chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 12-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 27-DEC-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005269: US-009507513-2403USA005270:
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 16-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 27-DEC-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from  the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005266: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005270:
Age: 3.0
Sex: U
Vaccine: HIBV, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was vaccinated with improper storage dose of LIQUID PEDVAXHIB and VAXNEUVANCE; This spontaneous report was received from a nurse practitioner and refers to a 3-year-old patient of unknown gender with no illness at the time of vaccination. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported.  On 19-OCT-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes.  On 20-NOV-2023, the patient was vaccinated with an improperly storage dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), intramuscularly, lot # X003664, expiration date 10-NOV-2025 (also reported as 12-NOV-2025),  and improperly storage dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), intramuscularly, lot # X019438, expiration date 07-NOV-2025 (also reported as 30-AUG-2025), both vaccines for prophylaxis (product storage error). The temperature excursion occurred because of a reading from Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2403USA004981: US-009507513-2403USA004979: US-009507513-2403USA004978: US-009507513-2403USA004977: US-009507513-2403USA004976: US-009507513-2403USA004975: US-009507513-2403USA004974: US-009507513-2403USA004980: US-009507513-2403USA004999: US-009507513-2403USA004998: US-009507513-2403USA004997: US-009507513-2403USA004996: US-009507513-2403USA004995: US-009507513-2403USA004994: US-009507513-2403USA004993: US-009507513-2403USA004986: US-009507513-2403USA004992: US-009507513-2403USA004991: US-009507513-2401USA016206: US-009507513-2403USA004989: US-009507513-2403USA004988: US-009507513-2403USA005000: US-009507513-2403USA004987: US-009507513-2403USA004990: US-009507513-2403USA005306: US-009507513-2403USA005305: US-009507513-2403USA005308: US-009507513-2403USA005309: US-009507513-2403USA005310: US-009507513-2403USA005311:
Age: 4.0
Sex: U
Vaccine: HIBV, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was vaccinated with improper storage dose of LIQUID PEDVAXHIB and VAXNEUVANCE; This spontaneous report was received from a nurse practitioner and refers to a 4-year-old patient of unknown gender with no illness at the time of vaccination. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported.  On 04-DEC-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion of at total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes.  On 18-DEC-2023, the patient was vaccinated with an improperly storage dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), intramuscularly, lot # X003664, expiration date 10-NOV-2025 (also reported as 12-NOV-2025),  and improperly storage dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), intramuscularly, lot # X019438, expiration date 07-NOV-2025 (also reported as 30-AUG-2025), both vaccines for prophylaxis (product storage error). The temperature excursion occurred because of a reading from Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2403USA004981: US-009507513-2403USA004979: US-009507513-2403USA004978: US-009507513-2403USA004977: US-009507513-2403USA004976: US-009507513-2403USA004975: US-009507513-2403USA004974: US-009507513-2403USA004980: US-009507513-2403USA004999: US-009507513-2403USA004998: US-009507513-2403USA004997: US-009507513-2403USA004996: US-009507513-2403USA004995: US-009507513-2403USA004994: US-009507513-2403USA004993: US-009507513-2403USA004986: US-009507513-2403USA004992: US-009507513-2403USA004991: US-009507513-2401USA016206: US-009507513-2403USA004989: US-009507513-2403USA004988: US-009507513-2403USA005000: US-009507513-2403USA004987: US-009507513-2403USA004990: US-009507513-2403USA005306: US-009507513-2403USA005307: US-009507513-2403USA005305: US-009507513-2403USA005309: US-009507513-2403USA005310: US-009507513-2403USA005311:
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Borrelia test negative, Feeling abnormal, Hypersomnia, Injection site pain
