chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Serum ferritin, Troponin I, Ultrasound Doppler, Urine analysis, Vitamin B12
Clinical narrative: Acute deep vein thrombosis
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Discomfort, Facial discomfort, Facial pain, Full blood count
Clinical narrative: Pt. received TB skin test placement (1st stept) then the  TDaP .5ml vaccine 5/28/2024 (booster) at approx. 2:30pm in left deltoid IM (to update vaccination status for nursing school/college).  Pt. reports morning of  5/30/2024 onset of numbness of left side of her tongue,  nausea, and non-productive cough,  Then later in the day numbness of lips (from midline to pts. left only)upper and lower, and left cheek area.  Pt. advised she had a headache on the left side of her head and neck which started the morning of 5/28/2024 before she received the vaccine (although pt. denied any symptoms at time of visit 5/28/2024).  H/A described as tension type and usual for this pt.  Late afternoon 5/28/2024, pt. reported onset of left side of nose "stuffy", Pt. took a dose of OtC benadryl with no relief of symptoms,  and on Friday, 5/31/2024 her throat "felt swollen".  Pt. denied any difficulty swallowing.  On 6/1/2024, left forehead and eye discomfort/cheek pain.  Took ibuprofen OTC x 1 dose 5/31/2024 and 6/1/2024 x 1 dose, with no relief of symptoms.  Denied any fever, chills, rashes, itching, SOB, tongue and/or facial/lip swelling, emesis, weakness, gait disturbance, visual disturbance, severe headache, etc.   V/S  were wnl in clinic on 5/28/2024 and 6/3/2024 when pt. came in for evaluation of possible adverse vaccine reaction.    In clinic on 6/3/2024 pt. with normal neuro exam, normal physical exam except for physical exam findings of acute left maxillary sinusitis.  Pt. advised that her left cheek and under left eye were uncomfortable, and when she leaned her head forward, she felt pressure.  She was tender on palpation.  No facial asymmetry, no tongue lag, no eyelid, facial, and/or lip droop, no meningismus, no fever,  no lymphadenopathy, no cough, no gait disturbance,  Mild hyperemia of throat without exudate, uvula midline.  collaborative physician was notified.  Pt. treated with Amoxicillin/Clavulanate 875/125mg tab Q 12 hrs x 10 days, mucinex 1200mg tab po BID prn for 5 days.  Pt. to RTC if symptoms not improving with medications, or if symptoms change or worsen.  Blood for CBC was drawn and sent to reference lab, results still pending 6/4/2024.  Pt. came in for second step TB skin test 6/5/2024 and without fever, or other complaints.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Head discomfort, Headache, Hyperaemia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Pt. received TB skin test placement (1st stept) then the  TDaP .5ml vaccine 5/28/2024 (booster) at approx. 2:30pm in left deltoid IM (to update vaccination status for nursing school/college).  Pt. reports morning of  5/30/2024 onset of numbness of left side of her tongue,  nausea, and non-productive cough,  Then later in the day numbness of lips (from midline to pts. left only)upper and lower, and left cheek area.  Pt. advised she had a headache on the left side of her head and neck which started the morning of 5/28/2024 before she received the vaccine (although pt. denied any symptoms at time of visit 5/28/2024).  H/A described as tension type and usual for this pt.  Late afternoon 5/28/2024, pt. reported onset of left side of nose "stuffy", Pt. took a dose of OtC benadryl with no relief of symptoms,  and on Friday, 5/31/2024 her throat "felt swollen".  Pt. denied any difficulty swallowing.  On 6/1/2024, left forehead and eye discomfort/cheek pain.  Took ibuprofen OTC x 1 dose 5/31/2024 and 6/1/2024 x 1 dose, with no relief of symptoms.  Denied any fever, chills, rashes, itching, SOB, tongue and/or facial/lip swelling, emesis, weakness, gait disturbance, visual disturbance, severe headache, etc.   V/S  were wnl in clinic on 5/28/2024 and 6/3/2024 when pt. came in for evaluation of possible adverse vaccine reaction.    In clinic on 6/3/2024 pt. with normal neuro exam, normal physical exam except for physical exam findings of acute left maxillary sinusitis.  Pt. advised that her left cheek and under left eye were uncomfortable, and when she leaned her head forward, she felt pressure.  