chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administering an expired vaccination with no adverse event; Initial information received on 04-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who had inappropriate use due to administering an expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no 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 15v (Crm197) (Vaxneuvance) and Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Prophylactic vaccination.  On 04-Jun-2024, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) (lot UJ958AB,Expiry date:02-Jun-2024, strength was unknown) via intramuscular route in the right thigh for Prophylactic vaccination (Immunization) and inappropriate use due to administering an expired vaccination with no adverse event (expired 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Steven's Johnson" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 27May2024 to 31May2024.
Age: 33.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: both vaccines were administered and the patient fainted within 1 minute for about 10 seconds and turned very pale sweating, patient has a needle phobia
Age: 76.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Balance disorder, Fall
Clinical narrative: After receiving the vaccines, patient quickly got up in an effort to exit the vaccine room.  He grabbed for the door handle, lost balance and fell.  He has a history of falls per wife and this was "not a bad one" according to her.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Urticaria
Clinical narrative: The patient developed diffuse urticaria of her extremities and torso on day 2 after receiving vaccines at her 2 month well child visit. She was taken to emergency department where she was assessed and diagnosed with urticaria secondary to vaccination in the absence of other suspected trigger. She had no symptoms of anaphylaxis. She received a dose of diphenhydramine after which, in about 10 minutes, her urticaria resolved. She had no recurrence of urticaria and had not had any prior to this episode. She was seen today for her 4 month well child visit and received the same vaccines after discussion with parent on risks/benefits. She was observed for 15 minutes and had no reactions. Mom was counseled on signs of anaphylaxis and use of diphenhdyramine for isolated urticaria. Referred to Allergy.
Age: 1.0
Sex: F
Vaccine: DTPPVHBHPB, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was due to receive 12 month old shots, patient also due for catch-up doses of polio, Hep B, and Dtap. Patient was inadvertently given varicella and MMRV instead of varicella and MMR vaccines.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Occupational exposure to product, Pain in extremity, Syringe issue, Underdose
Clinical narrative: Not really adverse event report but Administration/Vaccine error.  Upon Vaccinating the patient, when I went to inject the medication the vaccine, all of the vaccine came out the back of the syringe and splashed me.  I believe this was due to a faulty mechanism in the syringes I was using.  I do not believe the patient received any of the vaccine in her arm due to the volume that appeared to spill out.  I had to revaccinate using a different arm and different vial of the same lot.  Patient experience mild soreness in arm that received the full vaccine.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Mom was advised to apply cold compress and to give Zyrtec 5 mL in the morning and Benadryl at night.  Also to apply 1% hydrocortisone ointment 2 times a day and if it is still itchy may apply calamine lotion. Patient was unable to take the allergy medication.   At around 7 PM last night the redness and swelling got worse.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Herpes zoster, Pruritus, Urticaria
Clinical narrative: Pt noted hives right arm as well as right hip on the same night going into the next day, very pruritic.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Pain, Sleep disorder
Clinical narrative: Left shoulder pain.  Of note patient received in IM Tdap injection on May 8th 2024 I noted the shoulder pain beginning the day after.  Since then the persistent daily pain has subsided, however he has had persistent trouble flexing and abducting his shoulder due to pain.  He is also noted weakness with flexion and abduction as well.  He denies any, redness or fevers or tenderness to the region.  He states he has been tolerating ibuprofen and ice for the pain, however he will wake up with his shoulder aching most nights.  We will plan to have an x-ray of his shoulder performed and I have referred him to orthopedics for further evaluation.  I advised him to continue using ibuprofen/Tylenol as needed for pain, icing, rest his shoulder for many lifting, and to do range of motion of his shoulder as tolerated.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Wrong patient received product
