chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pruritus, Refusal of vaccination
Clinical narrative: 17 yo accompanied to well child visit with stepmother. Vaccines recommended and discussed. Stepmother and 17 y.o. refused Men B vaccine only wanting HPV vaccine which was given and Menquadfi vaccine. Mother (biological) called 2/6 to report adverse reaction to HPV - intense itching. She says she did not want HPV vaccination and blames the itching on HPV vaccine. Declined office visit for exam.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: DEEP PAIN IN THE LEGS STARTING FROM THE FOOT TO THE ANKLE TO THE SHIN TO MY CALF AND GOING UP TO MY ARM, IT'S LIKE NEUROPATHY; NUMBNESS; TINGLING; This spontaneous report received from a consumer by a Business partner (Pfizer Inc.) on 08-JAN-2024 was received on 08-JAN-2024 and concerned a 62 year old of unspecified sex. The patient's weight was 220 pounds, and height was 162.56 centimeters. The patient's past medical history included: covid-19, and concurrent conditions included: prediabetes, depression, and hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Concomitant medications included fluoxetine for depression, metformin for diabetes, and levothyroxine for prediabetes. On an unspecified date, the patient experienced deep pain in the legs starting from the foot to the ankle to the shin to my calf and going up to my arm, it's like neuropathy, numbness, and tingling (dose series 1). Patient developed a lot of deep pain in legs. The side effect was deep pain in the legs starting from the foot to the ankle to the shin to calf and going up to arm, it's like neuropathy, there was some numbness, tingling but mostly it was the deep pain. When the patient first had the COVID company vaccine, the patient had deep pain in legs, so they were concerned about DVT." When clarified the side effects: Consumer stated, "Deep pain that was after few days but I told the doctor and he wanted to run a test for DVT and did not have, they did not find a blood clot, they couldn't but it was a deep pain and then the patient had the second one and was encroached to have the second one because COVID was still around and did not have as many. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep pain in the legs starting from the foot to the ankle to the shin to my calf and going up to my arm, it's like neuropathy, numbness, and tingling. This report was non-serious. This case, involving the same patient is linked to 20240169244.  Version created to amend previously reported information on 08-JAN-2024. Upon review the following information was amended: Amendment Multiple (Events including atrial fibrillation, overweight, patient too sleepy, revaccination with different covid-19 vaccine, arm pain deleted and suspects including janssen covid-19 vaccine (dose series 2), and pfizer biontech covid-19 vaccine (dose series 3) deleted).; Sender's Comments: Medical assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), in May2021 as dose 2, 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. The following information was reported: MYOCARDITIS (death, medically significant) with onset 11May2021, 2 days after the suspect product(s) administration, outcome "fatal". The patient date of death was 11May2021. Reported cause of death: "Myocarditis". It was not reported if an autopsy was performed.  Clinical course: Reporter's wife never had any heart issues took Pfizer Covid Vaccine and two days after her second injection was dead from Myocarditis? Reporter just asking how should present this info in reporter's postings on the Internet? Her name was (name withheld) and because of Pfizer product she died on 11May2021. Her heart just stopped beating. Looking for answers and a response from Pfizer before reporter start reporter's campaign to get reporter's story out there in the public.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: Myocarditis
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Herpes symptoms came back; Herpes symptoms came back; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-726941.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FJ8757) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "herpes", start date: 1992 (unspecified if ongoing), notes: severe. The patient's concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (dose 1, 0.5 ml single in the left arm, lot: 039A21A), administration date: 01Apr2021; moderna COVID-19 vaccine (dose 2, 0.5 ml single in the left arm, lot: 045B21A), administration date: 29Apr2021. The following information was reported: HERPES VIRUS INFECTION (non-serious), DISEASE RECURRENCE (non-serious) all with onset 2021, outcome "unknown" and all described as "Herpes symptoms came back". Additional information: Herpes symptoms came back after the last 2 Moderna COVID-19 Boosters. After the first primary Moderna Shot, all Herpes symptoms stopped for about 1 month and exercising and drinking alcohol did not trigger a herpes reaction, COVID-19. The point is that several months went by with no outbreaks after the initial; 1-2 primary shots. By the time I had my boosters, they were ineffective as breakouts had commenced again.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Herpes virus infection
