chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Feeling hot, Flushing, Pain, Rash, Rash erythematous
Clinical narrative: The evening of the day (2/26/24) I received the vaccine around 8pm I felt flush and warm all of a sudden. The next morning (2/27/24)I woke up with red bumps on my face and they were itchy and hot. Later that day on the 27th I suddenly felt flush again my face was itchy red and tight. That evening my symptoms continued. I took a Benadryl before bed but woke up around 3 am on the 28th with lots of itchy bumps on my face. It was very hot to the touch and red. I washed my face with cold water to cool it down and felt hot itchy and stung. The next morning my symptoms felt worse than the day before but still the same kinds of symptoms. I reached out to the clinic that gave me the vaccine but was told I could leave a message on the nurse line or book an appointment. Due to the discomfort I was feeling, I wanted to be seen right away so I went to the clinic at my works campus. It was the doctor at the Clinic that diagnosed my symptoms as a reaction to the HPV vaccine. My bp was 168/103, my heart rate was 120 and and my temp was 98.1. The doctor said we should treat the symptoms with over the counter meds, Pepcid, Zyrtec and Ibuprofen. She told me to monitor my symptoms for if they were getting worse and go to the emergency room if I experience shortness of breath of pain in my legs/calves (concern of blood clotting). As of today 2/28/24 at 1:04pm  my symptoms are still the same with no improvement.
Age: 28.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Rash pruritic, Skin tightness, Skin warm
Clinical narrative: The evening of the day (2/26/24) I received the vaccine around 8pm I felt flush and warm all of a sudden. The next morning (2/27/24)I woke up with red bumps on my face and they were itchy and hot. Later that day on the 27th I suddenly felt flush again my face was itchy red and tight. That evening my symptoms continued. I took a Benadryl before bed but woke up around 3 am on the 28th with lots of itchy bumps on my face. It was very hot to the touch and red. I washed my face with cold water to cool it down and felt hot itchy and stung. The next morning my symptoms felt worse than the day before but still the same kinds of symptoms. I reached out to the clinic that gave me the vaccine but was told I could leave a message on the nurse line or book an appointment. Due to the discomfort I was feeling, I wanted to be seen right away so I went to the clinic at my works campus. It was the doctor at the Clinic that diagnosed my symptoms as a reaction to the HPV vaccine. My bp was 168/103, my heart rate was 120 and and my temp was 98.1. The doctor said we should treat the symptoms with over the counter meds, Pepcid, Zyrtec and Ibuprofen. She told me to monitor my symptoms for if they were getting worse and go to the emergency room if I experience shortness of breath of pain in my legs/calves (concern of blood clotting). As of today 2/28/24 at 1:04pm  my symptoms are still the same with no improvement.
Age: 28.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Blood pressure increased, Rash
Clinical narrative: The evening of the day (2/26/24) I received the vaccine around 8pm I felt flush and warm all of a sudden. The next morning (2/27/24)I woke up with red bumps on my face and they were itchy and hot. Later that day on the 27th I suddenly felt flush again my face was itchy red and tight. That evening my symptoms continued. I took a Benadryl before bed but woke up around 3 am on the 28th with lots of itchy bumps on my face. It was very hot to the touch and red. I washed my face with cold water to cool it down and felt hot itchy and stung. The next morning my symptoms felt worse than the day before but still the same kinds of symptoms. I reached out to the clinic that gave me the vaccine but was told I could leave a message on the nurse line or book an appointment. Due to the discomfort I was feeling, I wanted to be seen right away so I went to the clinic at my works campus. It was the doctor at the Clinic that diagnosed my symptoms as a reaction to the HPV vaccine. My bp was 168/103, my heart rate was 120 and and my temp was 98.1. The doctor said we should treat the symptoms with over the counter meds, Pepcid, Zyrtec and Ibuprofen. She told me to monitor my symptoms for if they were getting worse and go to the emergency room if I experience shortness of breath of pain in my legs/calves (concern of blood clotting). As of today 2/28/24 at 1:04pm  my symptoms are still the same with no improvement.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pruritus
Clinical narrative: Itchiness started on 2/27/24 in the evening, turned into 4 inch red spot
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Infant irritability, Injection site erythema, Pyrexia
Clinical narrative: Redness of left thigh, fever, fussy/irritable
Age: 13.0
Sex: M
Vaccine: FLU4, HEP, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Patient was given a total of 8 vaccines.  After administration, the patient appeared to be well.  After two minutes, the patient reported dizziness and lightheadedness.  The patient fainted in the chair.  He was brought safely to the floor and legs raised up.  Within one minute the patient became alert again.  The patient verbally stated he was okay and was brought safely back to the chair.  Water and a snack were provided to him.  Post vital signs were taken and within normal limits.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: afib  days later
Age: 5.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: A 5-year-old patient inadvertently received a dose of Tdap, Menquadfi and HPV9. These vaccines were prepared for the siblings.
