chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA157122, 2023SA157746, 2023SA157755, 2023SA157204, 2023SA156938, 2023SA157726 and 2023SA157752.  This case involves a 12 years old patient of unknown gender who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-May-2023, the patient received a dose of 0.5 ml (dose 1) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (lot: U7576AB; expiry date: 28-Feb-2025) via intramuscular route in the left arm for Immunization.  On 17-May-2023, the patient was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  It was reported, "Nurse says that the vaccine was administered to 8 people after the excursion. She says that the excursion was caused by additional gel packs being placed in the refrigerator. She asked for appropriate follow-up. The vaccines had been transported due to power outage and then cold packs were put into refrigerator and apparently made the refrigerator temperature drop."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Menquadfi reached a low temperature of 32.9F with no reported adverse event; the vaccine was administered with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA157204 and 2023SA157696.  This case involves a 11 years old and unknown gender patient who was administered with vaccine meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] that reached a low temperature of 32.9f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for prophylactic vaccination (Immunisation).  On 15-May-2023, the patient received a dose 1 of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (batch number: U7576AB; expiry date: 28-Feb-2025) via intramuscular route in the left arm for immunization with no reported adverse event (poor quality product administered) (same day latency) that on an unknown date, had underwent temperature excursion as a low temperature of 32.9f was reached with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event menquadfi reached a low temperature of 32.9f with no reported adverse event and was Unknown for the event the vaccine was administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Immunisation reaction
Clinical narrative: experienced a reaction; Initial information received on 22-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who had experienced a reaction after receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date 2019, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (form, batch number and expiry date unknown) via unknown route in unknown administration site for immunisation. Information on the batch number was requested.  On an unknown date the patient experienced a reaction (immunisation reaction) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (experienced a reaction).  At time of reporting, the outcome was Unknown for the event experienced a reaction.
Sex: U
Vaccine: IPV
Symptoms: Medication error, Product storage error
Clinical narrative: 1 dose of IPOL was administered with highest temperature reached 46.6 F and the total excursion lasted 20 minutes  with no reported adverse event; Initial information received on 22-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of unknown demographics and 1 dose of IPV (VERO) [IPOL] was administered with highest temperature reached 46.6 f and the total excursion lasted 20 minutes  with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) Suspension for injection strength, dose: not reported lot V1B891M expiry date: 01-Jun-2024 via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious 1 dose of ipol was administered with highest temperature reached 46.6 f and the total excursion lasted 20 minutes with no reported adverse event (poor quality product administered) on the same day following the administration of IPV (VERO).  It was reported "Caller reported a temperature excursion due to a power outage that occurred on 19MAY2023. The highest temperature reached 52.3 F and the total excursion lasted 2 hours and 20 minutes. The products have not been administered since the excursion occurred on 19MAY2023. Caller noted a previous excursion on 11MAY2023. The highest temperature reached 46.6 F and the total excursion lasted 20 minutes. The caller stated that they reported this information and were told that the products were suitable for use. The IPOL was open at the time of this excursion. 1 dose of IPOL was administered after 11MAY2023 but prior to 19MAY2023. The caller did not have the patient specific information available at the time of the caller".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 1 dose of ipol was administered with highest temperature reached 46.6 f and the total excursion lasted 20 minutes  with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: Long COVID-19 symptoms
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Atrioventricular block, Death, General physical health deterioration, Myocardial infarction
Clinical narrative: he died of a heart attack due to 95 percent blockage
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute sinusitis, Blindness, Eye inflammation, Eye pain, Headache
