chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case, initially received on 09-Oct-2018 reported by other non-health professional and concerns a female patient of unspecified age. The patient's medical history included stomach upset upon taking scrambled eggs. The patient stated that, she could eat boiled eggs and eggs in baked products. On an unspecified date in 2002, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacture: not reported). On an unspecified date in 2002 after vaccination, the patient's arm was swollen up to the size of a football. At the time of this report, the outcome of the event was not reported.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Ear swelling, Erythema, Pruritus generalised, Urticaria
Clinical narrative: We have an egg white allergy. Pediatrician assured us that the flu shot was okay. 20-30 min after (no food given in between) our daughter began reacting. Her face turned bright red, she had hives all over, her ears were red and swollen, and she was itching all over.
Age: 87.0
Sex: F
Vaccine: FLUA3
Symptoms: Discomfort, Fear, Pain, Pain in extremity
Clinical narrative: Severe arm pain left arm (shot arm) also some less severe in right. Pain throughout body like veins were having needles poked in them and all over discomfort and fear. Had both arm pain last year but Dr. said was not shot!
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dysstasia, Hypoaesthesia, Injection site erythema, Injection site nodule
Clinical narrative: On Oct 9 Received PNEUMOVAX 23 at 10:34 a.m. was fine all day then suddenly at 6pm, my arm went numb all the way to fingers, with extreme pain. Was driving at the time. Was difficult to talk. An hour later was too dizzy to stand. Took BENADRYL, sat for 2 hours, then a friend drove me home. Arm had a huge knot around shot, and on under side of arm also. Deep red rash all down my arm. Severe pain continued all night. Saw doc next morning. Used warm compress, redness localized to 3 inches round shot. Pain and swelling still present now, 54 hours later. Arm now itches, but I have regained strength in it.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Pain in extremity, Pruritus, Rash, Rash erythematous
Clinical narrative: On Oct 9 Received PNEUMOVAX 23 at 10:34 a.m. was fine all day then suddenly at 6pm, my arm went numb all the way to fingers, with extreme pain. Was driving at the time. Was difficult to talk. An hour later was too dizzy to stand. Took BENADRYL, sat for 2 hours, then a friend drove me home. Arm had a huge knot around shot, and on under side of arm also. Deep red rash all down my arm. Severe pain continued all night. Saw doc next morning. Used warm compress, redness localized to 3 inches round shot. Pain and swelling still present now, 54 hours later. Arm now itches, but I have regained strength in it.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Speech disorder, Swelling
Clinical narrative: On Oct 9 Received PNEUMOVAX 23 at 10:34 a.m. was fine all day then suddenly at 6pm, my arm went numb all the way to fingers, with extreme pain. Was driving at the time. Was difficult to talk. An hour later was too dizzy to stand. Took BENADRYL, sat for 2 hours, then a friend drove me home. Arm had a huge knot around shot, and on under side of arm also. Deep red rash all down my arm. Severe pain continued all night. Saw doc next morning. Used warm compress, redness localized to 3 inches round shot. Pain and swelling still present now, 54 hours later. Arm now itches, but I have regained strength in it.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Diarrhoea, Fatigue, Haematochezia, Muscle spasms
Clinical narrative: Received PNEUMOVAX 23 vaccination on same day I received the flu vaccination, different arms. Side effects included for 5 + days: sore arm, severe chills,fatigue,instant cramping, nausea diarrhea, bloody stools.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Pain in extremity
Clinical narrative: Received PNEUMOVAX 23 vaccination on same day I received the flu vaccination, different arms. Side effects included for 5 + days: sore arm, severe chills,fatigue,instant cramping, nausea diarrhea, bloody stools.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient developed a rash, redness, swelling to injection site. Patient applied ice and anti-itch cream to affected area x 2 weeks. Patient called PCP and was prescribed Prednisone and after five days reaction has cleared.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Urticaria
Clinical narrative: Patient reported welts around mouth 2 days after vaccines given that went away on their own after 15 minutes.
