chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate dose of vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 3FD3N, expiry date 9th July 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The nurse on the line who reported another nurse was preparing the vaccine and got distracted and just administered the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  Follow up information received from nurse on 15th May 2019: the patient received Shingrix via intramuscularly. The patient was notified and follow up resulted in no known harm to patient. It was medication error without harm.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Hyperhidrosis, Musculoskeletal pain, Nausea
Clinical narrative: Fever; Chills; Nausea; Loss of Appetite; Shoulder pain; sweating; This case was reported by a physician via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2019, the patient received the 2nd dose of Shingrix. On 24th May 2019, less than a day after receiving Shingrix, the patient experienced fever, chills, nausea, appetite lost, shoulder pain and sweating. On 25th May 2019, the outcome of the shoulder pain was recovered/resolved. On 27th May 2019, the outcome of the fever, chills, nausea, appetite lost and sweating were recovered/resolved.   It was unknown if the reporter considered the fever, chills, nausea, appetite lost, shoulder pain and sweating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix on Friday afternoon and then experienced 3 days of sweats, fever, no appetite and nausea.   The patient stated it was the worse medical experience of their life. The reporter consented to follow-up. This case was linked to case US2019096176 through same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Nausea; Loss of Appetite; Shoulder pain; sweating; This case was reported by a physician via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2019, the patient received the 2nd dose of Shingrix. On 24th May 2019, less than a day after receiving Shingrix, the patient experienced fever, chills, nausea, appetite lost, shoulder pain and sweating. On 25th May 2019, the outcome of the shoulder pain was recovered/resolved. On 27th May 2019, the outcome of the fever, chills, nausea, appetite lost and sweating were recovered/resolved.   It was unknown if the reporter considered the fever, chills, nausea, appetite lost, shoulder pain and sweating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix on Friday afternoon and then experienced 3 days of sweats, fever, no appetite and nausea.   The patient stated it was the worse medical experience of their life. The reporter consented to follow-up. This case was linked to case US2019096176 through same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal pain
Clinical narrative: Shoulder Pain; Headache; This case was reported by a physician via call center representative and described the occurrence of shoulder pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2019, the patient received the 2nd dose of Shingrix. On 24th May 2019, less than a day after receiving Shingrix, the patient experienced shoulder pain and headache. On 25th May 2019, the outcome of the shoulder pain and headache were recovered/resolved.   It was unknown if the reporter considered the shoulder pain and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband and did not was to provide her details. The age at vaccination was not provided. The patient got Shingrix on Friday and from the date of reporting had shoulder pain and headache for 24 hours. No vaccine information was provided. The reporter consented to follow-up. This case was linked to case US2019096151 through same reporter. There is a discrepancy between the outcome reported in the structured field (resolved/resolved) and the outcome reported in the source document (resolved with sequelae). The outcome of these events retains as per the structural field.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: burning at injection site/pain at injection site; achiness; weakness; headache; difficulty sleeping; nausea; heart pounding; chills; tired; cold feeling; This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 28th May 2019, less than a day after receiving Shingrix, the patient experienced injection site burning, pain, weakness, headache, difficulty sleeping, nausea, heart pounding, chills, tiredness and feeling cold. On an unknown date, the outcome of the injection site burning, pain, weakness, headache, difficulty sleeping, nausea, heart pounding, chills, tiredness and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site burning, pain, weakness, headache, difficulty sleeping, nausea, heart pounding, chills, tiredness and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow up with her pharmacy or physician on an unknown date. The reporter consented to follow up. Event tab and Analysis tab: the outcome reported for all AES in the structured field is "recovering" instead of "not resolved" (outcome uploaded).
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Nausea, Pain, Palpitations
Clinical narrative: burning at injection site/pain at injection site; achiness; weakness; headache; difficulty sleeping; nausea; heart pounding; chills; tired; cold feeling; This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 28th May 2019, less than a day after receiving Shingrix, the patient experienced injection site burning, pain, weakness, headache, difficulty sleeping, nausea, heart pounding, chills, tiredness and feeling cold. On an unknown date, the outcome of the injection site burning, pain, weakness, headache, difficulty sleeping, nausea, heart pounding, chills, tiredness and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site burning, pain, weakness, headache, difficulty sleeping, nausea, heart pounding, chills, tiredness and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow up with her pharmacy or physician on an unknown date. The reporter consented to follow up. Event tab and Analysis tab: the outcome reported for all AES in the structured field is "recovering" instead of "not resolved" (outcome uploaded).
