chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: Received 2nd of 2 doses of SHINGRIX vaccine at 10am. Had pain in the upper arm in the afternoon where the shot was applied. At about 9pm, experienced severe chills. Lay in bed with heavy quilt. Vaccine was administered at pharmacy. Detailed charges from receipt: GSK SHINGRIX 0/5 mL Recombinant IM; without preservative. Immunization admin, 1 single/comb Vac/Toxoid, mod INS. First dosage was administered on May 9, 2018. Had no arm pain or other reaction to first injection. Have had many travel vaccines notably without reaction.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Peripheral swelling
Clinical narrative: Severe reaction to SHINGRIX. Joint pain, arm swelling, overall pain.
Sex: F
Vaccine: HPV9
Symptoms: Cervix carcinoma
Clinical narrative: This spontaneous report was received from a physician, via a company representative, and refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not provided). On an unknown date, the patient developed cervical cancer. The outcome of cervix carcinoma was unknown. The causality between cervical cancer and GARDASIL 9 was not reported. Upon internal review, cervical cancer was determined to be a medically significant event.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 17-JUL-2018, the patient was vaccinated an expired dose of ROTATEQ via oral (dose and anatomical location were not reported) lot # M046008 and expiration date: 29-JUN-2018, indicated for prophylaxis. No known adverse effect were reported.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dry skin, Erythema, Pain in extremity, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 13th June 2018, the patient experienced skin eruption and erythema. In June 2018, the patient experienced burning sensation, swelling, dry skin and skin wrinkling. The patient was treated with prednisone and Prednisone Cream. On an unknown date, the outcome of the pain in arm, burning sensation, swelling and skin eruption were recovered/resolved and the outcome of the erythema was recovering/resolving and the outcome of the dry skin and skin wrinkling were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, burning sensation, swelling, skin eruption, erythema, dry skin and skin wrinkling to be related to SHINGRIX. Additional details were provided as follows: The patient stated that her arm was really sore on the night of the vaccination. The next morning, the patient started breaking out on the inside of both arms, chest including above and below the breasts, and across the stomach and she went to the physician the same day, and he ordered 5 days of Prednisone. A day or 2 after completing the Prednisone, the patient stated that the redness came back in her both armpits, and she also had a big oval circle that was swollen (maybe 4 inches long). She stated that the redness went past her elbows and also included her upper chest (below breasts) and across the stomach, and upper legs. The patient also reported burning under her arms. The patient went back to her physician who then prescribed her a stronger dose of Prednisone and also referred her to a dermatologist. The dermatologist prescribed her a Prednisone cream that she took for 14 days and stopped (per order). At the time of this report, the patient had light, red marks under her arms and on her stomach, and the skin above her breasts was dry and wrinkly. The patient had asked her physician if she should receive the 2nd vaccine, and physician referred her to the safety department. The patient had been informed that the safety department could not make any recommendations and referred her back to her physician. The contact details of the physician was provided. This case has also been linked with US2018122090, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin wrinkling, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 13th June 2018, the patient experienced skin eruption and erythema. In June 2018, the patient experienced burning sensation, swelling, dry skin and skin wrinkling. The patient was treated with prednisone and Prednisone Cream. On an unknown date, the outcome of the pain in arm, burning sensation, swelling and skin eruption were recovered/resolved and the outcome of the erythema was recovering/resolving and the outcome of the dry skin and skin wrinkling were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, burning sensation, swelling, skin eruption, erythema, dry skin and skin wrinkling to be related to SHINGRIX. Additional details were provided as follows: The patient stated that her arm was really sore on the night of the vaccination. The next morning, the patient started breaking out on the inside of both arms, chest including above and below the breasts, and across the stomach and she went to the physician the same day, and he ordered 5 days of Prednisone. A day or 2 after completing the Prednisone, the patient stated that the redness came back in her both armpits, and she also had a big oval circle that was swollen (maybe 4 inches long). She stated that the redness went past her elbows and also included her upper chest (below breasts) and across the stomach, and upper legs. The patient also reported burning under her arms. The patient went back to her physician who then prescribed her a stronger dose of Prednisone and also referred her to a dermatologist. The dermatologist prescribed her a Prednisone cream that she took for 14 days and stopped (per order). At the time of this report, the patient had light, red marks under her arms and on her stomach, and the skin above her breasts was dry and wrinkly. The patient had asked her physician if she should receive the 2nd vaccine, and physician referred her to the safety department. The patient had been informed that the safety department could not make any recommendations and referred her back to her physician. The contact details of the physician was provided. This case has also been linked with US2018122090, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that a friend of hers received SHINGRIX vaccine and reported to her that she shivered so bad that the bed rocked. For tolerance to next dose, refer case US2018GSK128827. This case has also been linked with US2018122089 reported by the same reporter.