She was tender on palpation.  No facial asymmetry, no tongue lag, no eyelid, facial, and/or lip droop, no meningismus, no fever,  no lymphadenopathy, no cough, no gait disturbance,  Mild hyperemia of throat without exudate, uvula midline.  collaborative physician was notified.  Pt. treated with Amoxicillin/Clavulanate 875/125mg tab Q 12 hrs x 10 days, mucinex 1200mg tab po BID prn for 5 days.  Pt. to RTC if symptoms not improving with medications, or if symptoms change or worsen.  Blood for CBC was drawn and sent to reference lab, results still pending 6/4/2024.  Pt. came in for second step TB skin test 6/5/2024 and without fever, or other complaints.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Mycobacterium tuberculosis complex test, Nasal congestion, Nausea, Neck pain, Ocular discomfort
Clinical narrative: Pt. received TB skin test placement (1st stept) then the  TDaP .5ml vaccine 5/28/2024 (booster) at approx. 2:30pm in left deltoid IM (to update vaccination status for nursing school/college).  Pt. reports morning of  5/30/2024 onset of numbness of left side of her tongue,  nausea, and non-productive cough,  Then later in the day numbness of lips (from midline to pts. left only)upper and lower, and left cheek area.  Pt. advised she had a headache on the left side of her head and neck which started the morning of 5/28/2024 before she received the vaccine (although pt. denied any symptoms at time of visit 5/28/2024).  H/A described as tension type and usual for this pt.  Late afternoon 5/28/2024, pt. reported onset of left side of nose "stuffy", Pt. took a dose of OtC benadryl with no relief of symptoms,  and on Friday, 5/31/2024 her throat "felt swollen".  Pt. denied any difficulty swallowing.  On 6/1/2024, left forehead and eye discomfort/cheek pain.  Took ibuprofen OTC x 1 dose 5/31/2024 and 6/1/2024 x 1 dose, with no relief of symptoms.  Denied any fever, chills, rashes, itching, SOB, tongue and/or facial/lip swelling, emesis, weakness, gait disturbance, visual disturbance, severe headache, etc.   V/S  were wnl in clinic on 5/28/2024 and 6/3/2024 when pt. came in for evaluation of possible adverse vaccine reaction.    In clinic on 6/3/2024 pt. with normal neuro exam, normal physical exam except for physical exam findings of acute left maxillary sinusitis.  Pt. advised that her left cheek and under left eye were uncomfortable, and when she leaned her head forward, she felt pressure.  She was tender on palpation.  No facial asymmetry, no tongue lag, no eyelid, facial, and/or lip droop, no meningismus, no fever,  no lymphadenopathy, no cough, no gait disturbance,  Mild hyperemia of throat without exudate, uvula midline.  collaborative physician was notified.  Pt. treated with Amoxicillin/Clavulanate 875/125mg tab Q 12 hrs x 10 days, mucinex 1200mg tab po BID prn for 5 days.  Pt. to RTC if symptoms not improving with medications, or if symptoms change or worsen.  Blood for CBC was drawn and sent to reference lab, results still pending 6/4/2024.  Pt. came in for second step TB skin test 6/5/2024 and without fever, or other complaints.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness, Tension headache, Throat tightness
Clinical narrative: Pt. received TB skin test placement (1st stept) then the  TDaP .5ml vaccine 5/28/2024 (booster) at approx. 2:30pm in left deltoid IM (to update vaccination status for nursing school/college).  Pt. reports morning of  5/30/2024 onset of numbness of left side of her tongue,  nausea, and non-productive cough,  Then later in the day numbness of lips (from midline to pts. left only)upper and lower, and left cheek area.  Pt. advised she had a headache on the left side of her head and neck which started the morning of 5/28/2024 before she received the vaccine (although pt. denied any symptoms at time of visit 5/28/2024).  H/A described as tension type and usual for this pt.  Late afternoon 5/28/2024, pt. reported onset of left side of nose "stuffy", Pt. took a dose of OtC benadryl with no relief of symptoms,  and on Friday, 5/31/2024 her throat "felt swollen".  Pt. denied any difficulty swallowing.  On 6/1/2024, left forehead and eye discomfort/cheek pain.  Took ibuprofen OTC x 1 dose 5/31/2024 and 6/1/2024 x 1 dose, with no relief of symptoms.  