chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site pruritus, Injection site swelling, Periarthritis, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of adhesive capsulitis in a 67-year-old female patient who received SHINGRIX. On 31st January 2018, the patient received the 1st dose of SHINGRIX. On 15th February 2018, 15 days after receiving SHINGRIX, the patient experienced injection site hematoma (serious criteria other: As per reporter). On an unknown date, the patient experienced adhesive capsulitis (serious criteria other: As per reporter), injection site swelling (serious criteria other: As per reporter), injection site itching (serious criteria other: As per reporter) and vaccine administered at inappropriate site. On an unknown date, the outcome of the adhesive capsulitis was not recovered/not resolved and the outcome of the injection site hematoma, injection site swelling and injection site itching were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the adhesive capsulitis, injection site hematoma, injection site swelling and injection site itching to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine in the left deltoid. Less than a month after receiving vaccination, the patient experienced frozen shoulder or adhesive capsulitis and developed swelling and itching that were specific to injection site. The injection site events resolved within several days after vaccination. The patient was required doctor's visit on 15th February 2018 due to the frozen shoulder. The health care professional also diagnosed an injection hematoma at that time. The health care professional prescribed PT for patient which she was currently undergoing. The patient required emergency room visit. The patient received the vaccine at low injection site, which led to inappropriate site of vaccination. The reporter did not feel as though SHINGRIX caused the issue but instead an inappropriately low injection site caused the issue.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient seen in office today (4/10/18), presented with night leg with 2 cm area of redness, sl warmth, and sl fullness. Noted to might be slightly tender. Clearly at site of vaccine. Knee and hip with full range of motion without discomfort. Diagnosed with cellulitis of right lower extremity prescribed antibiotic cephalexin.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Throat irritation, Urticaria
Clinical narrative: Hives. Epinephrine at urgent care on 4/7/18 approximately 5 PM with IM steroids and BENADRYL IM. BENADRYL at home approximately midnight 4/7/18. Rx steroids at Hospital on 4/17/18 12 PM. Started on PO steroids 4/8/18 at 9:30 AM. Throat was burning. Still has some hives today in office.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, VARCEL
Symptoms: Blood glucose, Seizure
Clinical narrative: Seizure lasting about 45 seconds that happened on 4/5/2017 at 18:15.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Warm rash starting about 1 inch around and growing  to 3 inches.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Lip swelling
Clinical narrative: Patient's father called the hospital on 04/09/2018 around 2130 to report patient's upper lip being swollen. Patient had received his one year vaccinations earlier in the day. He was concerned about patient's upper lip being an adverse reaction to the vaccinations. He says he just gave him BENADRYL 10 minutes prior to calling. Reported patient to be acting completely normal and showing no signs of respiratory distress. Dr. notified of phone call. Per instruction of Dr, nurse told father to closely monitor for wheezing, increased respiratory rate, or other signs of respiratory distress. Can give him TYLENOL or MOTRIN as needed. As well as POPSICLE or something cold on his lip. Said to monitor for signs of a rash as well. Father verified he understood these instruction and will either call back with further concerns or bring patient in to be seen if needed. Patient's mother brought patient into the clinic on 4/10/18 at 10:00 to see PCP. Upper lip swelling is improving and patient continues to show no signs of respiratory distress. Mother will continue to monitor and vaccine nurse will report event to VAERS.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Decreased appetite, Fatigue, Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 35-year-old female patient who received RABAVERT (batch number SWOI27AA, expiry date 31st August 2020). On 12th March 2018, the patient received the 1st dose of RABAVERT. On 12th March 2018, 2 hrs after receiving RABAVERT, the patient experienced tiredness, appetite lost and malaise. In March 2018, the outcome of the tiredness, appetite lost and malaise were recovered/resolved. The reporter considered the tiredness, appetite lost and malaise to be related to RABAVERT. Additional details were provided as follows: The patient was seen at hospital on 9th March 2018 and received rabies immunoglobulin but the hospital forgot to administer the 1st dose of rabies vaccine on that day. The healthcare professional reported that the patient received 1st dose of RABAVERT late post exposure in the right deltoid. The patient experienced tiredness, fatigue, loss of appetite and malaise that lasted for 2 days. For further tolerance to next dose, refer case US2018GSK054409.