chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: DTAP, HPV9, MNQ, MNQ, HPVX, MNQ, TDAP
Symptoms: Dyspnoea, Swelling face, Urticaria
Clinical narrative: Facial Swelling; Urticaria; This case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 97NL3, expiry date 5th June 2021) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis and Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) for an unknown indication.   On 14th August 2019, the patient received Boostrix, HPV vaccine and Meningococcal ACWY Vaccine (potential Menveo). On 14th August 2019, 6 hrs after receiving Boostrix, HPV vaccine and Meningococcal ACWY Vaccine (potential Menveo), the patient experienced facial swelling and urticaria. The patient was treated with cetirizine hydrochloride (Zyrtec), ranitidine hydrochloride (Ranitidine), montelukast sodium (Singulair), decadron (nos) (Decadron), benadryl (nos) (Benadryl) and epinephrine (Epi Pen). On 15th August 2019, the outcome of the facial swelling was recovered/resolved. On an unknown date, the outcome of the urticaria was unknown.   It was unknown if the reporter considered the facial swelling and urticaria to be related to Boostrix, HPV vaccine and Meningococcal ACWY Vaccine (potential Menveo).  Additional case details were reported as follows: The patient had 8:45am appointment where patient received Tdap, MCV4 and HPV, patient returned to office at 13:45 with urticaria, but no tongue or facial swelling and no signs of shortness of breathe.  The patient given decadron 4mg intramuscularly and benadryl 25mg. At 14:33, showed signs of facial swelling and was administered epi 0.3mg IM and at 14:35 ambulance was called and patient was taken to local emergency room and released the same day. On 15th August 2019, patient returned to office and was given epi-pen to take home and started on Zyrtec 10mg, ranitidine 150mg and Singulair 10mg. The patient had not returned since. The reporter gave permission to follow up.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV9, MNQ, MNQ, HPVX, MNQ, TDAP
Symptoms: Swelling face, Urticaria
Clinical narrative: Facial Swelling; Urticaria; This case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 97NL3, expiry date 5th June 2021) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis and Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) for an unknown indication.   On 14th August 2019, the patient received Boostrix, HPV vaccine and Meningococcal ACWY Vaccine (potential Menveo). On 14th August 2019, 6 hrs after receiving Boostrix, HPV vaccine and Meningococcal ACWY Vaccine (potential Menveo), the patient experienced facial swelling and urticaria. The patient was treated with cetirizine hydrochloride (Zyrtec), ranitidine hydrochloride (Ranitidine), montelukast sodium (Singulair), decadron (nos) (Decadron), benadryl (nos) (Benadryl) and epinephrine (Epi Pen). On 15th August 2019, the outcome of the facial swelling was recovered/resolved. On an unknown date, the outcome of the urticaria was unknown.   It was unknown if the reporter considered the facial swelling and urticaria to be related to Boostrix, HPV vaccine and Meningococcal ACWY Vaccine (potential Menveo).  Additional case details were reported as follows: The patient had 8:45am appointment where patient received Tdap, MCV4 and HPV, patient returned to office at 13:45 with urticaria, but no tongue or facial swelling and no signs of shortness of breathe.  The patient given decadron 4mg intramuscularly and benadryl 25mg. At 14:33, showed signs of facial swelling and was administered epi 0.3mg IM and at 14:35 ambulance was called and patient was taken to local emergency room and released the same day. On 15th August 2019, patient returned to office and was given epi-pen to take home and started on Zyrtec 10mg, ranitidine 150mg and Singulair 10mg. The patient had not returned since. The reporter gave permission to follow up.