Clinical narrative: Herpes symptoms came back; Herpes symptoms came back; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-726941.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FJ8757) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "herpes", start date: 1992 (unspecified if ongoing), notes: severe. The patient's concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (dose 1, 0.5 ml single in the left arm, lot: 039A21A), administration date: 01Apr2021; moderna COVID-19 vaccine (dose 2, 0.5 ml single in the left arm, lot: 045B21A), administration date: 29Apr2021. The following information was reported: HERPES VIRUS INFECTION (non-serious), DISEASE RECURRENCE (non-serious) all with onset 2021, outcome "unknown" and all described as "Herpes symptoms came back". Additional information: Herpes symptoms came back after the last 2 Moderna COVID-19 Boosters. After the first primary Moderna Shot, all Herpes symptoms stopped for about 1 month and exercising and drinking alcohol did not trigger a herpes reaction, COVID-19. The point is that several months went by with no outbreaks after the initial; 1-2 primary shots. By the time I had my boosters, they were ineffective as breakouts had commenced again.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC.; the first dose of GARDASIL 9 was administered to a female at the age of 57 years; This spontaneous report has been received from Medical Assistant, regarding to a 57-year-old female patient. The patient's pertinent medical history, concomitant medications, current conditions, and previous drug reactions or allergies were not reported.  On 20-OCT-2023, 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, at a dose of 0.5 milliliters (ml), lot number 1957404 which was determined to be valid, expiration date reported and validated as 05-OCT-2025, as prophylaxis (vaccination scheme, route of administration, and anatomical site of injection were not reported)(Product administered to patient of inappropriate age).  No additional adverse events were reported in the patient.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; HCP reported that a 4 year old female patient was inadverntly administered an expired dose of the PROQUAD vaccine.; This spontaneous report was received from a nurse referring to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-FEB-2024, the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) with lot # W024973, for prophylaxis (dose, route of administration, anatomical location, and expiration date were not provided). The reporter stated that no temperature excursions occurred during the lifetime of the vaccine.   No adverse event was reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: platelets count dropped to 38; This is a spontaneous report received from a Consumer or other non HCP.  An 88-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 87 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure abnormal" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal. The following information was reported: PLATELET COUNT DECREASED (medically significant) with onset Sep2023, outcome "not recovered", described as "platelets count dropped to 38". The patient underwent the following laboratory tests and procedures: Platelet count: (2022) 219, notes: dropped from 219 to 174; (Dec2022) 174, notes: had lab work done two months later and my platelet count had dropped from 219 to 174; (Sep2023) 38, notes: ninth month of this past year; (23Jan2024) 126. Therapeutic measures were taken as a result of platelet count decreased.  Clinical course: The patient just wanted to report an adverse event after taking the booster shot (Pfizer Bivalent GV3277 took it on 21Oct2022. The patient had lab work done two months later and his platelet count had dropped from 219 to 174. He didn't know whether the left arm or right arm. Consumer stated, "AL3249 and the expiration date is 5/21. There are two Lot number on this thing. I might be giving you the wrong one. The last I am showing is expiration date is 6/21 (June 2021) and lot# is AN6200. Well, I know there are two lot numbers on this card. The lot number are AN6200 and also AL3249 but the last one, the latest one only is AN6200." When probed if consumer received any vaccination prior to 4 weeks of taking the Pfizer vaccine: Consumer stated, "I don't know. I could have got the flu shot at the same time. I am not sure." Consumer stated that for lab test: "Oh yes, I have the whole. I am going about every two weeks and get lab work done because my platelets count dropped to 38 on the ninth month of this past year. The last lab work I have done was 23rd of January of this year. My platelet count was 126. I am assigned to a hematologist, and they all are monitoring me." She put him on B12, and folic acid and she also gave him some steroids pills as treatment. He would let know that his platelet count dropped to 38 that concerned him. They sent him to a hematologist.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 25Jan2024 until 30Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 1.33