Age: 90.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Local reaction, Pain, Skin mass, Swelling
Clinical narrative: Pt. received vaccine on Fri. at 2:45 PM by Sat. pt. came back to pharmacy complaining of pain and soreness. RPh advised pt. to take some TYLENOL and place ice on it. Pt. came back on Mon. with a bruise the size of a golf ball with a bump (knot) under the skin and still complaining of soreness. RPh took a look and advised the pt. that it looked like an adverse reaction to the shot. While not uncommon, it was still possible it could happen. The pt. was upset about the pain and swelling. RPh called her primary doctor and they agreed with the RPh that it sounds like a localized ADR and also advise pt. to use some ice and TYLENOL. RPh relayed the info to the patient. Chief complaints: swelling, bruise, knot under skin, soreness.
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, VARCEL
Symptoms: Rash, Varicella
Clinical narrative: 7/26/18 ER visit for rash that presented 2 days prior. Dx with chicken pox.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Ecchymosis, Erythema, Local reaction, Swelling
Clinical narrative: Extensive local reaction: erythema, ecchymosis, swelling, measuring 6 x 8 cm. TX: Ice compress. PO BENADRYL 125 mg tid x 5 d.
Age: 12.0
Sex: F
Vaccine: MMRV, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site appx. one hour following vaccination. It worsened x 2 days, then began to improve. Mom of patient treated with BENADRYL, MOTRIN, and cool compresses at home.
Age: 81.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Headache, Injection site mass, Injection site pain, Pain
Clinical narrative: Pain started day of injection at site and progressed down arm all way to elbow by 10-14-2018. Could not lift my arm without pain and it is less today but still hurts today from shoulder to elbow. Also had a lump at injection site that has not gone away. Having headaches which I do not usually have.
Age: 11.0
Sex: U
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Hyperhidrosis, Nausea
Clinical narrative: 10-8-18 2:30 PM pt. got dizzy, eyes rolled back was sweating and nauseous after receiving 4 vaccines.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Peripheral swelling
Clinical narrative: Inner left arm became inflamed and swollen 2 days after receiving vaccine. Prescribed prednisone 20 mg for one week. Symptoms lessened after 3 days. Gone within one week.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Chills, Dizziness, Headache
Clinical narrative: 8-31-18 9:00 p.m. headache, shivers, chills, slight nausea. 9-1-18 1:30 a.m. headache, shivers, chills, slight nausea. 9-1-18  7:00 a.m. dizzy, headache, weakness, slight nausea; fainted. 10-3-18 weakness continues.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Syncope, Urine analysis
Clinical narrative: 8-31-18 9:00 p.m. headache, shivers, chills, slight nausea. 9-1-18 1:30 a.m. headache, shivers, chills, slight nausea. 9-1-18  7:00 a.m. dizzy, headache, weakness, slight nausea; fainted. 10-3-18 weakness continues.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Oedema peripheral
Clinical narrative: The night after vaccine mild pain and soreness in elbow area. Reported pain resolved, but mild edema in arm. Slowly resolving. No redness, pain, or heat in skin as of 10/15/2018. Routine MD visit scheduled this week. Pt. instructed to discuss with MD.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Pt came to PCP with site reaction to Left mid upper arm and severe muscle stiffness of neck and shoulder muscles, mild fever post vaccination on 10/7/18.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Discomfort, Immediate post-injection reaction, Musculoskeletal pain, Product administered at inappropriate site
Clinical narrative: (L) UE (shoulder) pain. Vaccine was given high on shoulder. Had immediate discomfort. Now have ongoing joint pain.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling of upper, outer left thigh (inj. site). Given RX of KEFLEX and notified to take OTC BENADRYL.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Patient reported that the morning after she received her flu shot she awoke with her injection site raised, tender, and tough to the touch. She reported that a bruise approximate 2 1/2 to 3 inches in diameter had formed. She showed the bruise to her physician during the course of a regular appointment and he did not see any signs of infection. The bruise is improving but is still present 6 days after immunization. She says it is still a little sore to the touch and will follow up with her physician if it shows any signs of infection or does not continue to improve.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Mobility decreased, Rhinorrhoea, Swollen tongue, Syncope
Clinical narrative: Patient collapsed to the floor-15 min. after shot given. C/O runny nose/shortness of breath/tongue felt swollen and hard time moving legs (both). 911 called after vitals taken and she went to ER. She was discharged and went home from ER. Time frame from shot to symptoms 15 minutes.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Fatigue, Injection site pruritus, Pain in extremity, Peripheral swelling
Clinical narrative: Soon after vaccine got redness, swelling, pain from deltoid up to base of neck and down to elbow. Fevers of up to 102 for a couple of days. itchiness at site, fatigue. Treated OTC with BENADRYL. Improved by 10/2/18.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Soon after vaccine got redness, swelling, pain from deltoid up to base of neck and down to elbow. Fevers of up to 102 for a couple of days. itchiness at site, fatigue. Treated OTC with BENADRYL. Improved by 10/2/18.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Flushing
Clinical narrative: Patient was complaining of flushing feeling and warm sensation radiating through her chest.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Felt tingling sensation in arm. Arm was weak a day after flu shot. 2 weeks later her arm is still feeling weak.