Clinical narrative: patient experiences soreness at the injection site; sleeping more often; The patient has no energy; her body has a weird feeling; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 54G74, expiry date 24-MAY-2025) for prophylaxis.   On 28-DEC-2023, the patient received Boostrix (intramuscular, right deltoid) .5 ml. On an unknown date, an unknown time after receiving Boostrix, the patient experienced injection site pain (Verbatim: patient experiences soreness at the injection site), hypersomnia (Verbatim: sleeping more often), loss of energy (Verbatim: The patient has no energy) and weird feeling (Verbatim: her body has a weird feeling). The outcome of the injection site pain, hypersomnia, loss of energy and weird feeling were not resolved.   It was unknown if the reporter considered the injection site pain, hypersomnia, loss of energy and weird feeling to be related to Boostrix.     It was unknown if the company considered the injection site pain, hypersomnia, loss of energy and weird feeling to be related to Boostrix.   Additional Information: GSK Receipt Date: 12-MAR-2024. The patient received Boostrix and since then had experienced soreness at injection site and her body had a weird feeling. The patient had no energy and was sleeping more often.   The patient had lab work done because of the symptoms experienced the patient stated the lab work did not show anything.  The patient was tested for Lyme's Disease, mononucleosis and thyroid.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test normal, Mononucleosis heterophile test negative, Thyroid function test normal
Clinical narrative: patient experiences soreness at the injection site; sleeping more often; The patient has no energy; her body has a weird feeling; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 54G74, expiry date 24-MAY-2025) for prophylaxis.   On 28-DEC-2023, the patient received Boostrix (intramuscular, right deltoid) .5 ml. On an unknown date, an unknown time after receiving Boostrix, the patient experienced injection site pain (Verbatim: patient experiences soreness at the injection site), hypersomnia (Verbatim: sleeping more often), loss of energy (Verbatim: The patient has no energy) and weird feeling (Verbatim: her body has a weird feeling). The outcome of the injection site pain, hypersomnia, loss of energy and weird feeling were not resolved.   It was unknown if the reporter considered the injection site pain, hypersomnia, loss of energy and weird feeling to be related to Boostrix.     It was unknown if the company considered the injection site pain, hypersomnia, loss of energy and weird feeling to be related to Boostrix.   Additional Information: GSK Receipt Date: 12-MAR-2024. The patient received Boostrix and since then had experienced soreness at injection site and her body had a weird feeling. The patient had no energy and was sleeping more often.   The patient had lab work done because of the symptoms experienced the patient stated the lab work did not show anything.  The patient was tested for Lyme's Disease, mononucleosis and thyroid.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Second Arexvy dose given to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number Z7KM4, expiry date 31-AUG-2030) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 05-OCT-2023).   On 12-MAR-2024, the patient received the 2nd dose of Arexvy. On 12-MAR-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Second Arexvy dose given to a patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 12-MAR-2024.  The nurse called and wanted to know if there was any information, they should know about a patient that was given 2nd dose which led to extra dose administered. The reporter did not consent to follow-up. The vaccine administration facility was the same as primary reporter.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 1 year patient was inadvertently administered the Kinrix instead of a Infanrix dose; 1 year patient was inadvertently administered the Kinrix instead of a Infanrix dose; The Kinrix dose was administered in the patient's Left Thigh; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Previously administered products included DTaP (received 3rd dose on 18th September 2023) and IPV (received 3rd dose on 18th September 2023).   On 11-MAR-2024, the patient received the 4th dose of Kinrix (left thigh). On 11-MAR-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: 1 year patient was inadvertently administered the Kinrix instead of a Infanrix dose), inappropriate age at vaccine administration (Verbatim: 1 year patient was inadvertently administered the Kinrix instead of a Infanrix dose) and vaccine administered at inappropriate site (Verbatim: The Kinrix dose was administered in the patient's Left Thigh). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and vaccine administered at inappropriate site 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: 12-MAR-2024 The health care professional or Director of Pharmacy called and reported that the patient was inadvertently administered the Kinrix instead of a Infanrix dose in left thigh yesterday, which led to wrong vaccine administered, inappropriate age at vaccine administration and vaccine administered at inappropriate site. The reporter asked was any data available and how to proceed. The reporter was unable to provide vaccine details of lot number and expiration date. The reporter mentioned that Kinrix was the patient's 4th dose of DTaP and IPV.  