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Inappropriate schedule of drug administration, Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 35-year-old female patient who received RABAVERT (batch number SWOI27AA, expiry date 31st August 2020). On 12th March 2018, the patient received the 1st dose of RABAVERT. On 12th March 2018, 2 hrs after receiving RABAVERT, the patient experienced tiredness, appetite lost and malaise. In March 2018, the outcome of the tiredness, appetite lost and malaise were recovered/resolved. The reporter considered the tiredness, appetite lost and malaise to be related to RABAVERT. Additional details were provided as follows: The patient was seen at hospital on 9th March 2018 and received rabies immunoglobulin but the hospital forgot to administer the 1st dose of rabies vaccine on that day. The healthcare professional reported that the patient received 1st dose of RABAVERT late post exposure in the right deltoid. The patient experienced tiredness, fatigue, loss of appetite and malaise that lasted for 2 days. For further tolerance to next dose, refer case US2018GSK054409.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 35-year-old female patient who received RABAVERT (batch number SWOI27AA, expiry date 31st August 2020). On 12th March 2018, the patient received the 1st dose of RABAVERT. On 12th March 2018, 2 hrs after receiving RABAVERT, the patient experienced tiredness, appetite lost and malaise. In March 2018, the outcome of the tiredness, appetite lost and malaise were recovered/resolved. The reporter considered the tiredness, appetite lost and malaise to be related to RABAVERT. Additional details were provided as follows: The patient was seen at hospital on 9th March 2018 and received rabies immunoglobulin but the hospital forgot to administer the 1st dose of rabies vaccine on that day. The healthcare professional reported that the patient received 1st dose of RABAVERT late post exposure in the right deltoid. The patient experienced tiredness, fatigue, loss of appetite and malaise that lasted for 2 days. For further tolerance to next dose, refer case US2018GSK054409.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Decreased appetite, Fatigue, Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 35-year-old female patient who received RABAVERT (batch number SWOI27AA, expiry date 31st August 2020). Previously administered products included RABAVERT with an associated reaction of fatigue (see case US2018047677). On 16th March 2018, the patient received the 2nd dose of RABAVERT. On 16th March 2018, 1 hr after receiving RABAVERT, the patient experienced tiredness, appetite lost, malaise, upset stomach, vomiting and drug dose administration interval too long. On 19th March 2018, the outcome of the appetite lost, malaise, upset stomach and vomiting were recovered/resolved. On an unknown date, the outcome of the tiredness was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. The reporter considered the tiredness, appetite lost, malaise, upset stomach and vomiting to be possibly related to RABAVERT. Additional details were provided as follows: The patient was seen at hospital on 9th March 2018 and received rabies immunoglobulin but the hospital forgot to administer the 1st dose of rabies vaccine on that day. The healthcare professional reported that the patient received the 1st dose of RABAVERT late post exposure from the physician on 12th March 2018 and 2nd dose on 16 March 2018 on day 4 because the healthcare professional was under the impression that these were doses 2 and 3 of the series, which led to lengthening of vaccination schedule. It was later realized the patient never received dose 1. The patient experienced worsening of events which lasted for 1 days.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Inappropriate schedule of drug administration, Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 35-year-old female patient who received RABAVERT (batch number SWOI27AA, expiry date 31st August 2020). Previously administered products included RABAVERT with an associated reaction of fatigue (see case US2018047677). On 16th March 2018, the patient received the 2nd dose of RABAVERT. On 16th March 2018, 1 hr after receiving RABAVERT, the patient experienced tiredness, appetite lost, malaise, upset stomach, vomiting and drug dose administration interval too long. On 19th March 2018, the outcome of the appetite lost, malaise, upset stomach and vomiting were recovered/resolved. On an unknown date, the outcome of the tiredness was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. The reporter considered the tiredness, appetite lost, malaise, upset stomach and vomiting to be possibly related to RABAVERT. Additional details were provided as follows: The patient was seen at hospital on 9th March 2018 and received rabies immunoglobulin but the hospital forgot to administer the 1st dose of rabies vaccine on that day. The healthcare professional reported that the patient received the 1st dose of RABAVERT late post exposure from the physician on 12th March 2018 and 2nd dose on 16 March 2018 on day 4 because the healthcare professional was under the impression that these were doses 2 and 3 of the series, which led to lengthening of vaccination schedule. It was later realized the patient never received dose 1. The patient experienced worsening of events which lasted for 1 days.