chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Adenocarcinoma of the cervix, Cervical conisation, Colposcopy, Hysterectomy, Incomplete course of vaccination
Clinical narrative: the patient confirmed that she was not pregnant when she received the one dose of GARDASIL; adenocarcinoma of the cervix; Information has been received from a 28 years old female physician assistant referring to herself. The patient had no concomitant therapy, pertinent medical history or drug reactions/allergies.  On an unknown date in 2007 (approximately at 19 years old), she received the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (batch/lot #, expiration date, strength, dose and route were unknown) for prophylaxis. She did not receive any additional doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  On an unspecified date in 2016, she was diagnosed with adenocarcinoma of the cervix. Medical attention was sought with office visits. She had the following procedures colposcopy, loop electrical excision procedure (LEEP) and cold knife conization. On an unknown date, the adenocarcinoma was fully removed with surgery and she recovered from the event. She was monitored every 6 months with Pap smears. Eventually she would have a hysterectomy, however, she was still in her childbearing ears. It was reported at time of diagnosis, the event was not life threatening. However, if she had left the adenocarcinoma untreated, it eventually would have become life threatening. The patient mentioned that she recently had a baby. She confirmed that she was not pregnant when she received the one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (maternal exposure before pregnancy).  The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and adenocarcinoma of the cervix was not provided.  Upon internal review, adenocarcinoma of the cervix was determined to be medically significant.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Loop electrosurgical excision procedure, Maternal exposure before pregnancy, Smear cervix
Clinical narrative: the patient confirmed that she was not pregnant when she received the one dose of GARDASIL; adenocarcinoma of the cervix; Information has been received from a 28 years old female physician assistant referring to herself. The patient had no concomitant therapy, pertinent medical history or drug reactions/allergies.  On an unknown date in 2007 (approximately at 19 years old), she received the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (batch/lot #, expiration date, strength, dose and route were unknown) for prophylaxis. She did not receive any additional doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  On an unspecified date in 2016, she was diagnosed with adenocarcinoma of the cervix. Medical attention was sought with office visits. She had the following procedures colposcopy, loop electrical excision procedure (LEEP) and cold knife conization. On an unknown date, the adenocarcinoma was fully removed with surgery and she recovered from the event. She was monitored every 6 months with Pap smears. Eventually she would have a hysterectomy, however, she was still in her childbearing ears. It was reported at time of diagnosis, the event was not life threatening. However, if she had left the adenocarcinoma untreated, it eventually would have become life threatening. The patient mentioned that she recently had a baby. She confirmed that she was not pregnant when she received the one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (maternal exposure before pregnancy).  The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and adenocarcinoma of the cervix was not provided.  Upon internal review, adenocarcinoma of the cervix was determined to be medically significant.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient received improperly stored VARlVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 10-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose, route, frequency, were not provided) for prophylaxis; the Lot No. S003864 has been verified to be a valid lot number for [Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live], expiration date reported as 08-AUG-2020, and upon internal validation established as the same.   The medical assistant reported that the vaccine dose was administered to the patient and the vaccine was improperly stored (incorrect product storage). The vaccine presented a temperature excursion with a temperature of 6°F to 14°F (7.7 degrees F) for 30 minutes. And no adverse events were reported.   Moreover, it was stated that the sterile diluent that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored. The Lot was No. S016519 and the expiration date reported as 01-APR-2022.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Neuralgia
Clinical narrative: nerve pain; joint pain; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 05-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the prevention of shingles (the dosage regimen information was not reported) in a pharmacy. Shortly thereafter, the vaccine caused the patient to suffer from severe and persistent joint and nerve pain. As a direct and proximate result of vaccination, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue suffered significant medical expenses, pain, and suffering and other damages. The outcome of the events was considered as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX). The adverse events were considered to be disabling as the patient suffered serious and persistent injuries.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect reported; the patient was administered an expired dose of vaqta; This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies, historical drugs, familial history and concomitant medications were not reported.   On 09-SEP-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) Expiration date: 05-SEP-2019 (strength, route of administration, lot/batch # were not reported) for prophylaxis (expired product administered). The patient experienced no adverse event. No product quality complaint was reported.