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis. Previously administered products included ENGERIX B (1st dose received in December 2017). On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and the 2nd dose of ENGERIX B. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after receiving ENGERIX B, the patient experienced therapeutic response decreased and drug dose administration interval too long. On an unknown date, the outcome of the therapeutic response decreased and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient earlier had completed the Hepatitis B series (unknown brand) and had low titers for Hepatitis B. Thus, leading to therapeutic response decreased. The patient was told to re-start the Hepatitis B series again with ENGERIX B. At the time of reporting, the patient was returning for the 2nd dose of ENGERIX B which was late than the recommended interval. Thus, it would lead to lengthening of the vaccination schedule. No further information was provided. Lab Comments: On an unknown date, the patient's laboratory test for hepatitis B antibodies titer was found to be low.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (mild case of shingles). Previously administered products included ZOSTAVAX (anti-viral medication). On 22nd June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On 23rd June 2018, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced feeling unwell, night sweat, slight temperature, chills, exhaustion and presyncope. On an unknown date, the outcome of the influenza-like symptoms, injection site pain and presyncope were recovered/resolved and the outcome of the feeling unwell and injected limb mobility decreased were unknown and the outcome of the night sweat, slight temperature, chills and exhaustion were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, feeling unwell, injection site pain, night sweat, injected limb mobility decreased, slight temperature, chills, exhaustion and presyncope to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX on left deltoid which was a booster. The caller was reporting adverse reactions to her second injection of the SHINGRIX vaccine. Next day after vaccination the patient's arm was really sore could not move it for 3 days really painful with flu like symptoms. The patient still had night sweats and was not feeling well. The caller reported that when she received her second injection, several hours later she could barely move her left arm. The caller reported that she had flu symptoms for the next several days, and continues to had a low grade temperature with chills. The caller was also complaining of night sweats and exhaustion. The caller reported that she went shopping the other day and almost passed out. The caller reported her symptoms to her physician who told her they would eventually dissipate. She admits that she was slowly feeling a little better each day but her reaction to the second vaccine was much more severe than the first vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Night sweats, Presyncope, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (mild case of shingles). Previously administered products included ZOSTAVAX (anti-viral medication). On 22nd June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On 23rd June 2018, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced feeling unwell, night sweat, slight temperature, chills, exhaustion and presyncope. On an unknown date, the outcome of the influenza-like symptoms, injection site pain and presyncope were recovered/resolved and the outcome of the feeling unwell and injected limb mobility decreased were unknown and the outcome of the night sweat, slight temperature, chills and exhaustion were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, feeling unwell, injection site pain, night sweat, injected limb mobility decreased, slight temperature, chills, exhaustion and presyncope to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX on left deltoid which was a booster. The caller was reporting adverse reactions to her second injection of the SHINGRIX vaccine. Next day after vaccination the patient's arm was really sore could not move it for 3 days really painful with flu like symptoms. The patient still had night sweats and was not feeling well. The caller reported that when she received her second injection, several hours later she could barely move her left arm. The caller reported that she had flu symptoms for the next several days, and continues to had a low grade temperature with chills. The caller was also complaining of night sweats and exhaustion. The caller reported that she went shopping the other day and almost passed out. The caller reported her symptoms to her physician who told her they would eventually dissipate. She admits that she was slowly feeling a little better each day but her reaction to the second vaccine was much more severe than the first vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (mild case of shingles 10 years ago). Previously administered products included ZOSTAVAX (anti-viral medication). On 29th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, influenza-like symptoms and erythema of extremities. On an unknown date, the outcome of the injection site pain, influenza-like symptoms and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the injection site pain, influenza-like symptoms and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that she experienced left arm soreness at the injection site for the day and flu like symptoms for 4 days and then resolved. The patient also experienced redness of arm for the day. The patient had denied permission to contact their physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 5th July 2018, 3 days after receiving SHINGRIX, the patient experienced injection site rash. In July 2018, the patient experienced extensive swelling of vaccinated limb, general body pain, fever, injection site lump, injection site erythema and injection site itching. The patient was treated with ALEVE and BENADRYL. In July 2018, the outcome of the general body pain and fever