Clinical narrative: On March 25 2022 Discomfort begins in the eye (inflammation, redness and pain). March 28, 2022 visit to the hospital emergency room at 8:00am, they stabilize him and send him by ambulance to the Hospital. He is discharged with a diagnosis of Headache and acute sinusitis. March 29, 2022 visit to ophthalmologist and sends him by ambulance to the Hospital. In the hospital he has rashes and inflammation on the nose, left eye, forehead and head by the left side. On March 29, 2022 was admitted to the Hospital to be stabilized again, studies and diagnosis in the emergency room were conducted for 7 days. April 5, 2022 he was discharged from hospital with a referral to an ophthalmologist for treatment and treat blindness due to Herpes Zoster.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Inflammation, Magnetic resonance imaging, Ocular discomfort, Ocular hyperaemia
Clinical narrative: On March 25 2022 Discomfort begins in the eye (inflammation, redness and pain). March 28, 2022 visit to the hospital emergency room at 8:00am, they stabilize him and send him by ambulance to the Hospital. He is discharged with a diagnosis of Headache and acute sinusitis. March 29, 2022 visit to ophthalmologist and sends him by ambulance to the Hospital. In the hospital he has rashes and inflammation on the nose, left eye, forehead and head by the left side. On March 29, 2022 was admitted to the Hospital to be stabilized again, studies and diagnosis in the emergency room were conducted for 7 days. April 5, 2022 he was discharged from hospital with a referral to an ophthalmologist for treatment and treat blindness due to Herpes Zoster.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, X-ray
Clinical narrative: On March 25 2022 Discomfort begins in the eye (inflammation, redness and pain). March 28, 2022 visit to the hospital emergency room at 8:00am, they stabilize him and send him by ambulance to the Hospital. He is discharged with a diagnosis of Headache and acute sinusitis. March 29, 2022 visit to ophthalmologist and sends him by ambulance to the Hospital. In the hospital he has rashes and inflammation on the nose, left eye, forehead and head by the left side. On March 29, 2022 was admitted to the Hospital to be stabilized again, studies and diagnosis in the emergency room were conducted for 7 days. April 5, 2022 he was discharged from hospital with a referral to an ophthalmologist for treatment and treat blindness due to Herpes Zoster.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Lymph node pain
Clinical narrative: Erythematous around injection site, injection site swelling and pain, painful, pectoral muscles, painful axillary lymph node, painful arm, pruritic injection site
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Erythematous around injection site, injection site swelling and pain, painful, pectoral muscles, painful axillary lymph node, painful arm, pruritic injection site
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis, Nervous system disorder, Post herpetic neuralgia, Visual impairment
Clinical narrative: facial paralysis; post herpetic neuralgia; vision problems; neurological problems; Information has been received from a lawyer regarding a case in litigation and refers to a currently approximately 66-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-JUL-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route not specified) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently (date unknown), the patient was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): post herpetic neuralgia, facial paralysis, vision problems, and neurological problems. The outcome of the events was unknown. The causality between the events and zoster vaccine live (ZOSTAVAX) was considered to be related.  Upon internal review, facial paralysis was determined to be medically significant.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Social problem
Clinical narrative: never got the 2nd shot due to the COVID Pandemic; received 1st dose via intercostal route; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JAN-2020, the patient received the 1st dose of Shingrix (intercostal, left arm). On an unknown date, the patient received the 2nd dose of Shingrix. In JAN-2020, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: received 1st dose via intercostal route). On an unknown date, the patient experienced social problem (Verbatim: never got the 2nd shot due to the COVID Pandemic). The outcome of the intramuscular formulation administered by other route and social problem were unknown.   Additional Information: GSK Receipt Date: 19-MAY-2023 The reporter was the patient. The patient received 1st dose of Shingrix over 3 years ago, probably in January 2020 (no specific date provided), and never got the 2nd shot due to the covid pandemic. The reporter consented to follow up. Due to covid pandemic, the patient never got 2nd dose of Shingrix, which led to social problem. The patient received 1st dose of Shingrix via intercostal route, which led to intramuscular formulation administered by other route.