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; A 4 month old patient received a dose of PNEUMOVAX; This spontaneous report was received from a medical assistant concerning to a 4 month old patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 09-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (product administered to patient of inappropriate age) for prophylaxis (lot # S012247 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date reported as10-FEB-2021) (strength, dose, frequency and route of administration were not reported).   No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; The primary reporter reports a 56 year old patient was administered a dose of PROQUAD; This spontaneous report was received from a nurse, regarding a 56 year old patient of unknown gender. The patient's concurrent condition, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 22-AUG-2019, the patient of 56 year old was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (appropriate age at vaccine administration) for prophylaxis (strength, route of administration, dose, frequency, lot number and expiration date were not reported). No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; A patient received improperly stored PROQUAD; Information has been received from a medical assistant and refers to a 4 year old patient of unknown gender. There was no information about patient's concurrent conditions, medical history or concomitant medications.  On 04-SEP-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha)(PROQUAD) lot # S002494 with expiration date of 23-JUL-2020 (dose, frequency, route of administration and anatomical location were not reported), for prophylaxis which were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (10.2 Fahrenheit degrees) for 50 minutes. The vaccine was reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT). No previous temperature excursion was reported.  No adverse effects were reported.   Digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; improperly stored vaccine administration; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient with unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.      On 04-SEP-2019, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency and route were not reported) (lot # S002874, Expiration Date: 29-JAN-2021) for prophylaxis. There was no adverse effect. The stored temperature was 6 Fahrenheit (F) to 14 F (10.2 F, multiple) for 50 minutes and the data logger was involved. There was no previous temperature excursion. It was used to reconstitute sterile diluent (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The storage of sterile diluent was properly.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; improperly stored vaccine administration; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient with unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.      On 11-SEP-2019, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency and route were not reported) (lot # S002874, Expiration Date: 29-JAN-2021) for prophylaxis. There was no adverse effect. The stored temperature was 6 Fahrenheit (F) to 14 F (10.2 F, multiple) for 50 minutes and the data logger was involved. There was no previous temperature excursion. It was used to reconstitute sterile diluent (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The storage of sterile diluent was properly.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005220:
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: DRUG EXPOSURE DURING PREGNANCY; This case was reported by a healthcare professional and described the occurrence of drug exposure during pregnancy in a 18-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis while pregnant.  Concurrent vaccination included hepatitis B vaccine recombinant (Merck) given intramuscularly on 10 October 2007. Concurrent medications included Prenatal vitamins.   On 10 October 2007 at 16:25 the pregnant subject received a dose of Boostrix, intramuscularly, at 0.5 ml in the right arm.  This was considered a case of drug exposure during pregnancy.  No events were reported.  The subject is reportedly due to deliver in December 2007.  At the time of reporting the outcome of the event was unspecified.  Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
Age: 15.0
Sex: F
