chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Pt presented 7/23/18 with erythema and pain to the injection site. Site marked and pt started on Cephalexin. Pt re-evaluated 7/24/18, no progression of erythema, determined not to be bacterial infection but rather injection site reaction.
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a 17 month old female patient. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On the same day, in an unknown date, the patient was vaccinated with Oka-Merck PROQUAD and (wistar ra 27-3) M-M-R II for prophylaxis (inappropriate schedule of drug administration). Strength, dose, frequency, route of administration, lot#, and expiration date were unknown. No adverse effects were noted.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Post vaccination autoinoculation, Rash pustular, Scab, Vaccination site pustule, Vaccination site scab
Clinical narrative: On 12JUL2018, a report of autoinoculation was received from Study. Subject is a 34 year old male who was vaccinated with ACAM2000 (lot VV03-013-B) on 03JUL2018 at 12:15 hr. He reported no medical history. On 10JUL2018, the subject was seen by staff for day 7 site check and subject explained that after his gym workout on 09JUL2018, he took Band Aid off and removed top layer of skin approximately one half inch below vaccination site on left upper arm. The staff gave further site care instruction to prevent autoinoculation. On 12JUL2018, the subject came to the site early for day 12 site check (subject leaving town). On site check, subject had noted autoinoculation on open wound that was reported on 10JUL2018, day 7 site check. Both vaccination site and transfer site were in pustule stage. Subject was provided further site care instructions and site care kit. (Care kit contains 12 Band Aids and waterproof Band Aids. Subject was also given 4x4 gauze pads). As 16JUL2018, the lesions were in scabbing stage. Due to the size of the lesion, the Principal Investigator considers this as a case of autoinoculation. The case was reported as a mild and not serious adverse event that was related to the administration of ACAM2000. Company Medical Assessment: The Company agrees with the Investigator's assessment. The case was upgraded to serious and to be submitted as 15-day alert report to comply with the FDA post-marketing commitment.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Herpes zoster, Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. The patient had a Family History of shingles. On 12th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 11th July 2018, 29 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced injection site pain, myalgia upper extremities, pruritus, shoulder pain, neck pain, tenderness, nerve pain and bone pain. The patient was treated with Valacyclovir, Corticosteroid Cream and TYLENOL. On an unknown date, the outcome of the injection site pain and myalgia upper extremities were recovered/resolved and the outcome of the shingles was not recovered/not resolved and the outcome of the pruritus was recovering/resolving and the outcome of the shoulder pain, neck pain, tenderness, nerve pain and bone pain were unknown. It was unknown if the reporter considered the injection site pain, shingles, myalgia upper extremities, pruritus, shoulder pain, neck pain, tenderness, nerve pain and bone pain to be related to SHINGRIX. Additional details were reported as follows: The patient received the Shingles vaccine at left arm at around 11:00 AM and she experienced shingles on her right side and lower back quadrant after the vaccination. She was put on Valacyclovir last Thursday. She described it as a mild case of shingles. The patient also reported that she was terribly sore at the injection site compared to previous vaccinations including a tetanus shot that she had received previously. In 2018, less than a month after vaccination, the patient experienced itching. The itching was far worse than the pain from the shingles. She described the soreness as tolerable. The pain followed her muscle in her arm up her shoulder and up her neck. She was in a lot of pain for 3 days. The pain was tender to the touch and some pain followed for about one week afterwards. The pain followed her nerve endings up the neck. The patient explained that the pain radiated from the injection site up to her shoulder which made her shoulder ache in her neck and through her collarbone area. She treated the side effects with corticosteroid cream and TYLENOL. She claimed that her Shingles was resolving but was not fully resolved. She kept her TYLENOL levels up to prevent the pain. She had pain for about 3 days and then it was tender to the touch and some pain followed for about a week or so. The soreness was worse than the pain and she could tell when attempting to lift something. She claimed that the pain was a level 2 out of 10 and it was not anything she could not stand.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Neuralgia, Pruritus, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. The patient had a Family History of shingles. On 12th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 11th July 2018, 29 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced injection site pain, myalgia upper extremities, pruritus, shoulder pain, neck pain, tenderness, nerve pain and bone pain. The patient was treated with Valacyclovir, Corticosteroid Cream and TYLENOL. On an unknown date, the outcome of the injection site pain and myalgia upper extremities were recovered/resolved and the outcome of the shingles was not recovered/not resolved and the outcome of the pruritus was recovering/resolving and the outcome of the shoulder pain, neck pain, tenderness, nerve pain and bone pain were unknown. It was unknown if the reporter considered the injection site pain, shingles, myalgia upper extremities, pruritus, shoulder pain, neck pain, tenderness, nerve pain and bone pain to be related to SHINGRIX. Additional details were reported as follows: The patient received the Shingles vaccine at left arm at around 11:00 AM and she experienced shingles on her right side and lower back quadrant after the vaccination. She was put on Valacyclovir last Thursday. She described it as a mild case of shingles. The patient also reported that she was terribly sore at the injection site compared to previous vaccinations including a tetanus shot that she had received previously. In 2018, less than a month after vaccination, the patient experienced itching. The itching was far worse than the pain from the shingles. She described the soreness as tolerable. The pain followed her muscle in her arm up her shoulder and up her neck. She was in a lot of pain for 3 days. The pain was tender to the touch and some pain followed for about one week afterwards. The pain followed her nerve endings up the neck. The patient explained that the pain radiated from the injection site up to her shoulder which made her shoulder ache in her neck and through her collarbone area. She treated the side effects with corticosteroid cream and TYLENOL. She claimed that her Shingles was resolving but was not fully resolved. She kept her TYLENOL levels up to prevent the pain. She had pain for about 3 days and then it was tender to the touch and some pain followed for about a week or so. The soreness was worse than the pain and she could tell when attempting to lift something. She claimed that the pain was a level 2 out of 10 and it was not anything she could not stand.