Age: 61.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age/a 61-year-old patient received a dose of Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 61-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included asplenia.   On 17-APR-2023, the patient received the 1st dose of Bexsero. On 17-APR-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age/a 61-year-old patient received a dose of Bexsero). 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: 19-MAY-2023 The pharmacist reported that the 61 year old patient received a dose of Bexsero at inappropriate age, 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: M
Vaccine: COVID19-2
Symptoms: Back pain
Clinical narrative: it really affected their back/ He said his back pain was debilitating for 2 weeks; This spontaneous case was reported by an other health care professional and describes the occurrence of BACK PAIN (it really affected their back/ He said his back pain was debilitating for 2 weeks) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Back discomfort (Issue with back problems).    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (it really affected their back/ He said his back pain was debilitating for 2 weeks). At the time of the report, BACK PAIN (it really affected their back/ He said his back pain was debilitating for 2 weeks) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered BACK PAIN (it really affected their back/ He said his back pain was debilitating for 2 weeks) to be related.    No concomitant medication was reported.  Patient recently got the bivalent COVID booster shot and it really affected patient's back. Patient said he had gotten the booster 6 months ago before getting this bivalent shot. Patient had an issue with back problems and had been getting steroid shots in the back and had been pushing off surgery for it. But after getting the booster, patient was really considering it. Patient's back pain was debilitating for 2 weeks but reporter believed it was okay now.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Blister, Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; herpes like blisters also under arm/at bra line; pain under arm; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included losartan and evolocumab (Repatha).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 19-MAY-2023, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), vesicular rash (Verbatim: herpes like blisters also under arm/at bra line) and axillary pain (Verbatim: pain under arm). The outcome of the vaccination failure was unknown and the outcome of the shingles, vesicular rash and axillary pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, vesicular rash and axillary pain to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, vesicular rash and axillary pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 19-MAY-2023 The reporter was patient's sibling. The patient was vaccinated in 2021 with Shingrix, 2 doses administered 3-months apart. At the time of reporting, she reported her first case of shingles.  She presented with pain under arm and break out of herpes like blisters also under arm/at bra line. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Then another bivalent booster dose was administered on 8Apr2023; Caller states the pharmacist incorrectly administered a bivalent booster dose instead of a second primary series dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Caller states the pharmacist incorrectly administered a bivalent booster dose instead of a second primary series dose), EXTRA DOSE ADMINISTERED (Then another bivalent booster dose was administered on 8Apr2023) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. ASKU and 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Apr-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Caller states the pharmacist incorrectly administered a bivalent booster dose instead of a second primary series dose). On 08-Apr-2023, the patient experienced EXTRA DOSE ADMINISTERED (Then another bivalent booster dose was administered on 8Apr2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Caller states the pharmacist incorrectly administered a bivalent booster dose instead of a second primary series dose), EXTRA DOSE ADMINISTERED (Then another bivalent booster dose was administered on 8Apr2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Caller states the pharmacist incorrectly administered a bivalent booster dose instead of a second primary series dose) and EXTRA DOSE ADMINISTERED (Then another bivalent booster dose was administered on 8Apr2023).    No concomitant medications were reported.  The patient received 1st dose of Moderna vaccine on 23-Aug-2021 (lot no. 023D).  No treatment medications were reported.
Age: 65.0
Sex: U
Vaccine: COVID19-2
Symptoms: Arthralgia, Chest discomfort, Influenza, Nausea, Vaccination site pain
Clinical narrative: Had occasional chest pressure lasting 3 day; Flu-ish joint aches lasting for about 3 days.; nausea starting the day after administration and has continued.; Moderna booster on 5/15/23. was sore at site of injection.; Flu-ish joint aches lasting for about 3 days.; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Had occasional chest pressure lasting 3 day), INFLUENZA (Flu-ish joint aches lasting for about 3 days.), NAUSEA (nausea starting the day after administration and has continued), VACCINATION SITE PAIN (Moderna booster on 5/15/23. was sore at site of injection) and ARTHRALGIA (Flu-ish joint aches lasting for about 3 days) in a 65-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7180b) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First dose) on 18-Feb-2021, Moderna COVID-19 Vaccine (Second dose) on 13-Mar-2021, Moderna COVID-19 Vaccine (3rd Dose) on 07-Sep-2021 and Moderna COVID-19 Vaccine (4th Dose) on 07-Apr-2022; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (5th Booster dose) in October 2022, PFIZER BIONTECH COVID-19 VACCINE (5th Booster dose) in October 2022 and PFIZER BIONTECH COVID-19 VACCINE (5th Booster dose) in October 2022. Past adverse reactions to the above products included Injection site pain with PFIZER BIONTECH COVID-19 VACCINE; Low grade fever with PFIZER BIONTECH COVID-19 VACCINE; No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine; and Vertigo with PFIZER BIONTECH COVID-19 VACCINE.    On 15-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-May-2023, the patient experienced CHEST DISCOMFORT (Had occasional chest pressure lasting 3 day), INFLUENZA (Flu-ish joint aches lasting for about 3 days.), NAUSEA (nausea starting the day after administration and has continued.), VACCINATION SITE PAIN (Moderna booster on 5/15/23. was sore at site of injection.) and ARTHRALGIA (Flu-ish joint aches lasting for about 3 days.). In May 2023, CHEST DISCOMFORT (Had occasional chest pressure lasting 3 day), INFLUENZA (Flu-ish joint aches lasting for about 3 days) and ARTHRALGIA (Flu-ish joint aches lasting for about 3 days) had resolved. At the time of the report, NAUSEA (nausea starting the day after administration and has continued) had not resolved and VACCINATION SITE PAIN (Moderna booster on 5/15/23. was sore at site of injection) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.