Denied any fever, chills, rashes, itching, SOB, tongue and/or facial/lip swelling, emesis, weakness, gait disturbance, visual disturbance, severe headache, etc.   V/S  were wnl in clinic on 5/28/2024 and 6/3/2024 when pt. came in for evaluation of possible adverse vaccine reaction.    In clinic on 6/3/2024 pt. with normal neuro exam, normal physical exam except for physical exam findings of acute left maxillary sinusitis.  Pt. advised that her left cheek and under left eye were uncomfortable, and when she leaned her head forward, she felt pressure.  She was tender on palpation.  No facial asymmetry, no tongue lag, no eyelid, facial, and/or lip droop, no meningismus, no fever,  no lymphadenopathy, no cough, no gait disturbance,  Mild hyperemia of throat without exudate, uvula midline.  collaborative physician was notified.  Pt. treated with Amoxicillin/Clavulanate 875/125mg tab Q 12 hrs x 10 days, mucinex 1200mg tab po BID prn for 5 days.  Pt. to RTC if symptoms not improving with medications, or if symptoms change or worsen.  Blood for CBC was drawn and sent to reference lab, results still pending 6/4/2024.  Pt. came in for second step TB skin test 6/5/2024 and without fever, or other complaints.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; Product shipment delay; This spontaneous report was received from a healthcare worker, referring to a 12-month-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) (lot# X022479 has been verified to be a valid lot number, expiration date was not reported but upon internal validation established as 23-JAN-2026), hepatitis a vaccine (+) inactivated (VAQTA) (lot# X025482 has been verified to be a valid lot number, expiration date was not reported but upon internal validation established as 12-APR-2025).  Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was ordered on 28-FEB-2024. The vaccine was received late due to shipping issue. The shipment was supposed to be received by the office on or before 02-MAR-2024, but shipment was delayed during transmit for an additional 6 days and received in clinic 08-MAR-2024 (Product distribution issue). The vaccine was mistaken put into clinic stock.  On 21-MAR-2024, the patient was vaccinated inadvertently with possibly improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #X023876 has been verified to be a valid lot number, expiration date was reported and validated as 27-MAR-2025, administered subcutaneously on the left thigh for prophylaxis (strength and dose were not provided) (Product storage error). It was unable to confirm the temperature for those additional days. The patient was notified and scheduled for a repeat dose as per the agency recommendations after contacting the manufacturer. No adverse reactions were reported with initial dose or report dose (no adverse event).
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product distribution issue
Clinical narrative: No adverse event; the patient was vaccinated inadvertently with possibly improperly stored dose; shipment was delayed during transmit; This spontaneous report was received from a healthcare worker, referring to a 4-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included Concomitant therapies included diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (lot# U7908AA, route: intramuscular, site: left thigh).  Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was ordered on 28-FEB-2024. The vaccine was received late due to shipping issue. The shipment was supposed to be received by the office on or before 02-MAR-2024, but shipment was delayed during transmit for an additional 6 days and received in clinic on 08-MAR-2024 (Product distribution issue). The vaccine was mistaken put into clinic stock.  On 19-MAR-2024, the patient was vaccinated inadvertently with possibly improperly stored dose of the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #X023876 has been verified to be a valid lot number, expiration date was reported and validated as 27-MAR-2025, administered subcutaneously on the right thigh for prophylaxis (strength and dose were not provided) (Product storage error). It was unable to confirm the temperature for those additional days. The patient was notified and scheduled for a repeat dose as per the agency recommendations after contacting the manufacturer. No adverse reactions were reported with initial dose or report dose (no adverse event).