The patient's 3rd dose of each was administered back on 18th September 2023. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Underdose; Gave a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 57-year-old female patient who received HBV (Engerix B pediatric) (batch number KR3XD, expiry date 31-DEC-2025) for prophylaxis.   On 10-APR-2023, the patient received the 1st dose of Engerix B pediatric. On 10-APR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: Gave a pediatric dose of Engerix-B to an adult patient). 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: 12-MAR-2024 The nurse practitioner was reported that healthcare provider gave a pediatric dose of Engerix-B to adult patient, which led to underdose and adult use of a child product. The reporter consent to follow up. In structural field of source document vaccination date reported as 20230427, however in case narrative vaccination date reported as 10APR2023 due to this discrepancy, conservatively dates were captured as per narrative
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness at the injection; soreness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-MAR-2024, the patient received the 1st dose of Shingrix (left deltoid). On 12-MAR-2024, 5 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at the injection). In MAR-2024, the patient experienced injection site pain (Verbatim: soreness at the injection site). The outcome of the injection site pain was unknown and the outcome of the injection site erythema was not resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAR-2024 The patient received the first dose of Shingrix and experienced soreness at the injection site.  Today (on the time of reporting) the patient experienced redness at the injection site which was about 2 inches in diameter.  The patient had limited information.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: accidentally administered 1 expired dose of Boostrix; 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 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number H4Y3G, expiry date 12-MAR-2024) for prophylaxis.   On 13-MAR-2024, the patient received Boostrix. On 13-MAR-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: accidentally administered 1 expired dose of Boostrix). 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: 13-MAR-2024 The Other Health Professional (Medical Assistant) accidentally administered 1 expired dose of Boostrix to the patient which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Tachycardia
Clinical narrative: Pain at injection site; Tachycardia; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-MAR-2024, the patient received the 2nd dose of Shingrix. In MAR-2024, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site) and tachycardia (Verbatim: Tachycardia). The outcome of the injection site pain and tachycardia were resolving.   It was unknown if the reporter considered the injection site pain and tachycardia to be related to Shingrix.     It was unknown if the company considered the injection site pain and tachycardia to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2024 The patient self reported this case. The patient had pain at injection site and tachycardia after receiving dose of Shingrix.   The patient stated she was somewhat better on the morning of 14th March 2024. No further information was known. The reporter did not consent to follow-up. The reporter declined to provide any demographic information or doctor's information.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix diluent vial was punctured, but not withdrawn and reconstituted, how long was vial good for; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-MAR-2024, the patient received Shingrix. On 14-MAR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix diluent vial was punctured, but not withdrawn and reconstituted, how long was vial good for) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-MAR-2024 The health care professional requested data on if the Shingrix diluent vial was punctured, but not withdrawn and reconstituted, how long was vial good for which led to which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter disconnected chat communication prior to obtaining any demographic details or gathering any adverse event details. The reporter therefore, not sure what the intention was for the vial of Shingrix adjuvant.