Age: 5.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site; Redness and swelling at the injection site; This spontaneous report was received from a safety clinical coordinator refers to a 5 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 13-AUG-2019, the patient was vaccinated with (therapy type rHA) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) of one dosage form via subcutaneous route (lot # S006833, exp.date : 02-SEP-2020) for prophylaxis. Other suspect therapies included sterile diluent (DILUENT MRK INJ) of one dosage form (Lot No. N028746 has been verified to be a valid lot number for [sterile diluent], expiration date reported as 17-MAR-2020, but upon internal validation established as 10-MAR-2020). The patient immediately experienced injection site erythema and injection site swelling. The swelling was treated with Benadryl and ice. Exact diluent used to dilute the vaccine was unknown. The patient sought medical attention. No product quality issue was reported. The nurse reported that they are unable to point to specific lot of sterile diluent that was used for a specific vaccine. Sterile diluent was placed in a bin and vials are pulled as necessary from the bin to be used. The lot number for diluent was not recorded with a specific patient. The process has been changed. The four originally shared lot numbers for the diluent have been taken out of the bin, but it was not listed as product in the case product tab. The outcome for injection site swelling and injection site erythema was reported as recovered. The causality assessment between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  and events was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects; Inappropriate administration schedule; This spontaneous report was received from a registered nurse and refers to a 19-year-old patient on unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reaction or allergies were not reported.  On 25-JUN-2014, when the patient was 14 years old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of administration, lot# and expiration date were not reported). On 16-AUG-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot# 1602284, expiration date: 26-SEP-2021 (exact dose, site and route of administration were not reported). No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: she had received PNEUMOVAX 23, on an unspecified date and was now experiencing swelling at the injection site; This spontaneous report aws received from a consumer referring to herself, a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies. On an unknown date, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) and she experienced swelling at the injection site for 10 days.   Now, on an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, dose number, route of administration, anatomical injection site, lot number expiration number were not reported) and on an unknown date, the patient started to experience swelling at the injection site.  At the time of the report, the patient had not recovered from the event and she wanted medical advice for the treatment. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and injection site swelling was not reported.
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Paraesthesia, Rash
Clinical narrative: radiating pain and tingling in the same arm; radiating pain and tingling in the same arm; This spontaneous report as received from an Office manager refers to a 40-year-old female patient. The patient's concurrent condition included immune system depressed due to kidney transplant, lupus (Lupus erythematosus) and pertinent medical history included kidney transplant. The had drug allergies to Sulfa, Mesna.  On 08-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S013490, expiry date: 06-MAR-2021 strength, dosage information and anatomical locations were unknown) intramuscular for prophylaxis.         On 09-AUG-2019, the patient experienced radiating pain and tingling in the same arm (paraesthesia)  rash, and pain.  The patient was advised to administer cold packs to site of discomfort and take Tylenol (Acetaminophen) as needed for pain. No additional information provided. No product quality complaint (PQC). The outcome of paraesthesia, rash and pain was reported as recovered/resolved. Causality was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Crying, Musculoskeletal stiffness, Pain, Pain in extremity, Pyrexia
Clinical narrative: severe leg pain; low grade fever; screaming and crying; screaming and crying; pain and stiffness; This spontaneous report as received from a pharmacist refers to a 12-year-old female patient. No information was provided regarding the patient's medical history, , concomitant therapies and previous drug reactions.     The patient's concurrent conditions included juvenile idiopathic arthritis which she outgrew at around 6 years of age.  On an unknown date in October 2018, (at 8-9AM) during a yearly checkup the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# and expiry date, strength, dosage information, route of administration and anatomical locations were unknown for prophylaxis. On the same day at around 8PM that night, the patient experienced severe leg pain, a low grade fever (pyrexia) and was screaming and crying.   The reporter stated that the next day, the patient experienced a little bit of pain and stiffness (musculoskeletal stiffness) but was fine the following day. No additional adverse experience information provided. The patient had sought medical attention and was treated with motrin (IBUPROFEN) and acetaminophen (TYLENOL).   No additional adverse experience information provided.      On an unknown date in 2018 (reported as two days after vaccination), the patient was recovered from pain in extremity, musculoskeletal stiffness, crying, screaming and pyrexia was reported as recovered/resolved. Causality was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Screaming