Age: 0.08
Sex: M
Vaccine: UNK
Symptoms: Erythema, Eye swelling, Swelling face
Clinical narrative: Approximately 3 hours after vaccine administration, patient experienced facial swelling and redness and eye swelling.  Symptoms resolved after approximately 60 minutes with cool compress applied.  No fever, no medical intervention needed.   Very mild illness/reaction. Just reporting due to new immunization.
Age: 1.58
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Urticaria
Clinical narrative: PT developed hives after receiving vaccines, pt evaluated by provider and nurse gave Benadryl in office. PT was instructed to stay 20 mins to be monitored and sent home.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: pt c/o arm pain immediately after vaccination. the pain has continued now 19 days after vaccination. there was no localized reaction. mom has been giving motrin. her arm hurts to move. today in office pain continues. the motrin has not been helping. she was placed on a 5 day oral steroid
Age: 64.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Erythema
Clinical narrative: Continuous red patch from waist up to neck. Not painful, not itchy, not splotchy. Lasted approximately 2 days.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Flushing, Immediate post-injection reaction, Oedema peripheral, Swelling, Urticaria
Clinical narrative: Patient with immediate urticaria of left arm after given Trumenba vaccine. + flushing of skin and swelling. + urticaria of chest. No trouble breathing, no cough, no lip swelling or tongue swelling; no wheezing. Benadryl given and monitored --resolution of distal urticaria. Still with edema of left arm. Decadron given. ER precautions discussed at length . Patient remained in office and monitored >30min post reaction.  Vitals stable and no respiratory symptoms
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Fatigue, Mycobacterium tuberculosis complex test negative, Pyrexia, Rash
Clinical narrative: On 2/21/24 at 3:30pm the patient, a 12 year old female, I administered the initial doses for Hepatitis A, Meningococcal, and HPV, as well as, a TB skin test. The Screening Checklist was filled out by the parents prior to receiving the vaccinations. All questions were marked  no  except for the last question,  Is the child anxious about getting a shot today?  which was marked  yes . After reviewing the checklist and seeing no reason for immediate concern, I administered the three vaccinations and TB test with no complications. The patient remained under my supervision in my office for approximately 20 to 25 minutes exhibiting no signs of having an adverse reaction. The patient was instructed to return two days later on 2/23/24 at 4:00pm for a TB reading.   When the patient returned at the instructed time, nurse met with her and gave a negative diagnosis for the TB test. I was not present when the patient returned. The patient s mother then reported to the nurse that the patient had developed rashes around her mid and lower abdomen, and her back. The patient noted even though she was currently not experiencing any itching, pain, or subjective fever, she did show signs of fatigue and had a fever on the evening of the vaccinations. Patient s mother did state that the patient was now feeling better though. The nurse  recommended that the patient be taken to her Primary Care Physician or to the ER, particularly since the rashes were still present.   At approximately 9:30am on 2/27/24 I conferenced in the patient s mother and stepmother on a follow-up phone call. The patient was at school when LVN called and nor present on the call. Her mother stated that the patient felt tired and had a fever on the evening of 2/22/2024 and developed rashes on her mid-lower abdomen and mid-lower back. She said the patient was given 1ml of Tylenol and noted she has taken Tylenol before. There was no change in the patient s diet, and she had eaten no new foods. They did not seek medical attention for the patients since she had just arrived two months ago and has no insurance. I urged the parents to take the patient to Emergency Room especially since her mother stated that the rash is persisting and has spread to her neck. We scheduled a follow up call with mom on 2/28/24 at 9:30am.  Followed phone called with mom 02/28/2024 at 2:30, parent has not yet sought medical attention but is giving the patient Benadryl and wanted to wait to see if that help. Told mom about  Dr. suggestion of antihistamines for H1-H2 and topical steroids ( Claritin and Zantac) and to consider different times of vaccinations for next dose. I recommended and suggested  several sites where  mom can take the patient to be seen.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient missed their dose according to the vaccine schedule and did not receive it on time.; No additional adverse event/ PQC reported; HCP reported that the patient was administered the third dose of the ROTATEQ vaccine at the age; This spontaneous report has been received from a licensed practical nurse, referring to an 8-month and 10 days old patient, whom gender was not provided. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 05-JAN-2024, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at the age of 8-month and 10 days old outside of the product labeling (PL) as prophylaxis (Product administered to patient of inappropriate age) (formulation not reported, but entered as default as oral liquid, dose, route, and scheme not provided; lot number reported and expiration date reported and established as X005034 and 04-OCT-2024, respectively). It was added hat on unspecified date, the patient missed the vaccine dose according to the vaccine schedule and did not receive it on time (inappropriate schedule of product administration). No additional adverse events (AE) and/or product quality complaint (PQC) reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC; patient was inadvertently administered PROQUAD after it arrived two days past the acceptable "must be received by date".; patient was inadvertently administered PROQUAD after it arrived two days past the acceptable; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, previous drug allergies and concomitant therapies were not reported.  On 02-DEC-2023 the patient should have had to be vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD); but instead was vaccinated on 04-DEC-2023 with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5ml, albumin status recombinant human albumin (rHA) (lot #X021127, expiration date: 10-FEB-2025, which resulted as a valid lot number per internal review), administered for prophylaxis (strength, and route of administration were not provided) as it arrived two days after the day it was supposed to be administered (arrived on 04-DEC-2023) (Product distribution issue, Inappropriate schedule of product administration). No additional adverse events were reported.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE where product was administered to one patient. TE case number: 02552499. Operator of device =HCP. No additional AE/PQC.   RECOMBIVAX HB: x017743   exp: 02/21/2026   19.1C for 3 hours 30 min 0 seconds no previous excursions; Inappropriate dose (2.5/0.5); This spontaneous report was received from registered nurse and refers to an 1-day-old female.  The patient's medical history, concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-FEB-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 2.5/0.5 (units not provided), lot #x017743, expiration date: 21-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided) (Incorrect dose administered). On unknown date, this vaccine underwent temperature excursion in 19.1 degree Celsius for 3 hours 30 min without no previous excursion (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report an adverse event regarding VARIVAX.  HCP stated that the VARIVAX dose administered was involved in a temperature excursion on 2/20/2024 and was administered to a patient today, 2/21/2024.   HCP confirmed the patient did not repo; This spontaneous report was received from nurse prescriber and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-FEB-2024, varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion. On 21-FEB-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml / two dose series, lot #X021931, expiration date: 29-AUG-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient has not reported any medical concerns or symptoms/No additional AE; A patient was administered two GARDASIL 9 vaccines at a shorter than the recommended interval due to an error in processing the patient; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-FEB-2024, 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 ml (two or three dose series), administered for prophylaxis (strength, lot #, expiry date, route of administration, and anatomical location were not provided). Then on 13-FEB-2024, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 ml (two or three dose series), administered for prophylaxis (strength, lot #, expiry date, route of administration, and anatomical location were not provided). Therefore, the patient was administered the vaccines at a shorter than the recommended interval due to an error in processing patient (inappropriate schedule of product administration).   In addition, the reporter confirmed the patient had not reported any medical concerns or symptoms related to this adverse event (AE) or any additional AE (no adverse event). No additional information provided.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; Product had excursion 2/20/2024 and 2/21/2024 and was administered on 2/22/2024. ?; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patients' medical history, concurrent conditions, and historical drugs were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 22-FEB-2024, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number X021930 was verified, expiration date was reported and confirmed as 29-AUG-2025), administered as prophylaxis (strength, exact dose, route of administration, and anatomical location were not provided) (product storage error).   The suspect vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) suffered a temperature excursion of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit for 0 hours 50 minutes 0 seconds, 14 degrees Fahrenheit to 46 degrees Fahrenheit during a time frame 5 hours 10 minutes 0 seconds, and 47 degrees Fahrenheit  to 77 degrees Fahrenheit (46.7F) for 0 hours 50 minutes 0 seconds (on 20-FEB-2024, reported as previous temperature excursion) and underwent another temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.9F) during a time frame 0 hours 30 minutes 0 seconds (on 21-FEB-2024). It was reported that sterile diluent did not experience excursion.  