chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal distension, Abdominal pain upper, Constipation, Erythema, Nausea
Clinical narrative: Patient was in for well check and immunizations in the morning of 07/17 about 9am. Mother reports patient seemed fine until the evening on the 17th (same day as vaccinations) when she started complaining of stomachache.  Mom said patient looked pale and said that she felt like she was going to throw up.  She gagged a few times, but did not throw up. Mother also reported patient has eaten and kept fluids down that day.  She had tried without success to stool.  Mother denies fever, or rash.  Mom gave her Tylenol.  Mother states she called because patient's stomach was hard.  Provider recommended Benadryl 5 ml and to watch patient.  Mother was instructed that if patient is having difficulty breathing, color gets worse, or the abdominal pain gets worse, mom will call 9-1-1 or take patient to local hospital.  Today (07/20/2020) mother has sent a picture and there is a raised, red, round patch that appears to be comparable to a quarter in size. We have recommended applying ice packs and hydrocortisone to the site and to continue to monitor.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Retching, Swelling
Clinical narrative: Patient was in for well check and immunizations in the morning of 07/17 about 9am. Mother reports patient seemed fine until the evening on the 17th (same day as vaccinations) when she started complaining of stomachache.  Mom said patient looked pale and said that she felt like she was going to throw up.  She gagged a few times, but did not throw up. Mother also reported patient has eaten and kept fluids down that day.  She had tried without success to stool.  Mother denies fever, or rash.  Mom gave her Tylenol.  Mother states she called because patient's stomach was hard.  Provider recommended Benadryl 5 ml and to watch patient.  Mother was instructed that if patient is having difficulty breathing, color gets worse, or the abdominal pain gets worse, mom will call 9-1-1 or take patient to local hospital.  Today (07/20/2020) mother has sent a picture and there is a raised, red, round patch that appears to be comparable to a quarter in size. We have recommended applying ice packs and hydrocortisone to the site and to continue to monitor.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: severe redness and swelling to left thigh
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient had swelling on side of left thigh measuring 2.5 inches x 2.5 inches. It was swollen and tender to palpation. Mom advised to use warm compresses to the area to reduce swelling.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Feeling cold, Headache, Hyperaesthesia, Injection site pain
Clinical narrative: Pain and tenderness in upper left arm, radiating to neck and shoulders Feeling of being very cold, accompanied by severe shivering. Headache Letheragy Skin sensitivity to sunlight - sunburn in 30 minutes of sun exposure to head and face when areas were already well tanned.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Lethargy, Neck pain, Sunburn, Tenderness
Clinical narrative: Pain and tenderness in upper left arm, radiating to neck and shoulders Feeling of being very cold, accompanied by severe shivering. Headache Letheragy Skin sensitivity to sunlight - sunburn in 30 minutes of sun exposure to head and face when areas were already well tanned.
