chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Erythema, Fatigue
Clinical narrative: 1st shot my arm was extremely sore, with a three inch in diameter red spot which  was swollen and remained very sore for 3 weeks and the discoloration took 4 weeks to subside. The pain disrupted my sleep for weeks because I could not sleep on that side. I had fever chills and nausea and extreme fatigue for two days. I consulted with the pharmacist concerned about my strong reaction to the first shot and he still encouraged me to get the second shot on 9/19/19. Within hours I had extreme nausea, and complete flu like symptoms and my arm was extremely sore again. I was in bed for two days unable to function at all and felt horrid. I had the oddest Headache ever and a fever, body and joint aches, Day two i had diarrhea.  I have never had a reaction like this to ANY vaccine before. AT day 4 post injection I still feel foggy and not myself.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness, Loss of personal independence in daily activities, Nausea
Clinical narrative: 1st shot my arm was extremely sore, with a three inch in diameter red spot which  was swollen and remained very sore for 3 weeks and the discoloration took 4 weeks to subside. The pain disrupted my sleep for weeks because I could not sleep on that side. I had fever chills and nausea and extreme fatigue for two days. I consulted with the pharmacist concerned about my strong reaction to the first shot and he still encouraged me to get the second shot on 9/19/19. Within hours I had extreme nausea, and complete flu like symptoms and my arm was extremely sore again. I was in bed for two days unable to function at all and felt horrid. I had the oddest Headache ever and a fever, body and joint aches, Day two i had diarrhea.  I have never had a reaction like this to ANY vaccine before. AT day 4 post injection I still feel foggy and not myself.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Skin discolouration
Clinical narrative: 1st shot my arm was extremely sore, with a three inch in diameter red spot which  was swollen and remained very sore for 3 weeks and the discoloration took 4 weeks to subside. The pain disrupted my sleep for weeks because I could not sleep on that side. I had fever chills and nausea and extreme fatigue for two days. I consulted with the pharmacist concerned about my strong reaction to the first shot and he still encouraged me to get the second shot on 9/19/19. Within hours I had extreme nausea, and complete flu like symptoms and my arm was extremely sore again. I was in bed for two days unable to function at all and felt horrid. I had the oddest Headache ever and a fever, body and joint aches, Day two i had diarrhea.  I have never had a reaction like this to ANY vaccine before. AT day 4 post injection I still feel foggy and not myself.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Sleep disorder
Clinical narrative: 1st shot my arm was extremely sore, with a three inch in diameter red spot which  was swollen and remained very sore for 3 weeks and the discoloration took 4 weeks to subside. The pain disrupted my sleep for weeks because I could not sleep on that side. I had fever chills and nausea and extreme fatigue for two days. I consulted with the pharmacist concerned about my strong reaction to the first shot and he still encouraged me to get the second shot on 9/19/19. Within hours I had extreme nausea, and complete flu like symptoms and my arm was extremely sore again. I was in bed for two days unable to function at all and felt horrid. I had the oddest Headache ever and a fever, body and joint aches, Day two i had diarrhea.  I have never had a reaction like this to ANY vaccine before. AT day 4 post injection I still feel foggy and not myself.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise
Clinical narrative: 1st shot my arm was extremely sore, with a three inch in diameter red spot which  was swollen and remained very sore for 3 weeks and the discoloration took 4 weeks to subside. The pain disrupted my sleep for weeks because I could not sleep on that side. I had fever chills and nausea and extreme fatigue for two days. I consulted with the pharmacist concerned about my strong reaction to the first shot and he still encouraged me to get the second shot on 9/19/19. Within hours I had extreme nausea, and complete flu like symptoms and my arm was extremely sore again. I was in bed for two days unable to function at all and felt horrid. I had the oddest Headache ever and a fever, body and joint aches, Day two i had diarrhea.  I have never had a reaction like this to ANY vaccine before. AT day 4 post injection I still feel foggy and not myself.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Malaise, Pyrexia, Tachyphrenia, Vomiting