Vaccine: FLU3, HEP, IPV, TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 15-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis while pregnant.  Concurrent vaccination included hepatitis B vaccine (Recombivax, Merck), inactivated poliomyelitis virus vaccine (Sanofi) and seasonal influenza vaccine (Fluzone, Sanofi) given on 15 January 2009. Pervious vaccination included two TD vaccines given in 2005.  On 15 January 2009 at 10:45 the subject received a dose of Boostrix at 0.5 ml in the left arm. This was a case of vaccine exposure during pregnancy. No adverse events were reported.    On 27 January 2009, follow-up information was received from the reporting nurse. The nurse reported that the subject received only immunization series from her Health Department. She reported that she had no way of assessing the information requested on the Pregnancy Initial Notification Form. She tried to call unspecified phone numbers, but no one was available.  Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of drug exposure during pregnancy in a 31-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis while pregnant.   There were no concurrent medications.   On 20 December 2010 at 11:20 the subject received 1st dose of Boostrix at 0.5 ml inthe left arm. The subject experienced drug exposure during pregnancy. Her date of last menstrual period was not reported and her estimated date of delivery was 28 March 2011. No adverse events were noted at the time of reporting.  Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 38-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis while pregnant.   On 10 May 2011 at 16:45 the subject received a dose of Boostrix at 0.5 ml in the left arm. The subject experienced vaccine exposure during pregnancy. Her date of last menstrual period and estimated date of delivery were not provided. At the time of reporting the pregnancy was ongoing. No additional information is expected as subject's at this facility are only seen once and outcomes are not known.   Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a consumer (the subject's mother) and described the occurrence of vaccine exposure during pregnancy in a 19-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy. A physician or other health care professional has not verified this report.  Concurrent medications included Prenatal vitamins.   On an unspecified date in April 2011 the subject received a dose of Boostrix (details unknown), and experienced vaccine exposure during pregnancy.  The subject was 27 weeks pregnant at the time of vaccination.  The consumer believed that the dtap vaccine administered was Boostrix, but was not sure.  The subject had had 3 ultrasounds since the vaccination and there were no abnormalities or issues identified.  The pregnancy had been without complications at the time of reporting.  Estimated delivery date was 13 September 2011.   Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 40-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's medical history included two previous normal full-term live births. Concurrent medical conditions included anemia and depression.   Concurrent medications included Sertraline hydrochloride (Zoloft).   On 1 September 2011 the subject received a dose of Boostrix (.5 unknown units, intramuscular, unknown site), and experienced vaccine exposure during pregnancy.  The subejct was approximately 25 weeks gestation at the time of vaccination.  Date of last menstrual period was 15 March 2011 and estimated delivery date was 09 December 2011.  The subject had not been using contraception prior to becoming pregnant and the conception was reported to be normal.  Prenatal testing, including ultrasound and amniocentesis on 21 July 2011 revealed no evidence of a defect.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound and amniocentesis on 21 July 2011 revealed no evidence of a defect.
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Muscle twitching
Clinical narrative: Muscle twitching in the area of the injection; This case was reported by a consumer and described the occurrence of injection site muscle reaction in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site muscle reaction. On an unknown date, the outcome of the injection site muscle reaction was unknown.   It was unknown if the reporter considered the injection site muscle reaction to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked if the muscle twitching a normal side effect of the vaccine. The patient experienced muscle twitching in the area of the injection.
Age: 0.5
Sex: M
Vaccine: TDAP
Symptoms: Generalised tonic-clonic seizure, Immediate post-injection reaction
Clinical narrative: Grand mal seizure; This case was reported by a consumer via interactive digital media and described the occurrence of grand mal seizure in a 6-month-old patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, immediately after receiving DTPa vaccine, the patient experienced grand mal seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the grand mal seizure was unknown.   The reporter considered the grand mal seizure to be related to DTPa vaccine.  Additional details were provided as follows: This case received from interactive digital media. The patient mother reported case on behalf of her son. The patient received DTPa vaccine and reacted to pertussis. Right after that the patient had Grand mal seizure. The physician advised to the patient's mother that they would remove pertussis from DTPa for next doses.