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a elderly female patient who received SHINGRIX for prophylaxis. On 3rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell and viral infection. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the headache was recovered/resolved and the outcome of the viral infection was unknown. The reporter considered the feeling unwell and headache to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the viral infection to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient received SHINGRIX vaccine on the left arm. The patient stated that she did not feel well and felt almost like she had a virus. The patient stated that the symptoms lasted a couple of days and then resolved. The patient had denied permission to contact their physician.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received SHINGRIX (batch number 37KL2 ?, expiry date 12th February 2021. GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced headache, injection site erythema, injection site swelling and tiredness. On 16th July 2018, the patient experienced injection site pain. On an unknown date, the outcome of the headache, injection site pain, injection site erythema, injection site swelling and tiredness were unknown. It was unknown if the reporter considered the headache, injection site pain, injection site erythema, injection site swelling and tiredness to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX in the left arm. The patient experienced pain during injection. Less than a week, after receiving SHINGRIX, the patient had injection site reaction which included pain, redness and swelling at the injection site. The patient also experienced a low grade headache and felt tired.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of buttock pain in a 62-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 13th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 15th July 2018, 2 days after receiving SHINGRIX, the patient experienced buttock pain. On an unknown date, the outcome of the buttock pain was not recovered/not resolved. It was unknown if the reporter considered the buttock pain to be related to SHINGRIX. Additional details were provided as follows: On 13th July 2018 (Friday), the patient was given the vaccine in her left deltoid. On 15th July 2018 (Sunday) beginning, the patient started to experience pain in her right gluteal which was worsened on next day (Monday) and again on the reporting date.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site cellulitis in a 65-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 14th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. In July 2018, 2 days after receiving SHINGRIX, the patient experienced injection site cellulitis, injection site warmth and fever. The patient was treated with Antibiotic (Drug Name Unknown) and BENADRYL. On an unknown date, the outcome of the injection site cellulitis, injection site warmth and fever were not recovered/not resolved. It was unknown if the reporter considered the injection site cellulitis, injection site warmth and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Two days after the vaccination, the patient developed cellulitis at the injection site. It felt feverish and was warm to the touch. The patient was seen by the physician's office and started on antibiotics and BENADRYL. The reporter was transferred to Medical Information for additional assistance.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia (inactive) and allergic reaction to antibiotics. On 7th July 2018, the patient received the 1st dose of SHINGRIX. On 7th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 8th July 2018, the patient experienced erythema of extremities and injection site swelling. In July 2018, the patient experienced injection site itching. The patient was treated with Cortisone Cream (non-proprietary). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the erythema of extremities and injection site swelling were recovering/resolving and the outcome of the injection site itching was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, erythema of extremities, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the SHINGRIX on the left arm. The patient stated that, on the day of vaccination, she experienced pain at the injection site. The next day after receiving the SHINGRIX, the patient experienced redness on her left arm and extreme swelling at the injection site. The patient stated that, the redness was located on her left arm from the shoulder to the elbow. She also experienced itching at the injection site, however, she does not remember when the itching started. The patient went back to the pharmacy to let the pharmacist check out her arm. She called her doctor's office, but had not yet seen the doctor. She used 2.5 percent cortisone cream at the site to treat the symptoms. The patient was not sure which physician she would see for these symptoms and was not able to provide healthcare professional information at the time of the call.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in early 2000). Concomitant products included Aspirin. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. On 3rd April 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site pain. On 3rd April 2018, less than a day after receiving SHINGRIX, the patient experienced, injection site rash, numbness of upper extremities, and injection site erythema. On 3rd April 2018, the outcome of the numbness of upper extremities was recovered/resolved. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved and the outcome of the injection site rash and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site rash, numbness of upper extremities, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Immediately after receiving SHINGRIX, the patient experienced swelling and soreness at the injection site. Less than a day, after receiving SHINGRIX, the patient also broke out with red splotches about two inches in circumference around the injection site. Less than a day, after receiving SHINGRIX when the patient left the pharmacy, the patient experienced numbness in her entire left arm, starting as she was driving home from the pharmacy and lasting for approximately two hours. The swelling and soreness lasted for approximately two weeks. The red splotches were resolving but are still visible on the day of reporting. The reporter gave permission to contact her physician.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in early 2000). Concomitant products included Aspirin. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. On 3rd April 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site pain. On 3rd April 2018, less than a day after receiving SHINGRIX, the patient experienced, injection site rash, numbness of upper extremities, and injection site erythema. On 3rd April 2018, the outcome of the numbness of upper extremities was recovered/resolved. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved and the outcome of the injection site rash and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site rash, numbness of upper extremities, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Immediately after receiving SHINGRIX, the patient experienced swelling and soreness at the injection site. Less than a day, after receiving SHINGRIX, the patient also broke out with red splotches about two inches in circumference around the injection site. Less than a day, after receiving SHINGRIX when the patient left the pharmacy, the patient experienced numbness in her entire left arm, starting as she was driving home from the pharmacy and lasting for approximately two hours. The swelling and soreness lasted for approximately two weeks. The red splotches were resolving but are still visible on the day of reporting. The reporter gave permission to contact her physician.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 1 day after receiving SHINGRIX, the patient experienced erythema of extremities, pain in arm and extremities hot feeling of. The patient was treated with topical Steroid Cream. In May 2018, the outcome of the erythema of extremities, pain in arm and extremities hot feeling of were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, pain in arm and extremities hot feeling of to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX in left arm. Batch number, expiry date and dose of vaccine were not reported. In early May 2018, the reporter received a dose of SHINGRIX in left arm, exact date was not reported. On the day of vaccination, the patient experienced soreness in left arm. A day after vaccination, the patient experienced redness and heat in left arm. The patient saw her dermatologist and he was given steroid cream. The patient noted that the events were began to improve after using steroid cream for three days. The events were completely resolved within five days, the dates were not reported. The patient had denied permission to contact their physician. The reporter did not wish to be contacted for any further follow up. The reporter could not provide full address for the vaccine facility. The reporter could not provide the name of the pharmacist who administered the vaccine. The reporter declined to provide complete address details.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Nausea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of nausea in a adult patient who received SHINGRIX for prophylaxis. 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 nausea, fatigue and feeling unwell. On an unknown date, the outcome of the nausea, fatigue and feeling unwell were unknown. It was unknown if the reporter considered the nausea, fatigue and feeling unwell to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The healthcare professional reported that, after vaccination with the 2nd dose of SHINGRIX, the patient experienced nausea, fatigue and felt really sick. This case was linked to case US2018128811, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Nausea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of nausea in a adult patient who received SHINGRIX for prophylaxis. 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 nausea, fatigue and sickness. On an unknown date, the outcome of the nausea, fatigue and sickness were unknown. It was unknown if the reporter considered the nausea, fatigue and sickness to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The healthcare professional reported that, after vaccination with the 2nd dose of SHINGRIX, the patient experienced nausea, fatigue and felt really sick. This case was linked to case US2018128810, reported by the same reporter.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Loss of consciousness, Tremor, Visual impairment
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 18-years-old male patient of an unspecified ethnicity received first dose of TRUMENBA, via an unspecified route of administration in left arm on an unspecified date at single dose for immunisation, and second dose of MENACTRA, via an unspecified route of administration in left arm on an unspecified date at single dose for immunisation. Medical history included syncope related to heat and dehydration. The patient's concomitant medications were not reported. The patient passed out (medically significant) on an unspecified date with outcome of recovered, shaking/trembling (non-serious) on an unspecified date with outcome of recovering , vision blackening (non-serious) on an unspecified date with outcome of recovering, he felt weak (non-serious) on an unspecified date with outcome of recovering. The patient walked to reception area, felt vision blackening, then passed out. Was passed out for about 45 seconds and awoke. He felt weak, tried to get him to stand to get blood pressure, started shaking and trembling again, so laid him back down for about 20 or 30 minutes. Gave him some water (about 4 glasses). Was able to stand. Called mom about an hour they left and reported he was feeling better. The information on the batch number has been requested. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect TRUMENBA contributed to the development of the reported events.
