chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: 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 pain in a female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that sometime between 24th September 2018 to 28th of September 2018, the patient received SHINGRIX. The patient experienced soreness, swelling, redness and tenderness at the injection site the next day of vaccination. The patient was still experiencing pain at the injection site as of the day of reporting. The healthcare professional contacted MI and would like the efficacy and immunity after receiving just 1 dose. No additional information provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 68-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Within a few hours of vaccination the patient experienced rash across the chest. On 19th July 2018, the patient came into office and healthcare professional reported seeing rash on chest from shoulder to shoulder and on the front and back of neck area. No pain or itchiness was there. It lasted for 3 days. The healthcare professional would like to know if the patient should receive the 2nd dose based off these reactions. No additional information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter is a retired registered nurse and stated that the pharmacist at the pharmacy where she received her SHINGRIX vaccine, informed her that approximately 30% of their patients complained of redness down their arm after receiving the SHINGRIX vaccine. This redness occurred on the same arm as the injection and was located below the injection site and down the arm. The nurse did not have any additional details regarding this event. This case has been linked to case US2018179263, reported by the same reporter for herself.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cough, Dizziness, Dysphonia, Fatigue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included omeprazole and lisinopril. On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, dizziness, hoarseness and cough. On 24th September 2018, the patient experienced injection site pain and injected limb mobility decreased. On 25th September 2018, the patient experienced erythromacular rash and vesicular rash. On 26th September 2018, the patient experienced blister. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovering/resolving and the outcome of the erythromacular rash, fatigue, dizziness, hoarseness and cough were not recovered/not resolved and the outcome of the blister and vesicular rash were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, erythromacular rash, blister, vesicular rash, fatigue, dizziness, hoarseness and cough to be related to SHINGRIX. Additional details were provided as follows: The reporters were husband and wife. The patient was the wife and the husband was a physician. The patient current condition includes reflux. The patient stated that she received the 1st dose of SHINGRIX on Monday, 24th September 2018. The patient stated that her right arm was very sore on Monday and was so sore that she could not lift her right arm above her head on Monday and Tuesday. The patient had been taking TYLENOL for the soreness. The patient stated that on Tuesday that is 25th September 2018 she noticed red spots or bumps on her face and they grew in number throughout the day. The patient stated that she had approximately 12 on her face and when she woke up this morning there were more of them. The patient stated that by Wednesday on 26th September 2018 some of the bumps had blistered and the patient's husband (physician) stated that the red spots look like chickenpox. The patient also reported feeling fatigued and stated that the fatigue came and went. The patient reported that she experienced dizziness that came and went and goes. The patient stated that she had developed a cough and had some voice hoarseness. The patient stated that the hoarseness and cough could be related to her not taking her reflux medication regularly.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Rash macular, Rash vesicular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included omeprazole and lisinopril. On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, dizziness, hoarseness and cough. On 24th September 2018, the patient experienced injection site pain and injected limb mobility decreased. On 25th September 2018, the patient experienced erythromacular rash and vesicular rash. On 26th September 2018, the patient experienced blister. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovering/resolving and the outcome of the erythromacular rash, fatigue, dizziness, hoarseness and cough were not recovered/not resolved and the outcome of the blister and vesicular rash were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, erythromacular rash, blister, vesicular rash, fatigue, dizziness, hoarseness and cough to be related to SHINGRIX. Additional details were provided as follows: The reporters were husband and wife. The patient was the wife and the husband was a physician. The patient current condition includes reflux. The patient stated that she received the 1st dose of SHINGRIX on Monday, 24th September 2018. The patient stated that her right arm was very sore on Monday and was so sore that she could not lift her right arm above her head on Monday and Tuesday. The patient had been taking TYLENOL for the soreness. The patient stated that on Tuesday that is 25th September 2018 she noticed red spots or bumps on her face and they grew in number throughout the day. The patient stated that she had approximately 12 on her face and when she woke up this morning there were more of them. The patient stated that by Wednesday on 26th September 2018 some of the bumps had blistered and the patient's husband (physician) stated that the red spots look like chickenpox. The patient also reported feeling fatigued and stated that the fatigue came and went. The patient reported that she experienced dizziness that came and went and goes. The patient stated that she had developed a cough and had some voice hoarseness. The patient stated that the hoarseness and cough could be related to her not taking her reflux medication regularly.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received SHINGRIX for prophylaxis. On 27th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced headache, chills and fever. On an unknown date, the outcome of the headache, chills and fever were unknown. It was unknown if the reporter considered the headache, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The day before reporting the patient received 2nd dose of the new shingles vaccine and experienced the headaches, chills and fever. The patient asked if it was ok to take aspirin or ibuprofen for the event which the patient had experienced.