chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Adverse event
Clinical narrative: vaccine injure 2 teenagers in the last few years; This spontaneous report was received from a consumer via newspaper article referred to 2 adolescent patients (teenagers) of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with unidentified Merck hpv vaccine (name, lot #, dose, route of administration were not provided) for prophylaxis. The reporter stated that, vaccine injured (unspecified) (adverse event) the patients in the last few years. The outcome of adverse event was unknown.  This is one of the two reports received from the same reporter.; Sender's Comments:  AU-009507513-1907AUS011276:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; nurse reporting that MMR II was administered too son after VARIVAX; This spontaneous report was received from a registered nurse and refers to a 14 month old patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.     On 28-AUG-2018, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) one dose, lot # R011805, expiration date 23-APR-2020 (route and anatomical location were not provided) for prophylaxis. On 06-SEP-2018, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) one dose, lot # N024698, expiration date 08-SEP-2019 (route and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 20-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently administered PNEUMOVAX23 instead of receiving PREVNAR 13; no adverse effects reported; This spontaneous report was received from a physician refers to patients aged between 2 and 4 months of age. No information was given regarding the patient's concurrent conditions, medical history or concomitant medications.   On an unknown date, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number and expiration date were not reported instead of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13). However, no adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received one dose of ROTATEQ following temperature excursions; no adverse event; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. No information was provided regarding to the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On an unknown date, the patient was vaccinated with one improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R016790, orally, expiration date 20-APR-2019, for prophylaxis.  The dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a temperature excursion below 36° Fahrenheit / 2° Celsius, during a time frame of 3 hours and 1 minute, which was detected by the data logger. There was a previous temperature excursion of below 36° Fahrenheit/2° Celsius (33.8° Fahrenheit) for 29 hours and 38 minutes. No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient was administered M-M-R II which was involved in a non-supported temperature slability evaluation.; This spontaneous report was received from a nurse regarding a currently 51-year-old female patient. There was no information reported regarding the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On 23-JUL-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis, which was involved in a non- supported temperature stability evaluation (dose and route were not reported; lot number R036580 and expiration date 17-DEC-2020). The vaccine was reconstituted with properly stored STERILE DILUENT (lot number and expiration date were unknown by the reporter). The temperature was of 59 Fahrenheit degrees for a time frame of 6 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: No dverse effects were reported; a 19 year old patient was administered a pediatric dose of VAQTA in error; a 19 year old patient was administered a pediatric dose of VAQTA in error; This spontaneous report was received from a medical assistant and refers to a 19-year-old patient of unknown age. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 24-JUL-2019, the patient was administered a pediatric dose of hepatitis a vaccine, inactivated(VAQTA), lot number R030115 with expiration date 29-DEC-2019, (dose, route, and anatomical location were not reported) for prophylaxis.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse effect; The patietn was administered a dose of improperly stored VARIVAX; This spontaneous report has been received from a nurse, concerning to a patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies were not reported. Concomitant therapies included sterile diluent.  On 23-JUL-2019, the patient was vaccinated with a dose of improperly stored (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, and anatomical location were not reported)  (lot # R026715 and expiration date 18-SEP-2020) as prophylaxis.   In addition, temperature: total time in the range -9°C to 8°C (8.2C); time frame: 6 hours 12 minutes, with no previous temperature of excursion. The excursion call was made by a data logger.; Sender's Comments:  US-009507513-1907USA015149: US-009507513-1907USA015150:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; a patient received a dose of MMR II via the intramuscular route; This spontaneous report as received from a pharmacist 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 24-JUL-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) intramuscularly (incorrect route of product administration), lot # R000556, expiration date 08-JAN-2020 (strength and dose were not reported) for prophylaxis. There was no adverse event reported.