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Administered flu dose 3 at this time involved administering additional injection, patient tolerated pain from vaccine well,  easily consolable, f/u call on 1/23 confirmed no side effects or adverse rxn, mother reported patient well, playing, no signs of illness or discomfort.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Productive cough, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: coughing, sniffling, phlegm
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia, Rash macular
Clinical narrative: Patient received kindergarten vaccines the next day mom called ad left thigh is now swollen down towards knee. Mother notes redness at injection site and red blotchy patches toward knee. Patient did have a fever of 101.3, no troubles breathing. Advised ibuprofen and bath
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient had redness and swollen arm. He complained that never happened with other vaccines. First time this kind of reaction with Shingrix
Age: 0.58
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Wrong product administered
Clinical narrative: patient was seen in clinic today by NP for wellness exam. NP ordered a Vaxelis to be given. The clinical staff member gave Varivax in error.
Age: 0.58
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was seen in clinic today by NP for wellness exam. NP ordered a Vaxelis to be given. The clinical staff member gave Varivax in error.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC15, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: MMR-II and Varivax ordered. Proquad and Varivax administered. Patient received 2 doses of Varicella vaccine. No side-effects, symptoms, signs, adverse events.
Age: 33.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Vaginal haemorrhage
Clinical narrative: I had vaginal spotting which is unusual for me
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Blood electrolytes, Computerised tomogram normal, Decreased appetite, Diarrhoea
Clinical narrative: It started with like tingling and pins and needles sensation. That was all over the body, mostly my arms and my legs. Then I had the regular muscle pain, and some joint pain. Then I got diarrhea and a loss of appetite. Then the tingling feeling got worst. It got all over my legs and arm. I started having something where my body would tense up and would not release. I could not relax my body. When I finally went to the er, it finally went to my face and part of my head. Also my throat felt like someone was squeezing it, like the muscles were tensing up. My right arm felt really heavy, and it was hard for me to pick up things. It felt like a little bit numb. It's still happening. I had a headache.  I have occasional shortness of breath.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Hypoaesthesia, Limb discomfort, Mobility decreased, Muscle rigidity
Clinical narrative: It started with like tingling and pins and needles sensation. That was all over the body, mostly my arms and my legs. Then I had the regular muscle pain, and some joint pain. Then I got diarrhea and a loss of appetite. Then the tingling feeling got worst. It got all over my legs and arm. I started having something where my body would tense up and would not release. I could not relax my body. When I finally went to the er, it finally went to my face and part of my head. Also my throat felt like someone was squeezing it, like the muscles were tensing up. My right arm felt really heavy, and it was hard for me to pick up things. It felt like a little bit numb. It's still happening. I had a headache.  I have occasional shortness of breath.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Muscle tightness, Myalgia, Paraesthesia, Respiratory pathogen panel, Throat tightness
Clinical narrative: It started with like tingling and pins and needles sensation. That was all over the body, mostly my arms and my legs. Then I had the regular muscle pain, and some joint pain. Then I got diarrhea and a loss of appetite. Then the tingling feeling got worst. It got all over my legs and arm. I started having something where my body would tense up and would not release. I could not relax my body. When I finally went to the er, it finally went to my face and part of my head. Also my throat felt like someone was squeezing it, like the muscles were tensing up. My right arm felt really heavy, and it was hard for me to pick up things. It felt like a little bit numb. It's still happening. I had a headache.  I have occasional shortness of breath.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given an MMRV on 12/28/23. She was 13, MMRV can only be given through age 12. Insurance denying the MMRV vaccine because of her age.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Biopsy, Pemphigus