Age: 0.58
Sex: M
Vaccine: PNC13
Symptoms: Rash, Swelling
Clinical narrative: Bad rash and swelling of head
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Aggression, Decreased eye contact, Developmental regression, Disturbance in social behaviour, Insomnia
Clinical narrative: Severe regression in development; loss of language, tantrum behaviors, loss of eye contact with others, loss of socialization, sleep regression, developmentally set back over six months to year in skills
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Language disorder
Clinical narrative: Severe regression in development; loss of language, tantrum behaviors, loss of eye contact with others, loss of socialization, sleep regression, developmentally set back over six months to year in skills
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given pediarix instead of proquad, per the direction of Dr. patient was administered the proquad and he advised that  it would not lead to any adverse reaction to patient.  Patient's mom was made aware of wrong vaccine given.  After proquad was given, patient was monitored and left office with no reactions.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Dizziness, Fatigue, Nausea, Pruritus
Clinical narrative: Patient received vaccination at 15:22 on 7/16/20 and then went home and mowed her lawn. She woke up on 7/17/20 around 5 am feeling itching all over, and noted a few hives on her stomach and has felt some nausea and dizziness since.  She states she had mild congestion and a slight cough but cough/congestion has resolved.  She denies throat swelling, lip swelling, tongue swelling or facial swelling. She denies chest tightness, chest pain or SOB. No vomiting but does feel nauseated, she also feels dizzy and fatigued. Pt used hydrocortisone cream on her stomach and the rash has improved. Has not tried any OTCs Patient seeking treatment on 7/17/20 at 0840 am.  Pt instructed to take 1-2 Benedryl 25-50mg PO every 6-8hrs for the next 3-5days as needed for itching/hives; Zyrtec once daily for the next 3-5 days and Zantac BID for the next 3-5 days Patient called on 7/17/20 at 1500 for follow up and states she was feeling less dizzy and the itching has lessened with Benadryl.  Patient called on 7/20/20 at 0820 after the weekend. Patient had only been taking the Benadryl through the weekend and felt better. Patient did not take Benadryl today but encouraged to take an antihistamine such as zyrtec
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Respiratory tract congestion, Urticaria
Clinical narrative: Patient received vaccination at 15:22 on 7/16/20 and then went home and mowed her lawn. She woke up on 7/17/20 around 5 am feeling itching all over, and noted a few hives on her stomach and has felt some nausea and dizziness since.  She states she had mild congestion and a slight cough but cough/congestion has resolved.  She denies throat swelling, lip swelling, tongue swelling or facial swelling. She denies chest tightness, chest pain or SOB. No vomiting but does feel nauseated, she also feels dizzy and fatigued. Pt used hydrocortisone cream on her stomach and the rash has improved. Has not tried any OTCs Patient seeking treatment on 7/17/20 at 0840 am.  Pt instructed to take 1-2 Benedryl 25-50mg PO every 6-8hrs for the next 3-5days as needed for itching/hives; Zyrtec once daily for the next 3-5 days and Zantac BID for the next 3-5 days Patient called on 7/17/20 at 1500 for follow up and states she was feeling less dizzy and the itching has lessened with Benadryl.  Patient called on 7/20/20 at 0820 after the weekend. Patient had only been taking the Benadryl through the weekend and felt better. Patient did not take Benadryl today but encouraged to take an antihistamine such as zyrtec
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: At time of injection there was pain similar to getting Tetanus vaccine, MA alerted me that it might be sore in a similar way for a few days. That evening there was increased redness and swelling at the injection site, followed by a fever throughout the night. The following day, fever resolved, but fatigue continued for 3 days with increasing redness and pain, difficulty using arm, was hard to pull up pants after toileting due to pain and weakness in arm. By day 4 status post vaccine erythema and swelling greatly increased to most of outer upper left arm between elbow and shoulder. Went to urgent care on 6/27/2020, was diagnosed with cellulitis, given rx for Cephalexin 500mg bid x 7 days, resolved within those 7 days.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Muscular weakness, Musculoskeletal disorder, Pain in extremity, Pyrexia
Clinical narrative: At time of injection there was pain similar to getting Tetanus vaccine, MA alerted me that it might be sore in a similar way for a few days. That evening there was increased redness and swelling at the injection site, followed by a fever throughout the night. The following day, fever resolved, but fatigue continued for 3 days with increasing redness and pain, difficulty using arm, was hard to pull up pants after toileting due to pain and weakness in arm. By day 4 status post vaccine erythema and swelling greatly increased to most of outer upper left arm between elbow and shoulder. Went to urgent care on 6/27/2020, was diagnosed with cellulitis, given rx for Cephalexin 500mg bid x 7 days, resolved within those 7 days.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 10-JUN-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) prefilled syringe injection, lot # S026003, expiration date 17-OCT-2020 (exact dose and injection site were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026003; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA001137: US-009507513-2007USA001778: US-009507513-2007USA001779: US-009507513-2007USA001780: US-009507513-2007USA001781: US-009507513-2007USA001782: US-009507513-2007USA001783:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 29-JUN-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) prefilled syringe injection, lot # S026003, expiration date 17-OCT-2020 (exact dose and injection site were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026003; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA001777: US-009507513-2007USA001779: US-009507513-2007USA001780: US-009507513-2007USA001781: US-009507513-2007USA001782: US-009507513-2007USA001783: US-009507513-2007USA001137:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 12-JUN-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) prefilled syringe injection, lot # S026003, expiration date 17-OCT-2020 (exact dose and injection site were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026003; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA001137: US-009507513-2007USA001777: US-009507513-2007USA001778: US-009507513-2007USA001780: US-009507513-2007USA001781: US-009507513-2007USA001782: US-009507513-2007USA001783:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 05-JUN-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) prefilled syringe injection, lot # S026003, expiration date 17-OCT-2020 (exact dose and injection site were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S026003; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA001137: US-009507513-2007USA001781: US-009507513-2007USA001782: US-009507513-2007USA001783: US-009507513-2007USA001777: US-009507513-2007USA001778: US-009507513-2007USA001779:
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Product storage error
Clinical narrative: injection site redness; was adrninistered a dose of PROQUAD that bad a temperature excursion.; This spontaneous report was received from a physician and refers to a 15-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in May 2020 (reported as "2 months ago"), the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), which was involved in temperature excursion before administration (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. The exact temperature excursion was not reported. On an unknown date in May 2020, the patient experienced injection site redness that lasted a month. The hydrocortisone topical product was used as a treatment. The outcome of injection site erythema was reported as resolved.  Causality assessment was not provided.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Staff inadvertently administered expired dose to a patient, no AE; Initial information received on 15-Jul-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a patient (with unknown demographics) who was inadvertently administered an expired dose of vaccine IPV (VERO) [IPOL] (lot number and Expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was an actual medication error case due to expired vaccine used.  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 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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Tenivac left in the freezer for 20 minutes, No AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a female patient of an unknown age.  This case involves temperature excursion of the DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U663AA, expiry date: 12-APR-2022), which had occurred due to vaccine left in the freezer for 20 minutes (human errors) was detected and declared on an unknown date (vaccine indication is prophylactic vaccination).  It was a case of a potential medication error due to product storage error temperature too low.  At the time of reporting it was unknown if vaccine was administered to the patient or not.  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: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Menactra was given to patient/no AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 years old female patient who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number U6219BA, dosing details 0.5 ml and dosage interval: once) route and site of administration not reported on 14-Jul-2020 for prophylactic vaccination which was already expired on 16-Jun-2020 (Expired product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case 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: 7.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: female child received a dose of expired Ipol / no AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 years old female patient who was vaccinated with once 0.5 ml third dose of expired vaccine IPV (VERO) [IPOL (lot number unknown ) Expiry date-May-2020 via unknown route in the left thigh on 14-Jul-2020 for Prophylactic vaccination.  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications were also not provided.  It was an actual medication error case due to expired vaccine used.  No reported side effects.  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.  There will be no information available on the batch number for this case.
Age: 1.5
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received a dose of expired Menactra / no AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 18 year old male patient who was vaccinated with expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6207AB and Expiry date 25-May-2020) via intramuscular route in the left deltoid on 14-Jul-2020 for Prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event 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 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.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Adacel was administered to an individual when it was expired/no AE; Initial information was received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (unknown demographics) who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] when it was expired (batch number, route, site of administration and expiry date not reported) on an unknown date for prophylactic vaccination (Expired product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  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 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.  There will be no information available on batch number for this case.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Quadracel was given but it leaked and that led to the patient receiving less than the recommended dose/NO AE; Quadracel was given but it leaked due to syringe issue and that led to the patient receiving less than the recommended dose/NO AE; Initial information was received on 16-Jul-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a patient of an unknown demographics who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], but it leaked and that led to the patient receiving less than the recommended dose.  Medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose.  It was also the case of syringe leak.  A dose of Quadracel was given and then it experienced a syringe issue, there was leakage that led to the patient receiving less than the recommended dose.  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 Directiveand 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.  There will be no information available on the batch number in this case.