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 35-year-old female patient who received RABAVERT (batch number SWOI27AA, expiry date 31st August 2020). Previously administered products included RABAVERT with an associated reaction of fatigue (see case US2018047677). On 16th March 2018, the patient received the 2nd dose of RABAVERT. On 16th March 2018, 1 hr after receiving RABAVERT, the patient experienced tiredness, appetite lost, malaise, upset stomach, vomiting and drug dose administration interval too long. On 19th March 2018, the outcome of the appetite lost, malaise, upset stomach and vomiting were recovered/resolved. On an unknown date, the outcome of the tiredness was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. The reporter considered the tiredness, appetite lost, malaise, upset stomach and vomiting to be possibly related to RABAVERT. Additional details were provided as follows: The patient was seen at hospital on 9th March 2018 and received rabies immunoglobulin but the hospital forgot to administer the 1st dose of rabies vaccine on that day. The healthcare professional reported that the patient received the 1st dose of RABAVERT late post exposure from the physician on 12th March 2018 and 2nd dose on 16 March 2018 on day 4 because the healthcare professional was under the impression that these were doses 2 and 3 of the series, which led to lengthening of vaccination schedule. It was later realized the patient never received dose 1. The patient experienced worsening of events which lasted for 1 days.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of adverse drug reaction 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 adverse drug reaction and activities of daily living impaired. On an unknown date, the outcome of the adverse drug reaction and activities of daily living impaired were unknown. It was unknown if the reporter considered the adverse drug reaction and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician (patient) experienced some unexpected side effects after immunization with SHINGRIX recently and it did affect her ability to carry out daily activities for a couple of days. The reporter think that she was having second thoughts about getting the second dose. The reporter sent the product information (PI) to the patient, which did mention that the 2nd side effects are sometimes worse than the dose 1st, but the reporter also know that its better protection with a completed 2nd dose series. This might be something that the reporter need to counsel patients about in a very deliberate way, especially those younger than 70 years.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of edema in a female patient who received SHINGRIX. On 18th January 2018, the patient received SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced edema and erythema. In January 2018, the outcome of the edema and erythema were recovered/resolved. It was unknown if the reporter considered the edema and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's health care provided to GlaxoSmithKline field representative. The patient's symptoms resolved after five days post vaccination. The reporter provided permission to contact the patient's physician. No additional information was provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site reaction in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction was not reported and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient may have received a dose of SHINGRIX subcutaneously, which led to inappropriate route of vaccination. The patient experienced local injection site reaction where the SHINGRIX was given. The healthcare professional did not gave the vaccine so had no lot number or expiry date on the SHINGRIX. This was an accidental medication error associated with an adverse event.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date unknown). On 23rd March 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd March 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site swelling and injection site pain were recovered/resolved. The reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX vaccine in the left deltoid. The health care professional stated the patient developed raised, red, painful, swollen circle approximately 2 inches in diameter at the injection site within hours of receiving SHINGRIX vaccine. Symptoms lasted one week, all resolved except for slight redness remaining at the injection site which was still present on 3rd April 2018. The health care professional did not provide the expiration date for the SHINGRIX vaccine.