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: arm  achiness; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 49-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number MF9EA, expiry date 1st June 2021) for prophylaxis.   On 15th April 2019, the patient received Boostrix. In May 2019, 7 days after receiving Boostrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Boostrix.  Additional case details were provided as follows: The patient received Boostrix on the right arm. One week later, the patient's arm was ached.  It was the same arm where the injection was given.   He described it as feeling like he had been punched in the arm. No other visible reactions were seen.  No redness or swelling.   The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Rash, Rash pruritic
Clinical narrative: sore arm; tenderness at injection site; rash in his whole abdomen, chest, back and behind his knees; itching; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 3FD3N, expiry date 9th July 2021) for prophylaxis.   On 23rd May 2019, the patient received the 1st dose of Shingrix. On 24th May 2019, 1 days after receiving Shingrix, the patient experienced rash and itchy rash. On an unknown date, the patient experienced pain in arm and injection site tenderness. On an unknown date, the outcome of the rash and itchy rash were not recovered/not resolved and the outcome of the pain in arm and injection site tenderness were unknown.   It was unknown if the reporter considered the rash, itchy rash, pain in arm and injection site tenderness to be related to Shingrix.  Additional details were provided a follows: The patient had Shingrix vaccine last Thursday from the time of reporting and next morning the patient woke up with rash in his whole abdomen, chest, back and behind his knees. The rash was itching. The Reporter said that the rash looks like a sunburn, that was how it looked. The rest of the patient's arms and legs look fine. In May 2019, less the a week after receiving Shingrix, the patient did experience a sore arm but not swelling nor redness at the injection site, Just tenderness at the injection site. This case was linked to case US2019098262 through same reporter.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fall, Pyrexia, Urinary tract infection
Clinical narrative: Stated he experienced fever, chills, dizziness that caused him to fall. However patient went to his prescriber and is currently being treated for a UTI with antibiotics. Per patient prescriber felt what he experienced could have been from the UTI not the vaccine
Age: 59.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Nausea
Clinical narrative: Employee reported onset of pain  to left deltoid starting on 6/4/19 and nausea starting on 6/5/19 Instructed to take Tylenol, Ibuprofen and Ice.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature decreased, Bradycardia, Emotional distress, Hypotension, Hypothermia
Clinical narrative: Day after received vaccine at 2 month well child check mom reports infant extremly fussy and intermittently inconsolable.  Family called  office to report tempature of 94 degrees and were instructed to retake temp with new thermometer.  Per mom report infant temp remained at 94 and infant remained fussy although eating well and waking  to feeding.  No blood in stool noted.  Infant seen in the office 05/22/2019 for "possible reflux".  Infant noted to be gray, mottled, hypothermic (t= 94) , bradycardic (HR= 70s) and hypotensive (BP= 51/30).  Infant sent to the ER for further treatment and work up.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Laboratory test, Livedo reticularis, Skin discolouration
Clinical narrative: Day after received vaccine at 2 month well child check mom reports infant extremly fussy and intermittently inconsolable.  Family called  office to report tempature of 94 degrees and were instructed to retake temp with new thermometer.  Per mom report infant temp remained at 94 and infant remained fussy although eating well and waking  to feeding.  No blood in stool noted.  Infant seen in the office 05/22/2019 for "possible reflux".  Infant noted to be gray, mottled, hypothermic (t= 94) , bradycardic (HR= 70s) and hypotensive (BP= 51/30).  Infant sent to the ER for further treatment and work up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Significant Shivering for about 9 hours, starting about 6 hours after the shot was given.    Shivering was not alleviated by adding warmer cloths or coverings.    After about 9 hours, the shivering was not as noticeable, I was able to go to sleep.  In the morning (24 hrs after injection)  I did not notice any shivering.
