chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 4-19-19 Had Shingrix #2 @ 9AM. Then between 7-8 PM chills, increased fever nausea felt like going to pass out face edematous flushed felt "like run over by truck " the whole next day". Took OTC. meds. Thrus "felt entirely different no SX".
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Patient suffered from substantial edema and redness to the area of the injection site to the left thigh
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration
Clinical narrative: 6.5 in X 6 in Redness 4 X 4 Induration
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Eye irritation, Injection site discomfort, Ocular hyperaemia
Clinical narrative: Patient had no ill effect from vaccine at time of administration. Parent called to report dizziness and soreness at injection sites, the following day.  parent also reports burning , red eyes.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event yet, vaccines were administered yesterday, 5/8/19.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On or around 28-APR-2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot # and expiration date were not provided) for the prevention of shingles (herpes zoster). On an unknown date in approximately 2017 (reported as shortly after receiving ZOSTAVAX), the patient suffered herpes zoster and vision loss. It was stated that, as a direct or proximate result of ZOSTAVAX, the patient's symptoms resulted in physical limitations not present prior to using suspected vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The outcome of the events was unknown. The events were considered to be related to ZOSTAVAX. Upon internal review, the event of vision loss was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: MMR, UNK
Symptoms: Injection site pain
Clinical narrative: stinging at injection site during and after the injection; 58 year old was administered with first dose of MMR II; This spontaneous report was received from a patient's husband regarding his wife who was a 58-year-old female. It was reported that patient has no pertinent medical history and drug reactions or allergies. Concomitant medication included unspecified thyroid, cholesterol and glaucoma medications. On 26-APR-2019, the patient was vaccinated with first dose in series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# and expiry date was not reported) for measles protection along with sterile diluent(MERCK STERILE DILUENT) (lot# and expiry date was not reported) (Product administered to patient of inappropriate age). On 26-APR-2019 (also reported as during and after the injection), patient experienced stinging at the injection site (vaccination site pain). It was reported that no treatment was given for the treatment. The patient did not seek any medical attention. The outcome of vaccination site pain was reported as recovered/resolved. The outcome of the event product administered to patient of inappropriate age was unknown. The causality of the event vaccination site pain with respect to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent(MERCK STERILE DILUENT) was not reported.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: red injection site reaction; bumpy injection site reaction; pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 25th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced administration site reaction below the injection site on her left arm after getting her first Shingrix dose.  The pharmacist described the reaction as red, bumpy and that patient told her it hurt to touch the area.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   The patient's past medical history included shingles.   On 26th April 2019, the patient received Shingrix (intramuscular). On 26th April 2019, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on left deltoid. The patient developed a shingles rash on her trunk the day of vaccination.  The rash had not been verified by a physician to be shingles.  The patient does not think it was caused by the Shingrix, she thinks it was coincidence.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Fever; Inappropriate schedule of vaccine; This case was reported by a physician via call center representative and described the occurrence of fever in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 2HC47, expiry date 13th December 2020) for prophylaxis.   Concomitant products included DTPa-HBV-IPV (Pediarix).   On an unknown date, the patient received Pediarix. On an unknown date, less than a year after receiving Pediarix, the patient experienced fever and drug dose administration interval too short. On an unknown date, the outcome of the fever and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fever to be related to Pediarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Pediarix with batch number 9A2KC and Exp date 3rd July 2020. Eight days after initial dose, the patient inadvertently received another dose of Pediarix, which led to shortening of vaccination schedule. The reporter ask about any information on 2 doses given close (8 days apart) would cause the fever to be higher.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Red spots; Itching; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 2nd dose of Shingrix. On 27th April 2019, 1 days after receiving Shingrix, the patient experienced localized erythema and pruritus. On an unknown date, the outcome of the localized erythema and pruritus were recovered/resolved.   It was unknown if the reporter considered the localized erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The red spot went up and down the entire left arm within the next day. On 3rd day of vaccionation, the red spot covered the entire right arm. The red spots were associated with itching, and red spot continued to spread to the patient's chest and leg. The red spot had stared to disppear and there was no itching anymore. The patient consented to follow up. No further details were provided.
