chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Feeling hot, Injection site pain, Injection site swelling
Clinical narrative: On 4/3/2018, patient received the Tdap vaccine. On 4/4/2018, patient woke up with her left arm swollen at the injection site, and whole body ache for 2 days, chills/ hot spells, nausea, and no appetite. By Friday, reports she felt better and was able to eat again. Today reports she only has pain at the injection site when palpating area.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain
Clinical narrative: On 4/3/2018, patient received the Tdap vaccine. On 4/4/2018, patient woke up with her left arm swollen at the injection site, and whole body ache for 2 days, chills/ hot spells, nausea, and no appetite. By Friday, reports she felt better and was able to eat again. Today reports she only has pain at the injection site when palpating area.
Age: 16.0
Sex: M
Vaccine: FLUC4, MENB, MNQ
Symptoms: Pain
Clinical narrative: Client reported onset of pain increasing to "8" on 1-10 scale through the evening, overnight and into the next morning.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Patient developed headache, fever, erythema and mild swelling @ injection site and chills with malaise by the evening of 4/9/18. Was seen in office on 4/10/18 for evaluation. Rest and fluids recommended. Toradol 60 mg IM given in office.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient developed headache, fever, erythema and mild swelling @ injection site and chills with malaise by the evening of 4/9/18. Was seen in office on 4/10/18 for evaluation. Rest and fluids recommended. Toradol 60 mg IM given in office.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: Patient came into the pharmacy and recieved VARIVAX around 415-430p. According the patient, she went home and developed a purple and red rash about 7 hours later around 11pm. At that time she took a benedryl and the rash went away. However, the next day she developed a very painful, red rash around the injection site. She is still experiencing dizziness. It was recommended for her to go to the doctor after the patient called the pharmacy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity, Rash
Clinical narrative: Patient came into the pharmacy today to discuss potential allergic reaction to SHINGRIX. According to patient, she noticed immediate pain in her arm after recieving vaccine. By bedtime, she had "pain all over." She took MOTRIN to relieve the pain for this. Then she noticed that she developed a rash on both thighs, both arms, and across her chest. She took BENADRYL at bedtime that night and by the following morning, pain and rash were gone.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient comes in today and shows me her arm. The injection site is swollen and red. I advised her to go see her physician. Called her later that night. Her physician siad she was going to be ok and gave her some instructions. She didn't elaborate. I think she was tired and just wanted to go to bed so she didn't want to talk any longer.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Second vaccine was given at the wrong interval...Should have been given at 2 months after the initial and was given at 1 month after the initial dose. Patient stated no adverse reaction at this time. Pharmacy instructed to contact the patient and explain that the second dose was given at the wrong time, patient is to receive the next dose to complete the series, 2 months after the error dose. Patient will be called on or around May 6, 2018 for the final dose in the series.
Age: 75.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: Patient referred for left upper extremity pain and weakness. She states she had 2 "shots" about 2 weeks ago for pneumonia and tetanus (dates and vaccines confirmed via Statewide Immunization System) and since then has had pain and swelling at the site. She said it was very red for the first few days after the shots and this has abated somewhat, but it remains very painful and this pain limits her use of the arm. She says it feels weak but this is due to the pain. She thinks she might have had fevers but is not sure and hasn't measured them. No blistering, no drainage. The pain is more in the upper arm/deltoid region than her shoulder.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 53-year-old male patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). On 28th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd April 2018, 6 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. The reporter considered the shingles to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the left arm. The patient visited his physician and received a prescription for antiviral medication (brand not specified). The patient required emergency room visit. The reported batch number CE23T for SHINGRIX did not exist and was updated to C523T as per the sales database.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness facial in a 34-year-old female patient who received BOOSTRIX. On 3rd April 2018, the patient received BOOSTRIX. On 3rd April 2018, 15 min after receiving BOOSTRIX, the patient experienced numbness facial. On an unknown date, the outcome of the numbness facial was recovering/resolving. The reporter considered the numbness facial to be almost certainly related to BOOSTRIX. Additional details were provided as follows: The case was reported by the registered pharmacist. The pharmacist reports that his sister received a BOOSTRIX vaccine earlier today. The symptoms is improving.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX. On 18th January 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a year after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were reported as follows: The reporter stated that patient came in for second dose of SHINGRIX with a rash that appeared to be active shingles that stared in the week of reporting date. The patient received first dose of SHINGRIX at the same location he presented on the day of reporting for the second dose. The reporter agreed to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Spinal pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of headache in a female patient who received SHINGRIX. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. On 3rd April 2018, less than a day after receiving SHINGRIX, the patient experienced headache and pain in spine. On an unknown date, the outcome of the headache and pain in spine were unknown. It was unknown if the reporter considered the headache and pain in spine to be related to SHINGRIX. Additional details were reported as follows: The case was reported by a Clinic director. The age at vaccination was not reported. The patient was a provider in the office. The patient began experiencing a severe headache and spinal cord pain and she had called off work today.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 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 myalgia. On an unknown date, the outcome of the myalgia was unknown. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient experienced Myalgia after receiving SHINGRIX vaccine. The health care professional reported that the patient did not want to receive the second dose of SHINGRIX due to adverse effects from first dose. This question was sent in to health care professional by the patient. The health care professional did not receive any patient, vaccine or adverse event details except the adverse event myalgia. The patient wanted to know effectiveness of only one dose of SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Oral herpes
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever blister in a elderly patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown. The reporter considered the fever blister to be almost certainly related to SHINGRIX. Additional details were reported as follows: The case was reported by a Registered nurse. The age at vaccination was not reported. The patient received SHINGRIX on unknown arm. The patient experienced fever blisters on unknown site. Limited information was provided by the reporter.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concomitant products included Albuterol Inhaler, AMBIEN and tramadol. On 19th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injected mobility decreased was unknown. The reporter considered the injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional stated that patient reported that her left arm was so painful that she could not raise her left arm. The pain lasted approximately 3 to 4 days.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 80-year-old male patient who received SHINGRIX (batch number X3M27, expiry date 29th August 2020). Concomitant products included Aspirin, finasteride, metoclopramide, Nitroglycerin, omeprazole, clonazepam, LOMOTIL and TOBRADEX. On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced localized erythema and erythromacular rash. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced localized erythema and erythromacular rash. On an unknown date, the outcome of the erythema and erythromacular rash were not recovered/not resolved. The reporter considered the localized erythema and erythromacular rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was previously not reported on the behalf of the patient. The patient received SHINGRIX in the left arm. After receiving SHINGRIX, the patient came into the pharmacy and reported that he had a 5 cm by 3 cm oval shape redness on his left temple. The healthcare professional reported that the patient came into the pharmacy the day before reporting (yesterday) and the healthcare professional saw the redness as well. The patient also reported that he had redness on the chest that he described as several red dots on his chest right underneath the chin.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 4th July 2020). Concomitant products included BOOSTRIX. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site pain and injection site swelling were not recovered/not resolved. The reporter considered the injection site erythema, injection site warmth, injection site pain and injection site swelling to be related to SHINGRIX. Additional information was reported as follows: On 19th March 2018, the patient received a dose of BOOSTRIX (intramuscular, batch number; 9PD92, expiry date: 30th March 2020) in left arm. The patient received SHINGRIX on right arm. On the date of reporting, the patient came to the pharmacy to report that, she had redness on her right arm at the injection site. The healthcare professional described this redness as large and approximately 3 inches in diameter and irregular in shape. The healthcare professional also stated that, the red area was pretty tender and warm to touch. The patient had been putting an ice pack on the area.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Nausea, Vertigo
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 70-year-old female patient who received SHINGRIX. Previously administered products included BENADRYL (prior to vaccine). Concurrent medical conditions included granulomatosis with polyangiitis (diagnosed in 2001) and stent placement. Concomitant products included fluticasone propionate, ADVAIR, Fluticasone, Aspirin, Montelukast, valsartan, vitamin D, Calcium Citrate with Vitamin D, iron and risedronate sodium. On 18th March 2018, the patient received the 1st dose of SHINGRIX. On 18th March 2018, less than a day after receiving SHINGRIX, the patient experienced vertigo, weakness and nausea. On an unknown date, the outcome of the vertigo, weakness and nausea were not recovered/not resolved. The reporter considered the vertigo, weakness and nausea to be related to SHINGRIX. Additional information was reported as follows: This case was previously not reported to anyone. The patient received SHINGRIX on right arm. On the same day after receiving SHINGRIX, the patient experienced nausea, weakness and vertigo. The patient had denied permission to contact their physician. This case has been linked with the case US2018058870, reported by the same reporter.