Sex: U
Vaccine: TDAP
Symptoms: Laceration, Syringe issue
Clinical narrative: Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to case 2018SA196049. This case involves an individual, who experienced an accident,  while he/she received vaccine ADACEL, when the flange broke and it cut the medical office assistant's finger (administering the vaccine to the patient). On 06-Jul-2018, the patient  received a partial dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5875AA via skin contact. On 06-Jul-2018, the patient had a non-serious event of possible underdose. It was also a case of syringe issue (product use issue). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive  and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypotonia, Pyrexia, Unresponsive to stimuli
Clinical narrative: Patient after a couple of hours of receiving vaccines developed fever and had episodes where she would be limp and not responsive to parent. Parent took her to ER where she was examined and discharged after she was noted to be back to normal.
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Varicella post vaccine
Clinical narrative: Red, blistering spots consistent with chicken pox. Email sent to her physician, nurse called stating most likely chicken pox.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Gait disturbance, Hemiparesis, Pyrexia, Regressive behaviour, Seizure
Clinical narrative: Unsure about date of vaccination 2017. The day of vaccination, at night, patient had high fever and seizures. Patient taken to ER and stayed overnight. Baby transferred to Hospital and stayed for 4 days. Continued care with HCP and specialist; baby prescribed ONFI for seizures. 2 days after discharge, patient got a seizure again and followed up with doctor. Since then, seizures and fevers have continued periodically. Reporter has noted patient has speech problems and weakness on right side of bodythus, has problems walking. Patient was talking before vaccine and not talking now. Patient was potty-trained before vaccine and now regressed. Currently patient going to PCP about 4-5 times a month. Patient seeing neurologist Dr. who prescribed the seizure medication every 3 months. Baby has not received any other vaccines since then. Currently, patient receives speech therapy, occupational therapy, and physical therapy.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Speech disorder
Clinical narrative: Unsure about date of vaccination 2017. The day of vaccination, at night, patient had high fever and seizures. Patient taken to ER and stayed overnight. Baby transferred to Hospital and stayed for 4 days. Continued care with HCP and specialist; baby prescribed ONFI for seizures. 2 days after discharge, patient got a seizure again and followed up with doctor. Since then, seizures and fevers have continued periodically. Reporter has noted patient has speech problems and weakness on right side of bodythus, has problems walking. Patient was talking before vaccine and not talking now. Patient was potty-trained before vaccine and now regressed. Currently patient going to PCP about 4-5 times a month. Patient seeing neurologist Dr. who prescribed the seizure medication every 3 months. Baby has not received any other vaccines since then. Currently, patient receives speech therapy, occupational therapy, and physical therapy.
