chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: Patient only received adjuvant of Shingrix; patient only received Shingrix adjuvant.; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 57-year-old patient who received Herpes zoster (Shingrix) (batch number 44N2, expiry date 25-JAN-2026) for prophylaxis.   On an unknown date, the patient received Shingrix (right deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Patient only received adjuvant of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient only received Shingrix adjuvant.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-JUL-2024 This report was submitted via the online direct entry reporting system.  The reporter contacted him/her with a asking what the protocol was if a patient only received Shingrix adjuvant, which led to Inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: Patient only received adjuvant portion of shingrix; Patient only received adjuvant portion of shingrix; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 60-year-old patient who received Herpes zoster (Shingrix) (batch number 44N2, expiry date 25-JAN-2026) for prophylaxis.   On 09-JUL-2024, the patient received Shingrix. On 09-JUL-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Patient only received adjuvant portion of shingrix) and inappropriate dose of vaccine administered (Verbatim: Patient only received adjuvant portion of shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-JUL-2024 This report was submitted via the online direct entry reporting system.  The patient only received adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Shingrix was more than 1 year after the first; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose of Shingrix was more than 1 year after the first). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2024 The pharmacist (patient) told the reporter that he/she could get a 3rd dose of Shingrix, since the second dose of Shingrix was taken more than 1 year after the first dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case had been linked to US2024084041, reported by same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024084041:same reporter, different patient
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: an adult patient received a pediatric dose of Engerix B on July 1st 2024; an adult patient received a pediatric dose of Engerix B on July 1st 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 29-year-old female patient who received HBV (Engerix B pediatric) (batch number ZP72S, expiry date 15-DEC-2024) for prophylaxis.   On 01-JUL-2024, the patient received Engerix B pediatric. On 01-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: an adult patient received a pediatric dose of Engerix B on July 1st 2024) and adult use of a child product (Verbatim: an adult patient received a pediatric dose of Engerix B on July 1st 2024). The outcome of the underdose and adult use of a child product 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: 09-JUL-2024 The reporter was medical assistant. The reporter reported that an adult patient received a pediatric dose of Engerix B, which led to underdose and adult use of a child product. CDC was contacted about it and patient was recommended to get the full adult dose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15-month-old that was administered Kinrix; 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 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On 27-JUN-2024, the patient received Kinrix. On 27-JUN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 15-month-old that was administered Kinrix). 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: 09-JUL-2024 A medical assistant called to inform that they had a patient, 15-month-old that was administered Kinrix, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: Hiberix Administration of liquid portion only; Hiberix 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 patient who received Hib (Hiberix) (batch number 9e3bh, expiry date 09-JUN-2027) for prophylaxis.   In JUN-2024, the patient received Hiberix. In JUN-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Hiberix Administration of liquid portion only) and inappropriate dose of vaccine administered (Verbatim: Hiberix 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: 09-JUL-2024 The nurse reported that sometime in between 7th June 2024 and 18th June 2024, the patient (not sure which one from the list of patients) received a dose of Hiberix without prior reconstitution, administered the liquid portion only, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was same as Primary Reporter. The reporter did not consent to follow-up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: Administration of only the liquid portion; Administration of only the liquid portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 04-JUL-2024, the patient received Menveo. On 04-JUL-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administration of only the liquid portion) and inappropriate dose of vaccine administered (Verbatim: Administration of only the liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-JUL-2024 The reporter had a question on the Menveo vaccine, he/she accidentally injected the patient without the powder, so he/she need to know what should do, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter mentioned that he did not have the patient information. Also they did not have lot number or expiration date. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: 2nd dose administered/We gave a second dose after 6 months; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7X24T, expiry date 21-AUG-2025) for prophylaxis.   On 09-JUL-2024, the patient received the 2nd dose of Arexvy. On 09-JUL-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: 2nd dose administered/We gave a second dose after 6 months). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 09-JUL-2024 The reporter called to inform the following about Arexvy, gave a second dose after 6 months, which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: The patient received an additional dose of the Pediarix and such dose was administered earlier that day; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 2227K, expiry date 17-JAN-2026) for prophylaxis.   Previously administered products included Pediatrix (received an dose on 09-JUL-2024).   On 09-JUL-2024, the patient received Pediarix. On 09-JUL-2024, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: The patient received an additional dose of the Pediarix and such dose was administered earlier that day). The outcome of the overdose 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: 09-JUL-2024 The nurse called and informed that the patient received an additional dose of the Pediarix and such dose was administered earlier that day, which led to overdose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose at a local pharmacy on 12th August 2023 in the left arm).   On 29-MAR-2024, the patient received the 2nd dose of Shingrix (injection, left arm). On 29-MAR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 09-JUL-2024 The patient reported that she got her 2nd dose 7 months after the 1st dose. Lot and expiry dates were unknown.  No additional information was reported. The patient reported that she got the vaccine one month late.  The patient did not state the reason why she got the vaccine late. The reporter decline to provide complete demographics.  Consent for follow up was not obtained. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: The patient received a phone call later the same day stating that the SHINGRIX vaccine was improperly stored and that he would need to be revaccinated"; This non-serious case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes and hypertension. Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR;TETANUS VACCINE TOXOID (TDAP) and RSV VACCINE PROT. SUBUNIT PREF 2V (ABRYSVO).   On 09-JUL-2024, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: The patient received a phone call later the same day stating that the SHINGRIX vaccine was improperly stored and that he would need to be revaccinated"). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 09-JUL-2024 The reporter was the patient. The patient received the Shingrix.   The patient received a phone call later the same day stating that the Shingrix vaccine was improperly stored and that he would need to be revaccinated, which led to incorrect storage of vaccine. The patient also received Abrysvo and Tdap (manufacturer not specified) the same time as Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Maladministration of Bexsero After the Expiration Date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (expiry date 30-JUN-2024) for prophylaxis.   On 01-JUL-2024, the patient received Bexsero. On 01-JUL-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Maladministration of Bexsero After the Expiration Date). 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: 11-JUL-2024 The reporter reported that a colleague administered by error Bexsero after the expiration date, which led to expired vaccine used. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Male patient received expired HIBERIX injection; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old male patient who received Hib (Hiberix) (expiry date 13-JUN-2024) for prophylaxis.   On 11-JUL-2024, the patient received Hiberix (injection, unknown deltoid). On 11-JUL-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Male patient received expired HIBERIX injection). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 11-JUL-2024 Medical clinic staff called response center for GlaxoSmithKline to seek information after patient was injected in unknown deltoid with expired Hiberix vaccine, which led to expired vaccine used. No side-effects reported as this event just occurred. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: patient of 24 or 25 years old accidentally received a pediatric dose of Engerix B instead of an adult dose today; patient of 24 or 25 years old accidentally received a pediatric dose of Engerix B instead of an adult dose today; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) (batch number k4jh7, expiry date 09-JUL-2026) for prophylaxis.   On 11-JUL-2024, the patient received Engerix B pediatric. On 11-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: patient of 24 or 25 years old accidentally received a pediatric dose of Engerix B instead of an adult dose today) and accidental underdose (Verbatim: patient of 24 or 25 years old accidentally received a pediatric dose of Engerix B instead of an adult dose today). The outcome of the adult use of a child product and accidental underdose 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: 11-JUL-2024 The nurse who stated that a patient who was 24 or 25 years old accidentally received a pediatric dose of Engerix B instead of an adult dose on the reporting day, which led to adult use of a child product and accidental underdose. The reporter consent to follow up.
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: A 3 year old patient received a shot of Priorix which was stored at the freezer at -23°C, the vaccine was not stable anymore.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 3-year-old male patient who received MMR (Priorix) (batch number 53F2A, expiry date 01-NOV-2024) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: A 3 year old patient received a shot of Priorix which was stored at the freezer at -23°C, the vaccine was not stable anymore.). 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-JUL-2024 The patient received a shot of Priorix which was stored at the freezer at -23 degree C, the vaccine was not stable anymore, which led to incorrect storage of vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number P5414) for prophylaxis.   On 09-JUL-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 11-JUL-2024 The reporter reported that the son of one of his patients, received Shingrix at a local pharmacy and then he was contacted by the pharmacy stating he needed to come back for another dose because the injection he received was compromised due to not being refrigerated for a while, which led to incorrect storage of vaccine. The reporter did not know any details of the excursion.  