Age: 91.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash
Clinical narrative: Rash at injection site appeared about 10 days after shot was given
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left Shoulder painful to touch, welling  redness and hot
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: PATIENT REPORTED REDNESS AT INJECTION SITE, SWELLING, ITCHING. AREA IS WARM TO THE TOUCH . COMPLAINS OF PAIN REACHING UP TOWARDS HER NECK
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: redness, swelling, warm to the touch, itchiness. Was given ibuprofen 200 mg on 7/18/20 and 7/19/20
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Borrelia test negative, Genital rash, Rash, SARS-CoV-2 test negative
Clinical narrative: Rash on hands, lower legs, groin rash noted after receiving menactra booster, noted in the evening of the day he received the vaccine could not attribute cause for the rash.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Swollen tongue
Clinical narrative: Mom called Triage on 7/18/2020 (triage service outsourced during after hours) to report that son c/o tongue feeling swollen post vaccines given on 7/17/2020. Per triage note, no other symptoms. Advised to give Benadryl as directed. This RN spoke with mom on 7/20/2020 @ 1130 to confirm concerns. Per mom symptoms seem to be improving gradually using Benadryl. RN advised mom if not completely improved in the next 48-72 hours to call our office back for further advise. Mom agreed to do so.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Disorientation, Dizziness, Headache, Neck pain, Visual impairment
Clinical narrative: R arm pain w/in 1 hour of immunization. Several hours later developed sever headache, located behind her eyes.  Able to sleep overnight, but awoke w/ more severe headache, neck & occipital pain, described as "the worst headache I've ever had."  Was dizzy & disoriented, and described that her vision didn't seem normal.  Was taken to the ER at Hospital, where she received a "migraine cocktail" of IV fluids, Toradol, Benadryl, & Compazine.  She was eventually able to sleep, slept x 15 hours, then was better the following day.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphoedema, Pyrexia
Clinical narrative: fever, lymph accumulation in underarm of approx. 1 quart per patient. elevation of arm and 2 days of monitoring and it went away
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mom states that the first day patient c/o of arm hurting and was "grabbing" her arm.  Mom gave her tylenol for discomfort and applied ice pack that seemed to help.  About day 3 mom stated arm was "beet red" from the sight of the injection about down to her elbow.  Her arm hurt for about a week after the injection.  When I spoke with mom today she stated her arm doesn't hurt anymore and there is about an  area of 1 inch on her arm around the injection site that is still red.  Mom stated that her arm also looked swollen.
Age: 19.0
Sex: U
Vaccine: UNK
Symptoms: Chills, Dysphagia, Dyspnoea, Pain, Pharyngeal swelling
Clinical narrative: Box 17 - Varicella  Chills, body aches, swollen throat (hard to breath, swallow, talk). Seen at Emergent Care. Tested for strep, negative. Advised to stay home for 5 days, rest, take Advil every 4-6 hours. Denied relation to Varicella vaccine. Planning to follow up with PCP on 7/21/20.   Box 23 - Experienced flu after taking MMR vax
Age: 19.0
Sex: U
Vaccine: UNK
Symptoms: Speech disorder, Streptococcus test negative, Varicella post vaccine
Clinical narrative: Box 17 - Varicella  Chills, body aches, swollen throat (hard to breath, swallow, talk). Seen at Emergent Care. Tested for strep, negative. Advised to stay home for 5 days, rest, take Advil every 4-6 hours. Denied relation to Varicella vaccine. Planning to follow up with PCP on 7/21/20.   Box 23 - Experienced flu after taking MMR vax
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Cold sweat, Loss of consciousness, Pallor, Tremor