Clinical narrative: patient received 2 doses of shingrix instead of 1 dose of shingrix and 1 dose of spikevax. Patient came the pharmacy with her husband to receive 3 vaccines each. 1 shingrix+1 spikevax+1 boostrix. Both her and her husband entered the immunization booth. she was administered 1 dose of shingrix and 1 dose of boostrix in the left arm. Then she was administered an additional dose of shingrix intended for her husband in her right arm instead of spikevax
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Blood urine present, Computerised tomogram abnormal, Gait disturbance, Insomnia
Clinical narrative: My mom has been self medicating for back pain and insomnia, a couple of months ago she started to have blood in the urine, on May of 2024 she went to the hospital and they ran a CT scan and found two tumors, one 10 cms in her kidney and another one 5 cms in her lung.  She was told that they cannot remove the two tumors at one time because of her age and condition, she has another appointment with a cancer specialist in a couple of weeks. She has difficult walking and has to use a wheelchair when she has to go out.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lung neoplasm, Renal neoplasm, Self-medication, Wheelchair user
Clinical narrative: My mom has been self medicating for back pain and insomnia, a couple of months ago she started to have blood in the urine, on May of 2024 she went to the hospital and they ran a CT scan and found two tumors, one 10 cms in her kidney and another one 5 cms in her lung.  She was told that they cannot remove the two tumors at one time because of her age and condition, she has another appointment with a cancer specialist in a couple of weeks. She has difficult walking and has to use a wheelchair when she has to go out.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site discomfort
Clinical narrative: Injection site discomfort; fatigue/felt very tired; did not have a lot of energy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site discomfort (Verbatim: Injection site discomfort), fatigue (Verbatim: fatigue/felt very tired) and loss of energy (Verbatim: did not have a lot of energy). The outcome of the injection site discomfort, fatigue and loss of energy were not reported.   It was unknown if the reporter considered the injection site discomfort, fatigue and loss of energy to be related to Shingrix.     It was unknown if the company considered the injection site discomfort, fatigue and loss of energy to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-MAY-2024 The pharmacist stated that many patients who received Shingrix experienced fatigue, injection site discomfort, they felt tired and did not had a lot of energy. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024067180:subgroup case
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; HCP calling to report that patient received inappropriately stored VARIVAX.; This spontaneous report has been received from a medical assistant, concerning a 1-year-old patient of unknown gender. Information regarding the patient's pertienent medical history, concurrent conditions, drug reactions or allergies and concomitant medications was not provided.   On 23-MAY-2024, the patient was vaccinated with an inappropiately stored varicella virus vaccine live (oka/merck)(VARIVAX) formulation: Subcutaneous Injection, single dose, as prophylaxis, lot number X026789 and expiration date 14-NOV-2024. No adverse event was reported.   It was reported that the varicella virus vaccine live (oka/merck)(VARIVAX) underwent a temperature excursion of 19.8 fahrenheit degree during a timeframe of 20 hours and 15 minutes. There was no previous temperature excursion.   This is one of several reports, received from the same source.; Sender's Comments:  US-009507513-2405USA007588: US-009507513-2405USA007454: US-009507513-2405USA007600: US-009507513-2405USA007924:2405USA007648 US-009507513-2405USA007720: US-009507513-2405USA007692: US-009507513-2405USA007488: US-009507513-2405USA007916: US-009507513-2405USA007771: US-009507513-2405USA007912: US-009507513-2405USA007700: US-009507513-2405USA007935: US-009507513-2405USA007905: US-009507513-2405USA007722: US-009507513-2405USA007713: US-009507513-2405USA007573: US-009507513-2405USA007667: US-009507513-2405USA007578: US-009507513-2405USA007724: US-009507513-2405USA007617: US-009507513-2405USA007727: US-009507513-2405USA007728: US-009507513-2405USA007731: US-009507513-2405USA007901: US-009507513-2405USA007909: US-009507513-2405USA008015: US-009507513-2405USA007911: US-009507513-2405USA007841: US-009507513-2405USA007833: US-009507513-2405USA007761: US-009507513-2405USA007763: US-009507513-2405USA007791:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of expired ROTATEQ to a patient. Product expired on 17MAY2024 and was administered on 28MAY2024; This spontaneous report was received from a nurse a refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported.   On 28-MAY-2024, the patient was vaccinated with expire vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number: W036253 which was determined to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date: 17-MAY-2024, administered as prophylaxis (strength, dose, route of administration and anatomical location not provided) (expired product administered). No additional adverse event.