Age: 1.08
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other AE; Medical assistant reported an AE for VARIVAX and PROQUAD. The caller said there were two 13 month old patients that received VARIVAX and PROQUAD on the same day, 5/7/2024; This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-MAY-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #x025846, expiration date reported as and upon internal review confirmed as: 31-OCT-2025 (dose, route of administration and vaccination site were not provided) administered for prophylaxis, and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #x024913, expiration date reported as and upon internal review confirmed as: 14-APR-2025 (dose, route of administration and vaccination site were not provided) administered for prophylaxis.  On that day, it was reported that two 13 month old patients received varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) on the same day (accidental overdose). The reported said the two patients are twins. The caller said each patient received the same lot number of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD (other twin captured in # 2405USA008799). It was confirmed that no other adverse event (AE) occurred (no adverse event). No further information was provided. No product quality complaint (PQC) was noted.  This is one of two reports concerning one of two twins, recivied from the same reporter.; Sender's Comments:  US-009507513-2405USA008799:
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: diagnosed with Varicella virus; This spontaneous report was received from a nurse refers to a child patient of unknown exact age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 13-MAY-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # x026320, expiration date reported as and upon internal review confirmed as: 07-NOV-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.  On 23-MAY-2024 (also reported as: 10 days later), the patient returned to the office and was diagnosed with Varicella virus. No additional symptoms or side effects were reported. No additional adverse event (AE) and no product quality complaint (PQC) was noted. No additional information was reported. The outcome of varicella was not provided.  The causal relationship between varicella and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2405USA007994:
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE; 8 year old patient was inadvertently administered a dose of GARDASIL 9; This spontaneous report was received from an Other Health Professional and referred to an 8-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 25-MAY-2024 (conflict information, also reported as 52-MAY-2024), the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, injection, 0.5 milliliter, two or three dose series, administered for prophylaxis (lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). Nurse confirmed the patient did not report any medical concerns or symptoms due to the inadvertent administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to the 8 years old patient. No additional information provided regarding this adverse event.
Age: 1.08
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other AE; Medical assistant reported an AE for VARIVAX and PROQUAD. The caller said there were two 13 month old patients that received VARIVAX and PROQUAD on the same day, 5/7/2024; This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-MAY-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #x025846, expiration date reported as and upon internal review confirmed as: 31-OCT-2025 (dose, route of administration and vaccination site were not provided) administered for prophylaxis, and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #x024913, expiration date reported as and upon internal review confirmed as: 14-APR-2025 (dose, route of administration and vaccination site were not provided) administered for prophylaxis.  On that day, it was reported that two 13-month-old patients received varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) on the same day (accidental overdose). The reported said the two patients were twins. The caller said each patient received the same lot number of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD (other twin captured in MARRS # 2405USA007942). It was confirmed that no other adverse event (AE) occurred (no adverse event). No further information was provided. No product quality complaint (PQC) was noted.  This is one of two reports concerning one of two twins, received from the same reporter.; Sender's Comments:  US-009507513-2405USA007942:
Age: 1.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report T/E case for VAXNEUVANCE (PFS). VAXNEUVANCE was administered; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 29-FEB-2024, the vaccine pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) had a temperature excursion of 53.0F for 4 hours 30 minutes 0 seconds. The call was not because of a data logger. There was no previous temperature excursion.   On 05-MAR-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection  (lot #X022475 has been verified to be a valid lot number, expiration date: 23-JAN-2026) for prophylaxis (dose, strength, and route of administration were not provided) (product storage error). No additional adverse event was reported (no adverse event).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2405USA009558: US-009507513-2405USA009564: US-009507513-2405USA010079:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient had received an expired dose of PROQUAD; This spontaneous report was received from an Other Health Professional and referred to a 4-year-old female patient.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 28-MAY-2024, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD), 0.5 milliliter injection, 0.5 milliliter, lot #X006560, expiration date: 07-APR-2024, administered for prophylaxis (route of administration was not provided) (Expired product administered). No additional AE.
