chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Received seasonal COVID and flu vaccinations on 10/16, but fairly sure this was a reaction from the COVID vaccine, as the flu was in the right (opposite) arm. I also have a family history of strong autoimmune reaction to previous COVID vaccine (father has myesthenia gravis and had a debilitatingly strong autoimmune response after his second COVID dose several years ago). I was quite sick for about 3-4 days afterwards (10/17-10/19), including body aches and chills, joint pain, fatigue, nausea, headache, dizziness, racing heart, and a 3x3.5? wide injection site reaction. The area around the injection site got red, swollen, hot, itchy and quite painful and got increasingly worse (larger, more firm, and more painful and itchy) over the course of about 4-5 days and then it started to recede, although it is still visible and painful/itchy about a week later (10/23). I also had an abnormally elevated heart rate (120-140bpm) several times on 10/17-10/19 when I was seated or lying down and not doing anything active. I am still (as of 10/23/24, a full week after the dose) experiencing ongoing joint pain that is impacting my ability to type and do other normal daily activities, but it is less severe than it was last weekend and at the beginning of this week. I intend to see my PCP to discuss if the remaining symptoms have not resolved by next weekend.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Nausea, Pain, Palpitations
Clinical narrative: Received seasonal COVID and flu vaccinations on 10/16, but fairly sure this was a reaction from the COVID vaccine, as the flu was in the right (opposite) arm. I also have a family history of strong autoimmune reaction to previous COVID vaccine (father has myesthenia gravis and had a debilitatingly strong autoimmune response after his second COVID dose several years ago). I was quite sick for about 3-4 days afterwards (10/17-10/19), including body aches and chills, joint pain, fatigue, nausea, headache, dizziness, racing heart, and a 3x3.5? wide injection site reaction. The area around the injection site got red, swollen, hot, itchy and quite painful and got increasingly worse (larger, more firm, and more painful and itchy) over the course of about 4-5 days and then it started to recede, although it is still visible and painful/itchy about a week later (10/23). I also had an abnormally elevated heart rate (120-140bpm) several times on 10/17-10/19 when I was seated or lying down and not doing anything active. I am still (as of 10/23/24, a full week after the dose) experiencing ongoing joint pain that is impacting my ability to type and do other normal daily activities, but it is less severe than it was last weekend and at the beginning of this week. I intend to see my PCP to discuss if the remaining symptoms have not resolved by next weekend.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Received seasonal COVID and flu vaccinations on 10/16, but fairly sure this was a reaction from the COVID vaccine, as the flu was in the right (opposite) arm. I also have a family history of strong autoimmune reaction to previous COVID vaccine (father has myesthenia gravis and had a debilitatingly strong autoimmune response after his second COVID dose several years ago). I was quite sick for about 3-4 days afterwards (10/17-10/19), including body aches and chills, joint pain, fatigue, nausea, headache, dizziness, racing heart, and a 3x3.5? wide injection site reaction. The area around the injection site got red, swollen, hot, itchy and quite painful and got increasingly worse (larger, more firm, and more painful and itchy) over the course of about 4-5 days and then it started to recede, although it is still visible and painful/itchy about a week later (10/23). I also had an abnormally elevated heart rate (120-140bpm) several times on 10/17-10/19 when I was seated or lying down and not doing anything active. I am still (as of 10/23/24, a full week after the dose) experiencing ongoing joint pain that is impacting my ability to type and do other normal daily activities, but it is less severe than it was last weekend and at the beginning of this week. I intend to see my PCP to discuss if the remaining symptoms have not resolved by next weekend.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: patient came in for covid shot but received flu shot instead (this is his second flu shot for this year- one received in September 2024
Age: 1.33
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given flumist at 16 months, no adverse reactions while in clinic
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: ~36 hours after vaccination I my blood pressure was 190/110 and remained in Stages 1 and 2. Over the last 3 days, seven readings have been between 131/81 and 156/99. Prior to  this vaccination and the one before, my BP was lower and more stable--in the range of 110-120/70-80.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: patient came in for covid shot but received flu shot instead (this is his second flu shot for this year- one received in September 2024
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Patient complained of a painful rash, upon inspection she had a bit of redness on the injection site. This was 3 weeks after the shot and patient stated that it is getting better and is not painful anymore.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Eye contusion, Eye injury, Fall