Age: 0.17
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any adverse event or side effect; A HCP called to report that his data logger in his vaccine refrigerator quit working on 03/08/2024 but was not realized and reset until 05/31/2024, which resulted in unknown temperature condition exposure to the vaccines.  A dose of VAXNEUVANCE affec; This spontaneous report was received from a nurse and refers to a 11 week old patient of unknown gender. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported.  On 18-APR-2024, the patient was inadvertently vaccinated with a dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) lot # X019624, expiration date: 07-NOV-2025, administered 0.5 mL, once (route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion with unknown conditions, as the health care professional noted that the data logger in the vaccine refrigerator quit working (from 08-MAR-2024 until 31-MAY-2024 when it was reset); therefore, not data about temperatures was known (product storage error). No prior excursion were reported. The patient did not experience any adverse issue or side effects from the administered vaccine.
Age: 1.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any adverse issue or side effects; A HCP called to report that his data logger in his vaccine refrigerator quit working on 03/08/2024 but was not realized and reset until 05/31/2024, which resulted in unknown temperature condition exposure to the vaccines.  A dose of VAXNEUVANCE affec; This spontaneous report was received from a nurse and refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported.  On 22-APR-2024, the patient was inadvertently vaccinated with a dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) lot # X019624, expiration date: 07-NOV-2025, administered 0.5 mL, once (route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion with unknown conditions, as the health care professional noted that the data logger in the vaccine refrigerator quit working (from 08-MAR-2024 until 31-MAY-2024 when it was reset); therefore, not data about temperatures was known (product storage error). No prior excursions were reported. The patient did not experience any adverse issue or side effects from the administered vaccine.
Age: 2.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any adverse issues or side effects from the administered dose of VAXNEUVANCE; A dose of VAXNEUVANCE affected by the unknown temperature conditions was then inadvertently administered to a patient; This spontaneous report has been received from a nurse referring to a 2-year-old patient on unknown gender. The patients' concurrent conditions, medical history and concomitant medications were not provided.   On 08-MAR-2024, the data logger in the vaccine refrigerator quit working which resulted in unknown temperature condition exposure to the vaccines. Then, on 16-APR-2024, the patient was inadvertently vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection at a dose of 0.5 mL once, lot number X019624 that was verified to be a valid lot number (expiration date reported and validated as 07-NOV-2025) administered as prophylaxis (strength, scheme, and route of administration were not provided) (product storage error). The dose was affected by unknown temperature conditions, the heath care professional (HCP) was not realized and reset until 31-MAY-2024. The operator of the device was a heath professional. The patient did not experience any adverse issues or side effects from the administered dose of the vaccine (no adverse event). No prior excursions were reported. No other information was able to be provided.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any adverse issues or side effects from the administered dose of VAXNEUVANCE; Dose of VAXNEUVANCE exposed to unknown temperature conditions from 03/08/2024 through 05/31/2024 was inadvertently administered on 03/25/2024.; This spontaneous report was received from a nurse regarding to a currently 6-month-old patient of unspecified gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  The reporter called to report that his data logger in his vaccine refrigerator quit working on 08-MAR-2024, but was not realized and reset (until 31-MAY-2024), which resulted in unknown temperature condition exposure to the vaccines.   On 25-MAR-2024, a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, affected by the unknown temperature conditions, was inadvertently administered at 0.5 (mL), once, lot number X019624 (lot number X019624 had been verified to be valid lot number for pneumococcal 15v conj vaccine [CRM197] [VAXNEUVANCE]), expiration date 07-NOV-2025 (strength, route of administration and anatomical injection site were not provided) for prophylaxis (product storage error).  The patient did not experience any adverse issues or side effects from the administered dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE). No other information was able to be provided during the call.