Clinical narrative: severe leg pain; low grade fever; screaming and crying; screaming and crying; pain and stiffness; This spontaneous report as received from a pharmacist refers to a 12-year-old female patient. No information was provided regarding the patient's medical history, , concomitant therapies and previous drug reactions.     The patient's concurrent conditions included juvenile idiopathic arthritis which she outgrew at around 6 years of age.  On an unknown date in October 2018, (at 8-9AM) during a yearly checkup the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# and expiry date, strength, dosage information, route of administration and anatomical locations were unknown for prophylaxis. On the same day at around 8PM that night, the patient experienced severe leg pain, a low grade fever (pyrexia) and was screaming and crying.   The reporter stated that the next day, the patient experienced a little bit of pain and stiffness (musculoskeletal stiffness) but was fine the following day. No additional adverse experience information provided. The patient had sought medical attention and was treated with motrin (IBUPROFEN) and acetaminophen (TYLENOL).   No additional adverse experience information provided.      On an unknown date in 2018 (reported as two days after vaccination), the patient was recovered from pain in extremity, musculoskeletal stiffness, crying, screaming and pyrexia was reported as recovered/resolved. Causality was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events; an unspecified adult patient was administered an expired dose of VAQTA; This spontaneous report was received from an administrator and refers to an adult patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 21-AUG-2019, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA), lot # R009606, expiration date 07-AUG-2019 (strength, exact dose and route of administration were not reported) for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; One patient received one dose of improperly stored ROTATEQ; Information has been received from the office manager regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 29-JUL-2019, the patient received one dose of improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot number R025713 with expiration date on 20-JUN-2020 (strength not reported)  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature range of 33.9 degrees Fahrenheit (°F) for the time frame of 20 minutes. The previous temperature excursion was 30.3 °F for 93 hours and 50 minutes. Other previous excursions were reported: lowest temperature below 36 °F (30.3 °F) for 90 hours and 7 minutes, another temperature below 36 °F (30.5 °F) for 1 hour 45 minutes and other temperature below 36 °F (35.2 °F) for 2 hours and 5 minutes. The most recent temperature was below 36 °F (33.9 °F) for the time frame of 40 minutes.  The call was because of a data logger.   No adverse effects reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; One patient received one dose of improperly stored ROTATEQ; This spontaneous report was received from an office manager and refers to one patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On 01-JUL-2019, the patient was vaccinated with one improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R025713, expiration date: 20-JUN-2020 (dose, route of administration and anatomical location were not reported) as prophylaxis. The temperature excursion total time and lowest temperature below 36 °F, was 33.9 Fahrenheit (F) during a time frame of 40 minutes as recorded by data logger. A previous temperature excursion of 30.3 F was reported for 93 hours and 50 minutes. Also, it was reported previous temperature excursion as total time and lowest temperature below 36 °F (30.3 F) for 90 hours and 7 minutes; total time and lowest temperature below 36 °F (30.5 F) for 1 hour and 45 minutes; and total time and lowest temperature below 36 °F (35.2 F) for 2 hours and 5 minutes. No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received Dose 3 of GARDASIL 9 too early; This spontaneous report was received from a medical assistant and refers to an 18 year old male patient.  No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, route of administration, lot# and expiration date were unknown).         It was reported that the patient received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) too early, so the office considered the dose to be invalid. The office brought the patient back to receive an additional dose at a later unknown date.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; The patient was inadvertently administered a dose of ROTATEQ that had been improperly stored.; Information has been received from a certified medical assistant, concerning a 6 month-old patient of an unknown gender. The patient's pertinent medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported.  On 21-AUG-2019, the patient was vaccinated with one improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number S000961 with expiration date on 19-OCT-2020 and lot number R033255 with expiration date on 26-JUN-2020, administered orally (strength and dose number were not provided), for prophylaxis.  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at a temperature of 48.5 degrees Fahrenheit (°F) for a time frame of 15 minutes, there was a previous temperature excursion of 46.9 °F for a time frame of 5 minutes and the call was because of a data logger.   No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received one odse of improperly stored ROTATEQ; No adverse effects reported; This spontaneous report was received from a office manager and a healthcare business professional referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 27-JUN-2019, the patient received one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R025713 (verified to be a valid lot number), expiration date reported and established as 20-JUN-2020, for prophylaxis.   the vaccine was improperly stored at a temperature of 33.9°F during a time frame of 40 minutes. The previous temperature excursions were the following: 30.3°F for 93 hours and 50 minutes. Later, the stability information was updated: total time and lowest temperature below 36°F (30.3°F) for 90 hours and 7 minutes, total time and lowest temperature below 36°F (30.5°F) for 1 hour 45 minutes and total time and lowest temperature below 36°F (35.2°F) for 2 hours 5 minutes. The most recent temperature as total time and lowest temperature below 36°F (33.9°F). The call was because of a data logger and no adverse effects were reported.