Clinical narrative: Subsequent development of an auto immune disease, Pemphigus Vulgaris.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Nausea, Pneumonia, Pyrexia
Clinical narrative: dizzy, nausea, fever of 101
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: HIB vaccine was given on 2/12/24. It had expired on 2/11/24.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, PNC20, TDAP
Symptoms: Wrong product administered
Clinical narrative: Pneumococcal vaccine administered in error.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea
Clinical narrative: Donor reported difficulty breathing
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Pt experienced tingling and numbness in the arm along with feeling warm and having a headache. Pt had vitals checked by the nurse at (work) and everything normal
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bradycardia, Hyperhidrosis, Hypotension, Mental status changes, Vomiting
Clinical narrative: Altered Mental Status, Hypotension, Bradycardia, Vomiting, Diaphoresis.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MENB, MMRV, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MMRV given to a 17 year old, no adverse reaction noted
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hallucination, Influenza like illness, Pollakiuria
Clinical narrative: PT REPORTED HALLUCINATIONS, FLU-LIKE SYMPTOMS AND FREQUENT URINATION ON THE NIGHT OF HIS IMMUNIZATION. PT REPORTED BEING BACK TO NORMAL THE NEXT MORNING.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 37.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Phone call received from patient on 2/1/2024 c/o reaction to left arm where he received Shingrix vaccine- Private Vaccine- on 1/29/2024. States there is redness below injection site down left arm to elbow, slightly itchy and warm to touch. Instructed patient to use cool compress and OTC Ibuprofen/Tylenol/Benadryl as needed. Contact clinic with questions/concerns or of worsening symptoms.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Mononucleosis heterophile test negative, Rash, Rash pruritic, Skin warm, Streptococcus test negative
Clinical narrative: Broke out in a severe rash from head to toe. It was all over his entire body except his face. It was hot to the touch and ver yitchy
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: vasovagal reaction; patient cared for by FNP in clinic and released home with parent after being able to ambulate unassisted and without symptoms
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event or treament.  Pt due a PCV 20.  An IPV was  given instead of the PCV 20.  Rescheduled for the PCV 20. IPV dose won't be counted.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Injection site discolouration, Injection site induration, Injection site pain
Clinical narrative: Vaccine left a round skin induration and hyper pigmentaion.It is about an inch in diameter. It used to be tender,not any more.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mother noticed a vaccine reaction on Saturday. Patient complain of itchyness on injection site. Red and swollen around injecton site. In pain.  As of Tuesday 02/13/2024mother reports the injection site now looks more dry.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was given a second dose of Fluzone. First one was in October 2023. Patient was verbally asked if she had one before administration and she said no. Error was discovered upon documentation.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccination was frozen instead of refrigerated
Age: 55.0
Sex: M
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: provider noted that  he had of fever after the pneumonia vaccine
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccination was frozen instead of refrigerated
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Covid-related death
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccination was frozen instead of refrigerated
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient is newborn and should have received Beyfortus.  No adverse reactions noted.  Parents were made aware and Beyfortus given on 2/2/24.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: After receiving the vaccine patient walked out with family. 5 minutes later the family brought back the patient and stated he had fainted. Patient began to seize and we called 911. Paramedics came to take the patient to the hospital moments later. Parents were overheard telling the paramedics that the patient was epileptic, which he did not disclose to us. Patient was taken oh hospital via ambulance, but seemed to be responsive.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Incorrect influenza presentation given to patient 6months. vaccine is for 3 and up.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Troponin normal
Clinical narrative: Patient had complaints of chest pain 3 hours after receiving the TDAP Boosterix vaccine. Patient was seen at ED on 2/8/24 for chest pain, was evaluated and sent home. Patient was then seen at clinic on 2/9/24 as follow up for ED visit.
