chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 31 month old  was given QUADRACEL in error with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from other healthcare professional on 02-Oct-2020 via Medical Information (Reference number- 00298711).  This case involved a 31-month-old patient who received a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] in error (Product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.   Concomitant vaccinations included HEPATITIS A VACCINE (HEPATITIS A) and INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for prophylactic vaccination on 23-Aug-2020.  On 23-Aug-2020, the patient received a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE(Lot number- C5688AA, expiration date- 26-Nov-2021) via unknown route in unknown administration site for prophylactic vaccination .  It was a case of actual medication error due to Inappropriate age at vaccine administration (Latency: Same day).  At the time of report, no adverse event was reported.  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 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: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered with Menactra that had expired with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from other healthcare professional on 08-Oct-2020.  This case involved a 17 years old female patient who was administered with a dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. (Expired product administered),   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications was not reported.   On 08-Oct-2020, the patient received a 0.5 ml once dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Lot number- U6365AA, expiration date-24-Sep-2020) via unknown route in the left deltoid for prophylactic vaccination.  This is a case of actual medication error due to an expired vaccine used. (latency: on the same time of vaccination)  At the time of report, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: a patient received an expired ACT-HIB vaccine with no adverse event; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Lot number: UJ078AAA, expiration date; 02-Oct-2020) via an unknown route in unknown administration site for prophylactic vaccination on 09-Oct-2020 (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug was not reported.   It was a case of an actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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 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: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Gave pediatric patient Hep A for adult. Vaccine was administered at 1030am. Documented my vaccines for the day at end of day and noticed the lot number was not coming up. Thought it was a system error as we had some errors with other vaccines not coming up so entered it manually. Following day I decided to double check the lot numbers on both vaccines and reference the adult one because it seemed odd the lot number wasn't coming up and sure enough I had realized the lot number I had was for the adult one. Notified supervisor of the error.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Vomiting, lots of vomiting
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Nodule, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Pt's mom came in for a shot and was mentioning how her daughter had received the flu shot about 2 weeks ago and that he arm was so sore upon flu shot, that it was in pain for several days and then her forearm swelled up with a large lump. Patient then subsequently called me later that day to explain further. Her arm is still tingling and weak. She decided to come in to show me her arm. Upon observation, the administration site of the flu shot was correct. Deltoid looks pretty normal. Her forearm does look slightly swollen and she complains of continual weakness and tingling feelings.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Nausea, Pallor, Syncope
Clinical narrative: Patient had a form of syncope about 10 minutes after receiving vaccination. after getting up she complained of nauseousness and was pale and generally not feeling well.
Age: 73.0
Sex: F
Vaccine: FLUR4
Symptoms: Discomfort, Injection site nodule, Injection site swelling, Neck pain
Clinical narrative: Difficulty was experienced when inserting needle for injection, pt expressed discomfort. Patient stated that the needle felt like it went through her bone and that she was filling discomfort in her neck. Location of vaccine had some swelling and developed a knot. Gave patient 25 mg of benadryl and 200 mg of ibuprofen and advised patient to put an ice pack on vaccine location and neck.  Called patient at about 6:50p  on 10/29/20 to follow up, she stated that she was still experiencing some pain in her neck but felt like it would get better.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient states she experienced redness, tenderness and hotness on her right deltoid almost after the vaccination, with noticeable symptoms about 2 hours after. The patch of redness on her right upper arm grew larger over the next 8 days until she seen the doctor yesterday 10/29/20. Patient has received antibiotics, Keflex, Bactrim DS and Fluconazole for her condition. Today she states the redness is lighter.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chest pain, Hypoaesthesia, Immediate post-injection reaction, Injection site pain