Clinical narrative: high fever; vomiting; Racing thoughts; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 17th October 2021) and (batch number BSHP5 ?, expiry date 17th October 2021) for prophylaxis.   On 3rd September 2019, the patient received Shingrix. On an unknown date, the dose was an unknown dose. In September 2019, less than a week after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), vomiting (serious criteria hospitalization) and racing thoughts (serious criteria hospitalization). On an unknown date, the outcome of the fever, vomiting and racing thoughts were unknown.   It was unknown if the reporter considered the fever, vomiting and racing thoughts to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced vomiting, high fever and racing thoughts and was hospitalised for the events.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Tachyphrenia, Vomiting
Clinical narrative: high fever; vomiting; Racing thoughts; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 17th October 2021) and (batch number BSHP5 ?, expiry date 17th October 2021) for prophylaxis.   On 3rd September 2019, the patient received Shingrix. On an unknown date, the dose was an unknown dose. In September 2019, less than a week after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), vomiting (serious criteria hospitalization) and racing thoughts (serious criteria hospitalization). On an unknown date, the outcome of the fever, vomiting and racing thoughts were unknown.   It was unknown if the reporter considered the fever, vomiting and racing thoughts to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced vomiting, high fever and racing thoughts and was hospitalised for the events.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever; fatigue; Injection site redness; Injection site swelling; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA048A, expiry date unknown) for prophylaxis.   On 3rd September 2019, the patient received Menveo. On 5th September 2019, 2 days after receiving Menveo, the patient experienced fever, fatigue, injection site erythema and injection site swelling. On an unknown date, the outcome of the fever, fatigue, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the fever, fatigue, injection site erythema and injection site swelling to be related to Menveo.  Additional information received were as follows: The patient experienced fever, fatigue, injection site swelling, and injection site redness. The injection site symptoms were also around the patient's upper arm. The reporter consented to follow up. The patient's arm was back to normal on the reporting date.  The physician was going to order a CBC for the patient, and also asked to see if the patient possibly having mono at the time of administration could exacerbate a reaction to the vaccine. The permission was provided for follow-up. consented to follow up.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever; fatigue; Injection site redness; Injection site swelling; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA048A, expiry date unknown) for prophylaxis.   On 3rd September 2019, the patient received Menveo. On 5th September 2019, 2 days after receiving Menveo, the patient experienced fever, fatigue, injection site erythema and injection site swelling. On an unknown date, the outcome of the fever, fatigue, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the fever, fatigue, injection site erythema and injection site swelling to be related to Menveo.  Additional information received were as follows: The patient experienced fever, fatigue, injection site swelling, and injection site redness. The injection site symptoms were also around the patient's upper arm. The reporter consented to follow up. The patient's arm was back to normal on the reporting date.  The physician was going to order a CBC for the patient, and also asked to see if the patient possibly having mono at the time of administration could exacerbate a reaction to the vaccine. The permission was provided for follow-up. consented to follow up.
