chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Dose 2) and COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE. Concurrent medical conditions included Congestive heart failure and AFib.    On 18-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jan-2024,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. It was reported   that patient did not infect for covid from the cruise ship. But it was during travel when patient got down from the cruise ship when he got it. Patient got covid and on the cruise patient was three days.  On 17-Jan-2024 patient felt better but patient was unable to breath properly.   Patient received Moderna covid-19 vaccination on 10-Mar-2024 as fourth dose.  No treatment medications provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia, Raynaud's phenomenon
Clinical narrative: I have Reynaud's Syndrome and it was exacerbated after my last dose of Moderna/both hands were totally freezing, white and with blue finger tips; light shakes; low fever; chills; feels exhausted; pretty bad joint pain; This spontaneous case was reported by a patient and describes the occurrence of RAYNAUD'S PHENOMENON (I have Reynaud's Syndrome and it was exacerbated after my last dose of Moderna/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (low fever), CHILLS (chills) and FATIGUE (feels exhausted) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Raynaud's syndrome (Reynaud's Syndrome first diagnosed "30 years ago." The flair-ups and symptoms would be very rare usually only felt in the winter or if it was very cold and rainy).  In 2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced RAYNAUD'S PHENOMENON (I have Reynaud's Syndrome and it was exacerbated after my last dose of Moderna/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (low fever), CHILLS (chills), FATIGUE (feels exhausted) and ARTHRALGIA (pretty bad joint pain). At the time of the report, RAYNAUD'S PHENOMENON (I have Reynaud's Syndrome and it was exacerbated after my last dose of Moderna/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (low fever), CHILLS (chills), FATIGUE (feels exhausted) and ARTHRALGIA (pretty bad joint pain) had resolved.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient had Raynaud's syndrome, and it was exacerbated after her last dose of Moderna.   Patient had the most recent dose in September or October of 2023.  Patient reported being diagnosed with Reynaud's Syndrome 30 years ago and reported the flair-ups and symptoms would be very rare usually only felt in the winter or if it was very cold and rainy.  However, she reported the symptoms were immediately exacerbated following the most recent dose in Fall of 2023. She reported both hands were totally freezing, white and with blue fingertips. She reported the symptoms did subside however, following the last dose of Spikevax. The symptoms of Reynaud's Syndrome were a little bit worsened. She reported the flair-ups were more frequent and more severe then prior to the most recent dose of Spikevax. She reported feeling common symptoms of low fever, light shakes, chills, feels exhausted, pretty bad joint pain.  She stated symptoms always subsided after one or two days.  Treatment information was not provided.   This case was linked to MOD-2024-772808 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I have Reynaud's Syndrome and it was exacerbated after my last dose of Moderna/both hands were totally freezing, white and with blue finger tips; light shakes; low fever; chills; feels exhausted; pretty bad joint pain; This spontaneous case was reported by a patient and describes the occurrence of RAYNAUD'S PHENOMENON (I have Reynaud's Syndrome and it was exacerbated after my last dose of Moderna/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (low fever), CHILLS (chills) and FATIGUE (feels exhausted) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Raynaud's syndrome (Reynaud's Syndrome first diagnosed "30 years ago." The flair-ups and symptoms would be very rare usually only felt in the winter or if it was very cold and rainy).  In 2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced RAYNAUD'S PHENOMENON (I have Reynaud's Syndrome and it was exacerbated after my last dose of Moderna/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (low fever), CHILLS (chills), FATIGUE (feels exhausted) and ARTHRALGIA (pretty bad joint pain). At the time of the report, RAYNAUD'S PHENOMENON (I have Reynaud's Syndrome and it was exacerbated after my last dose of Moderna/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (low fever), CHILLS (chills), FATIGUE (feels exhausted) and ARTHRALGIA (pretty bad joint pain) had resolved.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient had Raynaud's syndrome, and it was exacerbated after her last dose of Moderna.   Patient had the most recent dose in September or October of 2023.  Patient reported being diagnosed with Reynaud's Syndrome 30 years ago and reported the flair-ups and symptoms would be very rare usually only felt in the winter or if it was very cold and rainy.  However, she reported the symptoms were immediately exacerbated following the most recent dose in Fall of 2023. She reported both hands were totally freezing, white and with blue fingertips. She reported the symptoms did subside however, following the last dose of Spikevax. The symptoms of Reynaud's Syndrome were a little bit worsened. She reported the flair-ups were more frequent and more severe then prior to the most recent dose of Spikevax. She reported feeling common symptoms of low fever, light shakes, chills, feels exhausted, pretty bad joint pain.  She stated symptoms always subsided after one or two days.  Treatment information was not provided.   This case was linked to MOD-2024-772808 (Patient Link).