Age: 0.33
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any adverse issues or side effects from the administered dose of VAXNEUVANCE; A dose of VAXNEUVANCE affected by the unknown temperature conditions was then inadvertently administered to a patient on 04/19/2024.; This spontaneous report was received from a Register Nurse (R.N) concerning a 4-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  A Register Nurse called to report that his data logger in his vaccine refrigerator quit working on 08-MAR-2024 but was not realized and reset until 31-MAY-2024, which resulted in unknown temperature condition exposure to the vaccines.  A dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0,5 ml/once, lot # X019624, expiration date: 07-NOV-2025 affected by the unknown temperature conditions was then inadvertently administered to a patient on 19-APR-2024 (route was not reported) for prophylaxis (product storage error).   The patient did not experience any adverse issues or side effects from the administered dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE).  No other information was able to be provided during the call.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC.; HBP calling. GARDASIL 9 was administered follow a TE.; This spontaneous report was received from other reporter regarding to a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 30-MAY-2024, the patient was vaccinated with human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot number 1957405 (lot number 1957405 had been verified to be valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine [yeast] [GARDASIL 9]), expiration date 11-NOV-2025 (strength, dose, frequency, route of administration and anatomical injection site were not provided) for prophylaxis, following a temperature excursion (product storage error). No additional adverse event (AE)/no product quality complaint (PQC).
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report a T/E for ROTATEQ and VAXELIS (vial) (see T/E case 02615297) and reported vaccines were administered to patient after T/E occurred.  No symptoms reported.  Consent to contact HCP provided.  No additional AE/PQC.; No symptoms reported; This spontaneous report was received from a nurse and refers to a patient of unknown age or gender. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported.   On an unspecified date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1975783, expiration date: 12-OCT-2024; and/or with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (manufacturer unknown) lot # 2CA52C1, expiration date: 24-FEB-2026 (strength, route of administration, anatomical location not provided for any vaccine) as prophylaxis, which underwent a temperature excursion before administration (product storage error). No symptoms were reported.
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: product storage error/ exposed to a maximum temperature of 9.8 degree Celsius for a total time out of range of 14 minutes; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9935H, expiry date 03-JUL-2026) for prophylaxis.   On 28-MAY-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: product storage error/ exposed to a maximum temperature of 9.8 degree Celsius for a total time out of range of 14 minutes). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-MAY-2024 The vaccine coordinator stated that the Havrix, Kinrix, Pediarix, Infanrix, Hiberix, Engerix-B, Rotarix (prefilled), Bexsero, Menveo (1-vial), Flulaval, Boostrix were exposed to a maximum temperature of 9.8 degree Celsius for a total time out of range of 14 minutes. No prior excursions.  One of the Boostrix vaccines was administered to one patient, which led to an incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: PNC20
Symptoms: Skin burning sensation, Skin exfoliation
Clinical narrative: skin felt like it was burning; white, and flaky; white, and flaky; This is a spontaneous report received from a Pharmacist from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Feb2024 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: SKIN BURNING SENSATION (non-serious) with onset Feb2024, outcome "unknown", described as "skin felt like it was burning"; SKIN DEPIGMENTATION (non-serious), SKIN EXFOLIATION (non-serious) all with onset Feb2024, outcome "unknown" and all described as "white, and flaky". The events "skin felt like it was burning" and "white, and flaky" required physician office visit. Additional information: Caller has a patient who received Prevnar 20 in February and reports that their "skin felt like it was burning, is white, and flaky". Caller stated that the patient reports having it all over her body since February and has been seen by a doctor, however the doctor has not done anything for her. Caller stated they weren't sure if the doctor thought anything was going on..  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Ophthalmological examination, Retinal white dots syndrome, Visual acuity tests