Clinical narrative: Approximately 4 minutes after completion of last shot at approximately 3: 04 PM , pt. slumped over in chair. Pt. was clammy, shaking and very pale. Pt. loss conscience for about 15 seconds before responding to verbal commands. Pt. mother states that she has history of passing out and she has not eaten all day. BP was undectable with first attempt at 0310 PM with automatic cuff, at 0311 BP was 90/60 with manual cuff, 0315 PM 90/58, and at 0320 BP was 92/58. At 310 pt. was responding and drinking orange juice but continued to be clammy and pale. At 0330 PM patient walked unassisted with her mother out of the health department.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal distension, Gastrointestinal disorder, Laboratory test normal, Nausea
Clinical narrative: I have nausea along with intestinal issues.  I was throwing up.  Stomach has been upset for weeks. It is a little better, but initially I could not even drink water as I felt full and nauseous.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: I have nausea along with intestinal issues.  I was throwing up.  Stomach has been upset for weeks. It is a little better, but initially I could not even drink water as I felt full and nauseous.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose given.  No adverse event at this time.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Confusional state, Rash, SARS-CoV-2 test negative
Clinical narrative: Patient experienced a severe back ache and mental confusion (fuzzy thinking) 2 weeks after receiving the vaccine, this episode lasted approximately 3 days. Patient also developed a bilateral "vascular" rash about 2 inches in diameter on each cheek that lasted approximately 1 week and started 2 weeks post vaccination date. Both episodes were self limiting with no treatment.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal pain lower, Chills, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Pallor, diaphoresis, nausea, vomiting, light-headedness, dizziness, chills, shivering, lower abdominal pain
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pallor, Vomiting
Clinical narrative: Pallor, diaphoresis, nausea, vomiting, light-headedness, dizziness, chills, shivering, lower abdominal pain
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: When I called the patient to remind her of needing the 2nd dose she told me she would not be getting the 2nd shot due to the pain and numbness/tingling she had from the first vaccine. She stated that it took about 4 months for it to feel better.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Swollen tongue, Tenderness
Clinical narrative: Day after shot left side of tongue swelling beginning gradually  End of second day  left side of  tongue  visibly swollen  arm  was red and slightly swollen below shot site Treatment: ice on tongue then took two Tylenol went to  bed Third day, in the morning,tongue less swollen  and by mid morning swelling almost gone  Arm still slightly red and tender below shot site
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient informed technician over the phone that he wanted to receive the tetanus vaccine. We offered the Boostrix vaccine and pt accepted per MD recommendations. When he arrived at the pharmacy, pharmacist verified with pt that this was the vaccine and what it was for and asked why he needed the vaccine. Pt stated that he needed his vaccinations up to date.  Pt was vaccinated and given the forms for verification and left the pharmacy. MD called and stated that the patient has been very confused about the various vaccines he needed and she informed us that he was given the Boostrix vaccine 1 week prior in her office and that he actually needed the MMR vaccine.  He received the MMR vaccine today as well at a different pharmacy. He verified that he is fine, is not feeling any symptoms or side effects and just wanted the incident reported.
Age: 76.0
Sex: F
Vaccine: FLU4, FLUA3
Symptoms: Cognitive disorder, Magnetic resonance imaging, Mobility decreased, Nausea, Personality change
Clinical narrative: Nausea, Fever, Pain Severed tendon, sepsis, MERSA Loss of Mobility, loss of cognitive skills, Change of personality.
Age: 76.0
Sex: F
Vaccine: FLU4, FLUA3
Symptoms: Pyrexia, Staphylococcal sepsis, Tendon pain, Tendon rupture, X-ray
Clinical narrative: Nausea, Fever, Pain Severed tendon, sepsis, MERSA Loss of Mobility, loss of cognitive skills, Change of personality.
