chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Arm Pain   Upper left arm pain, s/p Men B vaccine on 7/8/24, consistent pain - worse in AM, taking Ibuprofen & Tylenol, icing Pt had meningococcal B vaccine on 07/08/2024 administered in this clinic by MA as a clinical support visit.  States that when the vaccine was given it was almost immediately uncomfortable. Did not feel like a typical vaccine administration. She states it looked like it was given higher in arm than other vaccines.  That day within a few hours started to developed painful shoulder ROM which has persisted and it not improving. Sx worse in the morning.  Ice, heat slightly helpful.  Ibuprofen OTC - 2 tabs Q 6-8 hours does not seem to be helping very much.  No fevers, local swelling.  Painful and difficult to put on bra, shirt, move the shoulder around Painful at rest as well.  Of note prior to the vaccine on 07/08/2024 she had no shoulder issues.    She is a karate instructor this summer and having difficulty doing this job since the vaccine was administered.    ? Shoulder injury related to vaccine administration (SIRVA) Yes Her findings today are c/w vaccine administration. Site of injection appears superior to deltoid muscle. Pt having pain and decreased painful ROM starting the day of the vaccine and persisting now 3 d after the vaccine. Does not seem to be improving.   Plan: Will start with conservative treatment at this time.  Recommend regular nsaid for now.  Recommend aleve 2 pills BID with food or ibuprofen 3 pills TID (one or the other). Take with food. GI, renal, CV potential effects d/w her.  Ice to area.  Gentle shoulder exercises reviewed.  Recommend f/u in 1-2 weeks. Pending f/u would consider PT.  Imaging such as MRI not needed at this time but could be considered in the future.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Incorrect administration time, second dose of Hepatitis A (Vaqta) was early and counted as invalid
Age: 7.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient was given extra dose and guardian has been notified.
Age: 58.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Redness/Sore/Swelling at injection sight/arm. Patient went to hospital and was given steroid to reduce swelling/irritation. They were sent home after receiving medication.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, IPV, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No reaction.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Patient & dad came into pharmacy for 2 vaccine appointments required for school; Boostrix and Menveo. After patient received shots, she fainted and fell from the chair she was sitting in and her head hit the ground. Her dad picked her up and placed her on the chair. After 10 to 15 seconds, patient became conscious. Pharmacist gave patient a Coke soda. After patient took a few sips, patient felt better. Patient and her dad remained in the waiting area for pharmacist to monitor. EpiPen was not administered, 911 was not called and no CPR was given. After approximately 20 minutes, patient and dad left the pharmacy. SOC was notified. < End >
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Influenza like illness
Clinical narrative: Few days couldn't breath, flu-like symptoms then hospitalized for pulse oxygen.  Still have cough years later.
Age: 21.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Pain, Product storage error, Pyrexia
Clinical narrative: On 5/21/24, I administered three vaccines to the patient: Twinrix, MMR-II live and Varivax. I found all three vaccines in the pharmacy fridge. From prior experience, I knew that MMR-II live can stay in both fridge and freezer. It was my first time giving Varivax to patient so I assumed the same storage conditions applied to Varivax as it did to MMR-II live. The next day I was notified by another pharmacist that they found Varivax in the fridge. Through further investigation, we found that on 4/29/24, the pharmacist before me who administered Varivax to a different patient accidentally placed it in the fridge instead of freezer where they originally found it. I called Merck and spoke with provided the temperature excursion of Varivax at 40 degrees F from 4/29/24 at 9am to 5/21/24 at 3pm (total of 534 hours at 40 degrees F). Per Merck, there is in-house data to support the use of Varivax for 30 days from 4/29/24. It must be discarded after 30 days from 4/29/24. We did discard the remaining Varivax vials from that affected box. Per patient, the day after receiving the three vaccines, she only had a slight fever and body ache, the usual side effects one would experience from receiving vaccines.
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Feeling cold, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: 8 hours following vaccination persistent n/v q4 h , constant steady state temp of 100.9 with spikes 102+, shivering and cold spells while profuse sweating, inability to hold food down for 24 hours, fevers and other symptoms lasted just over 24 hours.