were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site lump were recovering/resolving and the outcome of the injection site rash, injection site erythema and injection site itching were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, general body pain, fever, injection site lump, injection site rash, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The patient also experienced injection site reaction that included swelling of an area about the size of her palm around the injection site with a knot. Then on 5th July 2018, the patient noted a rash on her arm around the injection site. The patient reported that, at the time of reporting, the injection site reaction had improved greatly but still had small knot, pink in color and little itchy. The patient reported that she was seen by her physician's office on Friday, 6th July 2018 and the patient was advised to take ALEVE and BENADRYL to help with the reaction. The contact details of the physician was provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 5th July 2018, 3 days after receiving SHINGRIX, the patient experienced injection site rash. In July 2018, the patient experienced extensive swelling of vaccinated limb, general body pain, fever, injection site lump, injection site erythema and injection site itching. The patient was treated with ALEVE and BENADRYL. In July 2018, the outcome of the general body pain and fever were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site lump were recovering/resolving and the outcome of the injection site rash, injection site erythema and injection site itching were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, general body pain, fever, injection site lump, injection site rash, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The patient also experienced injection site reaction that included swelling of an area about the size of her palm around the injection site with a knot. Then on 5th July 2018, the patient noted a rash on her arm around the injection site. The patient reported that, at the time of reporting, the injection site reaction had improved greatly but still had small knot, pink in color and little itchy. The patient reported that she was seen by her physician's office on Friday, 6th July 2018 and the patient was advised to take ALEVE and BENADRYL to help with the reaction. The contact details of the physician was provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 76-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced generalized rash. The patient was treated with prednisone. On an unknown date, the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharm D intern. The patient received SHINGRIX on the left arm. The patient experienced a body rash over her left arm and torso. The patient did see her doctor and was prescribed Prednisone. A clarification request was raised to confirm if the rash was generalized or localized, however, this was the only reported information.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 68-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and pain. On an unknown date, the outcome of the chills and pain were recovered/resolved. It was unknown if the reporter considered the chills and pain to be related to SHINGRIX. Additional details were provided as follows: The registered pharmacist was a patient. The age at vaccination was not reported, but it could be 67 year or 68 year. In 2018, the registered pharmacist received SHINGRIX vaccine at his pharmacy in left arm. He received the SHINGRIX vaccine 2 to 3 months ago from the date of reporting (9th July 2018). In 2018, the patient experienced chills and aches that lasted 12 to 18 hours after receiving the vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye irritation, Herpes zoster, Hypoaesthesia, Ophthalmic herpes zoster, Skin irritation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a 79-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date unknown) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, 14 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, skin irritation, eye irritation and numbness facial. On an unknown date, the outcome of the ophthalmic herpes zoster, shingles, skin irritation, eye irritation and numbness facial were recovering/resolving. It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, skin irritation, eye irritation and numbness facial to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Two weeks post vaccination, the patient developed Shingles. The patient had skin irritation on arm, face and eye. The left side of her face was numb. The patient mentioned that, her eye doctor noticed shingles in her eye, and her dermatologist also confirmed that, she had Shingles. The pharmacist stated that, the patient improved and was better at the time of reporting. No further details were provided.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Skin ulcer
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a 79-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date unknown) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, 14 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, skin irritation, eye irritation and numbness facial. On an unknown date, the outcome of the ophthalmic herpes zoster, shingles, skin irritation, eye irritation and numbness facial were recovering/resolving. It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, skin irritation, eye irritation and numbness facial to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Two weeks post vaccination, the patient developed Shingles. The patient had skin irritation on arm, face and eye. The left side of her face was numb. The patient mentioned that, her eye doctor noticed shingles in her eye, and her dermatologist also confirmed that, she had Shingles. The pharmacist stated that, the patient improved and was better at the time of reporting. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (shivering after receiving 1st dose, see case US2018122090). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shivering was unknown. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The shivering was not as bad as what the patient experienced after the 1st dose.