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: her leg was swollen; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the leg on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient's leg was swollen. The patient who was so little and skinny was administered with the vaccine in her leg rather than her arm since it was so little. The physician thought that because the patient was so skinny, it was not a good idea to give it in the arm as there was not enough fat. It was reported that the patient was fine at the time of the report. It was also reported that the physician was planning to administer the second dose into her leg again because the patient was so skinny and little. The outcome of the event was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Medication was administered at about 4.5 weeks of age follow-up instead of at 6 weeks per package insert due to mix-up at pediatrician office; Mild transient fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age  received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that medication was administered at about 4.5 weeks of age follow-up instead of at 6 weeks per package insert due to mix-up at pediatrician office ("earlier this week"). It was reported that no adverse event noted except potential mild transient fever (per grandmother) that resolved without medication within an hour or two that occurred approximately one day after administration.   No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling cold, Head discomfort, Skin burning sensation
Clinical narrative: Bad chills - from 11 pm - 8am next day skin felt like burning  couldn't stand very dizzy - felt like head explode called doctor next day for advise chivered for 5 hrs. Couldn't get warm enough.  very bad chills - very dizzy couldn't stand felt like head was going to explode skin felt like it was on fire - burning. Couldn't get warm enough -  didn't go to er that cost money.  Doctor advise not to get #2 shot.  Called Doctor on 4/3/19 for advise. Was able to eat on 4/4/19
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site rash, Injection site warmth
Clinical narrative: Rash at injection site, hot to the touch; difficulty breathing; patient reported to the ER at unknown time and date and was treated; patient reported to the pharmacy on 5/9/19 at 10am with no further s/s of reaction
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Immediately after receiving the vaccine, patient had pain 10/10 in left arm from should to elbow.  As day progressed area became swollen, red, hot and painful from injection site to elbow.  As of 5/9/19 at 10:00 am, pain is 8/10 with analgesics (Tylenol), area remains red, hot and swollen from injection site to elbow.  Patient advised that she could continue to take analgesics for pain (Tylenol or ibuprofen); seek medical attention if condition worsens.  No loss of range of motion or pain/swelling/redness distal to elbow.  Advised to contact public health nurse on 5/10/19 in follow-up.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood glucose increased, Blood potassium increased, Dehydration, Gastrostomy, Glucose urine present
Clinical narrative: VOMITING, DEHYDRATION, AND HYPERGLYCEMIA. DECREASED INTAKE, HAD MUTIPLE EPISODES OF NON-BILOUS NON BLOODY VOMITING 4/26/19 RESULTED IN PATIENT HAVING INTESTINAL OBSTRUCTION INTUSSECPTION AND ABD INTESTINAL PERFORATION PATIENT NOW HAS OSTOMY.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hyperglycaemia, Hypophagia, Intestinal obstruction, Intestinal perforation, Intussusception
Clinical narrative: VOMITING, DEHYDRATION, AND HYPERGLYCEMIA. DECREASED INTAKE, HAD MUTIPLE EPISODES OF NON-BILOUS NON BLOODY VOMITING 4/26/19 RESULTED IN PATIENT HAVING INTESTINAL OBSTRUCTION INTUSSECPTION AND ABD INTESTINAL PERFORATION PATIENT NOW HAS OSTOMY.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urine ketone body present, Vomiting, White blood cell count normal
Clinical narrative: VOMITING, DEHYDRATION, AND HYPERGLYCEMIA. DECREASED INTAKE, HAD MUTIPLE EPISODES OF NON-BILOUS NON BLOODY VOMITING 4/26/19 RESULTED IN PATIENT HAVING INTESTINAL OBSTRUCTION INTUSSECPTION AND ABD INTESTINAL PERFORATION PATIENT NOW HAS OSTOMY.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Extra dose administered
Clinical narrative: Hib administered along with pentacel.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: redness, swelling left upper arm and left clavicle area
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient broke out in rash all over his body.
