chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: PAIN, REDNESS AND SWELLING AT SITE OF SHOT, CHILLS, FEVER, ACHY FEELING; TOOK ASPIRIN, 4 WITHIN 8 HOURS, FEVER SUBSIDED; REDNESS AND SWELLING AND SORENESS AT SITE OF SHOT STILL THERE ON 03/04/2019.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: PAIN, REDNESS AND SWELLING AT SITE OF SHOT, CHILLS, FEVER, ACHY FEELING; TOOK ASPIRIN, 4 WITHIN 8 HOURS, FEVER SUBSIDED; REDNESS AND SWELLING AND SORENESS AT SITE OF SHOT STILL THERE ON 03/04/2019.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: The morning after the shot, I woke up sore all over with chills and a fever. It felt like the flu. I took acetaminophen and my fever went down. By the next morning I was fine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paralysis
Clinical narrative: Pt reported the adverse events on 3/4/19 to me. Pt stated that her shoulder "was like paralyzed". She was in so much pain she had to take Ibuprofen. The ibuprofen didn't help but the symptoms didn't last more than a day.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site haemorrhage
Clinical narrative: Excessive bleeding at injection site.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Hib powder component was inadvertently mixed with normal saline instead of DTAP-IPV diluent provided in the PENTACEL box. Inquiry was sent to CDC, and it was recommended to give PENTACEL vaccine again as the dose given would not count.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received second dose of SHINGRIX vaccine on 3/2/19 and started developing a really swollen, painful arm on her whole upper arm. She said it got worse on Sunday and also developed a fever of 100.9 degrees Fahrenheit, loss of appetite and had shakes/chills. She feels a little bit better today but her arm is still very red and swollen.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Patient received second dose of SHINGRIX vaccine on 3/2/19 and started developing a really swollen, painful arm on her whole upper arm. She said it got worse on Sunday and also developed a fever of 100.9 degrees Fahrenheit, loss of appetite and had shakes/chills. She feels a little bit better today but her arm is still very red and swollen.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Heart rate increased
Clinical narrative: On or about 6-8 hours after injection a fast heartbeat.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Acute kidney injury, Blood creatinine increased
Clinical narrative: Acute kidney injury.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) upper arm pain and swelling and redness.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Patient reported red, itchy rash approximately 4 inches above to 4 inches below left elbow. Started about 1 week after dose 1 of SHINGRIX, seemed to improve after about 1 week, but then got worse again. Pt visited pharmacy for consultation on 3-1-19. RPh logged info and called GlaxoSmithKline to report event. Spoke with medical info. who stated prior anecdotal reports.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site dermatitis, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient reported red, itchy rash approximately 4 inches above to 4 inches below left elbow. Started about 1 week after dose 1 of SHINGRIX, seemed to improve after about 1 week, but then got worse again. Pt visited pharmacy for consultation on 3-1-19. RPh logged info and called GlaxoSmithKline to report event. Spoke with medical info. who stated prior anecdotal reports.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dysstasia, Ear pruritus, Fall, Feeling cold
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vestibular neuronitis in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX. On 30th October 2018, immediately after receiving SHINGRIX, the patient experienced allergic reaction, ear pruritus and lip swelling. On 31st October 2018, the patient experienced vestibular neuronitis, spinning sensation and dizziness. On 1st November 2018, the patient experienced speech disorder, movement disorder and fall. On 18th January 2019, the patient experienced difficulty in standing and unable to walk. On an unknown date, the patient experienced feeling cold. The patient was treated with fexofenadine hydrochloride (Allegra). On an unknown date, the outcome of the vestibular neuronitis, dizziness and feeling cold were not recovered/not resolved and the outcome of the spinning sensation and allergic reaction were unknown and the outcome of the speech disorder, difficulty in standing, movement disorder, ear pruritus, lip swelling, unable to walk and fall were recovered/resolved. The reporter considered the vestibular neuronitis, spinning sensation, allergic reaction, dizziness, feeling cold, speech disorder, difficulty in standing, movement disorder, ear pruritus, lip swelling, unable to walk and fall to be related to SHINGRIX. Additional details were reported as follows: The patient stated that immediately after receiving SHINGRIX in the left arm, he experienced an allergic