Age: 4.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored Proquad; This spontaneous report was received from a nurse and refers to a 4-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 21-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), injection, lot # R023499 and expiration date 17-MAR-2020 or lot # R023499 and expiration date 13-FEB-2020 (dose and route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent. The temperature was from -14°C to -10°C (-11.91 C, multiple) for 8 hours. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effect was reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA003218:
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pallor, Injection site swelling
Clinical narrative: white colored bump away from the injection site, it became swollen and hard in the middle; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 41 years old female patient who experienced white colored bump away from the injection site, it became swollen and hard in the middle (injection site swelling), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 14-Sep-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6401AA and expiry date: 26-Jul-2021 via intramuscular route in the left deltoid.  On an unknown date, following the vaccination the patient experienced white colored bump away from the injection site, it became swollen and hard in the middle (injection site swelling.  (Other relevant tests included no lab data.)  Final diagnosis was injection site swelling.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Induration, Skin discolouration, Swelling
Clinical narrative: white colored bump away from the injection site, it became swollen and hard in the middle; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 41 years old female patient who experienced white colored bump away from the injection site, it became swollen and hard in the middle (injection site swelling), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 14-Sep-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6401AA and expiry date: 26-Jul-2021 via intramuscular route in the left deltoid.  On an unknown date, following the vaccination the patient experienced white colored bump away from the injection site, it became swollen and hard in the middle (injection site swelling.  (Other relevant tests included no lab data.)  Final diagnosis was injection site swelling.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  List of documents held by sender: none.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abnormal dreams, Headache, Insomnia, Malaise, Pain in extremity
Clinical narrative: Sick feeling; fever; Up all night because of the fever; Left arm soreness; Headache; Wild dreams; body aches; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain. On an unknown date, the outcome of the feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain were unknown.   It was unknown if the reporter considered the feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain to be related to Shingrix.  Additional information received were as follows: The nurse also stated that she administered the vaccine to other employees on the day before reporting, who she had called on the reporting date and 7 of the 10 had reported the exact same issues. The nurse did not had the specifics of the individuals other than 4 were females and 3 were males. They all received the same lot and expiration date of the product she received and it was the first dose of Shingrix for all. This case is 1 of the 8 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Sick feeling; fever; Up all night because of the fever; Left arm soreness; Headache; Wild dreams; body aches; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain. On an unknown date, the outcome of the feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain were unknown.   It was unknown if the reporter considered the feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain to be related to Shingrix.  Additional information received were as follows: The nurse also stated that she administered the vaccine to other employees on the day before reporting, who she had called on the reporting date and 7 of the 10 had reported the exact same issues. The nurse did not had the specifics of the individuals other than 4 were females and 3 were males. They all received the same lot and expiration date of the product she received and it was the first dose of Shingrix for all. This case is 1 of the 8 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abnormal dreams, Headache, Insomnia, Malaise, Pain
Clinical narrative: Sick feeling; fever; Up all night because of the fever; Left arm soreness; Headache; Wild dreams; body aches; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain. On an unknown date, the outcome of the feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain were unknown.   It was unknown if the reporter considered the feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain to be related to Shingrix.  Additional information received were as follows: The nurse also stated that she administered the vaccine to other employees on the day before reporting, who she had called on the reporting date and 7 of the 10 had reported the exact same issues. The nurse did not had the specifics of the individuals other than 4 were females and 3 were males. They all received the same lot and expiration date of the product she received and it was the first dose of Shingrix for all. This case is 1 of the 8 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sick feeling; fever; Up all night because of the fever; Left arm soreness; Headache; Wild dreams; body aches; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain. On an unknown date, the outcome of the feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain were unknown.   