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a 55-year-old male patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 26th March 2018, the patient received SHINGRIX. On 28th March 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX and gabapentin. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reported considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician and nurse (medical science liaison). The patient was not immunocompromised or had any other medications indicating he was being treated for an immunosuppressive medical condition. The age at vaccination was not reported but could be 54 or 55 years. Forty eight hours after vaccination, the patient developed shingles. Limited information was provided by the physician. The nurse was following up on case for additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood glucose increased, Emotional distress, Feeling cold
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of glucose increased in a elderly female patient who received SHINGRIX. On 3rd April 2018, the patient received SHINGRIX. On 4th April 2018, 1 days after receiving SHINGRIX, the patient experienced glucose increased, feeling cold and loss of energy. In April 2018, the patient experienced emotional distress. On an unknown date, the outcome of the glucose increased, feeling cold, loss of energy and emotional distress were unknown. It was unknown if the reporter considered the glucose increased, feeling cold, loss of energy and emotional distress to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Tuesday the patient received SHINGRIX and by Wednesday the patient's blood sugar had greatly elevated, she was cold and had no energy. The patient was very upset and very rude. The patient gave permission to contact her physician but could never get the name. The reporter said that she had things to do so information was limited. The reporter could contact later with more details.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 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 injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site erythema and injection site tenderness were unknown. It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional asked if the patient experienced a mild localized reaction from the SHINGRIX, what should he/she expect after the second dose, the same reaction or worse or no reaction. No further details were available at the reporting time.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. The reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional reported that at least one other patient experienced soreness after receiving the SHINGRIX. The health care professional did not know number of patients, product and patient information, they were unavailable at the time of the report. This case has been linked to the case US2018059361 and US2018059365 reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 29th March 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm, swelling arm and injected limb mobility decreased were not recovered/not resolved. The reporter considered the pain in arm, swelling arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine in the right deltoid. The patient then experienced soreness, swelling in the arm, and difficulty lifting the arm. The symptoms were improving on 2nd April 2018, but then worsened and were described as getting progressively worse at the time of the report. The patient did not require an emergency room or doctor visit prior to the report but the health care professional did state that he would refer the patient to their doctor. This case has been linked to the case US2018059362 and US2018059365 reported by the same reporter. The reported batch number 374KL for SHINGRIX did not exist and was updated to 3Z4KL as per the sales database.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, hot to touch, red.
Sex: U
Vaccine: MNQ
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and other: Serious per reporter. The subject was treated with epinephrine. The outcome of anaphylaxis was unknown. It was unknown if the investigator considered the anaphylaxis to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of anaphylaxis in a patient of aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention  (CDC)  and  the Food  and  Drug  Administration (FDA)-to summarize reports following immunization with MENVEO. The patient had a history of anaphylaxis immediately following receipt of an unknown vaccine 6 years earlier. No information on patient's family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and measles, mumps and rubella (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (32), Tdap (776) and human papillomavirus (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, 24 hours or more after the vaccination, the patient developed anaphylaxis. The case met the definition of Brighton level 2. This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). The patient was treated with epinephrine. The outcome of the event was not reported. The authors did not comment on the relationship between the event of anaphylaxis and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cased in the same literature article.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: HA, Dizziness, Nausea and Fever. Prescribed ZOFRAN-ODT 4mg and given ZOFRAN 2mg/ml 4mg injection in office 4/4/18 and TYLENOL tab 1000mg.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Severe itching of the back and severe itching of Rt. upper thigh.