Sex: U
Vaccine: PNC20
Symptoms: Device connection issue, Needle issue
Clinical narrative: was screwing on the needle, when they went to uncap it it snapped from the part that screws on. It snapped off from where you screw on to the syringe.; This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LA6406, Expiration Date: 31Dec2025) 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 "was screwing on the needle, when they went to uncap it it snapped from the part that screws on. It snapped off from where you screw on to the syringe.".  Causality for "was screwing on the needle, when they went to uncap it it snapped from the part that screws on. it snapped off from where you screw on to the syringe." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: the sample of the product was not available to be returned as discarded, but patient has a picture if needed. The packaging was sealed and intact.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dyspnoea, Peripheral swelling, Vaccination site reaction
Clinical narrative: Shortness of breath; the vaccine site gets like really bad; an allergic reaction after getting the COVID-19 vaccine; arm got swollen; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EWO150) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative cancer" (unspecified if ongoing); "allergic to Polysorbate" (unspecified if ongoing). Concomitant medication(s) included: ARIMIDEX taken for neoplasm malignant. The following information was reported: DYSPNOEA (non-serious) with onset Apr2021, outcome "unknown", described as "Shortness of breath"; ALLERGY TO VACCINE (non-serious) with onset Apr2021, outcome "unknown", described as "an allergic reaction after getting the COVID-19 vaccine"; PERIPHERAL SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "arm got swollen"; VACCINATION SITE REACTION (non-serious) with onset Apr2021, outcome "unknown", described as "the vaccine site gets like really bad".  Additional information: the patient mentioned that she developed an allergic reaction after getting the COVID-19 vaccine. So her arm got swollen. Patient had many vaccines and every time she gets it, she has been a shortness of breath and then the vaccine site gets like really bad and then the last one was the worse because shortly after getting the injection, she barely made it to the restroom.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400240124 Same patient, different vaccine dose and events.;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: 2023, stop date: 2023. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Aug2024, outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Aug2024) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; now have Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 30-JUL-2024, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: now have Shingles). The patient was treated with aciclovir (Acyclovir), nystatin, betamethasone and triamcinolone. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 17-AUG-2024 After receiving two doses of Shingrix, now the patient had shingles. As a result of having shingles the patient met with the primary care physician (PCP), they prescribed Nystatin Cream, USP, to be used twice/day for two weeks.  The patient also used Betamethasone and Triamcinolone 0.1 percent cream.  The products temporarily soothed the symptoms, but unfortunately, three weeks later continued  to be plagues with shingles.  The patient given her experience, the finding was the statistics quoted in the commercials were not true, nor reliable. The patient symptoms were treated. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (dose 1 and dose 2).
