chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of localized itching in a female patient who received SHINGRIX for prophylaxis. On 29th March 2019, the patient received the 1st dose of SHINGRIX. On 30th March 2019, 1 days after receiving SHINGRIX, the patient experienced localized itching and localized erythema. The patient was treated with BENADRYL. On an unknown date, the outcome of the localized itching and localized erythema were recovered/resolved. It was unknown if the reporter considered the localized itching and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by then nurse who administered SHINGRIX to the coworker. The following day, the patient developed a red, itchy area on the same arm as the injection but definitely not at the injection site. The patch of red, itchy skin (6cm X 6 cm) persisted 7 days later and was present at the time of reporting. The nurse was contacted on 8th April 2018 and she confirmed that the side effects were gone and the patient showed no additional signs of potential complications.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient experienced pain in her right arm following the 1st SHINGRIX dose. The patient provided the consent to follow up but did not wish to provide date of birth. For tolerance to the 2nd SHINGRIX dose, refer case US2019049129. This case has been linked with cases US2019049135 and US2019GSK055859, reported for patient's husband.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient experienced pain in her right arm following the 1st SHINGRIX dose. The patient provided the consent to follow up but did not wish to provide date of birth. For tolerance to the 2nd SHINGRIX dose, refer case US2019049129. This case has been linked with cases US2019049135 and US2019GSK055859, reported for patient's husband.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 16th October 2018, refer case US2019GSK065390). On 11th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 12th March 2019, 1 days after receiving SHINGRIX, the patient experienced fever, pain and chills. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, pain and chills were recovered/resolved. It was unknown if the reporter considered the fever, pain and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient reported that the next day after SHINGRIX vaccination into the right arm, she developed chills, achiness and a fever. The patient provided the consent to follow up but did not wish to provide date of birth. This case has been linked with cases US2019049135 and US2019GSK055859, reported for patient's husband.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 16th October 2018, refer case US2019GSK065390). On 11th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 12th March 2019, 1 days after receiving SHINGRIX, the patient experienced fever, pain and chills. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, pain and chills were recovered/resolved. It was unknown if the reporter considered the fever, pain and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient reported that the next day after SHINGRIX vaccination into the right arm, she developed chills, achiness and a fever. The patient provided the consent to follow up but did not wish to provide date of birth. This case has been linked with cases US2019049135 and US2019GSK055859, reported for patient's husband.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: Age at vaccination was not reported. After a flu shot, the patient's arm was very sore. The patient consented to follow up. The patient stated, she experienced same event when she got a Shingrix dose (refer case US2019060185).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Rash vesicular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vesicular rash in a 64-year-old female patient who received SHINGRIX (batch number 97H72, expiry date 8th February 2021) for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vesicular rash, injection site pain and injection site rash. The patient was treated with Diphenhydramine and Steroid Injection. On an unknown date, the outcome of the vesicular rash, injection site pain and injection site rash were recovered/resolved. It was unknown if the reporter considered the vesicular rash, injection site pain and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid and reported a painful herpes zoster like rash at the injection site. She was given a steroid injection and diphenhydramine three days after start of symptoms. The symptoms began to resolve the following day. The herpes zoster was not confirmed, as there was no culture done.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Insomnia, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX (batch number 4LH35, expiry date 20th December 2019) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of no adverse event (1st dose received on an unknown date). On 2nd April 2019, the patient received the 2nd dose of SHINGRIX 0.5 ml. On 2nd April 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm, muscle pain and sleeplessness. In April 2019, the patient experienced back pain, pain of lower extremities and pain in hip. On an unknown date, the outcome of the pain in arm, muscle pain, sleeplessness, back pain, pain of lower extremities and pain in hip were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, muscle pain, sleeplessness, back pain, pain of lower extremities and pain in hip to be related to SHINGRIX. Additional details were provided as follows: The patient did not have any symptoms with her 1st dose. On 2nd April 2019 around midday, the patient had her 2nd dose of SHINGRIX in the right deltoid. By the evening, the patient's arm was very sore. She did not sleep well during the night and felt it was due to muscle aches she was experiencing. The next day on 3rd April 2019, muscle ache was worsened in her lower legs, back and hips. She did not feel like she had any fever. The patient consented to follow up. The patient stated, she experienced same event when she got a flu shot (refer case US2019GSK065517).