Clinical narrative: recurrence of multiple evanescent white dot syndrome; recurrence of multiple evanescent white dot syndrome; This is a literature report.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MEWDS (OS)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Vaccination to symptoms onset - 3 months (Photopsia)), for COVID-19 immunisation, reaction(s): "COVID-19 vaccine-associated MEWDS/Contralateral recurrences of post-vaccination multiple evanescent white dot syndrome", "COVID-19 vaccine-associated MEWDS/Contralateral recurrences of post-vaccination multiple evanescent white dot syndrome". The following information was reported: RETINAL WHITE DOTS SYNDROME (medically significant), DISEASE RECURRENCE (medically significant), all with latency 4 months after the suspect product(s) administration, outcome "recovered" and all described as "recurrence of multiple evanescent white dot syndrome". The patient underwent the following laboratory tests and procedures: Ophthalmological examination: Multiple white lesions, notes: multiple hyperfluorescent lesions (FAF, FA), numerous hypocyanescent spots (ICGA) (1st); Active MEWDS temporally, notes: and recovering MEWDS nasally (2nd); Visual acuity tests: 20/20, notes: OD, OS. Final vision: 20/20 (1st); 20/20, notes: OD, OS. Final vision: 20/20 (2nd). Therapeutic measures were not taken as a result of retinal white dots syndrome, disease recurrence. Clinical course: Vaccination to symptoms onset - 4 months (Photopsia). No other examinations. No treatment received. Course of disease (2nd) was 6 months: recovery. Other vaccine types: Human papillomavirus combined with meningococcal vaccines.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of Multiple evanescent white dot syndrome might not be fully excluded, considering that similar episodes developed after first and second BNT162b2 vaccine use.  More epidemiologic and clinical data, together with immunological and biomolecular workups would be needed to determine the causal link and explore the plausible physiopathologic mechanism between the vaccination and the event occurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202400073861 Same article/drug/event/patient, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Ophthalmological examination, Retinal white dots syndrome, Visual acuity tests
Clinical narrative: COVID-19 vaccine-associated MEWDS/Contralateral recurrences of post-vaccination multiple evanescent white dot syndrome; COVID-19 vaccine-associated MEWDS/Contralateral recurrences of post-vaccination multiple evanescent white dot syndrome; This is a literature report for the following literature source(s).  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MEWDS (OS)" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: RETINAL WHITE DOTS SYNDROME (medically significant), DISEASE RECURRENCE (medically significant), all with latency 3 months after the suspect product(s) administration, outcome "recovered" and all described as "COVID-19 vaccine-associated MEWDS/Contralateral recurrences of post-vaccination multiple evanescent white dot syndrome". The patient underwent the following laboratory tests and procedures: Ophthalmological examination: Multiple white lesions, multiple hyperfluorescent, notes: lesions (FAF, FA), numerous hypocyanescent spots (ICGA) (1st); Visual acuity tests: 20/20, notes: (1st); 20/20, notes: (1st). Clinical course: Vaccination to symptoms onset - 3 months (Photopsia). Eyes involved: Right eye (OD). No other examinations. No treatment received. Course of disease (1st) was unknown.  Reported outcome was recovery. Other vaccine types: Human papillomavirus combined with meningococcal vaccines.; Sender's Comments: As there is limited information in the case provided, the causal association between the event retinal white dots syndrome, disease recurrence and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202400187186 Same article/ drug/event and different patient;
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administration of an extra dose of MENQUADFI one month after the previous dose was administered with no reported adverse event; Initial information received on 04-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 year old female patient who was administered an extra dose of meningococcal A-C-Y-W135 (T CONJ) VACCINE [Menquadfi] one month after the previous dose was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Jun-2024, the patient received a 0.5 ml dose (dose 2) of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection Strength: standard of lot U7986AC expiry date: 31-Mar-2026 Frequency: once via intramuscular route in the right arm for immunization. On 01-May-2024 the patient received dose 1 of same vaccine and extra dose of menquadfi one month after the previous dose was administered with no reported adverse event (extra dose administered) on 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 and Regulatory Authority 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: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Gastric dilatation, Pain in extremity, Swelling
Clinical narrative: 5/24/24: Normal o sore arm, chills--no treatment reported. ON 5/26/24: Severe stomach pain developed feeling like glass inside of stomach, swollen organs and swollen stomach, Treatment: CBD gummies because pt afraid of taking  Tylenol due to hurting/damaging liver (swollen organs).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis normal
Clinical narrative: 5/24/24: Normal o sore arm, chills--no treatment reported. ON 5/26/24: Severe stomach pain developed feeling like glass inside of stomach, swollen organs and swollen stomach, Treatment: CBD gummies because pt afraid of taking  Tylenol due to hurting/damaging liver (swollen organs).
