chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion product administered with no reported adverse event; Initial information was received on 30-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom temperature excursion of HIB (PRP/T) vaccine [ACT-HIB] administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Apr-2024, the patient received an unknown dose (total) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot number, expiry date, strength was unknown) via unknown route in unknown administration site for Prophylactic Vaccination (poor quality product administered) (Latency: same day).  The information on the batch number was requested.  This situation was not due to human error. Reason: Wire was not completely attached to the data logger  Max/Lowest Temp reached: 10.76F -13hrs 50minutes 10.69F - 8hrs 21 mins.  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: 15.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: medication error due to product being administered post excursion with no reported adverse event; Initial information received on 30-Apr-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 years old male patient where reporter reported medication error due to diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] product being administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Apr-2024, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (poor quality product administered) (latency- same day).Information on the batch number was requested.  Reportedly, temperature excursion Products: ADACEL, MENQUADFI, ACT-HIB, IPOL-punctured and unopened Reason: Wire was not completely attached to the data logger Max/Lowest Temp reached: 10.76F -13hrs 50minutes 10.69F - 8hrs 21 mins Human Error: NO Does extended stability data cover the excursion? NO If products have been administered: YES.  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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block left, Cardiac stress test, Chronic left ventricular failure, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: Pfzer Vaccine administered 7/7/2021, Second dose administered 1/7/2022.   Heart palpatations, pulse racing, and irregular pulse noticed in the fall of 2021.  Follwing an Electrocardiogram, new diagnosis of Left Bundle Block made by my my GP  2/9/2022 (Dr.)  Referred to a heart specialist (Dr) where testing resulted in a diagnosis of Chronic systolic Heart Failure (stage II) of unknown origin-no artery disease , diabetes or hypertension.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular, Magnetic resonance imaging, Palpitations
Clinical narrative: Pfzer Vaccine administered 7/7/2021, Second dose administered 1/7/2022.   Heart palpatations, pulse racing, and irregular pulse noticed in the fall of 2021.  Follwing an Electrocardiogram, new diagnosis of Left Bundle Block made by my my GP  2/9/2022 (Dr.)  Referred to a heart specialist (Dr) where testing resulted in a diagnosis of Chronic systolic Heart Failure (stage II) of unknown origin-no artery disease , diabetes or hypertension.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse reaction noted.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTIONS NOTED
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: The box of Hiberix vaccinations contain vials of the vaccine and a diluent that is to be mixed with the vial. Then administered to patient. Several Medical Assistants administered the Hiberix vaccine from said box. Our leader found a Hiberix in the box without a diluent. Bringing to the attention of us that had administered the Hiberix,, it appeared that one of us only used a diluent. Therefore,,, all parties involved called parent of patients, inform them of   situation,, and have child come back to receive the Hiberix.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTIONS NOTED
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram, Deep vein thrombosis, Peripheral vein occlusion, Renal pain
Clinical narrative: DVT deep vein thrombosis in left leg,  severe pain in right hip/kidney area, prescribed Xarelto 20 mg daily
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Scan abnormal, Scan with contrast
Clinical narrative: DVT deep vein thrombosis in left leg,  severe pain in right hip/kidney area, prescribed Xarelto 20 mg daily
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTIONS NOTED
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Blood glucose decreased, Dehydration, Loss of consciousness
Clinical narrative: Patient had passed out shortly after vaccine. EMS was called and thought the most likely cause was like dehydration and low blood sugar.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTIONS NOTED
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Presyncope, Visual impairment
Clinical narrative: after immunizations were given, pt went to sit down on chair by getting off of exam table and told her mom that she couldn't see, felt very lightheaded and dizzy, did not pass out completely. MA came and grabbed me (the provider) and we had patient lay down on exam table, placed ice pack on back of neck and rechecked BP 103/70.  Provided gatorade for patient to drink, was starting to feel better, helped pt sit up and vision returned, no more lightheadedness.  Pt's BP was 111/78 upon repeat. She was feeling better upon leaving clinic, no syncope.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: The vaccine administered on 5/8/24 expired on 5/4/24.  Pharmacist called Pfizer and was told there is no extension of expiration dates on this Comirnaty vaccine at this time.  This vaccine was received on 4/8/24 from our wholesaler.  We informed the patient and she was very understanding.  She said that she understands she should receive another dose of non-expired vaccine, but that she will wait for the next seasonal COVID vaccine.  She reports no symptoms or current adverse events.