Age: 83.0
Sex: F
Vaccine: DTAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: Provider ordered Tdap vaccine for pt. Pulled vaccine for pt to be varified by co-staff, Dtap pulled by writer, verified by co-staff but not caught by either staff.   Gave Dtap as error to left deltoid.  Error discovered within minutes of pt leaving office when entering  vacc given into computer.  Talked with provider, called to inform pt. of lesser dose given.  Pt will be called back with correct timing  of dosing to  get as originally ordered.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: red rash on lower arm. advised to use Benadryl or hydrocortisone for itchiness. Contact MD if worsening or no improvement
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: 9 days after the vaccine, I developed shingles. I have several rash sites - my right side torso and on my right breast.   I have taken acetaminophen and ibuprofen at night in order to sleep.  The pain is very unpleasant, but not as bad as I have heard from others.  I sent pictures of the rash to Dr. and she also thinks this is shingles.
Age: 1.0
Sex: F
Vaccine: MMR, UNK, UNK, VARCEL
Symptoms: Abnormal behaviour, Glassy eyes, Irritability, Lethargy, Pyrexia
Clinical narrative: started having a low grade fever on 7/12, child presented more symptoms on 7/13 including fluctuating fever throughout the day up to 103, vomiting, lethargy, glassy eyes, irritability and clingyness. Fever continue up to 7/14/20 symptoms were gone by 7/15/20.
Age: 1.0
Sex: F
Vaccine: MMR, UNK, UNK, VARCEL
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: started having a low grade fever on 7/12, child presented more symptoms on 7/13 including fluctuating fever throughout the day up to 103, vomiting, lethargy, glassy eyes, irritability and clingyness. Fever continue up to 7/14/20 symptoms were gone by 7/15/20.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on lower part of upper arm. not near injection site. started on 7/16. pt advised to use Benadryl or hydrocortisone for itching if needed. see doctor if worsening or no improvement
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Skin tightness, Skin warm
Clinical narrative: An area approximately 4x3 inches extending downward from top of deltoid muscle to approximately 1 inch above elbow.  Area was warm, reddened  and taunt .
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Pain in extremity, Rash
Clinical narrative: RASH (NO ITCHING), PAIN IN ARMS AND LEGS, EXTREMELY TIRED AND NO ENERGY.   L-LYSINE 1000MG, TURMERIC STRENGTH FOR LIVER, TYLENOL, ADVIL, 2 VITAMIN BAGS INTRAVENOUS BY NATURPATHIC DOCTOR  THE RASH WAS FIRST TO DISAPPEAR IN ABOUT 10 DAYS. IT TOOK OVER 2 WEEKS FOR THE PAIN TO DISAPPEAR AND TO HAVE ENOUGH ENERGY TO FUNCTION.
Age: 74.0
Sex: F
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: PATIENT ALREADY RECEIVED THE COMPLETE SERIES OF SHINGRIX, FIRST DOSE ON 11/06/2019 AND SECOND DOSE ON 01/07/2020.  INADVERTENTLY GIVEN THIRD DOSE.  PATIENT ALSO RECEIVED TDAP (BOOSTRIX) ON SAME DAY BUT IN LEFT ARM.  STATES HAD "FLU LIKE" SYMPTOMS FOR A FEW DAYS AFTER RECEIVING BOTH SHOTS.   REALIZED ON 07/19/2020 OF PREVIOUS DOSES AND CONTACTED PATIENT.  SHE STATES THAT SHE IS FINE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient stated arm was sore approximately 3 days after injection given.  Site was getting better until morning of 07/20/2020 where it flaired up and was sore.  Patient does not have a primary MD but recomended if it continues to hurt or worsen to go to Urgent Care or ER.  Patient states no fever or inflanmation.  I am asking patient to follow up with me in a few days.  Confirmed proper technique was used(proper site and form) upon speaking with patient.