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Neurological examination normal, Nuclear magnetic resonance imaging, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tremor in a 20-year-old female patient who received RABAVERT (batch number 590011A, expiry date April 2019). Concurrent medical conditions included dizziness (seen by syncope specialist) and benign positional vertigo. Concomitant products included Calcium, Vitamin D3, ZYRTEC and ORTHO-TRICYCLEN. On 26th March 2018, the patient received the 1st dose of RABAVERT (intramuscular). On 27th March 2018, 1 days after receiving RABAVERT, the patient experienced tremor. The patient was treated with VALIUM and ATIVAN. On an unknown date, the outcome of the tremor was not recovered/not resolved. The reporter considered the tremor to be possibly related to RABAVERT. Additional details were reported as follows: The patient had recently seen a neurologist the month before due to dizziness and was diagnosed with benign positional vertigo. The patient received RABAVERT in left deltoid and 24 to 36 hours after vaccination, the patient experienced tremors. The patient was seen in office on Friday of the week and at that time referred to follow up with neurologist at home. The patient before leaving the town that evening, presented to the local emergency room with tremors. Nuclear magnetic resonance imaging (MRI) was done to rule out Guillain-Barre syndrome, and was inconclusive. The patient was given VALIUM in the emergency room, which resolved the tremors for a while. On 2nd April 2018, physician saw the patient and prescribed ATIVAN for the tremors, that did not appear to have a specific pattern, but re-occur. The physician noted when the patient was distracted, the tremors were not present and there was no change in handwriting pattern from the day of vaccination to 2nd April 2018. The nurse stated that, she would report to VAERS as well.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Nuclear magnetic resonance imaging normal, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tremor in a 20-year-old female patient who received RABAVERT (batch number 590011A, expiry date April 2019). Concurrent medical conditions included dizziness (seen by syncope specialist) and benign positional vertigo. Concomitant products included Calcium, Vitamin D3, ZYRTEC and ORTHO-TRICYCLEN. On 26th March 2018, the patient received the 1st dose of RABAVERT (intramuscular). On 27th March 2018, 1 days after receiving RABAVERT, the patient experienced tremor. The patient was treated with VALIUM and ATIVAN. On an unknown date, the outcome of the tremor was not recovered/not resolved. The reporter considered the tremor to be possibly related to RABAVERT. Additional details were reported as follows: The patient had recently seen a neurologist the month before due to dizziness and was diagnosed with benign positional vertigo. The patient received RABAVERT in left deltoid and 24 to 36 hours after vaccination, the patient experienced tremors. The patient was seen in office on Friday of the week and at that time referred to follow up with neurologist at home. The patient before leaving the town that evening, presented to the local emergency room with tremors. Nuclear magnetic resonance imaging (MRI) was done to rule out Guillain-Barre syndrome, and was inconclusive. The patient was given VALIUM in the emergency room, which resolved the tremors for a while. On 2nd April 2018, physician saw the patient and prescribed ATIVAN for the tremors, that did not appear to have a specific pattern, but re-occur. The physician noted when the patient was distracted, the tremors were not present and there was no change in handwriting pattern from the day of vaccination to 2nd April 2018. The nurse stated that, she would report to VAERS as well.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tremor in a 20-year-old female patient who received RABAVERT (batch number 590011A, expiry date April 2019). Concurrent medical conditions included dizziness (seen by syncope specialist) and benign positional vertigo. Concomitant products included Calcium, Vitamin D3, ZYRTEC and ORTHO-TRICYCLEN. On 26th March 2018, the patient received the 1st dose of RABAVERT (intramuscular). On 27th March 2018, 1 days after receiving RABAVERT, the patient experienced tremor. The patient was treated with VALIUM and ATIVAN. On an unknown date, the outcome of the tremor was not recovered/not resolved. The reporter considered the tremor to be possibly related to RABAVERT. Additional details were reported as follows: The patient had recently seen a neurologist the month before due to dizziness and was diagnosed with benign positional vertigo. The patient received RABAVERT in left deltoid and 24 to 36 hours after vaccination, the patient experienced tremors. The patient was seen in office on Friday of the week and at that time referred to follow up with neurologist at home. The patient before leaving the town that evening, presented to the local emergency room with tremors. Nuclear magnetic resonance imaging (MRI) was done to rule out Guillain-Barre syndrome, and was inconclusive. The patient was given VALIUM in the emergency room, which resolved the tremors for a while. On 2nd April 2018, physician saw the patient and prescribed ATIVAN for the tremors, that did not appear to have a specific pattern, but re-occur. The physician noted when the patient was distracted, the tremors were not present and there was no change in handwriting pattern from the day of vaccination to 2nd April 2018. The nurse stated that, she would report to VAERS as well.