No additional adverse event (AE) (no adverse event) or details were provided.  This is one of the two cases received from the same reporter.; Sender's Comments:  US-009507513-2402USA008626:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse calling for TE evaluation reports VARIVAX product administered to two patients. Product had excursion 2/20/2024 and 2/21/2024 and was administered on 2/22/2024.; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Patient's concomitant therapies included sterile diluent The patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 20-FEB-2024, a varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 6 degrees Fahrenheit to 14 F for 0 hours 50 minutes 0 seconds, 14F to 46F for 5 hours 10 minutes 0 seconds, 47F to 77F (46.7F) for 0 hours 50 minutes 0 seconds. On 21-FEB-2024, a varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 6 degrees Fahrenheit to 14 F (5.9F) for 0 hours 30 minutes 0 seconds.  On 22-FEB-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis with lot number X021930 and expiration date reported as 29-AUG-2025 (strength, dose, frequency, route of administration and anatomical location were not provided) (incorrect product storage). It was reported that sterile diluent did not experience excursion.  No additional adverse event was reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2402USA008614:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: product storage error; This spontaneous report was received from a registered medical assistant and refers to a 2-months-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 20-NOV-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number 1932235, which had been verified to be a valid lot number, expiry date reported and confirmed as 12-APR-2024, administered orally for prophylaxis (strength not provided) (product storage error). It was mentioned that the medication error occurred in the process of storage in clinical practice.  This is one of the five cases received from the same reporter.; Sender's Comments:  US-009507513-2312USA000790:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness covered the upper part of upper arm and spread down to the elbow; Feeling Miserable; redness at the injection site; swelling at the injection site; pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles disease).   In DEC-2023, the patient received the 1st dose of Shingrix (unknown arm). In DEC-2023, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at the injection site), injection site swelling (Verbatim: swelling at the injection site) and injection site pain (Verbatim: pain at the injection site). On an unknown date, the patient experienced erythema of extremities (Verbatim: redness covered the upper part of upper arm and spread down to the elbow) and feeling miserable (Verbatim: Feeling Miserable). The outcome of the injection site erythema, injection site swelling, injection site pain, erythema of extremities and feeling miserable were resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, erythema of extremities and feeling miserable to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, injection site pain, erythema of extremities and feeling miserable to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-FEB-2024 The patient self-reported this case. The patient received the first dose of Shingrix about 2 months ago (from the date of reporting). That evening, after receiving Shingrix, the patient experienced pain, swelling, and redness at the injection site which lasted for one and one-half weeks. The redness covered the upper part of upper arm and spread down to the elbow. The patient also mentioned that she remembered feeling miserable after the shot. The patient could not specify or provide details of how she was feeling miserable. The patient declined follow up with physician. The reporter gave consent to contact pharmacy for follow up.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient did not return for the second and third doses.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 42-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received first dose of Engirix B in January 2023, batch number 337TC and expiry date 29 March 2024).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: patient did not return for the second and third doses.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-FEB-2024 The pharmacist stated patient received the first dose of Engerix-B and then did not return for the second and third doses which led to incomplete course of vaccination. The pharmacist asked for guidance on this situation. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient received Shingrix first dose without the powder component; patient received Shingrix first dose without the powder component; 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 9AT7A, expiry date 06-AUG-2024) for prophylaxis.   On 31-JAN-2024, the patient received the 1st dose of Shingrix. On 31-JAN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received Shingrix first dose without the powder component) and inappropriate dose of vaccine administered (Verbatim: patient received Shingrix first dose without the powder component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 19-FEB-2024 A reporter reported that they realized that back on 31 January 2024, a patient received Shingrix first dose without the powder component which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Age: 1.67
