chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Loss of personal independence in daily activities, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included shingles (received 7 years ago before the date of reporting). In October 2017, the patient received the 1st dose of SHINGRIX. In December 2017, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient having an episode of Shingles in May as well as a second episode that is currently ongoing. The batch number was unavailable as the reporter was the patient. Adeverse event obtained through chat, in which both consumer and agent had connection issues. During reconnection consumer stated that, the patient was the greatest advocate of shingles vaccines because she had the old vaccines 7 years ago but she would no longer encourage people to go through the expense of getting the new vaccines. The agent requested full demographics and consent to follow up. Follow-up consent provided however only an email address and telephone number was provided.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site reaction
Clinical narrative: PATIENT SAID HE HAD ON HIS RIGHT ARM IN THE GENERAL AREA OF WHERE THE VACCINE WAS ADMINISTERED. UNSURE OF WHEN HE SAW HIS DOCTOR REGARDING THE REACTION, BUT HE SAID THE RASH STARTED A FEW DAYS AFTER GETTING THE VACCINE. HE SAID THE DR TOLD HIM TO TAKE BENADRYL OVER THE COUNTER AND THAT HELPED TO CLEAR THE RASH. HE ALSO HAD A PNEUMONIA SHOT A WEEK PRIOR TO THE SHINGLES VACCINE, BUT WAS UNSURE WHICH ONE HE RECEIVED.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia
Clinical narrative: Severe shivering, fever (102), severe headache, upset stomach, severe chills started around 9:00 pm, chills and fever lasted until approximately 12:30 am, headache and upset stomach along with on/off chills lasted throughout next 24 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever (101), chills, body aches.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Cold sweat, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Immediately following administration of .5 mL TENIVAC, donor appeared clammy and lost color in face. Then, the donor lost consciousness for approx. 20 seconds. Center Medical Specialist lightly pinched the donor's trap to awaken the donor. Donor's feet were elevated. Donor again lost consciousness for approx.30 seconds. After laying down for approx. 15 minutes, the donor stated he felt well enough to sit up. Donor was given Powerade and a granola bar. From onset of event to time donor was well enough to leave the facility, was about 35 minutes.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Irritability, Pyrexia, Vomiting
Clinical narrative: The following day after vaccination developed low grade fever, irritability, significant vomiting and mild diarrhea for 2 days.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Headache, Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Initial headache and irritation at the injection site. Within 12 hours developed red raised area measuring 1 x 2 inches, continued headache, feeling feverish, dizziness. Area over the next 48 hours doubled in size and then dissipated within 72  hours to the size of a dime at the injection site. Headache and other symptoms fully resolved.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Initial headache and irritation at the injection site. Within 12 hours developed red raised area measuring 1 x 2 inches, continued headache, feeling feverish, dizziness. Area over the next 48 hours doubled in size and then dissipated within 72  hours to the size of a dime at the injection site. Headache and other symptoms fully resolved.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Computerised tomogram, Dizziness, Electrocardiogram, Seizure
Clinical narrative: I was at the Urgent Care for stitches after cutting my hand on a glass while doing dishes. Around 10 a.m. I was given the vaccination and I had a seizure almost immediately after injection, given 2 mg ATIVAN. Then transferred down the hall to the ER. Dizziness and vomiting x2 for 24 hours after. 3/10/2019. I have never had a seizure before in my entire life.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: I was at the Urgent Care for stitches after cutting my hand on a glass while doing dishes. Around 10 a.m. I was given the vaccination and I had a seizure almost immediately after injection, given 2 mg ATIVAN. Then transferred down the hall to the ER. Dizziness and vomiting x2 for 24 hours after. 3/10/2019. I have never had a seizure before in my entire life.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Left arm swelling, redness, headache, fever, chills, left arm stiffness.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Left arm swelling, redness, headache, fever, chills, left arm stiffness.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Genital rash, Pain, Pyrexia, Rash
Clinical narrative: Bad rash on legs and groin area as well as fever, pain.
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Rash - erythematous, diffuse, macular popular rash on all body surfaces (except palms & soles); Re-emergence of rash on subsequent day; Pt evaluated in ER - flu vaccine suspected by ER physician.