Age: 3.0
Sex: U
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: accidentally given an additional Pentacel with Prevnar at 3 years of age with no reported adverse event; Initial information received on 22-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3 years old and unknown gender patient who was accidentally given an additional diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] with prevnar with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   Concomitant medications included pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination (immunization).  On 22-May-2023, the patient accidentally received an extra dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (batch number and expiry date unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (immunization) along with prevnar with no reported adverse event (extra dose administered) (same day latency).  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event accidentally given an additional pentacel with prevnar at 3 years of age with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Neuralgia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Nerve pain from injection site down arm stopping below elbow-Medium, Additional Details: Patient had shingles back in 1997 with the type of nerve pain described above. Patient also had a dose of Zostavax when it was on the market, but date given was unknown. The first of the series of Shingrix on 10-12-2022 produced no side effects like she described here on the second of the series. Patient was given a 7 day course of Valacyclovir by her primary care doctor on 5-11-2023
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOXIA 2/14/2022 -- RECURRENCE OF SAME SYMPTOMS
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ALLERGIC REACTION, INIT
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA
Age: 51.0
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired medication   Re-given with unexpired medication
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 -- RECURRENCE OF SAME SYMPTOMS
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Fatigue, Head injury, Laboratory test
Clinical narrative: Fatigue, Dizziness, Nausea, Large area of swollen red hot 4" under vaccine sight
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Fatigue, Dizziness, Nausea, Large area of swollen red hot 4" under vaccine sight
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Embolic stroke
Clinical narrative: ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CRYPTOGENIC STROKE
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Chest X-ray abnormal, Malaise, Oropharyngeal pain, Productive cough
Clinical narrative: 10/1/2022 I had a sore throat, coughing, spitting clear mucous and was diagnosed with acute Bronchitis. I started an antibiotic and prednisone. I was sick for the entire month of October. Since then, I have been sick two more times with the same symptoms. I was prescribed antibiotics and prednisone for both times. The first night after starting these medications, I wake up soaking wet. Since the 4th vaccination, I have been sick with these symptoms every other month. On 5/22/23 I had a sore throat, nonstop coughing, spitting clear mucous at first then turned yellow. I went to the doctor yesterday. I was tested for Strep. The rapid test was negative, but am still waiting for the results of the one sent off. I was prescribed antibiotics and prednisone.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Sputum discoloured, Streptococcus test negative
Clinical narrative: 10/1/2022 I had a sore throat, coughing, spitting clear mucous and was diagnosed with acute Bronchitis. I started an antibiotic and prednisone. I was sick for the entire month of October. Since then, I have been sick two more times with the same symptoms. I was prescribed antibiotics and prednisone for both times. The first night after starting these medications, I wake up soaking wet. Since the 4th vaccination, I have been sick with these symptoms every other month. On 5/22/23 I had a sore throat, nonstop coughing, spitting clear mucous at first then turned yellow. I went to the doctor yesterday. I was tested for Strep. The rapid test was negative, but am still waiting for the results of the one sent off. I was prescribed antibiotics and prednisone.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Facial paresis, Hemiparesis
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY RIGHT FACIAL MUSCLE WEAKNESS
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Bursitis, Immediate post-injection reaction, Magnetic resonance imaging, Pain, Periarthritis
Clinical narrative: Shot placed way too high on shoulder, not in the muscle. Immediate pain that got worse over the next 24 hours and beyond.  Bursitis and adhesive capsulitis. Cortisone shots provide some relief. Still experiencing symptoms
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Product administered at inappropriate site, X-ray
Clinical narrative: Shot placed way too high on shoulder, not in the muscle. Immediate pain that got worse over the next 24 hours and beyond.  Bursitis and adhesive capsulitis. Cortisone shots provide some relief. Still experiencing symptoms
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: ANGINA, UNSPECIFIED
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Lip swelling, Pain, Pyrexia, Skin discolouration
Clinical narrative: Patient had initial vaccine with lip swelling and purple coloring (did not witness this). With 3rd vaccine, had fever to 102, headache, bodyaches and vomiting 2 hours after vaccine and into 48th hour.