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX (batch number 4LH35, expiry date 20th December 2019) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of no adverse event (1st dose received on an unknown date). On 2nd April 2019, the patient received the 2nd dose of SHINGRIX 0.5 ml. On 2nd April 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm, muscle pain and sleeplessness. In April 2019, the patient experienced back pain, pain of lower extremities and pain in hip. On an unknown date, the outcome of the pain in arm, muscle pain, sleeplessness, back pain, pain of lower extremities and pain in hip were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, muscle pain, sleeplessness, back pain, pain of lower extremities and pain in hip to be related to SHINGRIX. Additional details were provided as follows: The patient did not have any symptoms with her 1st dose. On 2nd April 2019 around midday, the patient had her 2nd dose of SHINGRIX in the right deltoid. By the evening, the patient's arm was very sore. She did not sleep well during the night and felt it was due to muscle aches she was experiencing. The next day on 3rd April 2019, muscle ache was worsened in her lower legs, back and hips. She did not feel like she had any fever. The patient consented to follow up. The patient stated, she experienced same event when she got a flu shot (refer case US2019GSK065517).
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Depressed mood, Fatigue, Pain in extremity, Productive cough
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 29th March 2019, the patient received the 1st dose of SHINGRIX. On 29th March 2019, 2 hrs after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced dry cough, productive cough, feeling down and fatigue. The patient was treated with ADVIL. On an unknown date, the outcome of the pain in arm, feeling down and fatigue were recovered/resolved and the outcome of the dry cough and productive cough were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, dry cough, productive cough, feeling down and fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on an unknown arm. The patient experienced arm pain that started 2 hours after the vaccine, and lasted about 4 hours until he took ADVIL that made him go to sleep. The patient woke up the next day with reduced arm pain. The was back to normal at the time of reporting. The patient felt run down for a couple of days and had symptoms of a wet and dry cough that's still going on. The patient's wet and dry cough has not resolved. The reporter did not consent to follow up with physician. This case has been linked with case US2019060937, reported by same reporter (for patient's wife).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received SHINGRIX (batch number ZP3P9, expiry date 11th September 2021) and (batch number 3K73L, expiry date 11th September 2021) for prophylaxis. On 3rd April 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 4th April 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness, injection site warmth, injection site swelling, injection site lump and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site tenderness, injection site warmth, injection site swelling, injection site lump and injection site induration were not reported. It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site warmth, injection site swelling, injection site lump and injection site induration to be related to SHINGRIX. Additional details were provided as follows: On 3rd April 2019, around noon eastern time, the patient received the 1st dose of SHINGRIX. The batch number was captured as 3K73L, instead of 3K7L, as per sales data sheet. On 4th April 2019, at the day of reporting, the patient reported that, the injection site was red, warm, swollen, sore, had a hard knot that was not raised but did have a quarter size spot around it. The patient also reported that the injection site was more tender at the hard spot.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received SHINGRIX (batch number ZP3P9, expiry date 11th September 2021) and (batch number 3K73L, expiry date 11th September 2021) for prophylaxis. On 3rd April 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 4th April 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness, injection site warmth, injection site swelling, injection site lump and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site tenderness, injection site warmth, injection site swelling, injection site lump and injection site induration were not reported. It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site warmth, injection site swelling, injection site lump and injection site induration to be related to SHINGRIX. Additional details were provided as follows: On 3rd April 2019, around noon eastern time, the patient received the 1st dose of SHINGRIX. The batch number was captured as 3K73L, instead of 3K7L, as per sales data sheet. On 4th April 2019, at the day of reporting, the patient reported that, the injection site was red, warm, swollen, sore, had a hard knot that was not raised but did have a quarter size spot around it. The patient also reported that the injection site was more tender at the hard spot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received SHINGRIX (intramuscular). On 30th March 2019, several hours after receiving SHINGRIX, the patient experienced headache, nausea, chills and influenza-like symptoms. On 1st April 2019, the patient experienced injection site erythema and injection site rash. The patient was treated with ADVIL. On an unknown date, the outcome of the headache, nausea, chills and influenza-like symptoms were recovered/resolved and the outcome of the injection site erythema and injection site rash were not recovered/not resolved. It was unknown if the reporter considered the headache, nausea, chills, influenza-like symptoms, injection site erythema and injection site rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left arm in morning and experience headache, nausea chills and a little bit of the flu in the evening. Following Monday, the patient began to experience redness at the injection site, which measured at 3 inches x 2 inches. All events have resolved except for the redness, which is slightly improving after patient took ADVIL. The lot number was not