Clinical narrative: Approximately 10 minutes after receiving the  injection, the child  fell and hit the on the corner of lunch table causing bruising to under the right eye. Parents were informed and came to pick up the child. The child stated at the nurses office for about 30 minutes since the school was in a secure lock down.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PATIENT HAD SOME ARM PAIN AFTER THE ADMINISTRATION OF VACCINE. THE PAIN WENT AWAY FOR A FEW DAYS BUT NOW THE ARM IS SORE AT THE INJECTION SITE. SHE WAS NOT HAVING ANY PAIN IN HER SHOULDER JUST AT THE INJECTION SITE. I ADVISED FOR HER CONTACT HER DOCTOR IF THE PAIN CONTINUES OR ANY SIGN OF INFECTION. I WILL BE CHECKING IN ON THE PATIENT IN A FEW DAYS TO SEE HOW SHE IS DOING.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Insomnia, Nausea, Pain
Clinical narrative: Throwing up, nausea, vomitting, whole body pain , difficulty going to sleep, shortness of breath, headache.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up, nausea, vomitting, whole body pain , difficulty going to sleep, shortness of breath, headache.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Dyspnoea, Flushing, Immediate post-injection reaction
Clinical narrative: Immediate reaction of redness at the injection site and itch.  Followed by edema at the injection site.  Approximately 1 hour post flu vaccine, shortness of breath began with a hoarse voice and cough, entire body rash noted.  Allegra 320 mg taken by self.  Symptoms improved slightly.  Condition began to deteriorate once again approximately 2 hours later post vaccine, with increasing shortness of breath and coughing, flushed face.  Epi 0.3mg administered to the left vastus lateralis.  Condition improved within minutes.  Caregiver transported to the ED for further evaluation.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Rash
Clinical narrative: Immediate reaction of redness at the injection site and itch.  Followed by edema at the injection site.  Approximately 1 hour post flu vaccine, shortness of breath began with a hoarse voice and cough, entire body rash noted.  Allegra 320 mg taken by self.  Symptoms improved slightly.  Condition began to deteriorate once again approximately 2 hours later post vaccine, with increasing shortness of breath and coughing, flushed face.  Epi 0.3mg administered to the left vastus lateralis.  Condition improved within minutes.  Caregiver transported to the ED for further evaluation.
Age: 1.08
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Parents requesting both flu and covid.  nurse identified patient has had both flu shots last spring 4/16/23 and 3/11 23 and told parents the child was eligible for annual flu shots now.  I did not see that he had a flu shot given on 9/19/24.  After flu shot given and the previous dose identified Dr. notified and parents told of incident.  No sign of distress.  Parents encouraged to seek medical attention for any distress.  Fluids encouraged.
Age: 86.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Patient has felt under the weather with malaise, fever, swelling, redness, in left arm. Unable to lift arm. Soreness at the sight.
Age: 86.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient has felt under the weather with malaise, fever, swelling, redness, in left arm. Unable to lift arm. Soreness at the sight.
Age: 0.17
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP called to report inadvertent administration of a first dose of MMR-II, VARIVAX, and VAQTA to an 11-week-old patient on 25SEP2024. Patient demographics were not provided. No additional details were provided by reporter. No additional AE/PQC.; HCP called to report inadvertent administration of a first dose of MMR-II, VARIVAX, and VAQTA to an 11-week-old patient on 25SEP2024. Patient demographics were not provided. No additional details were provided by reporter. No additional AE/PQC.; This spontaneous report was received from a physician referring to an 11-week-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-SEP-2024, the patient was inadvertently administered with the first doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (administered for prophylaxis, strength, dose, lot #, expiry date, and route of administration were not provided); hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (administered for prophylaxis, strength, dose, lot #, expiry date, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, (administered for prophylaxis, strength, dose, lot #, expiry date, and route of administration were not provided) (Accidental exposure to product). Operator of device was health professional. No additional adverse event (AE) (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported; expired dose of VAQTA that was inadvertently administered to a patient; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 09-OCT-2024, the patient was inadvertently vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA), strength reported as 50 (unit not reported), at a dose of 0.5 mL, administered once, intramuscularly, lot# X006702, expiry date 01-OCT-2024 (anatomical location was not reported) (expired product administered). The product did not have any previous temperature excursions. No symptoms were reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, Underdose
Clinical narrative: infant that spit out after the administration of the vaccine; HCP calling to inquire if a ROTATEQ dose should be repeated for an infant that spit out after the administration of the vaccine.  Caller stated that the infant that they administered the ROTATEQ had spit out the vaccine after the administration. Call; This spontaneous report was received from a other health professional referring to a infant patient of unknown gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral (dose, lot number and expiration date not reported) for prophylaxis, and after the vaccination, the patient spit out the vaccine (accidental underdose and infantile spitting up).