Age: 19.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Skin papilloma
Clinical narrative: Complaint of appearance of plantar warts on left foot 1 wk after 2nd vaccine.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Haematoma, Vaccination complication
Clinical narrative: Wife came back to fill NORCO and ZOFRAN. Wife states that pt has a hematoma resulting from the vaccination.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Red welt the size of 4 inches by 5 inches occurred at site of injection. Lasted for 2 days. Recommended ice, Acetaminophen, and oral antihistamine occurred on side PNEUMOVAX 23 was given.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster, Malaise, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Shingrix for prophylaxis. On 16th April 2018, the patient received the 1st dose of Shingrix. On 10th May 2018, 24 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient asked whether to dare to receive the 2nd dose of Shingrix.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Shingrix for prophylaxis. On 16th April 2018, the patient received the 1st dose of Shingrix. On 10th May 2018, 24 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient asked whether to dare to receive the 2nd dose of Shingrix.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Shingrix for prophylaxis. On 16th April 2018, the patient received the 1st dose of Shingrix. On 10th May 2018, 24 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient asked whether to dare to receive the 2nd dose of Shingrix.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysstasia, Fatigue, Headache, Injection site pain, Insomnia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, chills, fatigue, fever and injection site wheal. On 19th July 2018, the patient experienced vomiting and headache. On an unknown date, the outcome of the injection site pain, chills, vomiting, fatigue, fever, injection site wheal and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, chills, vomiting, fatigue, fever, injection site wheal and headache to be related to SHINGRIX. Additional details were provided as follows: The patient had also reported the above side effects to VAERS. The patient received SHINGRIX on left arm. The patient was a researcher in immunology.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, chills, fatigue, fever and injection site wheal. On 19th July 2018, the patient experienced vomiting and headache. On an unknown date, the outcome of the injection site pain, chills, vomiting, fatigue, fever, injection site wheal and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, chills, vomiting, fatigue, fever, injection site wheal and headache to be related to SHINGRIX. Additional details were provided as follows: The patient had also reported the above side effects to VAERS. The patient received SHINGRIX on left arm. The patient was a researcher in immunology.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, chills, fatigue, fever and injection site wheal. On 19th July 2018, the patient experienced vomiting and headache. On an unknown date, the outcome of the injection site pain, chills, vomiting, fatigue, fever, injection site wheal and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, chills, vomiting, fatigue, fever, injection site wheal and headache to be related to SHINGRIX. Additional details were provided as follows: The patient had also reported the above side effects to VAERS. The patient received SHINGRIX on left arm. The patient was a researcher in immunology.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, chills, fatigue, fever and injection site wheal. On 19th July 2018, the patient experienced vomiting and headache. On an unknown date, the outcome of the injection site pain, chills, vomiting, fatigue, fever, injection site wheal and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, chills, vomiting, fatigue, fever, injection site wheal and headache to be related to SHINGRIX. Additional details were provided as follows: The patient had also reported the above side effects to VAERS. The patient received SHINGRIX on left arm. The patient was a researcher in immunology.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blister in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included wet macular degeneration. On 1st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced blister and injection site pain. On 24th September 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the blister was not recovered/not resolved. It was unknown if the reporter considered the blister and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient was seen by her a physician. The patient planned to continue follow-up with her physician on an unknown date. This case has been linked with case US2018GSK187053 and US2018185589, reported by the same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blister in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included wet macular degeneration. On 1st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced blister and injection site pain. On 24th September 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the blister was not recovered/not resolved. It was unknown if the reporter considered the blister and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient was seen by her a physician. The patient planned to continue follow-up with her physician on an unknown date. This case has been linked with case US2018GSK187053 and US2018185589, reported by the same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Hyperhidrosis, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of oxygen saturation decreased in a 75-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease (had this condition prior to receiving the SHINGRIX vaccine).  