Age: 57.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Arexvy rather than the intended Shingrix; patient mistakenly received Arexvy rather than the intended Shingrix; 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 57-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number Z9EG2, expiry date 29-OCT-2024) for prophylaxis.   On 15-MAR-2024, the patient received the 1st dose of Arexvy (intramuscular, unknown deltoid). On 15-MAR-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: received Arexvy rather than the intended Shingrix) and wrong vaccine administered (Verbatim: patient mistakenly received Arexvy rather than the intended Shingrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-MAR-2024 The nurse reported patient mistakenly received Arexvy rather than the intended Shingrix which led to  Inappropriate age at vaccine administration and Wrong vaccine administered. The vaccine administration facility was the same as primary reporter. Nothing else was reported.  The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient was inadvertently administered an expired Engerix; 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 patient who received HBV (Engerix B) (batch number 29RN7, expiry date 25-FEB-2024) for prophylaxis.   On 04-MAR-2024, the patient received Engerix B. On 04-MAR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: patient was inadvertently administered an expired Engerix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 15-MAR-2024 A reporter reported that a patient was inadvertently administered an expired Engerix which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: she can't say for sure that this occurred and was administered until they investigate, but they have an extra Shingrix diluent.; Possible Inappropriate Reconstitution Technique and Administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: she can't say for sure that this occurred and was administered until they investigate, but they have an extra Shingrix diluent.) and inappropriate dose of vaccine administered (Verbatim: Possible Inappropriate Reconstitution Technique and Administration). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-MAR-2024 The reporter asked if the correct diluent for Shingrix was not used, was it considered an inactive dose. The reporter stated that she can not say for sure that occurred and was administered until they investigate, but they have an extra Shingrix diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The health care professional said she cannot identify a specific patient at that time.  No lot numbers or expiration dates were available. The reporter consented to follow up via postal.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B 0.5ml was administered to one more 20 year old or older patients instead of 1mg; Engerix-B 0.5ml was administered to one more 20 year old or older patients; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received Engerix B 10 mcg .5 ml. On an unknown date, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: Engerix-B 0.5ml was administered to one more 20 year old or older patients instead of 1mg) and adult use of a child product (Verbatim: Engerix-B 0.5ml was administered to one more 20 year old or older patients). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 15-MAR-2024. Pharmacist reported Engerix B 0.5ml was administered to one more 20 year old or older patients instead of 1mg which led to underdose and adult use of a child product but they were still researching and unsure of any more details at this time.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: an expired dose of Rotarix lyophilized presentation was administered; 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 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 9742m, expiry date 25-FEB-2024) for prophylaxis.   On 13-MAR-2024, the patient received the 1st dose of Rotarix lyophilized formulation. On 13-MAR-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: an expired dose of Rotarix lyophilized presentation was administered). 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: 15-MAR-2024 The reporter called to report an expired dose of Rotarix lyophilized presentation was administered to a 4-month-old patient which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: boostrix expired dose used; 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 57-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3JS9E, expiry date 18-MAR-2024) for prophylaxis.   On 21-MAR-2024, the patient received Boostrix. On 21-MAR-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: boostrix expired dose used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 21-MAR-2024 Boostrix with expiration date 18th March 2024 was administered today (on reporting day) to a patient, which led to expired vaccine used.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; One year after the second dose of GARDASIL ( quadrivalent) she received a dose of GARDASIL 9. Seven years later she received a second dose of GARDASIL 9 (2023).; This spontaneous report was received from a registered nurse concerning to a female patient of unspecified age. Her medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in Febraury 2014, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5ml/ series, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unspecified date in March 2015, the patient received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), 0.5ml/ series, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); hence, they had received 2 doses before the age of 15 (exact age not specified). On an unknown date in March 2016 (also related as one year after the second dose of quadrivalent human papillomavirus [types 6,11,16,18] recomb. vaccine [GARDASIL]), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/ series, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unspecified date in November 2023 (also reported as seven years later), she received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/ series, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered). Moreover, the reporter stated did not have the details regarding this vaccination history, as the patient had received them  in another facility by another health care professional (HCP). No further information or additional adverse events were reported.   Lot numbers were being obtained and would be reported once received.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: the reporter stated that she wants to know if the vaccine that she got was a placebo; This spontaneous case was reported by a patient and describes the occurrence of UNEVALUABLE EVENT (the reporter stated that she wants to know if the vaccine that she got was a placebo) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (the reporter stated that she wants to know if the vaccine that she got was a placebo). At the time of the report, UNEVALUABLE EVENT (the reporter stated that she wants to know if the vaccine that she got was a placebo) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   It was unknown whether the patient receive any other vaccines in the 4 weeks prior to COVID-19. Concomitant medication was not reported. Patient stated that she wants to know if the vaccine that she got was a placebo. She said that she will never get a vaccine again. She got the vaccine in the beginning. She also noted that she received her vaccine at a drug store.  Treatment medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2024: Live non-significant follow up received. Reference numbers added.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was accidentally given Hep A, instead of Prevnar 20 injection. Please note the Lot # is not documented within patient profile.