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash papular, Rash vesicular
Clinical narrative: On 06/02, I received the Shingrix vaccine.  Two days later, i started to develope a small rash near my left eye.  On 06/05, the rash was getting bigger with small blisters.  On 06/06, I went to urgent care to get it looked at.  I was diagnosis with Shingles.  I was offered 2 options for treatment.  Acyclovir topical or vaIACYclovir.  I decided to start with the topical ointment.   Today, 06/07, the rash is large and swollen.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Eyelid rash, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: On 06/02, I received the Shingrix vaccine.  Two days later, i started to develope a small rash near my left eye.  On 06/05, the rash was getting bigger with small blisters.  On 06/06, I went to urgent care to get it looked at.  I was diagnosis with Shingles.  I was offered 2 options for treatment.  Acyclovir topical or vaIACYclovir.  I decided to start with the topical ointment.   Today, 06/07, the rash is large and swollen.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: On 06/02, I received the Shingrix vaccine.  Two days later, i started to develope a small rash near my left eye.  On 06/05, the rash was getting bigger with small blisters.  On 06/06, I went to urgent care to get it looked at.  I was diagnosis with Shingles.  I was offered 2 options for treatment.  Acyclovir topical or vaIACYclovir.  I decided to start with the topical ointment.   Today, 06/07, the rash is large and swollen.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Vomiting
Clinical narrative: Chills resolved , headache ongoing, soreness @ injection site ongoing, vomiting x1, fatigue ongoing
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Butterfly rash, Fatigue, Headache, Injection site pain, Rash
Clinical narrative: Typical post injection soreness and fatigue and headache. Developed butterfly type facial rash and facial burning  sensation on 06/07/2024 while outside at work in AM. Went home and used some cool water to wash face and took cetirizine and has had some improvement.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: Typical post injection soreness and fatigue and headache. Developed butterfly type facial rash and facial burning  sensation on 06/07/2024 while outside at work in AM. Went home and used some cool water to wash face and took cetirizine and has had some improvement.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: patient reports to pharmacy on 6/8/2024 to report swelling redness and itching at site of injection. a 3" approximately circle of redness is noted on patients left arm in the area of injection site.  Pharmacist told patient to check in with an urgent care of her pcp as soon as possible, and watch for signs of cellulitis including weeping or fever. Patient is being currently treated for a tooth infection and is taking clindamycin starting today.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: patient developed itching and 2 hives over injection site and an additional hive below the site and experienced itching feeling.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Right shoulder and arm are achy, red, swollen
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event.  Reason for reporting is that patient is just 7 years old and the State rules specify that no vaccines be administered to patients less than 14 years of age.  No adverse event reported
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia
Clinical narrative: patient experienced pain in left arm and severe pain in left wrist. after a few minutes patient said the pain was gone. still had patient wait a few more minutes. informed patient to take Tylenol or use ice pack if experiences any pain or fever
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered vaccine that was expired. Vaccine administered 06/08/2024. Vaccine expired 05/04/2024. Patient didn't experience any adverse reaction after administration 06/08/2024.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Dyspnoea, Fluid retention, Myocarditis, Pericarditis
Clinical narrative: shortness of breath, retention of water(legs, around heart and lungs) weight gain 20 lbs in 10 days, Admitted to  Hospital 03/27/2023 with diagnosis of congestive heart failure, myocarditis and pericarditis. Released from hospital 04/03/2024.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: shortness of breath, retention of water(legs, around heart and lungs) weight gain 20 lbs in 10 days, Admitted to  Hospital 03/27/2023 with diagnosis of congestive heart failure, myocarditis and pericarditis. Released from hospital 04/03/2024.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Fatigue, Insomnia
Clinical narrative: Neurological symptoms - brain fog, fatigue, insomnia
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Headache, Hyperhidrosis, Loss of consciousness, Vision blurred
Clinical narrative: The morning following vaccination patient experienced blurry vision, head ache, sweating, and passed out at the post office.  Patient was cleared by EMS and left own her own.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood glucose normal, Febrile convulsion, Full blood count normal, Influenza virus test negative, Pyrexia
