chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, raised bump at injection site 3 months after injection; Red, raised bump at injection site 3 months after injection; This is a spontaneous report received from a Pharmacist.  A 69-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Dec2023 as dose 1, single (Lot number: HL9687), in left deltoid for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE, start date: 09Jan2024. Past drug history included: Levothyroxine, start date: 24May2017, notes: 75 mcg, Brand name: Lupin, Lot number: L301356; Furosemide, notes: 20 mg tablet, Brand name: Leading; Metoprolol succinate, notes: ER 25 mg tablet, Brand name: Zydus; Potassium cl, start date: 30Jan2020, notes: 10 mEq tablet, Brand name: Bluepoint. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE MASS (non-serious), outcome "not recovered" and all described as "Red, raised bump at injection site 3 months after injection". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site mass.  Additional information: Facility where vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine. The patient was taking any other medications within 2 weeks of the event starting. The patient reported red, raised bump at injection site 3 months after injection. She does not report any pain or itchiness.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm 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), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Apr2024 to 07Apr2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Pain, Pyrexia, Vomiting
Clinical narrative: Could not keep anything down, throwing up and come out the other end; Feverish; dehydrated; hurt; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose number unknown, single (Lot number: GJ6738), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing), notes: Diabetic; "COPD", start date: 2000 (ongoing), notes: Start: Early 2000s; "Emphysema", start date: 2000 (ongoing), notes: Emphysema, Start: Early 2000s. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: VOMITING (non-serious) with onset 2022, outcome "recovered with sequelae" (Jan2023), described as "Could not keep anything down, throwing up and come out the other end"; PYREXIA (non-serious) with onset 2022, outcome "recovered with sequelae" (Jan2023), described as "Feverish"; DEHYDRATION (non-serious) with onset 2022, outcome "unknown", described as "dehydrated"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "hurt".
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: dropped and the part where you screw in the needle was broken off/broke off right at the glass part; The initial case was missing the following minimum criteria: product complaint. Upon receipt of follow-up information on (12Apr2024), this case now contains all required information to be considered valid.   This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown (0.5 ml), single (Lot number: HH9320) 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 "dropped and the part where you screw in the needle was broken off/broke off right at the glass part". The reporter considered "dropped and the part where you screw in the needle was broken off/broke off right at the glass part" not related to pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein). Causality for "dropped and the part where you screw in the needle was broken off/broke off right at the glass part" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction).  Additional information: One syringe of the Prevnar 20 dropped and the part on the top where you screw the needle it came off, a reason why we wanted to report. So, on the top part you screw the needle, it came off and that why we wanted to report that and request for a replacement. It broke off right at the glass part; just in 2 pieces. Nothing shattered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: get a vaccine since they previously got four Pfizer vaccines in Sep2022 then, in 2023, they still got covid; get a vaccine since they previously got four Pfizer vaccines in Sep2022 then, in 2023, they still got covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 159558.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) and in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "get a vaccine since they previously got four Pfizer vaccines in Sep2022 then, in 2023, they still got covid". Clinical course: The caller was a senior citizen, calling for her and her husband. They were both trying to get a vaccine since they previously got four Pfizer vaccines in Sep2022 then, in 2023, they still got covid. Now, the caller was nervous about getting the vaccine since before, many people were getting it because of how it was being stored. She stated that she was confused about how people were getting the single-dose vials with gray caps, plastic filled, and glass manufactured fill because she called someplace and told her that there was a multi-dose vial. The caller was asking if both kinds were available with Pfizer which was the multi-dose or single dose as she was nervous that Pfizer was using the multi-dose and did not threw it out. And she added that she was looking for a single dose.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400088497 same reporter/product, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart issues; This is a spontaneous report received from a Physician, Program ID.  A child patient received BNT162b2 (BNT162B2 NOS), (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart issues". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. Additional information: A pediatrician reported in market research today that she had a friend who suspected their child had heart issues following a COVID-19 vaccination. The pediatrician was not sure if the complications were related to the vaccine or which COVID19 vaccine the child received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: my mother-in-law died six days after getting the COVID-19 vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), 6 days after the suspect product(s) administration, outcome "fatal", described as "my mother-in-law died six days after getting the COVID-19 vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400086284 same reporter, different patient/event;; Reported Cause(s) of Death: my mother-in-law died six days after getting the COVID-19 vaccine
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Tenivac was inadvertently administered to a patient, with no reported adverse event; Initial information received on 11-Apr-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 67 years old female patient who was inadvertently administered with expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Mar-2024, the patient had inadvertently received 0.5 ml (Frequency = once) (Strength = standard) of expired suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) (lot U7092AA, expiry date: 24-Jun-2023) via unknown route in the left deltoid for Immunization with no reported adverse event (expired product administered) (Latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave expired acthib to a patient with no reported adverse event; Initial information received on 15-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom expired HIB (PRP/T) vaccine [ACT-HIB] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Apr-2024, the patient received a 0.5 ml, total dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UJ864AB, expiry date: 26-Mar-2024, unknown strength) via unknown route in unknown administration site for Immunisation and gave expired acthib to a patient with no reported adverse event (expired product administered) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Contusion, Pain in extremity, Swelling
Clinical narrative: A 12-year-old female patient, presents with left arm bruising and pain following her second HPV vaccination five days ago. She reports noticing the bruising and swelling on Sunday. The patient has not attempted any ice or ibuprofen for pain relief. Patient denies any significant medical history and states that she is still able to eat and move her arm. no fevers. ROS neg otherwise stated in the HPI
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient complained of having rash
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site irritation, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Within 2  hours, site of inection was irritated; radiated to back of shoulder and neck. Next day, entire body aching, from knee down really weak, gradually most of pain is gone except calf pain.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: unknown
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered Rotavirus at 17 weeks of age, recommendation for vaccine is to not start series on or after age 15 weeks, 0 days.
Age: 11.0
Sex: M
Vaccine: COVID19, RAB, TYP
Symptoms: Loss of consciousness, Somnolence
Clinical narrative: Patient passed out after receiving the Imovax (rabies) vaccine. He regained consciousness quickly (within 10-15 seconds), but still felt a little groggy afterwards. Monitored pt for 15 minutes after receiving vaccine and pt felt ok before leaving, so contacting emergency services was not needed. Patient's father stated that he is normally a little squeamish when it comes to needles.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient upper arm was red, swollen and very painful. Went to MD office asked patient to take OTC medications and come back for follow up visit
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Pregnant at 28 weeks at the time of injection. Reported to my OB  that the medical assistant that gave it, gave it too high in the arm creating a shoulder injury  (Sirva). I talked to a pharmacist and consulted with them and the verified that it was given too high. The injection site was near the shoulder joint causing extreme pain. My OB stated it could not be reported unless I made another office visit and went in to be seen for the injury. Pharmacist told me to self report if the doctor?s office would not do anything about it.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong patient received product
Clinical narrative: Medical assistant administered a Tdap vaccine to a 60 year old adult patient who did not need the Tdap vaccine, it was 1 year early. Error was done due to administering the Tdap to the wrong patient. There were no adverse reactions after vaccine was administered to patient. Medical assistant called patient by name in the front lobby, wrong patient stood up and medical assistant proceeded to bring patient to the back office. Medical assistant then provided the patient name and date of birth and patient verified the information provided by saying "yes," in the exam room. Patient was provided the VIS for Tdap and was informed pt would be getting the Tdap vaccine that day and pt then said she was under the impression she would be getting the Covid vaccine. The medical assistant then told patient she could get the Covid vaccine as well, she would only have to wait 15 mins after receiving the vaccine. Patient then said she would get it another day as she did not want to wait. Patient then filled out and signed a screening check list. Unfortunately, the medical assistant did not catch that the signature did not match the name of the patient she was to be administering the Tdap vaccine.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Choking, Cyanosis, Respiratory rate decreased, Somnolence