Age: 19.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Eye pruritus, Nasal congestion, Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: Patient complaining of symptoms starting 6/5/19 in the evening.  He could not breath out of his nose.  Today he developed itchy, red bumps on his body, itchy eyes and his left arm hurt.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: My arm was sore within an hour of receiving the shot. I moved my arm around, trying to exercise it in some way to minimize the pain. The next day, I woke up and felt terrible. I was shivering, had a fever of 101.3, and had body aches all over my body. Flu-like symptoms.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Injection site induration, Pain, Skin warm
Clinical narrative: REDNESS, SWELLING, FIRM, PAINFUL, WARM AT TOUCH; THIS STARTED ON DAY 1. BY DAY 4, 75% OF SKIN WAS COVERED. SHE WAS GIVEN TYLENOL AND MOTRIN, USED A COLD PACK TO AREA, AND I APPLIED ESSENTIAL OILS TO THE AREA TO HELP WITH THE PAIN. BY DAY 7, THERE IS ONLY A LITTLE FIRMNESS TO WHERE THE SHOT WAS GIVEN.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Swelling
Clinical narrative: REDNESS, SWELLING, FIRM, PAINFUL, WARM AT TOUCH; THIS STARTED ON DAY 1. BY DAY 4, 75% OF SKIN WAS COVERED. SHE WAS GIVEN TYLENOL AND MOTRIN, USED A COLD PACK TO AREA, AND I APPLIED ESSENTIAL OILS TO THE AREA TO HELP WITH THE PAIN. BY DAY 7, THERE IS ONLY A LITTLE FIRMNESS TO WHERE THE SHOT WAS GIVEN.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: very sore armfor a week. Fever on second day
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Ill-defined disorder, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Extremely sore arm first day and night (couldn't lift it), then sore arm for a week.   Vomiting first night, fever. Several illnesses over next few weeks-one like pneumonia (which patient had once)--aches, fever, backache
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia, Pyrexia, Vomiting
Clinical narrative: Extremely sore arm first day and night (couldn't lift it), then sore arm for a week.   Vomiting first night, fever. Several illnesses over next few weeks-one like pneumonia (which patient had once)--aches, fever, backache
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Head discomfort, Peripheral swelling, Pharyngeal paraesthesia, Rash
Clinical narrative: Employee reported to ER for care on 6/5/19 reporting left sided arm redness and swelling  after receiving the tetanus vaccine.  Employee reported per ER report  "4 hours after receiving the vaccine that she had swelling, bumps on her hands spreading up her arm toward her neck and throat area.   She  describes some mild feeling of tingling in her throat and some discomfort going up the back of her head.  She denies any difficulty breathing, difficulty swallowing or any chest pain or discomfort.  She denies any other rashes or other recent illnesses".
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Employee reported to ER for care on 6/5/19 reporting left sided arm redness and swelling  after receiving the tetanus vaccine.  Employee reported per ER report  "4 hours after receiving the vaccine that she had swelling, bumps on her hands spreading up her arm toward her neck and throat area.   She  describes some mild feeling of tingling in her throat and some discomfort going up the back of her head.  She denies any difficulty breathing, difficulty swallowing or any chest pain or discomfort.  She denies any other rashes or other recent illnesses".