It was unknown if the reporter considered the feeling unwell, fever, sleeplessness, pain in arm, headache, abnormal dreams and general body pain to be related to Shingrix.  Additional information received were as follows: The nurse also stated that she administered the vaccine to other employees on the day before reporting, who she had called on the reporting date and 7 of the 10 had reported the exact same issues. The nurse did not had the specifics of the individuals other than 4 were females and 3 were males. They all received the same lot and expiration date of the product she received and it was the first dose of Shingrix for all. This case is 1 of the 8 cases, reported by the same reporter.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Feeding disorder, Headache, Lacrimation increased, Malaise
Clinical narrative: Patient developed fever (101.6 degrees), chills and aches about eight hours after injection.  He could not eat for the next 24 hours because of nausea and malaise.  On 9-21 he started getting bad headaches especially when he moved.  On 9-22 he developed a runny nose and red, watery eyes.  The symptoms have not yet subsided.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea, Ocular hyperaemia, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Patient developed fever (101.6 degrees), chills and aches about eight hours after injection.  He could not eat for the next 24 hours because of nausea and malaise.  On 9-21 he started getting bad headaches especially when he moved.  On 9-22 he developed a runny nose and red, watery eyes.  The symptoms have not yet subsided.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Urticaria noted on back areas from shoulders to mid-thigh,; red, slightly raised itchy patches; itch relieved by diphenhydramine but patches remain today. Wondering if unusual pattern on body is due to increased circulation to back area due to use of car seat warmer.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain
Clinical narrative: severe shoulder pain
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival discomfort, Gingival erythema, Lymph node pain, Lymphadenopathy, Tongue blistering
Clinical narrative: Toothache starting with pain, then severe pain swollen sore glands red irritated gums all on right side of mouth and base of tongue  a few small blisters that broke
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Toothache
Clinical narrative: Toothache starting with pain, then severe pain swollen sore glands red irritated gums all on right side of mouth and base of tongue  a few small blisters that broke
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Gastrointestinal disorder, Immediate post-injection reaction
Clinical narrative: immediately after the immunization every muscle in my body severely hurt. Within an hour of the immunization, I had sudden extreme  exhaustion and fatigue  to the point I feel asleep while eating and I had nausea, vomiting, diarrhea, stomach cramps and 103 degree fever. My skin also turned pink all over my body. I am still this many days out in extreme pain. All my muscle in my body hurt severely to the point my muscle pain wakes me up from sleeping. Last night I was again awaken from all of my muscles hurting. The pain was so bad that I felt I needed to an ER for pain control. The only reason that I did not go to an ER is because I do not live close to an ER. I am I so much pain and have so many GI symptoms and such bad fatigue that I do not feel that I can drive to my nearest ER which is far away from me. I considered calling for an ambulance but I was not sure if this is the type of thing you call an ambulance  for since I was not having an life threatening issue. I was not sick prior to this immunization. In fact, I have a berry healthy lifestyle and diet and I was feeling very well prior to this immunization.  Now that it is amiss business hours, I am going to see if I can get someone to drive me to the doctor today. I normally can drive but I have been too sick to drive since this immunization.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired driving ability, Malaise, Myalgia, Nausea, Pain
Clinical narrative: immediately after the immunization every muscle in my body severely hurt. Within an hour of the immunization, I had sudden extreme  exhaustion and fatigue  to the point I feel asleep while eating and I had nausea, vomiting, diarrhea, stomach cramps and 103 degree fever. My skin also turned pink all over my body. I am still this many days out in extreme pain. All my muscle in my body hurt severely to the point my muscle pain wakes me up from sleeping. Last night I was again awaken from all of my muscles hurting. The pain was so bad that I felt I needed to an ER for pain control. The only reason that I did not go to an ER is because I do not live close to an ER. I am I so much pain and have so many GI symptoms and such bad fatigue that I do not feel that I can drive to my nearest ER which is far away from me. I considered calling for an ambulance but I was not sure if this is the type of thing you call an ambulance  for since I was not having an life threatening issue. I was not sick prior to this immunization. In fact, I have a berry healthy lifestyle and diet and I was feeling very well prior to this immunization.  Now that it is amiss business hours, I am going to see if I can get someone to drive me to the doctor today. I normally can drive but I have been too sick to drive since this immunization.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Poor quality sleep, Pyrexia, Skin discolouration, Somnolence, Vomiting