Age: 42.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Asthenia, Back pain, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Started feeling nauseated, dizzy, fatigued,  no energy on 4/29/19. Diarrhea started around 5/4/19 or 5/5/19 and continues. Back pain and neck stiffness noted. Did not take temperature but woke up in "puddle of sweat" last night. He looked up side effects of vaccine online and feels like they match his symptoms.  Continues with these symptoms to date.
Age: 42.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Musculoskeletal stiffness, Nausea, Night sweats
Clinical narrative: Started feeling nauseated, dizzy, fatigued,  no energy on 4/29/19. Diarrhea started around 5/4/19 or 5/5/19 and continues. Back pain and neck stiffness noted. Did not take temperature but woke up in "puddle of sweat" last night. He looked up side effects of vaccine online and feels like they match his symptoms.  Continues with these symptoms to date.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling
Clinical narrative: swelling at injection site
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Amblyopia, Hypermetropia, Strabismus
Clinical narrative: Acute development of right eye strabismus. Evaluated by ophthalmology and diagnosed with amblyopia and farsightedness +3.25 on right and +2.75 on left.
Age: 9.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: He has stomach pains and nausea. He had to stay home from school today.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 08-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect reported; Inadvertently administered intramuscular route instead of subcutaneous route; Information has been received from a physician assistant referring to a patient of unknown age and gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 06-MAY-2019, the patient was inadvertently administered a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number: N032750 and expiration date: 20-NOV-2019; dose, and strength unspecified) by the intramuscular route instead of the subcutaneous route (Incorrect route of product administration), for prophylaxis. No adverse effect reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; two unspecified patients were administered expired doses of MMR II; This spontaneous report was received from a nurse and refers to two patients of unknown age and gender. No information regarding the patient's concurrent condition, past medical history, concomitant medications and drug reactions or allergies was provided.  On 06-MAY-2019, the patients were vaccinated subcutaneously with expired doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N013868, expiration date 04-MAY-2019 (exact doses were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Presyncope, Pyrexia
Clinical narrative: Chills; Fever; Nausea; near syncope; This case was reported by a physician via sales rep and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever, nausea and presyncope. On an unknown date, the outcome of the chills, fever, nausea and presyncope were recovered/resolved.   It was unknown if the reporter considered the chills, fever, nausea and presyncope to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced chills, fever, nausea and presyncope. The reporter did not agree to be followed up from GlaxoSmithKline.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Impaired work ability
Clinical narrative: Unable to go to work; Node remains swollen / enlarged tender lymph node; Local injection site pain mild; Shivering; Fatigue; Myalgia; GI discomfort; Headache on the left side; 4 cm axillary tender node on left same side as injection; Fever; This case was reported by a physician via sales rep and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th April 2019, the patient received the 1st dose of Shingrix. On 9th April 2019, less than a day after receiving Shingrix, the patient experienced fever, injection site pain, shivering, fatigue, myalgia, gastrointestinal discomfort, headache, lymph node tenderness and enlargement of lymph nodes. On 10th April 2019, the patient experienced inability to work. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever, injection site pain, shivering, myalgia, gastrointestinal discomfort and headache were recovered/resolved and the outcome of the fatigue, lymph node tenderness and enlargement of lymph nodes were not recovered/not resolved and the outcome of the inability to work was unknown.   