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; Patient 18 years of age, inadvertently received PROQUAD; This spontaneous report was received from a nurse referring to a 18 year old patient of unknown gender. Information regarding the patient's concurrent conditions, past medical history, concomitant medications and drug reactions or allergies was not provided.  On 25-JUL-2019, the patient inadvertently received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot # R024018 and expiration date 19-FEB-2020 (route and anatomical location were not reported), for prophylaxis (product administered to patient of inappropriate age). The vaccine was administered using a sterile diluent (lot # S007959 and expiration date 19-AUG-2021). No adverse effects were reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Anogenital warts, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: genital warts; HPV positive; This spontaneous report was received from a nurse referring to a currently 20 years old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date in 2012, the patient was vaccinated with the first and second doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (it was stated that it could not confirm which of the products was involved) (strength, dose, route, frequency, lot# and expiration date were not provided), both for prophylaxis.  In 2013, the patient received one dose of HPV rL1 16 18 VLP vaccine (baculovirus) (CERVARIX).   On an unspecified date in 2019, the patient reported to the nurse that she went to an unspecified physician for an exam and she was found to be "papilloma viral infection (HPV) positive". The patient also told the nurse that she thought she had genital warts. The nurse then referred the patient to an unspecified gynecologist for follow-up. The outcome of anogenital warts and papilloma viral infection was unknown by the time of reporting. No further information provided by the field representative.  The causal relationship between the events of anogenital warts and papilloma viral infection and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: one patient was administered an improperly stored dose of PROQUAD; No adverse effects reported.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information reported regarding the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On 22-JUL-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)) for prophylaxis (dose and route were not reported; lot number R017802and expiration date 19-DEC-2019). The vaccine was reconstituted with a properly stored DILUENT MRK INJ (lot number and expiration date were unknown by the reporter). The temperature was from -14 Celsius degrees to -10 Celsius degrees (-10.2 Celsius) for a time frame of 1 hour and 22 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse effect; The patietn was administered a dose of improperly stored VARIVAX; This spontaneous report has been received from a nurse, concerning to a patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies were not reported. Concomitant therapies included sterile diluent.  On 23-JUL-2019, the patient was vaccinated with a dose of improperly stored (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, and anatomical location were not reported)  (lot # R026715 and expiration date 18-SEP-2020) as prophylaxis.   In addition, temperature: total time in the range -9°C to 8°C (8.2C); time frame: 6 hours 12 minutes, with no previous temperature of excursion. The excursion call was made by a data logger.; Sender's Comments:  US-009507513-1907USA014540: US-009507513-1907USA015150:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse effect; The patietn was administered a dose of improperly stored VARIVAX; This spontaneous report has been received from a nurse, concerning to a patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies were not reported. Concomitant therapies included sterile diluent.  On 22-JUL-2019, the patient was vaccinated with a dose of improperly stored (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, and anatomical location were not reported)  (lot # S000133 and expiration date 02-JAN-2021) as prophylaxis.   In addition, temperature: total time in the range -9°C to 8°C (8.2C); time frame: 6 hours 12 minutes, with no previous temperature of excursion. The excursion call was made by a data logger.; Sender's Comments:  US-009507513-1907USA015149: US-009507513-1907USA014540:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymph node excision (right side) and cancer (with cancer pain).   On 17th April 2019, the patient received the 1st dose of Shingrix. On 17th April 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the retired pharmacist, who reported for herself. The patient experienced injection site pain, while it was given. For the tollerence of 2nd dose refere case US2019131719, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site soreness; Injection site redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. The patient experienced soreness and redness at the injection site. The healthcare professional would like recommendations he can share with the patient. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019131740.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Eye swelling, Lip swelling, Pruritus, Rash