Clinical narrative: Employee said she immediately felt a sharp pain in her left shoulder after the Influenza injection was given.  The pain continued and extended down her left arm and in her left shoulder.  She could not sleep on her left side because of severe pain in her left shoulder, chest and also left leg.  On 10/21/2020 she was evaluated by RN. On examination she had severe pain to light touch at the injection site, right arm and leg.  The injection site showed no signs of infection. She was experiencing severe nerve pain with numbness of her right arm and leg and difficulty with mobility. Employee was immediately referred to her PCP physician.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Neuralgia, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: Employee said she immediately felt a sharp pain in her left shoulder after the Influenza injection was given.  The pain continued and extended down her left arm and in her left shoulder.  She could not sleep on her left side because of severe pain in her left shoulder, chest and also left leg.  On 10/21/2020 she was evaluated by RN. On examination she had severe pain to light touch at the injection site, right arm and leg.  The injection site showed no signs of infection. She was experiencing severe nerve pain with numbness of her right arm and leg and difficulty with mobility. Employee was immediately referred to her PCP physician.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Rash
Clinical narrative: Mild rash and injection site (red and hard). Has not had any medication but plan to monitor site. Notified to seek help in ER if signs of anaphylactic reaction occurs.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Angiotensin converting enzyme, Anti-aquaporin-4 antibody, Anti-muscle specific kinase antibody, Anti-thyroid antibody, Antiacetylcholine receptor antibody
Clinical narrative: Severe reaction within 8 hours of receiving vaccine was right arm severe pain, small temp of 99.9, chills, body aches. Had severe fatigue and arm pain x4 days after. The following symptoms began 10/01/2020: Right eye double vision Loss of clear vision right eye, only able to see vague shapes Right eye pressure Headache and head pressure. Right eye drooping (ptosis) During admission had 2 days of IV Methylprednisolone and 3 days outpatient IV. Many tests were performed (see item 19). I was seen 10/16/2020 at Eye Institute with a neuro-ophthalmologist. I had more testing along with visual field testing and the final diagnosis and determination was Tolosa-Hunt Syndrome (related to the pneumonia vaccine). I continue to have double vision out of right eye when open which inhibits driving, walking and all daily activities. Have follow up with the Neuro-ophthalmologist the month of November 2020.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test, Blood magnesium, Blood thyroid stimulating hormone, Body temperature increased, Borrelia test
Clinical narrative: Severe reaction within 8 hours of receiving vaccine was right arm severe pain, small temp of 99.9, chills, body aches. Had severe fatigue and arm pain x4 days after. The following symptoms began 10/01/2020: Right eye double vision Loss of clear vision right eye, only able to see vague shapes Right eye pressure Headache and head pressure. Right eye drooping (ptosis) During admission had 2 days of IV Methylprednisolone and 3 days outpatient IV. Many tests were performed (see item 19). I was seen 10/16/2020 at Eye Institute with a neuro-ophthalmologist. I had more testing along with visual field testing and the final diagnosis and determination was Tolosa-Hunt Syndrome (related to the pneumonia vaccine). I continue to have double vision out of right eye when open which inhibits driving, walking and all daily activities. Have follow up with the Neuro-ophthalmologist the month of November 2020.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diplopia, Electrocardiogram, Eyelid ptosis, Fatigue
Clinical narrative: Severe reaction within 8 hours of receiving vaccine was right arm severe pain, small temp of 99.9, chills, body aches. Had severe fatigue and arm pain x4 days after. The following symptoms began 10/01/2020: Right eye double vision Loss of clear vision right eye, only able to see vague shapes Right eye pressure Headache and head pressure. Right eye drooping (ptosis) During admission had 2 days of IV Methylprednisolone and 3 days outpatient IV. Many tests were performed (see item 19). I was seen 10/16/2020 at Eye Institute with a neuro-ophthalmologist. I had more testing along with visual field testing and the final diagnosis and determination was Tolosa-Hunt Syndrome (related to the pneumonia vaccine). I continue to have double vision out of right eye when open which inhibits driving, walking and all daily activities. Have follow up with the Neuro-ophthalmologist the month of November 2020.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Gait disturbance, Head discomfort, Headache, Impaired driving ability
Clinical narrative: Severe reaction within 8 hours of receiving vaccine was right arm severe pain, small temp of 99.9, chills, body aches. Had severe fatigue and arm pain x4 days after. The following symptoms began 10/01/2020: Right eye double vision Loss of clear vision right eye, only able to see vague shapes Right eye pressure Headache and head pressure. Right eye drooping (ptosis) During admission had 2 days of IV Methylprednisolone and 3 days outpatient IV. Many tests were performed (see item 19). I was seen 10/16/2020 at Eye Institute with a neuro-ophthalmologist. I had more testing along with visual field testing and the final diagnosis and determination was Tolosa-Hunt Syndrome (related to the pneumonia vaccine). I continue to have double vision out of right eye when open which inhibits driving, walking and all daily activities. Have follow up with the Neuro-ophthalmologist the month of November 2020.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: International normalised ratio, Lipids, Loss of personal independence in daily activities, Metabolic function test, Ocular discomfort