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Fatigue, Injection site pain, Pyrexia, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tremor in a 20-year-old female patient who received RABAVERT (batch number 590011A, expiry date April 2019). Concurrent medical conditions included dizziness (seen by syncope specialist) and benign positional vertigo. Concomitant products included Calcium, Vitamin D3, ZYRTEC and ORTHO-TRICYCLEN. On 26th March 2018, the patient received the 1st dose of RABAVERT (intramuscular). On 27th March 2018, 1 days after receiving RABAVERT, the patient experienced tremor. The patient was treated with VALIUM and ATIVAN. On an unknown date, the outcome of the tremor was not recovered/not resolved. The reporter considered the tremor to be possibly related to RABAVERT. Additional details were reported as follows: The patient had recently seen a neurologist the month before due to dizziness and was diagnosed with benign positional vertigo. The patient received RABAVERT in left deltoid and 24 to 36 hours after vaccination, the patient experienced tremors. The patient was seen in office on Friday of the week and at that time referred to follow up with neurologist at home. The patient before leaving the town that evening, presented to the local emergency room with tremors. Nuclear magnetic resonance imaging (MRI) was done to rule out Guillain-Barre syndrome, and was inconclusive. The patient was given VALIUM in the emergency room, which resolved the tremors for a while. On 2nd April 2018, physician saw the patient and prescribed ATIVAN for the tremors, that did not appear to have a specific pattern, but re-occur. The physician noted when the patient was distracted, the tremors were not present and there was no change in handwriting pattern from the day of vaccination to 2nd April 2018. The nurse stated that, she would report to VAERS as well.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner, referring to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-APR-2018, the patient was vaccinated with a dose of PROQUAD lot number N012135, expiration date on 14-OCT-2018 (dose, administration route and anatomical location were not reported) for prophylaxis. On the same date, the patient was also vaccinated with a dose of VARIVAX lot number N021719, expiration date on 10-AUG-2019 (dose, administration route and anatomical location were not reported) also for prophylaxis. No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner, referring to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-APR-2018, the patient was vaccinated with a dose of PROQUAD lot number N012135, expiration date on 14-OCT-2018 (dose, administration route and anatomical location were not reported) for prophylaxis. On the same date, the patient was also vaccinated with a dose of VARIVAX lot number N021719, expiration date on 10-AUG-2019 (dose, administration route and anatomical location were not reported) also for prophylaxis. No adverse effects were reported.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced pain, redness, swelling, warmth at injection site.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced pain, redness, swelling, warmth at injection site.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: Sore arm x 3 days, low grade temperature to 99.8 from about 2 hrs to 7 hrs after, myalgia, flulike feeling.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, Chills, Headache, Tiredness.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Sore arm, muscle aches, fatigue.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Back pain, Blood creatine phosphokinase normal, Chest pain, Full blood count normal
Clinical narrative: Pt has had body ache and pains since injection. These include scalp (combing hair causes pain), back of neck, shoulders and arm (deltoid area mostly), chest, back (pain when lying down), legs (lower more than thighs), rectum and scrotum.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test normal, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Pt has had body ache and pains since injection. These include scalp (combing hair causes pain), back of neck, shoulders and arm (deltoid area mostly), chest, back (pain when lying down), legs (lower more than thighs), rectum and scrotum.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Proctalgia, Scrotal pain, Urine analysis normal
Clinical narrative: Pt has had body ache and pains since injection. These include scalp (combing hair causes pain), back of neck, shoulders and arm (deltoid area mostly), chest, back (pain when lying down), legs (lower more than thighs), rectum and scrotum.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Within several weeks of the injection I started to develop small bumps under the skin mostly on the left side of my jaw and also down the left side of the front of my neck. The bumps last for a few days and disappear. A few have turned red and get a head on them. They do itch somewhat. Then other bumps develop in the same general area. The neck in this area seems to be somewhat sensitive at times. The itching is able to be controlled with Cortisone. This has been going on since January. These have also developed occasionally around the anus. I have never had anything like this in the past.
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via a field representative regarding a currently 75 year old male patient. His past drug included PREVNAR 13 in 2017 (also reported about one year ago). His medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot and expiry date were unknown) 1 dose via an unknown route for pneumonia prevention. On an unspecified date after receiving the vaccine, the patient developed injection site swelling and shortness of breath. It was reported that, the patient sought medical attention by going to the emergency room on an unspecified date at an unknown hospital. However, the patient was not hospitalized and he was released from the emergency room on the same day. Treatment administered for the events was unknown. The patient did have a follow-up visit with the physician on 26-MAR-2018 (reported as this past Monday). The outcome of dyspnoea and injection site swelling were reported as recovered on an unknown date. The causality assessment was not provided by the reporter. No product quality complaint (PQC) was present.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 04-APR-2018, the patient was vaccinated with PROQUAD, by subcutaneous (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. On the same date, the patient also received vaccination with VARIVAX (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot number N028444 with expiration date on 09-APR-2019 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between negative 14°C to negative 10°C for 30 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effects reported. No product quality complaint was involved.
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. Medical history, concurrent conditions, and concomitant medications were not provided. During 2014, the patient was inoculated at a pharmacy with ZOSTAVAX for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. The female patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. During 2016, she was treated (by an unspecified healthcare professional) at a medical center, 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 5 inches redness surrounding injection site, warm to touch and painful.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Diarrhoea, Hypersomnia, Injection site pain, Lethargy
Clinical narrative: Patient became lethargic, was vomiting, and had diarrhea. She slept for 3 days straight (Friday through Sunday), waking only for very short periods. She vomited everything she ate or drank, including water. Vomiting started Friday at 2am and ended Sunday at 9am. Diarrhea started Sunday morning and lasted until Tuesday. Patient also complained her legs hurt (both legs) and would cry from the pain. No one else in our household of 5 got sick. Our household includes another child, age 4. We contacted our doctor and had a phone consultation and monitored patient closely for dehydration.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Patient became lethargic, was vomiting, and had diarrhea. She slept for 3 days straight (Friday through Sunday), waking only for very short periods. She vomited everything she ate or drank, including water. Vomiting started Friday at 2am and ended Sunday at 9am. Diarrhea started Sunday morning and lasted until Tuesday. Patient also complained her legs hurt (both legs) and would cry from the pain. No one else in our household of 5 got sick. Our household includes another child, age 4. We contacted our doctor and had a phone consultation and monitored patient closely for dehydration.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Limb discomfort, Tinnitus
Clinical narrative: Patient was told to wait 15 minutes after getting vaccines. During that time patient started to have ringing in her ears and started to feel lightheaded and very dizzy. She was also experiencing her arm feeling heavy. Patient was then monitored and given a PEDIALYTE popsicle and told to wait another 15 minutes. She still felt the same after waiting so she was told to lay back down and after about 10 minutes she stated that she was feeling better. She was checked again and was told they could leave.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Somnambulism
Clinical narrative: My son had a sleep walking incident at around 11:00 PM the same night that he received the vaccine that was dangerous and disturbing (and a little funny). He has no prior history of sleep walking. He woke me up at 11:30 PM to tell me he had made breakfast for me. He was highly excited and anxious for me to come and have my breakfast. I could smell toast. When I got up all the lights were on in the kitchen and dining room. There was a plate on the dining room table with toast that had a pile of peas and syrup on top. There was also a bowl with oatmeal, raisins, hot sauce, butterscotch ice cream topping, a hardboiled egg cracked in half with the shell still on on top of the oatmeal along with his karate mouth guard. Condiment jars and bottles were scattered around the table. In the kitchen he had combined, milk, Sprite, Root beer and Rice Vinegar in a tall glass. The Kitchen smelled strongly of the rice vinegar. All of the containers were scattered on the kitchen counter. He was extremely excited for me to eat the breakfast and seemed drunk. I thanked him and told him he could go back to bed and tucked him in. As I left the room, he asked me if I loved the breakfast.  When I cleaned up, I found a glue stick in the oatmeal bowl he'd prepared for me. It occurred to me that this must be related to the vaccine he'd received that day.  When I went online I found some disturbing references to sleep disorders related to Gardasil 9. We've been watching him for further sleep walking incidents and he hasn't had any, but I'm extremely hesitant to give him the booster shots.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Whole upper Right arm swollen and very itchy and pain with touch since date of vaccine 3/29/2018. Swelling decrease in two days.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Patient reported that about 4 hours after the event, patient had pain in the injection site arm. Throughout the night, the arm pain became worse and worse and "radiated to his whole body". He treated the aches with acetaminophen, which he said helped. He said the pain was worse in the middle of the night because he assumed that the acetaminophen had worn off at that point. The day after the vaccine, he reports muscle soreness, but he claims he is starting to feel better.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Pain, Pain in extremity
Clinical narrative: Arm pain (local reaction), full body aching.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: 07/26/17 Pt. c/o feeling achy that evening. 07/27/17 Pt. c/o injection site being swollen, red, warm, and tender. 07/28/17 Pt. reports arm being less sore, but still swollen, red, and warm. 07/31/17 Pt. reports symptoms are resolved - Pt. took BENADRYL and TYLENOL.