Age: 18.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Pyrexia, Tremor
Clinical narrative: 2 1/2 hrs after administration of Tdap + Bexsero - fever to 103' for 24' w/ shakes + "feeling" awful unable to work next day - mom refusing Bexsero Booster
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Pain, Pyrexia
Clinical narrative: fever after 12hrs 99. to 102.7 Local redness, warmth, pain Lasted 24HRS.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: fever
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Headache; Sweating; Fatigue; Sore Joints; Sore Muscles; This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sulfonamide allergy. Concomitant products included paracetamol (Tylenol).   On 12th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th July 2020, less than a day after receiving Shingrix, the patient experienced headache, sweating, fatigue, soreness of joint and muscle soreness. On an unknown date, the outcome of the headache, sweating, fatigue, soreness of joint and muscle soreness were recovering/resolving.   It was unknown if the reporter considered the headache, sweating, fatigue, soreness of joint and muscle soreness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient experienced sore muscles, sore joints, fatigue, sweating, and a headache since the injection.  The patient was reported taking Tylenol.  The patient was unable to provide lot number and expiration date. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Headache; Sweating; Fatigue; Sore Joints; Sore Muscles; This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sulfonamide allergy. Concomitant products included paracetamol (Tylenol).   On 12th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th July 2020, less than a day after receiving Shingrix, the patient experienced headache, sweating, fatigue, soreness of joint and muscle soreness. On an unknown date, the outcome of the headache, sweating, fatigue, soreness of joint and muscle soreness were recovering/resolving.   It was unknown if the reporter considered the headache, sweating, fatigue, soreness of joint and muscle soreness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient experienced sore muscles, sore joints, fatigue, sweating, and a headache since the injection.  The patient was reported taking Tylenol.  The patient was unable to provide lot number and expiration date. The reporter consented to follow up.
Age: 40.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Urticaria
Clinical narrative: Itchy throat, Hives   24 + hours after receiving  vaccine 36 hours after vaccine, lips swelling and occasional shortness of breath
Age: 40.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dyspnoea, Lip swelling, Throat irritation, Urticaria
Clinical narrative: Itchy throat, Hives   24 + hours after receiving  vaccine 36 hours after vaccine, lips swelling and occasional shortness of breath
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Low grade fever and sore arm
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event.; the patient was inadvertently administered a dose of Rotateq on 22-JUN-2020 that had been improperly stored.; This spontaneous report was received from a physician referring to a 9-week-old patient of unknown gender. Information about medical history, drug reactions/allergies and concomitant therapies was not provided.  On 22-JUN-2020, the patient was inadvertently administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S028768, expiration date 11-APR-2021) (strength, dose, frequency and route were not reported) that had been improperly stored for prophylaxis (product storage error). The vaccines were exposed to temperature 72 Fahrenheit degrees (F) for 47 hours. No previous excursion was reported. The data logger was involved. No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; one patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a physician, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 03-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, as prophylaxis (lot number S012036 which has been verified to be valid, expiration date reported and validated as 17-APR-2021) (dosage, vaccination scheme, route of administration and anatomical site of injection were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). The administered dose of the vaccine was stored at a temperature of 15 degrees Fahrenheit (F) to 46 F: 32.9 F, during a time frame of 5 hours, as recorded by a digital data logger. There was no previous temperature excursion. No additional adverse effects were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA005605: US-009507513-2007USA005952:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events; patient received an expired dose; This spontaneous report as received from a physician, concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 14-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at 0.5 milliliter dose, which had a lot # R018136 with expiration date in 10-JUL-2020 (expired product administered) (route of administration was not provided) for prophylaxis.  At the time of this report the patient had not had adverse events. No PQC was reported.
Sex: M
Vaccine: HPV4
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This spontaneous report has been received from the patient's mother, referring to her son, a 20 years old male patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.       On an unknown date in January 2013, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot #: H016960, expiration date reported as December 2013 but upon internal validation established as 02-DEC-2013; route and dose details were unknown) for prophylaxis.         On an unknown date in January 2013, the patient experienced Bell's Palsy after receiving the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).      The outcome of the event was not provided. The causality assessment between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not provided.  Upon internal review, Bell's Palsy was determined to be medically significant.