reaction that included itchy ears and swollen lips. The patient stated that he took some Allegra and that seemed to resolve the symptoms. The patient stated that the next day, on 31st October 2018, 1 day after vaccination, when he woke up, he was dizzy and later that day experienced the severe dizziness and was not able to drive. The patient stated that he took a nap and the next day, on 1st November 2018, 2 days after vaccination, he experienced the room spinning, trouble speaking, and could not move his arms. The patient stated that he collapsed and had to go to the emergency room. The patient was referred to an ear nose throat (ENT) who diagnosed him with vestibular neuritis and vertigo. The ENT doctor believed that the vestibular neuritis was caused by the SHINGRIX vaccine. The patient stated that his doctor advised him not to get the 2nd dose and referred the patient to a physical therapist. The patient stated that he was getting better and then on 18th January 2019, 80 days after vaccination, the dizziness started again and the vertigo was so bad that he could not walk or stand and was now back in physical therapy. Less than year after vaccination, the patient experienced feeling cold. The patient stated that he also feels cold all of the time and did not experience feeling cold before he received the SHINGRIX vaccine. The patient stated that he could only look at the computer for 10 to 15 minutes and then he would get dizzy. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Speech disorder, Vaccination complication, Vertigo, Vestibular neuronitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vestibular neuronitis in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX. On 30th October 2018, immediately after receiving SHINGRIX, the patient experienced allergic reaction, ear pruritus and lip swelling. On 31st October 2018, the patient experienced vestibular neuronitis, spinning sensation and dizziness. On 1st November 2018, the patient experienced speech disorder, movement disorder and fall. On 18th January 2019, the patient experienced difficulty in standing and unable to walk. On an unknown date, the patient experienced feeling cold. The patient was treated with fexofenadine hydrochloride (Allegra). On an unknown date, the outcome of the vestibular neuronitis, dizziness and feeling cold were not recovered/not resolved and the outcome of the spinning sensation and allergic reaction were unknown and the outcome of the speech disorder, difficulty in standing, movement disorder, ear pruritus, lip swelling, unable to walk and fall were recovered/resolved. The reporter considered the vestibular neuronitis, spinning sensation, allergic reaction, dizziness, feeling cold, speech disorder, difficulty in standing, movement disorder, ear pruritus, lip swelling, unable to walk and fall to be related to SHINGRIX. Additional details were reported as follows: The patient stated that immediately after receiving SHINGRIX in the left arm, he experienced an allergic reaction that included itchy ears and swollen lips. The patient stated that he took some Allegra and that seemed to resolve the symptoms. The patient stated that the next day, on 31st October 2018, 1 day after vaccination, when he woke up, he was dizzy and later that day experienced the severe dizziness and was not able to drive. The patient stated that he took a nap and the next day, on 1st November 2018, 2 days after vaccination, he experienced the room spinning, trouble speaking, and could not move his arms. The patient stated that he collapsed and had to go to the emergency room. The patient was referred to an ear nose throat (ENT) who diagnosed him with vestibular neuritis and vertigo. The ENT doctor believed that the vestibular neuritis was caused by the SHINGRIX vaccine. The patient stated that his doctor advised him not to get the 2nd dose and referred the patient to a physical therapist. The patient stated that he was getting better and then on 18th January 2019, 80 days after vaccination, the dizziness started again and the vertigo was so bad that he could not walk or stand and was now back in physical therapy. Less than year after vaccination, the patient experienced feeling cold. The patient stated that he also feels cold all of the time and did not experience feeling cold before he received the SHINGRIX vaccine. The patient stated that he could only look at the computer for 10 to 15 minutes and then he would get dizzy. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 22nd February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, several hours after receiving SHINGRIX, the patient experienced fever. On 22nd February 2019, the patient experienced pain in arm, erythema of extremities, headache, general body pain and chills. On 25th February 2019, the patient experienced itchy upper limbs. On an unknown date, the outcome of the pain in arm, erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the headache, general body pain, chills and fever were recovered/resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, itchy upper limbs, headache, general body pain, chills and fever to be related to SHINGRIX. Additional details were reported as follows: At 3:00 PM, the patient received SHINGRIX in the left arm. The arm became sore that evening and was red. The redness was a rectangle 2 by 3 inches. The patient also experienced a headache, body aches and chills that night of vaccination. In the morning of Saturday, 23rd February 2019, the patient experienced fever of 101 degree F. The patient stated that Saturday was worse day. On the day of reporting, 3 days after vaccination, the area on the arm become itchy. The symptoms lasted about 3 days. The reporter consented to follow up. This case has been linked with US2019034298, reported by same reporter for the patient's sister.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 22nd February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, several hours after receiving SHINGRIX, the patient experienced fever. On 22nd February 2019, the patient experienced pain in arm, erythema of extremities, headache, general body pain and chills. On 25th February 2019, the patient experienced itchy upper limbs. On an unknown date, the outcome of the pain in arm, erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the headache, general body pain, chills and fever were recovered/resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, itchy upper limbs, headache, general body pain, chills and fever to be related to SHINGRIX. Additional details were reported as follows: At 3:00 PM, the patient received SHINGRIX in the left arm. The arm became sore that evening and was red. The redness was a rectangle 2 by 3 inches. The patient also experienced a headache, body aches and chills that night of vaccination. In the morning of Saturday, 23rd February 2019, the patient experienced fever of 101 degree F. The patient stated that Saturday was worse day. On the day of reporting, 3 days after vaccination, the area on the arm become itchy. The symptoms lasted about 3 days. The reporter consented to follow up. This case has been linked with US2019034298, reported by same reporter for the patient's sister.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Headache, Pain, 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 58-year-old female patient who received SHINGRIX for prophylaxis. On 22nd February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, several hours after receiving SHINGRIX, the patient experienced fever. On 22nd February 2019, the patient experienced pain in arm, erythema of extremities, headache, general body pain and chills. On 25th February 2019, the patient experienced itchy upper limbs. On an unknown date, the outcome of the pain in arm, erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the headache, general body pain, chills and fever were recovered/resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, itchy upper limbs, headache, general body pain, chills and fever to be related to SHINGRIX. Additional details were reported as follows: At 3:00 PM, the patient received SHINGRIX in the left arm. The arm became sore that evening and was red. The redness was a rectangle 2 by 3 inches. The patient also experienced a headache, body aches and chills that night of vaccination. In the morning of Saturday, 23rd February 2019, the patient experienced fever of 101 degree F. The patient stated that Saturday was worse day. On the day of reporting, 3 days after vaccination, the area on the arm become itchy. The symptoms lasted about 3 days. The reporter consented to follow up. This case has been linked with US2019034298, reported by same reporter for the patient's sister.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 22nd February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, several hours after receiving SHINGRIX, the patient experienced fever. On 22nd February 2019, the patient experienced pain in arm, erythema of extremities, headache, general body pain and chills. On 25th February 2019, the patient experienced itchy upper limbs. On an unknown date, the outcome of the pain in arm, erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the headache, general body pain, chills and fever were recovered/resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, itchy upper limbs, headache, general body pain, chills and fever to be related to SHINGRIX. Additional details were reported as follows: At 3:00 PM, the patient received SHINGRIX in the left arm. The arm became sore that evening and was red. The redness was a rectangle 2 by 3 inches. The patient also experienced a headache, body aches and chills that night of vaccination. In the morning of Saturday, 23rd February 2019, the patient experienced fever of 101 degree F. The patient stated that Saturday was worse day. On the day of reporting, 3 days after vaccination, the area on the arm become itchy. The symptoms lasted about 3 days. The reporter consented to follow up. This case has been linked with US2019034298, reported by same reporter for the patient's sister.