Age: 3.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Bronchoscopy abnormal, Endoscopy upper gastrointestinal tract abnormal, Helicobacter gastritis, Immunohistochemistry
Clinical narrative: Adjuvant quadrivalent HPV vaccine series was also adminstered /  ESOPHAGEAL SQUAMOUS PAPILLOMA in the pediatric population; Adjuvant quadrivalent HPV vaccine series was also adminstered / 3 year old female;  This literature marketed report was received from the authors of a published article, and concerns to a 3 year old female patient.      On an unknown date, the 3 year-old female presented with respiratory symptoms, vomiting and abdominal pain. On an unknown date, laryngoscopy plus bronchoscopy plus upper endoscopy revealed laryngeal and diffuse esophageal papillomatoses as well as Helicobacter-pylori gastritis; following, in the immunohistochemistry of papillomatous lesions was confirmed Human Papillomavirus-subtype 6/11. The patient had Esophageal Squamous Papilloma.  Therefore, on an unknown date, the patient's laryngeal lesions were treated with laser ablation, the Helicobacter pylori gastritis was treated with an unspecified proton pump inhibitors (PPI) and antibiotics.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), dose reported as "series", (strength, frequency, route, anatomical location, lot number, and expired date were not reported), as adjuvant therapy for the Esophageal Squamous Papilloma (product administered to patient of inappropriate age and drug use for unapproved indication). No other suspect or concomitant therapies were administered.     On successive endoscopies, on an unknown dates, there was resolution of laryngeal and esophageal lesions.  This is one of two reports from the same literature article (CASE # 1908USA006182).    A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-1908USA006182:
Age: 3.0
Sex: F
Vaccine: HPV4
Symptoms: Laryngoscopy abnormal, Laser therapy, Oesophageal papilloma, Product administered to patient of inappropriate age, Product use in unapproved indication
Clinical narrative: Adjuvant quadrivalent HPV vaccine series was also adminstered /  ESOPHAGEAL SQUAMOUS PAPILLOMA in the pediatric population; Adjuvant quadrivalent HPV vaccine series was also adminstered / 3 year old female;  This literature marketed report was received from the authors of a published article, and concerns to a 3 year old female patient.      On an unknown date, the 3 year-old female presented with respiratory symptoms, vomiting and abdominal pain. On an unknown date, laryngoscopy plus bronchoscopy plus upper endoscopy revealed laryngeal and diffuse esophageal papillomatoses as well as Helicobacter-pylori gastritis; following, in the immunohistochemistry of papillomatous lesions was confirmed Human Papillomavirus-subtype 6/11. The patient had Esophageal Squamous Papilloma.  Therefore, on an unknown date, the patient's laryngeal lesions were treated with laser ablation, the Helicobacter pylori gastritis was treated with an unspecified proton pump inhibitors (PPI) and antibiotics.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), dose reported as "series", (strength, frequency, route, anatomical location, lot number, and expired date were not reported), as adjuvant therapy for the Esophageal Squamous Papilloma (product administered to patient of inappropriate age and drug use for unapproved indication). No other suspect or concomitant therapies were administered.     On successive endoscopies, on an unknown dates, there was resolution of laryngeal and esophageal lesions.  This is one of two reports from the same literature article (CASE # 1908USA006182).    A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-1908USA006182:
Age: 3.0
Sex: F
Vaccine: HPV4
Symptoms: Respiratory symptom, Vomiting
Clinical narrative: Adjuvant quadrivalent HPV vaccine series was also adminstered /  ESOPHAGEAL SQUAMOUS PAPILLOMA in the pediatric population; Adjuvant quadrivalent HPV vaccine series was also adminstered / 3 year old female;  This literature marketed report was received from the authors of a published article, and concerns to a 3 year old female patient.      On an unknown date, the 3 year-old female presented with respiratory symptoms, vomiting and abdominal pain. On an unknown date, laryngoscopy plus bronchoscopy plus upper endoscopy revealed laryngeal and diffuse esophageal papillomatoses as well as Helicobacter-pylori gastritis; following, in the immunohistochemistry of papillomatous lesions was confirmed Human Papillomavirus-subtype 6/11. The patient had Esophageal Squamous Papilloma.  