At the time of reporting, repeat dose had not been administered.   Reporter was unsure of the product lot number, but did see P5414 on a copy of the paperwork the patient had. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1 year old female patient was inadvertently administered second Havrix dose too soon; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 1-year-old female patient who received HAV (Havrix) (batch number 7PK53, expiry date 04-MAR-2026) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 21Feb2024 (lot number X2233, expiration date 14Nov2025)).   On 11-JUL-2024, the patient received the 2nd dose of Havrix. On 11-JUL-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: 1 year old female patient was inadvertently administered second Havrix dose too soon). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 11-JUL-2024 The reporter reported that a patient was inadvertently administered second Havrix dose too soon.  The Vaccine Administration Facility is the same as Primary Reporter. The patient received 2n dose of Havrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got first dose of Shingrix on 2020 they're not sure she got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020 ).   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: got first dose of Shingrix on 2020 they're not sure she got the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2024 The pharmacist reported that the patient got first dose of Shingrix (pharmacist did not have an exact date) and they were not sure she got the second dose and patient thought that she did but not sure. The pharmacist wanted to know if patient can get a second or third dose now. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hepatitis B vaccine (2 nd dose) administered on 13-JAN-1994; This spontaneous report has been received from a health care professional via an immunisation record from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)  (# 2407USA010941), concerning 1-month-old female patient. Her concurrent conditions, medical history and concomitant therapies were not provided.   On 18-DEC-1993, she was administered the first dose of hepatitis B vaccine (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On 13-JAN-1994, the patient received the second dose of hepatitis B vaccine (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (Inappropriate schedule of product administration). On 29-JUN-1994, she was administered the third dose of hepatitis B vaccine (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis.  This is one of 2 reports created for the same patient (linked #2211USA002428).; Sender's Comments:  US-009507513-2211USA002428:
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late dosing; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received HBV (Engerix B) (batch number 735qx, expiry date 31-AUG-2026) for prophylaxis.   Previously administered products included Engerix b (on 15th January 2020 received 1st dose with lot number xa4dd) and Engerix B adult (on 21th February 2020 received 2nd dose with lot number xa4dd and expiry date 19 May 2022).   On 08-JUL-2024, the patient received the 3rd dose of Engerix B. On 08-JUL-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late dosing). The outcome of the drug dose administration interval too long 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: 09-JUL-2024 A pharmacist reported that a patient received 3 doses of Engerix be on the following schedule: 1st dose 15 Jan 2020, 2nd dose 21 Feb 2020 and 3rd dose 8 July 2024 (late). The patient received 2nd dose of Engerix B later than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysgeusia, Erythema, Fear, Immediate post-injection reaction
Clinical narrative: The 1st booster at store. With in 20 minutes I had a high fever. The 2nd booster at another store I felt I had been poisoned. My friend was with me, It was a few days before I didnt have any symptoms. Immediate metallic taste + almost fainted. Friends said I turned frightened I regularly get flu, pneumonia, pertussis shots and every 10 years tetanus. I'm 78 years old and not any medications I do know that is unusual at my age. Please take attention. This is why I haven't taken "boosters" for covid - the third booster, as had unpleasant experiences with both of the first two. Thank you so very, very much  Friend said I turned " bright red" in the face + she thought about calling EMS. It was several days before the metallic taste + I could eat anything. Did immediately tell the folks at store is where I got the 2nd booster: They are the people who gave me your number.  BTW, I havent had covid, the I've friends who've had it 3 times! I' m a retired Registered Nurse. My specialy was medical oncology. I mean, whie I was sitting at store, my friend told the pharmacist I was in distress.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The 1st booster at store. With in 20 minutes I had a high fever. The 2nd booster at another store I felt I had been poisoned. My friend was with me, It was a few days before I didnt have any symptoms. Immediate metallic taste + almost fainted. Friends said I turned frightened I regularly get flu, pneumonia, pertussis shots and every 10 years tetanus. I'm 78 years old and not any medications I do know that is unusual at my age. Please take attention. This is why I haven't taken "boosters" for covid - the third booster, as had unpleasant experiences with both of the first two. Thank you so very, very much  Friend said I turned " bright red" in the face + she thought about calling EMS. It was several days before the metallic taste + I could eat anything. Did immediately tell the folks at store is where I got the 2nd booster: They are the people who gave me your number.  BTW, I havent had covid, the I've friends who've had it 3 times! I' m a retired Registered Nurse. My specialy was medical oncology. I mean, whie I was sitting at store, my friend told the pharmacist I was in distress.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Faeces discoloured, Infant irritability