Clinical narrative: coughing; swelling; Swelling of lips; Eye swelling; rash on the side of her breast, buttocks and side of her body; itching; This case was reported by a consumer via call center representative and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th November 2018).   On 22nd March 2019, the patient received the 2nd dose of Shingrix. On 23rd March 2019, 1 days after receiving Shingrix, the patient experienced rash and pruritus. On 23rd April 2019, the patient experienced facial swelling, lip swelling and eye swelling. On 18th July 2019, the patient experienced cough. On an unknown date, the outcome of the rash, pruritus and cough were not recovered/not resolved and the outcome of the facial swelling, lip swelling and eye swelling were unknown.   It was unknown if the reporter considered the rash, pruritus, facial swelling, lip swelling, eye swelling and cough to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After receiving 1st dose of Shingrix, the patient had no problems. The patient reported that, after vaccination with 2nd dose, experienced rash on the side of her breast, buttocks, and side of her body. The patient reported that 32 days after vaccination, the patient experiened swelling on her face, lips, and eye. 118 days after vaccination, the patient had cough. On an unknown date, the patient planned to continue follow up with her physician. The patient consented to follow up. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: coughing; swelling; Swelling of lips; Eye swelling; rash on the side of her breast, buttocks and side of her body; itching; This case was reported by a consumer via call center representative and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th November 2018).   On 22nd March 2019, the patient received the 2nd dose of Shingrix. On 23rd March 2019, 1 days after receiving Shingrix, the patient experienced rash and pruritus. On 23rd April 2019, the patient experienced facial swelling, lip swelling and eye swelling. On 18th July 2019, the patient experienced cough. On an unknown date, the outcome of the rash, pruritus and cough were not recovered/not resolved and the outcome of the facial swelling, lip swelling and eye swelling were unknown.   It was unknown if the reporter considered the rash, pruritus, facial swelling, lip swelling, eye swelling and cough to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After receiving 1st dose of Shingrix, the patient had no problems. The patient reported that, after vaccination with 2nd dose, experienced rash on the side of her breast, buttocks, and side of her body. The patient reported that 32 days after vaccination, the patient experiened swelling on her face, lips, and eye. 118 days after vaccination, the patient had cough. On an unknown date, the patient planned to continue follow up with her physician. The patient consented to follow up. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gastrooesophageal reflux disease, Headache, Nausea, Pain
Clinical narrative: Fever; Chills; Dry GERD; Headaches; Body Aches; Nausea; This case was reported by a physician via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 15th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th July 2019, less than a day after receiving Shingrix, the patient experienced fever, chills, gastroesophageal reflux disease, headache, general body pain and nausea. On an unknown date, the outcome of the fever, chills, gastroesophageal reflux disease, headache, general body pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, gastroesophageal reflux disease, headache, general body pain and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The physician reported that, the patient experienced fever, chills, dry GERD, headaches, body aches, nausea after 1st dose and it was not abating. The patient experienced adverse events in the same day the injection was given. No further details provided regarding dry GERD. Permission for follow up not queried. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Dry GERD; Headaches; Body Aches; Nausea; This case was reported by a physician via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 15th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th July 2019, less than a day after receiving Shingrix, the patient experienced fever, chills, gastroesophageal reflux disease, headache, general body pain and nausea. On an unknown date, the outcome of the fever, chills, gastroesophageal reflux disease, headache, general body pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, gastroesophageal reflux disease, headache, general body pain and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The physician reported that, the patient experienced fever, chills, dry GERD, headaches, body aches, nausea after 1st dose and it was not abating. The patient experienced adverse events in the same day the injection was given. No further details provided regarding dry GERD. Permission for follow up not queried. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Injection site soreness; Injection site redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st May 2019, refer linked case US2019AMR132554).   On 19th July 2019, the patient received the 2nd dose of Shingrix. On 19th July 2019, immediately after receiving Shingrix, the patient experienced injection site pain and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on right arm. Soon after, the patient experienced the same symptoms as soreness and redness at the injection site. The healthcare professional would like recommendations he could share with the patient. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Nausea, Syncope, Vomiting