Clinical narrative: Chocked on it immediately. Then 1 minute later  arm turned purple/blue and he started breathing really slow and fell asleep. (Dr said it probably turned blue because he was having trouble breathing from choking on it) if it wasn't from choking on it it could have been from any of the other vaccines he got because they gave them at the same time
Age: 50.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Immediate post-injection reaction
Clinical narrative: Pt states she was given HPV in her Left arm and Hepatatis in R arm on 9/19/23. Stated her L upper arm became very red and swollen and painful. Stated symptoms persisted for 1.5 months, but there is no indication of calls or clinic visit to report the symptoms. Patient states this most recent injection on 11/14/23 was also on her L upper arm(per pt.) along with the flu vaccine.  She immediately felt strong pain, but went home.  Hours later, pt called to speak with nurse stating the she was feeling very tired, dizzy, fatigued and in pain. Nurse provided reassurance and home care instructions.  No further notation in chart indicating that pt had contacted clinic until her phone visit on 4/18/24. At her phone appointment she complained of aching, sharp, burning pain. Aggravated by movement, relieved by Acetaminophen.  She has decreased mobility, joint tenderness, nocturnal pain, swelling and weakness.  She reports pain is felt all day and at night it is sharp and stabbing.  Clinician ordered Naprosyn and Voltarin gel for pain.  In addition, she was referred for a Left shoulder MRi as well as physical therapy.  She will follow up with clinician in person on 4/23/24.   Pt also stated she went to the emergency room on 4/15, but was given no treatment and informed to follow up with clinician.
Age: 50.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Pt states she was given HPV in her Left arm and Hepatatis in R arm on 9/19/23. Stated her L upper arm became very red and swollen and painful. Stated symptoms persisted for 1.5 months, but there is no indication of calls or clinic visit to report the symptoms. Patient states this most recent injection on 11/14/23 was also on her L upper arm(per pt.) along with the flu vaccine.  She immediately felt strong pain, but went home.  Hours later, pt called to speak with nurse stating the she was feeling very tired, dizzy, fatigued and in pain. Nurse provided reassurance and home care instructions.  No further notation in chart indicating that pt had contacted clinic until her phone visit on 4/18/24. At her phone appointment she complained of aching, sharp, burning pain. Aggravated by movement, relieved by Acetaminophen.  She has decreased mobility, joint tenderness, nocturnal pain, swelling and weakness.  She reports pain is felt all day and at night it is sharp and stabbing.  Clinician ordered Naprosyn and Voltarin gel for pain.  In addition, she was referred for a Left shoulder MRi as well as physical therapy.  She will follow up with clinician in person on 4/23/24.   Pt also stated she went to the emergency room on 4/15, but was given no treatment and informed to follow up with clinician.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Urinary incontinence
Clinical narrative: Reported Symptoms: 10046543:URINARY INCONTINENCE; 10047862:WEAKNESS; Narrative: Other Relevant HX: Other: URINARY INCONTINENCE; WEAKNESS
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Reported Symptoms: 10016558:FEVER; 10019211:HEADACHE, 10028322:MUSCLE PAIN; 10028411:Myalgia;   Narrative: Other Relevant HX:  Other: MUSCLE PAIN:  FEVER
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Reported Symptoms: 10008531:CHILLS; 10016558:FEVER; 10028322:MUSCLE PAIN; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: CHILL; FEVER; MUSCLE PAIN
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS;  Narrative:  Other Relevant HX: Other: ANAPHYLAXIS
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; Narrative: Other Relevant HX:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Needle issue, Underdose
Clinical narrative: No symptoms reported; patient who was administered less than recommended dose of PROQUAD; due to an issue with syringe needle. Caller reported that needle came off of syringe during administration.; This spontaneous report was received from a medical assistant concerning to a 4-year-old patient of unspecified gender.  The patient's medical history, historical drugs, known allergies, concurrent, and concomitant therapies were not reported.  On 01-APR-2024, the patient was vaccinated with less than the recommended dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter/dose (conflicting information), administered for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided), due to an issue with the syringe needle, as it came of off during the administration (incomplete dose administered) (needle issue). No symptoms were reported.  Lot number was being request and would be updated upon received.