Clinical narrative: immediately after the immunization every muscle in my body severely hurt. Within an hour of the immunization, I had sudden extreme  exhaustion and fatigue  to the point I feel asleep while eating and I had nausea, vomiting, diarrhea, stomach cramps and 103 degree fever. My skin also turned pink all over my body. I am still this many days out in extreme pain. All my muscle in my body hurt severely to the point my muscle pain wakes me up from sleeping. Last night I was again awaken from all of my muscles hurting. The pain was so bad that I felt I needed to an ER for pain control. The only reason that I did not go to an ER is because I do not live close to an ER. I am I so much pain and have so many GI symptoms and such bad fatigue that I do not feel that I can drive to my nearest ER which is far away from me. I considered calling for an ambulance but I was not sure if this is the type of thing you call an ambulance  for since I was not having an life threatening issue. I was not sick prior to this immunization. In fact, I have a berry healthy lifestyle and diet and I was feeling very well prior to this immunization.  Now that it is amiss business hours, I am going to see if I can get someone to drive me to the doctor today. I normally can drive but I have been too sick to drive since this immunization.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain, Pruritus, Swelling
Clinical narrative: muscle weakness, itching, pain, ,swelling
Age: 19.0
Sex: M
Vaccine: TYP, UNK, UNK
Symptoms: Neurodermatitis, Seasonal allergy
Clinical narrative: Neurodermatitis; Seasonal allergy; This case (DE-PEI-PEI2019005917) was received from a consumer via health authority (EMA) on 09-Sep-2019. It described a 19-year-old male consumer who developed neurodermatitis (PT: neurodermatitis) and pollinosis (PT: seasonal allergy) after administration of Typhoral L, Pocken and Telanol for prophylactic vaccination.  Case report: The consumer took a dose of Typhoral-L on 14-Jul-1976, along with Pocken on 18-Aug-1976 and Tetanol on 02-Jul-1976. Subsequently, he developed pollinosis and neurodermitis in 1976 & 1977, respectively. The consumer showed disabling/incapacitating.  Action taken with Typhoral L with respect to the event pollinosis was unknown, while with respect to the event neurodermatitis was not applicable while that with Pocken, and Tetanol with respect to the events pollinosis. The consumer had recovered with sequelae from the reported events.  Company's Comment: In this case, it was reported that a 19-year-old adult male consumer developed neurodermatitis and pollinosis after the administration of Typhoral L, Pocken, and Tetanol. There is lack of information regarding start date of events, course of events, medical history and concomitant medications. Hence, the causality is assessed as not assessable for the reported events with respect to intake of Typhoral-L.; Sender's Comments: Company's Comment: In this case, it was reported that a 19-year-old adult male consumer developed neurodermatitis and pollinosis after the administration of Typhoral L, Pocken, and Tetanol. There is lack of information regarding start date of events, course of events, medical history and concomitant medications. Hence, the causality is assessed as not assessable for the reported events with respect to intake of Typhoral-L.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient received unspecified dose of PEDVAXHIB that was improperly stored/experienced excursion on 5/10/2018.; Information has been received from a nurse referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 10-MAY-2018, the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # N003536, expiration date wasreported as November 2019, but upon internal validation established as 02-NOV-2019) was improperly stored. The stored temperature was 8.72 degree Celsius. The time frame was 1 hours and 35 minutes. There was more than 1 previous temperature excursion. The temperature excursion was detected by a data logger.    On 23-JUL-2018, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # N003536, expiration date was reported as November 2019, but upon internal validation established as 02-NOV-2019, strength, dose, frequency and route were unknown) for prophylaxis (improper storage of product in use).  No adverse effects were reported.
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; one male patient received improperly stored ROTATEQ; Information has been received from an office manager referring to a 6-week-old male patient. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.        On 25-JUL-2019, the patient was vaccinated with received improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot S000945, expiration date: 13-JUL-2020; strength, dose and route were not reported) for prophylaxis (product storage error). The call was because of data logger. Total time and lowest temperature below 2 degrees Celsius ("-0.2 C") for 1 hour and 12 minutes and total time and highest temperature above 9 degrees Celsius ("11 C") for 2 hours and 44 minutes. There was no previous temperature excursion. No adverse effect reported.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: injection site pain, redness, and swelling traveling to her wrist; injection site pain, redness, and swelling traveling to her wrist; injection site pain, redness, and swelling traveling to her wrist; injection site pain, redness, and swelling traveling to her wrist; injection site pain, redness, and swelling traveling to her wrist; Information has been received from a medical assistant, referring to a 74 years old female patient. The patient had none concomitant therapy, pertinent medical history or drug reactions/allergies. It was also reported on an unknown date, the patient received pneumococcal 13v conj vaccine (CRM197)(PREVNAR 13).  