Age: 17.0
Sex: M
Vaccine: HEP, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 17 years old and received Heplisav-B vaccine, State Supplied.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Skin discolouration, Skin exfoliation, Tenderness
Clinical narrative: 6 INCH AREA OF REDNESS AND TENDERNESS,12 DAYS LATER SUPERFICIAL PEELING OF SKIN IN DAREKNING OF SKIN
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Differential white blood cell count, Electrocardiogram, Eye movement disorder, Full blood count
Clinical narrative: Shoulder pain upon inoculation, pain worsened throughout the day, worse with movement. Initially radiated to elbow now localized to the upper arm.  Shaking episode, sitting upright with eyes rolled back and hands upward in front of her, rigid and shaking.  Able to lower self to ground and verbally spoke to parent.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Lipase, Metabolic function test, Muscle rigidity, Pain, Tremor
Clinical narrative: Shoulder pain upon inoculation, pain worsened throughout the day, worse with movement. Initially radiated to elbow now localized to the upper arm.  Shaking episode, sitting upright with eyes rolled back and hands upward in front of her, rigid and shaking.  Able to lower self to ground and verbally spoke to parent.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Crying, Diet refusal, Dyskinesia
Clinical narrative: 1 HOUR INCONSOLABILITY WITH HIPS FLEXED AND WOULD NOT RELAX OR FEED. NO STOOL CHANGE. HAS BEEN WELL SINCE.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Physician ordered 5-11yr 2023-24 Covid-19 vaccine for this patient who turned 12 years old 10 days prior to the appointment date. Nurses pulled up and scanned vaccine but did not note age discrepancy. Our EMR did not alert provider that patient was too old for this version of the vaccine.  No adverse effects reported.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Immediate post-injection reaction, Rash, Rash pruritic
Clinical narrative: patient says immediately got shingles (rash under right arm, itching and burning)
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy lymph gland, Lymphoma, Mass
Clinical narrative: Within 2 months of receiving vaccine, patient developed facial mass and now has lymphoma.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: 0.3mL of undiluted Covid-19 vaccine 2023-2024 formula, 6m-<5y dose administered to 12y 6m old patient.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy, Dyspnoea, Haemophagocytic lymphohistiocytosis, Imaging procedure, Interstitial lung disease
Clinical narrative: New onset Shortness of breath after a couple weeks of receiving the vaccine. Had never had this issue prior. Had just had a family medicine visit a few weeks prior to getting vaccine and was in good health.  Ultimately she was admitted to the hospital close to 7 weeks after getting vaccine and remained hospitalized for 11 days. Being treated for sepsis, shortness of breath, new onset thrombocytopenia and leukopenia on admission. She was diagnosed with HLH prior to being discharged from  hospital. And also ILD which continues to progress.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laboratory test, Leukopenia, Sepsis, Thrombocytopenia
Clinical narrative: New onset Shortness of breath after a couple weeks of receiving the vaccine. Had never had this issue prior. Had just had a family medicine visit a few weeks prior to getting vaccine and was in good health.  Ultimately she was admitted to the hospital close to 7 weeks after getting vaccine and remained hospitalized for 11 days. Being treated for sepsis, shortness of breath, new onset thrombocytopenia and leukopenia on admission. She was diagnosed with HLH prior to being discharged from  hospital. And also ILD which continues to progress.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myeloid leukaemia, Myelofibrosis, Night sweats, Pancytopenia, Weight decreased
Clinical narrative: Pt went to ER with pancytopenia  and 6 months of 50lb wt loss and night sweats. DX with myelofibrosis AML.