Sex: U
Vaccine: PNC20
Symptoms: Allergy to vaccine, Injection site rash
Clinical narrative: I am allergic to something in the vaccine; I developed a rash on my arm below the injection site of my Prevnar 20 vaccination; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "I am allergic to something in the vaccine"; VACCINATION SITE RASH (non-serious), outcome "unknown", described as "I developed a rash on my arm below the injection site of my Prevnar 20 vaccination". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: patient and her husband both tested positive for Covid. Patient and her husband both tested positive for Covid and they went to the hospital and prescribed Paxlovid but cannot pick up the medication and they were told to call Pfizer to get medications. They already had 5 doses of the vaccine and doesn't know if they needed some more.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400241625 same reporter/product/event, different patient;
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Muscular weakness, Pain in extremity
Clinical narrative: WEAK MUSCLES, PAIN IN LEGS, SICK
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Neck mass
Clinical narrative: Patient presented to the clinic for his 2nd Bexsero vaccine. He states that 2 days after receiving the 1st dose of the Bexsero, he developed a lump near his right collarbone. He states that this lump moves over and under his collarbone. Patient denies any pain associated with this.     Provider evaluated and palpated this lump. She states that it feels like a fluid filled cyst. Patient has not experienced any other lumps or swelling in any other part of his body. He denies any recent fevers.      Provider discussed this with the pediatric on call provider, who recommends testing to see if there is fluid in this lump and then testing this fluid if there is any. Recommendations were relayed by provider to patient who is going to discuss this with his guardian. He will schedule an appointment after he discusses this with his guardian. We will hold off on giving the 2nd dose of Bexsero and will report this to the VAERS website.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dermatitis contact, Injection site induration, Pain, Urticaria, Vomiting
Clinical narrative: Mom states 4-5 hours after vaccine given patient with body aches, vomiting, hardness to the injection site. No symptoms after HPV #1 was given.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Lacrimation increased, Vision blurred
Clinical narrative: Pt. presents to health department for Td following cut to her arm with a wire yesterday.  Td administered to left deltoid between 1015 and 1030 on 08/23/2024.   Pt. calls health department at 1112 to report blurry vision.  Reports onset of blurry vision at 1045. RN, calls pt. at approximately 1140 to complete VAERs form.  Pt. reports she has gone home and laid down and feels that blurriness is improving.   1450--RN, calls pt. on cell phone.  Pt. reports the watery blurriness seems to be going away, states she is doing better now.
Age: 0.83
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was administered a Hepatitis A vaccine today at 10 months old. There have been no adverse outcomes yet.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal discomfort, Diarrhoea, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Vaccine was given by patient's request as patient has asthma and other conditions. Given on 08/11/2024. Per patient, patient had redness/hardness around the injection area half of her upper arm. Reported to pharmacy on 08/21/2024 to rph. Rph relayed the message to rph and she is reporting it. Called patient on 08/23/2024 at 825am, now the redness and hardness is gone but a little itchy. Did not seek for doctor's attention but applied hydrocortisone topical. Redness began 2 - 3 days after the vaccine and hardness couple hours after the vaccine per patient.  Diarrhea and stomach upset happened along with redness started after 2 to 3 days after the vaccine. But as of 08/23/2024, no more redness nor hardness around the injection area but a little itchiness. The diarrhea and stomach upset comes and goes. We told patient if reactions come back or not get any better, seek doctor's attention and let us know. As of today 08/23/2024: itchiness. diarrhea and stomach upset still comes and goes.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Anosmia, Chills, Cough, Fatigue
Clinical narrative: Starting 12 hours after the shot:  severe chills, aches, headache, fatigue, and respiratory symptoms.  The respiratory symptoms were sinus congestion and sinus drainage plus coughing and sneezing.  The cough was a severe dry cough that persisted for 6 days and is now finally resolved.  The sinus congestion continues along with fatigue and an impaired ability to smell and taste.  The aches lasted 4 days; the chills lasted 4 days.  The headache lasted 4-5 days.  Again, the cough finally resolved after 6 days.  None of the respiratory symptoms are published anywhere as possible side effects of the vaccine, but they were certainly there for me along with the other flu-like symptoms, and all the symptoms including respiratory started at the same time, exactly 12 hours after receiving the shot.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Paranasal sinus hypersecretion, Sinus congestion