Clinical narrative: irritability and dark stools
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, PPV
Symptoms: Erysipelas, Injection site cellulitis, Vomiting
Clinical narrative: Erysipelas; Injection site cellulitis; Vomiting; Information was obtained on a request by Regulatory Authority (RA) via a Public Case Detail (Agency # AU-TGA-0000786668) on 15-JUL-2024.  This spontaneous report has been received from an other health professional, referring to an (PRIVACY) 4-year-old female patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported. She had no previous vaccine reactions.  On 17-JUL-2023, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) in right arm (dose, route of administration, indication, lot# and expiry date were not reported), with hepatitis a vaccine, inactivated (VAQTA 25U/0.5 ML) in left arm  (dose, route of administration, indication, lot# and expiry date were not reported), and with diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL), administered in left arm (dose, route of administration, indication, lot# and expiry date were not reported).  On 18-JUL-2023, the patient experienced erysipelas, injection site cellulitis and vomiting. That day, she developed swelling which rapidly increased for 1/52. On 20-JUL-2023, she attended emergency department (ED) and was diagnosed with erysipelas. She had symptoms of pain, redness, swelling, reduced range of motion (ROM) and hot to touch. Vomiting and decreased diet. She was prescribed cefalexin orally (PO). On 22-JUL-2023, she represented with increasing size of reaction. Redness and swelling were extended to just below the shoulder to 5 cm above the elbow. Prescribed trimoxazole PO. The diagnosis (Dx) was cellulitis. The symptoms eventually resolved. On 27-JUL-2023, the patient had recovered from injection site cellulitis. The patient's mother reported that swelling did end up extending to elbow as well. No ongoing issues. However, mother reported vaccine hesitancy now with younger child due to this reaction.  At the time of reporting, the patient had recovered from erysipelas, injection site cellulitis and vomiting.  The causal relationship between the event and suspect vaccines was not provided by the reporter, however, the Agency considered the evens of erysipelas, injection site cellulitis and vomiting to be related to the suspect vaccines (reported as causality possible).  Upon internal review, the event of erysipelas was determined to be medically significant.  Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash pruritic, Rash vesicular
Clinical narrative: On left hand, three itchy bumps that look like chickenpox. They are solid, raised and not weeping. The hand also swelled slightly while on a long, hot walk on 7/21. Also, a lot of general itchiness around the body.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: CMA thought provider ordered Shingrix but actually provider wanted menigococal vacine to be given.  Pt had already received 2 doses of shingrix at pharmacy.. This was a 3rd dose of Shingrix
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: 11 year pt in for immunization, he was sitting in his mother's lap, TDAP given in RD 1st, then meningococcal given LD and then HPV given in LD, right after HPV immunization was given, pt's head went back and both arms went straight out, his eyes were not focused and he could not answer his mother or me when we asked if he was okay, he stayed like that for approx. 15 seconds, after he was able to answer questions, he had clammy skin, and he could not remember what happened. at 1450: BP was 92/60, HR: 58, SPO2: 99%, RR: 15, at 1455: BP was 90/58, HR: 72, SPO2: 99%, RR: 20, at 1511: BP: 118/68, HR: 77, SPO2: 99%, RR: 18, LCTA, assisted to lay down with head back and legs elevated, fan blowing on pt, cool rags on forehead, face and torso, had pt lay down for 20 mins in Trendelenburg then assisted pt to sitting position for 5 mins, gave coke and candy, assisted pt to stand, pt was steady on feet, encouraged mother to follow up with PCP or go to ER if emergent, pt stated he felt find and was able to leave with mother. VAERS and occurrence completed.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: Red around injection site immediately after vaccine.  Patient said did not hurt or have any irritation, but very red
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: Extra dose given as clerk did not check system to verify immunizations.
Age: 27.0
Sex: M
Vaccine: JEV1, MMR, TYP
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Syncope of patient. Placed patient in Trendelenburg recliner with ice pack. Monitored blood pressure during recovery. 0818 first blood pressure taken was 77/44 and pulse of 52 bpm. Patient was alert and oriented X4. Reported he did not eat this morning and was feeling faint and nauseous. Next blood pressure taken at 0824 was 89/57 and pulse 59 bpm. Patient was responding to questions and reported no prior reactions to immunizations. Next blood pressure obtained was 92/63 at 0829 and pulse was 55 bpm. Patient was drinking water and ate a protein bar offered. Last blood pressure taken in the trendelenburg position was at 0839 and bp was 99/64 with pulse of 57. Sat patient into the upright position in chair and repeated blood pressure at 0841 which was 113/61. Patient reported he felt better. Advised patient to report history of "fainting" to staff when receiving vaccines or blood work.  Patient was then assessed by APRN prior to leaving clinic at 0855.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: Extra dose given as clerk did not check database for immunizations.
Age: 0.75
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Hep A too early, no reaction reported.
Age: 0.58
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given MMR to early, minimum age is 12months
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: There was no adverse reaction to the vaccine. Pt is 38 weeks pregnant.