Clinical narrative: fainting; shivering; nausea; vomiting; This case was reported by a pharmacist via call center representative and described the occurrence of fainting in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd April 2019, immediately after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant), shivering, nausea and vomiting. On an unknown date, the outcome of the fainting, shivering, nausea and vomiting were recovered/resolved.   It was unknown if the reporter considered the fainting, shivering, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient came in the pharmacy requesting for the 2nd dose of Shingrix and reported that shortly after 1st dose she experienced shivering, fainting, nausea and vomiting. The reporter consented for follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Dermatitis, Herpes zoster, Herpes zoster oticus, Pain
Clinical narrative: diagnosed as shingles although had ZOSTAVAX 3 years prior; Ramsay hunt syndrome/ Herpes Zoster Oticus; teeth extracted; Dermatitis; Shingles; Information has been received from an approximately 67 years old male consumer with a history of stent in heart 12 years ago and with no drug reactions or allergies, concerning himself who in approximately 2009 ("about 3 years prior") was vaccinated with a dose of zoster vaccine live (Oka/Merck) (dose, route and lot # not reported).   Concomitant therapy included unspecified pain medication.  In October 2011, the patient had some teeth extracted and after that the patient developed a rash on his face that got worse. The patient went to the emergency room where it was diagnosed as dermatitis, but 2 days later it was diagnosed as shingles, although he had had the zoster vaccine live (Oka/Merck) vaccine about 3 years prior. From that he developed Ramsay Hunt syndrome that was diagnosed by an ear doctor. The patient still had pain. The patient was given ointment and pain medications. Blood test was performed (results not reported). At the time of the report, the patient did not  recover.  Follow up information was received from a health care professional reporting that the approximately 67 year old white male patient "3 to 4 years ago" in approximately 2009 was vaccinated with a dose of zoster vaccine livec(ZOSTAVAX) (dose, dose number, route, lot number and expiration date not reported). It was reported that the patient developed shingles 3-4 years after getting zoster vaccine live(ZOSTAVAX) vaccine. No adverse reactions were reported.   Follow up report was received on 17-JUL-2019, from a lawyer regarding a case in litigation and referred to a male patient (currently 76 years old). No information was provided regarding concurrent conditions, or concomitant medications.   On or about 04-JAN-2008 (previously reported as "approximately 2009"), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for Ramsay Hunt Syndrome. The outcome of the event Ramsay Hunt Syndrome was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event Herpes Zoster Oticus was determined to be medically significant.  Additional information has been requested. Company Causality Assessment: Episode Profile: Medically Confirmed: N
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Tooth extraction
Clinical narrative: diagnosed as shingles although had ZOSTAVAX 3 years prior; Ramsay hunt syndrome/ Herpes Zoster Oticus; teeth extracted; Dermatitis; Shingles; Information has been received from an approximately 67 years old male consumer with a history of stent in heart 12 years ago and with no drug reactions or allergies, concerning himself who in approximately 2009 ("about 3 years prior") was vaccinated with a dose of zoster vaccine live (Oka/Merck) (dose, route and lot # not reported).   Concomitant therapy included unspecified pain medication.  In October 2011, the patient had some teeth extracted and after that the patient developed a rash on his face that got worse. The patient went to the emergency room where it was diagnosed as dermatitis, but 2 days later it was diagnosed as shingles, although he had had the zoster vaccine live (Oka/Merck) vaccine about 3 years prior. From that he developed Ramsay Hunt syndrome that was diagnosed by an ear doctor. The patient still had pain. The patient was given ointment and pain medications. Blood test was performed (results not reported). At the time of the report, the patient did not  recover.  