Clinical narrative: Starting 12 hours after the shot:  severe chills, aches, headache, fatigue, and respiratory symptoms.  The respiratory symptoms were sinus congestion and sinus drainage plus coughing and sneezing.  The cough was a severe dry cough that persisted for 6 days and is now finally resolved.  The sinus congestion continues along with fatigue and an impaired ability to smell and taste.  The aches lasted 4 days; the chills lasted 4 days.  The headache lasted 4-5 days.  Again, the cough finally resolved after 6 days.  None of the respiratory symptoms are published anywhere as possible side effects of the vaccine, but they were certainly there for me along with the other flu-like symptoms, and all the symptoms including respiratory started at the same time, exactly 12 hours after receiving the shot.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Sneezing
Clinical narrative: Starting 12 hours after the shot:  severe chills, aches, headache, fatigue, and respiratory symptoms.  The respiratory symptoms were sinus congestion and sinus drainage plus coughing and sneezing.  The cough was a severe dry cough that persisted for 6 days and is now finally resolved.  The sinus congestion continues along with fatigue and an impaired ability to smell and taste.  The aches lasted 4 days; the chills lasted 4 days.  The headache lasted 4-5 days.  Again, the cough finally resolved after 6 days.  None of the respiratory symptoms are published anywhere as possible side effects of the vaccine, but they were certainly there for me along with the other flu-like symptoms, and all the symptoms including respiratory started at the same time, exactly 12 hours after receiving the shot.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Exposure via skin contact, Injection site discharge
Clinical narrative: patient had bicep flexed and even when relaxed vaccine ran out of injection site down patient arm
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Injection site swelling, Rash papular
Clinical narrative: Received 2nd HPV to L deltoid 8/21/24. She now has some bruising, redness, swelling, and a papular, pruritic rash. Denies feeling ill, respiratory distress, or inability to move L arm. No previous reactions to vaccines.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Rash pruritic
Clinical narrative: Received 2nd HPV to L deltoid 8/21/24. She now has some bruising, redness, swelling, and a papular, pruritic rash. Denies feeling ill, respiratory distress, or inability to move L arm. No previous reactions to vaccines.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received vaccines 8/21/24. Swelling and redness to both legs where vaccines were placed. MOC marked area y'day and today area is even larger. No c/o respiratory distress. No pain with ambulation.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: cellulitis,  treated with clindamycin 300 mg by mouth three times a day; signs: redness, swelling, inflammation, hot at the site of injection, lethargic and malesia,
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Lethargy, Malaise
Clinical narrative: cellulitis,  treated with clindamycin 300 mg by mouth three times a day; signs: redness, swelling, inflammation, hot at the site of injection, lethargic and malesia,
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, UNK
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: ARM IS RED, HOT TO TOUCH, TENDER, AND ENTIRE ARM IS SWOLLEN (ACCORDING TO PARENT)
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives appearing on upper left arm and on right side of face. Patient was given liquid diphenhydramine 12.5mg/5mL 10ml, dexamethasone 10mg/ml, monitored for an hour. Heart rate was 96 and his oxygen levels were 98%. When he was relieved from the clinic, his hives disappeared and he was feeling much better. Mother knows to notify Dr. if there are any concerns and to go to ER if something else occurs. This reaction happened in the exam room after administration of vaccine. Patient was laying on exam table after administration to monitor for reaction. Patient will continue with diphenhydramine for a few more days
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine was administered. expiration date of vaccine was 8/22/2024 and the expired vaccine was administered on 8/23/2024. no adverse reactions from vaccine noted at this time,
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine give past used by date, no reaction
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse events were noted. This VAERS submission is being made due to the vaccine being administered outside of the established recommended interval. The 2nd dose of the vaccine was administered early, 16 days after the initial dose instead of the recommended one-month interval between doses.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: pt was in doctor office and called and dr described that patient has rash on her shoulder, back and ankles
Age: 75.0
Sex: M
Vaccine: COVID19-2, HEP, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site dryness, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient received high-dose influenza vaccine on 8/20/24, on 8/23/24 pt came to pharmacy stating they might have reaction to vaccine. Upon inspecting the left arm, it looks pink-red in color on lower area close to elbow, has  signs of dry skin, pt states its itching and slightly painful to touch. No other symptoms reported. Patient was instructed by pharmacist that administered the vaccine to use hydrocortisone 1% otc 3-4 times a day for itchiness and apply ice for pain/cooling effect, continue for 2-3 days. Patient appreciated the advice.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: PATIENT CLAIMS NUMBNESS STARTED IN HER L ARM ABOUT 15 MINUTES AFTER RECEIVING THE INJECTION. SOON AFTER SHE NOTICED ITCHING FROM HER L SHOULDER TO L ELBOW. SINCE THEN SHE HAS DEVELOPED ITCHING IN HER R ARM, WITHOUT RESOLUTION IN HER L ARM. THE ITCHING SEEMED TO HAVE EXTENDED TO HER CHEST FIRST AND THEN TO THE R ARM, BUT SHE NO LONGER HAS ITCHING IN HER CHEST. THERE IS NO OBVIOUS RASH. PT SAYS INJECTION SITE WAS HOT AND RED WHEN SHE ARRIVED HOME THAT DAY.