Age: 48.0
Sex: F
Vaccine: HEP, IPV, MMR, TYP
Symptoms: Fatigue, Herpes zoster, Rash
Clinical narrative: CLIENT STATES HAVING SEVERE FATIGUE ON DAY 3 FOLLOWING VACCINE ADMINISTRATION, WITH DIFFUSE RASH RADIATING FROM LEFT SIDE OF BACK TO FRONT SIDE OF LEFT ABDOMEN. SHE WAS SEEN LATER THAT WEEK AT URGENT CARE BY NP AND WAS TOLD THE VACCINES SHE RECEIVED OVERWHELMED HER IMMUNE SYSTEM CAUSING HER SHINGLES. SHE WAS TREATED WITH VALTREX 1GM 3XDAY FOR 1 WEEK. CLIENT CALLED HEALTH ON DAY 20 FOLLOWING VACCINE ADMINISTRATION TO REPORT SYMPTOMS OF ADVERSE REACTION AND STATES HER SYMPTOMS HAVE NOW RESOLVED.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Injection site erythema, Loss of personal independence in daily activities
Clinical narrative: For the first 10 hours it was more or less just the sore arm. During the first night I began to experience systemic muscle soreness and pain, fatigue, chills, probably a mild fever though I never took my temperature, and redness of injection area. The systemic symptoms continued for 2 full days and were gone by day 4. The red and sore arm continued for 6 days. On days 2 and 3 I also had intermittent stomach pain (no vomiting, no diarrhea, no significant nausea) which may or may not have been related to the NSAIDS I took for the other symptoms. On day 3 I had a mild red rash covering most of my body above the waist, no itchiness, no hives, no pain to it. By day 4 this rash had retreated to only parts of my arm and armpit within 8 inches of the injection site. I returned to full normal activities on day 5.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia, Rash, Rash erythematous
Clinical narrative: For the first 10 hours it was more or less just the sore arm. During the first night I began to experience systemic muscle soreness and pain, fatigue, chills, probably a mild fever though I never took my temperature, and redness of injection area. The systemic symptoms continued for 2 full days and were gone by day 4. The red and sore arm continued for 6 days. On days 2 and 3 I also had intermittent stomach pain (no vomiting, no diarrhea, no significant nausea) which may or may not have been related to the NSAIDS I took for the other symptoms. On day 3 I had a mild red rash covering most of my body above the waist, no itchiness, no hives, no pain to it. By day 4 this rash had retreated to only parts of my arm and armpit within 8 inches of the injection site. I returned to full normal activities on day 5.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Severe Joint and muscle pain. Lethargy. Headache. Pain and swelling at injection site. Symptoms lasted around 36 hours. The vaccine was the currrent Shingles shot. Will take the second vaccine with 2-6 months.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Severe Joint and muscle pain. Lethargy. Headache. Pain and swelling at injection site. Symptoms lasted around 36 hours. The vaccine was the currrent Shingles shot. Will take the second vaccine with 2-6 months.