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Patient had initial vaccine with lip swelling and purple coloring (did not witness this). With 3rd vaccine, had fever to 102, headache, bodyaches and vomiting 2 hours after vaccine and into 48th hour.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood sodium decreased, Blood test abnormal, Body temperature increased, Chest X-ray abnormal, Cough
Clinical narrative: 5/16/23  I started with congestion and cough. It got really bad during the night. I woke up the next day and had a headache, coughing a lot and some congestion. Every day it progressively got worse.  On 5/19/23 I was coughing up dark red phlegm. I went to the doctor and was referred to the emergency room because I had a urine test which showed a high level of keystones.  At the emergency room, they did blood work, chest x-Ray and EKG. I had a temperature of 102.7. Bloodwork was abnormal, main issue was low sodium.  I was diagnosed with a nonspecific upper respiratory infection, Ketosis, UTI, tachycardia and sepsis. I had starvation ketones because I had not eaten in 3 days.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram abnormal, Headache, Ketosis, Productive cough, Respiratory tract congestion
Clinical narrative: 5/16/23  I started with congestion and cough. It got really bad during the night. I woke up the next day and had a headache, coughing a lot and some congestion. Every day it progressively got worse.  On 5/19/23 I was coughing up dark red phlegm. I went to the doctor and was referred to the emergency room because I had a urine test which showed a high level of keystones.  At the emergency room, they did blood work, chest x-Ray and EKG. I had a temperature of 102.7. Bloodwork was abnormal, main issue was low sodium.  I was diagnosed with a nonspecific upper respiratory infection, Ketosis, UTI, tachycardia and sepsis. I had starvation ketones because I had not eaten in 3 days.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sepsis, Sputum discoloured, Starvation ketoacidosis, Tachycardia, Upper respiratory tract infection
Clinical narrative: 5/16/23  I started with congestion and cough. It got really bad during the night. I woke up the next day and had a headache, coughing a lot and some congestion. Every day it progressively got worse.  On 5/19/23 I was coughing up dark red phlegm. I went to the doctor and was referred to the emergency room because I had a urine test which showed a high level of keystones.  At the emergency room, they did blood work, chest x-Ray and EKG. I had a temperature of 102.7. Bloodwork was abnormal, main issue was low sodium.  I was diagnosed with a nonspecific upper respiratory infection, Ketosis, UTI, tachycardia and sepsis. I had starvation ketones because I had not eaten in 3 days.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urinary tract infection, Urine analysis abnormal, Urine ketone body present
Clinical narrative: 5/16/23  I started with congestion and cough. It got really bad during the night. I woke up the next day and had a headache, coughing a lot and some congestion. Every day it progressively got worse.  On 5/19/23 I was coughing up dark red phlegm. I went to the doctor and was referred to the emergency room because I had a urine test which showed a high level of keystones.  At the emergency room, they did blood work, chest x-Ray and EKG. I had a temperature of 102.7. Bloodwork was abnormal, main issue was low sodium.  I was diagnosed with a nonspecific upper respiratory infection, Ketosis, UTI, tachycardia and sepsis. I had starvation ketones because I had not eaten in 3 days.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI 6/16/2022,  1/14/2023,  1/10/2023  --  RECURRENCE OF SAME SYMPTOMS
Age: 18.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Blindness, Blood glucose, Blood magnesium, Differential white blood cell count, Dizziness
Clinical narrative: light headed, vision went out and syncope
Age: 18.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Echocardiogram, Electrocardiogram, Full blood count, Metabolic function test, Syncope
Clinical narrative: light headed, vision went out and syncope