Clinical narrative: Low dose fever with in12 hours; Gave Motrin around midnight after shot. Gave Motrin at 6:30 am due to fever of 100 degrees. Then followed by high fever of 104 degrees at 10:00 a.m.  which caused a febrile seizure lasting 3 minutes.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: Low dose fever with in12 hours; Gave Motrin around midnight after shot. Gave Motrin at 6:30 am due to fever of 100 degrees. Then followed by high fever of 104 degrees at 10:00 a.m.  which caused a febrile seizure lasting 3 minutes.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: NO REACTION TO VACCINE GIVEN: PATIENT WANTED TWINRIX NOT Tdap.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cataplexy, Fatigue, Irritability, Major depression, Narcolepsy
Clinical narrative: Chronic fatigue, narcolepsy with cataplexy, major depressive disorder, irritability, suicidal thoughts
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sleep study, Suicidal ideation
Clinical narrative: Chronic fatigue, narcolepsy with cataplexy, major depressive disorder, irritability, suicidal thoughts
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: PATIENT EXPIRED 8 DAYS AFTER VACCINE WAS ADMINISTERED.
Age: 61.0
Sex: M
Vaccine: PNC20
Symptoms: Chills, Decreased appetite, Headache, Injection site pain, Injection site warmth
Clinical narrative: Fever 100.3 degrees, chills, headache, transient muscle pain, decreased appetite. Tenderness and warmth at injection site with no redness.
Age: 61.0
Sex: M
Vaccine: PNC20
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever 100.3 degrees, chills, headache, transient muscle pain, decreased appetite. Tenderness and warmth at injection site with no redness.
Age: 25.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: THE PATIENT RETURNED TO THE PHARMACY 2 DAYS POST VACCINATION WITH A N INJECTION SITE REACTION.  HER ARM WAS RED AND DISCOLORED, SWOLLEN, ITCHING, AND PAINFUL.  SHE RECEIVED BOTH VACCINES IN THE SAME ARM.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Pain, swelling, redness, heat, itchiness at the vaccination site (unresolved after 2 days), malaise and fever first night post vaccinen/a
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Pain, swelling, redness, heat, itchiness at the vaccination site (unresolved after 2 days), malaise and fever first night post vaccinen/a
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring normal, Dizziness, Dyspnoea, Echocardiogram normal, Fatigue
Clinical narrative: Fatigue, dizziness, headaches, dyspnea, palpitations.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head normal, Palpitations, Ventilation/perfusion scan
Clinical narrative: Fatigue, dizziness, headaches, dyspnea, palpitations.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Cough, Ischaemic stroke, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Ischemic Stroke suffered on 4/25/2024. Symptoms since shots administered: chronic cough, chest congestion, phlegm discharge, stiffness/pain in right arm, back
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Productive cough, Respiratory tract congestion
Clinical narrative: Ischemic Stroke suffered on 4/25/2024. Symptoms since shots administered: chronic cough, chest congestion, phlegm discharge, stiffness/pain in right arm, back
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Erythema, Induration, Nodule
Clinical narrative: patient states he has a hard know and it's red. he said its the size of his palm of his hand.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Dizziness, Erythema, Headache, Lethargy
Clinical narrative: Swollen arm (shoulder to hand), redness, pain in joints (shoulder, elbow, hand), headache, dizziness, nausea, night sweats, lethargy; treated with benedryl and ice
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Nausea, Night sweats, Peripheral swelling
Clinical narrative: Swollen arm (shoulder to hand), redness, pain in joints (shoulder, elbow, hand), headache, dizziness, nausea, night sweats, lethargy; treated with benedryl and ice
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Patient woke up Friday morning thinking something bit him overnight - As the day progressed he broke out in hives all over his stomach, back, arms, and legs.  We administered Benadryl that evening.  In the morning he woke up with it all over his body including his face.  We gave additional doses of Benadryl all day every 4 hours.  Saturday night he woke up at 12:40 AM and was completely covered again in hives - I gave him another dose of Benadryl.  An hour later it continued to spread and we went to ER.  He was given prednisone and is currently taking that with the benadryl.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Osteonecrosis, X-ray
Clinical narrative: I have been diagnosed with AVN of the right femoral head.  I neeed a total hip replacement.  This is crazy.  I fit none of the causations for AVN.   This has to have been caused by the COVID vacine.