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to receive a Tdap and was given a Dtap.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: Unevaluable event
Clinical narrative: None noted
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is an 11 year old and was given a dose of the Moderna 12+ COVID vaccine. Parent and provider are aware of the mistake.
Age: 47.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: " CAN BARELY LIFT ARM, NO LUMP OR SWELLING. PAIN IN BICEPS DOWN TO ELBOW."
Age: 0.58
Sex: M
Vaccine: UNK
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: Reaction post influenza vaccine --- unknown which influenza vaccine manufacturer.  Diffuse erythema, macular rash 20 min post influenza booster vaccination at pediatrician's office. Started on face and spread to full body. Reporting agency is the Hospital patient reported to ED of, not administering clinic.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Pyrexia
Clinical narrative: 100.3 fever, upset stomach to the point that the patient had to contact MD, excessive fatigue
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC20, RV5
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Nurse went to draw up medication. She accidentally drew up IPV instead of the HIB vaccine. She administered vaccines above. Therefore, patient received and extra IPV dose instead of the hib
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Months after the last dose of Pfizer I began having seizures disorder (Grand Mal) Which I was hospitalized Multiple Times.
Age: 36.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Erythema, Feeling hot, Hypersensitivity, Swelling
Clinical narrative: Redness, warmth, swelling, - initially managed as allergic reaction which worsened and was treated as cellulitis. Recently began antibiotics.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Cardiomegaly, Cough, Fibrin D dimer increased, Musculoskeletal chest pain
Clinical narrative: Hospitalized 11/29/22-11/30/22. Radiating right rib/abd pain, cough, pleural effusion, cardiomegaly, PE, elevated d-dimer,
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pleural effusion
Clinical narrative: Hospitalized 11/29/22-11/30/22. Radiating right rib/abd pain, cough, pleural effusion, cardiomegaly, PE, elevated d-dimer,
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Skin discolouration, Skin warm, Swelling
Clinical narrative: red, swollen, warm to the touch with some blue hues. Over the counter Benadryl
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Eye discharge, Fatigue, Nausea
Clinical narrative: Hospitalized 11/30/22-12/3/22 Nausea with vomiting, fatigue, weakness, cough, rhinorrhea, bilateral eye redness with discharge, PNA with effusion,
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pleural effusion, Pneumonia, Rhinorrhoea, Vomiting
Clinical narrative: Hospitalized 11/30/22-12/3/22 Nausea with vomiting, fatigue, weakness, cough, rhinorrhea, bilateral eye redness with discharge, PNA with effusion,
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chemotherapy, Hepatic enzyme increased, Limb mass, Liver disorder, Petechiae
Clinical narrative: Started having fever for 1 week then petechia, went to ER. Elevated liver enzymes first thought Tylenol OD, GI doc said viral liver illness. Pt later developed right arm sarcoma mass in soft tissue needing chemo and radiation in 2024
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Radiotherapy, Sarcoma
Clinical narrative: Started having fever for 1 week then petechia, went to ER. Elevated liver enzymes first thought Tylenol OD, GI doc said viral liver illness. Pt later developed right arm sarcoma mass in soft tissue needing chemo and radiation in 2024
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Pt less than 2kg and received hep B vaccine
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was scheduled for HPV #2 and blood draw. To verify, when I put the patient in the room I asked her if she was here for HPV #2 and blood draw and she replied yes. When I report the vaccine in IR I realized he had her 2nd HPV one month ago and she need Men B#2.  I called Immunization Branch and talked to the nurse. She said there should be no adverse affect. I called the patient and reported to her that she was suppose to have gotten Men B#2 and there should be no adverse affect but if she had any problem to contact out office.  She understood.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose of IPV
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Swelling face, Throat irritation, Throat tightness
Clinical narrative: Generalized body aches, facial swelling particular around the eyes, scratchy throat, nausea and vomiting 2 days after her initial shingles vaccine.Patient felt throat closing.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Generalized body aches, facial swelling particular around the eyes, scratchy throat, nausea and vomiting 2 days after her initial shingles vaccine.Patient felt throat closing.