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: 8 hours following vaccination persistent n/v q4 h , constant steady state temp of 100.9 with spikes 102+, shivering and cold spells while profuse sweating, inability to hold food down for 24 hours, fevers and other symptoms lasted just over 24 hours.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additonal AE; TE where product was administered to a patient; This spontaneous report has been received from a medical assistant concerning a 13-month-old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications was not provided.   On 19-JUN-2024, the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) Subcutaneous Injection, dose was reported as0.5 mL for prophylaxis, lot number X023322, expiration date 22-AUG-2024, albumin status was established as recombinant human albumin (rHA) (strength and route of administration were not provided).   The temperature excursion reported was at 47.6 Fahrenheit degrees for a time frame of 54 minutes. There was no previous temperature excursion and the patient did not experience any adverse event.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Inappropriate preparation of medication; she administered two vials of the same lyophilized component; product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA987A, expiry date 31-OCT-2024) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate preparation of medication), inappropriate dose of vaccine administered (Verbatim: she administered two vials of the same lyophilized component) and pharmaceutical product complaint (Verbatim: product complaint). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 02-JUL-2024 Pharmacist called to report that by error she administered Menveo 2 vial presentation to 2 patients: For patient one, she administered only the lyophilized vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case is linked with US2024AMR083381, by same reporter.; Sender's Comments:  US-GSK-US2024AMR083381:another patient case
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Administration only of the diluent; Administration only of the diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old male patient who received Hib (Hiberix) (batch number 7AC3C, expiry date 30-SEP-2025) for prophylaxis.   On 27-JUN-2024, the patient received Hiberix. On 27-JUN-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Administration only of the diluent) and inappropriate dose of vaccine administered (Verbatim: Administration only of the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-JUL-2024 The reporter reported that a patient, that was administer the Hib vaccine Hiberix vaccine, and they actually only received the  diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter just wanted to confirm that there was no harm and if we were going to have to readminister the proper Hiberix. The batch number and expiration date that caller provide is the one on the box of the vaccine.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, Underdose
Clinical narrative: Pediatric Dose Administered to an Adult patient; Pediatric Dose Administered to an Adult patient; Inadvertent Administration of Expired Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 38-year-old male patient who received HBV (Engerix B 10 mcg) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 02-JUL-2024, the patient received Engerix B 10 mcg. On 02-JUL-2024, an unknown time after receiving Engerix B 10 mcg, the patient experienced accidental underdose (Verbatim: Pediatric Dose Administered to an Adult patient), adult use of a child product (Verbatim: Pediatric Dose Administered to an Adult patient) and expired vaccine used (Verbatim: Inadvertent Administration of Expired Vaccine). The outcome of the accidental underdose, adult use of a child product and expired vaccine used were unknown.   Additional Information: GSK Receipt Date: 02-JUL-2024 Pharmacist called to report that they administered a 38 year old male patient a Pediatric Dose (10 µg) by mistake and also, they administered an expired dose of this pediatric dose to the same 38 year old male patient which led to accidental underdose, adult use of a child product and expired vaccine used. She wanted to know what to do, maybe if they have to re administer it. No further detail provided in the call.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness around vaccine site about 1.5 invhes wide and three inches in height. Pain at injection site
Age: 63.0
Sex: F
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS OF LEFT ARM, SLIGHT SWELLING, AND PAIN SENSATION UP TO SHOULDER.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: swollen arm and tenderness
Age: 7.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea, vomiting
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: patient states after 1st vaccine 11/2023, pt has muscle weakness/aches in arm and cant elavatge arm above shoulder
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Her left arm was swelling. She said she didn't see doctor. The symptoms was gone away after 3 days
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Generalised oedema, Pruritus, Urticaria
Clinical narrative: Hives, red swollen patches all over body, itching
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after receiving 1st Trumenba injection
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Hypotension, Pain, Pyrexia
Clinical narrative: Patient experienced fever, chills, body aches, and low blood pressure. Symptoms lasted for around 24 hours. Patient visited doctor's office and was advised to monitor blood pressure.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: Progressive redness, pain, itching, swelling and fever at the injection sight that spread to about a 2" welp.