The reporter considered the fever, injection site pain, shivering, fatigue, myalgia, gastrointestinal discomfort, headache and lymph node tenderness to be probably related to Shingrix. It was unknown if the reporter considered the inability to work and enlargement of lymph nodes to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in left deltoid. The reactions began within 3 hours of receiving the first dose of Shingrix and consisted of fatigue, myalgia, headache, fever, gastrointestinal discomfort without vomiting or diarrhea, as well as a tender 4 cm axillary node on the left. On 10th April 2019, 1 day after receiving Shingrix the patient was unable to go to work on due to intensity of reactions. The patient responded to ibuprofen in general, but fatigue persisted into 11th April 2019 and the node remains swollen and tender. The symptoms worsened over the first 24 hours and then at 48 hours had largely resolved or improved. Less than a week after receiving Shingrix, the patient had the enlarged tender lymph node, injection site pain and shivering. The fatigue persisted but was improved whereas the rest of the systemic symptoms were resolved. The events did not cause the patient to be admit to the hospital overnight or prolong an existing hospitalization. The reporting health care professional did not consider the events to be life threatening. The reporting health care professional did not consider the events to result in persistent or significant disability/incapacity. The events did not result in a congenital anomaly or birth defect. The patient was alive. The patient agreed to have a follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Unable to go to work; Node remains swollen / enlarged tender lymph node; Local injection site pain mild; Shivering; Fatigue; Myalgia; GI discomfort; Headache on the left side; 4 cm axillary tender node on left same side as injection; Fever; This case was reported by a physician via sales rep and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th April 2019, the patient received the 1st dose of Shingrix. On 9th April 2019, less than a day after receiving Shingrix, the patient experienced fever, injection site pain, shivering, fatigue, myalgia, gastrointestinal discomfort, headache, lymph node tenderness and enlargement of lymph nodes. On 10th April 2019, the patient experienced inability to work. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever, injection site pain, shivering, myalgia, gastrointestinal discomfort and headache were recovered/resolved and the outcome of the fatigue, lymph node tenderness and enlargement of lymph nodes were not recovered/not resolved and the outcome of the inability to work was unknown.   The reporter considered the fever, injection site pain, shivering, fatigue, myalgia, gastrointestinal discomfort, headache and lymph node tenderness to be probably related to Shingrix. It was unknown if the reporter considered the inability to work and enlargement of lymph nodes to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in left deltoid. The reactions began within 3 hours of receiving the first dose of Shingrix and consisted of fatigue, myalgia, headache, fever, gastrointestinal discomfort without vomiting or diarrhea, as well as a tender 4 cm axillary node on the left. On 10th April 2019, 1 day after receiving Shingrix the patient was unable to go to work on due to intensity of reactions. The patient responded to ibuprofen in general, but fatigue persisted into 11th April 2019 and the node remains swollen and tender. The symptoms worsened over the first 24 hours and then at 48 hours had largely resolved or improved. Less than a week after receiving Shingrix, the patient had the enlarged tender lymph node, injection site pain and shivering. The fatigue persisted but was improved whereas the rest of the systemic symptoms were resolved. The events did not cause the patient to be admit to the hospital overnight or prolong an existing hospitalization. The reporting health care professional did not consider the events to be life threatening. The reporting health care professional did not consider the events to result in persistent or significant disability/incapacity. The events did not result in a congenital anomaly or birth defect. The patient was alive. The patient agreed to have a follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Influenza like illness, Pain, Pain in extremity
Clinical narrative: flu-like symptoms; chills; achiness; feeling cold; arm was extremely sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2019, the patient received the 1st dose of Shingrix. In February 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, chills, pain and feeling cold. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the pain in arm, influenza-like symptoms, chills, pain and feeling cold were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, chills, pain and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in his unknown arm and his arm was extremely sore.  Later in the day, the patient experienced chills, achiness and felt cold.  The patient took Aleve to treat the arm soreness. Within 24 to 36 hours, the flu-like symptoms was resolved, but the arm soreness lasted an additional 3 to 4 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: weak; flu like; felt really bad; shivering; sore arm; feeling tired/ very tired; achy; fever; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On 12th April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, tiredness, pain, fever, shivering and feeling bad. On an unknown date, the patient experienced weakness and influenza like illness. The patient was treated with ibuprofen and benadryl (nos) (Benadryl). On 14th April 2019, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the tiredness and weakness were not recovered/not resolved and the outcome of the fever, shivering, influenza like