Age: 16.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 16 year old patient (gender not reported). No information was provided regarding the patient's medical history, concurrent conditions, drug reaction/allergy history or concomitant medications. On an unknown date, the patient was vaccinated with PROQUAD, lot # R024017, expiration date 19-FEB-2020 subcutaneously in the right arm for prophylaxis, and a dose of VARIVAX, lot # R026547, expiration date 17-SEP-2020, subcutaneously in the left arm for prophylaxis (strength, dose and frequency were not provided for either of the therapies). No adverse events were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 01-MAR-2019 regarding a case in litigation concerning a female  patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a pharmacist. The patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Trigeminal neuralgia
Clinical narrative: Information has been received on 01-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 28-AUG-2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a hospital. On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injuries resulting from the patient's ZOSTAVAX use: shingles and postherpetic trigeminal neuralgia. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the events was unknown. The causality of the events was considered to be related. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Insomnia, Pain
Clinical narrative: This spontaneous report was received from office staff via company representative regarding a 14 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant medications included AVIANE for birth control and Benzaclin. On 27-FEB-2019, the patient was vaccinated with GARDASIL 9 dose 2 (lot# and expiry date was not reported) via intramuscular for HPV prevention. On 28-FEB-2019 (also reported as the following day), the patient experienced dizziness, body aches, felt like passing out and insomnia. It was reported that patient did not receive any treatment and no lab tests were performed. The patient's mother contacted the office and sought for medical attention. On an unspecified date, at an unspecified time in approximately 2019, the patient was recovered from the events dizziness, insomnia, dizziness and pain. The causality of the events with respect to GARDASIL 9 were not reported.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster. In April 2018, the patient received the 1st dose of SHINGRIX. In August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, eruption, pain and pruritus. On an unknown date, the outcome of the vaccination failure, eruption, pain and pruritus were unknown and the outcome of the herpes zoster was recovered/resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster, eruption, pain and pruritus to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose in April 2018 and 2nd dose in August 2018. The patient reported that last year she continued to had zoster outbreaks that last 4-6 days. The patient took pictures of the bubbly eruptions on my backside. The patient took a CE program presented by one of your educators and was very impressed at the safety profile and efficacy of SHINGRIX. The patient would like for someone representing your company to draw blood and find out if there was a immune response or titers in my blood appropriate to 2 injections of the drug. The outbreaks are about the same in duration, pain and itch as they were before the inoculations.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster. In April 2018, the patient received the 1st dose of SHINGRIX. In August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, eruption, pain and pruritus. On an unknown date, the outcome of the vaccination failure, eruption, pain and pruritus were unknown and the outcome of the herpes zoster was recovered/resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster, eruption, pain and pruritus to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose in April 2018 and 2nd dose in August 2018. The patient reported that last year she continued to had zoster outbreaks that last 4-6 days. The patient took pictures of the bubbly eruptions on my backside. The patient took a CE program presented by one of your educators and was very impressed at the safety profile and efficacy of SHINGRIX. The patient would like for someone representing your company to draw blood and find out if there was a immune response or titers in my blood appropriate to 2 injections of the drug. The outbreaks are about the same in duration, pain and itch as they were before the inoculations.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Adverse reaction, Malaise, Nausea
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient declared she was hospitalized for a reaction to SHINGRIX vaccine. The patient called for information about what medication was on Xeljanz. This question was originated because the patient felt nausea and sickness with Otezla and her Physician recommended her to change to Xeljanz. The patient had not started on Xeljanz. The call was disconnected before the transfer was completed and after the callback the proper information was provided.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Joint stiffness, Musculoskeletal stiffness, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 13th February 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 14th February 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm and general body pain. On 19th February 2019, the patient experienced myalgia, fatigue and headache. On 27th February 2019, the patient experienced stiff back and stiff joint. On an unknown date, the outcome of the pain in arm, fatigue and headache were unknown and the outcome of the general body pain, myalgia, stiff back and stiff joint were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, general body pain, myalgia, fatigue, headache, stiff back and stiff joint to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The physician on the line reporting a patient who received SHINGRIX two weeks ago was still complaining of diffuse myalgia and pain. On 14th February 2019 the patient had soreness in the arm and significant body aches, but felt better on 15th February 2019. On 19th February 2019, the patient relapsed and had myalgia and fatigue with headache. On 27th February 2019, the patient reports overall achiness and back and joints are stiff and these events are ongoing. The product was administered in a different location. This case has been linked with the case US2019037727, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 13th February 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 14th February 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm and general body pain. On 19th February 2019, the patient experienced myalgia, fatigue and headache. On 27th February 2019, the patient experienced stiff back and stiff joint. On an unknown date, the outcome of the pain in arm, fatigue and headache were unknown and the outcome of the general body pain, myalgia, stiff back and stiff joint were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, general body pain, myalgia, fatigue, headache, stiff back and stiff joint to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The physician on the line reporting a patient who received SHINGRIX two weeks ago was still complaining of diffuse myalgia and pain. On 14th February 2019 the patient had soreness in the arm and significant body aches, but felt better on 15th February 2019. On 19th February 2019, the patient relapsed and had myalgia and fatigue with headache. On 27th February 2019, the patient reports overall achiness and back and joints are stiff and these events are ongoing. The product was administered in a different location. This case has been linked with the case US2019037727, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Myalgia, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported for the patient. The physician on the line reporting the patient received SHINGRIX two weeks ago was still complaining of diffuse myalgia and pain. While reporting on patient the reporter heard of this for 24 to 48 hours but not two weeks. The reporter declined to provide further details regarding other patients. This case has been linked with the case US2019037720, reported by the same reporter. The age group was not reported, but was selected adult as per vaccine indication' in additional narrative.