Therefore, on an unknown date, the patient's laryngeal lesions were treated with laser ablation, the Helicobacter pylori gastritis was treated with an unspecified proton pump inhibitors (PPI) and antibiotics.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), dose reported as "series", (strength, frequency, route, anatomical location, lot number, and expired date were not reported), as adjuvant therapy for the Esophageal Squamous Papilloma (product administered to patient of inappropriate age and drug use for unapproved indication). No other suspect or concomitant therapies were administered.     On successive endoscopies, on an unknown dates, there was resolution of laryngeal and esophageal lesions.  This is one of two reports from the same literature article (CASE # 1908USA006182).    A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-1908USA006182:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine administered; NO adverse effect; This spontaneous report was received from an office manager refers to a patient of unknown age.     The patient's medical history, concurrent conditions and concomitant medications were unknown. On 08-JUL-2019, the patient was vaccinated with one dose of improperly stored (Product storage error) therapy type of digital data logger rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R025713 exp.date: 20-JUN-2020) (strength, frequency, anatomical location was unknown) for prophylaxis. No adverse events was reported. The vaccine was stored at a temperature of 33.9 Fahrenheit for a time frame of 20 minutes. There was a previous temperature excursion of 30.3 Fahrenheit for 93 hours and 50 minutes. The outcome of product storage error and no adverse event was unknown.
Age: 12.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect reported; a 12 year old patient received PEDVAXHIB; This spontaneous report as received from a Nurse refers to a 12-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concomitant therapies, concurrent conditions and previous drug reactions.     On 15-AUG-2019, the 12-year-old patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (dose, frequency, lot#, expiry date and indication was not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported. No product quality complaint was reported.    The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; received one dose of improperly stored ROTATEQ; This spontaneous report was received from an office manager refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-AUG-2019, the patient was vaccinated with one dose of improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot # R025713, expiry date 20-JUN-2020, dose, strength, route, vaccination site unspecified) for prophylaxis (product storage error). The vaccine was stored at a temperature of 33.9 degree fahrenheit for time frame of 20 minutes. It was further mentioned as the most recent temperature in which Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) included total time and lowest temperature below 36 degree fahrenheit (33.9 degree fahrenheit) and updated the timeframe to 40 minutes, instead of the previously reported 20 minutes.  The vaccine's previous temperature excursion included previous excursions reported as total time and lowest temperature below 36 degree fahrenheit (30.3 degree fahrenheit) for 90 hours and 7 minutes, Total time and lowest temperature below 36 degree fahrenheit (30.5 degree fahrenheit) for 1 hour 45 minutes and total time and lowest temperature below 36 degree fahrenheit (35.2 degree fahrenheit) for 2 hours 5 minutes (30.3 degree fahrenheit for 93 hours and 50 minutes). Digital data logger was involved. No adverse effects were reported.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report was received from a health professional (medical assistant) refers to a 5 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 22-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, route of administration, anatomical location and dosage information were unknown) of lot # S000133 and expiration date of 02-JAN-2021 for prophylaxis.  The concomitant medication included sterile diluent (lot# S015085 and expiration date 31-JAN-2022) which was reported to be stored properly (product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of -9 degree Celsius (C) to 8 degree Celsius (-5.3 C) for a time frame of 32 minutes. There was previous temperature excursion reported as -9 degree Celsius (C) to 8 degree Celsius (-3.4 C) for a time frame of 3 hours and 15 minutes. Data logger was involved. The outcome of product storage error was unknown. No product quality complaint (PQC) was associated with this report.