Age: 28.0
Sex: F
Vaccine: COVID19, VARCEL
Symptoms: Blister, Erythema, Papule, Pruritus, Skin abrasion
Clinical narrative: The patient presented with discrete erythematous papules on an erythematous base. One with clear vesicle on the chest and the rest she said no longer have vesicles. There is a large 10 ovoid area of erythema on the right lower portion of the posterior right arm with some small papules and excoriation. It is raised. All lesions are raised and very itchy.
Age: 28.0
Sex: F
Vaccine: COVID19, VARCEL
Symptoms: Skin lesion, Swelling
Clinical narrative: The patient presented with discrete erythematous papules on an erythematous base. One with clear vesicle on the chest and the rest she said no longer have vesicles. There is a large 10 ovoid area of erythema on the right lower portion of the posterior right arm with some small papules and excoriation. It is raised. All lesions are raised and very itchy.
Age: 60.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Fatigue, Pruritus, Rash
Clinical narrative: Patient came to the pharmacy  on  Sunday  6/9/24  stating  that ,he got rash after vaccination. Patient received vaccine on 6/7 /24  around 4.14 pm and observed rash next day 6/8/24  evening around 5 pm .  He felt tired and rash and itching  spreading on the body on Saturday .  no other side effectes.  Told him to use Hydrocortison Cream  OTC and Benadryl tablet OTC.
Age: 60.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Fatigue, Rash pruritic, Throat irritation
Clinical narrative: Patient came to the pharmacy  on  Sunday  6/9/24  stating  that ,he got rash after vaccination. Patient received vaccine on 6/7 /24  around 4.14 pm and observed rash next day 6/8/24  evening around 5 pm .  He felt tired and rash and itching  spreading on the body on Saturday .  no other side effectes.  Told him to use Hydrocortison Cream  OTC and Benadryl tablet OTC.
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was administered to a pregnant patient outside of agency season guidelines.  No adverse events occurred.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Alcohol abuse, Amnesia, Aneurysm, Asthenia, Balance disorder
Clinical narrative: A month after second shot, I woke up in the middle of the night hearing the loud sound of gushing fluid; it was blood pouring out of my nose. I managed to call EMS, and that was all I remember .....until I woke up after 18 days in the hospital.  My 50th birthday passed while I was in the hospital.  I had suffered a massive aneurysm, and was put into a medically induced coma while receiving drug treatment that constricted the blood vessels in my brain to allow it to hopefully heal.  I came out of the experience having constant seizures, and being unable to walk; I had to relearn over the course of six months. In addition to having seizures after that, my forearms began to experience accellerated aging and I cannot even brush against a wall without having tremendous bruising that does not heal, and often decubitus ulcer. My skin on both forearms is crepey, very fragile and always has black and blues and I must wear forearm protectors even inside the house. Since that time, I have had difficulty having and/or maintaining an erection. Additionally, my formerly strong constitution has been very reduced and I feel weak and unsteady all the time.  All these terrible problems have been going on and on for the last four years, and the stress of it has amplified my desire to self-medicate with alcohol, which has become another significant problem, as it is the only thing which has made me able to deal with the symptoms. The medical profession has responded by prescribing a huge list of pharmaceutical products which caused me to have massive mood swings and angry outbursts, as well as increasing the already bad tremors. I've been told that my executive function is also significantly impaired, as I have a hard time being able to anticipate the realistic consequences of actions/choices that I make.