Clinical narrative: Severe reaction within 8 hours of receiving vaccine was right arm severe pain, small temp of 99.9, chills, body aches. Had severe fatigue and arm pain x4 days after. The following symptoms began 10/01/2020: Right eye double vision Loss of clear vision right eye, only able to see vague shapes Right eye pressure Headache and head pressure. Right eye drooping (ptosis) During admission had 2 days of IV Methylprednisolone and 3 days outpatient IV. Many tests were performed (see item 19). I was seen 10/16/2020 at Eye Institute with a neuro-ophthalmologist. I had more testing along with visual field testing and the final diagnosis and determination was Tolosa-Hunt Syndrome (related to the pneumonia vaccine). I continue to have double vision out of right eye when open which inhibits driving, walking and all daily activities. Have follow up with the Neuro-ophthalmologist the month of November 2020.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Prothrombin time, Red blood cell count, Thyroid function test
Clinical narrative: Severe reaction within 8 hours of receiving vaccine was right arm severe pain, small temp of 99.9, chills, body aches. Had severe fatigue and arm pain x4 days after. The following symptoms began 10/01/2020: Right eye double vision Loss of clear vision right eye, only able to see vague shapes Right eye pressure Headache and head pressure. Right eye drooping (ptosis) During admission had 2 days of IV Methylprednisolone and 3 days outpatient IV. Many tests were performed (see item 19). I was seen 10/16/2020 at Eye Institute with a neuro-ophthalmologist. I had more testing along with visual field testing and the final diagnosis and determination was Tolosa-Hunt Syndrome (related to the pneumonia vaccine). I continue to have double vision out of right eye when open which inhibits driving, walking and all daily activities. Have follow up with the Neuro-ophthalmologist the month of November 2020.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Thyroxine free, Tolosa-Hunt syndrome, Tri-iodothyronine free, Ultrasound thyroid, Visual field tests
Clinical narrative: Severe reaction within 8 hours of receiving vaccine was right arm severe pain, small temp of 99.9, chills, body aches. Had severe fatigue and arm pain x4 days after. The following symptoms began 10/01/2020: Right eye double vision Loss of clear vision right eye, only able to see vague shapes Right eye pressure Headache and head pressure. Right eye drooping (ptosis) During admission had 2 days of IV Methylprednisolone and 3 days outpatient IV. Many tests were performed (see item 19). I was seen 10/16/2020 at Eye Institute with a neuro-ophthalmologist. I had more testing along with visual field testing and the final diagnosis and determination was Tolosa-Hunt Syndrome (related to the pneumonia vaccine). I continue to have double vision out of right eye when open which inhibits driving, walking and all daily activities. Have follow up with the Neuro-ophthalmologist the month of November 2020.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Visual impairment
Clinical narrative: Severe reaction within 8 hours of receiving vaccine was right arm severe pain, small temp of 99.9, chills, body aches. Had severe fatigue and arm pain x4 days after. The following symptoms began 10/01/2020: Right eye double vision Loss of clear vision right eye, only able to see vague shapes Right eye pressure Headache and head pressure. Right eye drooping (ptosis) During admission had 2 days of IV Methylprednisolone and 3 days outpatient IV. Many tests were performed (see item 19). I was seen 10/16/2020 at Eye Institute with a neuro-ophthalmologist. I had more testing along with visual field testing and the final diagnosis and determination was Tolosa-Hunt Syndrome (related to the pneumonia vaccine). I continue to have double vision out of right eye when open which inhibits driving, walking and all daily activities. Have follow up with the Neuro-ophthalmologist the month of November 2020.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Mobility decreased, Weight decreased
Clinical narrative: Patient stated he has been in bed since Saturday (10/24/2020) after injection was given. Hasn't eaten and has lost 20lbs.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Pyrexia, Urticaria
Clinical narrative: spoke w/ an employee before taking vaccine due to  reaction before that was not documented. She said to  come back if reaction. Thursday took vaccine after  a few hours started to feel weak, tired, low grade  fever, hives. Took Benadryl and symptoms were away by  Sunday.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Syncopal episode with walking away post-injection. Pt sent to Urgent Care for evaluation by doctor. He was monitored due to nausea and vomiting and released later that evening to home. He had multiple episodes of nausea and vomiting on the day he received the vaccine (after vaccination only)
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pustule
Clinical narrative: redness around injection site with small area of pus at injection site
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Nausea, Urticaria
Clinical narrative: Nausea, headache, hives on entire body
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient said she developed redness, swelling and fever in the area where to vaccine was administered. she presented to the pharmacy 5 days since receiving the immunization and said it has been much worse, but still red, swollen, hot to the touch. she has been treating with tylenol.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin mass, Swelling