Age: 78.0
Sex: F
Vaccine: VARZOS, 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 78-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date unknown). On 23rd March 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd March 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site swelling and injection site pain were recovered/resolved. The reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX vaccine in the left deltoid. The health care professional stated the patient developed raised, red, painful, swollen circle approximately 2 inches in diameter at the injection site within hours of receiving SHINGRIX vaccine. Symptoms lasted one week, all resolved except for slight redness remaining at the injection site which was still present on 3rd April 2018. The health care professional did not provide the expiration date for the SHINGRIX vaccine.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 78-year-old female patient who received SHINGRIX. Concomitant products included PREMARIN. On 28th February 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th February 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 2nd March 2018, the patient experienced injection site rash. On 7th March 2018, the outcome of the injection site rash was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site rash and injection site pain to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient's daughter. The reporter was a floater and the facility address was where she was working on the day of reporting. The patient never had chicken pox but her physician advised her to get the vaccine anyway. On 2nd March 2018 at 2:00 hours, the patient received SHINGRIX on left deltoid. Forty eight hours after receiving SHINGRIX, the patient developed a circle shaped rash presenting an inch below the injection site approximately 5 inches in length stopping at her elbow. The patient also mentioned slight pain at the injection site when injected. The reporter provided her home address for further follow up.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Pruritus, Swelling face
Clinical narrative: Patient was given her final Hep B dose in the series of 3 by Employee Health Nurse (myself). She had no previous reactions to vaccine. The vaccine was given around 11:30 or Noon on 3/26 and by 6 AM on 3/27 she was feeling itching on her hands. The itching increased as the morning went on. Patient tried a OTC steroid cream to calm the itching, but by end of the day she had itching up to her elbows and could feel itching on her knees also. When reporting to work on Wed 3/28, patient's manager noticed her face looked a little puffy. Then noticed a occasional dry cough. Patient's clinic manager contacted me to question next step. Patient's manager drove her to ED and stayed with her until discharge. Patient followed up with Occupational Medicine Department on Fri 3/30 per ED physicians order. Patient had not changed any of her behaviors or the product she uses as she has a family member with allergies and this is the only thing in her routine that changed.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy test, Diarrhoea, Eye swelling, Fatigue, Thyroid function test
Clinical narrative: Hives, swelling of eyes, diarrhea, vomiting, fatigue. Symptoms peaked at 5 months. Hives still occurring 7 months post injection though less severe than previously.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria, Vomiting
Clinical narrative: Hives, swelling of eyes, diarrhea, vomiting, fatigue. Symptoms peaked at 5 months. Hives still occurring 7 months post injection though less severe than previously.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Abdominal pain upper, Fatigue, Headache, Immediate post-injection reaction, Influenza virus test negative
Clinical narrative: Very tired and lethargic immediately after the shot but 104 fever presented first Wednesday afternoon. The high fever lasted 4 full days. Very lethargic. Very sore throat and headache and stomach ache still ongoing.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Lethargy, Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Very tired and lethargic immediately after the shot but 104 fever presented first Wednesday afternoon. The high fever lasted 4 full days. Very lethargic. Very sore throat and headache and stomach ache still ongoing.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Acne, Blood test, Decreased appetite, Diet refusal, Discomfort
Clinical narrative: Lymph nodes on the back of neck were noted to be inflamed on  4/5/2017. The following morning at approximately 11 AM pt spiked a mild fever. Motrin was administered around 2:30 PM. The fever then spiked to 103.9 degrees around 10:30 PM. At that point we brought pt to the emergency room at Hospital. Urine samples were collected as well as blood. Vital signs were taken and the initial prognosis was noted to be viral. Children's Motrin and Children's Tylenol was recommended to be alternated approximately every 4 hours. Pt exhibited overall discomfort and was inconsolable over the next 2 days with fevers spiking up to 104 degrees. Appetite was non-existent with exception to nursing. Pt refused water and solids for the next 2  days. Pt was extremely lethargic and somewhat unresponsive during the height of her fever. Sunday showed signs of promise as pt started to show an appetite and began eating solid food at approximately 2:00 PM. She also accepted water. At this point pt still exhibited a mild fever that did not exceed 100.5 degrees. By Monday evening pt exhibited extreme pain, arching her back and crying incessantly. At approximately 3AM we noted a rash on most of pt's body and included white "pimples" in mouth.  Her last fever was Tuesday morning at 3 AM.  Motrin was used to bring the fever down.  Pt has remained "not herself" since composing this report.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Emotional distress, Inflammation, Lethargy, Opisthotonus, Pain