Follow up information was received from a health care professional reporting that the approximately 67 year old white male patient "3 to 4 years ago" in approximately 2009 was vaccinated with a dose of zoster vaccine livec(ZOSTAVAX) (dose, dose number, route, lot number and expiration date not reported). It was reported that the patient developed shingles 3-4 years after getting zoster vaccine live(ZOSTAVAX) vaccine. No adverse reactions were reported.   Follow up report was received on 17-JUL-2019, from a lawyer regarding a case in litigation and referred to a male patient (currently 76 years old). No information was provided regarding concurrent conditions, or concomitant medications.   On or about 04-JAN-2008 (previously reported as "approximately 2009"), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for Ramsay Hunt Syndrome. The outcome of the event Ramsay Hunt Syndrome was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event Herpes Zoster Oticus was determined to be medically significant.  Additional information has been requested. Company Causality Assessment: Episode Profile: Medically Confirmed: N
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 64 w/out a recommended diagnosis to receive the vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Rectal temp of 100.6. Resolved with Tylenol.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asymptomatic bacteriuria, Blood culture negative, Computerised tomogram normal, Culture urine positive, Differential white blood cell count normal
Clinical narrative: patient developed shingles across back and abdomen, no rash but unknown pain for 2 weeks before rash eruption starting 7/12/19, unspecified rash starting 7/22/19, visited ER on 7/12/19, 7/18/19, 7/23/19 for unspecified pain (resident cannot communicate much to clarify pain), unscheduled doctor visit 7/25/19 with diagnosis of shingles
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Herpes zoster, Laboratory test normal, Pain, Rash
Clinical narrative: patient developed shingles across back and abdomen, no rash but unknown pain for 2 weeks before rash eruption starting 7/12/19, unspecified rash starting 7/22/19, visited ER on 7/12/19, 7/18/19, 7/23/19 for unspecified pain (resident cannot communicate much to clarify pain), unscheduled doctor visit 7/25/19 with diagnosis of shingles
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Scan with contrast normal
Clinical narrative: patient developed shingles across back and abdomen, no rash but unknown pain for 2 weeks before rash eruption starting 7/12/19, unspecified rash starting 7/22/19, visited ER on 7/12/19, 7/18/19, 7/23/19 for unspecified pain (resident cannot communicate much to clarify pain), unscheduled doctor visit 7/25/19 with diagnosis of shingles
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness and swelling and pain at injection site
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness with tenderness and swelling to Injection site that increased in size over 24 hour period. Next day complained also of itching to Injection site.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: chills, fever symptoms, slight nausea during the night with improvement  in the morning.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness and pain and swelling at injection site and beyond
Age: 1.83
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Irritability, Rash generalised
Clinical narrative: Mother called stating the child had a rash all over his body, she brought the child to the LHU and there was small pin point rash scattered all over his body. Mother states he has been a little fussy and just doesn't want anyone to touch him. Mother states he has not ran a temperature, no shortness of breath. Encouraged mother to take child to PCP for evaluation. Child was down on floor playing and no acute distress.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoantibody positive, Injection site erythema
Clinical narrative: day after pt said she it looked like she had red needle pricks all around injection site
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Soreness at injection site   Couldn?t lift my arm. Fatigue. Shivers and very cold. Very bad headache. Felt weak and exhausted   These lasted about 36 hours and then I was fine
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Soreness at injection site   Couldn?t lift my arm. Fatigue. Shivers and very cold. Very bad headache. Felt weak and exhausted   These lasted about 36 hours and then I was fine
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Date of visit was Friday afternoon 7/26/2019.Left deltoid area. Lump 3cm. hard and swollen for 4 days.Patient reports area was red but now it is looking better. Treatment is warm compresses and to keep taking the Zyrtec. Area resolved.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus generalised, Rash erythematous, Varicella post vaccine