On 20th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain in arm. On 29th September 2018, the patient experienced oxygen saturation decreased (serious criteria hospitalization), excess sweating and vomiting. The patient was treated with oxygen. On an unknown date, the outcome of the oxygen saturation decreased was unknown and the outcome of the influenza-like symptoms, excess sweating, pain in arm and vomiting were recovered/resolved.  It was unknown if the reporter considered the oxygen saturation decreased, influenza-like symptoms, excess sweating, pain in arm and vomiting to be related to SHINGRIX. Additional details were provided as follows: The patient reported that 2 to 3 days after receiving the vaccine, the patient experienced flu-like symptoms and pain in her left arm. On day 9, the patient experienced uncontrollable vomiting and was profusely sweating. The patient went to the emergency room on 29th September 2018 for the sweating and vomiting. While the patient was in the emergency room, they discovered that her oxygen saturation levels were abnormal (84 to 88 percent) and so the patient was hospitalized. The patient was hospitalized due to decrease in oxygen saturation. The patient was discharged from the hospital on 7th October 2018. The patient was discharged home with home oxygen and was not previously on oxygen before this event occurred.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Oxygen saturation decreased, Pain in extremity, Pulmonary function test, Vomiting
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of oxygen saturation decreased in a 75-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease (had this condition prior to receiving the SHINGRIX vaccine).  On 20th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain in arm. On 29th September 2018, the patient experienced oxygen saturation decreased (serious criteria hospitalization), excess sweating and vomiting. The patient was treated with oxygen. On an unknown date, the outcome of the oxygen saturation decreased was unknown and the outcome of the influenza-like symptoms, excess sweating, pain in arm and vomiting were recovered/resolved.  It was unknown if the reporter considered the oxygen saturation decreased, influenza-like symptoms, excess sweating, pain in arm and vomiting to be related to SHINGRIX. Additional details were provided as follows: The patient reported that 2 to 3 days after receiving the vaccine, the patient experienced flu-like symptoms and pain in her left arm. On day 9, the patient experienced uncontrollable vomiting and was profusely sweating. The patient went to the emergency room on 29th September 2018 for the sweating and vomiting. While the patient was in the emergency room, they discovered that her oxygen saturation levels were abnormal (84 to 88 percent) and so the patient was hospitalized. The patient was hospitalized due to decrease in oxygen saturation. The patient was discharged from the hospital on 7th October 2018. The patient was discharged home with home oxygen and was not previously on oxygen before this event occurred.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hyperhidrosis, Influenza like illness, Oxygen saturation decreased, Pain in extremity, Vomiting
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of oxygen saturation decreased in a 75-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease (had this condition prior to receiving the SHINGRIX vaccine).  On 20th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain in arm. On 29th September 2018, the patient experienced oxygen saturation decreased (serious criteria hospitalization), excess sweating and vomiting. The patient was treated with oxygen. On an unknown date, the outcome of the oxygen saturation decreased was unknown and the outcome of the influenza-like symptoms, excess sweating, pain in arm and vomiting were recovered/resolved.  It was unknown if the reporter considered the oxygen saturation decreased, influenza-like symptoms, excess sweating, pain in arm and vomiting to be related to SHINGRIX. Additional details were provided as follows: The patient reported that 2 to 3 days after receiving the vaccine, the patient experienced flu-like symptoms and pain in her left arm. On day 9, the patient experienced uncontrollable vomiting and was profusely sweating. The patient went to the emergency room on 29th September 2018 for the sweating and vomiting. While the patient was in the emergency room, they discovered that her oxygen saturation levels were abnormal (84 to 88 percent) and so the patient was hospitalized. The patient was hospitalized due to decrease in oxygen saturation. The patient was discharged from the hospital on 7th October 2018. The patient was discharged home with home oxygen and was not previously on oxygen before this event occurred.