Clinical narrative: Red swelling knot under skin Itching
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Patient fainted about 5 minutes after administration of vaccine while shopping in the warehouse with her grandmother.  Patient came around quickly, paramedics were called and arrived, but patient left on her own accord.  She was not transported by the paramedic.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Eye pain, Headache, Nausea, Neck pain
Clinical narrative: Headache( back of head, base of neck and eyes) Nausea (resolved) lack of appetite (resolved)
Age: 79.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Bursitis, Musculoskeletal discomfort, Tenderness
Clinical narrative: Patient describe shoulder discomfort starting 15 minutes after injection. As of today 10/30/2020, is still reporting  shoulder soreness/tenderness. I am reporting to ensure if bursitis or shoulder discomfort continues long term.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Tenderness
Clinical narrative: Patient received vaccine on 8/12/2020, the following morning noticed an irritating lump in her arm pit of her left arm, painful if pressed upon. This lump remained present for roughly 3 days and then went away completely. She did not need to take anything to treat the lump. She reports no other side effects
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Bone pain, Chills, Fatigue
Clinical narrative: within hours of the shot, severe chills and vomiting. Vomiting all night and into next day. Pain in joints and nausea. No fever. Extreme fatigue. These symptoms lasted for days. Now after two weeks, still suffering from pain in my bones and lack of energy. Did not go to ER out of covid concerns. Monitored fever constantly. No cough. Second year in a row with the senior shot that I had a bad reaction, but this year is much worse than last year. I had my primary doctor add this to my chart via my chart on the internet.  At this point, I will never be willing to receive this vaccine again.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: within hours of the shot, severe chills and vomiting. Vomiting all night and into next day. Pain in joints and nausea. No fever. Extreme fatigue. These symptoms lasted for days. Now after two weeks, still suffering from pain in my bones and lack of energy. Did not go to ER out of covid concerns. Monitored fever constantly. No cough. Second year in a row with the senior shot that I had a bad reaction, but this year is much worse than last year. I had my primary doctor add this to my chart via my chart on the internet.  At this point, I will never be willing to receive this vaccine again.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain, Pain in extremity
Clinical narrative: Experienced severe right arm pain that radiated to her back that last until the next day.
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Occurred today - redness, swelling at location of vaccine
Age: 80.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: The patient received the shingrix vaccine too high in the shoulder and has experienced limited range of motion and pain. She tried aspirin and heat patches but still is experiencing pain. I had her follow up with her doctor and they are referring her to physical therapy. Her pain started immediately with the vaccination but it has not been painful to touch.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt with trumenba on R deltoid on 10/28; noted redness with some itching 10/29. Seen 10/30 with 2x2 inch redness on deltoid
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; herpes zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 31-AUG-2009, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles.  On an unspecified date,subsequently to the vaccionation, the patient presented shingles and post-herpetic neuralgia.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; consumer reporting improperly stored vaccine administration; This spontaneous report was received from a nurse and refers to patient of unknown age and gender. The patient's concurrent condition and medical history were not provided. Concomitant therapy included sterile diluent (manufacturer unknown).   On 21-OCT-2020, the patient was vaccinated with the first dose of improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) therapy type rHa, lot# T015600 is a valid lot number, expiration date 02-NOV-2021 (strength, route and site of administration were not provided) for prophylaxis. The temperature was 10 Fahrenheit (F) degrees for 2 hours. There were no previous temperature excursion. The digit data logger was involved. No additional adverse event was reported. The outcome was unknown.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA009775: US-009507513-2010USA009997: US-009507513-2010USA010221:
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Product preparation error
Clinical narrative: PNEUMOVAX23 and SHlNGRIX were mixed in the same syringe/PNEUMOVAX23 was inadvertently used as diluent; PNEUMOVAX23 and SHlNGRIX were mixed in the same syringe/PNEUMOVAX23 was inadvertently used as diluent; PNEUMOVAX23 was inadvertently used as diluent; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.  On 26-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(one dose; route, lot number and expiration date were not reported) for prophylaxis. It was stated pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and zoster rge vaccine (mammalian)(SHINGRIX) were mixed in the same syringe and administered to the patient. Pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was inadvertently used as diluent (wrong product administered, product preparation error and product confusion).
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: pain at injection site; trouble moving arm that she received the injection in; This spontaneous report was received from a female patient of unknown age, who was reporting on herself. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 20-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 dose at administration, intramuscularly for prevention of pneumonia (exact dose, anatomical location, lot # and expiry date were not provided).   On the same day, the patient returned to the pharmacy due to feeling pain at injection site. She was also having trouble moving arm that she received the injection in. The patient did not sought medical attention.  The outcome of the events was unknown. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: RN reported a improperly stored VARIVAX administration.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 15-OCT-2020, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T012551, which has been verified to be valid, expiration date reported and validated as 10-APR-2022). The vaccine administered experienced a temperature excursion from 6 degrees Fahrenheit (F) to 14F (11.8F), for a time frame of 31 hours, as recorded by a data logger. There was no previous temperature excursion reported.     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010902: US-009507513-2010USA011004:
Sex: U
Vaccine: PPV
Symptoms: Recalled product administered
Clinical narrative: No other AE information given at this time; HCP calling to report patient was given PNEUMOV AX 23 that was recalled; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 19-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) which was recalled at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, route and anatomical location of administration; lot # S036495, expiration date reported 13-SEP-2021) (recalled product administered). No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: HCP called to report a temperature excursion (see case# 01766674) and reported that ROTATEQ was administered to 2 patients on l0/26/2020 after a temperature excursion and prior to having vaccines evaluated.; This spontaneous report was received from a physician, referring to a two patients of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 26-OCT-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered by oral route, as prophylaxis (formulation, strength, dose and vaccination scheme were not reported; lot number 1684163, which has been verified to be valid, expiration date reported and validated as 26-JUN-2021). The vaccine administered experienced a temperature excursion below 36 degrees Fahrenheit (F)/2 degrees Celsius (C) (0.9C to 1.9C) for 10 hours; above 47F/9C (9.1C) for 30 minutes, for a time frame of 10 hours and 30 minutes. There was no previous temperature excursion reported, and no data logger was involved in the report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA011171:
Sex: U
Vaccine: PPV
Symptoms: Recalled product administered
Clinical narrative: No other AE information; HCP calling to report patient was given PNEUMOVAX 23 that was recalled; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 15-OCT-2020, the patient received a recalled pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml as prophylaxis (lot number: S036495 with expiration 13-SEP-2021) (strength, route of administration and anatomical location were not reported) (recalled product administered).  No adverse events reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: PPV
Symptoms: Recalled product administered
Clinical narrative: No other AE information given at this time; HCP calling to report patient was given PNEUMOV AX 23 that was recalled; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 09-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) which was recalled at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, route and anatomical location of administration; lot # S036495, expiration date reported 13-SEP-2021) (recalled product administered). No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: Recalled product administered
Clinical narrative: No other AE information given at this time; HCP calling to report patient was given PNEUMOV AX 23 that was recalled; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 14-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) which was recalled at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, route and anatomical location of administration; lot # S036495, expiration date reported 13-SEP-2021) (recalled product administered). No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: shot stung; sore right arm for a day; This case was reported by a consumer via call center representative and described the occurrence of stinging in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (In November patient had shingles on her left arm.), pain in arm and pruritus (Patient had neuropathic itching). Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced stinging and pain in arm. On an unknown date, the outcome of the stinging and pain in arm were recovered/resolved.   It was unknown if the reporter considered the stinging and pain in arm to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It as reported that patient had post neuropathic itching also in last November patient had bad shingles on her left arm and patient also has shingles vaccine before shingrix. Patient had previously soreness in arm and was not able to sleep at that time on that side.due to soreness It was reported that patient received the 1st dose of shingrix 6 months before and experienced shot stung and sore right arm for a day. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212982:Same suspect, same reporter, different dose (1st dose)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Injection site extravasation, Underdose
Clinical narrative: the dose leaked down her arm after injection; the dose leaked down her arm after injection; the dose leaked down her arm after injection; the dose leaked down her arm after injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received the 2nd dose of Shingrix. On 17th October 2020, immediately after receiving Shingrix, the patient experienced injection site leaking, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the injection site leaking, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that a female patient was at the pharmacy for the second dose of Shingrix on 17Oct2020 and reported the dose leaked down her arm after injection, which led to injection site leaking, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Rash papular
Clinical narrative: little bumps on the top of the left hand; burning sensation from the left shoulder to the elbow / burning extended down the arm all the way to the top of the left hand; had redness and burning sensation from the left shoulder to the elbow; This case was reported by a pharmacist via call center representative and described the occurrence of papular rash in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) for prophylaxis.   On 25th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th August 2020, 1 days after receiving Shingrix, the patient experienced burning sensation and erythema. On 27th August 2020, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was unknown and the outcome of the burning sensation and erythema were recovered/resolved.   It was unknown if the reporter considered the papular rash, burning sensation and erythema to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine on left deltoid via intramuscularly and around the next day, the customer had redness and burning sensation from the left shoulder to the elbow and the following day the redness and burning extended down the arm all the way to the top of the left hand. Also he had some little bumps on the top of the left hand. The events was lasted for a week. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Fatigue, Feeling cold, Headache
Clinical narrative: tiredness; headache; stomach upset; Feeling of chills; pharmacist gave the shingrix vaccine it was hurting and the pain; Arm is sore, painful/ leg ache; Arm is sore, painful and slightly red; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 22nd October 2020, immediately after receiving Shingrix, the patient experienced injection site pain, pain in extremity and erythema of extremities. On 23rd October 2020, the patient experienced tiredness, headache, upset stomach and chilliness. On an unknown date, the outcome of the injection site pain, pain in extremity, erythema of extremities, tiredness, headache, upset stomach and chilliness were unknown.   It was unknown if the reporter considered the injection site pain, pain in extremity, erythema of extremities, tiredness, headache, upset stomach and chilliness to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. On 20th October 2020, the patient received Flu vaccine in left arm. On 22nd October 2020, the patient received the first dose of the Shingrix in her right arm. The patient stated when the pharmacist gave the Shingrix it was hurting, and the pain continued and now the right arm was sore, painful and slightly red. On the day of reporting, 1 day after receiving Shingrix, the patient woke up with feeling of chills, stomach upset, headache, leg ache and tiredness. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: tiredness; headache; stomach upset; Feeling of chills; pharmacist gave the shingrix vaccine it was hurting and the pain; Arm is sore, painful/ leg ache; Arm is sore, painful and slightly red; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 22nd October 2020, immediately after receiving Shingrix, the patient experienced injection site pain, pain in extremity and erythema of extremities. On 23rd October 2020, the patient experienced tiredness, headache, upset stomach and chilliness. On an unknown date, the outcome of the injection site pain, pain in extremity, erythema of extremities, tiredness, headache, upset stomach and chilliness were unknown.   It was unknown if the reporter considered the injection site pain, pain in extremity, erythema of extremities, tiredness, headache, upset stomach and chilliness to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. On 20th October 2020, the patient received Flu vaccine in left arm. On 22nd October 2020, the patient received the first dose of the Shingrix in her right arm. The patient stated when the pharmacist gave the Shingrix it was hurting, and the pain continued and now the right arm was sore, painful and slightly red. On the day of reporting, 1 day after receiving Shingrix, the patient woke up with feeling of chills, stomach upset, headache, leg ache and tiredness. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 17 years old patient received a dose of Flublok with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from pharmacist and transmitted to Sanofi on 09-Oct-2020.  This case involved a 17-year-old male patient received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number and expiration date were not reported) via unknown route in unknown administration site (Product administered to patient of inappropriate age) for prophylactic vaccination on 08-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.  This was an actual medication error case as 17 years old patient received a dose of Flublok (Latency: Same day).  At the time of reporting, the patient did not experience any adverse event.  There will be no information available on the batch number for this case.  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 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: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was given to a 17 year old patient with no adverse event; Initial information regarding this valid unsolicited non-serious case from via Information (Reference number- 00309004) was received from nurse and transmitted to Sanofi on 09-Oct-2020.  This case involved a 17-year-old female patient received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- UJ446AA, expiration date- 18-Mar-2021) via intramuscular route in the left arm for prophylactic vaccination (Product administered to patient of inappropriate age) on 05-Oct-2020.  The patient's medical history, medical treatments and family history were not provided.   No vaccination and concomitant medications were given.  It was actual medication error due to inappropriate age at vaccine administration (Latency: Same day).  At the time of reporting the patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 16 years old patient received FLUBLOK vaccine with no adverse event; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old male who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- UJ448AA, expiration date- 22-Mar-2021) via unknown route in the left deltoid for prophylactic vaccination (product administered to patient of inappropriate age) on 26-Sep-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.   No concomitant vaccines given to the patient.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  The patient experienced no adverse events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.