Sex: U
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: This literature marketed information has been received from a published literature article and refers to 61 patients of 65 years and older. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Prior or after the protocol implementation on an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, route, vaccination site were not provided), for prophylaxis, which was not correct as they should had received PREVNAR. This is one of two reports from the same literature (US-009507513-1903USA001313, US-009507513-1903USA001315, US-009507513-1903USA001314 and US-009507513-1903USA001316).; Sender's Comments:  US-009507513-1903USA001313: US-009507513-1903USA001315: US-009507513-1903USA001314: US-009507513-1903USA001316:
Sex: F
Vaccine: HEP, HEPA, HIBV, MMR, PPV, RV5, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a consumer (the mother of the patient) referring to a female patient of unknown age. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with M-M-R II, RECOMBIVAX HB, ROTATEQ, Hib conj vaccine (unspecified carrier) (manufacturer unknown), PNEUMOVAX 23, VARIVAX and VAQTA according to CDC guidelines for prophylaxis. On an unknown date, the patient experienced a "side effect" to these vaccines (Merck could not be ruled out). The outcome of "side effect" was unknown. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided. The causality assessment between "side effect" with these vaccines was related.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 38-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided. On an unknown date in July 2018, the patient was vaccinated with first dose of VAQTA (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date in September 2018, the patient was vaccinated with the second dose of VAQTA (lot number and expiration date were not provided) and on 05-FEB-2019 the patient received another dose of VAQTA, lot # R030120, expiration date 15-NOV-2019. It was reported that this schedule was not recommended. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an immunocompetent 65 years of age or older (exact age not specified) female patient. Information about concomitant medication, pertinent medical history and drug reactions was not provided. On 02-DEC-2018, the patient was administered a dose of PREVNAR 13 (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 14-FEB-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 (intramuscular, lot # R031961, expiration date 09-JUN-2020; strength and dose were not reported) for prophylaxis. The patient did not tell the pharmacist that she had received PREVNAR 13 less than a year ago until after the dose of PNEUMOVAX 23 was administered. No adverse effect was reported. Sender's Comments: US-009507513-1902USA006096.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a medical assistant concerning an unspecified adult patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history of the patient was unknown. On 15-FEB-2019, the patient inadvertently received one pediatric formulation dose of VAQTA (strength 25/0.5 (unit was not provided), 0.5 ml once, lot # and expiration date were unknown) intramuscularly for prophylaxis instead of the intended adult formulation dose of VAQTA (strength, dose, lot # and expiration date were not reported). This was confirmed as medication error and not product confusion. No adverse effects was reported.
Sex: U
Vaccine: PPV
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer (manufacturer control number# 2018377061) regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, frequency, lot# and expiry date unknown) for prophylaxis. On an unknown date, the patient experienced vaccination site pain and vaccination site swelling. The outcome of vaccination site pain and vaccination site swelling was unknown. Causality assessment was not provided.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 6 month old patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 09-OCT-2018 the patient was vaccinated with ROTATEQ (dose 3, lot # R002517, expiration date 19-SEP-2019) orally for prophylaxis. On the same day, the patient was also vaccinated with PREVNAR 13 (0.5 ml on the left thigh via intramuscular; lot # W28770, expiration date 30-MAY-2020) at 16:46 and PENTACEL (dose 3, on the right thigh via intramuscular; lot # C5527AA) for prophylaxis. It was reported that the temperature excursion of vaccines was out of range for 11 to 12 hours with highest temperature at 69.1 degrees Fahrenheit. The patient received improperly stored vaccines. No adverse reaction reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer via other company (Pfizer) regarding herself a female patient of unknown age. There was no information about concurrent condition, concomitant medication and historical medication. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced a lot of pain, redness and swelling at the injection site. She also experienced fever and muscle aches for several days. The outcome of vaccination site swelling, myalgia, pyrexia, vaccination site erythema and vaccination site pain was unknown. Causality assessment was not provided. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 27-FEB-2019, the patient was vaccinated with PROQUAD intramuscularly in the right thigh, lot # N025924, expiration date 18-MAR-2019 (exact dose was not reported) and VARIVAX intramuscularly in the left thigh, lot # R017641, expiration date 20-JUN-2020 (exact dose was not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Vaccination error
Clinical narrative: This literature marketed information has been received from a published literature article title and refers to 3 patients of 65 years and older. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Prior or after the protocol implementation on an unknown date, the patients that should not have received PNEUMOVAX 23 were vaccinated with PNEUMOVAX 23 (dose, route, vaccination site were not provided), for prophylaxis. This is one of two reports from the same literature (US-009507513-1902USA002078, US-009507513-1903USA001315, US-009507513-1903USA001314 and US-009507513-1903USA001316).; Sender's Comments:  US-009507513-1902USA002078:
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This literature marketed information has been received from a published literature article title and refers to 27 patients younger than 65 years old. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Prior or after the protocol implementation on an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, route, vaccination site were not provided), for prophylaxis, which should not have received a vaccine at the time. This is one of two reports from the same literature (US-009507513-1903USA001313, US-009507513-1902USA002078, US-009507513-1902USA002078 and US-009507513-1903USA001316). Sender's Comments:  US-009507513-1902USA002078: Original Case: 1902USA002078.