Age: 23.0
Sex: F
Vaccine: HEP, MENB, MMR
Symptoms: Contusion, Injection site reaction
Clinical narrative: Right arm had Heplisav and Bexsero. Bruise was on right arm. This is second dose of Heplisav so we believe bruise most likely attributed to Bexsero. Four parallel, vertical line showed up around the injection site on 7/11/24. Patient states she has a cat but doesn't remember the cat scratching her.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Myalgia Patient had Tdap vaccine 6/11 and developed generalized muscle ache involving both upper and lower extremities.  Denies any fever, chill, cough but had mild shortness of breath.  Lately she is having more ache over the right leg but otherwise feeling better.  She is taking acetaminophen for pain.  She is on Eliquis for anticoagulation and the risk for blood clot is low.  Order CBC, BMP and CPK today.  Continue current management.  Patient had Tdap vaccine in the past without any reaction.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Nausea, Tremor, Vomiting
Clinical narrative: shakiness, nausea, severe headache, vomiting
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhagic stroke
Clinical narrative: Hemorrhagic  stroke  2 months after recieving moderna vaccine x 2 doses
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure increased, Condition aggravated, Hypertension
Clinical narrative: pt received the boostrix shot on 7/9 @9:49am. On Thursday, July 11 @ 9am his blood pressure went up to 220/110. He called his new cardiologist to let them know & they said it MAY be related to the vaccine(but pt also has high blood pressure). By 3pm on July 11, his blood pressure had slowly dropped to normal & he has had no other issues since. He received no treatment for this condition.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately after administration of vaccine, patient stated she was feeling a little light headed. I asked patient if she would like a cold compress for her forehead and she accepted. She was still feeling lightheaded  after several seconds, so I asked patient if she would like to lie on the floor with her feet up in the chair and she accepted. Very quickly after changing positions, patient stated she started to feel better. Stayed in that position for a minute or two until she felt better at which time she returned to sitting in the chair with the cold compress for another minute or so. Once she felt better, she went to sit on the bench outside the pharmacy. I told her to let us know if she started to feel unwell again. Patient left after waiting a bit.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Pruritus, Rash, Skin irritation, Skin lesion
Clinical narrative: I have received 4 previous Moderna Mrna COVID vaccines since 2021, and this was the first Pfizer vaccine I have received. I began feeling itchiness and skin irritation on my neck and eyelid on Monday, 7/8. By Tuesday 7/9 I went to Urgent care because the rash of psoriasis-like lesions with blisters were spreading. The topical steroid given did not help and by Thursday 7/11 I went to an ER and received a steroid injection and PO prescription. After my 2nd COVID infection in April of 2023, I developed similar psoriasis-like issues in my skin during the infection and over the year since, but never experienced a flare-up to this degree.
Age: 83.0
Sex: M
Vaccine: HEPAB
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: Patient received TWINRIX vaccine on 6/28/2024. patient stopped by pharmacy on 7/12 and stated that he had a severe rash and hives between his thighs as an allergic reaction to TWINRIX vaccine. Patient said that he spoke with his health  care provider and came to pick up a topical prescription that was prescribed for him.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Musculoskeletal stiffness, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: hot and raised rash on right arm that spread and continued through 7/13/24. Pain in arm, Stiffness and Swelling in arm and in armpit, body aches and fatigue. Rash continued to spread through the next 2 days. Started to subside evening of 7/13.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Rash papular, Skin warm
Clinical narrative: hot and raised rash on right arm that spread and continued through 7/13/24. Pain in arm, Stiffness and Swelling in arm and in armpit, body aches and fatigue. Rash continued to spread through the next 2 days. Started to subside evening of 7/13.