Age: 59.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient did not experience any adverse issues or side effects; A HCP called to report that she inadvertently administered an expired dose of both MMR II and STERILE DILUENT to a patient on 04/10/2024.; This spontaneous report was received from a nurse and refers to a 59-year-old patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-APR-2024, the patient was vaccinated with measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) injection, rHA, 0.5 milliliter/once, lot #W019425, expiration date: 07-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided) diluted in sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, expiration date: 30-JAN-2024 (strength, lot #, route of administration, and indication were not provided) (Expired product administered). The patient did not experience any adverse issues or side effects.
Age: 6.0
Sex: U
Vaccine: COVID19, DTAPIPV, HEPA, PNC15, VARCEL
Symptoms: Vaccination site pain
Clinical narrative: Email received in the Contact Center mailbox on 15APR2024 at 0858 an attached form from Sanofi reporting an AE for VAQTA, VARIVAX, and VAXNEUVANCE. Sanofi case number 2024SA086975. Event verbatim: "This case involves a 6 years old and unknown; This spontaneous report was received from a consumer via other company letter and refers to a 6-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-OCT-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X010374, expiration date: 13-NOV-2024, administered intramuscularly for immunisation (strength was not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X020316, expiration date: 18-OCT-2025, administered intramuscularly for immunisation (strength was not provided); varicella virus vaccine live (OKA/MERCK) (VARIVAX) subcutaneous injection, lot #X011424, expiration date: 19-APR-2025, administered subcutaneously for prophylaxis (strength was not provided); diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL), lot# 07656A A, administered intramuscularly for immunisation (strength, formulation, and expiry date were not provided); and elasomeran (COVID-19 VACCINE MODERNA), 0.5 milliliter, lot# AU5558B, administered intramuscularly for covid-19 prophylaxis (strength, formulation, and expiry date were not provided).  On an unknown date in 2023, the patient developed after the vaccination no noticeable side effects besides achy shot site. At the reporting time, the outcome of the event was unknown.  The causal relationship between vaccination site pain and suspect vaccines was not provided.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no symptomatic adverse events were reported.; Inbound call from nurse calling to report temperature excursions that occurred for GARDASIL-9.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.  Confirmed no symptomatic adverse events were reported.  No additional; This spontaneous report was received from nurse and refers to an 11-year-old male patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.   It was reported previous temperature excursions for the  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine on the following dates: 1) 07-JUN-2023: 33F for 3 hours 0 minutes 0 seconds, 2) 13-JUN-2023 60F for 4 hours 30 minutes 0 seconds and 34.10F for 240 hours 0 minutes.   On 11-SEP-2023, the patient was vaccinated with improper storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection,  lot #W010663, expiration date: 11-MAR-2024 (upon internal review, it was determined to be a valid lot number and same expiration date), administered for prophylaxis (strength, and route of administration were not provided). In addition, the vaccine experienced more temperature excursion on 30-NOV-2023 52F for 5 hours 45 minutes and 01-DEC-2023 to 09-DEC-2023 51.78F for 192 hours (product storage error). No additional adverse event.