available. The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received SHINGRIX (intramuscular). On 30th March 2019, several hours after receiving SHINGRIX, the patient experienced headache, nausea, chills and influenza-like symptoms. On 1st April 2019, the patient experienced injection site erythema and injection site rash. The patient was treated with ADVIL. On an unknown date, the outcome of the headache, nausea, chills and influenza-like symptoms were recovered/resolved and the outcome of the injection site erythema and injection site rash were not recovered/not resolved. It was unknown if the reporter considered the headache, nausea, chills, influenza-like symptoms, injection site erythema and injection site rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left arm in morning and experience headache, nausea chills and a little bit of the flu in the evening. Following Monday, the patient began to experience redness at the injection site, which measured at 3 inches x 2 inches. All events have resolved except for the redness, which is slightly improving after patient took ADVIL. The lot number was not available. The reporter did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 24th October 2018, the patient received the 1st dose of SHINGRIX. On 24th October 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved. It was unknown if the reporter considered the pain in arm and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she experienced arm soreness right away and had problems sleeping that night because of her soreness in her arm. The day after of the vaccine it was almost gone. Within a couple of days, it was gone completely. She also felt tiredness but she said that it also went away quickly. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Product preparation issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th April 2019, the patient received the 2nd dose of SHINGRIX. On 4th December 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In April 2019, the patient experienced pain in arm and malaise. On an unknown date, the outcome of the pain in arm and malaise were not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the pain in arm and malaise to be related to SHINGRIX. Additional details were provided as follows: The wife of the patient reported that her husband possibly only received the adjuvant because the pharmacist withdrew the medication out of a vial with a red metal collar into the syringe, which led to the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. The wife reported that her husband experienced arm pain and experienced malaise. The wife reported that with her husband's 2nd dose, the vaccine was withdrawn from a vial with a green metal collar into the syringe. The wife reported that her husband planned to follow up with his pharmacy, and physician on an unknown date. This case linked with US2019061877, reported by same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The batch number was not reported. The patient received SHINGRIX vaccine on left arm and only experienced a slight bump at the injection site which resolved within a few days. The reporter consented to follow up. For tolerance of 2nd dose refer linked case US2019GSK065616.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Musculoskeletal pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 53-year-old male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced shoulder pain. On an unknown date, the patient experienced tiredness and fever. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved and the outcome of the tiredness and fever were recovered/resolved. It was unknown if the reporter considered the shoulder pain, tiredness and fever to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he experienced right shoulder soreness ever since receiving his 1st dose of SHINGRIX in October 2018. The patient also had tiredness and fever that began within the 2 days after the vaccination but those had resolved. The patient's doctor had advised him that he should wait a while before receiving the 2nd shot, he was not sure he would get the 2nd shot. The patient provided the consent to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain, Nerve injury
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 18th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain, nerve injury and product administration error. SHINGRIX was discontinued. On an unknown date, the outcome of the injection site muscle pain and nerve injury were not recovered/not resolved and the outcome of the product administration error was unknown. It was unknown if the reporter considered the injection site muscle pain and nerve injury to be related to SHINGRIX. Additional information were reported as follows: The patient received SHINGRIX and did not experience pain upon administration, but later developed pain at the site that was continued till the time of report. The pain was not terrible, but the patient decided not to get the 2nd dose. The patient consulted with her physician and chiropractor and felt that there might have been an issue with the administration and perhaps a nerve was affected. The pain was localized to the muscle. There was consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site rash, Peripheral swelling, Rash
Clinical narrative: This case was reported by an other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 4th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a month after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site rash. In March 2019, the outcome of the extensive swelling of vaccinated limb and injection site rash were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was reported. The physician assistant reported that the patient received their 1st dose of SHINGRIX around 4th March 2019 and had swelling and rash that covered the majority of their arm and lasted for 5 days. The reporter did not know exactly how many hours after the injection the events occurred. The patient received the vaccine at an outside pharmacy, information specific to vaccine, including lot number/expiry date was unknown. The reporter declined to provide patient's date of birth.