Age: 48.0
Sex: F
Vaccine: PNC20
Symptoms: Inflammation, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pt complains of inflamed and swollen arm. painful and unable to move
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Condition aggravated, Immediate post-injection reaction, Seizure like phenomena
Clinical narrative: Seizure like activity immediately following vaccination
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTIONS NOTED
Age: 19.0
Sex: M
Vaccine: HEP, HEPA, TYP, UNK, UNK, UNK, UNK, YF
Symptoms: No adverse event, Wrong product administered
Clinical narrative: On 8MAY24 at approximately 1530, patient was given a HEP A vaccine instead of receiving a HEP B vaccine.  The vaccine was was administered by staff after he accidently verfied the patient's vaccine status off of an outdated vaccine roster instead of the corrected screening forms that indicated that HEP A was no longer needed and only HEP B, Yellow Fever, and Typhoid were required at this time.  Upon discovering the mistake, the incident was immediately reported. He discussed the incident with the patient who experienced no adverse side effects.  Patient was then given the correct HEP B vaccine.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTIONS NOTED
Age: 76.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Paraesthesia
Clinical narrative: Sporadic tingling in Arm/Shoulder not triggered by specific action.  No pain, more of a tingling/tickling sensation.  Her mobility/movement not affected. Started on 04/25/2024 after getting vaccines. Patient still mentioning symptoms day 8 post-vaccination.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Fatigue, Pyrexia
Clinical narrative: pt complaining about fatigue, fever, confusion. recommended some otc meds to relieve symptoms and hydration. informed pt that pt must be seen by the pcp if symptoms gets worse over time.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chest pain, Chills, Confusional state, Dyspepsia
Clinical narrative: pt complaining about fatigue, fever, confusion. recommended some otc meds to relieve symptoms and hydration. informed pt that pt must be seen by the pcp if symptoms gets worse over time.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Erythema, Headache, Oropharyngeal pain, Pain
Clinical narrative: pt complaining about fatigue, fever, confusion. recommended some otc meds to relieve symptoms and hydration. informed pt that pt must be seen by the pcp if symptoms gets worse over time.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: pt complaining about fatigue, fever, confusion. recommended some otc meds to relieve symptoms and hydration. informed pt that pt must be seen by the pcp if symptoms gets worse over time.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Hyperhidrosis, Sleep paralysis
Clinical narrative: Sleep Paralysis, Chills and sweating
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Bone pain, Burning sensation, Eye irritation, Eye swelling
Clinical narrative: Sleep Paralysis, Chills and sweating
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid function disorder, Feeling abnormal, Mobility decreased, Nightmare, Osteoporosis
Clinical narrative: Sleep Paralysis, Chills and sweating
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Paralysis, Somnolence, Swelling face
Clinical narrative: Sleep Paralysis, Chills and sweating
Age: 42.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19, Treponema test positive
Clinical narrative: I have been so upset about this since getting the COVID vaccine.  I received my two doses of COVID vaccine in August of 2021 at the behest of the government and my job.  I get COVID two different times three months apart right afterwards, anyway!  I go to clinic in December for POTS testing, and I didn't even know I was tested for Syphilis.  That night I received an alert that the Syphilis test came back positive.   Well, at the time I had been married 15 years.  I was flabbergasted.  So, upset!  I called clinic back and they made me wait until next day.  I found out that I had to have another test.  In the meantime, thankfully, I had a friend who told me that the COVID test was causing false positives with Syphilis.  I looked online and there is a FDA alert on it.  Well, I  am one of them!  I have had two Syphilis tests since getting married as I've had two children - I think they do them.  Also, I have zero concern my husband is un faithful.  While the second test came back negative, I am fearful the vaccine did something to my genes.  Why did a COVID vaccine do this to me?  No one ever offered to get me retested again or provided any suggestions.   I've been ruminating on this since December of 2021.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Chest discomfort, Chills, Dizziness, Dyspnoea
Clinical narrative: Within 30 minutes of leaving vaccination site patient felt light-headed, had chills, and SOB/chest tightness. Mother brought child to Urgent Care where she received  Solu-Medrol, and was sent to ER with EMS. Upon arrival to our ER, patient had Temp 38.3, HR 104, BP 132/65. This was ~1-1.5 hr post vaccination.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Human chorionic gonadotropin negative, Laboratory test normal, Urine analysis normal, White blood cell count normal
Clinical narrative: Within 30 minutes of leaving vaccination site patient felt light-headed, had chills, and SOB/chest tightness. Mother brought child to Urgent Care where she received  Solu-Medrol, and was sent to ER with EMS. Upon arrival to our ER, patient had Temp 38.3, HR 104, BP 132/65. This was ~1-1.5 hr post vaccination.