Age: 81.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Inbound call from nurse calling to report temperature excursions that occurred for VAXNEUVANCE.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.  Confirmed no symptomatic adverse events were reported.  No additiona; This spontaneous report was received from a Registered Nurse and referred to a 81-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 15-NOV-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 mL injection, 1 dosage form (lot #w036242 is a valid lot number of prefilled syringe pneumococcal 15v conj vaccine (crm197), expiration date was reported as 01-OCT-2024), administered for prophylaxis. The vaccine was found to experiencing multiple times of temperature excursion (TE) (on 07-JUN-2023 to 09-DEC-2023, conflicting information since the onset date was reported as 15-NOV-2023) (product storage error). It was confirmed that no symptomatic adverse events were reported. No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 10th out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Reporter's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the fatal event of Death, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 10 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 45 out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Reporter's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the fatal event of Death, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 45 out of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. As date of death was reported as 01-Jan-1990 which was a discrepancy, and no dates were reported in the narrative, so date of death was captured as unknown. The treatment medication was not reported by reporter. This case contains information for patient 52 out of 68 described by the reporter.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 52 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. As date of death was reported as 01-Jan-1990 which was a discrepancy, and no dates were reported in the narrative, so date of death was captured as unknown. The treatment medication was not reported by reporter. This case contains information for patient 53 out of 68 described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Reporter's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the fatal event of Death, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 53 out of 68; Reported Cause(s) of Death: Unknown cause of death
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Joint range of motion decreased, Magnetic resonance imaging normal, Pain, Rotator cuff syndrome
Clinical narrative: During vaccination, administrator was standing over seated patient. Right away, sharp, stabbing pain, rapid onset. Limited range of motion, weakness and constant pain. Shoulder tendonitis diagnosed six months after flu vaccine. Six months after still symptomatic. External/internal rotation, overhead motions, lateral and frontal raises are painful.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray normal
Clinical narrative: During vaccination, administrator was standing over seated patient. Right away, sharp, stabbing pain, rapid onset. Limited range of motion, weakness and constant pain. Shoulder tendonitis diagnosed six months after flu vaccine. Six months after still symptomatic. External/internal rotation, overhead motions, lateral and frontal raises are painful.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Chills, Nausea, Pyrexia
Clinical narrative: High fever (max 102), chills, intermittent abdominal pain and nausea. High fever reduced to 99ish degrees without medication to return 24 hours later and then reduce within 2 hours without medication and then normalize.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Blood pressure increased, Condition aggravated, Hypertension
Clinical narrative: Increasing BP since injection when previously controlled by BP medication.
Sex: U
Vaccine: COVID19-2
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Fatigue and Diarrhea  for three days
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: Patient started experiencing burning under the skin since 04/13/24 which is 1 month after the vaccine even though patient did not go any medication of dietary changes. Consulted with dermatologist and ended up going to ER on 04/19/24 and planning to visit the neurologist once patient gets a referral from the PCP.
Age: 65.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Arthralgia, Inflammation, Pain in extremity, Pyrexia, Rash