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No symptoms reported as the office has not spoken with the patient; Caller states a pregnant patient was inadvertently administered the GARDASIL 9 Vaccine on 10/15/2024. The patient was 29 weeks and 4 days pregnant; This spontaneous report has been received from a physician regarding a 29-year-old female. Information regarding medical history, concurrent conditions and concomitant therapies was not reported.  The patient got pregnant with a last menstrual period (LMP) on 26-MAR-2024 (with estimated delivery date (EDD) on 31-DEC-2024). On 15-OCT-2024, the patient was 29 weeks and 4 days pregnant and was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis, lot number 1967338 which has been verified to be valid, expiration date reported and validated as 26-JAN-2026 (strength, dose, scheme, route of administration and anatomical site not reported) (vaccine exposure during pregnancy). No symptoms reported as the office had not spoken with the patient. No additional details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak after taking 1 dose of the 2 dose series of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles outbreak after taking 1 dose of the 2 dose series of Shingrix). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2024 The physician reported that the patient who had experienced Shingles prior to vaccination with Shingrix had symptoms of Shingles outbreak after taking 1st dose of the 2 dose series of Shingrix. She was trying to decide if these patient should move forward with a second dose. This case is linked with US2024AMR118502, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR118502:Same reporter, different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never came back for her second 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 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her first dose of Shingrix on 16th October 2023 as an intramuscular injection.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never came back for her second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-OCT-2024 and 04-OCT-2024 The pharmacist had a 70 year old, female patient. The patient received her first dose of Shingrix as an intramuscular injection, and never came back for her second dose of Shingrix. The pharmacist asked for the second shot, was it ok to give it to her. Till the time of reporting the patient did not receive second dose of Shingrix which led to incomplete course of vaccination.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: unfortunately he only gave the liquid antigen prior to mixing it with the powder; unfortunately he only gave the liquid antigen prior to mixing it with the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number N9592, expiry date 11-OCT-2026) for prophylaxis.   On 30-SEP-2024, the patient received Arexvy. On 30-SEP-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: unfortunately he only gave the liquid antigen prior to mixing it with the powder) and inappropriate dose of vaccine administered (Verbatim: unfortunately he only gave the liquid antigen prior to mixing it with the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-OCT-2024 The nurse unfortunately gave the liquid antigen prior to mixing it with the powder, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Fluarix was administered subcutaneous instead of intramuscular; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2023-2024 season (subcutaneous). On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced intramuscular formulation administered by other route (Verbatim: Fluarix was administered subcutaneous instead of intramuscular). The outcome of the intramuscular formulation administered by other route 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: 02-OCT-2024 The reporter reported that Fluarix was administered subcutaneous instead of intramuscular, which led intramuscular formulation administered by other route. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Administration to adult patient/2nd dose received on 17-SEP-2024; Less than recommended interval; Administration to adult patient/1st dose received on 28-AUG-2024; 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 54-year-old female patient who received MMR (Priorix) (batch number 9594A, expiry date 01-DEC-2024) for prophylaxis.   Co-suspect products included MMR (Priorix) (batch number 9594A, expiry date 01-DEC-2024) for prophylaxis.   On 17-SEP-2024, the patient received the 2nd dose of Priorix. On 28-AUG-2024, the patient received the 1st dose of Priorix. On 28-AUG-2024, not applicable after receiving Priorix and an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to adult patient/1st dose received on 28-AUG-2024). On 17-SEP-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to adult patient/2nd dose received on 17-SEP-2024) and drug dose administration interval too short (Verbatim: Less than recommended interval). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and drug dose administration interval too short were 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: 04-OCT-2024 The patient did not had immunity to rubella and did not had verification of receiving 2 previous MMR vaccines. The patient received 2 doses of Priorix and they did not wait the whole 28 days in between doses, the second dose was administered at day 21. The reporter asked, was the 2nd dose valid. The vaccine administration facility was the same as primary reporter. The patient received 2 doses of Priorix above than the recommended age limit, which led to inappropriate age at vaccine administration. The patient received 2nd dose of Priorix earlier than recommended time interval, which led to shortening of the vaccination schedule.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an administration a month ago to a 4 month old patient.; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   In SEP-2024, the patient received the 1st dose of Kinrix. In SEP-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: an administration a month ago to a 4 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: 08-OCT-2024 The nurse asked about any advise or recommendation since there was an administration of 1st dose of Kinrix vaccine a month ago (prior to the reporting day) to a 4 month old patient and the intention was for the patient to receive DTaP and IPV, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: an expired vaccine was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced expired vaccine used (Verbatim: an expired vaccine was administered to a patient). 