).  A 68-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Oct2023 as dose number unknown, single (Lot number: HF5014) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "a-fib" (unspecified if ongoing), notes: no episode since 2019. Concomitant medication(s) included: ELIQUIS; ATORVASTATIN; ESCITALOPRAM. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 19Nov2023, outcome "recovered" (22Nov2023); CONDITION AGGRAVATED (medically significant) with onset 19Nov2023, outcome "recovered" (22Nov2023). The events "atrial fibrillation" and "condition aggravated" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown results; Electrocardiogram: Unknown results. Therapeutic measures were taken as a result of atrial fibrillation, condition aggravated. The patient had an episode of a fib on 19Nov2023, was treated with diltiazem on 19Nov2023. It discontinued on 22Nov2023. The current illness and allergies was reported as none. The case was not reported as serious.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (04Dec2023): This case is being submitted to notify that the initial information for this case was first received by the company on 04Dec2023 and not on 05Dec2023 as previously reported.
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Atrial fibrillation, Chest X-ray normal, Condition aggravated, Electrocardiogram abnormal, Laboratory test normal
Clinical narrative: Atrial Fibrillation; Condition aggravated; Electrocardiogram abnormal; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2716010-1 (VAERS ID).  A 68-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Oct2023 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for immunisation. The patient's relevant medical history included: "Thoracic aneurysm" (unspecified if ongoing); "mild depression" (unspecified if ongoing); "Episodic Afib" (unspecified if ongoing), notes: Episodic Afib ( 3 prior episodes, last episode 2019). Concomitant medication(s) included: ELIQUIS; ATORVASTATIN; ESCITALOPRAM. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 19Nov2023, outcome "recovered" (2023); CONDITION AGGRAVATED (medically significant) with onset 19Nov2023, outcome "recovered" (2023); ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 19Nov2023, outcome "recovered" (2023). The patient underwent the following laboratory tests and procedures: Chest X-ray: normal; Electrocardiogram: abnormal; normal, notes: Seen in ER - EKG , labwork, CXR Other than Afib on EKG, all labs were normal; Laboratory test: normal.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (04Dec2023): This case is being submitted to notify that the initial information for this case was first received by the company on 04Dec2023 and not on 05Dec2023 as previously reported.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Atrial fibrillation, Chest X-ray, Condition aggravated, Electrocardiogram
Clinical narrative: Atrial Fibrillation; Condition aggravated; Electrocardiogram abnormal; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2716010-1 (VAERS ID).  A 68-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Oct2023 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for immunisation. The patient's relevant medical history included: "Thoracic aneurysm" (unspecified if ongoing); "mild depression" (unspecified if ongoing); "Episodic Afib" (unspecified if ongoing), notes: Episodic Afib ( 3 prior episodes, last episode 2019). Concomitant medication(s) included: ELIQUIS; ATORVASTATIN; ESCITALOPRAM. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 19Nov2023, outcome "recovered" (2023); CONDITION AGGRAVATED (medically significant) with onset 19Nov2023, outcome "recovered" (2023); ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 19Nov2023, outcome "recovered" (2023). The patient underwent the following laboratory tests and procedures: Chest X-ray: normal; Electrocardiogram: abnormal; normal, notes: Seen in ER - EKG , labwork, CXR Other than Afib on EKG, all labs were normal; Laboratory test: normal.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (04Dec2023): This case is being submitted to notify that the initial information for this case was first received by the company on 04Dec2023 and not on 05Dec2023 as previously reported.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 1.0
Sex: F
Vaccine: FLUC4, HEPA, MMRV, PNC20, FLUC4, HEPA, MMRV, PNC20, FLUX(H1N1), HEPA, MMRV, PNC20, TD, UNK, UNK, UNK
Symptoms: Death
Clinical narrative: patient passed away shortly after receiving vaccinations/ Caller states patient was found in crib no signs of life; preliminary report showed large amount of mucous in lungs; This spontaneous report has been received from a nurse prescriber and refers to a 12-month-old female patient.  The patient's pertinent medical history included gastrointestinal viral infection. The patient's concurrent conditions, other drug reactions or allergies and concomitant therapies were not reported.  On 21-NOV-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, as a single dose (lot number X018584 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported and validated as 05-JAN-2025, Recombinant Human Albumin (rHA therapy type), administered subcutaneously as routine vaccination (strength, vaccination scheme and anatomical site of administration were not provided); plus pneumococcal vaccine conj 20v (crm197) (PREVNAR 20); the second dose of hepatitis a vaccine; and  influenza a(h1n1)pdm09 vaccine (INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE). All vaccines were administered as single doses for prophylaxis (strength, formulation, vaccination scheme, lot #, expiry date, anatomical site of administration and route of administration were not provided).  On 26-NOV-2023 (also reported as 'shortly after receiving vaccinations'), the patient passed away. She was found in crib no signs of life (death). The parents reportedly performed cardiopulmonary resuscitation (CPR) at home but no other treatment was given. A preliminary report showed large amount of mucous in lungs (lung disorder) as a possible cause. It was unknown whether an autopsy was performed.   The causal relationship between the events and the suspect therapies was not established.  The reporter considered the event lung disorder to be a disability, and a life threatening event.; Reported Cause(s) of Death: Patient passed away/ Patient was found in crib with no signs of life
Age: 1.0
Sex: F
Vaccine: FLUC4, HEPA, MMRV, PNC20, FLUC4, HEPA, MMRV, PNC20, FLUX(H1N1), HEPA, MMRV, PNC20, TD, UNK, UNK, UNK
Symptoms: Death, Increased bronchial secretion, Lung disorder, Resuscitation