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Axillary pain, Exposure during pregnancy, Feeling hot, Hyperaemia
Clinical narrative: 33 week and 4 days pregnant; Initial information received on 04-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 30 years old female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that the patient was pregnant and gestation period was 33 week and 4 days.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The actual date of delivery was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had previous pregnancy or not.  On 28-Feb-2019, the patient received a 3rd dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6202BA (expiry date: 26-Feb-2021) via intramuscular route in the right deltoid.  On an unknown date, the patient had exposure during pregnancy.  The patient outcome is reported as Not Applicable for exposure during pregnancy, as Recovered / Resolved on an unknown date for feverish/pyrexia, as Recovered / Resolved on an unknown date for pain in the axilla area, as Recovered / Resolved on an unknown date for hyperemia, as Recovered / Resolved on an unknown date for general weakness, as Recovered / Resolved on an unknown date for sweating, as Recovered / Resolved on an unknown date for inner hot sensation and as Recovered / Resolved in November 2018 for fever. Additionally, at time of reporting, the outcome of the pregnancy is unknown.  List of documents held by sender- none.
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: 33 week and 4 days pregnant; Initial information received on 04-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 30 years old female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that the patient was pregnant and gestation period was 33 week and 4 days.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The actual date of delivery was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had previous pregnancy or not.  On 28-Feb-2019, the patient received a 3rd dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6202BA (expiry date: 26-Feb-2021) via intramuscular route in the right deltoid.  On an unknown date, the patient had exposure during pregnancy.  The patient outcome is reported as Not Applicable for exposure during pregnancy, as Recovered / Resolved on an unknown date for feverish/pyrexia, as Recovered / Resolved on an unknown date for pain in the axilla area, as Recovered / Resolved on an unknown date for hyperemia, as Recovered / Resolved on an unknown date for general weakness, as Recovered / Resolved on an unknown date for sweating, as Recovered / Resolved on an unknown date for inner hot sensation and as Recovered / Resolved in November 2018 for fever. Additionally, at time of reporting, the outcome of the pregnancy is unknown.  List of documents held by sender- none.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Dizziness postural, Loss of personal independence in daily activities
Clinical narrative: With both doses (2), I was very ill. Pain throughout body, chills, achiness, feverish. Slept all day, feeling sick and unable to function or barely move. Dizzy when trying to stand up. No energy. For first shot, I was like that for 2 days. Second shot one day. Have never felt that sick before.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased, Pain, Pyrexia
Clinical narrative: With both doses (2), I was very ill. Pain throughout body, chills, achiness, feverish. Slept all day, feeling sick and unable to function or barely move. Dizzy when trying to stand up. No energy. For first shot, I was like that for 2 days. Second shot one day. Have never felt that sick before.