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test, Burning sensation, Immunoglobulins increased, Pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 64-year-old female patient who received Shingrix (batch number 524S7, expiry date unknown) for prophylaxis. Concomitant products included Armour Thyroid. On 12th September 2018, the patient received the 1st dose of Shingrix. On 12th September 2018, less than a day after receiving Shingrix, the patient experienced injection site itching, injection site swelling, generalized pruritus and eyeball itching. In September 2018, the patient experienced antibody test abnormal. On an unknown date, the patient experienced injection site burning, burning sensation, tingling sensation and shooting pain. On an unknown date, the outcome of the injection site itching, injection site burning and injection site swelling were recovered/resolved and the outcome of the burning sensation, tingling sensation, shooting pain and generalized pruritus were not recovered/not resolved and the outcome of the antibody test abnormal and eyeball itching were unknown. It was unknown if the reporter considered the injection site itching, injection site burning, injection site swelling, burning sensation, tingling sensation, shooting pain, generalized pruritus, antibody test abnormal and eyeball itching to be related to Shingrix. Additional details were reported as follows: The caller was the patient. The patient received Shingrix on left arm. The patient stated that on the same day in which she received the injection, she experienced swelling, burning, and itching at the injection site that lasted for approximately 1 to 2 days. The patient stated that approximately 6 to 7 hours after receiving the vaccine, her entire body began itching. The patient itches from the top of her head to the bottoms of her feet and that even her eyeballs are itching. The patient stated that approximately 1 to 2 days following the injection, she started experiencing a prickly, burning sensation all over her body and every once in a while, she also experienced shooting pains in random areas of her body. The went to see her physician and also saw an allergist. The patient stated that the allergist ran an IgG test and her antibody levels were 3622 and that it was way over the normal range. The patient had an appointment scheduled with a neurologist today. The had been prescribed various medications that had not helped with symptom relief. The patient had only thing that would give her any relief at all was sleeping with ice on her legs and being in the cold.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 64-year-old female patient who received Shingrix (batch number 524S7, expiry date unknown) for prophylaxis. Concomitant products included Armour Thyroid. On 12th September 2018, the patient received the 1st dose of Shingrix. On 12th September 2018, less than a day after receiving Shingrix, the patient experienced injection site itching, injection site swelling, generalized pruritus and eyeball itching. In September 2018, the patient experienced antibody test abnormal. On an unknown date, the patient experienced injection site burning, burning sensation, tingling sensation and shooting pain. On an unknown date, the outcome of the injection site itching, injection site burning and injection site swelling were recovered/resolved and the outcome of the burning sensation, tingling sensation, shooting pain and generalized pruritus were not recovered/not resolved and the outcome of the antibody test abnormal and eyeball itching were unknown. It was unknown if the reporter considered the injection site itching, injection site burning, injection site swelling, burning sensation, tingling sensation, shooting pain, generalized pruritus, antibody test abnormal and eyeball itching to be related to Shingrix. Additional details were reported as follows: The caller was the patient. The patient received Shingrix on left arm. The patient stated that on the same day in which she received the injection, she experienced swelling, burning, and itching at the injection site that lasted for approximately 1 to 2 days. The patient stated that approximately 6 to 7 hours after receiving the vaccine, her entire body began itching. The patient itches from the top of her head to the bottoms of her feet and that even her eyeballs are itching. The patient stated that approximately 1 to 2 days following the injection, she started experiencing a prickly, burning sensation all over her body and every once in a while, she also experienced shooting pains in random areas of her body. The went to see her physician and also saw an allergist. The patient stated that the allergist ran an IgG test and her antibody levels were 3622 and that it was way over the normal range. The patient had an appointment scheduled with a neurologist today. The had been prescribed various medications that had not helped with symptom relief. The patient had only thing that would give her any relief at all was sleeping with ice on her legs and being in the cold.