Age: 1.0
Sex: F
Vaccine: PNC20, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives appeared that evening. Had not reacted to PCV before, this was his first dose of varicella. Called the after hours line and was advised to give Benadryl. Hives resolved and did not reappear.
Age: 75.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 76.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 24.0
Sex: F
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 64.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Sex: M
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: about to get a cochlear implant on 23Sep; Case assessed invalid as other - info not qualifying for adverse event reporting - medical information.   This is a spontaneous report received from a Nurse from medical information team.  A 20-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 15Apr2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine conj 15v (CRM197) (PNEUMOCOCCAL VACCINE CONJ 15V (CRM197)), on 07May2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COCHLEA IMPLANT (medically significant), outcome "unknown", described as "about to get a cochlear implant on 23Sep". Clinical course: A nurse called about a patient about to get a cochlear implant on 23Sep2024 asking how often they can get the vaccine: Prevnar 13. She mentioned he is behind on his pneumococcal vaccines, he took Prevnar 13 (PCV13) last Apr2023, PCV 15 last 07May2024 this year and needs two more.    Follow-up (18Jul2024): This is a spontaneous follow-up report received from a same nurse.  Updated Information: reporter Email address subsumed; treatment information updated and clinical course added.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. Follow-up (23Aug2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no patient symptoms have been reported; Accidental overdose; This spontaneous report was received from a physician referring to a 1-year-old patient.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  A dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, lot #X011979, expiration date: 18-JUL-2024; and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X021930, expiration date: 29-AUG-2025 were inadvertently administered to the patient (strength, and route of administration were not provided) for prophylaxis on 20-JUN-2024 (accidental overdose). No patient symptoms have been reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/ no PQC.; The HCP also reports that the patients third dose did not meet the minimal interval requirements for administration; HCP called to report that the patient received her second dose of GARDASIL 9 late.; This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 06-APR-2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, as prophylaxis (route of administration, anatomical location and expiration date were not reported). On 23-JAN-2024, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, as prophylaxis (route of administration, anatomical location and expiration date were not reported); which was late (inappropriate schedule of product administration). On 25-MAR-2024, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, as prophylaxis (route of administration, anatomical location and expiration date were not reported); which did not meet the minimal interval requirements for administration (inappropriate schedule of product administration). No additional adverse events were reported.   Lot numbers are being requested and will be submitted if received.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; The caller said the product was administered to a patient on 8/13/2024 after a temperature excursion.; This spontaneous report was received from a physician concerning to a male patient of unspecified age.  The patient's medical history, concurrent conditions concomitant therapies and drug reactions/allergies were not reported.  On unspecified date, varicella virus vaccine live (oka/merck) (VARIVAX) dose underwent a temperature excursion of 6 degree Farenheit (F) up to 14 F for 50 minutes and 14 F up to 46 F (26.9 F) for a time frame of 1 hour 20 minutes without previous temperature excursion.  On 13-AUG-2024, after temperature excursion, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X026789, expiration date 14-NOV-2025 (dosage regimen, anatomical location and route of administration were not provided) (product storage error) administered as prophylaxis.  It was confirmed that no other adverse events (AE) occurred (no adverse event.)
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No additional AE/PQC.; Nurse called stating while giving a VARIVAX to a 6 year old child, they moved and the patient only got less than half the dose of VARIVAX.; This spontaneous report was received from a Nurse and refers to a 6-year-old child patient of an unknown gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 21-AUG-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided). The nurse stating while giving a with varicella virus vaccine live (oka/merck) (VARIVAX), the child moved, and the patient only got less than half the dose of with varicella virus vaccine live (oka/merck) (VARIVAX) (Underdose). No further information was provided. Operation of device was reported as health professional. No additional adverse event or product quality complaint were reported.  Lot # is being requested and will be submitted if received.