Age: 29.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Hypoaesthesia, Injection site erythema
Clinical narrative: client's brother called clinic 4/12/19 around 8:40 am.  Stated client woke up 4/12/19 in AM complaining of redness on left arm from elbow to top of arm. States redness is not painful and not itching. Also is complaining of "numbness" down left arm.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Dyspepsia, Frequent bowel movements, Oral mucosal eruption, Sleep disorder
Clinical narrative: Starting 18 hours post-vaccination, patient began passing multiple bowel movements. Consistency was that of diarrhea and occurred 6 times in the following 24 hours. Patient also developed small rash around mouth that resembled the bumps of a heat rash. Since the vaccination, this has been almost constantly present on the patient's face. Additionally, patient now experiences sleep disturbances that seem to indicate digestive distress that was not previously present.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Fatigue, Sinus congestion
Clinical narrative: Major head congestion that has lasted for 10 days. Cough that continued for about one week. Chills, general lassitude. No fever.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Pruritus, Urticaria
Clinical narrative: Erythema, Multiform and Urticaria, Pruritus.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Febrile convulsion, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Pyrexia
Clinical narrative: Fever of 103. Febrile Seizure around 4:30 PM - seen in ER, advised to give Tylenol and Motrin as needed. Continued with fever until 3-31-19.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Respiratory syncytial virus test negative, Spinal X-ray normal
Clinical narrative: Fever of 103. Febrile Seizure around 4:30 PM - seen in ER, advised to give Tylenol and Motrin as needed. Continued with fever until 3-31-19.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Local muscle pain at injection site. Approx 8 hours after injection started to develop low grade fever and nausea, Approximately 15-16 hours after injection fever at 101.5 F. Following day low grade fever (99-100 F) remained. Symptoms dissipated by 48 hour mark.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Myalgia
Clinical narrative: Redness and heat on the right arm, 4 days. Shivering, achiness in muscles and joints, fatigue.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Redness and heat on the right arm, 4 days. Shivering, achiness in muscles and joints, fatigue.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site nodule, Injection site pain, Lipoma
Clinical narrative: Patient developed a lipoma in his right arm after receiving the flu vaccine.  He has had numbness in his right arm, index finger and no feeling in his right thumb.  Patient has seen a general surgeon and a arm specialist and is awaiting surgery to remove the lipoma.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain, Pain in extremity, X-ray limb normal
Clinical narrative: Patient developed a lipoma in his right arm after receiving the flu vaccine.  He has had numbness in his right arm, index finger and no feeling in his right thumb.  Patient has seen a general surgeon and a arm specialist and is awaiting surgery to remove the lipoma.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Body tinea, Cough, Dermatitis contact, Ear infection, Ear pain
Clinical narrative: Patient presented for the first time after 10/11/18 vaccinations on 11/01/2018 complaining of scattered, scaly rash all over trunk, chest wall, and legs. Office note states mother noticed a swollen area on left upper thigh approximately 1 or 2 days prior to this office visit.  The nurse's note states that the site was swollen, warm and tender to touch, without drainage. Patient was afebrile. The diagnoses for this date was pruritis, tinea corporis, and cutaneous abscess of left lower limb. Medications prescribed at this visit were Griseofulvin, Sulfamethazole-Trimethoprim, and topical Mupirocin. On 12/6/2018 patient returned to office complaining of bilateral eyelid swelling and eye pain. She was afebrile and denied cough. Medications continued were Griseofulvin and topical Ketoconazole 2% for the tinea rash. Zaditor and Cetirizine were also added.  She still complained that the left thigh abscess had not resolved and was referred to wound care with Dr. Office notes on 12/7/19 state that mother noticed lesion on left thigh 3 weeks prior to the office visit and stated that child did not have any pain at that time. Notes state the lesion on that date measured 1x1x1cm with serosanguineous drainage, red granulation, and subcutaneous tissue exposed. The wound was cleaned and dressed.  