illness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness, pain, fever, weakness, shivering, influenza like illness and feeling bad to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix and next morning of Friday the patient arm was sore and through the day she started feeling tired and achy and her arm got more sore. By the time, the patient got home from work she felt really bad, was shivering and she had a fever, which was 102 degree F at its highest. The patient took some Ibuprofen and Benadryl and fell asleep and when the patient woke up her fever was down to 100 degree F. On Saturday, the patient felt very tired and achy and did not do anything all day. On Sunday she felt okay since she did not have to do any activities. But now today, Monday, the patient was back at work and feels weak and tired on the date of reporting, like the patient had the flu for several days.  The patient had no longer achiness and her arm was lot better.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: weak; flu like; felt really bad; shivering; sore arm; feeling tired/ very tired; achy; fever; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On 12th April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, tiredness, pain, fever, shivering and feeling bad. On an unknown date, the patient experienced weakness and influenza like illness. The patient was treated with ibuprofen and benadryl (nos) (Benadryl). On 14th April 2019, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the tiredness and weakness were not recovered/not resolved and the outcome of the fever, shivering, influenza like illness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness, pain, fever, weakness, shivering, influenza like illness and feeling bad to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix and next morning of Friday the patient arm was sore and through the day she started feeling tired and achy and her arm got more sore. By the time, the patient got home from work she felt really bad, was shivering and she had a fever, which was 102 degree F at its highest. The patient took some Ibuprofen and Benadryl and fell asleep and when the patient woke up her fever was down to 100 degree F. On Saturday, the patient felt very tired and achy and did not do anything all day. On Sunday she felt okay since she did not have to do any activities. But now today, Monday, the patient was back at work and feels weak and tired on the date of reporting, like the patient had the flu for several days.  The patient had no longer achiness and her arm was lot better.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Autoimmune thyroiditis, General physical health deterioration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hashimoto's disease in a infant female patient who received INFANRIX for prophylaxis. On an unknown date, the patient received INFANRIX at an unknown dose. On an unknown date, unknown after receiving INFANRIX, the patient experienced hashimoto's disease (serious criteria GSK medically significant). On an unknown date, the outcome of the hashimoto's disease was unknown. The reporter considered the hashimoto's disease to be related to INFANRIX. Additional details were provided as follows: In 2015, the patient received INFANRIX. The patient's health started to decline and in 2016, the patient was daignosed with Hashimoto's disease. The mother of the patient believed that the vaccine had caused the condition because the patient's blood work was perfect at birth and this was the only vaccine she had. The reporter did not consent to follow up.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fall, Haemorrhage, Loss of consciousness, Pain in jaw, Skin laceration
Clinical narrative: The pt. received the Men B vaccine - Bexsero in the office. The pt. was sitting on the exam table and less than 1minute after receiving the vaccine the pt. passed out and fell face first onto the floor. The pt. had no warning signs or symptoms. The pt. was bleeding from a chin laceration and c/o jaw pain. EMS was called and pt was transferred to Hospital.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fall, Loss of consciousness, Pain in jaw, Skin laceration
Clinical narrative: The pt. received the Men B vaccine - Bexsero in the office. The pt. was sitting on the exam table and less than 1minute after receiving the vaccine the pt. passed out and fell face first onto the floor. The pt. had no warning signs or symptoms. The pt. was bleeding from a chin laceration and c/o jaw pain. EMS was called and pt was transferred to Hospital.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient reported chills and fever of 103F for 2 days following vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Limb discomfort, Pain, Pyrexia
Clinical narrative: Aches all over, slight fever and chills at night Arm very sore
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Blood test, Bradycardia, Cerebral circulatory failure, Computerised tomogram
Clinical narrative: Bradycardia , stay, bluing of the lips, spontaneous breathing, lethargic, watery stools, uncontrollable crying, apnea, changes in blood flow on right side of the brain hospitalized for a week until symptoms resolved