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm swelling and redness after Pneumococcal vaccine 23 valent. No report of SOB or fever. Given Prednisone 20 mg tab, 1 tablet daily x 3 days & Loratadine 10 mg tab, 1 tab daily Dispense #30 with no refill. Use cool packs on affected areas & return for worsening symptoms to reevaluate promptly.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Left arm swelling and redness after Pneumococcal vaccine 23 valent. No report of SOB or fever. Given Prednisone 20 mg tab, 1 tablet daily x 3 days & Loratadine 10 mg tab, 1 tab daily Dispense #30 with no refill. Use cool packs on affected areas & return for worsening symptoms to reevaluate promptly.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chromaturia, Feeling abnormal, Headache, Posture abnormal
Clinical narrative: 1. Next day tremendous headache-gradually easing 2. Sunday morning grass green pee (one insident) 3. Burning at the old shingles location (from Nov2017) 4. Weakness increasing as the days went by...to the point of almost falling off chair; severe drowsiness. pt had  to hold her head up 5. Patient felt as if she was poisoned 2 weeks later started slowly getting better but still weak.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation, Somnolence
Clinical narrative: 1. Next day tremendous headache-gradually easing 2. Sunday morning grass green pee (one insident) 3. Burning at the old shingles location (from Nov2017) 4. Weakness increasing as the days went by...to the point of almost falling off chair; severe drowsiness. pt had  to hold her head up 5. Patient felt as if she was poisoned 2 weeks later started slowly getting better but still weak.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: administered a dose of improperly stored VARIVAX; No adverse effects were reported; Information has been received from an office manager referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided.  On an unknown date, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R033656, expiration date was 20-NOV-2020; strength, dose and route were not reported) for prophylaxis. The vaccine had temperature excursion of the range 15 Fahrenheit (F) degree to 46 F degree (26 F degree) for 6 hours. There has no previous temperature excursion. The call was due to the digital data logger. No adverse effects were reported.  This is one of five reports which have the same reporter regarding different patients.; Sender's Comments:  US-009507513-1906USA002087: US-009507513-1906USA002088: US-009507513-1906USA002089: US-009507513-1906USA002090:
Sex: F
Vaccine: HPV9
Symptoms: Anogenital warts, Stress
Clinical narrative: Outbreak of genital warts that was worse in severity than any prior outbreak; lot of stress; This spontaneous report was received from a physician via company representative refers to an adult female patient of age between 30 to 32 years old. The patient's prior history included genital warts. Information drug reactions or allergies were not reported. On unknown dates, the patient was vaccinated with 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route, dose, lot # and expiry date unknown) for prophylaxis. On an unknown date, following administration of the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced a new outbreak of genital warts which was worse in severity than any prior outbreak (anogenital warts). The patient received two weeks treatment with "TCA" (Trichloroacetic Acid). On an unknown date, the patient also was under a lot of stress (stress) and she felt that the new outbreak of genital warts was related to the stress. The outcome of the events anogenital warts and stress was unknown. The reporter assessed the event anogenital warts to be not related with the suspect drug hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The reporter did not provide the causality assessment between the event stress and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). There were no cancer or overdose involved to this report.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: administered a dose of improperly stored VARIVAX; No adverse effects were reported; Information has been received from an office manager referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided.  On an unknown date, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R033656, expiration date was 20-NOV-2020; strength, dose and route were not reported) for prophylaxis. The vaccine had temperature excursion of the range 15 Fahrenheit (F) degree to 46 F degree (26 F degree) for 6 hours. There has no previous temperature excursion. The call was due to the digital data logger. No adverse effects were reported.  This is one of five reports which have the same reporter regarding different patients.; Sender's Comments:  US-009507513-1905USA006861:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect reported; 1 dose of Varivax was administered intramuscular; This spontaneous report was received from a pharmacy student and refer to a 22 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 03-MAY-2019, the patient was vaccinated with one dose varicella virus vaccine live (oka/merck)(VARIVAX) injection, that was administered intramuscularly (dose, lot number, expiration date and frequency were not reported) for prophylaxis (incorrect route of product administration).     No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Patient has reddened area approximately 2" x 2 1/2".  Patient noted about 7:00 am and states that it has continued to increase in size as day has passed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injected limb mobility decreased, Muscular weakness, Nausea