On 28-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R034248, expiration date: 07-AUG-2020, 1 dosage form, strength and frequency were unknown) intramuscularly in the left arm for prophylaxis.         On the same day, the patient called to report "injection site pain, redness, and swelling traveling to her wrist". The medical assistant told the patient to "apply ice to her wrist". On 30-AUG-2019 (or 31-AUG-2019), the patient returned to the office and was prescribed unspecified oral steroids. Treatments were given for the events. None lab diagnostics or studies were performed. The patient had sought medical attention. The outcome of the events was unknown. The causality assessment was not provided by the reporter.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: injection site pain, redness, and swelling traveling to her wrist; injection site pain, redness, and swelling traveling to her wrist; injection site pain, redness, and swelling traveling to her wrist; injection site pain, redness, and swelling traveling to her wrist; injection site pain, redness, and swelling traveling to her wrist; Information has been received from a medical assistant, referring to a 74 years old female patient. The patient had none concomitant therapy, pertinent medical history or drug reactions/allergies. It was also reported on an unknown date, the patient received pneumococcal 13v conj vaccine (CRM197)(PREVNAR 13).  On 28-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R034248, expiration date: 07-AUG-2020, 1 dosage form, strength and frequency were unknown) intramuscularly in the left arm for prophylaxis.         On the same day, the patient called to report "injection site pain, redness, and swelling traveling to her wrist". The medical assistant told the patient to "apply ice to her wrist". On 30-AUG-2019 (or 31-AUG-2019), the patient returned to the office and was prescribed unspecified oral steroids. Treatments were given for the events. None lab diagnostics or studies were performed. The patient had sought medical attention. The outcome of the events was unknown. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; an improperly stored dose of PEDVAX HIB administered to patient on 8/20/2019; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.  On 20-AUG-2019, the patient was administered a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(PEDVAXHIB) ( Lot No. R027326 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 10-JUL-2021; strength and dose were not reported), intramuscularly for prophylaxis. No adverse events were reported. The temperature of storage was below 36 degrees Fahrenheit/ 2 degrees centigrade (35.4 F) for 27 minutes. There was no previous temperature excursion. Data logger was involved.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: a patient received improper stored vaccine; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.      On 17-APR-2019, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R021078, expiration date 12-JUN-2021; one dose; route and dose number were unknown) for prophylaxis.        The storage temperature of the vaccine was reported as 52.5 degrees Fahrenheit (F) for a time frame of 4 hours and 40 minutes. There was no previous temperature excursion. No product quality complaint (PQC) was involved. The call was due to a data logger.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effects reported; an unspecified patient with date of birth 7/31/2016, received a dose of MMR II (M035388, expiration 8/2/2018) on 7/25/2017 "5 days before they turned one year old"; Information has been received from a nurse referring to a 11 months old patient with unknown gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported.  On 25-JUL-2017 (5 days before turning one year old), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot number: M035388; expiration date: 02-AUG-2018; strength and route were not reported) for prophylaxis (Inappropriate age at vaccine administration). No adverse effects reported. The outcome of the event was unknown.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: a patient received improperly stored vaccine on 4/24/2019; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.  On 24-APR-2019, the patient was administered a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(PEDVAXHIB) (lot number: R021078; expiration date: 12-JUN-2021; strength and route were not reported) and a dose improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number: R028189; expiration date: 06-JUN-2020; strength and route were not reported) for prophylaxis. The temperature of storage was 52.5 degrees Fahrenheit for 4 hours and 40 minutes. There was no previous temperature excursion. Data logger was involved. The outcome of the event was unknown.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored Proquad; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 21-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), injection, lot # R026722 and expiration date 17-MAR-2020 or lot # R023499 and expiration date 13-FEB-2020 (dose and route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent. The temperature was from -14°C to -10°C (-11.91 C, multiple) for 8 hours. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effect was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA003212:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported.; patient was vaccinated with expired VARIVAX; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 05-SEP-2019, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: N021318, expiration date: 07-AUG-2019, frequency, route and dose details were unknown) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) did not have any temperature excursions prior to administration. No adverse symptoms reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one dose of improperly stored GARDASIL 9 was inadvertently administered to the one 11-year-old male patient; This spontaneous report was received from a healthcare business professional referring to a 11 years old male patient. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.    On 12-JUL-2019, the patient was inadvertently vaccinated with one dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1602283, expiration date: 16-AUG-2021, but upon internal validation established as 18-AUG-2021 (dose, unit, and route were not reported) for prophylaxis (Product storage error). There was no previous temperature excursion. The vaccine was exposed at the temperature below 2 degree Celsius (C) (-0.6 C) for 50 minutes. Data digital logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No known adverse effects; A patient received a dose ofGARDASIL 9 into the gluteal area on an unknown date in September 2018 and in December 2018; A patient received a dose ofGARDASIL 9 into the gluteal area on an unknown date in September 2018 and in December 2018; This spontaneous report has been received from a registered nurse and referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.        The patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot number and expiration date were not reported) into the gluteal area for prophylaxis on an unknown date in September 2018 and in December 2018 (vaccine administered at inappropriate site). No known adverse effects were reported. There was no product quality complaint involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient received unspecified dose of ROTATEQ on 09/09/2019 after temperature excursion; This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-SEP-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # R026541, expiration date 11-JUL-2020, for prophylaxis (dose, frequency, route of administration and anatomical location were not provided). The vaccine underwent a temperature excursion of 34.1 degree Fahrenheit for 20 minutes and 47.6 degrees Fahrenheit for 40 minutes on 30-AUG-2019. There were no previous temperature excursion. The call was made because of digital data logger. There were no adverse effects reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patients that were over 15 weeks of age received their first dose of ROTATEQ; No known adverse effects; This spontaneous report was received from a physician and refers to an unknown number of patients of unknown age and gender. The patient's concurrent conditions, pertinent medical histories, drug reactions/allergies and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial (strength, dose, route of administration, lot number and expiry date were not reported) for prophylaxis.   At the time of vaccination, the patients were over 15 weeks of age. There were no known adverse effects.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: 'This Monday, the patient came to the office with a mild rash; This spontaneous report has been received from a physician via a company representative referring to a 1-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.       On 06-SEP-2019 (reported as last Friday), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot number and expiration date were not reported) for prophylaxis (reported as routine vaccine) along with all vaccines related to the one year old visit (no further details).         On 09-SEP-2019 (reported as this Monday), the patient came to the office with a mid rash. The outcome of rash was unknown. The causality between rash and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; a patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 04-SEP-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S002874, expiration date: 29-JAN-2021 (exact dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion between 6 to 14 degrees Fahrenheit (F) (10.2 F, multiple) for 50 minutes. There was no previous temperature excursion reported. Digital data logger was involved to capture the temperature excursion. No adverse effect was reported. This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005231: US-009507513-1909USA005525: US-009507513-1909USA005468: US-009507513-1909USA005424: US-009507513-1909USA005375: US-009507513-1909USA005139: US-009507513-1909USA005134: US-009507513-1909USA005129: US-009507513-1909USA005124: US-009507513-1909USA005119: US-009507513-1909USA005078: US-009507513-1909USA005220: US-009507513-1909USA005223:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse affects reported; patient received an extra dose of VARN AX after receiving PROQUAD; Information has been received from a nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/ allergies was not provided.       On 07-AUG-2019, the patient an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R008394, expiration date 20-MAR-2020; frequency and route of administration were not reported) for prophylaxis after receiving measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number, expiration date, frequency and route of administration were not reported) for prophylaxis also on 07-AUG-2019 (extra dose administered). No adverse affects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effrct; the patient was inadvertently administered a dose of PNEUMOV AX 23 (LOT#S02l 740/EXP:3/25/202l) that was improperly stored; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.     On 17-SEP-2019, the patient was inadvertently vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S021740, expiration date: 25-MAR-2021; dose and route were not reported) for prophylaxis (product storage error).  The vaccine underwent temperature excursion of 12 Celsius for 1 hour 5 minutes. There were no previous temperature excursions. The digital data logger was involved in recording excursion details. No adverse effect was reported.