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: Rash on the arm; This case was reported by a nurse via sales rep and described the occurrence of rash in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 4 days after receiving Bexsero, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix on an unknown arm. Four to five days after vaccination, the patient experienced a rash on the arm, not in the area of the injection, but same arm. The event was resolved without treatment. The reporter did not agree to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Influenza like illness, Pain in extremity, Peripheral swelling
Clinical narrative: Felt like he had the flu; Arm was sore below injection sit; Arm was swollen bellow injection site; Red spot below the injection site that was swollen and hard; Red spot below the injection site that was swollen and hard; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 7th August 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On 9th August 2019, the patient experienced pain in arm and swelling arm. In August 2019, the patient experienced localized erythema and induration. On 9th August 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the pain in arm, swelling arm, localized erythema and induration were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, swelling arm, localized erythema and induration to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient felt like he had the flu the next day after receiving the vaccination and resolved after two days. The third day after receiving the vaccination, the patient's arm was sore and swollen approximately 4 inches below the injection site.  The patient also experienced red spot again 4 inches below the injection site that was swollen, and hard. The patient gave permission for her physician to be contacted. This case has been linked with case US2019160424, reported by the same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site indentation
Clinical narrative: Indented line at the site of the injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site indentation in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   On 31st August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd September 2019, 3 days after receiving Shingrix, the patient experienced injection site indentation. On an unknown date, the outcome of the injection site indentation was unknown.   It was unknown if the reporter considered the injection site indentation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in his left deltoid. The patient noticed an indented line at the site of the injection on left upper arm. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly male patient who received Herpes zoster (Shingrix) (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that patient developed Shingles after receiving first dose of Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Laboratory test
Clinical narrative: joint pain; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder injury and shoulder pain.   On 3rd September 2019, the patient received the 1st dose of Shingrix. On 3rd September 2019, 30 min after receiving Shingrix, the patient experienced joint pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The patient reported the adverse event for himself. The age at vaccination was not reported. The day before the reporting date, the patient received Shingrix.  About half an hour later, he started experiencing joint pain. The pain was a 10 from a scale of 1 to 10.  The joint pain was specifically happening on the joint in his shoulder where he previously had an injury in that shoulder. The patient went down to pharmacy and then to emergency room and did a series of tests and he received Tylenol 1,000 mg.  The joint pain was decreased a little bit but he still had it. The patient consented to follow up and provided contact details of his doctor who treated patient's should pain previously.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: joint pain; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder injury and shoulder pain.   On 3rd September 2019, the patient received the 1st dose of Shingrix. On 3rd September 2019, 30 min after receiving Shingrix, the patient experienced joint pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The patient reported the adverse event for himself. The age at vaccination was not reported. The day before the reporting date, the patient received Shingrix.  About half an hour later, he started experiencing joint pain. The pain was a 10 from a scale of 1 to 10.  The joint pain was specifically happening on the joint in his shoulder where he previously had an injury in that shoulder. The patient went down to pharmacy and then to emergency room and did a series of tests and he received Tylenol 1,000 mg.  The joint pain was decreased a little bit but he still had it. The patient consented to follow up and provided contact details of his doctor who treated patient's should pain previously.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date unknown) for prophylaxis.   On 2nd September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information received were as follows: The pharmacist called to report that the patient received Shingrix. The patient experienced pain at injection site for 4 days. The reporter consented to follow up. The caller did not have expiration date of Shingrix.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient was hesitant to provide demographics. The patient received dose 1 of Shingrix and she experienced redness at the injection site measuring approximately 2 inches by two inches. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like Symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced Flu-like symptoms after receiving a dose of Shingrix. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLUX
Symptoms: Paralysis, Wheelchair user