Clinical narrative: spoke with pt she had a pneumovax in her right deltoid in the office  Arm was very painful and was unable to use it on 6/4/19 Arm was limp per pt. She continues to have a mild headache sl nausea and chills. No fever. She says her arm is getting better using heat and ice as needed. Apap and ibuprofen as needed for discomfort . patent had declined an office visit.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: spoke with pt she had a pneumovax in her right deltoid in the office  Arm was very painful and was unable to use it on 6/4/19 Arm was limp per pt. She continues to have a mild headache sl nausea and chills. No fever. She says her arm is getting better using heat and ice as needed. Apap and ibuprofen as needed for discomfort . patent had declined an office visit.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Injection site reaction, Pain
Clinical narrative: Pressure/aching soreness and burning pain at injection site.  States is unable to lift arm above shoulder.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin decreased
Clinical narrative: fever, bulging fontanelle, fussiness, decreased PO intake within a few hours within 1 day after receiving 4 month vaccines
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood glucose normal
Clinical narrative: fever, bulging fontanelle, fussiness, decreased PO intake within a few hours within 1 day after receiving 4 month vaccines
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased, CSF culture negative
Clinical narrative: fever, bulging fontanelle, fussiness, decreased PO intake within a few hours within 1 day after receiving 4 month vaccines
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Carbon dioxide normal, Culture urine negative, Fontanelle bulging, Haematocrit normal, Haemoglobin normal
Clinical narrative: fever, bulging fontanelle, fussiness, decreased PO intake within a few hours within 1 day after receiving 4 month vaccines
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Hypophagia, Irritability, Platelet count normal, Protein total normal, Pyrexia
Clinical narrative: fever, bulging fontanelle, fussiness, decreased PO intake within a few hours within 1 day after receiving 4 month vaccines
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: White blood cell count increased
Clinical narrative: fever, bulging fontanelle, fussiness, decreased PO intake within a few hours within 1 day after receiving 4 month vaccines
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Patient had no issue with the first dose of vaccine. He is experiencing shingle like rashes on his leg and fore arm. The rashes have blisters and are drying up. No pain, itchiness or fever noted.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Patient began with inflammation and pain at injection site.  By 8:00 PM that same evening inflamed area was erythematous and measured approximatel 5 cm in diamete in an uneven roughly oval shape.  Patient was brought back into the office on 06/06/2019 at 1:15 PM for evaluation.  Inflamed area now measured approximately 12.5 cm erythematous, pruritic, and painful.  Patient diagnosed with cellulitis, placed on augmentin 400mg-57 mg/5 ml  with order of 5 ml twice daily via oral route x 10 days, prednisolone 15 mg/ 5 ml with order of 5 ml twice daily via oral rout x 5 days.  Will re-evaluate in office in 5 days or earlier as needed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, nausea, fever. lasting one day.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Feeling hot, Hyperhidrosis, Nausea, Syncope, Vomiting
Clinical narrative: Two minutes after administration of both vaccines, pt experienced syncope for approximately 10-15 seconds. Pt felt hot, sweaty, and nauseous proceeded to vomit 20 minutes later.  EMS was dispatched and Vital Signs were WNL, pt was release ROR to MOC.  Pt was given water, juice, and cold compresses throughout recovery time. Total recovery time was approximately 25 minutes.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration around injection site
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: About 6pm arm started to hurt by bedtime is was extremely painful to move up/down 6/4 in morning, arm sore to move and upper arm was swollen and bright red 6/5 in morning, was able to move arm more and there was still swelling, redness, itching. Patient contacted doctor and was directed to ER (Urgency Room).  Patient was diagnosed in urgent care with severe allergic reaction to vaccine and was prescribed Prednisone and ice packs.   Followed up with doctor via phone on 6/6 to get vaccine info. Medication has helped, swelling and redness has decreased. There still is itching but it improves with medicine. Patient is able to move arm fine now
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: About 6pm arm started to hurt by bedtime is was extremely painful to move up/down 6/4 in morning, arm sore to move and upper arm was swollen and bright red 6/5 in morning, was able to move arm more and there was still swelling, redness, itching. Patient contacted doctor and was directed to ER (Urgency Room).  Patient was diagnosed in urgent care with severe allergic reaction to vaccine and was prescribed Prednisone and ice packs.   Followed up with doctor via phone on 6/6 to get vaccine info. Medication has helped, swelling and redness has decreased. There still is itching but it improves with medicine. Patient is able to move arm fine now
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Blood thyroid stimulating hormone normal, Electrocardiogram, Lymph node pain, Lymphadenopathy, Red blood cell sedimentation rate normal
Clinical narrative: Patient seen 2 days after TDAP.  Pt complained of left lymph node swelling over left collar bone, tender to touch.  Symptomatic treatment given, ECG and labs
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Treponema test negative
Clinical narrative: Patient seen 2 days after TDAP.  Pt complained of left lymph node swelling over left collar bone, tender to touch.  Symptomatic treatment given, ECG and labs
Age: 1.42
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Immunization : Hep A 2nd dose given 15 days before it was due.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injected limb mobility decreased, Injection site pain, Limb mass, Periarthritis