Age: 12.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 12 year old female given SHINGRIX.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: The vaccine was not on the pull down list: SHINGRIX VIAL KIT.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient came in 7/24/18 for evaluation of a skin rash. Yesterday, 5 days from BEXSERO #2 on R arm she took off her sweater and noted a red irregular rash on her R arm. She has been well. Recently traveled. No known Lyme exposure. The rash is not raised and does not hurt or itch. Today she noted that the rash seemed bigger and seemed to spread up the lateral part of her arm. I consider the possibility of an atypical presentation of Lyme disease or possibly a mild local reaction to the BEXSERO vaccine. Called at 7:30AM to follow up. She tells me that it has faded considerably since yesterday and is almost gone.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Headache x 3 days, Moderate pain worsened in right deltoid/large bump in deltoid muscle x 3 days, Fatigue, body aches, and low-grade temperature x 3 days.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Headache x 3 days, Moderate pain worsened in right deltoid/large bump in deltoid muscle x 3 days, Fatigue, body aches, and low-grade temperature x 3 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and red rash at injection site of left arm (deltoid region) that was warm to the touch, starting 7/22/18 and reported to pharmacy on 7/24/18; recommended patient to take BENADRYL for rash.  Patient stated that swelling and red rash had completely resolved on 7/26/18 10:55 a.m., when she was in pharmacy to pick up other medications.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Patient said she had extreme nausea the next day.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Headache, Pain
Clinical narrative: The late evening of the day I received the second injection for shingles I had chills, headache and joint pain. Next morning chills were gone but very achy and feeling weak.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Arthralgia, Headache, Vomiting
Clinical narrative: Arm pain shortly after, then woke up in the middle of the night with HA and emesis x 3.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Blister, Chest discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Right arm swelling, pain, blistering and chest tightness for 2 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling on the right upper arm (deltoid region) where MENACTRA and ADACEL were placed. No issues on left arm where GARDASIL was placed. No fever or itchiness. Parent reported it started later on the day of injection and got worse the next morning. I saw pt 2 days after injection. Marked the area and will monitor for now. She has  been applying ice. Will be follow up to see if it gets better tomorrow. If not, will possibly start antibiotics for cellulitis.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient experiencing arm soreness that is very painful and it has been at least 5 days.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Anger, Influenza like illness, Mood altered, Pain
Clinical narrative: This shot both times made me feel like I had the flu for 2 to 3 days. Severe body aches. Strangely enough both times it altered my mood and any little thing could send me into a rage attack.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site pain, and red and warm skin reaction below the injection site.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Chills, Cough, Discomfort, Headache
Clinical narrative: Very sore, slightly swollen left arm, headache, swollen glands, sore throat, body aches, chills, maybe a fever. Seemed to develop into bronchitis like symptoms. Exposure to sick person day before -rode in car for several hours with persons who had bronchitis. So do not know if I got sick because of exposure, or my immune system was weak ....Dr. gave prescription for Zpack which was filled with Azithromycin 250 MG Tablets (6) on 7/23/2018.  Couldn't believe I was so sick so went over the weekend before I got the prescription. Living in senior living :  Wellness Center nurse came to our Apt.  to check on me. Said lungs were clear. Take Aleeve for discomfort and inflammation in swollen throat. I also took 12 Hour Mucinex DM to clear my head and stop the cough.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Lymphadenopathy, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Very sore, slightly swollen left arm, headache, swollen glands, sore throat, body aches, chills, maybe a fever. Seemed to develop into bronchitis like symptoms. Exposure to sick person day before -rode in car for several hours with persons who had bronchitis. So do not know if I got sick because of exposure, or my immune system was weak ....Dr. gave prescription for Zpack which was filled with Azithromycin 250 MG Tablets (6) on 7/23/2018.  Couldn't believe I was so sick so went over the weekend before I got the prescription. Living in senior living :  Wellness Center nurse came to our Apt.  to check on me. Said lungs were clear. Take Aleeve for discomfort and inflammation in swollen throat. I also took 12 Hour Mucinex DM to clear my head and stop the cough.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Very sore, slightly swollen left arm, headache, swollen glands, sore throat, body aches, chills, maybe a fever. Seemed to develop into bronchitis like symptoms. Exposure to sick person day before -rode in car for several hours with persons who had bronchitis. So do not know if I got sick because of exposure, or my immune system was weak ....Dr. gave prescription for Zpack which was filled with Azithromycin 250 MG Tablets (6) on 7/23/2018.  Couldn't believe I was so sick so went over the weekend before I got the prescription. Living in senior living :  Wellness Center nurse came to our Apt.  to check on me. Said lungs were clear. Take Aleeve for discomfort and inflammation in swollen throat. I also took 12 Hour Mucinex DM to clear my head and stop the cough.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood test, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Fever up to 102.8 for two days, freezing, sweating, all of my joints hurt, horrible headache, so sleepy!!!
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Somnolence
Clinical narrative: Fever up to 102.8 for two days, freezing, sweating, all of my joints hurt, horrible headache, so sleepy!!!