Clinical narrative: Child's whole body is covered in red itchy spots.  Nurse practitioner believes it is chicken pox.  Treatment recommended to relive itching.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: patient received a dose of PNEUMOV AX 23 and developed "egg sized swelling" near the injection site.; This spontaneous report was received from a Registered Nurse concerning a 65 years old female patient. The patient had none pertinent medical history or concurrent conditions. Her drug reactions and allergies included azithromycin (ZITHROMAX) and sulfamethoxazole, trimethoprim (BACTRIM). The patient's concomitant therapies included albuterol, dupilumab (DUPIXENT), fluticasone propionate (FLONASE), fluticasone propionate, salmeterol xinafoate (ADVAIR), hydrochlorothiazide, lisinopril, omeprazole (PRILOSEC), tiotropium bromide (SPIRIVA) and zoledronic acid (RECLAST).  On 15-JUL-2019, the patient was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, for prophylaxis (Lot No. R031810 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date not reported, but upon internal validation established as 02-SEP-2020) On the same date, the patient developed "egg sized swelling" near the injection site. The patient didn't seek medical attention, received any treatment or laboratory diagnostics or studies were performed for the adverse event.  On 18-JUL-2019, the patient recovered from egg sized swelling near the injection site.  The causal relationship between the Injection site swelling and therapy with of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Malaise, Myalgia, Nausea
Clinical narrative: muscle aches; Chills; Nausea; do not feel all that great; This case was reported by a consumer and described the occurrence of muscle pain in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2019, the patient received Shingrix. On 19th July 2019, 1 days after receiving Shingrix, the patient experienced muscle pain, chills, nausea and feeling unwell. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the muscle pain, chills, nausea and feeling unwell were unknown.   It was unknown if the reporter considered the muscle pain, chills, nausea and feeling unwell to be related to Shingrix.  Additional information received were as follows: The patient did not felt all that great and had muscle aches. The patient was told that they would be happy to transfer this conversation to one of our product specialists.They could answer the questions. The pharmacist told that anything they chat about should not be taken as medical advice.  The pharmacist would refer the patient to their health care provider as their primary resource for patient care. The pharmacist provided link for Shingrix package insert. The pharmacist was using this document to research your question. The pharmacist told that majority of solicited local adverse reactions and general adverse events seen with Shingrix had a median duration of 2 to 3 days. The pharmacist asked for any question and assistance. The pharmacist thanked for sharing your experience with them and told the patient that they may receive a letter from their safety department. The patient told the pharmacist that the patient just was taking advil and it seemed to help.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash erythematous
Clinical narrative: Chills; Rash in upper extremity; fever; Body aches; This case was reported by a nurse and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 7447A, expiry date 25th April 2020) for prophylaxis.   The patient's past medical history included allergic rhinitis. Concurrent medical conditions included drug allergy (allergy to cefotan).   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th June 2019, 1 days after receiving Shingrix, the patient experienced chills, red rash, fever and general body pain. On an unknown date, the outcome of the chills, red rash, fever and general body pain were recovered/resolved.   The reporter considered the chills, red rash, fever and general body pain to be probably related to Shingrix.  Additional information received were as follows: The patient experienced red rash to her upper arm associated with chills, fever and body ache. The events were self resolved in 3 days.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Peripheral swelling, Pyrexia
Clinical narrative: swollen arm; fever; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 17th July 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 18th July 2019, the patient experienced swelling arm and fever. On an unknown date, the outcome of the swelling arm and fever were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the swelling arm and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was a pharmacist and also the patient. The age at vaccination was not reported. The patient reported that, Shingrix was given subcutaneously, which led to intramuscular formulation administered by other route. After vaccination, the patient experienced fever in spike and his arm was swollen. The patient was transferred to medical information for questions. The patient was unable to ask, if it was ok to follow up with his physician. The patient consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Injection site pain, Muscle spasms, Myalgia