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test abnormal, Burning sensation, Eye pruritus, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 64-year-old female patient who received Shingrix (batch number 524S7, expiry date unknown) for prophylaxis. Concomitant products included Armour Thyroid. On 12th September 2018, the patient received the 1st dose of Shingrix. On 12th September 2018, less than a day after receiving Shingrix, the patient experienced injection site itching, injection site swelling, generalized pruritus and eyeball itching. In September 2018, the patient experienced antibody test abnormal. On an unknown date, the patient experienced injection site burning, burning sensation, tingling sensation and shooting pain. On an unknown date, the outcome of the injection site itching, injection site burning and injection site swelling were recovered/resolved and the outcome of the burning sensation, tingling sensation, shooting pain and generalized pruritus were not recovered/not resolved and the outcome of the antibody test abnormal and eyeball itching were unknown. It was unknown if the reporter considered the injection site itching, injection site burning, injection site swelling, burning sensation, tingling sensation, shooting pain, generalized pruritus, antibody test abnormal and eyeball itching to be related to Shingrix. Additional details were reported as follows: The caller was the patient. The patient received Shingrix on left arm. The patient stated that on the same day in which she received the injection, she experienced swelling, burning, and itching at the injection site that lasted for approximately 1 to 2 days. The patient stated that approximately 6 to 7 hours after receiving the vaccine, her entire body began itching. The patient itches from the top of her head to the bottoms of her feet and that even her eyeballs are itching. The patient stated that approximately 1 to 2 days following the injection, she started experiencing a prickly, burning sensation all over her body and every once in a while, she also experienced shooting pains in random areas of her body. The went to see her physician and also saw an allergist. The patient stated that the allergist ran an IgG test and her antibody levels were 3622 and that it was way over the normal range. The patient had an appointment scheduled with a neurologist today. The had been prescribed various medications that had not helped with symptom relief. The patient had only thing that would give her any relief at all was sleeping with ice on her legs and being in the cold.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Pain, Paraesthesia, Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 64-year-old female patient who received Shingrix (batch number 524S7, expiry date unknown) for prophylaxis. Concomitant products included Armour Thyroid. On 12th September 2018, the patient received the 1st dose of Shingrix. On 12th September 2018, less than a day after receiving Shingrix, the patient experienced injection site itching, injection site swelling, generalized pruritus and eyeball itching. In September 2018, the patient experienced antibody test abnormal. On an unknown date, the patient experienced injection site burning, burning sensation, tingling sensation and shooting pain. On an unknown date, the outcome of the injection site itching, injection site burning and injection site swelling were recovered/resolved and the outcome of the burning sensation, tingling sensation, shooting pain and generalized pruritus were not recovered/not resolved and the outcome of the antibody test abnormal and eyeball itching were unknown. It was unknown if the reporter considered the injection site itching, injection site burning, injection site swelling, burning sensation, tingling sensation, shooting pain, generalized pruritus, antibody test abnormal and eyeball itching to be related to Shingrix. Additional details were reported as follows: The caller was the patient. The patient received Shingrix on left arm. The patient stated that on the same day in which she received the injection, she experienced swelling, burning, and itching at the injection site that lasted for approximately 1 to 2 days. The patient stated that approximately 6 to 7 hours after receiving the vaccine, her entire body began itching. The patient itches from the top of her head to the bottoms of her feet and that even her eyeballs are itching. The patient stated that approximately 1 to 2 days following the injection, she started experiencing a prickly, burning sensation all over her body and every once in a while, she also experienced shooting pains in random areas of her body. The went to see her physician and also saw an allergist. The patient stated that the allergist ran an IgG test and her antibody levels were 3622 and that it was way over the normal range. The patient had an appointment scheduled with a neurologist today. The had been prescribed various medications that had not helped with symptom relief. The patient had only thing that would give her any relief at all was sleeping with ice on her legs and being in the cold.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Immediately after injection bump appeared on injection site, along with steady bleeding. Patient did not have signs of anaphylaxis and did not experience syncope. Patient left pharmacy. Roughly two hours later patient was called at home and seemed to be fine; no anaphylaxis, no redness at site, no problems with motion of arm and no tingling sensations, although there was the expected soreness at injection site.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Pruritus, Skin mass
Clinical narrative: Patient reported a red lump formed, hard under the skin, painful and started itching, lasted a full 1 going on 2 weeks.