Age: 16.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was supposed to receive Tdap but DTaP was ordered and administered.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Pain/soreness at injection site. no redness or bruising, no swelling. Prolonged pain, radiating to shoulder, limited range of motion.
Sex: U
Vaccine: COVID19
Symptoms: Arachnoiditis, Gait disturbance, Incorrect dose administered, Muscle spasms, Muscular weakness
Clinical narrative: Arachnoiditis; the second vaccine; eye stroke; pain; barely walk; muscle weakness; calf muscle cramping; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1 Manufacturer: unknown), reaction(s): "COVID-19 Immunization". The following information was reported: ARACHNOIDITIS (medically significant), outcome "unknown"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "the second vaccine"; OCULAR VASCULAR DISORDER (non-serious), outcome "unknown", described as "eye stroke"; PAIN (non-serious), outcome "not recovered"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "barely walk"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "muscle weakness"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "calf muscle cramping".  Additional information: For almost a year and a half patient was having pain and muscle weakness. It started with calf muscle cramping right after the second vaccine. Now patient can barely walk; also had an eye stroke. One doctor said all of this "Could" be because of the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Ocular vascular disorder, Pain
Clinical narrative: Arachnoiditis; the second vaccine; eye stroke; pain; barely walk; muscle weakness; calf muscle cramping; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1 Manufacturer: unknown), reaction(s): "COVID-19 Immunization". The following information was reported: ARACHNOIDITIS (medically significant), outcome "unknown"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "the second vaccine"; OCULAR VASCULAR DISORDER (non-serious), outcome "unknown", described as "eye stroke"; PAIN (non-serious), outcome "not recovered"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "barely walk"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "muscle weakness"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "calf muscle cramping".  Additional information: For almost a year and a half patient was having pain and muscle weakness. It started with calf muscle cramping right after the second vaccine. Now patient can barely walk; also had an eye stroke. One doctor said all of this "Could" be because of the vaccine.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient who was administered improperly stored PROQUAD. No symptoms reported.; Patient who was administered improperly stored PROQUAD. No symptoms reported.; This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 05-APR-2024, the patient started was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter/dose, lot #X021126 with expiration date on 12-FEB-2025, administered for prophylaxis (route of administration and anatomical location were not provided) (Product storage error).  It was reported that the temperature excursion was at 20.1 / 14°F up to 46°F for 9 hours and 15 minutes. No prior excursions and no symptoms or additional adverse events were reported.  Lot number X021126 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant called to report an excursion.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.   On an unknown date, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection (lot #W019422, expiration date: 20-JUN-2024) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #X017486, expiration date: 25-JUN-2025) experienced temperature excursion. 7.9 degree Fahrenheit (F)/ 6F up to 14F for 0 Hours 38 Minutes 0 Seconds, prior temperature excursion showed 6.3F / 6F up to 14F for 13 Hours 0 Minutes and 0 Seconds.  On 01-APR-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, lot #W019422, expiration date: 20-JUN-2024, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X017486, expiration date: 25-JUN-2025, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) (Product storage error). No further information provided. No additional adverse event (AE) (no AE).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; administered after a temperature excursion to patient; This spontaneous report was received from medical assistant and referred to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 01-MAY-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once, lot #X025342, expiration date: 12-MAY-2025, administered for prophylaxis (strength, dose and route of administration were not provided) after a temperature excursion of 32.9 degree F for 3 hours 18 minutes (product storage error). There was no previous temperature excursion. No addition adverse event reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2405USA000864:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: no AE; ROTATEQ was administered after a temperature excursion to patient.; This spontaneous report was received from medical assistant and referred to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 25-APR-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1968386, expiration date: 23-MAY-2024, administered orally for prophylaxis (strength and exact dose was not provided) after a temperature excursion of 32.9 degree F for 3 hours 18 minutes (product storage error). There was no previous temperature excursion. No addition adverse event reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA000864:
Age: 18.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no further AE details; RN in the unit gave a dose of PROQUAD to an 18 year old male patient; This spontaneous report was received form a nurse practitioner (also reported as nurse prescriber) and referred to an 18-year-old male patient. His pertinent medical history, underlying concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 06-MAY-2024, the reporter indicated that a registered nurse (RN) in the unit gave a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live [rHA (recombinant human albumin)] (PROQUAD) injection, at a dose of 0.5 milliliter (ml) once for prophylaxis (strength, dose number, route of administration, and anatomical location of application were not reported; lot number X020565 that was verified to be valid with an expiration date reported and established as 03-FEB-2025) (product administered to patient of inappropriate age).  The reporting nurse practitioner stated that she had no further adverse event (AE) details (no adverse event).
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Fatigue, Pyrexia
Clinical narrative: pain, swelling, redness in arm, headache, shivering, slight fever, burning in stomach nd chest area, weakness, sore throat, hoarsness, confusion
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chest pain, Chills, Confusional state, Dyspepsia
Clinical narrative: pain, swelling, redness in arm, headache, shivering, slight fever, burning in stomach nd chest area, weakness, sore throat, hoarsness, confusion
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Erythema, Headache, Oropharyngeal pain, Pain
Clinical narrative: pain, swelling, redness in arm, headache, shivering, slight fever, burning in stomach nd chest area, weakness, sore throat, hoarsness, confusion
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: pain, swelling, redness in arm, headache, shivering, slight fever, burning in stomach nd chest area, weakness, sore throat, hoarsness, confusion
Sex: F
Vaccine: RSV
Symptoms: Injection site nodule
Clinical narrative: developed an injection site nodule; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site nodule in a 81-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-OCT-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site nodule (Verbatim: developed an injection site nodule). The outcome of the injection site nodule was resolved.   It was unknown if the reporter considered the injection site nodule to be related to Arexvy.     It was unknown if the company considered the injection site nodule to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-APR-2024 The reporter called in to report that a healthcare professional mentioned that the patient received a dose of Arexvy and developed an injection site nodule which subsided 2 to 4 weeks later. The agent did not provide any additional data beyond what was presented in the case for this particular patient but mentioned that the healthcare professional agreed to receive follow-up. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reported expired dose of ROTATEQ was administered.  No other information reported.  No additional AEs or PQC reported.; Caller reported expired dose of ROTATEQ was administered.  No other information reported.  No additional AEs or PQC reported.; This spontaneous report was received from a registered nurse, concerning to a patient of unspecified age and gender.  The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 29-APR-2024, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 (unit not reported) oral liquid  (formulation also reported as vial), 2 milliliter (mL), lot #1933914, expiration date: 24-APR-2024, administered orally as prophylaxis by a health professional (Expired product administered). No other information reported. No additional adverse events (AEs) or product quality complaint (PQC) reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; inadvertently administering VARIVAX vaccine after experiencing a temperature excursion.; This spontaneous report was received from nurse practitioner and referred to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-APR-2024, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, one dose, lot #X025846, expiration date: 31-OCT-2025, administered for prophylaxis (strength, exact dose and route of administration were not provided) after experiencing a temperature excursion of 22.1 degree F for 2 hours (product storage error). There was no previous temperature excursion. No addition adverse event reported (no adverse event).