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17-FEB-2024) for prophylaxis.   On 20-FEB-2024, the patient received the 3rd dose of Pediarix. On 20-FEB-2024, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-FEB-2024 The nurse reported that a child was administered a dose of Pediarix and afterward they realized the vaccine had an expiration date of 17th February 2024.  At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The patient received one dose of expired Pediarix, which led to expire vaccine used. The reporter consented to follow up.
Age: 1.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidentally administered to an 18-month-old" patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On 21-FEB-2024, the patient received Kinrix. On 21-FEB-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidentally administered to an 18-month-old" patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-FEB-2024 A medical assistant called to inform that earlier that day, a dose of Kinrix was accidentally administered to an 18 month old patient, which led to inappropriate age at vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received only one dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received unsure whether 2 or 3 years ago prior to the reporting).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient received only one dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-Feb-2024 The reporter reported that the patient received only one dose of Shingrix vaccine and was unsure if this happened two or three years ago. Later on the call reporter reported that it may be a possible third dose, unsure of patient record. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year-old patient received a dose of Twinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received HAB (Twinrix) for prophylaxis.   In AUG-2023, the patient received Twinrix. In AUG-2023, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 15 year-old patient received a dose of Twinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 23-FEB-2024 A nurse reported that in August 2023 a 15 year-old patient received a dose of Twinrix which led to inappropriate age at vaccine administration, The reporter was concerned about expected adverse reactions. The reporter did not provided patient initials nor information about the Twinrix dose given (lot number, expiration date).  Did not consent to follow-up.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Electrocardiogram, Palpitations
Clinical narrative: experience a racing heart; This non-serious case was reported by a consumer via call center representative and described the occurrence of heart racing in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   In SEP-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient received COVID-19 vaccine. On an unknown date, 1 day after receiving Shingrix, the patient experienced heart racing (Verbatim: experience a racing heart). The outcome of the heart racing was resolved (duration 6 hrs).   It was unknown if the reporter considered the heart racing to be related to Shingrix.     It was unknown if the company considered the heart racing to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 The reporter was the patient. The patient received the Shingrix in September 2023 at 4pm. The next morning, the patient began to experience a racing heart which lasted for about 6 hours. The patient went to an urgent care facility in which an EKG was done. The AFIB (atrial fibrillation) was not noticed on the EKG (electrocardiogram). The patient stated that she had experienced a racing heart after a COVID vaccine. The patient/reporter declined follow up with MD but welcome follow up with her and her pharmacy. It was unknown if the reporter considered the heart racing to be related to Covid-19 vaccine.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: now i cannot get myself to sleep and waking up is horrible, i feel like i didn't sleep at all when its time to wake up; This spontaneous case was reported by a patient and describes the occurrence of SLEEP DISORDER (now i cannot get myself to sleep and waking up is horrible, i feel like i didn't sleep at all when its time to wake up) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 microgram. On 30-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SLEEP DISORDER (now i cannot get myself to sleep and waking up is horrible, i feel like i didn't sleep at all when its time to wake up). At the time of the report, SLEEP DISORDER (now i cannot get myself to sleep and waking up is horrible, i feel like i didn't sleep at all when its time to wake up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No concomitant medication was reported. It was reported that patient was in army and never had issues waking up or sleeping. It was unknown if the patient experienced any additional symptoms and events. Patient have done no meds just been struggling. The patient had no concomitant disease or risk factor. There were no lab data results available.  No treatment medication was reported.