Age: 15.0
Sex: F
Vaccine: HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MMRV VACCINE GIVEN TO CHILD > 12 INSTEAD OF SEPERATE DOSES OF MMR AND VARICELLA
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Chest X-ray, Dyspnoea, Lethargy, Periorbital swelling, Rash
Clinical narrative: Mom reports child started  having a reaction approximately 20-30 minutes after leaving the health unit. Reports child was at restaurant and began to have sneezing, difficulty breathing, wheezing and later noted that he had rash to his chest ,puffy eyes and he was lethargic. Reports that she called his pcp but didn't get a response to her call then she called the  local health dept and was instructed by nurse to take child to the ER. Reports that child was treated with Epinephrine, IV fluids and oxygen. Reports that child slept for an hour to two hours in the ER and awaken. Reports that child was much improved and was discharged home with prednisone to do follow up with pcp Dr. and to watch closely for the next 72 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Sneezing, Somnolence, Wheezing
Clinical narrative: Mom reports child started  having a reaction approximately 20-30 minutes after leaving the health unit. Reports child was at restaurant and began to have sneezing, difficulty breathing, wheezing and later noted that he had rash to his chest ,puffy eyes and he was lethargic. Reports that she called his pcp but didn't get a response to her call then she called the  local health dept and was instructed by nurse to take child to the ER. Reports that child was treated with Epinephrine, IV fluids and oxygen. Reports that child slept for an hour to two hours in the ER and awaken. Reports that child was much improved and was discharged home with prednisone to do follow up with pcp Dr. and to watch closely for the next 72 hours.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Feeling abnormal, Frequent bowel movements, Haematochezia, Infant irritability, Ultrasound abdomen normal
Clinical narrative: Hematochezia roughly 24 hours after administration of vaccines along with increased fussiness/irritability and increased stool frequency.
Age: 59.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Injection site looks like a red welt that is warm to the touch, some itching like hives. Didn't really notice it until the following day, and 48 hours later it is still red.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 7/12/24
Age: 0.83
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received MMR before the age appropriate guidelines
Age: 7.0
Sex: F
Vaccine: PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Invalid dose given, patient too old for dose received
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Apathy, Asthenia, Blood test, Bradykinesia
Clinical narrative: She got her vaccine, felt soreness in her arm.  Woke up the next morning, felt something on her forehead and felt another and noticed sores on her hairline on both sides of her forehead.  She popped them she thinks, and then they spread.  There was one by her eye.  She started having heart palpitations and dizziness, weakness, and fatigue and confusion.  She did not want to do anything, the idea of getting dressed was miserable.  She went to the cardiologist and was diagnosed with PVC's, and still having anxiety about doing things, like beginning something and following through.  She has sores on her arms, by her private areas, her butt and her legs as well.  It is not like there are multiple of them and usually comes in 2's.  They itch, she scratches them and then they pop and has something that looks like an open wound like she took some of the skin off.  She is tired of having sores, they are itching, and don't look pretty.  She also has one on her chin.  She has them on her upper arms.  She usually has 10-12 going at a time on different parts of her body, and not on her hands or feet.  She did not go to the doctor for her sores as she has been focusing on her heart.  She went to an UC and then was sent to the  ER while traveling, and ended up that her lungs were good, but was having PVC's, which they recommended for her to go to the cardiologist.  She goes for a test for electrodes on her heart, and going to have an MRI.  She is on a heart monitor at this time.  She had a cath in her arm, no blockage.  Had x-ray of her lungs, no fluid or any cancer, and continued having multiple tests performed.  She is having the MRI on 7/31/24 locally.  They are not finding a reason why she is having an irregular heart beat.  She was given a medicine to regulate her heartbeat Flecanide which she takes 50 mg twice a day.  She did not have any heart issues prior to the vaccine.  She did have COVID twice and wondes if she has long-COVID now.   She sees a cardiologist.  She had a sonogram on her carotid artery, on her heart, testing on her heart.  She had a thallium  stress test but the medicine made her so weak she could not continue with it.  She did not have any other health issues prior to receiving the vaccine.   She was at the ER for hours, and recommended to see a cardiologist.  She went home and saw her PCP and got her into the cardiologist who as ordered tests.  She would slowly get up, her legs were heavy, was dizzy and spreading throughout her body and her arms were heavy.   She wants to know whether this is from the vaccine or not so that she can get on with her life.  She wants to be able to move around without being dizzy.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac monitoring, Catheterisation cardiac normal, Chest X-ray normal, Confusional state, Dizziness