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Back pain, Headache, Laboratory test, Neck pain, X-ray
Clinical narrative: Patient in office with Grandmother on 6-7-18 stated that 3 day after vaccine she started with back pain, neck pain and headache.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's mother called at 4:10 on 6/29 and stated patient's left arm is swollen and red. Patient received Tdap in left arm at approximately 2:00pm. Contacted patient's mother on 7/3 and she stated the swelling got worse Saturday (7/30) and into Sunday. Monday it started to get better. She stated you cannot see it but it is still hard when touching it. No fever or chills. Did not take any medication or seek medical treatment. The arm was very painful when touched.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: Patient states had cold like symptoms after vaccine.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Malaise, Neck pain, Pain, Pain in extremity
Clinical narrative: Pt complained of body aches, teeth aching, sore arm, pain going up neck, and not feeling well. Fourty-eight hours after she received the shot she developed fluid filled blisters along her right leg.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Toothache
Clinical narrative: Pt complained of body aches, teeth aching, sore arm, pain going up neck, and not feeling well. Fourty-eight hours after she received the shot she developed fluid filled blisters along her right leg.
Age: 30.0
Sex: M
Vaccine: RAB
Symptoms: Ear pain, Fatigue, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient called on 7/3 and reported that after receiving Rabies vaccine dose #3 yesterday his arm swelled and his whole body ached. Stated he felt "like a truck hit me last night." States pain radiated from his arm to the rest of his body. No fever or chills. Today when he woke up his cheeks feel "tingly." Not painful but tingly. Advised to contact physician for advice. He mentioned he had a slight earache when he received the vaccine. At 2:45 pm on 7/3  patient called and said his physician advised him to go to ER. He stated ER physician said it was probably a reaction to the vaccine and come back if it got worse. Patient states his toes are tingly now. He stated that the ER physician discussed the risk vs. benefit of the vaccine and recommended that he complete the series. The patient was scratched by a wild cat. He went to a public health hospital on 6/21 and received IG and vaccine. On 6/24 he was in another part of the country and went to the public hospital and receive what he described as a large amount of fluid in the gluteus. Because there was no documentation as to what he received, it sounded like it could have been another dose of IG, that was not counted as part of the post exposure vaccine series. He received what was considered dose #2 rabies vaccine on 6/28 with no problems. He subsequently received dose #4 on 7/9. He reported no problems after that vaccine.