Age: 3.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Cough, Erythema, Rhinorrhoea, Wrong product administered
Clinical narrative: runny nose; cough; red cheeks; HCP stated that Spikevax 2023-2024 was given to 3 year old patient on 22Feb2024, however, only 0.25ML was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of RHINORRHOEA (runny nose), COUGH (cough), ERYTHEMA (red cheeks) and WRONG PRODUCT ADMINISTERED (HCP stated that Spikevax 2023-2024 was given to 3 year old patient on 22Feb2024, however, only 0.25ML was administered) in a 3-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058856) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 22-Feb-2024, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .25 milliliter and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 22-Feb-2024, the patient experienced RHINORRHOEA (runny nose), COUGH (cough), ERYTHEMA (red cheeks) and WRONG PRODUCT ADMINISTERED (HCP stated that Spikevax 2023-2024 was given to 3 year old patient on 22Feb2024, however, only 0.25ML was administered). At the time of the report, RHINORRHOEA (runny nose), COUGH (cough) and ERYTHEMA (red cheeks) had resolved and WRONG PRODUCT ADMINISTERED (HCP stated that Spikevax 2023-2024 was given to 3 year old patient on 22Feb2024, however, only 0.25ML was administered) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The patient had no relevant allergy, concomitant diseases and risk factor. It was reported that the patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The expiry date of Spikevax was reported as 30-APR-2024. It was reported that the HCP contacted the father of the child and was informed that the patient had a runny nose, cough and red cheeks on 22Feb2024, but was resolved.  No treatment medication was reported.
Sex: U
Vaccine: PNC13
Symptoms: Product storage error
Clinical narrative: Only the Prevnar 13 has been administered; temperature excursion; This is a spontaneous report received from an Other HCP, Program ID.  A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Only the Prevnar 13 has been administered"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "temperature excursion". Additional information: The reporter had a temperature excursion and wants to know if the vaccines (PREVNAR 13, PREVNAR 20, AND TRUMENBA) are still okay. The reporter is a CMA (Certified-medical assistant) calling on behalf of an HCP (Healthcare professional) reporting for temperature excursion for PREVNAR 13, PREVNAR 20 AND TRUMENBA and inquiring for stability of the vaccines to see if it's still in the timeframe to give the vaccines. Only the Prevnar 13 has been administered.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Started Paxlovid; Started Paxlovid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: 172086.  A 68-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: Bnt162b2 (Primary Immunization series complete), for COVID-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN), for COVID-19 Immunization. The patient had had all of the Pfizer BioNTech COVID-19 vaccines.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Started Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient started nirmatrelvir, ritonavir (PAXLOVID) on Monday night (19Feb2024).  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400049595 Same patient, different drug and event;
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective
Clinical narrative: Got diagnosed also with COVID despite all the vaccinations; Got diagnosed also with COVID despite all the vaccinations; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetic " (ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Got diagnosed also with COVID despite all the vaccinations". The event "got diagnosed also with covid despite all the vaccinations" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (Feb2024) Unknown results, notes: Just at emergency room on Monday when they took blood test. Therapeutic measures were taken as a result of drug ineffective, covid-19 as paxlovid from 19Feb2024. Clinical course: He was Type 2 Diabetic and with the normal ailments for senior. So, there were some other meds.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400049976 same reporter/ events, different patient;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; COVID-19 VACCINE MODERNA; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 65 years for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 03Feb2021 as dose 1, single (Lot number: 042L20A), on 03Mar2021 as dose 2, single (Lot number: 011A21A), on 22Oct2021 as dose 3 (booster), single (Lot number: 71F21A), on 08Sep2022 as dose 5 (booster), single (Lot number: A57144B), on 11Jun2023 as dose 6 (booster), single (Lot number: A57104B) and on 01Nov2023 as dose 7 (booster), single), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "known allergies: Keflex". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022, outcome "unknown", described as "COVID-19 VACCINE MODERNA"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as paxlovid from 13Feb2024 to 17Feb2024.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 12:30 as dose 1, single (Lot number: HF9275) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: previous cancer; "Known allergies:Dairy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: LUPIN, start date: 01Jan2022, stop date: 12Feb2024. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as paxlovid treatment from 12Feb2024 to 17Feb2024.