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain
Clinical narrative: Arm very sore at injection site for several days (2-3 days) - felt "under the weather" for 2 weeks.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Got injection on 7/24/18. Injection was painful. Later in evening felt pain to my Lt arm going down arm  into my fingers & down my Lt leg. Did not look at injection site until next day 7/25/18, noted redness and swelling at site 2x 1.5 inch, H/A, Stomach upset, Fever, Tired, weak, Felt so bad Unable to go to work or do normal activity day after injection, spent most of the day lying around & sleeping. Feeling better the next day 7/26/18. I did not call my PCP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Got injection on 7/24/18. Injection was painful. Later in evening felt pain to my Lt arm going down arm  into my fingers & down my Lt leg. Did not look at injection site until next day 7/25/18, noted redness and swelling at site 2x 1.5 inch, H/A, Stomach upset, Fever, Tired, weak, Felt so bad Unable to go to work or do normal activity day after injection, spent most of the day lying around & sleeping. Feeling better the next day 7/26/18. I did not call my PCP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Got injection on 7/24/18. Injection was painful. Later in evening felt pain to my Lt arm going down arm  into my fingers & down my Lt leg. Did not look at injection site until next day 7/25/18, noted redness and swelling at site 2x 1.5 inch, H/A, Stomach upset, Fever, Tired, weak, Felt so bad Unable to go to work or do normal activity day after injection, spent most of the day lying around & sleeping. Feeling better the next day 7/26/18. I did not call my PCP.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Sore arm for almost a week, body aches started 2 days out from shot and continued for 4 days, felt very tired/fatigued for 1 week.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Eye movement disorder, Fatigue, Injection site pain, Somnolence
Clinical narrative: Daughter has never had trouble or problem or dizziness with any vaccination including flu, MMR TDap etc. About a minute after getting her first HPV injection Tuesday afternoon during her 14 year physical, her eyes rolled back and she collapsed. At first I thought she was kidding me but then she slumped over onto the exam table. The nurse caught her head and laid her down. She was out for about 30 seconds then came too wondering what happened. She said the shot hurt a bit, then she felt dizzy then that's all she remembers. The nurse said 2 days before another patient collapsed after getting the HPV and that it seems even those who never had a reaction to shots are with this one and they now recommend lying down when getting it. I wish I would have known that was a possible reaction. She was groggy and not quite with it for the rest of the day. Her eyes weren't really focused although she was responding and able to walk out after laying down and being monitored in the office. They recommend her lying down now for all shots, although this is the first time it's ever happened this way. I think it's the shot itself. She was tired for another 24 hours.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Daughter has never had trouble or problem or dizziness with any vaccination including flu, MMR TDap etc. About a minute after getting her first HPV injection Tuesday afternoon during her 14 year physical, her eyes rolled back and she collapsed. At first I thought she was kidding me but then she slumped over onto the exam table. The nurse caught her head and laid her down. She was out for about 30 seconds then came too wondering what happened. She said the shot hurt a bit, then she felt dizzy then that's all she remembers. The nurse said 2 days before another patient collapsed after getting the HPV and that it seems even those who never had a reaction to shots are with this one and they now recommend lying down when getting it. I wish I would have known that was a possible reaction. She was groggy and not quite with it for the rest of the day. Her eyes weren't really focused although she was responding and able to walk out after laying down and being monitored in the office. They recommend her lying down now for all shots, although this is the first time it's ever happened this way. I think it's the shot itself. She was tired for another 24 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient received SHINGRIX vaccine in her left arm on 7/23/18. Patient came in on 7/25/18 and complained about redness on her left arm. I recommended that she try using OTC pain relievers or a cold compress to help with the symptoms and to follow up with her PCP if condition worsens. She was satisfied with this information.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt called pharmacy to inquire about fever after SHINGRIX shot--she started running the fever almost exactly 24 hours after her 2nd shot--Her fever is measuring at 103 degrees Fahrenheit.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Laboratory test, Migraine
Clinical narrative: Approximately 8 hours after receiving the PREVNAR 13 shot I had a terrible headache that lasted 36-48 hours; and left me bed-room confined. I recovered and seemed ok. However, I started to note that occasionally, particularly associated with an alcohol drink I got a headache. I reported to my doctor and he said don't worry and don't drink. The frequency of the headaches slowly increased. After many appts and test it was determined that I developed a Migraine Headache Syndrome. I see a neurologist and he has prescribes meds that help but I continue to get 10-15 headaches a month. The medical community just thinks this happened however, I wanted to find out if there are any other cases or reason that have been reported after seniors receiving PREVNAR 13. Most importantly, are there any other treatment options.  Migraines are considered chronic and the treatment is to find the triggers and reduce if possible. This condition has lasted over 3 years and there is much additional information available. What I need to know is if PREVNAR 13 has caused Migraines and then be directed to those who understand. If there are no other cases that would be helpful to know.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Laboratory test normal, Nausea, Neuralgia
Clinical narrative: Severe nerve pain in left leg, headache, shivering, 102.4 fever, nausea. Was in the hospital for 3 days. Was kept because of fever and elevated white blood count. Had many tests but no cause was found.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Severe nerve pain in left leg, headache, shivering, 102.4 fever, nausea. Was in the hospital for 3 days. Was kept because of fever and elevated white blood count. Had many tests but no cause was found.