Clinical narrative: patient passed away shortly after receiving vaccinations/ Caller states patient was found in crib no signs of life; preliminary report showed large amount of mucous in lungs; This spontaneous report has been received from a nurse prescriber and refers to a 12-month-old female patient.  The patient's pertinent medical history included gastrointestinal viral infection. The patient's concurrent conditions, other drug reactions or allergies and concomitant therapies were not reported.  On 21-NOV-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, as a single dose (lot number X018584 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported and validated as 05-JAN-2025, Recombinant Human Albumin (rHA therapy type), administered subcutaneously as routine vaccination (strength, vaccination scheme and anatomical site of administration were not provided); plus pneumococcal vaccine conj 20v (crm197) (PREVNAR 20); the second dose of hepatitis a vaccine; and  influenza a(h1n1)pdm09 vaccine (INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE). All vaccines were administered as single doses for prophylaxis (strength, formulation, vaccination scheme, lot #, expiry date, anatomical site of administration and route of administration were not provided).  On 26-NOV-2023 (also reported as 'shortly after receiving vaccinations'), the patient passed away. She was found in crib no signs of life (death). The parents reportedly performed cardiopulmonary resuscitation (CPR) at home but no other treatment was given. A preliminary report showed large amount of mucous in lungs (lung disorder) as a possible cause. It was unknown whether an autopsy was performed.   The causal relationship between the events and the suspect therapies was not established.  The reporter considered the event lung disorder to be a disability, and a life threatening event.; Reported Cause(s) of Death: Patient passed away/ Patient was found in crib with no signs of life
Age: 1.0
Sex: F
Vaccine: FLUC4, HEPA, MMRV, PNC20, FLUC4, HEPA, MMRV, PNC20, FLUX(H1N1), HEPA, MMRV, PNC20, TD, UNK, UNK, UNK
Symptoms: Death
Clinical narrative: DEATH Died sometime in late evening 11/25/2023 or likely early morning 11/26/2023.  W one up to find baby dead in crib. Patient died 11/26/2023 No AE to prior vaccines
Age: 1.0
Sex: F
Vaccine: FLUC4, HEPA, MMRV, PNC20, FLUC4, HEPA, MMRV, PNC20, FLUX(H1N1), HEPA, MMRV, PNC20, TD, UNK, UNK, UNK
Symptoms: Death, Increased bronchial secretion, Lung disorder, Resuscitation
Clinical narrative: DEATH Died sometime in late evening 11/25/2023 or likely early morning 11/26/2023.  W one up to find baby dead in crib. Patient died 11/26/2023 No AE to prior vaccines
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site urticaria, Lip erythema, Lip swelling, Urticaria
Clinical narrative: Patient given vaccines  in the clinic.  They tolerated them well in the clinic. Patient went back to the clinic a few minutes later because of itching, sensation of tongue swelling  and mother noted lips were mildly swollen.  Patient examined., vitals were normal with no obvious tongue or lip swelling and no wheezing.  Patient was given Benadryl 50 mg IM and monitored.  Itching and sensation of "thick tongue" resolved. Patient was discharged after repeat physical exam and vitals. Which were all within normal limits.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Lip swelling, Pruritus, Swollen tongue, Tongue disorder
Clinical narrative: Patient given vaccines  in the clinic.  They tolerated them well in the clinic. Patient went back to the clinic a few minutes later because of itching, sensation of tongue swelling  and mother noted lips were mildly swollen.  Patient examined., vitals were normal with no obvious tongue or lip swelling and no wheezing.  Patient was given Benadryl 50 mg IM and monitored.  Itching and sensation of "thick tongue" resolved. Patient was discharged after repeat physical exam and vitals. Which were all within normal limits.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Lip swelling, Pruritus
Clinical narrative: Patient given vaccines  in the clinic.  They tolerated them well in the clinic. Patient went back to the clinic a few minutes later because of itching, sensation of tongue swelling  and mother noted lips were mildly swollen.  Patient examined., vitals were normal with no obvious tongue or lip swelling and no wheezing.  Patient was given Benadryl 50 mg IM and monitored.  Itching and sensation of "thick tongue" resolved. Patient was discharged after repeat physical exam and vitals. Which were all within normal limits.
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia
Clinical narrative: pain in her shoulders; pain in the back of her legs; inhibited her from sitting down properly and from getting up out of bed at night; It was very painful to sit down on the stool; She has weakness; If she's not using a certain muscle for 30 minutes or so this pain and weakness sets in.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "knee injury" (unspecified if ongoing), notes: She had a previous knee injury from gardening a few years back. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset Nov2023, outcome "unknown", described as "If she's not using a certain muscle for 30 minutes or so this pain and weakness sets in."; PAIN (non-serious) with onset Nov2023, outcome "not recovered", described as "It was very painful to sit down on the stool"; ASTHENIA (non-serious) with onset Nov2023, outcome "unknown", described as "She has weakness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Nov2023, outcome "unknown", described as "inhibited her from sitting down properly and from getting up out of bed at night"; ARTHRALGIA (non-serious) with onset Nov2023, outcome "not recovered", described as "pain in her shoulders"; PAIN IN EXTREMITY (non-serious) with onset Nov2023, outcome "not recovered", described as "pain in the back of her legs". Additional information: patient stated that she received the Abrysvo vaccine on 10Nov2023 and 3-4 days later developed a lot of pain in her shoulders and the back of her legs that inhibited her from sitting down properly and from getting up out of bed at night to use the bathroom.  It was very painful to sit down on the stool. The pain is continuing and she wanted to know if this was something associated with the vaccine weeks later and if this would resolve on it's own.  She has weakness that makes it hard to get up and to bend down to pick things up. She had a previous knee injury from gardening a few years back. If she's not using a certain muscle for 30 minutes or so this pain and weakness sets in.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.