Age: 1.33
Sex: F
Vaccine: HEPA, MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was administered dose #2 of hep A too soon for dose #2 in series
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Pt was given Rotavirus which just expired 02/09/2024
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site rash
Clinical narrative: Rash noted to left upper arm and shoulder. Assessed by Dr. Given 25 mg Benadryl by mouth. Kept for observation 30 minutes before discharge home.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient given incorrect vaccine after given same vaccine 1 month and 2 days ago.  (Flu vaccine)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Beginning 2-13-2024 6:00 am. Left upper arm sore to touch , swollen and  very painful to lift at all. Needed help from right arm.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized for covid
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: On the evening of 2/12 the area of injection began to hurt, was hard to the touch, turned red, and is a little itchy. Patient took Tylenol and Benadryl with no relief. The symptoms are the same since they started 48 hours ago. I observed the injection area and it is red, hard and warm to the touch today.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Moderna Covid 19 vaccine is labeled incorrectly. 0.25ml with when drawn up 0.50ml. Per doctors & preceptor gave full dose of 0.50ml to patient. Patient is had no side effects then or up to this point. Thank you.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient broke out in a rash on both arms.
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The monoclonal RSV product was what was ordered, but the medical assistant pulled the Abrusvo from the machine in error. Patient received Abrysvo rather than intended monoclonal RSV product. Mother of child was contacted when the error was discovered. Patient not experiencing any adverse events from the vaccine as of 2/9/24.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction reported.  Moderna COVID 19 vaccine is labeled incorrectly at 0.25ml. When drawn up the amount is 0.50ml. Before giving patient vaccine, I verbally verified with my doctor & preceptor, and they advised to give vaccine as drawn up.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Incorrect dose administered, Product administered to patient of inappropriate age, Somnolence
Clinical narrative: Our medical assistant administered the adult dose of the COVID vaccine to a 30-month-old child. The MA notified the provider Dr. immediately for service recovery. Dr. documented the outcome:  please see below:                                                                                       DOCUMENTATION: Post-visit, we realized that patient actually got the 12 yo+ version of the COVID Spikevax vaccine.  Talked to Mom 2/9/24 and informed of our mistake. Patient did have side effects after the vaccines. Was very tired and sleepy, and was waddling with walking.  She is feeling better today and was able to go to daycare. Mom will continue to keep an eye on patient, and let us know if noticing any other side effects.
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administered a Kinrix vaccination(DTAP+IPV) to a 2.5yo patient who just needed Infanrix (DTAP). No adverse reactions noted, no further treatment needed. Pt will need an extra IPV at age 4.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody, Arthralgia, Brain fog, Dyspnoea exertional, Electrocardiogram
Clinical narrative: see previous description
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Magnetic resonance imaging, Muscle fatigue, Palpitations, Rash
Clinical narrative: see previous description
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: see previous description
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient came to initiate series for Hep B, information was obtained, consent was completed but it was not until medication administration that it was identified that medication retracted from refrigerator was a pediatric vaccine. The occurrence was immediately reported to the charge nurse (after hours). Upon arrival the provider was notified.  - Charge Nurse called Poison Control and they advised the provider to administer a second dose of pediatric vaccine to achieve the full immunity purpose. Case T 4963596
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Poor quality sleep, Sleep disorder
Clinical narrative: Sudden severe pain in both shoulders with pain running done both arms. Finger tips seemed a bit numb. During day there was little pain but at night pain returned with a vengeance interrupting ability to get a restful sleep. This continued for a few days, but now the pain in my left arm seems to have receded.  My right arm- front and rear, forearm and sometimes hand continue to be painful. Interruptions to my sleep continue. Even with my cpap sleep is interrupted.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: X-ray
Clinical narrative: Sudden severe pain in both shoulders with pain running done both arms. Finger tips seemed a bit numb. During day there was little pain but at night pain returned with a vengeance interrupting ability to get a restful sleep. This continued for a few days, but now the pain in my left arm seems to have receded.  My right arm- front and rear, forearm and sometimes hand continue to be painful. Interruptions to my sleep continue. Even with my cpap sleep is interrupted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: Potential incorrect reconstitution of vaccine. No adverse effect.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Febrile convulsion
Clinical narrative: Patient had a febrile seizure and was taken to the ER. Patient had some type of cold virus in her system. She received immunizations the day before.