Sex: U
Vaccine: RSV
Symptoms: Injection site nodule
Clinical narrative: developed an injection site nodule; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site nodule in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site nodule (Verbatim: developed an injection site nodule). The outcome of the injection site nodule was unknown.   It was unknown if the reporter considered the injection site nodule to be related to Arexvy.     It was unknown if the company considered the injection site nodule to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-APR-2024 The health professional reported that the various patients received a dose of Arexvy and developed an injection site nodule.  The agent did not provide any additional data beyond what was presented in the case for these particular patients but mentioned that the healthcare professional agreed to receive follow-up The vaccine administration facility was the same as primary reporter.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Borrelia test negative, Brain fog, Fatigue, Formication, Inflammatory marker increased
Clinical narrative: Generalized joint discomfort and creepy/crawly sensation going up my spine into my shoulders where I had never felt arthritic symptoms before; increase in late day fatigue with appearance of late day ?brain fog/fatigue? that makes daily activities severely challenging. No current treatment, symptoms have been gradually increasing.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of personal independence in daily activities, Musculoskeletal discomfort
Clinical narrative: Generalized joint discomfort and creepy/crawly sensation going up my spine into my shoulders where I had never felt arthritic symptoms before; increase in late day fatigue with appearance of late day ?brain fog/fatigue? that makes daily activities severely challenging. No current treatment, symptoms have been gradually increasing.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Injection site pain, Pain in extremity
Clinical narrative: Pain at the injection site , shoulder and left arm( iced area) systemic reaction > elevated body  temp
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ear discomfort, Ear pain, Tinnitus
Clinical narrative: Tinnitus (bilateral) started 4/15, preceded by sharp ear pain 3/31, and then off an on ear pain and odd ear sensations which have continued. Less pain, but odd sensation in one ear Tinnitus has continued to date, bilateral. Occasional days with no tinnitus, each time that only lasts one day and then it's back.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Nurse did not use the diluent in the box, use saline.  No adverse result.  Pt needs to repeat dose in 4 wks
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Confusional state, Hyperhidrosis, Mental status changes
Clinical narrative: Change in mentation, increased confusion, increased anxiety, diaphoresis, skin irritation
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: Change in mentation, increased confusion, increased anxiety, diaphoresis, skin irritation
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Hypertension, Scan abnormal
Clinical narrative: Brain bleed in 3 areas., and stroke, high BP started through the night and rushed to hospital at 5am and diagnosed after scans
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Patient spiked a fever with no other symptoms.  Fever has persisted over 24 hours and has spiked to 103.6 F without the constant usage of fever-reducing medicines (Tylenol and ibuprofen).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure increased, Chills, Computerised tomogram, Dizziness
Clinical narrative: A couple hours after the injection, I was nauseous, started having chills, fatigue and fever.  This lasted for  five days.  I've never experienced this with a vaccine.  I seemingly recovered but about two weeks later I couldn't walk up flights up stairs without getting  short of breath.  I assumed I needed to work out more.  I took my vital signs and my heart rate was elevated and blood pressure was higher than my baseline blood pressure.  On 3/18/2022 I ended up in the ER while at work.  I experienced nausea, sore throat, migraine, dizziness and stomach pain.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Echocardiogram, Fatigue, Heart rate increased