Age: 30.0
Sex: F
Vaccine: PNC20
Symptoms: Asthma, Burning sensation, Chest X-ray, Computerised tomogram, Condition aggravated
Clinical narrative: Extreme Asthmatic exacerbation, arm tingling and burning, redness and soreness at injection site.  All symptoms happen the day of shot and or day after ( Asthmatic exacerbation)
Age: 30.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: Extreme Asthmatic exacerbation, arm tingling and burning, redness and soreness at injection site.  All symptoms happen the day of shot and or day after ( Asthmatic exacerbation)
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain, Fatigue, Flatulence, Headache
Clinical narrative: Moderate Abdominal pain, bloating and flatulence ongoing.  Mild headache ongoing..  Insomnia 12 midnight - 5am.   Fatigue 8am 7/14 and ongoing as of 1pm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: Moderate Abdominal pain, bloating and flatulence ongoing.  Mild headache ongoing..  Insomnia 12 midnight - 5am.   Fatigue 8am 7/14 and ongoing as of 1pm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient woke up and arm was red, warm and swollen where shingles vaccine was administered. Patient took ibuprofen however; noticed it was getting larger. Patient came into pharmacy around noon on 7/14/2024 and spoke to pharmacist. Skin was warm to touch, I took her temp and it was 99.5, and was very red. I advised that although some of these symptoms can be due to the vaccine that she should contact her MD.  No other symptoms.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Balance disorder, Dizziness, Vertigo
Clinical narrative: Severe Vertigo onset 7/13/2024 early morning. Patient continues to have recurring issues with dizziness, difficulty with balance.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Dyskinesia, Gaze palsy, Head circumference abnormal, Seizure
Clinical narrative: Received Pediarix vaccine at 4 months old. Infantile seizures with eyes rolling upward and head moving back and forth began three days after he received this vaccine and continued to occur for another few months. His head size also grew dramatically by 6 months of age.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Vaxelis vaccine too early.  First dose given 6/13/2024, second dose given 7/12/2024 which was 29 days after first dose
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives on face approximately 48 hours post vaccine. I will be filling out a report for my son who had a similar reaction in 2022 about a week after having dose 1 of the samevaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: SYSTEMIC INFLAMATORY PROBLEMS STARTING DAY OF INJECTION AND CONTINUE SINCE INJECTION, SWOLLEN LYMPH GLANDS.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pruritus
Clinical narrative: The patient experienced anaphylaxis and itching, which was noted on 7/12/24.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Patient developed shortness of breath and back pain from a minor strain to his back in mid May from lifting a heavy object.  Symptoms continued without resolve and a chest x-ray indicated a collapsed lung and further tests showed bilateral pulmonary embolisms.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest X-ray abnormal, Computerised tomogram, Dyspnoea, Laboratory test abnormal
Clinical narrative: Patient developed shortness of breath and back pain from a minor strain to his back in mid May from lifting a heavy object.  Symptoms continued without resolve and a chest x-ray indicated a collapsed lung and further tests showed bilateral pulmonary embolisms.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle strain, Pneumothorax, Pulmonary embolism
Clinical narrative: Patient developed shortness of breath and back pain from a minor strain to his back in mid May from lifting a heavy object.  Symptoms continued without resolve and a chest x-ray indicated a collapsed lung and further tests showed bilateral pulmonary embolisms.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller stated no patient symptoms have been reported. No additional AE/no PQC reported.; ROTATEQ was administered to a patient after the product was involved in a temperature excursion.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 28-MAY-2024, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #2003148, expiration date: 31-MAY-2025, administered orally for prophylaxis (strength and exact dose were not provided) (Product storage error). The temperature excursion lasted for 30 minutes 0 seconds in temperature of 8.94 Celsius degrees (C) . There was no previous temperature excursion. No patient symptoms have been reported. No additional adverse event and no product quality complaint reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2407USA003758: US-009507513-2407USA003825: US-009507513-2407USA003893: US-009507513-2407USA003997: US-009507513-2407USA004012: US-009507513-2407USA004169: US-009507513-2407USA004176: US-009507513-2407USA004183: US-009507513-2407USA004183:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller stated no patient symptoms have been reported./ No additional AE/no PQC reported.; ROTATEQ was administered to a patient after the product was involved in a temperature excursion.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 21-JUN-2024, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #2003148, expiration date: 31-MAY-2025, administered orally for prophylaxis (strength and exact dose were not provided) (Product storage error). The temperature excursion lasted for 30 minutes 0 seconds in temperature of 8.35 Celsius degrees (C). There was a previous temperature excursion of 8.94 C for 0 hours 30 minutes and 0 seconds. No patient symptoms have been reported. No additional adverse event and no product quality complaint reported.   This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2407USA003806: US-009507513-2407USA003758: US-009507513-2407USA003893: US-009507513-2407USA003997: US-009507513-2407USA004012: US-009507513-2407USA004169: US-009507513-2407USA004176: US-009507513-2407USA004183: US-009507513-2407USA004237:
Age: 26.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose of Heplisav-B, and Received Second Dose Twinrix; Received second dose of hepatitis B 6 months after the first; Initial report received on 19-Jun-2024.  A pharmacist in the reported that a 26-year-old female patient (race and ethnicity not provided), received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received the second dose with TWINRIX.  Medical history, concomitant medications, and allergies were not reported.   On 04-Dec-2023, the patient received the first dose of HEPLISAV-B (Lot number 944609, expiration date 29-Jan-2026, and NDC 43528-003-05) intramuscularly in the left arm.   On 17-Jun-2024, 198 days after having been vaccinated with HEPLISAV-B, the patient received TWINRIX (Lot number 344J3, expiration date 12-Sep-2026, and NDC 58160081552) intramuscularly in the right arm.  This was to be the second dose of a hepatitis B vaccine.  No adverse side effects have been reported.  No additional information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 50.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received first dose , have not received the second dose; Initial report received on 08-Jul-2024.  A consumer, who is also the patient, in the reported that a 50-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose.  The patient has an allergy to penicillin (hives and fever) and an allergy to naproxen sodium (trouble breathing).  No relevant concomitant medications were reported.    On 24-Mar-2024, the patient received the first dose of HEPLISAV-B (lot #, expiration date, NDC #, route and site administered not reported).  As of date of reporting, 08-Jul-2024, the patient has not received the second dose.  No further information was available.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported 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. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pulmonary embolism (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism was not reported. The reporter assessed the causality between covid-19 vaccine ad26.cov2.s and pulmonary embolism as related. Company causality between covid-19 vaccine ad26.cov2.s and pulmonary embolism was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:Pulmonary embolism: The event is labelled per Regulatory Agency, hence assessed as potentially related
Sex: M
Vaccine: MEN
Symptoms: Neurological symptom, Seizure
Clinical narrative: suffered three seizures on the pediatricians floor just 1-2 minutes after the meningococcal vaccine; Initial information received on 04-Jul-2024 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who suffered three seizures on the pediatricians floor just 1-2 minutes after the Meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a Booster dose 2 of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot number not reported via unknown route in unknown administration site (strength and expiration date: not provided) for Immunisation. Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  On an unknown date the patient suffered three seizures on the pediatricians floor just 1-2 minutes after the meningococcal vaccine (seizure) (latency- 2 mins). This event was assessed as medically significant.  Reportedly, He had last adverse neurological effects for months after.  Action taken- Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.; Sender's Comments: Sanofi Company Comment dated 09-Jul-2024: This case involves an unknown age male patient who suffered three seizures on the pediatricians floor just 1-2 minutes after the Meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Splenectomy
Clinical narrative: Act-hib use in an adult with no reported adverse event; vaccine was given for splenectomy with no reported adverse event; Initial information received on 05-Jul-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare (patient).  This case involves Adult female patient whom HIB (PRP/T) Vaccine [ACT-HIB] use in an adult with no reported adverse event and vaccine was given for splenectomy with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Sep-2021, the patient received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot- UJ587AA) via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Splenectomy (product administered to patient of inappropriate age) and (product use in unapproved indication) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Module of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA203029:
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccine was provided  beyond expiration,with no reported adverse event; Initial information received on 05-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient with unknown demographics whom vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was provided beyond expiration, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Jul-2024, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot U7453AA and expiration date: 29-Jun-2024 (strength; not reported) via unknown route in unknown administration site as immunization (latency: on same day) vaccine was provided  beyond expiration, with no reported adverse event (expired product administered).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: medication error/an inappropriate use due to patient receiving partial dose of MENQUADFI with no reported adverse event; Initial information received on 09-Jul-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 19-year-old female patient who had medication error/an inappropriate use due to patient receiving partial dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 09-Jul-2024, the patient received a 0.5 ml total (dose 1) dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (strength: unknown) (lot: U7986AA, expiry date: 31-Mar-2026) via intramuscular route in the left deltoid as Immunization and patient had medication error/an inappropriate use due to patient receiving partial dose of menquadfi with no reported adverse event (incorrect dose administered) (latency: same day).  Reportedly, Caller reports during administration an unknown amount of the vaccine leaked, approximately 1/2 but unsure. Caller reports the leaking occurred where the needle screws onto the syringe. She initially thought she had not screwed the needle on tightly but checked and it was attached tightly. Therefore, caller thinks the syringe must have been defective.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: inappropriate use due to the off schedule administration of IMOVAX Rabies to a patient with no adverse event; Initial information received on 09-Jul-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68-year-old male patient who had inappropriate use due to the off schedule administration of rabies (HDC) vaccine [Imovax Rabies] to a patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 08-Jun-2024, the patient received a 1 ml total dose of suspect RABIES (HDC) vaccine, Powder and solvent for suspension for injection (lot: W1D211M, expiry date: 30-Nov-2025)  via intramuscular route in unknown administration site as immunization  On an unknown date the patient developed a non-serious inappropriate use due to the off schedule administration of imovax rabies to a patient with no adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of RABIES (HDC) VACCINE.  Reportedly, The patients were off schedule since they received their first dose and then had to travel afterwards, preventing the subsequent doses. This was a preexposure administration for both patients for traveling out of the country   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo lasting 3-4 weeks and then a second episode of vertigo lasting one month about 6 months later. Patient has never before experienced vertigo or any other similar symptoms to this prior to vaccination.  Patient otherwise healthy with no significant PMH.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: Administration of liquid portion only; Administration of liquid portion only; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number YL7LR, expiry date 15-MAY-2026) for prophylaxis.   On 05-JUL-2024, the patient received Shingrix. On 05-JUL-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administration of liquid portion only) and inappropriate dose of vaccine administered (Verbatim: Administration of liquid portion only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-JUL-2024 The medical assistant called and reported that the patient administrated the liquid portion only of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked when should the complete dose be administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: DUE TO MISINTERPRETATION OF INFORMATION ABOUT EXPIRATION DATES IN VACCINES THAT FOR A GIVEN TIME, HAD DIFFERENT EXPIRATION DATES, THIS ONE IS ADMINISTERED, OUTSIDE THE EXPIRATION DATE FOR ITS USE FOR 11 DAYS. THE PATIENT IS CALLED TO IDENTIFY ANY SIDE EFFECTS AND HE VERBALIZES THAT HE DID NOT PRESENT ANY. WE PROCEED TO MAKE AND SEND THE PERTINENT REPORT.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain
Clinical narrative: Erythema, induration, pain
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 17 year old patient was administered a pediatric Pfizer vaccine instead of an adult (12+) COVID-19 vaccine. Patient's guardian informed of the error. Patient's guardian does not report any adverse effects.
Age: 0.75
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pt was here about 7 minutes after receiving the vaccines. pt left without experiencing any symptoms.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pain, Pyrexia, Rash
Clinical narrative: Fever started  4 days after shot and lasted 5 days. Abdominal rash started on day 10. Extremely irritable and seemingly in pane over night day 9/10.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Herpes zoster, Infection, Rash
Clinical narrative: Patient rather quickly developed painful, itchy rash on scalp that progressed.  Patient was hospitalized for shingles with secondary cellulitis.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Varicella virus test positive, Viral test positive
Clinical narrative: Patient rather quickly developed painful, itchy rash on scalp that progressed.  Patient was hospitalized for shingles with secondary cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Pruritus, Skin warm
Clinical narrative: Red, swollen arm at injection site. Itchy. Healthcare provider was concerned for possible cellulitis as it was hot to the touch. Started around 40hrs after vaccination and improved 2 days later. Still itchy 5 days out from vaccination.