Sex: F
Vaccine: HEP
Symptoms: Crying, Cyanosis, Diarrhoea, Lethargy, Urine analysis
Clinical narrative: Bradycardia , stay, bluing of the lips, spontaneous breathing, lethargic, watery stools, uncontrollable crying, apnea, changes in blood flow on right side of the brain hospitalized for a week until symptoms resolved
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Nausea, Pain
Clinical narrative: chilling, body aches , nausea, headache, exhaustion.  Woke up at 1 AM chilling so bad I thought I was going to break my crowns off.  Could not stop for over 2 hours.  Whole body aches   The chilling lasted from 1-5 am and the exhaustion all day.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Irritability, Pityriasis rosea, Rash
Clinical narrative: Developed rash on 05/04/2019, seen in office, Dx with  Pityriasis Rosea with Hearld patch. Given 1% Hydrocortisone cream.  Seen 05/06/19 for continued watery stools which started on 05/04/19. Had 1-2 normal stools. No fevers, is taking in fluids but less than usual amounts. Overall affect happy but is a bit fussy at times.  Monitoring, is to return to office if not resolved in 48 hours or worsens.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site bruising, Injection site pain, Nausea, Skin warm
Clinical narrative: Patient came in the office on 5-8-19 stating feeling nauseated and shot site pain.  After looking at site it was bruised the size of a quarter then a red area from just under shot site down 7 inches long and 4 inches wide redness and warm to touch this has been getting worse day by day  a provider looked at it told her to take Benadryl and if it keeps getting worse to return to the office
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 13-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; tired; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (in right side). Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2019076856).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and tiredness were unknown.   It was unknown if the reporter considered the fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's husband. The reporter couldn't recall which arm she received the vaccine in, however, the patient had a history of breast cancer in her right side, so he believed she received the Shingrix in the left arm. It was reported that, with the second shot the patient had a worse fever around 101 degrees F.  The patient felt fine the first day and the next day her symptoms hit. With the second dose, her fever was higher than the first dose. The reporter did not consent to follow-up.      Lab Comments: On an unknown date, the body temperature was recorded as 101 degree F.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2019, 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 recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had pain in her arm for 3 days, to the point where she could not lay on the arm.  This case was linked with case ID US2019075310, reported for tolerance dose.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 2nd February 2019, see case US2019GSK080985). On 22nd April 2019, the patient received the 2nd dose of SHINGRIX. On 22nd April 2019, less than a day after receiving SHINGRIX and an unknown time after starting Keflex, the patient experienced injection site pain. On 24th April 2019, the patient experienced cellulitis (serious criteria GSK medically significant), erythema of extremities, skin warm, welts, red blotches and swelling. The patient was treated with cephalexin (Keflex), antihistamine and methylprednisolone (Medrol). On an unknown date, the outcome of the cellulitis and swelling were unknown and the outcome of the injection site pain, erythema of extremities, skin warm, welts and red blotches were recovering/resolving. It was unknown if the reporter considered the cellulitis, injection site pain, erythema of extremities, skin warm, welts, red blotches and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient had her dose of SHINGRIX this past Monday afternoon in her left deltoid and experienced pain and soreness with the injection itself and afterwards. The soreness was improving but not resolved. She noticed last evening on her left upper arm at the injection site and below the site red blotchy patches that were raised, hot and appeared like whelps on her arm. The patient called the pharmacy, who referred her to GlaxoSmithKline, but it was after hours. The patient contacted her physician office who requested to see her in the morning, of the date of reporting. The patient went to the Emergency room the night before the date of reporting and was told it appeared to be cellulitis and was given Keflex 500mg to take three times a day for seven days. The patient did see her primary care physician in the morning, who did concur with the Emergency Department on the cellulitis and also encouraged to take an antihistamine and prescribed a medrol dose pack if it was not better by the weekend. The patient had not started the medrol at the time of this report. The patient noted the issues did appear less intense but they had not resolved. The patient noted it was 3 to 4 patches on, below and around the