Age: 1.67
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC15
Symptoms: Injection site erythema, Injection site infection, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Noted large amount of redness, swelling and warmth to immunization site of left leg reported by mother that saturday area was slightly swollen on sunday area had worsened
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: Public School nurse reported that patient had "red/blotchy hives from Left mid upper arm to 3-4 inches above the wrist, approximately 2 inches wide down through the forearm and on the right arm mid upper arm to elbow red/blotchy hives about a 3 inch by 7-8 inch patch. States shot site to left arm looks good.  Patient took a hot shower that morning and noticed the rash."  Nurse reports patient took tylenol and she applied cortisone cream.  Mother reported that the rash was also down his legs by ankles and that patient had golf practice on Wednesday afternoon after he received the vaccine.  Mother reported that the golf course was possibly spraying chemical on the grounds and thinks patient may have had a reaction from that. Denies going to clinic.  States using Benadryl and lotion to help with itching.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Night sweats, Rash macular
Clinical narrative: Patient reports has had a notably red face, splotchy on chest. Night sweats since he received the vaccine
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Bacteraemia, Chest pain, Diarrhoea
Clinical narrative: Hospitalized 12/1/22-12/7/22 weakness, decreased O2 saturation, dizziness, SOB, chest pain, diarrhea, nausea without vomiting, hypotensive, lethargic, elevated d-dimer, AKI, elevated LFTs, thrombocytopenia, O2, respiratory failure, bacteremia, hypoxia,
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fibrin D dimer increased, Hypotension, Hypoxia
Clinical narrative: Hospitalized 12/1/22-12/7/22 weakness, decreased O2 saturation, dizziness, SOB, chest pain, diarrhea, nausea without vomiting, hypotensive, lethargic, elevated d-dimer, AKI, elevated LFTs, thrombocytopenia, O2, respiratory failure, bacteremia, hypoxia,
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Liver function test increased, Nausea, Oxygen saturation decreased, Respiratory failure
Clinical narrative: Hospitalized 12/1/22-12/7/22 weakness, decreased O2 saturation, dizziness, SOB, chest pain, diarrhea, nausea without vomiting, hypotensive, lethargic, elevated d-dimer, AKI, elevated LFTs, thrombocytopenia, O2, respiratory failure, bacteremia, hypoxia,
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Hospitalized 12/1/22-12/7/22 weakness, decreased O2 saturation, dizziness, SOB, chest pain, diarrhea, nausea without vomiting, hypotensive, lethargic, elevated d-dimer, AKI, elevated LFTs, thrombocytopenia, O2, respiratory failure, bacteremia, hypoxia,
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itching all over body. Non-anaphylactic
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Panniculitis, Skin mass, Skin swelling
Clinical narrative: Patient had previously received the previous pneumococcal vaccine in 2022 from Merck.  Patient endorsed localized skin reaction (swelling, redness) with panniculitis.  Swelling and redness improved w/o medical intervention and support measures only (heat/ice). Only the subcutaneous nodule remains. Onset of symptoms occurred approximately one week after the administration of the vaccine.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Patient developed diffuse rash 12 days post Varivax vaccination.  Diagnosed with vaccine induced varicella sequela.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: pt had a red round rash at site of injection that is spreading. Pt is reaching out to physician
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Atrial fibrillation, Blood creatine phosphokinase increased, Chest pain
Clinical narrative: Hospitalized 12/1/22-12/6/22 syncope, chest pain, lightheaded, a-fib, tachycardic, weakness, AKI, dyspnea, O2, respiratory failure, PNA, cough, elevated CPK, sepsis, hypoxia, hyponatremia, elevated troponin,