Sex: F
Vaccine: SMALL
Symptoms: Diarrhoea, Exposure to vaccinated person, Fatigue, Headache, Rash
Clinical narrative: Rash on her stomach, back and both of her arms/ not sure of contact with partner's vaccinated arm; Bad headache; Fatigue; Diarrhea; Vomiting; Information received on 13AUG2019 from a consumer.   A 23-year-old female reported developing rash on her stomach, back, and both her arms/ not sure of contact with partner's vaccinated arm (PT: Secondary transmission), diarrhea (PT: Diarrhoea), vomiting (PT: Vomiting), bad headache (PT: Headache), and fatigue (PT: Fatigue), after being in contact with her partner who was vaccinated with ACAM2000 vaccine. She stated the rash takes up 5% or less of her body surface area. She stated that the day the rash appeared (11AUG2019) she went to her general practitioner who prescribed some creams. She had vomiting on 12AUG2019 and diarrhea on 12AUG2019 and 13AUG2019. She also had bad headache and felt fatigued since an unknown date. She stated that her doctor believed that she had food poisoning but she had not eaten anything strange. On 16AUG2019 additional information was received from the reporter and she reported that her rash was resolving and fatigue and headache were still apparent.  Action taken was not applicable.  Treatments included mometasone furoate and Bactrim (trimethoprim/sulfamethoxazole).  Company comment: In this case, a female patient was exposed to vaccinia virus through contact with her partner who was vaccinated with ACAM2000 vaccine and experienced the events "secondary transmission, diarrhea, vomiting, headache and fatigue". These events are known effects of ACAM2000, and therefore are considered to be causally related to ACAM2000.; Sender's Comments: Company comment: In this case, a female patient was exposed to vaccinia virus through contact with her partner who was vaccinated with ACAM2000 vaccine and experienced the events "secondary transmission, diarrhea, vomiting, headache and fatigue". These events are known effects of ACAM2000, and therefore are considered to be causally related to ACAM2000.
Sex: F
Vaccine: SMALL
Symptoms: Vomiting
Clinical narrative: Rash on her stomach, back and both of her arms/ not sure of contact with partner's vaccinated arm; Bad headache; Fatigue; Diarrhea; Vomiting; Information received on 13AUG2019 from a consumer.   A 23-year-old female reported developing rash on her stomach, back, and both her arms/ not sure of contact with partner's vaccinated arm (PT: Secondary transmission), diarrhea (PT: Diarrhoea), vomiting (PT: Vomiting), bad headache (PT: Headache), and fatigue (PT: Fatigue), after being in contact with her partner who was vaccinated with ACAM2000 vaccine. She stated the rash takes up 5% or less of her body surface area. She stated that the day the rash appeared (11AUG2019) she went to her general practitioner who prescribed some creams. She had vomiting on 12AUG2019 and diarrhea on 12AUG2019 and 13AUG2019. She also had bad headache and felt fatigued since an unknown date. She stated that her doctor believed that she had food poisoning but she had not eaten anything strange. On 16AUG2019 additional information was received from the reporter and she reported that her rash was resolving and fatigue and headache were still apparent.  Action taken was not applicable.  Treatments included mometasone furoate and Bactrim (trimethoprim/sulfamethoxazole).  Company comment: In this case, a female patient was exposed to vaccinia virus through contact with her partner who was vaccinated with ACAM2000 vaccine and experienced the events "secondary transmission, diarrhea, vomiting, headache and fatigue". These events are known effects of ACAM2000, and therefore are considered to be causally related to ACAM2000.; Sender's Comments: Company comment: In this case, a female patient was exposed to vaccinia virus through contact with her partner who was vaccinated with ACAM2000 vaccine and experienced the events "secondary transmission, diarrhea, vomiting, headache and fatigue". These events are known effects of ACAM2000, and therefore are considered to be causally related to ACAM2000.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Bullous impetigo, Injection site bruising, Injection site vesicles