Clinical narrative: A couple hours after the injection, I was nauseous, started having chills, fatigue and fever.  This lasted for  five days.  I've never experienced this with a vaccine.  I seemingly recovered but about two weeks later I couldn't walk up flights up stairs without getting  short of breath.  I assumed I needed to work out more.  I took my vital signs and my heart rate was elevated and blood pressure was higher than my baseline blood pressure.  On 3/18/2022 I ended up in the ER while at work.  I experienced nausea, sore throat, migraine, dizziness and stomach pain.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Laboratory test, Migraine, Nausea, Oropharyngeal pain
Clinical narrative: A couple hours after the injection, I was nauseous, started having chills, fatigue and fever.  This lasted for  five days.  I've never experienced this with a vaccine.  I seemingly recovered but about two weeks later I couldn't walk up flights up stairs without getting  short of breath.  I assumed I needed to work out more.  I took my vital signs and my heart rate was elevated and blood pressure was higher than my baseline blood pressure.  On 3/18/2022 I ended up in the ER while at work.  I experienced nausea, sore throat, migraine, dizziness and stomach pain.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test, Pyrexia, Walking distance test, X-ray
Clinical narrative: A couple hours after the injection, I was nauseous, started having chills, fatigue and fever.  This lasted for  five days.  I've never experienced this with a vaccine.  I seemingly recovered but about two weeks later I couldn't walk up flights up stairs without getting  short of breath.  I assumed I needed to work out more.  I took my vital signs and my heart rate was elevated and blood pressure was higher than my baseline blood pressure.  On 3/18/2022 I ended up in the ER while at work.  I experienced nausea, sore throat, migraine, dizziness and stomach pain.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster
Clinical narrative: Developed shingles within 60 days, know side effect for 7 of 1,000,000 per recent study.  Dr. visit 11/19 confirmed, he prescribed anti viral and prednisone. Full recovery took 2 weeks.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects noted
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects known
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Crying, Discomfort, Ear pain, Facial pain
Clinical narrative: Patient spiked a high fever around 9pm the evening of the vaccination. He was restless and crying-out in his sleep from 9pm-2am. At 2am he started vomiting and was then crying-out in pain like I haven't seen him do before. He was holding the right side of his face and neck saying, "Ow", "Help me", "Please get this boo-boo off of me". He could not fall back asleep for the remainder of that night; very uncomfortable and crying in pain from his face and neck, fever and chills. That morning (4/24) he slept nearly all day and was acting very lethargic. I contacted his pediatrician's office at this time and they told me that it did not seem like a typical reaction to the MMR vaccine. Fever and chills aHe didn't want to do anything but sleep. This went on the duration of the day. He had a fever for this as well. At night his fever spiked to 104. He slept better that night but was still burning up and restless/uncomfortable. The next day there was still no improvement and that is when he started to state that his ear hurt. I continued to give Tylenol and let him sleep as that is all he wanted/could do. Friday (4/26/24) when his fever and pain still persisted I made an appointment at his pediatricians office. His fever did not let up until Sunday the 28th.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Lethargy, Lymphadenopathy, Myringitis, Neck pain, Pyrexia
Clinical narrative: Patient spiked a high fever around 9pm the evening of the vaccination. He was restless and crying-out in his sleep from 9pm-2am. At 2am he started vomiting and was then crying-out in pain like I haven't seen him do before. He was holding the right side of his face and neck saying, "Ow", "Help me", "Please get this boo-boo off of me". He could not fall back asleep for the remainder of that night; very uncomfortable and crying in pain from his face and neck, fever and chills. That morning (4/24) he slept nearly all day and was acting very lethargic. I contacted his pediatrician's office at this time and they told me that it did not seem like a typical reaction to the MMR vaccine. Fever and chills aHe didn't want to do anything but sleep. This went on the duration of the day. He had a fever for this as well. At night his fever spiked to 104. He slept better that night but was still burning up and restless/uncomfortable. The next day there was still no improvement and that is when he started to state that his ear hurt. I continued to give Tylenol and let him sleep as that is all he wanted/could do. Friday (4/26/24) when his fever and pain still persisted I made an appointment at his pediatricians office. His fever did not let up until Sunday the 28th.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Restlessness, Sleep disorder, Somnolence, Vomiting