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccine was administered on 5/12 in the right deltoid muscle. Pt reports that on 5/15 she had a large bump at the vaccine site that was slightly red and warm to touch. On 5/18 Pt reports that the bump decreased in size and the redness increased. On 5/19 Pt presented to clinic with a red, warm to touch area 2.5 in X 2.0 in at the injection site. At the center of the area was a white circular area, 0.5 in diameter, that was a hard bump with palpation. Pt denied any pain at the injection site and stated "it is more itchy that painful". The red area was outlined in pen. Per the Pt the redness did not go outside on the pen outline. On 5/23 the Pt presented to the clinic for a another recheck. The injection site was no longer red, with palpation the bump decreased in size to approximately 0.4 mm.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Infection, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: I experienced a breakthrough case of COVID-19 with sore throat, runny nose and coughing.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I experienced a breakthrough case of COVID-19 with sore throat, runny nose and coughing.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Obstructive sleep apnoea syndrome, Respiratory failure
Clinical narrative: OBSTRUCTIVE SLEEP APNEA CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Gout, Injection site pain, Joint swelling, Pain
Clinical narrative: After I took the shot, the sec dose in my right arm, May 17,2023, the morning of,  there was a little soreness where the shot was injected, but other than that there was nothing. The next morning, around 7 or 8 am, I still had the soreness in my right arm, and then I noticed the swelling of my right hand, it was painful for me to rotate my hand inward and outward. Not only was my hand swollen, but my wrist was swollen as well. At that point, I called my pcp and requested the prescription I normally take for gout. It was forward to my pharmacies and I went and picked it up. It was the normal medication my pcp gives me when I have a flare up of my gout, Methylerednisolone (4mg tablet). I took 2 doses of that, first day and the second day. It didnt have any effect of the condition of my right hand. So that is what prompt me to do a report. I am sitting here now in pain, and cannot use my hand. I have made contact with my pcp about my condition. I had a virtual appointment.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: After I took the shot, the sec dose in my right arm, May 17,2023, the morning of,  there was a little soreness where the shot was injected, but other than that there was nothing. The next morning, around 7 or 8 am, I still had the soreness in my right arm, and then I noticed the swelling of my right hand, it was painful for me to rotate my hand inward and outward. Not only was my hand swollen, but my wrist was swollen as well. At that point, I called my pcp and requested the prescription I normally take for gout. It was forward to my pharmacies and I went and picked it up. It was the normal medication my pcp gives me when I have a flare up of my gout, Methylerednisolone (4mg tablet). I took 2 doses of that, first day and the second day. It didnt have any effect of the condition of my right hand. So that is what prompt me to do a report. I am sitting here now in pain, and cannot use my hand. I have made contact with my pcp about my condition. I had a virtual appointment.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE PERIPHERAL NEUROPATHY
Age: 40.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reactions dDtap given insted of Tdap
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: I had a sore throat, runny nose, cough, I had been exposed to COVID-19. I went in the pharmacy to have a PCR COVID-19 test that did come back positive. I will be letting my Primary Care Physician know later today, if I am available to take the Paxlovid I will take it.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a sore throat, runny nose, cough, I had been exposed to COVID-19. I went in the pharmacy to have a PCR COVID-19 test that did come back positive. I will be letting my Primary Care Physician know later today, if I am available to take the Paxlovid I will take it.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Cardiac failure congestive, Cardiogenic shock, Condition aggravated