injection site that were raised, and red. The one just below the site was the largest. The patient consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash macular, Skin warm, Swelling, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 2nd February 2019, see case US2019GSK080985). On 22nd April 2019, the patient received the 2nd dose of SHINGRIX. On 22nd April 2019, less than a day after receiving SHINGRIX and an unknown time after starting Keflex, the patient experienced injection site pain. On 24th April 2019, the patient experienced cellulitis (serious criteria GSK medically significant), erythema of extremities, skin warm, welts, red blotches and swelling. The patient was treated with cephalexin (Keflex), antihistamine and methylprednisolone (Medrol). On an unknown date, the outcome of the cellulitis and swelling were unknown and the outcome of the injection site pain, erythema of extremities, skin warm, welts and red blotches were recovering/resolving. It was unknown if the reporter considered the cellulitis, injection site pain, erythema of extremities, skin warm, welts, red blotches and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient had her dose of SHINGRIX this past Monday afternoon in her left deltoid and experienced pain and soreness with the injection itself and afterwards. The soreness was improving but not resolved. She noticed last evening on her left upper arm at the injection site and below the site red blotchy patches that were raised, hot and appeared like whelps on her arm. The patient called the pharmacy, who referred her to GlaxoSmithKline, but it was after hours. The patient contacted her physician office who requested to see her in the morning, of the date of reporting. The patient went to the Emergency room the night before the date of reporting and was told it appeared to be cellulitis and was given Keflex 500mg to take three times a day for seven days. The patient did see her primary care physician in the morning, who did concur with the Emergency Department on the cellulitis and also encouraged to take an antihistamine and prescribed a medrol dose pack if it was not better by the weekend. The patient had not started the medrol at the time of this report. The patient noted the issues did appear less intense but they had not resolved. The patient noted it was 3 to 4 patches on, below and around the injection site that were raised, and red. The one just below the site was the largest. The patient consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Colonoscopy, Decreased appetite, Dehydration, Diarrhoea, Insomnia
Clinical narrative: dehydration; pelvic pain; could not sleep; couldn't eat; diarrhea/Diarrhea Symptoms; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 9th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th April 2019, 11 days after receiving Shingrix, the patient experienced diarrhea, pelvic pain, insomnia and appetite absent. On 25th April 2019, the patient experienced dehydration. On an unknown date, the outcome of the diarrhea and pelvic pain were not recovered/not resolved and the outcome of the dehydration, insomnia and appetite absent were unknown.   It was unknown if the reporter considered the diarrhea, dehydration, pelvic pain, insomnia and appetite absent to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix on left arm. The patient experienced diarrhea symptoms and on 1st day she had diarrhea over 14 times and she couldn't sleep and she stopped eating. The patient was also dehydrated. On 27th April 2019, the patient felt like she could control her bowels. On 27th April 2019, the patient had her bowel tests and results are pending. The patient had colonoscopy to determine if her symptoms are related to the vaccine or to another condition. Till the time of reporting, the patient still had diarrhea and pain in pelvic area.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pelvic pain, Stool analysis
Clinical narrative: dehydration; pelvic pain; could not sleep; couldn't eat; diarrhea/Diarrhea Symptoms; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 9th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th April 2019, 11 days after receiving Shingrix, the patient experienced diarrhea, pelvic pain, insomnia and appetite absent. On 25th April 2019, the patient experienced dehydration. On an unknown date, the outcome of the diarrhea and pelvic pain were not recovered/not resolved and the outcome of the dehydration, insomnia and appetite absent were unknown.   It was unknown if the reporter considered the diarrhea, dehydration, pelvic pain, insomnia and appetite absent to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix on left arm. The patient experienced diarrhea symptoms and on 1st day she had diarrhea over 14 times and she couldn't sleep and she stopped eating. The patient was also dehydrated. On 27th April 2019, the patient felt like she could control her bowels. On 27th April 2019, the patient had her bowel tests and results are pending. The patient had colonoscopy to determine if her symptoms are related to the vaccine or to another condition. Till the time of reporting, the patient still had diarrhea and pain in pelvic area.