Age: 60.0
Sex: F
Vaccine: IPV
Symptoms: Burning sensation, Limb discomfort, Paraesthesia
Clinical narrative: 4/15/24 Patient has been in travel clinic, going to be abroad in Country, with immunization only visit 07/15/24:  adult booster IPV vaccine at 9:10 this am.   10:55 am call to clinic - patient reports is experiencing new onset of bilateral leg tingling sensation/burning sensation down both legs. Is able to walk/ambulate, and otherwise feels fine.   Denies Headache/Fever/Chills, no neurological S/s-visual changes, speech is clear.   Denies respiratory issues. No DOE/no SOB/no wheezing, speaking in complete audible sentence. No tingling/swelling/itching in face/throat/tongue   Denies GI/GU issues.   Denies dermatological issues - no rashes/no hives. Reports skin is dry/intact.   Is on concomitant course of Typhoid (oral) started last week 7/12/24 with no issues, will complete day prior to travel. Of note Polio vaccine may be given at the same time as other vaccines.   Reviewed CDC VIS for Polio.   VAERS-Vaccine Adverse Event Reporting System: Adverse reactions should be reported to the Vaccine  Adverse Event Reporting System (VAERS). Your health care provider will usually file this report, or you can do it yourself. Visit the VAERS website. VAERS is only for reporting reactions, and VAERS staff members do not give medical advice.   VAERS report to be filed.   CC note and page/call ID attending Dr. for next steps. Advised that is worsening of BIL LE tingling/burning to see Urgent Care/ER visit. Patient is 4/10 on leg discomfort. She will monitor throughout the day, if increased to 6/10 will go to ER. If she is to experience any other sign/symptoms as reviewed above will go to ER.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient came to get second dose of Shingrix shot. She was new to us so we didn't have record of her first dose. She insisted that her first dose was on 5/17/24. She was aggravated when we questioned her multiple times. After I gave her the shot, she later told us she recently moved here from another town. Upon looking again, I found her profile which showed that her first dose was on 5/22/24. Thus, it was too early for her to get it. When I informed the patient of the mistake, she said she did not care. She was very rude and left. She was more upset because of the wait as I was trying to find her again in the system.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Loss of consciousness, Mydriasis, Pallor, Syncope
Clinical narrative: Patient experienced syncopal episode with loss of consciousness within 1 minute of vaccine administration. She came to within 2 seconds. Pallor and pupil dilation was observed. BP was low at 60/40. HR WNL. Placed into supine position with legs elevated. SpO2 was 100%. Radial pulses normal. EMS called. Patient remained in supine position until BP returned to normal. Assisted to sitting position. Provided with juice and water. Transported to ER via EMS.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events.  Patient had received RSV Abrysvo in January, that was missed and he received it again. I spoke with him today and he said he felt fine, no reactions, no feeling ill. I just let him know that there is no indication to receive a second dose in 6 months, he understood and said he did not recall receiving it back in January, but we do have documentation of this. He knows to follow up if he has any other questions or concerns.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Hypoaesthesia, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Typical arm soreness 2-3 days after vaccine.  However 2 weeks later still experiencing mild, intermittent upper L arm soreness when engaging muscle.  Additionally, awaking from sleep with left hand numb, asleep.  Also experiencing mild to moderate left hand numbness intermittently during waking hours along with intermittent ache in left arm and elbow region.
Age: 63.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received DTap (Daptacel) vaccination instead of Tdap (Adacel) vaccination, as ordered by provider. Patient has not reported any major adverse reactions to the incorrect vaccination. Provider was notified of the error.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: The patient became unresponsive a few minutes after receiving the vaccine. The patient's daughter said the patient had become unresponsive and almost fainted, so the daughter had the patient lying on a chair. The patient  was breathing and had her eyes open but was unresponsive to sound and touch. The pharmacy staff called 911 and an epinephrine pen was administered. The patient became responsive and began to vomit. The patient was then able to speak. EMS arrived a few minutes later.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site discolouration
Clinical narrative: Patient stated shortly after receiving the COVID vaccine her arm turned blue/black at the injection site.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 month old child received expired vaccine. No adverse side effects noted. Physician and parent made aware. Repeat dosing completed following day, 7/3/24.
Age: 8.0
Sex: M
Vaccine: COVID19, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: client had reaction to both vaccines, with rash at injection sites and across upper chest and back. Rash is fading after 15 minutes.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Headache
Clinical narrative: Patient has reported daily headaches sometimes with associated dizziness since time of vaccination. Yesterday was the first day without headache.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Immediately after giving Tdap, the client experienced redness around the injection site and began to itch, when asked he said he felt itchy. The child remained calm and showed no further signs of distress. After 5 minutes, the rash faded on his arm and the skin returned to normal color.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: unknown
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: unknown
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient age 7 years was given Kinrix vaccine which is approved for 4-6 years.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Patient vomited immediately after injections were administered.