Age: 58.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse events reported. Patient received the RSV vaccine before the age of 60
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chest pain, Diarrhoea, Erythema, Eye pain
Clinical narrative: She got her vaccine, had fatigue, general unwellness.  Began getting a headache, slight nausea and then as the day progressed she developed and took some Tylenol due to feeling a fever coming on.  By the afternoon she had extreme left body pain in her chest, from her left arm through her left side of her body toward her heart.  This proceeded through the night and then progressed across her chest, constant searing pain from her left chest across to her right shoulder.  She had face swelling, still feverish the next day.  This went on for a full day and into a 2nd day.  Then she had searing headache, same type of pain through her head, through her eyes.  It was not tightness, definitely pain, and thought she was having a heartache.  Her arm was red, swollen and painful and the swelling was obviously red, hot to touch.  The symptoms lasted through the weekend, not all of them, but she would have different ones every day.  Once the chest pains dissipated then developed into headache.  Friday and Saturday she was having the same searing pain through her stomach, the entire area like somebody had stuck a knife in her stomach.  Her bowels were orange in color to red, loose in nature to the point of watery until Sunday.  She had red blotches on her arms on Saturday, that could range from 2-4" on her arms.   She has more blotchy areas on her arms too.  Her face was also swollen and puffy on Sunday.  On Saturday she was starting to feel number other than the blotchy skin and swollen face.  She did not notify her doctor of this situation.  She just took Tylenol for her symptoms mainly for fever.   She had similar reaction with the first Shingrix vaccine, but this time she had the searing pain with it.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Faeces discoloured, Fatigue, Headache, Malaise, Nausea
Clinical narrative: She got her vaccine, had fatigue, general unwellness.  Began getting a headache, slight nausea and then as the day progressed she developed and took some Tylenol due to feeling a fever coming on.  By the afternoon she had extreme left body pain in her chest, from her left arm through her left side of her body toward her heart.  This proceeded through the night and then progressed across her chest, constant searing pain from her left chest across to her right shoulder.  She had face swelling, still feverish the next day.  This went on for a full day and into a 2nd day.  Then she had searing headache, same type of pain through her head, through her eyes.  It was not tightness, definitely pain, and thought she was having a heartache.  Her arm was red, swollen and painful and the swelling was obviously red, hot to touch.  The symptoms lasted through the weekend, not all of them, but she would have different ones every day.  Once the chest pains dissipated then developed into headache.  Friday and Saturday she was having the same searing pain through her stomach, the entire area like somebody had stuck a knife in her stomach.  Her bowels were orange in color to red, loose in nature to the point of watery until Sunday.  She had red blotches on her arms on Saturday, that could range from 2-4" on her arms.   She has more blotchy areas on her arms too.  Her face was also swollen and puffy on Sunday.  On Saturday she was starting to feel number other than the blotchy skin and swollen face.  She did not notify her doctor of this situation.  She just took Tylenol for her symptoms mainly for fever.   She had similar reaction with the first Shingrix vaccine, but this time she had the searing pain with it.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Rash, Rash macular
Clinical narrative: She got her vaccine, had fatigue, general unwellness.  Began getting a headache, slight nausea and then as the day progressed she developed and took some Tylenol due to feeling a fever coming on.  By the afternoon she had extreme left body pain in her chest, from her left arm through her left side of her body toward her heart.  This proceeded through the night and then progressed across her chest, constant searing pain from her left chest across to her right shoulder.  She had face swelling, still feverish the next day.  This went on for a full day and into a 2nd day.  Then she had searing headache, same type of pain through her head, through her eyes.  It was not tightness, definitely pain, and thought she was having a heartache.  Her arm was red, swollen and painful and the swelling was obviously red, hot to touch.  The symptoms lasted through the weekend, not all of them, but she would have different ones every day.  Once the chest pains dissipated then developed into headache.  Friday and Saturday she was having the same searing pain through her stomach, the entire area like somebody had stuck a knife in her stomach.  Her bowels were orange in color to red, loose in nature to the point of watery until Sunday.  She had red blotches on her arms on Saturday, that could range from 2-4" on her arms.   She has more blotchy areas on her arms too.  Her face was also swollen and puffy on Sunday.  On Saturday she was starting to feel number other than the blotchy skin and swollen face.  She did not notify her doctor of this situation.  She just took Tylenol for her symptoms mainly for fever.   She had similar reaction with the first Shingrix vaccine, but this time she had the searing pain with it.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling face