Child returned to pediatrician?s office on 2/7/19 with rash, cough and congestion. She was diagnosed with viral URI, hives, contact dermatitis, pruritis, left thigh abscess improved. She was prescribed Prednisolone 15mg/5ml twice daily for 5 days and Cetirizine 10 ml daily. Returned to Pediatrician?s office on 2/22/19 for skin peeling of hands and feet. Complained of burning skin. She was diagnosed with Eczema and Allergic Rhinitis. Patient was prescribed topical hydrocortisone 2.5% cream bid for 5-10 days and Children?s Loratadine 5ml once daily. Returned to Pediatrician 3/21/19 for congestion and ear pain. She had an ear infection and was prescribed Augmentin 600-42.9mg/5ml for 10 days. She returned to wound care on 4/10/19 complaining of left thigh pain at site of abscess for 3 weeks duration after bumping into an object. Wound care nurse reported that the abscess on left thigh had not healed since vaccines were given on 10/11/18. Wound had serous fluid and some tenderness. The wound was cleaned dressed and patient was referred for a surgical evaluation with Dr. 4/11/19 phone note from nurse practitioner stated that mother says the wound site was healed for months then started swelling again so she went back wound care to have it checked. She stated her allergies were also flaring again causing her eyes to swell. She was prescribed Zaditor eye drops and advised to continue Cetirizine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Eczema, Exfoliative rash, Eye pain, Injection site abscess, Injection site discharge
Clinical narrative: Patient presented for the first time after 10/11/18 vaccinations on 11/01/2018 complaining of scattered, scaly rash all over trunk, chest wall, and legs. Office note states mother noticed a swollen area on left upper thigh approximately 1 or 2 days prior to this office visit.  The nurse's note states that the site was swollen, warm and tender to touch, without drainage. Patient was afebrile. The diagnoses for this date was pruritis, tinea corporis, and cutaneous abscess of left lower limb. Medications prescribed at this visit were Griseofulvin, Sulfamethazole-Trimethoprim, and topical Mupirocin. On 12/6/2018 patient returned to office complaining of bilateral eyelid swelling and eye pain. She was afebrile and denied cough. Medications continued were Griseofulvin and topical Ketoconazole 2% for the tinea rash. Zaditor and Cetirizine were also added.  She still complained that the left thigh abscess had not resolved and was referred to wound care with Dr. Office notes on 12/7/19 state that mother noticed lesion on left thigh 3 weeks prior to the office visit and stated that child did not have any pain at that time. Notes state the lesion on that date measured 1x1x1cm with serosanguineous drainage, red granulation, and subcutaneous tissue exposed. The wound was cleaned and dressed.  Child returned to pediatrician?s office on 2/7/19 with rash, cough and congestion. She was diagnosed with viral URI, hives, contact dermatitis, pruritis, left thigh abscess improved. She was prescribed Prednisolone 15mg/5ml twice daily for 5 days and Cetirizine 10 ml daily. Returned to Pediatrician?s office on 2/22/19 for skin peeling of hands and feet. Complained of burning skin. She was diagnosed with Eczema and Allergic Rhinitis. Patient was prescribed topical hydrocortisone 2.5% cream bid for 5-10 days and Children?s Loratadine 5ml once daily. Returned to Pediatrician 3/21/19 for congestion and ear pain. She had an ear infection and was prescribed Augmentin 600-42.9mg/5ml for 10 days. She returned to wound care on 4/10/19 complaining of left thigh pain at site of abscess for 3 weeks duration after bumping into an object. Wound care nurse reported that the abscess on left thigh had not healed since vaccines were given on 10/11/18. Wound had serous fluid and some tenderness. The wound was cleaned dressed and patient was referred for a surgical evaluation with Dr. 4/11/19 phone note from nurse practitioner stated that mother says the wound site was healed for months then started swelling again so she went back wound care to have it checked. She stated her allergies were also flaring again causing her eyes to swell. She was prescribed Zaditor eye drops and advised to continue Cetirizine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Patient presented for the first time after 10/11/18 vaccinations on 11/01/2018 complaining of scattered, scaly rash all over trunk, chest wall, and legs. Office note states mother noticed a swollen area on left upper thigh approximately 1 or 2 days prior to this office visit.  The nurse's note states that the site was swollen, warm and tender to touch, without drainage. Patient was afebrile. The diagnoses for this date was pruritis, tinea corporis, and cutaneous abscess of left lower limb. Medications prescribed at this visit were Griseofulvin, Sulfamethazole-Trimethoprim, and topical Mupirocin. On 12/6/2018 patient returned to office complaining of bilateral eyelid swelling and eye pain. She was afebrile and denied cough. Medications continued were Griseofulvin and topical Ketoconazole 2% for the tinea rash. Zaditor and Cetirizine were also added.  