Clinical narrative: Patient describes pain at the injection site after receiving the shot. Then her arm turned into a golf-ball size lump that felt hard to the touch. She then describes that for a month after receiving the injection, she was having a hard time raising her arm and that it was still painful to the touch. She decided to go see her doctor after about a month and they described her as having "frozen shoulder". Two steroid shots, physical therapy, and a meloxicam prescription later, she still cannot move her arm well.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient describes pain at the injection site after receiving the shot. Then her arm turned into a golf-ball size lump that felt hard to the touch. She then describes that for a month after receiving the injection, she was having a hard time raising her arm and that it was still painful to the touch. She decided to go see her doctor after about a month and they described her as having "frozen shoulder". Two steroid shots, physical therapy, and a meloxicam prescription later, she still cannot move her arm well.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscular weakness, Musculoskeletal disorder, Pyrexia
Clinical narrative: Patient reported fever (101-102) starting 11 pm on 6/2/19 along with headache.  At approximately 9:00 AM on 6/3/19, patient developed muscle weakness in both legs and lost use of both legs.  This lasted until about 10 PM on 6/3/19.  Patient still complains of mild headache as of 6/6/19.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; The patient was inadvertently administered one dose of expired VAQTA; This spontaneous report was received from the office manager regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 05-JUN-2019, the patient was vaccinated inadvertently with expired (expired product administered) Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5, one dose, lot number R013515, expiration date 30-MAY-2019 for prophylaxis (route of administration was not reported). No adverse effects were reported.
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: 11 year-old female received 6th dose of Daptacel; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA151476 (same reporter).  This case involves an 11 years old female patient who experienced received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation received on 24-May-2019 in the left deltoid.  On 24-May-2019, the patient received a single 0.5 ml 6th dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA via unknown route in the right deltoid.  It was of actual medication error due to extra dose administered.  It was unknown whether adverse event occurred.  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.  List of documents held by sender: none.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: the DTaP/IPV portion only of Pentacel vaccine was given to a 4 month old child; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a four months old patient who was vaccinated with a DTaP/IPV portion only of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (DTaP- lot: UJ067AAA, expiry date: 13-Jun-2020, ActHIB- lot: UJ067AA, expiry date: 13-Jun-2020) via intramuscular route in right thigh on 29-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It is an actual medication error case due to inappropriate reconstitution technique. It was reported that the reported that the DTaP/IPV portion only of Pentacel vaccine was given to a 4 month old child.  It was unknown whether the patient had any adverse event or not or the patient will be re-vaccinated.  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.  List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist via other company (Pfizer).  This case involves patient with unknown age and gender who experienced hives, while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious hives (urticaria) with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not provided.  Final diagnosis was hives.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for hives.  List of documents held by sender- none. Information on batch number was requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received Menactra vaccine that had expired; Initial information received on 31-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 11 years old male patient who received an expired dose (1 dose) of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5866CF, expiry date-22-May-2019 via intramuscular route in the right arm on 31-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  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.  Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: 13 month old child received the DTaP-IPV diluent portion only of prescribed Pentacel/ no adverse events reported; Initial information received on 31-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 13 months old patient (gender unknown) who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, vaccinations, treatments and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) on 13-May-2019.  On 13-May-2019, the patient received a third dose 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, DTaP-IPV Lot- C5458AA, expiry date 03-Jun-2019, HIB- Lot- C5262AD, expiry date 03-Jun-2019 via intramuscular route in the left thigh.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that 13 month old child received the DTaP-IPV diluent portion only of prescribed Pentacel.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: 27 years old patient received rabies vaccine in left thigh; Initial information received on 31-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 27 years old female patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RABIES IMMUNEGLOBULIN (RABIES IMMUNEGLOBULIN).   On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via intramuscular route in the left thigh.  It was an actual medication error due to vaccine administered at inappropriate site.  It was reported that 27 years old patient received rabies vaccine in left thigh.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on Batch number was requested.  List of documents held by sender: none.