Clinical narrative: She got her vaccine, had fatigue, general unwellness.  Began getting a headache, slight nausea and then as the day progressed she developed and took some Tylenol due to feeling a fever coming on.  By the afternoon she had extreme left body pain in her chest, from her left arm through her left side of her body toward her heart.  This proceeded through the night and then progressed across her chest, constant searing pain from her left chest across to her right shoulder.  She had face swelling, still feverish the next day.  This went on for a full day and into a 2nd day.  Then she had searing headache, same type of pain through her head, through her eyes.  It was not tightness, definitely pain, and thought she was having a heartache.  Her arm was red, swollen and painful and the swelling was obviously red, hot to touch.  The symptoms lasted through the weekend, not all of them, but she would have different ones every day.  Once the chest pains dissipated then developed into headache.  Friday and Saturday she was having the same searing pain through her stomach, the entire area like somebody had stuck a knife in her stomach.  Her bowels were orange in color to red, loose in nature to the point of watery until Sunday.  She had red blotches on her arms on Saturday, that could range from 2-4" on her arms.   She has more blotchy areas on her arms too.  Her face was also swollen and puffy on Sunday.  On Saturday she was starting to feel number other than the blotchy skin and swollen face.  She did not notify her doctor of this situation.  She just took Tylenol for her symptoms mainly for fever.   She had similar reaction with the first Shingrix vaccine, but this time she had the searing pain with it.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Covid-related death on 1/7/2024
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states her arm is sore and she cannot lift it. She has tried aleve, ibuprofen, aspirin, heat and ice.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Pyrexia, Vomiting
Clinical narrative: Patient had high fever, cough, vomit right after getting home from the vaccine and lasted for 3 days without treatment.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Blister, Injection site pruritus
Clinical narrative: itchiness at inection site, blisters on nipple
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event, Product label issue
Clinical narrative: Patient was given double dose d/t mislabeled vial. No adverse effects noted
Age: 3.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Injection site pain, Injection site swelling, Irritability, Product preparation error
Clinical narrative: Pt was accidentally given COVID-19 vaccine without dilution.  When mom was contacted about administration error, she reported that pt was having increased pain and swelling at the injection site with fussiness and had taken 7.5ml of ibuprofen for pain relief. No fever has been noted.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Product label issue
Clinical narrative: Vaccine vial was mislabeled and patient was given double dose
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: no ae; HCP called to report that a single dose of GARDASIL 9 that was in a not supported TE was administered to a patient. HCP gives permission to contact. HCP reports there are 2 GARDASIL 9 Lot numbers that were involved in the TE and HCP was unable to be; This spontaneous report as received from a registered nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 12-JAN-2024, the patient was vaccinated with a dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, once, lot # X014788 with an expiration date 07-MAR-2025 or lot# W028573 with an expiration date 06-JAN-2025 (route and site of administration were not reported) for prophylaxis (Product storage error). The vaccines underwent a temperature excursion of -13.21 degrees Celsius for 6 minutes and 44 seconds. Previous temperature excursions was reported as 8.07 degrees Celsius for 29 minutes and  8.08 degrees Celsius for 14 minutes and 15 seconds. It was not reported if digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA008146: US-009507513-2401USA007870: US-009507513-2401USA008054: US-009507513-2401USA007615: US-009507513-2401USA007941: US-009507513-2401USA007528: US-009507513-2401USA007600: