chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, less than an hour after receiving Hepatitis B vaccine, the patient experienced rash and hives. On an unknown date, the outcome of the rash and hives were unknown. It was unknown if the reporter considered the rash and hives to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional declined to provide patient's date of birth. The vaccine was not administered by the reporting facility and was administered possible 20 years ago. The patient experienced a rash within a few minutes after receiving an unknown brand Hepatitis B vaccine. The patient's symptoms were described as a rash on the face, and trunk, and hives. No additional information was available.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were recovered/resolved. It was unknown if the reporter considered the fever and shivering to be related to SHINGRIX. Additional details were reported as follows: The patient was a friend of a friend of reporter. The age at vaccination was not reported. The fever and shivering lasted for approximately 4 to 5 days. Limited information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in a female patient who received SHINGRIX. 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 headache and nausea. On an unknown date, the outcome of the headache and nausea were unknown. It was unknown if the reporter considered the headache and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, her physician's office never mentioned that she should get a 2nd dose. The patient saw this when she looked up for the side effects because, she had headache and nausea. The patient asked to send an email reminder in couple of months for her 2nd shot.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chills in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills, nausea and vomiting. On an unknown date, the outcome of the chills, nausea and vomiting were recovered/resolved. It was unknown if the reporter considered the chills, nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: GSK case number US2018GSK072329 is a duplicate of US2018GSK072330. Case US2018GSK072329 will be deleted and all future correspondence will be submitted to US2018GSK072330 which stand as case of record for this patient. Within 12 hours of vaccination, the patient had chills, nausea and vomiting which resolved by 24 hours. The call came in as part of Medical Science Liaison on demand. The physician stated that he would prefer to submit the information by himself for HIPPA reasons and would do so if he received a link to the portal. Thus no other patient data was given and the report might be a duplicate of a report that would be put in by the doctor himself. However, no more duplicate case was identified. The reporter did not agree upon follow up from GlaxoSmithKline.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received SHINGRIX. On 23rd April 2018, the patient received SHINGRIX (intramuscular). On 25th April 2018, 2 days after receiving SHINGRIX, the patient experienced pain in arm. The patient was treated with TYLENOL. In April 2018, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient reports arm pain, which began the next day after receiving a SHINGRIX injection in the left arm. The patient reports he took TYLENOL and the event resolved after one week.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Hypersomnia, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 91-year-old female patient who received SHINGRIX (batch number 4492P, expiry date April 2019). On 28th April 2018, the patient received SHINGRIX (intramuscular) 1 ml. On 28th April 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, sleep excessive and overdose. On 29th April 2018, the patient experienced dizziness, injection site erythema, injection site swelling, injection site warmth, injection site pain and injection site itching. On 30th April 2018, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the fatigue, sleep excessive, injection site erythema, injection site warmth, injection site pain and injection site itching were recovering/resolving and the outcome of the injection site swelling and overdose were unknown. The reporter considered the fatigue, sleep excessive, dizziness, injection site erythema, injection site swelling, injection site warmth, injection site pain and injection site itching to be possibly related to SHINGRIX. Additional details were provided as follows: The reporter was daughter of the patient. On 28th April 2018 (Saturday), the patient received SHINGRIX 1 ml but the dosing regimen of 0.5 ml was noted from the prescribed information, which led to an overdose. On same day, the patient experienced extremely fatigued caused her to sleep a lot. On 29th April 2018 (Sunday), the patient had redness, swelling, hotness, pain, and itching at the site. The patient also noted dizziness that began on Sunday but appeared to have resolved today. The patient had not told her doctor, but was encouraged to do so. The representative did not ask HCP information.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Overdose
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 91-year-old female patient who received SHINGRIX (batch number 4492P, expiry date April 2019). On 28th April 2018, the patient received SHINGRIX (intramuscular) 1 ml. On 28th April 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, sleep excessive and overdose. On 29th April 2018, the patient experienced dizziness, injection site erythema, injection site swelling, injection site warmth, injection site pain and injection site itching. On 30th April 2018, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the fatigue, sleep excessive, injection site erythema, injection site warmth, injection site pain and injection site itching were recovering/resolving and the outcome of the injection site swelling and overdose were unknown. The reporter considered the fatigue, sleep excessive, dizziness, injection site erythema, injection site swelling, injection site warmth, injection site pain and injection site itching to be possibly related to SHINGRIX. Additional details were provided as follows: The reporter was daughter of the patient. On 28th April 2018 (Saturday), the patient received SHINGRIX 1 ml but the dosing regimen of 0.5 ml was noted from the prescribed information, which led to an overdose. On same day, the patient experienced extremely fatigued caused her to sleep a lot. On 29th April 2018 (Sunday), the patient had redness, swelling, hotness, pain, and itching at the site. The patient also noted dizziness that began on Sunday but appeared to have resolved today. The patient had not told her doctor, but was encouraged to do so. The representative did not ask HCP information.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Oral mucosal blistering, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX. On 24th April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain, blistering of mouth and blister. On an unknown date, the outcome of the pain, blistering of mouth and blister were unknown. It was unknown if the reporter considered the pain, blistering of mouth and blister to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient developed severe pain and blisters on jaw and neck. No further information was provided at the time of reporting. The healthcare professional (HCP) requested a follow up call from Medical Information (MI) on recommendations on how to proceed.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX (batch number YS53Y, expiry date January 2020). On 22nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain and adverse event. On an unknown date, the outcome of the pain and adverse event were unknown. It was unknown if the reporter considered the pain and adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left arm. The health care professional stated that the patient felt like someone punched him in the arm. The reporter was the patient and the health care professional reported a total of 4 adverse events during call.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX. On 30th April 2018, the patient received the 1st dose of SHINGRIX. On 30th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The reporter's sister experienced pain on injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 65-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received in 2016). In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be possibly related to SHINGRIX. Additional details were reported as follows: The reporter's wife received SHINGRIX vaccine about a week before him and had soreness at site of injection on the day of the injection.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX. Concomitant products included EFFEXOR. On 27th April 2018 09:30, the patient received the 1st dose of SHINGRIX. On 27th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 27th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 27th April 2018 19:00, the patient experienced generalized joint pain and generalized muscle aches. The patient was treated with TYLENOL. On 28th April 2018, the outcome of the generalized joint pain and generalized muscle aches were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm, generalized joint pain and generalized muscle aches to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's spouse. On 27th April 2018 19:00, 09:30 hours after receiving SHINGRIX, the patient experienced generalized joint pain and generalized muscle aches. The patient developed muscle and joint pain all over her body about 7 or 8 PM. The patient took a TYLENOL and felt fine the next day. She went to sleep around 5:30 AM.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a elderly female patient who received SHINGRIX. Concurrent medical conditions included food allergy. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved. The reporter considered the pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. None of the concomitant medicines were started recently. The patient was a pharmacy technician received the 1st dose of the series of the SHINGRIX vaccination into her upper left arm at a pharmacy sometime last week before the date of reporting. The reporter did not know the exact dosing or other dosing related details. Later that same night the patient experienced itching symptom. The patient was still itching all over her arms and back at the time of reporting. The patient obtained a prescription for SHINGRIX from her health care professional but was told that she did not need a prescription at the pharmacy because she was over 50 years of age. The patient routinely took blood pressure medicine and other medicines whose exact names the reporter could not now recall. The reporter called GlaxoSmithKline on the day of reporting to inquire on his wife's (the patient) behalf if SHINGRIX contained any soy, because his wife is she was allergic to soy. The reporter's inquiry had been submitted to the GlaxoSmithKline response center team lead for further research. The reporter was advised that someone from the GlaxoSmithKline response center would be calling him back after further research of his inquiry. The reporter requested that his wife be contacted back by GlaxoSmithKline and provided her phone number. The reporter was referred to the prescribing healthcare provider during the call.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received SHINGRIX. Concomitant products included Levothyroxine, Simvastatin, citalopram and Lisinopril. On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema. On 25th April 2018, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling and injection site erythema were unchanged. The reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The reporter stated that the patient had 2.5 to 3 inch enlarged circle with swelling and redness at injection site. Less than a week after receiving SHINGRIX, the patient experienced injection site erythema. All questions were asked. According to the pharmacist, the patient would follow up if any changes occurred in condition.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 58-year-old female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, 2 days after receiving SHINGRIX, the patient experienced joint pain, mobility decreased and chills. The patient was treated with ADVAIR. On an unknown date, the outcome of the joint pain, mobility decreased and chills were not recovered/not resolved. The reporter considered the joint pain, mobility decreased and chills to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right arm 2.5 weeks ago around 2 pm and she cannot raise her arm up over her head. The patient's joints were sore and she took ADVAIR and it did not help her. The patient had chills that come and go and she claimed that her symptoms were worsening.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 90-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concomitant products included hydralazine and Levothyroxine. On 24th April 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 24th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 30th April 2018, the patient experienced stiff neck. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the stiff neck was unknown. It was unknown if the reporter considered the injection site pain and stiff neck to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The next day after receiving vaccine, the patient had excessive soreness at the injection site. On the day of reporting, 6 days after receiving SHINGRIX, the patient woke up with a stiff neck on the same side that she received SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: 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 female patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was a consumer that visited the pharmacy to get the SHINGRIX injection. The patient was the person working at the pharmacy said that she also took the SHINGRIX vaccine a week before he did and was still experienced some pain at the injection site. This case has been linked with case US2018075817 and US2018075815, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced swelling, erythema and pain. On an unknown date, the outcome of the swelling, erythema and pain were unknown. It was unknown if the reporter considered the swelling, erythema and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. However, it could be 74 or 75 years. The reporter was friend of patient. The patient received SHINGRIX on an unknown arm. The reporter did not know what date the patient received the vaccination or how soon after that these symptoms which occurred on the site of the arm where the vaccine was administered. The reporter had no further information about in which arm or the exact dosing administered or at what facility the vaccine was administered. The symptoms might have started within 5 or 6 days after receiving the vaccine, but the reporter was not sure. The patient was still experiencing the symptoms as of this past Sunday (on 29th April 2018), but the status of the symptoms was currently unknown to the reporter today. The reporter granted permission to be contacted with further related questions.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 injection site pain in a 76-year-old female patient who received SHINGRIX. On 24th April 2018, the patient received SHINGRIX (intramuscular). On 24th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. The patient was treated with ALEVE. In April 2018, the outcome of the injected limb mobility decreased was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in arm. This case was reported by the partner of the patient. The patient could not lift her arm the very beginning after receiving the injection. The patient put ice on her arm to help her with the symptoms. It was gradually got better. The patient still had pain and achiness at the site of injection. This case has been linked with case US2018075815 and US2018075819, reported by same reporter.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Adverse event
Clinical narrative: Adverse effect of other bacterial vaccines, init encntr on 2018-05-07.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pain, Pyrexia, Rash
Clinical narrative: 104 fever after advil,rash on upper chest like sunburn, chills, body aches, felt like joints were on fire.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: 104 fever after advil,rash on upper chest like sunburn, chills, body aches, felt like joints were on fire.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, MMRV
Symptoms: Asthenia, Chest pain, Malaise, Pallor
Clinical narrative: Client left exam room at 11:52 AM following immunizations. At approximately 12:00 PM the client's mother yelled "excuse me, she's going into a convulsion." Clinical staff responded immediately. Client was found on mom's lap, fully conscious, alert and oriented, and displaying no seizure-like activity. She did appear weak and pale and was complaining of chest pain and not feeling well. No respiratory distress was noted. The client was moved back to the exam room and vitals were taken at 12:06 PM: BP: 80/50 Pulse: 54 Respirations: 16 Temperature: 98.5 F. The client remained alert and oriented and answered questions appropriately. At 12:09 PM she reported that her chest no longer hurt and she was feeling better. The client's grandmother called EMS and they left the clinic shortly after to wait for EMS in the lobby (grandmother's request). A nurse accompanied the family to the lobby. EMS arrived at 12:20 PM. A follow up phone call was made to the client's mother on 5/8/18. She indicated that she took the client to Hospital, where they found the client to be stable and did not admit her.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Gait inability
Clinical narrative: PATIENT'S MOTHER REPORTS SHE WAS GIVEN THE VACCINATION ON 10-25-17 AND WITHIN 24 HOURS, SHE COULD NOT WALK AND HAD TO BE TAKEN TO THE EMERGENCY ROOM.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Rash
Clinical narrative: Redness and pain at the site of injection, followed by rash the following day that spread across her back to the other side of her body. The rash seems to have red patches with raised bumps. No systemic signs of anaphylaxis.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 67-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date unknown). On 20th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever to be probably related to SHINGRIX. Additional details were provided as follows: The reporter was a registered pharmacist. The patient received SHINGRIX in left deltoid. The patient experienced fever of 102 degree F on the same day or next day of vaccination and then low grade following the next two days. The patient had returned for 2nd dose and seeking information about potential repeat or worse of the fever with the 2nd dose. This was texted to the medical information system (MIS).
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 30th April 2019). On 24th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 25th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site itching were not recovered/not resolved. The reporter considered the injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the day after she was vaccinated with SHINGRIX on, she experienced injection site soreness. The patient took BENADRYL and it helped but she called the pharmacy on the day of reporting and stated that the redness comes and goes and the area was itching.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Burning sensation, Headache, Mass, Occipital neuralgia, Pain
Clinical narrative: Two days after the shot, large lumps on the back and sides of the head formed and cause throbbing pain. Headaches often occur throughout the day. Extreme burning and pain are present daily to this day (May 08, 2018).
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Dizziness
Clinical narrative: She presents to the Occupational Health Clinic on 5/8/2018 for evaluation of a rash, history of receiving the Varicella vaccination on April 24, 2018. The vaccine was administer subcutaneously in her right arm. Thursday, May 3, she developed discomfort at the injection site and mild erythema. On Friday she had symptoms of general malaise including fever and chills; she did not take her temperature. On Saturday she felt generally worse with weakness and diffuse joint pain. On Sunday she sought treatment in the Emergency Department for her persistent symptoms. In addition she felt lightheaded and dizzy, she was having diarrheal stools. Impression at the time of the ED evaluation included a viral syndrome; possible cellulitis at the injection site. An ultrasound of the area of the vaccination site did not reveal an abscess; lab work was within normal limits. She was provided with a prescription for KEFLEX for potential soft tissue infection. Today 5/8/2018 she has a rash along her anterior chest, arms and upper back. She has itching along the areas of the rash and her scalp. Her supervisor recommended evaluation in Occupational Health to rule out a potential contagious rash. She reports continued general malaise, she has not had a fever or chills. She reports she has not taken the KEFLEX today.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Laboratory test normal, Malaise, Pruritus
Clinical narrative: She presents to the Occupational Health Clinic on 5/8/2018 for evaluation of a rash, history of receiving the Varicella vaccination on April 24, 2018. The vaccine was administer subcutaneously in her right arm. Thursday, May 3, she developed discomfort at the injection site and mild erythema. On Friday she had symptoms of general malaise including fever and chills; she did not take her temperature. On Saturday she felt generally worse with weakness and diffuse joint pain. On Sunday she sought treatment in the Emergency Department for her persistent symptoms. In addition she felt lightheaded and dizzy, she was having diarrheal stools. Impression at the time of the ED evaluation included a viral syndrome; possible cellulitis at the injection site. An ultrasound of the area of the vaccination site did not reveal an abscess; lab work was within normal limits. She was provided with a prescription for KEFLEX for potential soft tissue infection. Today 5/8/2018 she has a rash along her anterior chest, arms and upper back. She has itching along the areas of the rash and her scalp. Her supervisor recommended evaluation in Occupational Health to rule out a potential contagious rash. She reports continued general malaise, she has not had a fever or chills. She reports she has not taken the KEFLEX today.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Ultrasound scan abnormal
Clinical narrative: She presents to the Occupational Health Clinic on 5/8/2018 for evaluation of a rash, history of receiving the Varicella vaccination on April 24, 2018. The vaccine was administer subcutaneously in her right arm. Thursday, May 3, she developed discomfort at the injection site and mild erythema. On Friday she had symptoms of general malaise including fever and chills; she did not take her temperature. On Saturday she felt generally worse with weakness and diffuse joint pain. On Sunday she sought treatment in the Emergency Department for her persistent symptoms. In addition she felt lightheaded and dizzy, she was having diarrheal stools. Impression at the time of the ED evaluation included a viral syndrome; possible cellulitis at the injection site. An ultrasound of the area of the vaccination site did not reveal an abscess; lab work was within normal limits. She was provided with a prescription for KEFLEX for potential soft tissue infection. Today 5/8/2018 she has a rash along her anterior chest, arms and upper back. She has itching along the areas of the rash and her scalp. Her supervisor recommended evaluation in Occupational Health to rule out a potential contagious rash. She reports continued general malaise, she has not had a fever or chills. She reports she has not taken the KEFLEX today.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Muscle spasms, Pyrexia
Clinical narrative: Fever of 101.8 for two hours on first day of fever. Tylenol controlled to 100.3 for remainder of day and next. Three doses of maximum dose Tylenol first 18 hours, then let low grade fever run it's course. Third day temperature was normal. Intermittent Chills for about 12 hours  and constant  muscle cramping body wide from about 12 hours after shot, through third day.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Severe swelling in immunized arm. Advised her to use ice pack, and BENADRYL if needed. If size didn't decrease, seek medical attention at walk in clinic.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 01-MAY-2018, the patient was vaccinated with a dose of ZOSTAVAX via the intramuscular route in error for prophylaxis (anatomical location, lot# and expiration date were not reported). There was no adverse effect reported. Product quality compliant was not reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Hypertonia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 2-month-old patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On an unknown date (reported as 2-3 years ago), the patient was vaccinated with a first dose of ROTATEQ orally (dose, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient went completely limp, hypertonic and went to the hospital. It was also reported that the child received an unspecified treatment for the events. The outcome of the events was unknown. The relatedness between ROTATEQ and the events was not provided.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Renal disorder
Clinical narrative: This spontaneous report was received from a consumer, who referred to her niece, a 20-year-old female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date in approximately 2011, reported as at age 13, the patient began vaccination (1st dose) with GARDASIL or GARDASIL 9 for prophylaxis (type of vaccine, strength, dose, route of administration and anatomical location were not reported) and she received full 3 doses (administration date for 2nd and 3rd dose were not provided). On an unknown date, the patient experienced as unspecified kidney disorder and was going to have a kidney transplant in the near future. As a part of pre-transplant process, she had a human papilloma virus test preformed with the positive result, on an unknown date. On 02-MAY-2018, the patient was informed by her physician that she was HPV positive. The outcome of the events was unknown. Causality assessment was not provided. Upon internal review, the event of unspecified kidney disorder requiring kidney transplantation was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a 68 year old male patient reporting on himself. The patient's concurrent conditions included a metastatic malignant melanoma diagnosed in approximately 2006, reported as "12 years ago". The patient had no drug reactions/allergies. On an unspecified date in 2008, the patient was vaccinated with PNEUMOVAX 23 dose 1 as vaccination from pneumonia (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, as after the first PNEUMOVAX 23 dose, the patient started ipilimumab for metastatic melanoma. On approximately August 2017, reported as "8 months ago", the patient was vaccinated with PNEUMOVAX 23 dose 2 as vaccination from pneumonia (dose, route of administration, lot number and expiration date were not reported). No adverse effect was reported. No lab diagnostic studies were performed. The patient sought unspecified medical attention. At the reporting time, the patient's outcome was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. During 2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 01-JUN-2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of vaccination failure and herpes zoster were unknown. The lawyer considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, itching, pain, hot to touch.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received a couple of years ago). On 28th April 2018 11:48, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced stomach cramps, shivers and erythema of extremities. On 28th April 2018, the patient experienced pain in arm and injection site pain. In April 2018, the outcome of the stomach cramps was recovered/resolved. On 29th April 2018, the outcome of the shivers was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the erythema of extremities was unknown and the outcome of the injection site pain was recovered/resolved. The reporter considered the pain in arm, stomach cramps, shivers, erythema of extremities and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The site of injection of the vaccination hurt during the injection of the product and her left arm was a little sore that day. In the night after receiving the vaccine, the patient experienced shivers and stomach cramps. The stomach cramps resolved within a couple of hours and the shivers resolved by the next morning. Progressively, since the vaccination was administered the patient's arm had become more sore and redness began to develop that extends six inches down her arm. Less than a week after vaccination, the patient experienced redness. The redness spread approximately one inch from 30th April 2018 to 1st May 2018. The patient's arm was not as sore as it was on 30th April 2018. The patient had denied permission to contact their physician. The reporter did not currently have a physician as she has just moved to the area. The reporter was unable to provide additional information.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash, Rash erythematous, Rash generalised
Clinical narrative: After 2-5 minutes of administered vaccines patient was getting red spots on face mostly right side, arm, legs. Noticed at 10:29 AM vaccines administered at 10:25 AM. RL PEDIARIX, LL HIBERIX, LL PCV13.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Severe local reaction on injection site, swelling, redness whole upper arm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: The patient was given the vaccine Saturday afternoon and by Monday morning had redness and swelling going down her arm. She went to the doctor and was given a steroid injection and told it was an allergic reaction.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Hours after getting Hep A shot he got hives on both legs and red sheet of hives on left thigh.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Swelling face
Clinical narrative: Patient had facial swelling serious enough to be seen in the ER. Patient was told that it was a localized reaction to the vaccine. Swelling was gone the next morning.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse outcome. 2nd GARDASIL given too soon. Supposed to be 1-2 months from the 1st GARDASIL shot which was administered on 4/12/18. Merck recommends giving the 2nd injection again at least 1 month after the last injection administered. Scheduled to re-administer the 2nd GARDASIL on May 29, 2018.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt stated that she received the injection in her left arm, and afterwards the site was very itchy, very sore, and seemed to have a raised bump. Pt stated that today (5/3/18) that the site is very tender, and the tenderness has moved from her shoulder to under her armpit, pt denies any itching today (5/3/18). Talking with pt further-she does state it feels the aching in her arm/shoulder. I told her this can be normal since the injection goes into muscle the arm can feel like she lifted weights with just that arm and she agrees that's what she is feeling. She states there is not any redness or swelling and itching has gone. I instructed to call me if she notices any redness or the itching becomes worse. I also told her she can stop by anytime for me to take a look at the site for her. She verbalized understanding.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Pt stated that she received the injection in her left arm, and afterwards the site was very itchy, very sore, and seemed to have a raised bump. Pt stated that today (5/3/18) that the site is very tender, and the tenderness has moved from her shoulder to under her armpit, pt denies any itching today (5/3/18). Talking with pt further-she does state it feels the aching in her arm/shoulder. I told her this can be normal since the injection goes into muscle the arm can feel like she lifted weights with just that arm and she agrees that's what she is feeling. She states there is not any redness or swelling and itching has gone. I instructed to call me if she notices any redness or the itching becomes worse. I also told her she can stop by anytime for me to take a look at the site for her. She verbalized understanding.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles occurred 7days after shot.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mobility decreased
Clinical narrative: Patient said her arm is hard to move and it spread to her lymph nodes. Appears red. Clinic told her to let us know.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: NUMBNESS AND TINGLING IN THE INJECTION SITE SIDE, INCLUDING DOWN THE ARM AND REACHING THE OUTERMOST FINGERS OF THE RIGHT HAND. DIAGNOSED WITH SHINGLES, INTERNALLY ONE MONTH FOLLOWING ADMINISTRATION OF VACCINATION.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling even 1 week after administration of vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local reaction on injection site - swelling, redness of whole upper arm!
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: NAUSEA, VOMITING, MALAISE.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site pain, Limb discomfort
Clinical narrative: NUMBNESS AND WEAK GRIP FOR TWO DAYS AFTER INJECTION; STILL HAS NUMBNESS AND LEFT ARM FEELS HEAVY FROM ELBOW TO FINGERTIPS. LEFT AREM IS PAINFUL AT INJECTION SITE; NO REDNESS OR SWELLING AT INJECTION SITE NOTED.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: 70 BY 65MM RED AREA ON LEFT ARM.
Age: 54.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: 40 BY 60MM RED AREA AROUND INJECTION SITE.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 40 BY 45MM REDNESS AT INJECTION SITE; WARM TO THE TOUCH AND TENDER EXTENDING TO THE SHOULDER.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Chills, Eye pain, Fatigue, Headache
Clinical narrative: Patient awoke morning after vaccination and noted a 7mm spot on her right arm without pain or pruritus. She left the country on 5/5/18 as anticipated and contacted the clinic on 5/7/18 with complaints of diffuse whole body rash that she noted when awakening in her hotel on 5/6. First noted rash on chest but quickly spread to entire upper body including arms, back, some on buttocks. By follow up email somewhat improved. By photo maculopapular. She reports a moderate, dull headache and bilateral eye pain for about 48hrs when going to the airport on 5/5, but no rash then. She noted chills and subjective fevers, but did not take her temperature that resolved by time she reached the hotel in another country. Generalized weakness and fatigue.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: Patient awoke morning after vaccination and noted a 7mm spot on her right arm without pain or pruritus. She left the country on 5/5/18 as anticipated and contacted the clinic on 5/7/18 with complaints of diffuse whole body rash that she noted when awakening in her hotel on 5/6. First noted rash on chest but quickly spread to entire upper body including arms, back, some on buttocks. By follow up email somewhat improved. By photo maculopapular. She reports a moderate, dull headache and bilateral eye pain for about 48hrs when going to the airport on 5/5, but no rash then. She noted chills and subjective fevers, but did not take her temperature that resolved by time she reached the hotel in another country. Generalized weakness and fatigue.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 45 by 38 mm raised red area at injection site; warm to the touch.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site (1.5 inches in diameter).
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Lymph gland infection
Clinical narrative: Patient said a few days after vaccine, she noticed swelling at the site of the injection, which then over time started to move down her arm. On Sunday, patient went to Urgent Care where the MD diagnosed infection in the lymph nodes. Patient said she was prescribed antibiotics since Sunday and the swelling and symptoms have started to improve as of today, 5/9/18.