Age: 1.25
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine to a 15 month old child; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.   This case involves a 15 months old patient (gender not reported) who was vaccinated with a 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5206AA and expiry date: 17-May-2019) via intramuscular route in the left thigh on 03-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included patient was vaccinated with a dose of HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation on an unknown date.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   Documents held by the sender: none.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: "Normal" strong arm pain for 4 or 5 days, then horrible shoulder pain for 6 weeks so far, including tingling, weakness, pain in the left arm. Chiropractic treatment, physical therapy, X-rays, MRI, appt. with orthopedic surgeon and still horrible pain.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: "Normal" strong arm pain for 4 or 5 days, then horrible shoulder pain for 6 weeks so far, including tingling, weakness, pain in the left arm. Chiropractic treatment, physical therapy, X-rays, MRI, appt. with orthopedic surgeon and still horrible pain.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: C-reactive protein, Full blood count, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Patient's arm started hurting on 6/4/19 night. Left arm was swollen, bruised form injection site all the way down to elbow and extremely painful.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient's arm started hurting on 6/4/19 night. Left arm was swollen, bruised form injection site all the way down to elbow and extremely painful.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood test, C-reactive protein, Full blood count, Injection site erythema, Vaccination site induration
Clinical narrative: Patient's arm started hurting on 6/4/19 night. Left arm was swollen, bruised form injection site all the way down to elbow and extremely painful.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient's arm started hurting on 6/4/19 night. Left arm was swollen, bruised form injection site all the way down to elbow and extremely painful.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: Chills, sweats, severe fatigue (unable to stand for about an hour), arm soreness, dizziness
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Pt stated to pharmacist that she noticed "nerve sensitivity" in left arm within hours of receiving shot.  She described the sensitivity like mild electric shocks.  She stated that on the day after the shot (shot given on 6-5-19 in afternoon) that she felt the same nerve sensitivity all over.  Twenty-four hours after the shot, she was still having these sensations.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Heart rate increased, Injection site erythema, Injection site pain
Clinical narrative: A couple hours after the vaccine I experiences dizziness, fast heartbeat and weakness.  This lasted about 40 minutes.  The weakness continued for about 18 hours.  I also had pain at the site for  three days and redness at the site for four days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: by following day patient had soreness and a slight rash on upper arm. by second day patient stated upper arm was swollen and very rashy.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Axillary pain, Musculoskeletal stiffness, Peripheral swelling, Pyrexia
Clinical narrative: Within the first 24-30 hours, swelling in entire arm, joint pain, stiffness, tender to touch, fever, rash,  pain in armpit.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Tenderness
Clinical narrative: Within the first 24-30 hours, swelling in entire arm, joint pain, stiffness, tender to touch, fever, rash,  pain in armpit.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Started to swell the evening after vaccine given and painful for 3 to 4 days. Later became bruised but no longer painful.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: PATIENT RECEIVED HER FLU SHOT. APRROXIMATELY, 20 MINUTES LATER, SHE RETURNED TO THE PHARMACY FEELING FAINT. SHE WAS SWEATING AND PALE. SHE ADMITTED THAT SHE HAD NOT HAD A VACCINE IN AWHILE, AND SHE REMEMBERS SHE HAD TO STOP A TATTOO PROCESS WHEN SHE WAS 18 BECAUSE OF HER FAINTNESS. I CHECKED HER BLOOD PRESSURE, WHICH WAS LOW. I GAVE HER WATER TO DRINK. I OFFERED TO CALL AN AMBULANCE OR HER SPOUSE. BUT, SHE PREFERRED TO STAY AT THE PHARMACY, AND CALLED HER FRIEND TO KEEP HER COMPANY OVER THE PHONE. I CONTINUED TO CHECK HER BLOOD PRESSURE, WHICH GRADUALLY RETURNED TO NORMAL OVER APPROXIMATELY 30 MINUTES. SHE DIDN'T REQUIRE FURTHER TREATMENT AND WAS FINE GOING HOME.