Clinical narrative: She got her vaccine, felt soreness in her arm.  Woke up the next morning, felt something on her forehead and felt another and noticed sores on her hairline on both sides of her forehead.  She popped them she thinks, and then they spread.  There was one by her eye.  She started having heart palpitations and dizziness, weakness, and fatigue and confusion.  She did not want to do anything, the idea of getting dressed was miserable.  She went to the cardiologist and was diagnosed with PVC's, and still having anxiety about doing things, like beginning something and following through.  She has sores on her arms, by her private areas, her butt and her legs as well.  It is not like there are multiple of them and usually comes in 2's.  They itch, she scratches them and then they pop and has something that looks like an open wound like she took some of the skin off.  She is tired of having sores, they are itching, and don't look pretty.  She also has one on her chin.  She has them on her upper arms.  She usually has 10-12 going at a time on different parts of her body, and not on her hands or feet.  She did not go to the doctor for her sores as she has been focusing on her heart.  She went to an UC and then was sent to the  ER while traveling, and ended up that her lungs were good, but was having PVC's, which they recommended for her to go to the cardiologist.  She goes for a test for electrodes on her heart, and going to have an MRI.  She is on a heart monitor at this time.  She had a cath in her arm, no blockage.  Had x-ray of her lungs, no fluid or any cancer, and continued having multiple tests performed.  She is having the MRI on 7/31/24 locally.  They are not finding a reason why she is having an irregular heart beat.  She was given a medicine to regulate her heartbeat Flecanide which she takes 50 mg twice a day.  She did not have any heart issues prior to the vaccine.  She did have COVID twice and wondes if she has long-COVID now.   She sees a cardiologist.  She had a sonogram on her carotid artery, on her heart, testing on her heart.  She had a thallium  stress test but the medicine made her so weak she could not continue with it.  She did not have any other health issues prior to receiving the vaccine.   She was at the ER for hours, and recommended to see a cardiologist.  She went home and saw her PCP and got her into the cardiologist who as ordered tests.  She would slowly get up, her legs were heavy, was dizzy and spreading throughout her body and her arms were heavy.   She wants to know whether this is from the vaccine or not so that she can get on with her life.  She wants to be able to move around without being dizzy.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Echocardiogram, Fatigue, Genital lesion, Heart rate irregular, Laboratory test
Clinical narrative: She got her vaccine, felt soreness in her arm.  Woke up the next morning, felt something on her forehead and felt another and noticed sores on her hairline on both sides of her forehead.  She popped them she thinks, and then they spread.  There was one by her eye.  She started having heart palpitations and dizziness, weakness, and fatigue and confusion.  She did not want to do anything, the idea of getting dressed was miserable.  She went to the cardiologist and was diagnosed with PVC's, and still having anxiety about doing things, like beginning something and following through.  She has sores on her arms, by her private areas, her butt and her legs as well.  It is not like there are multiple of them and usually comes in 2's.  They itch, she scratches them and then they pop and has something that looks like an open wound like she took some of the skin off.  She is tired of having sores, they are itching, and don't look pretty.  She also has one on her chin.  She has them on her upper arms.  She usually has 10-12 going at a time on different parts of her body, and not on her hands or feet.  She did not go to the doctor for her sores as she has been focusing on her heart.  She went to an UC and then was sent to the  ER while traveling, and ended up that her lungs were good, but was having PVC's, which they recommended for her to go to the cardiologist.  She goes for a test for electrodes on her heart, and going to have an MRI.  She is on a heart monitor at this time.  She had a cath in her arm, no blockage.  Had x-ray of her lungs, no fluid or any cancer, and continued having multiple tests performed.  She is having the MRI on 7/31/24 locally.  They are not finding a reason why she is having an irregular heart beat.  She was given a medicine to regulate her heartbeat Flecanide which she takes 50 mg twice a day.  She did not have any heart issues prior to the vaccine.  She did have COVID twice and wondes if she has long-COVID now.   She sees a cardiologist.  She had a sonogram on her carotid artery, on her heart, testing on her heart.  She had a thallium  stress test but the medicine made her so weak she could not continue with it.  She did not have any other health issues prior to receiving the vaccine.   She was at the ER for hours, and recommended to see a cardiologist.  She went home and saw her PCP and got her into the cardiologist who as ordered tests.  She would slowly get up, her legs were heavy, was dizzy and spreading throughout her body and her arms were heavy.   She wants to know whether this is from the vaccine or not so that she can get on with her life.  She wants to be able to move around without being dizzy.