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: 08-OCT-2024 The registered nurse at a family medicine clinic reported that an expired vaccine was administered to a patient which led to, expired vaccine used. She was unable to provide patient's initials, gender, and date of birth. The error was discovered after patient left office.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: a patient received the diluent portion only of Hiberix; a patient received the diluent portion only of Hiberix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old male patient who received Hib (Hiberix) (batch number 4777F, expiry date 17-MAR-2026) for prophylaxis.   On 14-SEP-2024, the patient received Hiberix. On 14-SEP-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: a patient received the diluent portion only of Hiberix) and inappropriate dose of vaccine administered (Verbatim: a patient received the diluent portion only of Hiberix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2024 The nurse reported that a patient received the diluent portion only of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They did not knew which patient was the one receiving the non-reconstituted vaccine and asked how to proceed. The Vaccine Administration Facility was the same as Primary Reporter The case is 1 of the 3 linked case, by same reporter; Sender's Comments:  US-GSK-US2024125036:Same reporter/Diffrent patient US-GSK-US2024125018:Same reporter/Diffrent patient
Age: 0.42
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: a patient received the diluent portion only of Hiberix.; a patient received the diluent portion only of Hiberix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 6-month-old female patient who received Hib (Hiberix) (batch number 4777F, expiry date 17-MAR-2026) for prophylaxis.   On 14-SEP-2024, the patient received Hiberix. On 14-SEP-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: a patient received the diluent portion only of Hiberix.) and inappropriate dose of vaccine administered (Verbatim: a patient received the diluent portion only of Hiberix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2024 The nurse reported that a patient received the diluent portion only of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They did not knew which patient was the one receiving the non-reconstituted vaccine and asked how to proceed. The Vaccine Administration Facility was the same as Primary Reporter The case is 1 of the 3 linked case, by same reporter; Sender's Comments:  US-GSK-US2024125036:Same reporter/Diffrent patient US-GSK-US2024125018:Same reporter/Diffrent patient
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Possible administration of liquid portion only; Possible administration of liquid portion only; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 1-year-old male patient who received Hib (Hiberix) (batch number 4777F, expiry date 17-MAR-2026) for prophylaxis.   On 14-SEP-2024, the patient received Hiberix. On 14-SEP-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Possible administration of liquid portion only) and inappropriate dose of vaccine administered (Verbatim: Possible 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: 10-OCT-2024 The nurse reported that a patient received the diluent portion only of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They did not knew which patient was the one receiving the non-reconstituted vaccine and asked how to proceed. The Vaccine Administration Facility was the same as Primary Reporter The case is 1 of the 5 linked case, by same reporter; Sender's Comments:  US-GSK-US2024125036:Same reporter/Diffrent patient US-GSK-US2024125020:Same reporter/Diffrent patient US-GSK-US2024125012:Same reporter/Diffrent patient US-GSK-US2024125010:Same reporter/Diffrent patient
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received a second RSV vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 17th November 2023 with batch number 9TR3N expiry date 03rd July 2025).   On an unknown date, the patient received the 2nd dose of Arexvy. In OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received a second RSV vaccine). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2024 The pharmacist explained that a patient received a first dose of Arexvy on at their facility, but then patient forgot he already took the first dose and accidentally received a second RSV vaccine (unknown by caller if it was also Arexvy) in another facility on October 2024 which led to extra dose administered. Lot number and expiration date for second dose are unknown by caller.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster before 6 months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old female patient who received HAV (Havrix) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On 21-MAY-2024, the patient received the 2nd dose of Havrix. On 21-MAY-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Booster before 6 months). The outcome of the drug dose administration interval too short 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: 10-OCT-2024 A pharmacist called to ask for a recommendation on the situation that a patient received the first Havrix dose on 04th April 2024 and a second dose was given on 21st May 2024. The reporter reported that patient received all doses of Havrix within one month of time period which led to shortening of vaccination schedule. The pharmacist asked if a third dose was necessary.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Additional dose given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5j9s9, expiry date 25-OCT-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 11-OCT-2024, the patient received the 2nd dose of Arexvy. On 11-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Additional dose given). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 11-OCT-2024 The pharmacist reported that the request information about the administration of an Arexvy additional dose for a patient who received their first dose on 18th September 2024 and was accidentally given a second dose on 11th October 2024, which led to extra dose administered.