Age: 30.0
Sex: M
Vaccine: RAB
Symptoms: Peripheral swelling
Clinical narrative: Patient called on 7/3 and reported that after receiving Rabies vaccine dose #3 yesterday his arm swelled and his whole body ached. Stated he felt "like a truck hit me last night." States pain radiated from his arm to the rest of his body. No fever or chills. Today when he woke up his cheeks feel "tingly." Not painful but tingly. Advised to contact physician for advice. He mentioned he had a slight earache when he received the vaccine. At 2:45 pm on 7/3  patient called and said his physician advised him to go to ER. He stated ER physician said it was probably a reaction to the vaccine and come back if it got worse. Patient states his toes are tingly now. He stated that the ER physician discussed the risk vs. benefit of the vaccine and recommended that he complete the series. The patient was scratched by a wild cat. He went to a public health hospital on 6/21 and received IG and vaccine. On 6/24 he was in another part of the country and went to the public hospital and receive what he described as a large amount of fluid in the gluteus. Because there was no documentation as to what he received, it sounded like it could have been another dose of IG, that was not counted as part of the post exposure vaccine series. He received what was considered dose #2 rabies vaccine on 6/28 with no problems. He subsequently received dose #4 on 7/9. He reported no problems after that vaccine.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Nausea, Pruritus, Urticaria
Clinical narrative: Nausea, weakness, headache, itchy head, giant hives head, face, stomach, thighs and legs.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Erythema, Nausea, Pain
Clinical narrative: Arm Swelling, redness, 101 F fever. Chills, nausea, warm to touch, little painful. Patient went to Urgent care. MD diagnosed it as Cellulitis, prescribed Cephalaxin 500 mg Q6h for 7 days on 7/18/2018.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Arm Swelling, redness, 101 F fever. Chills, nausea, warm to touch, little painful. Patient went to Urgent care. MD diagnosed it as Cellulitis, prescribed Cephalaxin 500 mg Q6h for 7 days on 7/18/2018.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness of approx. 2 inches, induration of unknown size and warmth at site.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Eye movement disorder, Grunting, Loss of consciousness, Musculoskeletal stiffness, Nausea
Clinical narrative: After receiving vaccine pt c/o nausea, then became unconscious with eyes rolling back, stiff body and grunting respirations. After a period of approx. 5 minutes, pt regained consciousness, was alert and orient to person, place and time, able to converse with staff. EMS was called due to family hx of seizures and pt was transported to hospital for further evaluation.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Feeling abnormal, Hypotonia, Palpitations, Tremor
Clinical narrative: Mother stated child had racing heart, felt shaky, arms felt limp, not feeling right.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Feeling abnormal, Headache, Induration
Clinical narrative: Monday night after the vaccine my arm turned red and hot and started hurting. Tuesday the next day the redness increased to a circle about 4inches x 4inches and I had a severe headache with aching in all of my joints and my arm increased in pain immensely and the red circle on my arm turned increased in redness and it turned hard. That night I could not sleep since everything in my body hurt so much. Wednesday the body aches went away but the red circle on my arm was getting larger and I still felt not myself. Thursday the redness was bigger and still hurt I took a prednisone 20mg and put Benadryl cream on it. It feels a little better.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Skin warm
Clinical narrative: Monday night after the vaccine my arm turned red and hot and started hurting. Tuesday the next day the redness increased to a circle about 4inches x 4inches and I had a severe headache with aching in all of my joints and my arm increased in pain immensely and the red circle on my arm turned increased in redness and it turned hard. That night I could not sleep since everything in my body hurt so much. Wednesday the body aches went away but the red circle on my arm was getting larger and I still felt not myself. Thursday the redness was bigger and still hurt I took a prednisone 20mg and put Benadryl cream on it. It feels a little better.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bone pain, Erythema, Extensive swelling of vaccinated limb, Headache, Incorrect route of drug administration