Age: 89.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Bedridden, Confusional state, Death, Depressed level of consciousness
Clinical narrative: Fever. Confusion. Got up to go to the bathroom but did not need to go. Then said he went in his depends. Next morning he asked me what all that was about. I said I don't know. It was not his normal state if being. I attributed it to the flu vaccine. Dad started getting weaker and weaker and having trouble walking. He could not get out of bed. He was finally confined to bed and needed 100% assistance. He had to start using the commode only. With help. Also depends undergarments  all the time. Dad was bed bound and could do nothing. We had the tv on for him and music but he did not watch. Dad was having a harder and harder time of it. Everyday he got worse. I called Dr and he recommended hospice. Dad got weaker and could not talk anymore. He understood but could not speak. I could not understand why dad went downhill so fast could not move and could not speak. I called hospice knowing they help with the last 6 months of life if someone is dying. Hospice cake. Dad did not rouse when they pushed on his sternum. He was very hot. Hospice said he would be dead in 3 days. I was astounded. Why was my dad dying like this? I thought he would have 6 months at least. Dad could not talk but did waken somewhat when I had family say goodbye to him in the phone. I know it was the flu vaccine that made dad go downhill like that in one month and a half and die. The flu shot killed him. Dad wasn't like that before. Dad could walk and talk. No more after the flu vaccine. The heavy metals in the flu vaccine like mercury could have given him heavy metal poisoning and also made his Parkinson's worse. Dad was 90 years old. Your form keeps telling me he was 89 he was 90. Flue vaccine: influenza PF Quad ped/adol/Adult psat type t or vial dosage .5 milaliters right side. Dad died unexpectedly October 29th 2016, a month and 2 weeks after the flu shot, at the age of 90 years old.
Age: 89.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Loss of personal independence in daily activities, Mobility decreased, Pyrexia, Skin warm
Clinical narrative: Fever. Confusion. Got up to go to the bathroom but did not need to go. Then said he went in his depends. Next morning he asked me what all that was about. I said I don't know. It was not his normal state if being. I attributed it to the flu vaccine. Dad started getting weaker and weaker and having trouble walking. He could not get out of bed. He was finally confined to bed and needed 100% assistance. He had to start using the commode only. With help. Also depends undergarments  all the time. Dad was bed bound and could do nothing. We had the tv on for him and music but he did not watch. Dad was having a harder and harder time of it. Everyday he got worse. I called Dr and he recommended hospice. Dad got weaker and could not talk anymore. He understood but could not speak. I could not understand why dad went downhill so fast could not move and could not speak. I called hospice knowing they help with the last 6 months of life if someone is dying. Hospice cake. Dad did not rouse when they pushed on his sternum. He was very hot. Hospice said he would be dead in 3 days. I was astounded. Why was my dad dying like this? I thought he would have 6 months at least. Dad could not talk but did waken somewhat when I had family say goodbye to him in the phone. I know it was the flu vaccine that made dad go downhill like that in one month and a half and die. The flu shot killed him. Dad wasn't like that before. Dad could walk and talk. No more after the flu vaccine. The heavy metals in the flu vaccine like mercury could have given him heavy metal poisoning and also made his Parkinson's worse. Dad was 90 years old. Your form keeps telling me he was 89 he was 90. Flue vaccine: influenza PF Quad ped/adol/Adult psat type t or vial dosage .5 milaliters right side. Dad died unexpectedly October 29th 2016, a month and 2 weeks after the flu shot, at the age of 90 years old.