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This literature marketed information has been received from a published literature article and refers to 16 patients younger than 65 years old. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Prior or after the protocol implementation on an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, route, vaccination site were not provided), for prophylaxis, which was not correct as they should had received PREVNAR. This is one of two reports from the same literature (US-009507513-1903USA001313, US-009507513-1902USA002078, US-009507513-1903USA001314 and US-009507513-1903USA001316). ; Sender's Comments: US-009507513-1902USA002078: Original Case : 1902USA002078.
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This literature marketed information has been received from a published literature article and refers to 13 patients younger than 65 years old. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Prior or after the protocol implementation on an unknown date, in 8 cases, no vaccine order was placed, which was correct for 2 patients (5 patients should have received PNEUMOVAX 23 and in 31 cases, no vaccine order was placed, which was correct for 21 patients (8 patients should have received PNEUMOVAX 23. This is one of two reports from the same literature (US-009507513-1903USA001313, US-009507513-1902USA002078, US-009507513-1903USA001314 and US-009507513-1902USA002078).; Sender's Comments:  US-009507513-1902USA002078: Original Case : 1902USA002078
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received SHINGRIX for prophylaxis. On 17th February 2019, the patient received SHINGRIX. On 17th February 2019, less than a day after receiving SHINGRIX, the patient experienced headache, muscle pain and shivers. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache and muscle pain were not recovered/not resolved and the outcome of the shivers was unknown. It was unknown if the reporter considered the headache, muscle pain and shivers to be related to SHINGRIX. Additional details were provided as follows: At morning of the day before the reporting date, the patient got vaccine and had headache, muscle pain (back and neck area) and shivers all night. Till the reporting time, the patient had headache and muscle pain.
Sex: F
Vaccine: VARZOS
Symptoms: Lichen planus
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of lichen planus in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced lichen planus. On an unknown date, the outcome of the lichen planus was unknown.  It was unknown if the reporter considered the lichen planus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced lichen planus one to two weeks after receiving SHINGRIX. The reporter agreed to follow up from GlaxoSmithKline.
Sex: F
Vaccine: HEPA
Symptoms: Ascites, Confusional state, Dyspnoea, Liver disorder, Renal disorder
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of ascites in a female patient who received HAVRIX for prophylaxis. In June 2018, the patient received HAVRIX. On an unknown date, less than a year after receiving HAVRIX, the patient experienced ascites (serious criteria hospitalization and GSK medically significant), renal disorder (serious criteria hospitalization), liver disorder (serious criteria hospitalization), confusion and difficulty breathing. On an unknown date, the outcome of the ascites, renal disorder, liver disorder, confusion and difficulty breathing were unknown. It was unknown if the reporter considered the ascites, renal disorder, liver disorder, confusion and difficulty breathing to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received Havrix (unknown lot, unknown expiration date). On an unspecified date, the patient developed severe ascites, confusion, had trouble breathing and needed a liver and kidney transplant. The pharmacist also stated that the patient was hospitalized at an unspecified hospital on unspecified dates for unspecified reason. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was concerned about the side effects of Shingles vaccine. The reporter's mother got shingles infection in eye after getting the vaccine. The reporter was afraid if the same would happen to him or her. This case was considered as suspected vaccination failure as status of primary vaccination schedule and time to onset for the event were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, 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 male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown 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 unknown. 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 reporter was the patient's wife. The patient experienced very sore arms, tiredness, et cetera and the sore arms were pretty bad. The reporter wanted to know that how long does this typically last. This case has been linked to the case US2019AMR032823, reported by the same reporter.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site rash
Clinical narrative: PT reported pain on left upper leg starting 02/28/19. Pain increased on 03/01/19. Rash on left leg started on Saturday 03/02/2019. PT was seen by PCP today 03/04/19 and was diagnosed with shingles.