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received the 2nd dose of SHINGRIX. On 1st March 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain and lightheadedness. On 2nd March 2019, the patient experienced injection site erythema. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the injection site pain and lightheadedness were not reported and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, injection site pain, light headedness and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received her second dose of SHINGRIX, on Friday, March 1st at a retail pharmacy. She reports pain at the injection site immediately. She also reported that she felt a bit lightheaded right after the injection as well. The patient reports that there was some redness and soreness the next day, which resolved. The reporter cousin of the patient stated that the flu like symptoms were not elaborated. The patient did not wish for physician to be contacted. The reporter did not consent to follow-up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Product storage error
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received the 2nd dose of SHINGRIX. On 1st March 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain and lightheadedness. On 2nd March 2019, the patient experienced injection site erythema. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the injection site pain and lightheadedness were not reported and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, injection site pain, light headedness and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received her second dose of SHINGRIX, on Friday, March 1st at a retail pharmacy. She reports pain at the injection site immediately. She also reported that she felt a bit lightheaded right after the injection as well. The patient reports that there was some redness and soreness the next day, which resolved. The reporter cousin of the patient stated that the flu like symptoms were not elaborated. The patient did not wish for physician to be contacted. The reporter did not consent to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2019, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced generalized pruritus. The patient was treated with valaciclovir hydrochloride and BENADRYL. On an unknown date, the outcome of the generalized pruritus was recovered/resolved and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the generalized pruritus and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient experienced itching all throughout her body in areas such as arms, underneath elbows, wrist, and thighs. Most of the itching was on the left side of the body. She had also broken out with shingles twice on her tail bone. Initially she experienced Shingles was two weeks after receiving the SHINGRIX and then it cleared up. Three days before the date of reporting, shingles reappeared. The day before reporting, the patient went to her primary care physician on and she was advised to start BENADRYL for itching and valacyclovir for shingles. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose unknown date). On 15th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 1 hr after receiving SHINGRIX, the patient experienced injection site pain and shoulder blade pain. SHINGRIX was continued with no change. On an unknown date, the outcome of the injection site pain was resolved with sequelae and the outcome of the shoulder blade pain was recovering/resolving. It was unknown if the reporter considered the injection site pain and shoulder blade pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient in his 70's experienced injection site soreness for about 3 days and then resolved. The patient also reported that he had pain in both shoulder blades, particularly when sitting at a computer. The event was not resolved at the time of reporting. The reporter did not consent to follow-up. There is a discrepancy with respect time to onset. As per reported dates it is 4 days; however, as per source document (time between suspect drug administration and start of reaction/event) it is 1 hour. The clarification has been requested for the same.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Impaired work ability, Injection site pain, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 65-year-old male patient who received SHINGRIX (batch number 22AZ9, expiry date 19th March 2021) for prophylaxis. On 3rd March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd March 2019, less than a day after receiving SHINGRIX, the patient experienced tiredness, insomnia and injection site pain. On 4th March 2019, the patient experienced weakness and inability to work. On an unknown date, the outcome of the tiredness, weakness and injection site pain were not recovered/not resolved and the outcome of the insomnia and inability to work were unknown. It was unknown if the reporter considered the tiredness, insomnia, weakness, inability to work and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on the left arm. Around 4:00 pm of the vaccination day, the patient started to feel tired and laid down for approximately an hour. In the evening of the day of vaccination, the patient started experiencing pain at the injection site. When the patient went to bed that night, he could not sleep, describing that his eyes were wide open. On the day of reporting, 4th March 2019, 1 day after receiving SHINGRIX, he felt weak and tired so he did not go into work. The pain at the injection site was worse than it was yesterday. The reporter gave permission to contact his physician.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, RVX
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 04-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four months old male patient who received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation on an unknown date. On 04-Mar-2019, the patient received a single dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5497AA (expiry date: 17-Jul-2020) via unknown route in left thigh. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown whether adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow-up information was received on 05-MAR-2019 from other health professional. No new information received. List of documents held by sender: none.