Age: 89.0
Sex: M
Vaccine: FLU4
Symptoms: Speech disorder
Clinical narrative: Fever. Confusion. Got up to go to the bathroom but did not need to go. Then said he went in his depends. Next morning he asked me what all that was about. I said I don't know. It was not his normal state if being. I attributed it to the flu vaccine. Dad started getting weaker and weaker and having trouble walking. He could not get out of bed. He was finally confined to bed and needed 100% assistance. He had to start using the commode only. With help. Also depends undergarments  all the time. Dad was bed bound and could do nothing. We had the tv on for him and music but he did not watch. Dad was having a harder and harder time of it. Everyday he got worse. I called Dr and he recommended hospice. Dad got weaker and could not talk anymore. He understood but could not speak. I could not understand why dad went downhill so fast could not move and could not speak. I called hospice knowing they help with the last 6 months of life if someone is dying. Hospice cake. Dad did not rouse when they pushed on his sternum. He was very hot. Hospice said he would be dead in 3 days. I was astounded. Why was my dad dying like this? I thought he would have 6 months at least. Dad could not talk but did waken somewhat when I had family say goodbye to him in the phone. I know it was the flu vaccine that made dad go downhill like that in one month and a half and die. The flu shot killed him. Dad wasn't like that before. Dad could walk and talk. No more after the flu vaccine. The heavy metals in the flu vaccine like mercury could have given him heavy metal poisoning and also made his Parkinson's worse. Dad was 90 years old. Your form keeps telling me he was 89 he was 90. Flue vaccine: influenza PF Quad ped/adol/Adult psat type t or vial dosage .5 milaliters right side. Dad died unexpectedly October 29th 2016, a month and 2 weeks after the flu shot, at the age of 90 years old.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dehydration, Pain, Pyrexia, Syncope
Clinical narrative: Body ache, fever, chills, dehydration, fainting.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: The patient reported having a grape-sized, painful, swollen area around the injection site the night of the injection. She experienced difficult moving her arm because of the soreness. She self-treated with Tylenol and Motrin. She reported the area of swelling moved to an area distal to the initial area and that the swelling was approximately the size of an orange. She is now taking Tylenol and Aleve and will follow-up with her primary care physician if the condition worsens.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain, Product administered at inappropriate site
Clinical narrative: Received vaccine did not feel like any other vaccine I had ever received. Pain was a. It more excruciating. Felt shot was administered a bit higher in deltoid than usual and thought the pain at the site would subside after a couple of days. Noticed left arm weakness in the evening of vaccination, which has been present until now. Weakness in left arm and difficulty lifting arm or moving arm in certain positions. Still feel similar pain felt when I received vaccine.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Received vaccine did not feel like any other vaccine I had ever received. Pain was a. It more excruciating. Felt shot was administered a bit higher in deltoid than usual and thought the pain at the site would subside after a couple of days. Noticed left arm weakness in the evening of vaccination, which has been present until now. Weakness in left arm and difficulty lifting arm or moving arm in certain positions. Still feel similar pain felt when I received vaccine.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Antineutrophil cytoplasmic antibody positive, Appendicectomy, Appendicitis, Arthralgia, Biopsy kidney
Clinical narrative: 1st series April 18, 2017: immediate fatigue, muscle pain, joint pain, cold sweat, nightmares. 2nd series 6 June 2017: uncontrollable high blood pressure, insomnia, joint pain, fatigue, indigestion, gall stone, lung infection/bronchitis (September 2017: later determined to be vasculitis). 3rd series 28 Nov 2017: fatigue, insomnia, uncontrollable high blood pressure, severe joint pain, inflamed appendix (April 2018: appendectomy); kidney function drop to 15%; diagnosed with Microscopic Polyangitis (MPA) in Jul 2018.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Bronchitis, Cholelithiasis, Cold sweat, Computerised tomogram thorax, Dyspepsia
Clinical narrative: 1st series April 18, 2017: immediate fatigue, muscle pain, joint pain, cold sweat, nightmares. 2nd series 6 June 2017: uncontrollable high blood pressure, insomnia, joint pain, fatigue, indigestion, gall stone, lung infection/bronchitis (September 2017: later determined to be vasculitis). 3rd series 28 Nov 2017: fatigue, insomnia, uncontrollable high blood pressure, severe joint pain, inflamed appendix (April 2018: appendectomy); kidney function drop to 15%; diagnosed with Microscopic Polyangitis (MPA) in Jul 2018.