Clinical narrative: bullous impetigo; blistering around the injection site; bruising around the injection site; This case was reported by a physician via sales rep and described the occurrence of bullous impetigo in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 14th August 2019 11:30, the patient received the 2nd dose of Bexsero (intramuscular). In August 2019, 12 hrs 30 min after receiving Bexsero, the patient experienced bullous impetigo, injection site blisters and injection site bruising. The patient was treated with antibiotics nos. On an unknown date, the outcome of the bullous impetigo, injection site blisters and injection site bruising were unknown.   It was unknown if the reporter considered the bullous impetigo, injection site blisters and injection site bruising to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero around 11:30 AM and around midnight, she reported developing blisters. The patient had blistering around the injection site, one very large and other small ones. On 15th August 2019, the patient was seen by the health care professional. The physician stated, she had never seen this before and this looked like bullous impetigo but she was not sure so covered her bases with antibiotics.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Dyspnoea, Hyperhidrosis, Vomiting
Clinical narrative: vomiting; sweating; clammy; looked like she was having difficulty breathing/grab her throat; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number XC972, expiry date 29th August 2021) for prophylaxis.   The patient's past medical history included headache (patient complained of a headache prior to the vaccination and it was hot outside to).   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2019, 4 min after receiving Shingrix, the patient experienced vomiting, sweating, clamminess and difficulty breathing. On an unknown date, the outcome of the vomiting, sweating, clamminess and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the vomiting, sweating, clamminess and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The pharmacist vaccinated a patient and 4-5 minutes later, the patient started to vomit. She was sweating, clammy and started to grab her throat which looked like she was having difficulty breathing. The pharmacist at the time of reporting believes that her response was due to the acid from the vomit.  The Pharmacist followed up with the patient the following day and the patient felt fine and her symptoms were resolved. The patient complained of a headache prior to the vaccination and it was hot outside too.  The reporter consented to follow up and can follow-up with the Pharmacist directly.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Head injury, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: passed out; chills; difficulty sleeping; nausea; hit head; redness at injection site; swelling at injection site; hot at injection site; hard at injection site; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site induration. On 14th August 2019, the patient experienced passed out (serious criteria GSK medically significant), chills, difficulty sleeping, nausea and head injury. On an unknown date, the outcome of the passed out, injection site erythema, injection site swelling, injection site warmth and injection site induration were not recovered/not resolved and the outcome of the chills, difficulty sleeping and nausea were recovered/resolved and the outcome of the head injury was unknown.   It was unknown if the reporter considered the passed out, injection site erythema, injection site swelling, injection site warmth, injection site induration, chills, difficulty sleeping, nausea and head injury to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. One day after vaccination, the patient experienced passed out and hit head, chills, difficulty sleeping and nausea. The patient planned to continue follow-up with her physician specifically for the reason of passed out. The reporter consented to follow up. No further information was provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Insomnia, Loss of consciousness, Nausea
Clinical narrative: passed out; chills; difficulty sleeping; nausea; hit head; redness at injection site; swelling at injection site; hot at injection site; hard at injection site; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site induration. On 14th August 2019, the patient experienced passed out (serious criteria GSK medically significant), chills, difficulty sleeping, nausea and head injury. On an unknown date, the outcome of the passed out, injection site erythema, injection site swelling, injection site warmth and injection site induration were not recovered/not resolved and the outcome of the chills, difficulty sleeping and nausea were recovered/resolved and the outcome of the head injury was unknown.   It was unknown if the reporter considered the passed out, injection site erythema, injection site swelling, injection site warmth, injection site induration, chills, difficulty sleeping, nausea and head injury to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. One day after vaccination, the patient experienced passed out and hit head, chills, difficulty sleeping and nausea. The patient planned to continue follow-up with her physician specifically for the reason of passed out. The reporter consented to follow up. No further information was provided.