Sex: U
Vaccine: RVX
Symptoms: Cough, Illness
Clinical narrative: Sick; bad cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, 1 week after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sick) and cough (Verbatim: bad cough). The outcome of the sickness and cough were not resolved.   It was unknown if the reporter considered the sickness and cough to be related to RSV vaccine.     It was unknown if the company considered the sickness and cough to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 24-MAY-2024 The case was received from the patient via interactive digital media. The patient self-reported this case for himself. A week after taking the vaccine, the reporter got sick with a bad cough and it lasted 4 weeks (November).  The reporter reported, since the middle of April the reporter was sick again with another bad cough.  Both times the reporter had to go to Urgent Care.  The reporter reported that he/she was sorry that he/she took this vaccine
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number M7YY5, expiry date 12-AUG-2025) for prophylaxis.   On 23-MAY-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 24-MAY-2024 The reporter stated that a patient received Boostrix vaccine after experiencing a temperature excursion which was above 9 degree Celsius (13.0 degree Celsius) for twelve hours thirty minutes on 22nd and 23rd May, which led to incorrect storage of drug. The reporter confirmed that patient had not reported any additional adverse event since dose was administered. No further information available currently. No product quality complaint or additional adverse event reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed getting the second vaccination by six months from; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missed getting the second vaccination by six months from). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2024 The patient missed getting the second vaccination by six months from the first one, almost three months late.  The patient enquired should he/she go ahead and get the second one at the time of reporting and also enquired how being late getting the second one affect the immunity to shingles. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: an MMR and it was expiry; 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 1-year-old female patient who received MMR (Priorix) (batch number CB979, expiry date 13-MAY-2024) for prophylaxis.   On 20-MAY-2024, the patient received the 1st dose of Priorix. On 20-MAY-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: an MMR and it was expiry). 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: 23-MAY-2024 The reporter reported that they gave an MMR to patient, and it was expiry which led to expired vaccine used.  The reporter needed to know what to do.  The vaccine administration facility was the same as primary reporter. During the call, the caller confirmed that the MMR vaccines was the Priorix vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: soreness of the arm; numbness on the affected arm; weakness on the affected arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: soreness of the arm), numbness of upper extremities (Verbatim: numbness on the affected arm) and weakness of arms (Verbatim: weakness on the affected arm). The outcome of the pain in arm, numbness of upper extremities and weakness of arms were unknown.   It was unknown if the reporter considered the pain in arm, numbness of upper extremities and weakness of arms to be related to Shingrix.     It was unknown if the company considered the pain in arm, numbness of upper extremities and weakness of arms to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAY-2024 The patient self-reported this case for himself. The reporter reported that, after receiving the 2nd shot of Shingrix he was experiencing soreness of the arm, numbness on the affected arm, and weakness on the affected arm.  The reporter did not consented to follow up.