Sex: U
Vaccine: HEP, HEPA, HEPAB, TDAP
Symptoms: Product storage error
Clinical narrative: temperature excursion with a maximum temperature of 13 degree C during 2 months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Twinrix, Engerix B, Havrix and Boostrix. On an unknown date, an unknown time after receiving Twinrix, Engerix B, Havrix and Boostrix, the patient experienced incorrect storage of drug (Verbatim: temperature excursion with a maximum temperature of 13 degree C during 2 months). The outcome of the incorrect storage of drug 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: 11-OCT-2024 The reporter explained that Twinrix, Boostrix, Havrix and Engerix-B vaccines experienced a temperature excursion with a maximum temperature of 13 degree Celsius for 2 months which led to, incorrect storage of drug. The reporter mentioned that they did not know if the vaccines were administered to patients but they would call them back later if any patients were involved.
Sex: F
Vaccine: COVID19
Symptoms: Disease progression, Neoplasm malignant
Clinical narrative: Cancer was exacerbated; Cancer was exacerbated; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer was exacerbated) and DISEASE PROGRESSION (Cancer was exacerbated) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer (in remission 18-20 years).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer was exacerbated) (seriousness criteria death and medically significant) and DISEASE PROGRESSION (Cancer was exacerbated) (seriousness criterion medically significant). The patient died on 12-Dec-2023. The reported cause of death was cancer was exacerbated and cancer was exacerbated. An autopsy was performed, but no results were provided. At the time of death, DISEASE PROGRESSION (Cancer was exacerbated) had not resolved.        No concomitant medication was reported.  Cancer was exacerbated after receiving the original vaccine and died of cancer within 2 years of the vaccine. Patient had been in remission 18-20 years and lived the last month in a nursing home.  As per reporter, an autopsy was done. Upon asking for the results of the autopsy, it was told as grim, and that she got too many COVID shots.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-775284 (E2B Linked Report).; Reporter's Comments: Company comment: The history of elderly and Cancer (in remission 18-20 years) remains as a confounder for the events. The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775284:Male patient (SM) Master case; Reported Cause(s) of Death: Cancer was exacerbated; Cancer was exacerbated
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling, Skin haemorrhage
Clinical narrative: the armpit of my vaccinated arm had swelling; Bruising has continued down my arm and along the outside edge of my breast; showed areas of under skin bleeding; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (the armpit of my vaccinated arm had swelling), CONTUSION (Bruising has continued down my arm and along the outside edge of my breast) and SKIN HAEMORRHAGE (showed areas of under skin bleeding) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 14-Jul-2024 and Renal transplant. Concurrent medical conditions included Immunosuppression (Immunosuppressed for 23 Years).    On 12-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 13-Oct-2024, the patient experienced PERIPHERAL SWELLING (the armpit of my vaccinated arm had swelling), CONTUSION (Bruising has continued down my arm and along the outside edge of my breast) and SKIN HAEMORRHAGE (showed areas of under skin bleeding). At the time of the report, PERIPHERAL SWELLING (the armpit of my vaccinated arm had swelling), CONTUSION (Bruising has continued down my arm and along the outside edge of my breast) and SKIN HAEMORRHAGE (showed areas of under skin bleeding) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.  On October 10, two days before the vaccination power was knocked out and patient was doubtful if refrigeration of the vaccine was compromised. Patient stated she will meet her physician on October 18 morning.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; feeling a bit tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling a bit tired) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042914) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (All previous vaccine was pfizer); for COVID-19 prophylaxis: Moderna COVID-19 vaccine (took Moderna). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine and Pfizer.    On 17-Oct-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 17-Oct-2024, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling a bit tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling a bit tired) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had no fever. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-775677 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775677:Wife case
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Exposure via skin contact, Syringe issue