Clinical narrative: Lymph nodes on the back of neck were noted to be inflamed on  4/5/2017. The following morning at approximately 11 AM pt spiked a mild fever. Motrin was administered around 2:30 PM. The fever then spiked to 103.9 degrees around 10:30 PM. At that point we brought pt to the emergency room at Hospital. Urine samples were collected as well as blood. Vital signs were taken and the initial prognosis was noted to be viral. Children's Motrin and Children's Tylenol was recommended to be alternated approximately every 4 hours. Pt exhibited overall discomfort and was inconsolable over the next 2 days with fevers spiking up to 104 degrees. Appetite was non-existent with exception to nursing. Pt refused water and solids for the next 2  days. Pt was extremely lethargic and somewhat unresponsive during the height of her fever. Sunday showed signs of promise as pt started to show an appetite and began eating solid food at approximately 2:00 PM. She also accepted water. At this point pt still exhibited a mild fever that did not exceed 100.5 degrees. By Monday evening pt exhibited extreme pain, arching her back and crying incessantly. At approximately 3AM we noted a rash on most of pt's body and included white "pimples" in mouth.  Her last fever was Tuesday morning at 3 AM.  Motrin was used to bring the fever down.  Pt has remained "not herself" since composing this report.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Unresponsive to stimuli, Urine analysis
Clinical narrative: Lymph nodes on the back of neck were noted to be inflamed on  4/5/2017. The following morning at approximately 11 AM pt spiked a mild fever. Motrin was administered around 2:30 PM. The fever then spiked to 103.9 degrees around 10:30 PM. At that point we brought pt to the emergency room at Hospital. Urine samples were collected as well as blood. Vital signs were taken and the initial prognosis was noted to be viral. Children's Motrin and Children's Tylenol was recommended to be alternated approximately every 4 hours. Pt exhibited overall discomfort and was inconsolable over the next 2 days with fevers spiking up to 104 degrees. Appetite was non-existent with exception to nursing. Pt refused water and solids for the next 2  days. Pt was extremely lethargic and somewhat unresponsive during the height of her fever. Sunday showed signs of promise as pt started to show an appetite and began eating solid food at approximately 2:00 PM. She also accepted water. At this point pt still exhibited a mild fever that did not exceed 100.5 degrees. By Monday evening pt exhibited extreme pain, arching her back and crying incessantly. At approximately 3AM we noted a rash on most of pt's body and included white "pimples" in mouth.  Her last fever was Tuesday morning at 3 AM.  Motrin was used to bring the fever down.  Pt has remained "not herself" since composing this report.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site vesicles, Malaise
Clinical narrative: Vaccinated 4/4/18 late afternoon. 4/5 am, Felt nauseated and generally ill the next couple of days and also noticed redness and irritation at vaccination site left deltoid. She stated that the site was initially small and now is much more swollen and looks a little like it's getting a blister. 4/9/18 Sent to Dr's office who diagnosed cellulitis and began keflex. Follow up in 3 days. Other symptoms are better
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Vaccination site irritation
Clinical narrative: Vaccinated 4/4/18 late afternoon. 4/5 am, Felt nauseated and generally ill the next couple of days and also noticed redness and irritation at vaccination site left deltoid. She stated that the site was initially small and now is much more swollen and looks a little like it's getting a blister. 4/9/18 Sent to Dr's office who diagnosed cellulitis and began keflex. Follow up in 3 days. Other symptoms are better
Age: 36.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Endothermic indurated mass and pain at site, malaise.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Eye swelling, Pain, Rash
Clinical narrative: Had the MENACTRA vaccine on 4/2/2018, puffy around one eye on 4/3/2018. Rash appeared on 4/4/2018. Took son to his pediatrician 4/5/2018 where they gave him a prescription of Triamcinolone Acetonide. That evening child said he had pain all over. Went to Emergency Room that night. He was given a prescription for Prednisolone.  He is currently still using the Triamcinolone and Benadryl.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain, Peripheral swelling
Clinical narrative: Patient called on 4/10 to report that he experienced knee pain, swollen leg, and pain on both shoulders. I advised patient to seek medical care for those symptoms.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash started on 4-6-18 and started as itching, then rash on left arm, the both arms, then chest, then face and legs.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Hyperhidrosis, Infection, Pain, White blood cell count increased