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Hyponatraemia, Hypoxia
Clinical narrative: Hospitalized 12/1/22-12/6/22 syncope, chest pain, lightheaded, a-fib, tachycardic, weakness, AKI, dyspnea, O2, respiratory failure, PNA, cough, elevated CPK, sepsis, hypoxia, hyponatremia, elevated troponin,
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Respiratory failure, Sepsis, Syncope, Tachycardia
Clinical narrative: Hospitalized 12/1/22-12/6/22 syncope, chest pain, lightheaded, a-fib, tachycardic, weakness, AKI, dyspnea, O2, respiratory failure, PNA, cough, elevated CPK, sepsis, hypoxia, hyponatremia, elevated troponin,
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Hospitalized 12/1/22-12/6/22 syncope, chest pain, lightheaded, a-fib, tachycardic, weakness, AKI, dyspnea, O2, respiratory failure, PNA, cough, elevated CPK, sepsis, hypoxia, hyponatremia, elevated troponin,
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Mother of child called our health department on Monday 3-22-24 and stated that her child had the MMRV and the kinrix vaccines on the previous Friday and that on Saturday the child complained of itchiness at the vaccine site.  Mom noticed a red rash around the site and that it was warm to touch and slightly hard.  Mother of child did state that it had not grown larger and denied that the child was running a fever, or had any other signs of reaction.  She stated that child was not "bothered" by this but it was recommended by child's pediatrician that a VAERS be written by the health department.
Age: 32.0
Sex: M
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient came into the clinic with his partner for a follow up appt. Patient needed an HPV #3 but the MD told me to get a P20  so I pulled that vaccine and gave it to the patient. Once I put it in the computer I noticed where he had already received the P20 in August 2023. I let the MD know that the wrong vaccine was ordered and she said that he would not have any side effects from it and we could give the right vaccine at the next visit.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Circular rash on right arm that lasted several weeks.  Patient's doctor prescribed a medrol dose pack which helped but the doctor wanted the rash to be reported as an adverse event.
Age: 20.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient was supposed to have been given a Hepatitis B but instead a Hepatitis A was ordered. The employee states ordered the wrong vaccine and gave patient a pediatric dose of Hepatitis B.  It is unknow which one the patient actually received.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pyrexia, Rash
Clinical narrative: 2/28 at 8:00pm: Systemic rash on stomach, back, and inside of arms. Was advised by a nurse to seek medical care at 11:00pm. Went to the hospital, was treated with benadryl. Also had a low grade fever, resolved with ibuprofen.  2/29 at 8:00am: both hands swollen and red. Became worse with gripping or picking anything up, to which it felt like it was burning. Did not resolve with antihistamines. Only icing and stretching helped. 3/6 at 3:15 pm: took antihistamines an hour before second dose, had no adverse reactions
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Erythema of approximately 10 cm round patch to area surrounding the injection site.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Condition aggravated, Drooling, Muscle fatigue, Seizure
Clinical narrative: I experienced a Nocturnal seizure from this new Trigger event. Friday March 22, I received my first Shingles vaccine shot. That night I had another seizure. After I awoke, I felt extreme muscle fatigue and weakness from head to toe. Had a bad tongue bite and noticed a little bit of urinating and drooling occurred when asleep. This was my 7 NS in 2 years and the others were triggered by high levels of emotional stress lasting an extended period of time.