Age: 33.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Fatigue, Headache, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: Soreness at injection site right away, soreness extending to entire upper arm by about 3 hours after injection. Injection arm pain turned to difficultly moving arm that lasted from 8/20 pm to 8/23 am. Soreness spread through to right arm from 8/20 pm to 8/22 am. Full body fatigue starting 8/20 around 4pm, lasting until the evening of 8/22. Headache for first 24 hours. Muscle and joint aches from evening of 8/20 to evening of 8/22. Excessive tiredness from evening of 8/20 to evening of 8/22. Injection site pain still present at time of reporting, 8/23 at 10:25pm. Taking ibuprofen has consistently done very little to alleviate pain and other symptoms.
Age: 33.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Soreness at injection site right away, soreness extending to entire upper arm by about 3 hours after injection. Injection arm pain turned to difficultly moving arm that lasted from 8/20 pm to 8/23 am. Soreness spread through to right arm from 8/20 pm to 8/22 am. Full body fatigue starting 8/20 around 4pm, lasting until the evening of 8/22. Headache for first 24 hours. Muscle and joint aches from evening of 8/20 to evening of 8/22. Excessive tiredness from evening of 8/20 to evening of 8/22. Injection site pain still present at time of reporting, 8/23 at 10:25pm. Taking ibuprofen has consistently done very little to alleviate pain and other symptoms.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site swelling, Pain in extremity
Clinical narrative: hours after the receiving the vaccine the patient exp arm pain, Thursday the morning the pt arm site was red , swollen and a knot appears the size of a golf ball, pt could not lift her arm. Friday patient still could not lift arm, begin to exp itching feet and hives on knees and face.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus, Urticaria
Clinical narrative: hours after the receiving the vaccine the patient exp arm pain, Thursday the morning the pt arm site was red , swollen and a knot appears the size of a golf ball, pt could not lift her arm. Friday patient still could not lift arm, begin to exp itching feet and hives on knees and face.
Age: 1.25
Sex: F
Vaccine: IPV
Symptoms: Blood glucose normal, Febrile convulsion, Gaze palsy, Influenza virus test negative, Pyrexia
Clinical narrative: At 3:41am 8/23/2024 she spiked a fever about 99.4 and I gave her 2ml of tylenol. I checked it again at 8am and it was around 100.8. At 9:00am I went to give her more tylenol and I gave her 1ml and turned to pull more and I look over and my daughter is having a seizure (the day after her polio vaccine, the only vaccine she received that day). I have it video taped if needed. She was doing fine and then she became unresponsive with her eyes looking to the left, NO convulsing. This lasted for at least 2 minutes. We believe it to be a febrile seizure as her temperature went from 100.8  (around 8am) to 102.8 (during the seizure we took her tempature). We called EMS, they took vitals and blood sugar. Heart rate was in the 160s and tachy, fever was 102.3 (axillary) in the ambulance, blood glucose 112. All other vitals normal. At the hospital the only change was a rise in fever to 103. They tested her for viruses and she was negative for all (she was not sick prior, I am a nurse myself and she had no symptoms of any illness). Doctor said it was most likely a febrile seizure due to the temperature spike, the temperature the vaccine caused.
Age: 1.25
Sex: F
Vaccine: IPV
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Seizure, Tachycardia, Unresponsive to stimuli
Clinical narrative: At 3:41am 8/23/2024 she spiked a fever about 99.4 and I gave her 2ml of tylenol. I checked it again at 8am and it was around 100.8. At 9:00am I went to give her more tylenol and I gave her 1ml and turned to pull more and I look over and my daughter is having a seizure (the day after her polio vaccine, the only vaccine she received that day). I have it video taped if needed. She was doing fine and then she became unresponsive with her eyes looking to the left, NO convulsing. This lasted for at least 2 minutes. We believe it to be a febrile seizure as her temperature went from 100.8  (around 8am) to 102.8 (during the seizure we took her tempature). We called EMS, they took vitals and blood sugar. Heart rate was in the 160s and tachy, fever was 102.3 (axillary) in the ambulance, blood glucose 112. All other vitals normal. At the hospital the only change was a rise in fever to 103. They tested her for viruses and she was negative for all (she was not sick prior, I am a nurse myself and she had no symptoms of any illness). Doctor said it was most likely a febrile seizure due to the temperature spike, the temperature the vaccine caused.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Headache
Clinical narrative: Persistent headache every day since and it has been 2 months since administration of vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Aches/pains, febrile, stabbing pain on bottom of feet
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed redness and swelling around injection site. Area became very warm to the touch, and caused a great deal of pain. Rash grew to 2.5 inches at largest.  By the  evening of the third day after injection, pain had increased to unbearable. Diagnosed with cellulitis on fourth day.  Given antibiotics, and started feeling relief after second or third dose.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Developed redness and swelling around injection site. Area became very warm to the touch, and caused a great deal of pain. Rash grew to 2.5 inches at largest.  By the  evening of the third day after injection, pain had increased to unbearable. Diagnosed with cellulitis on fourth day.  Given antibiotics, and started feeling relief after second or third dose.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Employee was administered the incorrect vaccine, employee was supposed to receive Hep B vaccine and Tdap was given.  No treatment was required employee had no adverse events.