Clinical narrative: A few days following the vaccine the patient experienced sweating, chills, and full body soreness. Went to the doctor 4.10.18 and was diagnosed with an infection ("high WBC count"). Was prescribed Cefdinir 300mg BID for 10 days.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: It started with a powerful headache, near migraine level, nausea and a low grade fever. It faded the next day and I only had a general headache and the nausea. All seemed fine and under control and I went about my business taking aspirin but that night, around 11pm I got intense chills and was up all night shaking. It was so extreme I nearly called the ER except I saw on the site that this might be a side effect. Diarrhea started that evening and kept up all through the next day. The chills were nearly gone by about 10 am but the stomach and diarrhea continued and as of today 5 days after having the vaccine, the stomach is still unsettled and the diarrhea, while under control, is still continuing. The stomach is making a lot of noises but other than that I'm back to normal. I haven't felt the need to have a doctor's visit because it seems to be slowly fading but if it continues tomorrow I will go in to see what to do about the stomach.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: It started with a powerful headache, near migraine level, nausea and a low grade fever. It faded the next day and I only had a general headache and the nausea. All seemed fine and under control and I went about my business taking aspirin but that night, around 11pm I got intense chills and was up all night shaking. It was so extreme I nearly called the ER except I saw on the site that this might be a side effect. Diarrhea started that evening and kept up all through the next day. The chills were nearly gone by about 10 am but the stomach and diarrhea continued and as of today 5 days after having the vaccine, the stomach is still unsettled and the diarrhea, while under control, is still continuing. The stomach is making a lot of noises but other than that I'm back to normal. I haven't felt the need to have a doctor's visit because it seems to be slowly fading but if it continues tomorrow I will go in to see what to do about the stomach.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Eating disorder, Regressive behaviour, Speech disorder
Clinical narrative: Stop eating and talking.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Hyperaesthesia, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 67-year-old female patient. The patient's drug reactions/allergies included allergy to penicillin. The patient's historical condition included rash when taking penicillin. On 14-MAR-2018, the patient was vaccinated with ZOSTAVAX, 0.65 ml, once (lot # and expiry date was unknown by reporter) for prevention of Shingles. Concomitant therapies included levothyroxine sodium, LIPITOR and FOSAMAX. On 15-MAR-2018 the patient experienced redness and soreness at the injection site (injection site erythema)(injection site pain). On 17-MAR-2018, the patient felt unwell (malaise). On 18-MAR-2018, the patient experienced a burning sensation on right side from the middle of lower back around to umbilicus. The pain was not excruciating but it was annoying. The patient stated that there was no rash, but her skin was sensitive at the site of the adverse event and she feels pain whenever she leans against something or her clothes rub against that part of her body (hyperaesthesia). The patient sought medical attention (spoke with provider). The outcome of injection site erythema, chills, pain, hyperaesthesia, burning sensation, malaise and injection site pain was reported as not recovered. Causality assessment was not provided by reporter. No product quality complaint was involved.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Malaise, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 67-year-old female patient. The patient's drug reactions/allergies included allergy to penicillin. The patient's historical condition included rash when taking penicillin. On 14-MAR-2018, the patient was vaccinated with ZOSTAVAX, 0.65 ml, once (lot # and expiry date was unknown by reporter) for prevention of Shingles. Concomitant therapies included levothyroxine sodium, LIPITOR and FOSAMAX. On 15-MAR-2018 the patient experienced redness and soreness at the injection site (injection site erythema)(injection site pain). On 17-MAR-2018, the patient felt unwell (malaise). On 18-MAR-2018, the patient experienced a burning sensation on right side from the middle of lower back around to umbilicus. The pain was not excruciating but it was annoying. The patient stated that there was no rash, but her skin was sensitive at the site of the adverse event and she feels pain whenever she leans against something or her clothes rub against that part of her body (hyperaesthesia). The patient sought medical attention (spoke with provider). The outcome of injection site erythema, chills, pain, hyperaesthesia, burning sensation, malaise and injection site pain was reported as not recovered. Causality assessment was not provided by reporter. No product quality complaint was involved.