Age: 5.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Blister, Peripheral swelling, Rash, Rash erythematous, Varicella virus test positive
Clinical narrative: Lt hand swollen with erythematous rash on palm and smaller rashes on lt forearm, clustered vesicular lesions on fingers also.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, 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 an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown 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 unknown. 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 experienced very sore arms, tiredness, et cetera and the sore arms were pretty bad. The patient wanted to know that how long does this typically last. This case has been linked to the case US2019GSK039085 (husband's case), reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash generalised
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and generalized rash. On an unknown date, the outcome of the influenza-like symptoms and generalized rash were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX, 5 month before reporting date and experienced flu like symptoms for almost a week followed by a rash all over body. The patient was wondering if he did not get the booster, does the one shot still provide any immunity.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling cold, Muscle tightness, Musculoskeletal pain, Neck pain, Sensitive skin
Clinical narrative: Muscle tightness/Soreness in neck and shoulders, feeling cold, skin sensitivity.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Hypoaesthesia, Laboratory test, Transient ischaemic attack
Clinical narrative: This spontaneous report as received from a 73-year-old male patient refers to himself. The patient had none pertinent medical history and no drug reactions/ allergies. On 20-DEC-2017 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiry date not reported) in the left arm. Concomitant therapies included LIPITOR, ELIQUIS and TOPROL XL TABLETS. On 18-SEP-2018, the patient went to emergency room with his left arm completely numb and was diagnosed with transient ischaemic attack. The patient was admitted and stayed overnight (1 day), received unspecified treatment and underwent various unspecified lab tests and blood work. The patient stated that all health conditions he experienced since his administration of ZOSTAVAX were related to the above mentioned adverse event, and therefore did not feel as though he had recovered fully from his adverse event (specific symptoms were not clarified). No further symptoms or specifics were provided. The outcome of transient ischaemic attack was reported as recovering/resolving. The causality assessment was not provided. Upon internal review event of transient ischaemic attack was considered to be medically significant.
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On an unknown date, the patient was inadvertently vaccinated with PNEUMOVAX 23 injection, lot # R021045 and expiry date 14-APR-2020 (exact dose and anatomical location were not provided) instead of intended PREVNAR 13 for prophylaxis. Physician reported the nurse mistook PNEUMOVAX 23 for PREVNAR 13 because she was not paying close attention and only noticed the label said "pneumococcal vaccine" and thought she was giving PREVNAR 13. No adverse effect reported.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 83-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, sickness, fever and weakness. On an unknown date, the outcome of the influenza-like symptoms, sickness, fever and weakness were unknown. It was unknown if the reporter considered the influenza-like symptoms, sickness, fever and weakness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and got very sick, fever (101.4 degree F), flu-like symptoms for 5 days and at the time of reporting she was very weak. The patient asked should she get the 2nd dose in 2 months and would she get as sick. Lab Comments: Lab test performed on unknown date.
Sex: U
Vaccine: FLU4
Symptoms: Drug hypersensitivity, Nausea, Vomiting
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of drug allergy in a patient who received FLUARIX TETRA for prophylaxis. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, less than a year after receiving FLUARIX TETRA, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to FLUARIX TETRA. Additional details were provided as follows: The reporter was the prescribing healthcare professional. The patient's other allergies included meperidine unknown allergy, carisoprodol unknown allergy, propoxyphene N-acctaminaphen unknown allergy and allergy to morphine associated with nausea and vomiting. It was unknown whether these occurred prior or post vaccination with FLUARIX. The age at vaccination was not reported. It was unknown if the reporter consent to further follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a male patient who received SHINGRIX for prophylaxis. On 17th February 2019, the patient received the 1st dose of SHINGRIX. On 17th February 2019, less than a day after receiving SHINGRIX, the patient experienced shivering and upset stomach. On an unknown date, the outcome of the shivering and upset stomach were unknown. It was unknown if the reporter considered the shivering and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At night, the patient experienced very bad shivering and upset stomach. The patient was wondering at the reporting time, if there were any reports of people getting chicken pox afterwards. The patient asked if he would experience the same side effects with the second shot.