Clinical narrative: Patient developed pain in his left shoulder area within 24 hours following immunization with Prevnar 20. He says he did not experience inflammation, rash, fever, or other adverse reaction. I recommended patient apply an ice pack and consider taking oral analgesic like ibuprofen or APAP, but I am unsure if he did either. Patient states his arm is still sore 3 months later. He says pain is minor but constant. It worsened when he moves it but he says he does not have any restrictions on his range of motion.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered a vaccine that had expired 2 days prior.  No adverse outcome
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Laboratory test
Clinical narrative: Extreme chest pain and difficulty breathing starting 4/12/24; ER visit 4/15/24; diagnosed with acute pericarditis/myocarditis
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Extreme chest pain and difficulty breathing starting 4/12/24; ER visit 4/15/24; diagnosed with acute pericarditis/myocarditis
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Fall, Head injury, Nausea, Skin laceration
Clinical narrative: Nausea /lightheaded/ leading to fall and head  injury and scalp laceration needing staples
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: Wound closure
Clinical narrative: Nausea /lightheaded/ leading to fall and head  injury and scalp laceration needing staples
Age: 76.0
Sex: F
Vaccine: PNC20, RSV, VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient came in to the pharmacy on 04/19 to report experiencing side effects occurring roughly 24 hours after administration. Side effects include fever, weakness, swelling and redness at the site of injection. Patient reported on 04/19 that they are no longer experiencing weakness/fever and the injection site reactions are also decreasing. Pt self treated with rest and no otc medication, recommended the patient use an OTC NSAID for any remaining pain and swelling and continue to monitor the swelling and redness. Pt is aware to seek medical attention if condition worsens.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Severe nausea, inability to keep food or water down, body aches.  Unable to consume medication without vomiting.  We intend to wait 24 hours and if symptoms have not improved seek medical help.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Discomfort, Headache, Hypertension, Ocular discomfort
Clinical narrative: Patient wanted me to report her blood pressure has been running very high starting about 24 hours after having her shot. She also claims  she has had extreme headaches to the point she feels her eyes  and nose are going to burst. Prior to this shot her blood pressure has always been under control with medication.  At the present time she is only taking Tylenol to control her pain.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: Patient presented with complaint of  soreness where the vaccine was given as well as body aches over the side of the body that patient received the vaccine. The patient complains of knee pain in particular since vaccine
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Fever and body aches within 24 hours after.  August of 1998-numbness in lower right leg for two weeks of unknown onset at the time.  Leg numbness resolved after that 1998 episode.  April 2005 numbness and tingling in right lower leg, left lower arm and left rib cage.  Subsequent diagnosis in June of 2005 of multiple sclerosis.  Please note that I do not know which form of the vaccine for Hep B that I received.  It is not noted on my records that I received.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Multiple sclerosis, Pain, Paraesthesia, Pyrexia
Clinical narrative: Fever and body aches within 24 hours after.  August of 1998-numbness in lower right leg for two weeks of unknown onset at the time.  Leg numbness resolved after that 1998 episode.  April 2005 numbness and tingling in right lower leg, left lower arm and left rib cage.  Subsequent diagnosis in June of 2005 of multiple sclerosis.  Please note that I do not know which form of the vaccine for Hep B that I received.  It is not noted on my records that I received.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Musculoskeletal discomfort, Thirst
Clinical narrative: Date of vaccination about 4 pm CST ; Frontal headache with neck discomfort;  Tylenol 350 mg po 2 tabs;; night chills.    Same headache with waking next morning;  extremely thirty;  same dose Tylenol taken.  Headache relieved by noon
Age: 1.75
Sex: M
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Exposure to communicable disease, Gait disturbance, Influenza A virus test negative, Influenza B virus test negative, Injection site pain
Clinical narrative: Fever of 102.3 which started the night of vaccination, right leg pain, refusing to walk. Day 1 after vaccine started to have nasal discharge.  Tylenol and Motrin given around the clock to reduce fever.  Exposed to influenza B via 6 yo sister whose symptoms started 4 days prior to vaccination.  Presented to clinic on day 2 of symptoms, rapid influenza A & B swab was negative. Rapid Covid also negative.