Age: 71.0
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Maladministration of Boostrix after the expiration date; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 71-year-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594, expiry date 18-JAN-2024) for prophylaxis.   On 21-FEB-2024, the patient received the 1st dose of Boostrix. On 21-FEB-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Maladministration of Boostrix after the expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2024 The pharmacist reported that the immunocompetent patient who received one dose of expired Boostrix vaccine, which led to expired vaccine used. The reporter declined to had a medical information account. This case was linked with US2024064938, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2024064938:Same reporter/Diffrent patient
Age: 72.0
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: who received Boostrix one dose on 2/21/2024 but the expiration date was 1/18/2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594, expiry date 18-JAN-2024) for prophylaxis.   On 21-FEB-2024, the patient received the 1st dose of Boostrix. On 21-FEB-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: who received Boostrix one dose on 2/21/2024 but the expiration date was 1/18/2024). 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: 24-MAY-2024 The reporter was Pharmacist. The reporter had 72 years old immunocompetent patient, who received Boostrix one dose on 21st February 2024 but the expiration date was 18th January 2024 which led to expired vaccine used. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2024064942:Same reporter/Diffrent patient
Sex: U
Vaccine: VARZOS
Symptoms: Dehydration, Erythema, Flushing
Clinical narrative: left arm was erythematous; dehydrated; face flush; This non-serious case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2024, the patient received the 1st dose of Shingrix (left arm). In MAY-2024, less than a week after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: left arm was erythematous), dehydration (Verbatim: dehydrated) and facial flushing (Verbatim: face flush). The outcome of the erythema of extremities, dehydration and facial flushing were unknown.   It was unknown if the reporter considered the erythema of extremities, dehydration and facial flushing to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, dehydration and facial flushing to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAY-2024 The nurse reported patient received a first dose of Shingrix 1 or 2 days ago and after the dose patient's left arm was erythematous, face was flush and was dehydrated.  The reporter did not consent to follow-up. This case is linked with US2024064945 for same reporter.; Sender's Comments:  US-GSK-US2024064945:Same reporter
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: he developed shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles outbreak once before, about 20 years ago).   In DEC-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). In JAN-2024, 1 month after receiving Shingrix, the patient experienced shingles (Verbatim: he developed shingles). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 31-MAY-2024 The reporter was the patient.  He received his first Shingrix dose and about one month later, he developed shingles.  He had a history of a shingles outbreak once before, about 20 years ago.  He had not yet received his second Shingrix dose.  Nothing else was reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Underdose
Clinical narrative: child got only partial dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number KX3LM, expiry date 31-JUL-2025) for prophylaxis.   On 31-MAY-2024, the patient received the 1st dose of Menveo. On 31-MAY-2024, an unknown time after receiving Menveo, the patient experienced accidental underdose (Verbatim: child got only partial dose). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 31-MAY-2024 The patient was administered menveo and the child only got a partial dose which led to accidental underdose. When the nurse started to administer, the kid pulled and the needle came out of his arm and the rest went on the table.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: CHF; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "CHF". Therapeutic measures were taken as a result of cardiac failure congestive.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.
Age: 0.33
Sex: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was supposed to receive pentacel yesterday, but the patient was given a different infanrix vaccine with no reported adverse event; Initial information received on 29-May-2024 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 4 months old male patient where patient was supposed to receive diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] yesterday, but the patient was given a different Infanrix vaccine 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 pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) and rotavirus vaccine for Prophylactic vaccination.  On 28-May-2024, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported via intramuscular route in right leg (strength, lot/batch number and expiration date: not provided) for Immunisation and dose of suspect Infanrix not produced by Sanofi Pasteur lot Z53J4 via intramuscular route in unknown administration site (formulation, strength and expiration date: not provided) for Immunisation (wrong product administered) (latency- same day).  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: M
Vaccine: RSV
Symptoms: Injection site discharge, Scar, Underdose
Clinical narrative: not all of the dose was administered to the patient due to the scar tissue in the injection site and content of the vaccine leaked out; not all of the dose was administered to the patient due to the scar tissue in the injection site and content of the vaccine leaked out; not all of the dose was administered to the patient due to the scar tissue in the injection site and content of the vaccine leaked out; This is a spontaneous report received from a Pharmacist from medical information team, Program ID.  A 71-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), VACCINATION SITE DISCHARGE (non-serious), UNDERDOSE (non-serious), outcome "unknown" and all described as "not all of the dose was administered to the patient due to the scar tissue in the injection site and content of the vaccine leaked out".  Additional information: A pharmacist, mentioned about administering the Abrysvo to a patient but only part of the dose was received because the patient body went through scar tissue and it did not go all the way in. The pharmacist wanted to know if they need to repeat the dose or not because they didn't know how much the patient received. The reporter informed that it was confirmed that not all of the dose was administered to the patient due to the scar tissue in the injection site and content of the vaccine leaked out.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Device breakage, Injury associated with device, Occupational exposure to product