Sex: F
Vaccine: IPV, MENB, MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Initial information received on 06-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 years old female patient who received a 0.5ml fourth dose of vaccine IPOL batch number: N1J451M, expiration date: 05-Oct-2019 via subcutaneous route in the right arm on 06-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was MENACTRA and BEXSERO. It was an actual medication error due to Inappropriate schedule of vaccine administered. The patient received 3 IPOL vaccinations when she was young, however missed her 4th IPOL vaccination at age 4 and she was administered the 4th IPOL injection when she was 16 years of age. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 06-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 54 years old male patient who was vaccinated with a 0.5 ml booster dose of ADACEL (lot number: U6217AA, expiry date, route of administration were not reported) in Arm on 01-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered because the vaccine was delayed delivery, delayed Transit vaccine stability. No reported reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 06-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 12 months old female patient who was inadvertently vaccinated with an 0.5 ml expired fourth dose of ACT-HIB (Batch number: UI894AAA, expiry date: 21-Feb-2019, route and site of administration were not reported) on 06-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: 101.3 fever, less than 24 hours persisted. Mom states high fever and fussy at 6 hours after leaving clinic and by the next day resolved.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient complains of having a sore arm and some minor loss of function since about a week after injection. This was reported to the facility in late Feb, 3 months post injection. She has yet to have physician look at her arm, she believes that the injection was made into the bursa of the shoulder.
Age: 50.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Client describes having significant redness that extended down her arm and it became swollen. This lasted a few days.
Age: 17.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Crying, Dizziness
Clinical narrative: PATIENT WAS SCARED TO RECEIVE VACCINATIONS. CRYING DURING ADMINISTRATION. PATIENT FELT LIGHTHEADED AFTER ADMINISTRATION OF VACCINES. SHE LAID DOWN ON EXAM TABLE FOR 5 MINUTES. BP LAYING DOWN 112/59, STANDING UP 106/64.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient received MMR vaccine 2/28/19 and developed redness at the site 3/7/19. Redness has spread/widened and is warm with induration - measuring 3x2.7cm.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Rash pruritic, Skin lesion
Clinical narrative: Patient developed a tactile fever (per mom) 2 days after receiving the vaccine. The fever waned by days 3-4 post vaccine, and on the evening of day 5, mom noticed "bumps" of rash on the child's neck and chest after her bath. Mom called the morning of day 6 post vaccine, and the child is developing more lesions on her back and near hairline. The bumps are itchy, no vesicular "blisters" yet.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Injection site erythema, Pain
Clinical narrative: Received vaccines at early morning well visit and felt normally all day at school. Mom reports that he participated in rowing practice that afternoon and attended a banquet in the evening when he started feeling achy, complaining of headache, and developed an area of redness around injection site on his R deltoid. Mom phoned office triage and discussed concerns, then decided to go to ER for evaluation. Chose not to stay due to wait time. Mom denies swelling at the site and symptoms had resolved within 24 hours.