Clinical narrative: ACUTE NON ST ELEVATION MI 1/17/2023 CHF EXACERBATION, UNSPECIFIED ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 1/7/2023 CHF EXACERBATION, UNSPECIFIED ACUTE RESPIRATORY FAILURE 1/17/2023 CHF EXACERBATION, UNSPECIFIED CARDIOGENIC SHOCK 1/31/2023 CHF EXACERBATION, UNSPECIFIED ACUTE NON ST ELEVATION MI 1/17/2023 HX OF NON ST ELEVATION MI  ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 1/7/2023 HX OF NON ST ELEVATION MI ACUTE RESPIRATORY FAILURE 1/17/2023 HX OF NON ST ELEVATION MI CARDIOGENIC SHOCK 1/31/2023 HX OF NON ST ELEVATION MI
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Sleep apnoea syndrome, Symptom recurrence
Clinical narrative: SLEEP APNEA NEUROPATHY 2/26/2022  --  RECURRENCE OF SAME SYMPTOMS
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Communication disorder, Herpes zoster, Herpes zoster meningoencephalitis, Lumbar puncture abnormal, Nausea
Clinical narrative: On 04/10/2023, I had a respiratory infection  and on 04/13/2023 I developed a Shingles rash. On 04/16/2023, I developed a high fever, extreme pain and nausea. I had a tele visit and was diagnosed with Shingles. I was prescribed an anti-viral.  I went to urgent care for pain medication. Fever and pain continued and I began to not be able to communicate well.  I went to the urgent care and was diagnosed with VZV Encephalitis. I was started on IV Antivirals and was admitted to the hospital. I was dismissed on 04/21/2023. I am still recovering from Shingles.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiratory tract infection
Clinical narrative: On 04/10/2023, I had a respiratory infection  and on 04/13/2023 I developed a Shingles rash. On 04/16/2023, I developed a high fever, extreme pain and nausea. I had a tele visit and was diagnosed with Shingles. I was prescribed an anti-viral.  I went to urgent care for pain medication. Fever and pain continued and I began to not be able to communicate well.  I went to the urgent care and was diagnosed with VZV Encephalitis. I was started on IV Antivirals and was admitted to the hospital. I was dismissed on 04/21/2023. I am still recovering from Shingles.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiogenic shock
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/22/2023 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 2/27/2023 CARDIOGENIC SHOCK
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: My symptoms were like a very bad cold.  The outcome is that symptoms resolved after three or four days.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aortic aneurysm, Asthenia, Chronic respiratory failure, Coagulopathy
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/14/2021 WEAKNESS I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 12/31/2022 WEAKNESS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/5/2022 WEAKNESS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 WEAKNESS D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/14/2021 ABDOMINAL AORTIC ANEURYSM >=5.5 CM W HX OF ENDOVASCULAR REPAIR I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 12/31/2022 ABDOMINAL AORTIC ANEURYSM >=5.5 CM W HX OF ENDOVASCULAR REPAIR J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/5/2022 ABDOMINAL AORTIC ANEURYSM >=5.5 CM W HX OF ENDOVASCULAR REPAIR J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 ABDOMINAL AORTIC ANEURYSM >=5.5 CM W HX OF ENDOVASCULAR REPAIR
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Respiratory failure
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/14/2021 WEAKNESS I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 12/31/2022 WEAKNESS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/5/2022 WEAKNESS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 WEAKNESS D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/14/2021 ABDOMINAL AORTIC ANEURYSM >=5.5 CM W HX OF ENDOVASCULAR REPAIR I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 12/31/2022 ABDOMINAL AORTIC ANEURYSM >=5.5 CM W HX OF ENDOVASCULAR REPAIR J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/5/2022 ABDOMINAL AORTIC ANEURYSM >=5.5 CM W HX OF ENDOVASCULAR REPAIR J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 ABDOMINAL AORTIC ANEURYSM >=5.5 CM W HX OF ENDOVASCULAR REPAIR
Age: 0.5
Sex: F
Vaccine: COVID19-2, DTAPHEPBIP, PNC13, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong vaccine given, no adverse event.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ANGIOEDEMA, INIT
Age: 1.25
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient have the high fever (104 F) Arm pains for 2 weeks