Clinical narrative: Nurse got a needle stick after administering vaccine; Vaccine broke in half; This is a spontaneous report received from a Nurse from a sales representative.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 29May2024 as dose number unknown, single (Lot number: Hm0311) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), described as "Nurse got a needle stick after administering vaccine"; DEVICE BREAKAGE (non-serious), described as "Vaccine broke in half". Therapeutic measures were not taken as a result of accidental exposure to product, device breakage.  Causality for "nurse got a needle stick after administering vaccine" and "vaccine broke in half" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "recovered" (May2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2024) positive; (May2024) negative; (May2024) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 15May2024 to 20May2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 21May2024 to 26May2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain swelling and redness. I've had pain and swelling before but the redness is a new reaction; Pain swelling and redness. I've had pain and swelling before but the redness is a new reaction; Pain swelling and redness. I've had pain and swelling before but the redness is a new reaction; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28May2024 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: unspecified drug reported. Concomitant medication(s) included: ZOLOFT; ATORVASTATIN; VIT D3. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunisation, reaction(s): "I've had pain and swelling before", "I've had pain and swelling before". The following information was reported: PAIN (non-serious), SWELLING (non-serious), ERYTHEMA (non-serious), outcome "recovering" and all described as "Pain swelling and redness. I've had pain and swelling before but the redness is a new reaction". Therapeutic measures were not taken as a result of pain, swelling, erythema.  Additional information: Reason for batch/lot is unknown was unable to locate or read the details. Facility where the most recent COVID-19 vaccine was administered pharmacy or drug store. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was ability zoloft Atorvastatin vit D3 multivitamin. Patient had not received Prior to vaccination, was the patient diagnosed with COVID-19. Patient had not been tested for COVID-19, Since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: I've had pain and swelling before; I've had pain and swelling before; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "I've had pain and swelling before".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Immune system disorder
Clinical narrative: knocks down the part of the immune system; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 4898833.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Recovered Alcoholic" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Broke arm" (unspecified if ongoing); "Memory issue (focus)" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Over active Bladder" (unspecified if ongoing); "Muscle spasms" (unspecified if ongoing); "Drop foot" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Cellulitis" (unspecified if ongoing); "Leg swelling" (unspecified if ongoing); "Menopause" (unspecified if ongoing); "Falls" (unspecified if ongoing); "Nature allergies" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CITALOPRAM; AMPYRA; OXYBUTYNIN; AMANTADINE; ALBUTEROL [SALBUTAMOL]; BACLOFEN; MELOXICAM; DULERA; DICLOFENAC SODIUM; FUROSEMIDE; VITAMIN D3; LORATADINE; GARLIC [ALLIUM SATIVUM]; FIBER; IRON. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "knocks down the part of the immune system". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported as, Patient past medical history included Childhood disease, Shrinking. On unknown date, it was reported that patient experienced: When asked about the immune response to the Vaccine the patient stated "Her doctor does a blood test twice a year, and he says that it knocks down the part of the immune system that it is supposed to".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction". Additional information: Caller is a patient asking what type of substance she was allergic to after she received the Pfizer covid19 vaccine last January 2021, as per her she was advised that time not to take the pills for covid19 since the coated film on the pills also has the same substance she was allergic to. Caller is asking if there is a record of the incident about her allergic reaction and what is the substance she was allergic to. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt broke out in hives for a day and a half after receiving vaccine. Pt also had welts on the arm which lasted for a few days. Pt took Benadryl to treat hives. The arm is now completely healed.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Bradycardia, Presyncope
Clinical narrative: Patient had a near syncope that occurred about 5 minutes after vaccine administration, was unresponsive with brief bradycardia to the 50's, but normal BP, no hypotension, normal oxygen saturation. Bradycardia lasted about 1-2 minutes, then patient began taking some juice. Patient then vomited juice, blood sugar was checked and was 90.  HR was checked and was in the 80's, normal BP and oxygen saturation and patient began taking juice and was alert and oriented. Patient was then observed for an additional 20 minutes and was able to ambulate out of the clinic.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Hypersomnia
Clinical narrative: Hypersomnia. Patient sleeps about 18-20 hours a day.