Age: 35.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Rash in right arm since the day after her vaccine, no other symptoms.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "HSV-2" (unspecified if ongoing); "Known allergies: Penicillin, Sulfa drugs, Oxycodone" (unspecified if ongoing); "Allergy: sulfites" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 06Feb2024 to 10Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: red rash on lower left side of back and different parts of body
Age: 30.0
Sex: F
Vaccine: YF
Symptoms: Eye pain, Injection site erythema, Injection site swelling, Photophobia
Clinical narrative: Client describes having small red area at injection site 1 day after receiving YF vaccine. Since then, the redness has become raised and increased to 3"x4" in diameter. Client also reports pain behind eyes and light sensitivity which developed approximately 7 days after receiving vaccine.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: No adverse event
Clinical narrative: NONE- PATIENT HAS NOT HAD ANY ADVERSE REACTIONS THAT HAVE BEEN REPORTED
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Impaired work ability, Injection site pain, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: You 2/28/2024 12:59 PM ? Patient called in to clinic This AM with concerns that she has had arm pain since receiving her TDAP in clinic on Monday. She states that she can barely move her arm today and had to have her daughter help her get dressed. Offered patient immediate appointment for evaluation. During the rooming process patient told the CNA that "she gave me the shot really high" pointing at the acromion process. "she gave it to me here" Patient also tells CNA " immediately felt a burning pain all the way to my fingertips." Patient states that she had to call in to work today because it hurt so badly. Patient was then seen and treated by employee
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: You 2/28/2024 12:59 PM ? Patient called in to clinic This AM with concerns that she has had arm pain since receiving her TDAP in clinic on Monday. She states that she can barely move her arm today and had to have her daughter help her get dressed. Offered patient immediate appointment for evaluation. During the rooming process patient told the CNA that "she gave me the shot really high" pointing at the acromion process. "she gave it to me here" Patient also tells CNA " immediately felt a burning pain all the way to my fingertips." Patient states that she had to call in to work today because it hurt so badly. Patient was then seen and treated by employee
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Aphasia, Blood test normal, Brain fog, Chest crushing, Chest pain
Clinical narrative: I received a flu shot Friday, Dec 1st, and got sick with "flu-like" symptoms for the following two days with a very sore left arm. That Monday, I woke up with bilateral tingling in my feet and hands. These symptoms progressed, as well as chest and neck pain. I went to urgent care on Dec 18th. The urgent care Dr wanted to rule out MS and set up an MRI and PCP consult. Around Dec 20th, I developed a limp and weakness on my left side, as well as brain fog and aphasia. Dec 27th, I left work to go to the ED due to crushing chest pain and worsening tingling moving up both arms and up to my buttock. The ED Doctor ordered MRI, CT, ECG, and blood work to rule out MS, meningitis, and mineral deficiencies. These tests all came back negative for those issues. The ED doctor, my PCP, and my neurologist all believed these symptoms could be related to the flu vaccine.