Sex: F
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report was received from a physician assistant refers to a female patient of unknown age. The patient has no pertinent medical history. Concomitant therapy included sterile diluent. The patient had drug allergy for pork. On an unknown date the patient was vaccinated with VARIVAX (dose, units and frequency were unknown) (lot # and expiry date was not reported) for prevention of chicken pox. On an unknown date the patient had a varicella titre, with the result that showed a low titre (viral titre decreased). It was reported that no treatment was given for the event low titre. It was also reported that the patient sought treatment from reporter. It was reported that no intervention was performed to prevent the serious criteria. The outcome of the event low titre was not recovered. The casual relationship between the event low titre and VARIVAX was not provided. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 10-APR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, by a physician, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. During 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, 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. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Phone from Mom. She states that patient had a reaction to the TRUMENBA vaccine that she had on Wed last week. Swelling and redness at the injection site, fever and body aches the next day and headache. Mom states that she did some research and found that people with latex allergies have more trouble with this vaccine. She said that patient has a latex allergy but I don't see it in the chart. Mom said she just wanted to make you aware if this.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Haemoptysis, Influenza virus test positive, Muscular weakness, Pain, Productive cough
Clinical narrative: Client called me in January to report that in December, 2 months after receiving her flu shot she developed weakness of her lower extremities, hurting all over, burning throat, productive cough with bloody, green, yellow sputum. Went to her primary care provider and had a negative rapid flu test. Returned to the doctor a few days later and tested positive for Flu. I told her that the flu shot is the best protection against the flu, but was not 100% effective.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Sputum discoloured, Throat irritation
Clinical narrative: Client called me in January to report that in December, 2 months after receiving her flu shot she developed weakness of her lower extremities, hurting all over, burning throat, productive cough with bloody, green, yellow sputum. Went to her primary care provider and had a negative rapid flu test. Returned to the doctor a few days later and tested positive for Flu. I told her that the flu shot is the best protection against the flu, but was not 100% effective.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient woke up 4/10 with injection site swollen and painful.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Immediate post-injection reaction, Injection site discomfort, Limb discomfort, Musculoskeletal stiffness
Clinical narrative: Bilateral upper arm discomfort and possible synovitis of the hands following SHINGRIX vaccine. She felt fine immediately after other than the expected arm pain. The following day, she noticed that both of her arms were sore. Since then, she has seen pain spread throughout her body. She reports that her feet do not hurt, and she is not having any pain in her head, but otherwise the rest of her body hurts. Yesterday, she noticed that her hands had also become swollen. They feel very stiff. She has never felt like this before. Other than the body aches, she is feeling in her usual state of health. No fevers or chills. No headaches. No vision changes. No sore throat or trouble swallowing. No nasal symptoms. No cold symptoms. No chest pain or shortness of breath. No cough or wheezing. No abdominal pain, nausea, vomiting, or diarrhea. No rashes. Other than her hands, she has not noticed joint swelling elsewhere.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Bilateral upper arm discomfort and possible synovitis of the hands following SHINGRIX vaccine. She felt fine immediately after other than the expected arm pain. The following day, she noticed that both of her arms were sore. Since then, she has seen pain spread throughout her body. She reports that her feet do not hurt, and she is not having any pain in her head, but otherwise the rest of her body hurts. Yesterday, she noticed that her hands had also become swollen. They feel very stiff. She has never felt like this before. Other than the body aches, she is feeling in her usual state of health. No fevers or chills. No headaches. No vision changes. No sore throat or trouble swallowing. No nasal symptoms. No cold symptoms. No chest pain or shortness of breath. No cough or wheezing. No abdominal pain, nausea, vomiting, or diarrhea. No rashes. Other than her hands, she has not noticed joint swelling elsewhere.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Herpes zoster, Injection site pain, Injection site vesicles