Clinical narrative: Monday night after the vaccine my arm turned red and hot and started hurting. Tuesday the next day the redness increased to a circle about 4inches x 4inches and I had a severe headache with aching in all of my joints and my arm increased in pain immensely and the red circle on my arm turned increased in redness and it turned hard. That night I could not sleep since everything in my body hurt so much. Wednesday the body aches went away but the red circle on my arm was getting larger and I still felt not myself. Thursday the redness was bigger and still hurt I took a prednisone 20mg and put Benadryl cream on it. It feels a little better.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Monday night after the vaccine my arm turned red and hot and started hurting. Tuesday the next day the redness increased to a circle about 4inches x 4inches and I had a severe headache with aching in all of my joints and my arm increased in pain immensely and the red circle on my arm turned increased in redness and it turned hard. That night I could not sleep since everything in my body hurt so much. Wednesday the body aches went away but the red circle on my arm was getting larger and I still felt not myself. Thursday the redness was bigger and still hurt I took a prednisone 20mg and put Benadryl cream on it. It feels a little better.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Monday night after the vaccine my arm turned red and hot and started hurting. Tuesday the next day the redness increased to a circle about 4inches x 4inches and I had a severe headache with aching in all of my joints and my arm increased in pain immensely and the red circle on my arm turned increased in redness and it turned hard. That night I could not sleep since everything in my body hurt so much. Wednesday the body aches went away but the red circle on my arm was getting larger and I still felt not myself. Thursday the redness was bigger and still hurt I took a prednisone 20mg and put Benadryl cream on it. It feels a little better.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Pain, Peripheral swelling
Clinical narrative: Soreness for 7 days; swelling and redness spreading on upper arm for 7 days; bad headaches for 4 days (reminded me of previously having shingles); chills and fever for 2 days.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Soreness for 7 days; swelling and redness spreading on upper arm for 7 days; bad headaches for 4 days (reminded me of previously having shingles); chills and fever for 2 days.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Asthenia, Balance disorder, Blood culture, Chills, Fatigue
Clinical narrative: Rec'd SHINGRIX and PNEUMOVAX 23 on 7/16. A few hours later, developed bilateral arm pain at site of injections. Pain overnight so couldn't sleep on either side/arm. Awoke 7/17 with increased pain and barely able to move arm(s). Also felt fatigued. By afternoon on 7/17 had shaking chills, nausea, headache, fever, weakness, unsteadiness, and severe right arm pain. Was taken to ER found to have a fever of 102. Heart rate 130. WBC count of 22,000. Both arms found to be very warm and tender. R arm swollen and hot. No redness. Treated with intravenous fluids, lab work including blood cultures, pain medication, fever medication, IV steroids and IV antibiotics. No source of infection identified. Was admitted to hospital.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Insomnia, Laboratory test
Clinical narrative: Rec'd SHINGRIX and PNEUMOVAX 23 on 7/16. A few hours later, developed bilateral arm pain at site of injections. Pain overnight so couldn't sleep on either side/arm. Awoke 7/17 with increased pain and barely able to move arm(s). Also felt fatigued. By afternoon on 7/17 had shaking chills, nausea, headache, fever, weakness, unsteadiness, and severe right arm pain. Was taken to ER found to have a fever of 102. Heart rate 130. WBC count of 22,000. Both arms found to be very warm and tender. R arm swollen and hot. No redness. Treated with intravenous fluids, lab work including blood cultures, pain medication, fever medication, IV steroids and IV antibiotics. No source of infection identified. Was admitted to hospital.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Rec'd SHINGRIX and PNEUMOVAX 23 on 7/16. A few hours later, developed bilateral arm pain at site of injections. Pain overnight so couldn't sleep on either side/arm. Awoke 7/17 with increased pain and barely able to move arm(s). Also felt fatigued. By afternoon on 7/17 had shaking chills, nausea, headache, fever, weakness, unsteadiness, and severe right arm pain. Was taken to ER found to have a fever of 102. Heart rate 130. WBC count of 22,000. Both arms found to be very warm and tender. R arm swollen and hot. No redness. Treated with intravenous fluids, lab work including blood cultures, pain medication, fever medication, IV steroids and IV antibiotics. No source of infection identified. Was admitted to hospital.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Tenderness, Tremor, White blood cell count increased
Clinical narrative: Rec'd SHINGRIX and PNEUMOVAX 23 on 7/16. A few hours later, developed bilateral arm pain at site of injections. Pain overnight so couldn't sleep on either side/arm. Awoke 7/17 with increased pain and barely able to move arm(s). Also felt fatigued. By afternoon on 7/17 had shaking chills, nausea, headache, fever, weakness, unsteadiness, and severe right arm pain. Was taken to ER found to have a fever of 102. Heart rate 130. WBC count of 22,000. Both arms found to be very warm and tender. R arm swollen and hot. No redness. Treated with intravenous fluids, lab work including blood cultures, pain medication, fever medication, IV steroids and IV antibiotics. No source of infection identified. Was admitted to hospital.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Blood culture, Fatigue, Headache, Laboratory test, Pain in extremity