She still complained that the left thigh abscess had not resolved and was referred to wound care with Dr. Office notes on 12/7/19 state that mother noticed lesion on left thigh 3 weeks prior to the office visit and stated that child did not have any pain at that time. Notes state the lesion on that date measured 1x1x1cm with serosanguineous drainage, red granulation, and subcutaneous tissue exposed. The wound was cleaned and dressed.  Child returned to pediatrician?s office on 2/7/19 with rash, cough and congestion. She was diagnosed with viral URI, hives, contact dermatitis, pruritis, left thigh abscess improved. She was prescribed Prednisolone 15mg/5ml twice daily for 5 days and Cetirizine 10 ml daily. Returned to Pediatrician?s office on 2/22/19 for skin peeling of hands and feet. Complained of burning skin. She was diagnosed with Eczema and Allergic Rhinitis. Patient was prescribed topical hydrocortisone 2.5% cream bid for 5-10 days and Children?s Loratadine 5ml once daily. Returned to Pediatrician 3/21/19 for congestion and ear pain. She had an ear infection and was prescribed Augmentin 600-42.9mg/5ml for 10 days. She returned to wound care on 4/10/19 complaining of left thigh pain at site of abscess for 3 weeks duration after bumping into an object. Wound care nurse reported that the abscess on left thigh had not healed since vaccines were given on 10/11/18. Wound had serous fluid and some tenderness. The wound was cleaned dressed and patient was referred for a surgical evaluation with Dr. 4/11/19 phone note from nurse practitioner stated that mother says the wound site was healed for months then started swelling again so she went back wound care to have it checked. She stated her allergies were also flaring again causing her eyes to swell. She was prescribed Zaditor eye drops and advised to continue Cetirizine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site swelling, Injection site warmth, Pruritus, Rash, Respiratory tract congestion
Clinical narrative: Patient presented for the first time after 10/11/18 vaccinations on 11/01/2018 complaining of scattered, scaly rash all over trunk, chest wall, and legs. Office note states mother noticed a swollen area on left upper thigh approximately 1 or 2 days prior to this office visit.  The nurse's note states that the site was swollen, warm and tender to touch, without drainage. Patient was afebrile. The diagnoses for this date was pruritis, tinea corporis, and cutaneous abscess of left lower limb. Medications prescribed at this visit were Griseofulvin, Sulfamethazole-Trimethoprim, and topical Mupirocin. On 12/6/2018 patient returned to office complaining of bilateral eyelid swelling and eye pain. She was afebrile and denied cough. Medications continued were Griseofulvin and topical Ketoconazole 2% for the tinea rash. Zaditor and Cetirizine were also added.  She still complained that the left thigh abscess had not resolved and was referred to wound care with Dr. Office notes on 12/7/19 state that mother noticed lesion on left thigh 3 weeks prior to the office visit and stated that child did not have any pain at that time. Notes state the lesion on that date measured 1x1x1cm with serosanguineous drainage, red granulation, and subcutaneous tissue exposed. The wound was cleaned and dressed.  Child returned to pediatrician?s office on 2/7/19 with rash, cough and congestion. She was diagnosed with viral URI, hives, contact dermatitis, pruritis, left thigh abscess improved. She was prescribed Prednisolone 15mg/5ml twice daily for 5 days and Cetirizine 10 ml daily. Returned to Pediatrician?s office on 2/22/19 for skin peeling of hands and feet. Complained of burning skin. She was diagnosed with Eczema and Allergic Rhinitis. Patient was prescribed topical hydrocortisone 2.5% cream bid for 5-10 days and Children?s Loratadine 5ml once daily. Returned to Pediatrician 3/21/19 for congestion and ear pain. She had an ear infection and was prescribed Augmentin 600-42.9mg/5ml for 10 days. She returned to wound care on 4/10/19 complaining of left thigh pain at site of abscess for 3 weeks duration after bumping into an object. Wound care nurse reported that the abscess on left thigh had not healed since vaccines were given on 10/11/18. Wound had serous fluid and some tenderness. The wound was cleaned dressed and patient was referred for a surgical evaluation with Dr. 4/11/19 phone note from nurse practitioner stated that mother says the wound site was healed for months then started swelling again so she went back wound care to have it checked. She stated her allergies were also flaring again causing her eyes to swell. She was prescribed Zaditor eye drops and advised to continue Cetirizine.