Clinical narrative: Three weeks after receiving her MMRV the child developed several watery painful blisters around the injection site. The family took her to her primary care provider and the doctor said that the child had the shingles. I reviewed the side effect information with the family and pointed out that a side effect of the varicella live virus vaccination is to have some chicken pox type blisters of limited quanitity within 3 weeks of vaccination and that she was not contagious and the blisters should crust and fade within a few days, just to keep them covered until crusted over. The mother wanted to file this report with VAERS.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis within 5 minutes.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea, Intensive care, Iodine allergy
Clinical narrative: Patient had very bad pain in right arm moved to chest had SOB. Went to ER. Patient then diagnosed with Pericarditis. Had an MRI with Contrast had a Iodine allergy ended with patient in ICU x 3 days with anaphylaxis.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Pericarditis, Scan with contrast
Clinical narrative: Patient had very bad pain in right arm moved to chest had SOB. Went to ER. Patient then diagnosed with Pericarditis. Had an MRI with Contrast had a Iodine allergy ended with patient in ICU x 3 days with anaphylaxis.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Employee complained of "itchy, red, swollen and hot to site of injection. Reports redness around arm about 4 inches long." Symptoms started approximately one and a half days after administration of vaccine.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Dizziness, Headache, Hypoaesthesia, Neck pain
Clinical narrative: Started with headache/dizziness - side of face became numb within 24 hours of shot. From there, it went to neck/back pain. Those are main symptoms experiencing with multiple hospital visits. Patient believes that MS or viral meningitits could be present.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Malaise
Clinical narrative: Patient states her arm was sore at injection site and she had a headache and chills for a day.  When asked if she would have been able to go to work that day she said no she really didn't feel well.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Malaise
Clinical narrative: Patient's wife states his arm was very red and painful at the injection site and complained of malaise. Injection site was red and tender for 5 days.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain, Sleep disorder, Swelling
Clinical narrative: Severe pain for first 36 hours following injection. Significant shoulder swelling and pain slowly improving but still affecting sleep. Active range of motion limited to 30 degrees, passive range of motion to 90 degrees. Able to hold arm elevated against gravity but not against resistance.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Insomnia, Myalgia, Peripheral swelling, Pruritus generalised, Rash macular
Clinical narrative: On the same day as the employee received the vaccine at 10:00pm she began having itching all over her body difficulty sleeping and muscle aches in upper extremities/back areas. No rash at the time nor shortness of breath. The next day she noted that her whole body seemed swollen arms, legs, face and then she noted blotches of red all over body - not raised, they were flat. She did take a ZYrtec  which seemed to help a little. She saw her provider on 4/9/18 who suggested she take Benadryl 25 mg. which helped a lot. She reported this to Employee Health on 4/10/18 and her sore muscles and blotchy rash and swelling had gone. She is still slightly itchy but no rash.  She is concerned about getting additional Hepatitis B vaccination IF she needs it.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Swelling face
Clinical narrative: On the same day as the employee received the vaccine at 10:00pm she began having itching all over her body difficulty sleeping and muscle aches in upper extremities/back areas. No rash at the time nor shortness of breath. The next day she noted that her whole body seemed swollen arms, legs, face and then she noted blotches of red all over body - not raised, they were flat. She did take a ZYrtec  which seemed to help a little. She saw her provider on 4/9/18 who suggested she take Benadryl 25 mg. which helped a lot. She reported this to Employee Health on 4/10/18 and her sore muscles and blotchy rash and swelling had gone. She is still slightly itchy but no rash.  She is concerned about getting additional Hepatitis B vaccination IF she needs it.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Vaccination site induration, Vaccination site nodule, Vaccination site swelling
Clinical narrative: Swollen hard nodule approximately 1-2 inches from the vaccine site. Vaccine was given in the right vastus lateralis and the nodule is palpable towards the inner thigh (not the groin). No redness, no fever, no apparent pain when palpated.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Vaccination site induration, Vaccination site nodule, Vaccination site swelling
Clinical narrative: Swollen hard nodule approximately 1-2 inches from the vaccine site. Vaccine was given in the right vastus lateralis and the nodule is palpable towards the inner thigh (not the groin). No redness, no fever, no apparent pain when palpated.