Age: 63.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
Clinical narrative: At first, dizziness, headache & some nausea.  By the following morning I had, body aches over my entire body, continued headache and fever.  Fever reached 101.4.  Still had a low-grade morning of August 24, 2024, which has since subsided.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abdominal pain, Fatigue, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: I sent this message to his Dr. and recieved a response included:  Message sent May 16 at 10:06 AM  You May 16, 10:06 AM Patient is still complaining today that his legs hurt from the shots Tuesday. Yesterday morning at 5am he woke up in pain and said it was making his belly hurt. His legs were both warm then, but he sleeps hot, so it might have been that although they were warmer than the rest of his body. I gave him tylenol. He had a slight fever when it wore off so I gave him more. He was lazy all day yesterday, he asked to go home from the park, which is crazy, and he even took a 4 hour nap, which is also super out of character. Then this morning around 730am he woke up and said his belly and legs hurt again. I gave him a small glass of apple juice and about 5 minutes later he vomited it all over the kitchen. He seems okay now, he had a small bowl of oatmeal at 9 and hasn't complained of his belly but he is saying his legs still hurt. The injection sites aren't red or warm or anything, and he's not able to tell me if one leg hurts worse than the other. He usually has a little pain after shots, but never this long, and he is never so fatigued the next day, and he has never vomited. I wondered if there's anything I should watch for?  Message sent May 16 at 11:26 AM  MD May 16, 11:26 AM Sounds like patient is having a more robust immune reaction (not a bad thing ultimately).  These are normal and I would just schedule tylenol every 4-6 hours for the next 24 hours to help symptomatically. Showing 2 of 2 You cannot reply to this conversation. It is too old to be replied to.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Somnolence, Vomiting
Clinical narrative: I sent this message to his Dr. and recieved a response included:  Message sent May 16 at 10:06 AM  You May 16, 10:06 AM Patient is still complaining today that his legs hurt from the shots Tuesday. Yesterday morning at 5am he woke up in pain and said it was making his belly hurt. His legs were both warm then, but he sleeps hot, so it might have been that although they were warmer than the rest of his body. I gave him tylenol. He had a slight fever when it wore off so I gave him more. He was lazy all day yesterday, he asked to go home from the park, which is crazy, and he even took a 4 hour nap, which is also super out of character. Then this morning around 730am he woke up and said his belly and legs hurt again. I gave him a small glass of apple juice and about 5 minutes later he vomited it all over the kitchen. He seems okay now, he had a small bowl of oatmeal at 9 and hasn't complained of his belly but he is saying his legs still hurt. The injection sites aren't red or warm or anything, and he's not able to tell me if one leg hurts worse than the other. He usually has a little pain after shots, but never this long, and he is never so fatigued the next day, and he has never vomited. I wondered if there's anything I should watch for?  Message sent May 16 at 11:26 AM  MD May 16, 11:26 AM Sounds like patient is having a more robust immune reaction (not a bad thing ultimately).  These are normal and I would just schedule tylenol every 4-6 hours for the next 24 hours to help symptomatically. Showing 2 of 2 You cannot reply to this conversation. It is too old to be replied to.
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Second Prevnar 20 vaccine was administered in a one month period.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain, Rash, Vertigo
Clinical narrative: Patient states she developed rash, pain, dizziness and vertigo that ultimately resulted in hospital visit.  Patient has no chronic symptoms at this time.  Adverse event has resolved.