Age: 1.75
Sex: M
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: Fever of 102.3 which started the night of vaccination, right leg pain, refusing to walk. Day 1 after vaccine started to have nasal discharge.  Tylenol and Motrin given around the clock to reduce fever.  Exposed to influenza B via 6 yo sister whose symptoms started 4 days prior to vaccination.  Presented to clinic on day 2 of symptoms, rapid influenza A & B swab was negative. Rapid Covid also negative.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: hot, sweaty, nauseous, vomiting, diarrhea, feeling dizzy
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: hot, sweaty, nauseous, vomiting, diarrhea, feeling dizzy
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Thrombosis, Ultrasound scan, X-ray
Clinical narrative: I had 5 or 6 shots total of vaccines and boosters from 12/20 til 10/22. Approx 08/ 23, I developed severe clotting in left leg, and being treated by 5 Dr's. Cause of clots unknown as no history of blood clots before shots or family history
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthritis, Asthenia, Blood thyroid stimulating hormone, Blood uric acid
Clinical narrative: Shortly after receiving Pfizer Covid-19 vaccine, I began experiencing debilitating joint stiffness in my hips, knees, and ankles and a flare up of arthritis in my lumbar spine. I've been a lifelong runner and a rock climber for over two decades and found it was difficult to perform these activities. Sitting or lying (sleeping) for even a small period of time would result in very stiff joints, making it difficult to walk. My ankles often felt like they were so weak that they could crumble and in fact, I collapsed to the floor one morning  upon waking and getting out of my bed. I had taken my dog for a long walk the evening before, which weakened my ankles. No injuries were sustained from this. I continue to have issues, though I've learned to manage with supplements and medications; however, I can no longer run as a result of this.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Condition aggravated, Full blood count, Gait disturbance, Joint stiffness
Clinical narrative: Shortly after receiving Pfizer Covid-19 vaccine, I began experiencing debilitating joint stiffness in my hips, knees, and ankles and a flare up of arthritis in my lumbar spine. I've been a lifelong runner and a rock climber for over two decades and found it was difficult to perform these activities. Sitting or lying (sleeping) for even a small period of time would result in very stiff joints, making it difficult to walk. My ankles often felt like they were so weak that they could crumble and in fact, I collapsed to the floor one morning  upon waking and getting out of my bed. I had taken my dog for a long walk the evening before, which weakened my ankles. No injuries were sustained from this. I continue to have issues, though I've learned to manage with supplements and medications; however, I can no longer run as a result of this.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Red blood cell sedimentation rate, Rheumatoid factor increased, Syncope
Clinical narrative: Shortly after receiving Pfizer Covid-19 vaccine, I began experiencing debilitating joint stiffness in my hips, knees, and ankles and a flare up of arthritis in my lumbar spine. I've been a lifelong runner and a rock climber for over two decades and found it was difficult to perform these activities. Sitting or lying (sleeping) for even a small period of time would result in very stiff joints, making it difficult to walk. My ankles often felt like they were so weak that they could crumble and in fact, I collapsed to the floor one morning  upon waking and getting out of my bed. I had taken my dog for a long walk the evening before, which weakened my ankles. No injuries were sustained from this. I continue to have issues, though I've learned to manage with supplements and medications; however, I can no longer run as a result of this.
Age: 61.0
Sex: M
Vaccine: RSV
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Muscle pain and low grade fever.  Symptoms are flu like. Still experiencing symptoms two days after the shot.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Adiposis dolorosa, Blood test, Burning sensation, Chest pain, Gait disturbance
Clinical narrative: Increased Migraines, extreme burning sensation left side, loss of left leg use (zero muscle resistance when asked to push, foot drop/drag, trouble walking), extreme leg cramps, left side face numbness, chest pain, ....years later bilateral leg pain, degenerative arthritis in joints (back, hands, elbows, wrists, ankles, ect..), dercums disease, shooting bouts of all over pain, headaches
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Hypoaesthesia, Laboratory test, Magnetic resonance imaging, Migraine
Clinical narrative: Increased Migraines, extreme burning sensation left side, loss of left leg use (zero muscle resistance when asked to push, foot drop/drag, trouble walking), extreme leg cramps, left side face numbness, chest pain, ....years later bilateral leg pain, degenerative arthritis in joints (back, hands, elbows, wrists, ankles, ect..), dercums disease, shooting bouts of all over pain, headaches
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Muscle spasms, Musculoskeletal disorder, Osteoarthritis, Pain, Pain in extremity
Clinical narrative: Increased Migraines, extreme burning sensation left side, loss of left leg use (zero muscle resistance when asked to push, foot drop/drag, trouble walking), extreme leg cramps, left side face numbness, chest pain, ....years later bilateral leg pain, degenerative arthritis in joints (back, hands, elbows, wrists, ankles, ect..), dercums disease, shooting bouts of all over pain, headaches