Clinical narrative: muscle cramps; Nausea; Muscle Pain; Tiredness; Soreness at Injection Site; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th July 2019, several hours after receiving Shingrix, the patient experienced nausea, muscle pain, tiredness and injection site pain. On an unknown date, the patient experienced muscle cramp. On an unknown date, the outcome of the nausea, muscle pain, tiredness, injection site pain and muscle cramp were not recovered/not resolved.   It was unknown if the reporter considered the nausea, muscle pain, tiredness, injection site pain and muscle cramp to be related to Shingrix.  Additional information received were as follows: On Wednesday afternoon, the patient received Shingrix on left arm. Immediately, the patient experienced  soreness at the injection site.  The patient's upper half of left arm still sore. In the evening at unspecified hours, the patient experienced nausea, tiredness and muscle pain. The caller described muscle pain occurs in her left leg that felt similar to muscle cramps and a Charlie Horse. All symptoms were unresolved. The reporter did not consent to follow-up. The outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: muscle cramps; Nausea; Muscle Pain; Tiredness; Soreness at Injection Site; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th July 2019, several hours after receiving Shingrix, the patient experienced nausea, muscle pain, tiredness and injection site pain. On an unknown date, the patient experienced muscle cramp. On an unknown date, the outcome of the nausea, muscle pain, tiredness, injection site pain and muscle cramp were not recovered/not resolved.   It was unknown if the reporter considered the nausea, muscle pain, tiredness, injection site pain and muscle cramp to be related to Shingrix.  Additional information received were as follows: On Wednesday afternoon, the patient received Shingrix on left arm. Immediately, the patient experienced  soreness at the injection site.  The patient's upper half of left arm still sore. In the evening at unspecified hours, the patient experienced nausea, tiredness and muscle pain. The caller described muscle pain occurs in her left leg that felt similar to muscle cramps and a Charlie Horse. All symptoms were unresolved. The reporter did not consent to follow-up. The outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient statement that he went to urgent care after the shot on 7/6 and was diagnosed with Shingles.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: none
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Skin warm
Clinical narrative: redness extended to elbowon pt's right arm but not at the injection side, warm to touch. pt c/o pain started 4 hrs post injection, and have trouble lifting arm day after injection. pt has been taking APAP for pain, and will follow up with pcp today
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Rash erythematous, Rash macular
Clinical narrative: Patient's left arm was sore and had a blotchy red rash.  Patient was instructed to continue Benadryl 25 mg every 8 hours for the next 2 days. Use cool pack 3 times daily for the next 2 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Full blood count, Headache, Pyrexia
Clinical narrative: Headache fever
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood glucose, Dizziness, Hypotension, Local reaction
Clinical narrative: Dizziness, hypotension, local Rxn
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Childs mother reports that client had fever of 100.3 beginning the evening after vaccine.  She also reported extreme nausea, headache and vomited x 3 the next 24 hours with severe pain and moderate swelling. around injection area for 24 hours.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Childs mother reports that client had fever of 100.3 beginning the evening after vaccine.  She also reported extreme nausea, headache and vomited x 3 the next 24 hours with severe pain and moderate swelling. around injection area for 24 hours.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: pt states his right arm became red at site the day after injection and has increased in swelling over past 4 days with heat and redness increasing . no other symtpoms reported
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient experienced syncope withing 5 minutes of receiving injection.  Patient remained is sitting position after injection.  Patient placed in recovery position.  After regaining consciousness the patient ate crackers and juice.  Patient stayed in office resting times 20 minutes after regaining consciousness.  Per mother the patient had a extended football practice that morning and may of had mild dehydration.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Autonomic nervous system imbalance, Blood pH decreased, Brain injury, Cardiac arrest, Chest X-ray abnormal
Clinical narrative: Child developed fussiness and vomiting within 24 hours of vaccine. Arrested en route to the ED for evaluation of listlessness on 7/26/19.  Child had CPR for 14 minutes with return of heart rate, however due to prolonged arrest had severe  hypoxic injury to the brain and developed autonomic instability. Support was withdrawn on 7/28 and patient died 7/28/19.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Death, Echocardiogram abnormal, Intensive care, Irritability, Listless
Clinical narrative: Child developed fussiness and vomiting within 24 hours of vaccine. Arrested en route to the ED for evaluation of listlessness on 7/26/19.  Child had CPR for 14 minutes with return of heart rate, however due to prolonged arrest had severe  hypoxic injury to the brain and developed autonomic instability. Support was withdrawn on 7/28 and patient died 7/28/19.