Clinical narrative: In a wheelchair totally paralyzed; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced paralysis (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the paralysis was unknown.   The reporter considered the paralysis to be related to Flu vaccine.  Additional details were provided as follows: This case reported by the reporter's friend sister. The age at vaccination was not reported. The patient was in a wheelchair and totally paralyzed from the Flu shot. The reporter stated that the reporter knew too many people getting lupus and auto-immune disease after an unspecified vaccine. The reporter stated that there was massive aluminum in vaccines (name not specified) and 1 in 3 get Alzheimers and they found the aluminum in their brains at autopsies.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient received a dose Daptacel vaccine that reached at 1.7 degree Celsius for 30 minutes due to temperature excursion on July 30 in refrigerator due an unknown reason/No AE; Based on information received on 06-SEP-2019, the report previously considered as non-valid became valid: [patient identifier updated].  Initial information received on 09-Aug-2019 regarding an unsolicited non-valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who received a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Lot: C55118A, Expiry date: 30-Aug-2020 and Lot: C53668A, Expiry date: 07-Feb-2020), which had a temperature excursion for reasons not known. Nurse stated on July 30 the refrigeratore reached a temperature of 1.7 degree Celsius for 30 minutes.  It was as actual medication error due to incorrect product storage.  The patient did not experience any averse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.  Follow up information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  Case became valid and the patient experienced no adverse event.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Pain, Skin warm
Clinical narrative: rash at the injection site that spreads down to the elbow; abnormal pain; hotness to touch; Initial information received on 05-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age female patient who experienced rash at the injection site that spreads down to the elbow (rash), abnormal pain (pain) and hotness to touch (skin warm), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 05-Sep-2019, 28-Aug-2019, the patient received a first and second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Expiry date unknown) via intramuscular route in unknown administration site.  On an unknown date, the patient developed a non-serious rash at the injection site that spreads down to the elbow (rash), abnormal pain (pain) and hotness to touch (skin warm) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was Localized rash, pain and Skin warm.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Recovering for Localized rash, pain and Skin warm.  Information on the batch number was requested.  List of documents held by sender- none.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: pregnant females that were given the invalid Adacel, no side effects observed; It was reported that excursion was caused by Human Error, The Excursion was Negative 40 degrees C and 22.7 degrees C/ There were no side effects observed.; Initial information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case ID: 2019SA250866 and 2019SA250874 (same reporter).  This case involves a 25 year old female pregnant patient who was exposed to a second dose vaccine of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (dosage form: Prefilled Syringe) lot U6273AA, expiry date: 24-Apr-2021 via intramuscular route in the right arm on 21-Aug-2019.  The reported pregnant females that were given Adacel and no side effects observed occurred at unknown gestation period and the patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 31 weeks of pregnancy, during third pregnancy trimester for DIPHTHERIA- 2/TETANUS/5 AC PERTUSSIS VACCINE. The date of last menstrual period was reported as 19-Jan-2019. The estimated due date is 25-Oct-2019. The patient previous pregnancy was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is a case of vaccine exposure during pregnancy. It was reported that excursion was caused by Human Error, The Excursion was Negative 40 degrees C and 22.7 degrees C/ There were no side effects observed. Incorrect product storage.  It was reported that the patient had no adverse event following the vaccination.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old was administered Fluzone High Dose, no AE; 17 year old was administered Fluzone High Dose, no AE; Initial and follow up information received on 06-Sep-2019 and 10-Sep-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case is linked to cases 2019SA251863 and 2019SA251864 (same reporter).  This case involves a 17 years old male patient who was received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ232AA, Exp. Date 10-Apr-2020) via intramuscular route in the left deltoid on 05-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was also a case of overdose.  At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pain, Vomiting
Clinical narrative: Chills, nausea-vomiting, headache, body aches
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Ear pain, Eye swelling, Oropharyngeal pain, Pain, Swelling face
Clinical narrative: Sore throat, shooting pains in ears, swollen eyes/face
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pruritus
Clinical narrative: The next day after the vaccine she got a weird itch across her shoulders and base of neck. No sign of rash , no sign of shingle. Described the itch as under her skin. Continuous for a month, bad at beginning but has gotten better. Also had a headache the day after but went away the same day.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Injection site soreness - lasting days, flu like symptoms beginning the next day and lasting 48 hours, 101 fever beginning 12 hours post injection and lasting 30 hours managed by Tylenol. Fever re-emerged 3 times
Age: 0.17
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flu vaccine administered in error in 2 month old patient, no adverse outcomes noted at this time
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Muscle tightness, Peripheral swelling
Clinical narrative: Patient described  arm as red and swollen. States the muscle is tight. It is now red from injection site and traveled to elbow. Stated starting to feel side effects within a few hours of vaccine.