Clinical narrative: Rec'd SHINGRIX and PNEUMOVAX 23 on 7/16. A few hours later, developed bilateral arm pain at site of injections. Pain overnight so couldn't sleep on either side/arm. Awoke 7/17 with increased pain and barely able to move arm(s). Also felt fatigued. By afternoon on 7/17 had shaking chills, nausea, headache, fever, weakness, unsteadiness, and severe right arm pain. Was taken to ER found to have a fever of 102. Heart rate 130. WBC count of 22,000. Both arms found to be very warm and tender. R arm swollen and hot. No redness. Treated with intravenous fluids, lab work including blood cultures, pain medication, fever medication, IV steroids and IV antibiotics. No source of infection identified. Was admitted to hospital.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Pyrexia, Systemic inflammatory response syndrome
Clinical narrative: Rec'd SHINGRIX and PNEUMOVAX 23 on 7/16. A few hours later, developed bilateral arm pain at site of injections. Pain overnight so couldn't sleep on either side/arm. Awoke 7/17 with increased pain and barely able to move arm(s). Also felt fatigued. By afternoon on 7/17 had shaking chills, nausea, headache, fever, weakness, unsteadiness, and severe right arm pain. Was taken to ER found to have a fever of 102. Heart rate 130. WBC count of 22,000. Both arms found to be very warm and tender. R arm swollen and hot. No redness. Treated with intravenous fluids, lab work including blood cultures, pain medication, fever medication, IV steroids and IV antibiotics. No source of infection identified. Was admitted to hospital.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Itchy welts all over body, including groin region. Patient stated he took diphenhydramine within 24 hours and it lasted a total of 48 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Itchy all over body. Patient took benadryl within 24 hours and symptoms resolved within 48 hours of start.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test normal, Gianotti-Crosti syndrome, Laboratory test normal, Pruritus, Rash generalised
Clinical narrative: Following the vaccine my daughter developed a whole body rash with severe itching that took 4 months to resolve. She was diagnosed with Gianotti Crosti syndrome and there was absolutely no treatment that could help her until it finally resolved on its own.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills
Clinical narrative: Shivering/chills, joint aches.
Age: 1.67
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient developed fever of approximately 102.7f  and began to seize. Taken to Medical Center by ambulance. Parent gave Tylenol for fever.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 10th July 2018, the patient received SHINGRIX (intramuscular). On 11th July 2018, 1 days after receiving SHINGRIX, the patient experienced fever, shivering and muscle pain. On an unknown date, the outcome of the fever and muscle pain were unchanged and the outcome of the shivering was unknown. The reporter considered the fever, shivering and muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient woke up in the morning, on the day of reporting, with fever, aching muscles and shivering.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling. On 2nd July 2018, the patient experienced injection site warmth and injection site erythema. On 7th July 2018, the outcome of the injection site swelling, injection site warmth and injection site erythema were recovered/resolved. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be probably related to SHINGRIX. Additional details were reported as follows: At 13:00, the patient received Shingrix in the left deltoid. Two days after vaccination, the patient's injection site was hot and red. The injection site red, swollen and hot lasted for about a week and recovered 100 per cent.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Asthenia, Chills, Dehydration, Diarrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (very mild case of shingles on the back). Concurrent medical conditions included drug allergy (allergy to DEMEROL) and penicillin allergy. On 4th July 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th July 2018 18:00, 7 hrs 30 min after receiving SHINGRIX, the patient experienced nausea, diarrhea, headache, injection site erythema, injection site swelling, dehydration, shivering, fever, abdominal pain, swelling of eyelid, weakness, vomiting and muscle pain. The patient was treated with BENADRYL and TYLENOL. On 10th July 2018, the outcome of the swelling of eyelid was recovered/resolved. On an unknown date, the outcome of the nausea, diarrhea, headache, injection site erythema and weakness were recovering/resolving and the outcome of the injection site swelling, dehydration, shivering, fever, abdominal pain, vomiting and muscle pain were recovered/resolved. It was unknown if the reporter considered the nausea, diarrhea, headache, injection site erythema, injection site swelling, dehydration, shivering, fever, abdominal pain, swelling of eyelid, weakness, vomiting and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. By 6:00 PM, the patient started to experience adverse reactions that were worse in the next morning. The patient experienced swelling on the top of her eyelids. The patient was dehydrated and went to the emergency room via the ambulance. The patient received fluids for rehydration and BENADRYL while in the emergency room. The patient was not admitted to the hospital. The patient had reported the event to her doctor and decided to not get the 2nd dose. The patient was taking TYLENOL for the headache. The patient provided contact details of the physician.