Clinical narrative: Patient spiked a high fever around 9pm the evening of the vaccination. He was restless and crying-out in his sleep from 9pm-2am. At 2am he started vomiting and was then crying-out in pain like I haven't seen him do before. He was holding the right side of his face and neck saying, "Ow", "Help me", "Please get this boo-boo off of me". He could not fall back asleep for the remainder of that night; very uncomfortable and crying in pain from his face and neck, fever and chills. That morning (4/24) he slept nearly all day and was acting very lethargic. I contacted his pediatrician's office at this time and they told me that it did not seem like a typical reaction to the MMR vaccine. Fever and chills aHe didn't want to do anything but sleep. This went on the duration of the day. He had a fever for this as well. At night his fever spiked to 104. He slept better that night but was still burning up and restless/uncomfortable. The next day there was still no improvement and that is when he started to state that his ear hurt. I continued to give Tylenol and let him sleep as that is all he wanted/could do. Friday (4/26/24) when his fever and pain still persisted I made an appointment at his pediatricians office. His fever did not let up until Sunday the 28th.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects known
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Deafness bilateral, Hearing aid user, Neurological examination
Clinical narrative: Woke up the following night morning of Sept. 27, with lack of balance and loss of hearing in my right ear. I was hospitslized for amost 6 weeks and contince to see doctors and physical thearapy. Balance has improved but I still have more work to do. Hearing in my right ear has not come back. I have a hearing aide in my left ear where  I also have some loss of hearing
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: chills, fever, body aches, nausea, tiredness, and rash around collar line All symptoms resolved within 5 days of vaccine
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: chills, fever, body aches, nausea, tiredness, and rash around collar line All symptoms resolved within 5 days of vaccine
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NO symptoms, NO signs
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amyotrophic lateral sclerosis, Anti-ganglioside antibody positive, Cytogenetic analysis, Dysarthria, Electromyogram normal
Clinical narrative: ALS symptoms became noticeable 2 weeks after her second Pfizer COVID vaccine shot (March 30, 2021). Here are how her symptoms presented:  End March of 2021 ?Started to feel tingling and numbness in her left hand.   July 2021. ?Went to see Primary Care Manager (PCM) at Facility, but was sent to ER because of high blood pressure related to lab coat fear (I am a retired, and during that time, we used the medical facility).  January 2022 established a new PCM (Not related to installation), because of increased left finger weakness. ?Difficulty holding clipper and clipping right fingernails ?Numbness, reduced dexterity, and mobility ?Referred to Electromyography (EMG) for carpal tunnel syndrome -prognosis negative (PCM suspected pinched nerve). Electromyography (EMG) measures muscle response or electrical activity in response to a nerve's stimulation of the muscle. The test is used to help detect neuromuscular abnormalities.  ?Referred to MRI for neck, and Physical Therapy ?No pinched nerve on MRI ?Physical Therapy had no effects, grip in hand weaker after 1 month   April 28, 2022. After visiting again with a new PCM because her left finger was getting weaker, suggested MRIs. ?MRI of the brain for Parkinson?s Disease -negative. ?MRI Brachial Plexus W/ & W/O Contrast -negative ?Referral to In-Network Neurologist   June 21, 2022. Visit with Dr (Neurologist) ?Blood work ordered ?EMG ordered   August 22, 2022. Visit with Dr for EMG ?Motor Nerve Conduction Studies completed ?Blood work ordered ?B12 High, Asialo-GM1 High    Late Sep 2022  ?left leg weakness and right finger tingling, numbness & weakness.   Mid Oct 2022  ?Slurred speeches on and off  ?Burning tingling sensation on my tongue   Late NOV 2022 Seen by Dr., -Medical Neurology ?EMG Ordered ?Invitae Genetic Testing ?Diagnosed with ALS   Mid-February 2023 Seen by Dr., for second opinion. ?EMG Ordered ?Invitae Genetic Testing ?Prevention Genetics Genetic Testing ?Diagnosed with ALS