Age: 2.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Fever to Tmax of 104 persisting for 48 hours.  No other associated signs or symptoms.  Exam on 9/16/2019 normal
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram abnormal, Heart rate increased, Hypertension, Vomiting
Clinical narrative: 3 hours post vaccination violent vomiting, rapid heart rate, high blood pressure, abnormal ekg
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Face injury, Fall, Syncope, Tooth fracture, X-ray
Clinical narrative: Patient fainted within a few minutes after injection, patient was sitting on exam table while medical assistant and patient's aunt were scheduling the patient's follow up visit, patient fell forward onto the floor, patient landed on her face and broke off part of her two front teeth.
Age: 8.0
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse effects; reconstituted in error with the diluent that is for "Menveo"; This spontaneous report as received from a nurse refers to a 8-year-old male patient. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported.  On 19-AUG-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R035221, expiration date reported as 04-DEC-2020, but upon internal validation established as 04-DEC-2019, dose and route of administration were not reported) and was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (lot # reported as: S006646, expiration date reported as 05-MAR-2021, dose and route of administration were not reported), that were reconstituted in error with the diluent for meningococcal ACYW conj vaccine (CRM197) (MENVEO) (NDC 58160-959-01 MenCYW-135 liquid conjugate component), both vaccines were administered for prophylaxis. No adverse effects were reported.
Age: 4.0
Sex: F
Vaccine: MMRV, UNK
Symptoms: Circumstance or information capable of leading to medication error, Device connection issue, Needle issue, No adverse event, Underdose
Clinical narrative: No adverse effects; needle bent; child received a partial dose of PROQUAD; This spontaneous report was received from a registered nurse and refers to a 4-year-old female patient. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not reported.  On 23-AUG-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection in the right thigh (lot # S002497 and expiry date 23-JUL-2020; exact dose was not provided) which was reconstituted with sterile diluent (lot # S000978 and expiry date 22-JUL-2021) for prophylaxis. There was administered a partial dose, because the child was moving so much during the vaccination, that the needle bent and the syringe had to be removed from the thigh. The needle disengaged from the syringe and the remainder of the product was lost on the table. No adverse effects were reported. The outcome of the event was unknown.  The causality assessment was not provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored doses of PROQUAD and VARIVAX were administered to patient; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     On 19-AUG-2019, the patient was vaccinated with an improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R034398, expiration date 27-NOV-2020 and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003178, expiration date 30-JUL-2020 (dose, frequency, route of administration and anatomical location were not provided) for prophylaxis. The temperature excursion was between 6 to 14 degree Fahrenheit for 2 hours and 30 minutes and between 15 to  46 degree Fahrenheit (36 F) for 2 hours and 30 minutes. There was no previous temperature excursion. The digital data logger was involved. Concomitant therapies included sterile diluent which was stored properly. The patient did not experience adverse event.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects; on 3/7/2017 a 12 month old patient was administered 1 dose of PROQUAD and 1 dose of VARIVAX, On 7/31/2019 the patient who is now 3 years old was administered 1 dose of VARIVAX; This spontaneous report was received from a medical assistant referring to a 12-months old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On 07-MAR-2017, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# N028459 (is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX)), expiration date: 07-JUN-2018, dose and route were not reported) and one dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# was reported as N035689, expiration date: 06-FEB-2018, dose and route were not reported) for prophylaxis (overdose).  On 31-JUL-2019, the patient was 3 years old and was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# R018933, expiration date: 02-JUL-2020, dose and route were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; patient was administered a dose of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's drug reactions or allergies, medical history and concomitant medications were not reported.   On 28-AUG-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S003863, expiration date 08-AUG-2020) (dose, route of administration were not reported) for prophylaxis. No adverse effects was reported. The vaccine underwent temperature excursion of -14 degree Celsius to -10 degree Celsius (also reported as "-14.4 C") for 18 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complains involved. No further information provided.