Age: 5.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A female patient in her 40's received PREVNAR 13 (lot number and expiration date unknown), via an unspecified route of administration at the arm, on an unspecified date at a single dose for immunization. Medical history included arthritis (possibly RA). The patient's concomitant medications were not reported. It was reported that on an unspecified date, the patient's arm went bright red and swelled when vaccinated. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Myalgia, Nasopharyngitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 61-year-old female patient received PREVNAR 13 (unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for vaccination; obeticholic acid (OCALIVA), oral from 19Nov2018 to an unspecified date at 5 mg, three times a week for primary biliary cirrhosis; and influenza vaccine (FLU VACCINE), via an unspecified route of administration on an unspecified date at an unspecified dose for vaccination. Medical history included primary biliary cholangitis from an unknown date and unknown if ongoing.  Concomitant medication included vitamin b complex; aloe vera oil; ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER); hydrochlorothiazide, losartan potassium (HYZAAR); levothyroxine sodium (SYNTHROID); calcium, colecalciferol, magnesium, zinc (CALCIUM MAGNESIUM ZINC FORTE); folic acid; ascorbic acid (VITAMIN C); nicotinamide (VITAMIN B3); fish oil (FISH OIL); and curcuma longa rhizome (TURMERIC [CURCUMA LONGA RHIZOME]). On an unspecified date, the patient experienced chills, muscle ache, pain, injection site pain, nasal drip, head cold, injection site redness, upper respiratory infection, and fever. The events were reported as non-serious. The action taken for obeticholic acid was permanently withdrawn (reported as stopped). Outcome of the events was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pain, Pyrexia, Upper respiratory tract infection, Upper-airway cough syndrome
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 61-year-old female patient received PREVNAR 13 (unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for vaccination; obeticholic acid (OCALIVA), oral from 19Nov2018 to an unspecified date at 5 mg, three times a week for primary biliary cirrhosis; and influenza vaccine (FLU VACCINE), via an unspecified route of administration on an unspecified date at an unspecified dose for vaccination. Medical history included primary biliary cholangitis from an unknown date and unknown if ongoing.  Concomitant medication included vitamin b complex; aloe vera oil; ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER); hydrochlorothiazide, losartan potassium (HYZAAR); levothyroxine sodium (SYNTHROID); calcium, colecalciferol, magnesium, zinc (CALCIUM MAGNESIUM ZINC FORTE); folic acid; ascorbic acid (VITAMIN C); nicotinamide (VITAMIN B3); fish oil (FISH OIL); and curcuma longa rhizome (TURMERIC [CURCUMA LONGA RHIZOME]). On an unspecified date, the patient experienced chills, muscle ache, pain, injection site pain, nasal drip, head cold, injection site redness, upper respiratory infection, and fever. The events were reported as non-serious. The action taken for obeticholic acid was permanently withdrawn (reported as stopped). Outcome of the events was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: DTAP
Symptoms: Autism spectrum disorder
Clinical narrative: Initial information received on 28-Feb-2019 regarding an unsolicited valid serious case received from a consumer. This case involves a female patient (age unknown) who experienced autism, while she received vaccine  DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapy were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a serious autism (autism spectrum disorder) (Unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. case details: patients mother reported that my daughter got the DTap vaccine and now she has autism. (Other relevant tests included no lab data.) Final diagnosis was autism. It was not reported if the patient received a corrective treatment. The patient outcome was not reported for autism. List of documents held by sender: none.; Sender's Comments: This case concerns a female patient who presented with autism spectrum disorder after vaccination with DAPTACEL. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site paraesthesia, Injection site reaction
Clinical narrative: In notes that I received: HEPATITIS B VACC 20MCG/ML (REC) 1ML SYR, INJECT 20MCG INTO THE MUSCLE ONCE AN IMMUNIZATION DOCUMENTATION NOTE MUST BE ENTERED WHEN THE IMMUNIZATION IS ADMINISTERED. I am not sure of the type of Hep B vaccine or the manufacturer.  As far as adverse effects, the muscle (bicep) where the injection was given has had a numb or dead feeling since the afternoon of the day the injection was given. The skin has feeling but the muscle is tingling on and off and has the feeling of being "asleep". It has of right now been five days that this has been going on.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Limb discomfort
Clinical narrative: Chills, heavy arms and legs, achy. Pretty bad the 15th. Same thing the next day but started at 8:30 pm. Had just tired and yucky feeling for another week. Took Tylenol.