Age: 0.58
Sex: M
Vaccine: UNK
Symptoms: Abnormal behaviour, Attention deficit/hyperactivity disorder, Developmental delay, Emotional distress, Irritability
Clinical narrative: Night terrors - inconsolable. Change in temperament went from happy baby to withdrawn and extremely needy. No focus as he grew. Barely crawled or spoke until past 2 years. Our son has had life long issues. He is 31 now and enrolled in special ed at school for most of his school life under the umbrella of ADD/ADHD. His behaviors and choices are not consistent with his upbringing. He now has a job which takes all his energy. He once described a memory of a bad dream and he described it as a tangle of woodland where it's growing around him and is unable to break free. He prefers to be alone and animals are his friends. Processing information is very difficult, following through and poor judgement. The reason for such a late appeal is we had no idea this even existed. If I had known this when he was young I would have applied. I often told friends how he changed after his vaccines, he went from a happy little guy to one that was 'vacant'. I deeply regret vaccinating my child and robbing him of the life he was capable of having. Deeply affected our whole family!
Age: 0.58
Sex: M
Vaccine: UNK
Symptoms: Judgement impaired, Nightmare, Sleep terror, Social avoidant behaviour, Thinking abnormal
Clinical narrative: Night terrors - inconsolable. Change in temperament went from happy baby to withdrawn and extremely needy. No focus as he grew. Barely crawled or spoke until past 2 years. Our son has had life long issues. He is 31 now and enrolled in special ed at school for most of his school life under the umbrella of ADD/ADHD. His behaviors and choices are not consistent with his upbringing. He now has a job which takes all his energy. He once described a memory of a bad dream and he described it as a tangle of woodland where it's growing around him and is unable to break free. He prefers to be alone and animals are his friends. Processing information is very difficult, following through and poor judgement. The reason for such a late appeal is we had no idea this even existed. If I had known this when he was young I would have applied. I often told friends how he changed after his vaccines, he went from a happy little guy to one that was 'vacant'. I deeply regret vaccinating my child and robbing him of the life he was capable of having. Deeply affected our whole family!
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. In or around September of 2016, the patient was inoculated with ZOSTAVAX (lot# and route not provided) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles. In or around March 2017, the patient was diagnosed with shingles by a physician. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Shingles was reported by the lawyer to be disabling. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 01-MAR-2019 regarding a case in litigation concerning a female  patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 24-MAR-2017, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a pharmacist. The patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 01-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a physician's office. On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial Report Received: 27-Feb-2019. Non-significant Follow-up Report Received on 06-Mar-2019 included duplicative data that was already received for this report. A nurse reported that patient, a 46-year-old male patient (race not provided) was administered with HEPLISAV-B for hepatitis B immunization that was reported to be stored at the wrong temperature. Relevant medical history and concomitant medications were reported as unknown. Allergies were reported as unknown. On an unknown date, the patient received the second injection of HEPLISAV-B (lot #1036463, expiration date 28-Jul-2019, NDC #43528-002-05) by a physician. On 27-Feb-2019, a nurse reported that she received a call from a customer service representative at the distributor on this day. The nurse was instructed to remove all vaccines that were received because they were stored at the wrong temperature on distributor's end. The nurse was instructed to return it to the distributor and contact Dynavax. The nurse reported that six patients received HEPLISAV-B from the same lot number. The nurse also reported that all six patients were contacted on this day. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial Report Received: 27-Feb-2019. Non-significant Follow-up Report Received on 06-Mar-2019 included duplicative data that was already received for this report. A nurse reported that patient, a 56-year-old female patient (race not provided) was administered with HEPLISAV-B for hepatitis B immunization that was reported to be stored at the wrong temperature. She was also administered with an extra dose of HEPLISAV-B. Relevant medical history and concomitant medications were reported as unknown. Allergies were reported as unknown. On an unknown date, the patient received the third injection of HEPLISAV-B (lot #1036463, expiration date 28-Jul-2019, NDC #43528-002-05) by a physician. On 27-Feb-2019, a nurse reported that she received a call from a customer service representative at the distributor on this day. The nurse was instructed to remove all vaccines that were received because they were stored at the wrong temperature on distributor's end. The nurse was instructed to return it to the distributor and contact Dynavax. The nurse reported that six patients received HEPLISAV-B from the same lot number. The nurse also reported that all six patients were contacted on this day. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the events of product storage error and extra dose administered as non-serious. The event of product storage error and extra dose administered are unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the events of product storage error and extra dose administered as non-serious. The events of product storage error and extra dose administered are unlisted per HEPLISAV-B USPI.