Sex: M
Vaccine: HPV9
Symptoms: Nausea
Clinical narrative: nausea; This spontaneous report was received from a medical assistant refers to a male patient of 15-16 year old. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot and expiry date unknown) for prophylaxis. On an unknown date in July 2019 (about a month ago), when the patient was about 17-18 years old, he returned to finish the last dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the series. On the same day after the injection, the patient had one episode of nausea (apparently he suffers from nausea with anything that involves needles). The patient was kept under observation for 30 minutes and had blood pressure rechecked which was normal. The patient received treatment. The outcome of the event nausea was recovered after 30 minutes on the same day. The patient had left with no side effects. Causality assessment was not provided
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: peripheral neuropathy; This case was reported by a physician via sales rep and described the occurrence of peripheral neuropathy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the peripheral neuropathy was unknown.   It was unknown if the reporter considered the peripheral neuropathy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced peripheral neuropathy following administration of shingrix. The reporter agreed to follow up with GlaxoSmithKline.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza, Malaise, Pyrexia
Clinical narrative: Patient states day after receiving vaccine, she began to develop mild flu symptoms (fever, chills, etc.)  that persisted and progressively gotten worse throughout the week. She reported still being sick as of 8/26/19.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Chills, Confusional state, Cough, Dizziness
Clinical narrative: Pain and redness in arm (widespread), fever (recorded at 100.6F with 800 mg of ibuprofen in system), chills, sweats, body aches, severe headaches, neck pain and stiffness, sore throat, cough, nausea, blurry vision, dizziness, confusion, general weakness, numbness in toes. The symptoms lasted for 3 days before beginning to improve. I did call the doctor's office but I did not go in for a visit.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Headache, Hyperhidrosis, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Pain and redness in arm (widespread), fever (recorded at 100.6F with 800 mg of ibuprofen in system), chills, sweats, body aches, severe headaches, neck pain and stiffness, sore throat, cough, nausea, blurry vision, dizziness, confusion, general weakness, numbness in toes. The symptoms lasted for 3 days before beginning to improve. I did call the doctor's office but I did not go in for a visit.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Nausea, Neck pain, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Pain and redness in arm (widespread), fever (recorded at 100.6F with 800 mg of ibuprofen in system), chills, sweats, body aches, severe headaches, neck pain and stiffness, sore throat, cough, nausea, blurry vision, dizziness, confusion, general weakness, numbness in toes. The symptoms lasted for 3 days before beginning to improve. I did call the doctor's office but I did not go in for a visit.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Pain and redness in arm (widespread), fever (recorded at 100.6F with 800 mg of ibuprofen in system), chills, sweats, body aches, severe headaches, neck pain and stiffness, sore throat, cough, nausea, blurry vision, dizziness, confusion, general weakness, numbness in toes. The symptoms lasted for 3 days before beginning to improve. I did call the doctor's office but I did not go in for a visit.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives starting on 8/19/19 on leg  (took Benadryl to address them) then progressed over day of travel to full body hives, precipitating in an ER visit in Hospital (work related  trip) that evening (7pm ET) - hives reached from feet to tops of ears. Treated with Prednisone and  released with a 5 day prescription for prednisone and counseled to continue with antihistamines.  Did not receive epinephrine due to potential for irregular heartbeat (I have a history of PVCs).
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No adverse affects; improperly stored MMR II was administered on 8/15/2019; This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status rHa, subcutaneously, lot # R027063, expiration date 20-SEP-2020 (dose was not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 70 degrees Fahrenheit for 4 days. There were no previous excursions reported. The data logger was involved.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Gait inability, Groin pain
Clinical narrative: painful muscle spasms; prevent from walking; knee pain; chills; back pain moved down into groin and then into thigh; back pain moved down into groin and then into thigh; back pain moved down into groin and then into thigh; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2019, the patient received Shingrix (intramuscular). On 20th July 2019, less than a day after receiving Shingrix, the patient experienced chills, back pain, pain in thigh and groin pain. On an unknown date, the patient experienced muscle spasm, unable to walk and knee pain. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the back pain, pain in thigh, groin pain, muscle spasm and unable to walk were not recovered/not resolved and the outcome of the knee pain was unknown.   It was unknown if the reporter considered the chills, back pain, pain in thigh, groin pain, muscle spasm, unable to walk and knee pain to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's husband. The reporter reported that, when the patient came back to home, experinced chills and back pain. The chills resolved after 24 hours, but the back pain moved down into his groin and then into his thigh. The patient had painful muscle spasms, that prevent him from working.