Clinical narrative: she is going to wash her hands since it is still leaking; she is going to wash her hands since it is still leaking; she has the vial and syringe when putting it all together the product leaked out; This is a spontaneous report received from a Pharmacist.  A 36-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: Oct2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient's relevant medical history was not reported. Date of last menstrual period: May2024. The patient was 20 weeks pregnant at the event onset. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS] oral (ongoing). The following information was reported: DEVICE LEAKAGE (non-serious) with onset 16Oct2024, outcome "unknown", described as "she has the vial and syringe when putting it all together the product leaked out"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious) all with onset 16Oct2024, outcome "unknown" and all described as "she is going to wash her hands since it is still leaking".  Additional information: The caller is a pharmacist reporting on Abrysvo. She stated she has the vial and syringe when putting it all together the product leaked out. The defective Abrysvo was not administered to a patient. The reporter stated she is going to wash her hands since it is still leaking and therefore the reporter is listed as the patient in this report. Stated this just happened today (16Oct2024) and she was holding the vaccine when calling to report this. The reporter stated she is 20 weeks pregnant (last menstrual period date was May2024) and then laughs and states her baby may get a little protection ahead of time. When attempting clarification, caller states she does not know what the side effects are going to be and was not expecting it to leak. The reporter takes prenatal vitamin and it is one tablet once a day by mouth. She would like to get a replacement. Confirmed the Abrysvo presentation includes the vial, syringe and adapter.  Abrysvo Carton Lot number: KC7884, Expiration Date: Sep2025, NDC: 0069-0344-01. Abrysvo Antigen Vial Lot number: KC7884, Expiration Date: Oct2025, NDC: 0069-0207-01. Abrysvo Diluent Syringe Lot number: HM8389, Expiration Date: Sep2025, NDC: 0069-0250-01.  Causality for "she is going to wash her hands since it is still leaking" and "she has the vial and syringe when putting it all together the product leaked out" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: had a shingles exacerbation in my head; This is a spontaneous report received from a Nurse from medical information team.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "recovered", described as "had a shingles exacerbation in my head".  Additional information: When patient received first booster dose patient had a shingles exacerbation in head. It lasted for 2 weeks. Patient got 2 additional COVID-19 vaccine doses from Pfizer after that. Patient didn't have shingles but an extreme immune response.  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-202400280245 Same patient, different dose/event;US-PFIZER INC-202400280246 Same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: extreme immune response; This is a spontaneous report received from a Nurse from medical information team.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose number unknown (Booster)), for COVID-19 Immunization, reaction(s): "shingles exacerbation in head". The following information was reported: IMMUNISATION REACTION (non-serious), outcome "unknown", described as "extreme immune response". Additional information: when the patient received the first booster, patient had a shingles exacerbation in the head. Patient got additional Covid-19 vaccine from Pfizer after that and did not have shingles but an extreme immune response. 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-202400279519 Same patient, different dose/event;US-PFIZER INC-202400280246 Same patient/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Rhabdomyolysis
Clinical narrative: rhabdomyolysis; This is a spontaneous report received from a Physician from medical information team.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHABDOMYOLYSIS (medically significant), outcome "unknown".  The lot number for BNT162b2 omicron (kp.2), was not provided and will be requested during follow up.; Sender's Comments: The reasonable possibility that the event rhabdomyolysis is related to BNT162B2 OMICRON (KP.2) administration cannot be excluded. However, information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Heart rate increased, Illness, Pyrexia
Clinical narrative: fever; headache; diarrhea; heart beating fast; it made her very sick; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; HEADACHE (non-serious), outcome "recovered"; DIARRHOEA (non-serious), outcome "recovered", described as "diarrhea"; HEART RATE INCREASED (non-serious), outcome "recovered", described as "heart beating fast"; ILLNESS (non-serious), outcome "recovered", described as "it made her very sick". It was unknown if therapeutic measures were taken as a result of pyrexia, headache, diarrhoea, heart rate increased, illness.  Additional information: The reporter stated "they all got the Covid shot since they were going on vacation. For some reason it made her very sick".   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, life threatening), COVID-19 (hospitalization, life threatening), outcome "unknown" and all described as "COVID-19". The clinical course was reported as follows: The patient had both vaccinations and still got COVID twice. The first time, the patient stopped breathing at home and had to be taken to the hospital in an ambulance. Her family was told she probably would not make it. The patient was on a ventilator for four days. Therapeutic measures were taken as a result of drug ineffective, covid-19.    The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.