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear, Fine motor skill dysfunction, Hypertension, Hypoaesthesia, Magnetic resonance imaging head normal
Clinical narrative: ALS symptoms became noticeable 2 weeks after her second Pfizer COVID vaccine shot (March 30, 2021). Here are how her symptoms presented:  End March of 2021 ?Started to feel tingling and numbness in her left hand.   July 2021. ?Went to see Primary Care Manager (PCM) at Facility, but was sent to ER because of high blood pressure related to lab coat fear (I am a retired, and during that time, we used the medical facility).  January 2022 established a new PCM (Not related to installation), because of increased left finger weakness. ?Difficulty holding clipper and clipping right fingernails ?Numbness, reduced dexterity, and mobility ?Referred to Electromyography (EMG) for carpal tunnel syndrome -prognosis negative (PCM suspected pinched nerve). Electromyography (EMG) measures muscle response or electrical activity in response to a nerve's stimulation of the muscle. The test is used to help detect neuromuscular abnormalities.  ?Referred to MRI for neck, and Physical Therapy ?No pinched nerve on MRI ?Physical Therapy had no effects, grip in hand weaker after 1 month   April 28, 2022. After visiting again with a new PCM because her left finger was getting weaker, suggested MRIs. ?MRI of the brain for Parkinson?s Disease -negative. ?MRI Brachial Plexus W/ & W/O Contrast -negative ?Referral to In-Network Neurologist   June 21, 2022. Visit with Dr (Neurologist) ?Blood work ordered ?EMG ordered   August 22, 2022. Visit with Dr for EMG ?Motor Nerve Conduction Studies completed ?Blood work ordered ?B12 High, Asialo-GM1 High    Late Sep 2022  ?left leg weakness and right finger tingling, numbness & weakness.   Mid Oct 2022  ?Slurred speeches on and off  ?Burning tingling sensation on my tongue   Late NOV 2022 Seen by Dr., -Medical Neurology ?EMG Ordered ?Invitae Genetic Testing ?Diagnosed with ALS   Mid-February 2023 Seen by Dr., for second opinion. ?EMG Ordered ?Invitae Genetic Testing ?Prevention Genetics Genetic Testing ?Diagnosed with ALS
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck normal, Magnetic resonance imaging normal, Mobility decreased, Muscular weakness, Musculoskeletal disorder
Clinical narrative: ALS symptoms became noticeable 2 weeks after her second Pfizer COVID vaccine shot (March 30, 2021). Here are how her symptoms presented:  End March of 2021 ?Started to feel tingling and numbness in her left hand.   July 2021. ?Went to see Primary Care Manager (PCM) at Facility, but was sent to ER because of high blood pressure related to lab coat fear (I am a retired, and during that time, we used the medical facility).  January 2022 established a new PCM (Not related to installation), because of increased left finger weakness. ?Difficulty holding clipper and clipping right fingernails ?Numbness, reduced dexterity, and mobility ?Referred to Electromyography (EMG) for carpal tunnel syndrome -prognosis negative (PCM suspected pinched nerve). Electromyography (EMG) measures muscle response or electrical activity in response to a nerve's stimulation of the muscle. The test is used to help detect neuromuscular abnormalities.  ?Referred to MRI for neck, and Physical Therapy ?No pinched nerve on MRI ?Physical Therapy had no effects, grip in hand weaker after 1 month   April 28, 2022. After visiting again with a new PCM because her left finger was getting weaker, suggested MRIs. ?MRI of the brain for Parkinson?s Disease -negative. ?MRI Brachial Plexus W/ & W/O Contrast -negative ?Referral to In-Network Neurologist   June 21, 2022. Visit with Dr (Neurologist) ?Blood work ordered ?EMG ordered   August 22, 2022. Visit with Dr for EMG ?Motor Nerve Conduction Studies completed ?Blood work ordered ?B12 High, Asialo-GM1 High    Late Sep 2022  ?left leg weakness and right finger tingling, numbness & weakness.   Mid Oct 2022  ?Slurred speeches on and off  ?Burning tingling sensation on my tongue   Late NOV 2022 Seen by Dr., -Medical Neurology ?EMG Ordered ?Invitae Genetic Testing ?Diagnosed with ALS   Mid-February 2023 Seen by Dr., for second opinion. ?EMG Ordered ?Invitae Genetic Testing ?Prevention Genetics Genetic Testing ?Diagnosed with ALS