Age: 27.0
Sex: F
Vaccine: MMRV
Symptoms: Dysphagia, Erythema, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Had a little bump right after injection 3 weeks later had a 4 inch lump under the skin with 7 inches of redness around area. Left arm pain, shoulder, and neck pain.
Age: 27.0
Sex: F
Vaccine: MMRV
Symptoms: Skin mass
Clinical narrative: Had a little bump right after injection 3 weeks later had a 4 inch lump under the skin with 7 inches of redness around area. Left arm pain, shoulder, and neck pain.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Faeces discoloured
Clinical narrative: She has had 3 green looking stools since July 25, 2018.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Very red, very painful, its been at least 2 days after injection and still symptoms persist but has gotten better.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Conjunctivitis, Malaise
Clinical narrative: Malaise for 3 days, eye conjunctivitis. Feeling no malaise now, but advised pt to get eyes checked out for infection.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash (redness and swelling) developed at site of injection and continued to spread over 5 days before patient contacted provider and pharmacy. Patient to follow up with primary care provider for treatment.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Pain in arm, generalized muscle pain, low grade fever (99.5), loose stool, significant fatigue, mild  nausea, mild headache. I am not able to continue my daily activities. I read that this may last another 1-2 days.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm, generalized muscle pain, low grade fever (99.5), loose stool, significant fatigue, mild  nausea, mild headache. I am not able to continue my daily activities. I read that this may last another 1-2 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Malaise, Nausea
Clinical narrative: Awoke knowing I was not feeling well. Had severe headache, nausea, body aches, chills, fever up to 101.6-normal temperature is 97.2. Symptoms lasted all day. Started feeling better mid-afternoon and fever broke. Sore muscle at injection site. Was back to normal after evening dinner and next day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Awoke knowing I was not feeling well. Had severe headache, nausea, body aches, chills, fever up to 101.6-normal temperature is 97.2. Symptoms lasted all day. Started feeling better mid-afternoon and fever broke. Sore muscle at injection site. Was back to normal after evening dinner and next day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Lip dry, Lip swelling, Pruritus
Clinical narrative: Patient reports she had pain and red lines/redness in injection arm after injection. Later on she experienced lip swelling and itching. The skin on her lips subsequently peeled off. Patient took BENADRYL at some point during the lip swelling. Vaccination was Thursday 7/19 and symptoms were reportedly resolved by Sunday 7/22.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Patient reports she had pain and red lines/redness in injection arm after injection. Later on she experienced lip swelling and itching. The skin on her lips subsequently peeled off. Patient took BENADRYL at some point during the lip swelling. Vaccination was Thursday 7/19 and symptoms were reportedly resolved by Sunday 7/22.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Patient experienced shivering, fever,upset stomach, nausea and diarrhea which resolve after resting. No medication used.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: Patient states that he was dizzy and had nausea for 72 hours. He emailed his primary care doctor and is waiting for a response.
Age: 69.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Myalgia
Clinical narrative: Patient complaining of persistent muscle pain that has failed to resolve.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: Patient experienced muscle pain, feeling tired and weak, and headache. Symptoms resolved after resting.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: Patient experience muscle pain, feeling tired and weak and headache on the second day after the injection. All symptoms resolved after resting.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Paraesthesia, Pyrexia, Wheezing
Clinical narrative: Patient called 7/26/18 to report experiencing wheezing, asthma attack, tingling in the fingers and fever.