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Incorrect route of product administration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On 20th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In September 2018, less than a month after receiving SHINGRIX, the patient experienced adverse reaction. On 20th September 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse reaction and intramuscular formulation administered by other route were 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. On Thursday, the patient received the dose of shingles vaccine subcutaneously instead of intramuscular by the pharmacist, which led to inappropriate route of vaccination. The patient's primary care doctor had already taken the proper steps to report this and treated her for the adverse reaction. The patient had question that what would be the impact, if any, would the error have impact on the efficacy of the first dose.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 30th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced adverse reaction and product supply issue. On an unknown date, the outcome of the adverse reaction and product supply issue were 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 age group was not reported but was selected adult as per vaccine indication. The patient was set to begin on insurance on 1st October 2018, knowing that the SHINGRIX vaccine was not covered under that insurance (like other vaccines), she planned to get both doses of the vaccine before 1st October 2018 so her current insurance would cover them. The patient was disappointed and quite angry to go back to the pharmacy in August 2018 (after clearing her schedule for a few days in anticipation of a reaction similar to the one she had after the first dose), only to find that there was no SHINGRIX vaccine available due to a nationwide shortage. The patient had checked back several times since then and got the same response. The patient was on a waiting list of people who have received the 1st dose and need the 2nd. The patient reported that, due to the company's mismanagement and spending more funds on advertising instead of producing enough of the vaccine to supply the demand, the patient would have to spend at least $150 to get 2nd dose and it seemed like she would not get it before the 6 month "window" which would be closed for on 30th October 2018. The patient stated she understood that the company believed it was not crucial to get the 2nd dose in the 2 to 6 month period recommended after the 1st dose, but the vaccine was not researched beyond that window. Again, the patient was very upset about handling of the rollout of this vaccine and would like for reimbursement for expense when the 2nd dose of SHINGRIX would become available to the patient. The patient would be happy to send receipts when she would finally have access to the shot.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. The reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not take temperature. The patient's wife said he was very hot. The reporter thought it was vaccine related. The reporter was agree to follow up from GlaxoSmithKline. This case was linked with the case US2018GSK178688, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of erythema of extremities in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were unknown. The reporter considered the erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's arm was very red and sore for a couple days.  Nurse thought it was related to vaccine. The reporter was agree to follow up from GlaxoSmithKline. This case was linked with the case US2018GSK177931, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown. It was unknown if the reporter considered the chills and fever to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter did not have any patient information. The reporter had not agreed to follow-up with GlaxoSmithKline. This case was linked with case US2018100654, reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient and pharmacist both were standing while receiving the shot. The patient experienced pain and soreness at the injection site which lasted for 24 hours. For tolerance after 2nd dose of SHINGRIX, refer case US2018176482.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient did not know exact date of first vaccination or the lot number and expiration date. The age at vaccination was not reported. The patient experienced some soreness in her arm. This case was linked with US2018176425, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of discomfort in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced discomfort and pain. On an unknown date, the outcome of the discomfort and pain were recovered/resolved. It was unknown if the reporter considered the discomfort and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The physician casually reported that, everyone (not specified number of patients) complained of discomfort or pain which lasted for 2 to 3 days. The healthcare professional wondered the occurrence of systemic adverse events and provided general statements of what he had heard in terms of patient experiences but did not had an adverse event to directly report. This case has been linked with US2018176413, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on unknown date, refer case US2018177053). On 7th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The patient's husband could not remember the vaccination date for the 1st dose of SHINGRIX. The reporter's wife experienced injection site pain for a day after vaccination. This case was linked with case US2018177053, case reported for 1st dose.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (for tolerance to the 1st dose refer case US2018177049). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The second shot was administered a few weeks ago and he had some soreness again but not as bad. It also resolved within a couple of days.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received SHINGRIX for prophylaxis. 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, however it could be 73 or 74 years. The patient did not remember the date he received a dose of SHINGRIX. The patient had pain after a dose of SHINGRIX. The first dose felt like a bubble was being injected into his arm and it made his arm painful. The pain resolved after a few days and did not return prior to his 2nd dose. The patient stated that he wanted to personally receive a letter from GlaxoSmithKline (GSK) so he could document his experience after receiving the SHINGRIX vaccine. This case has been linked to the US2018165488, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster (started on  October 2017). On 27th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, shivering, pain in arm, erythema and pain. On an unknown date, the outcome of the headache, shivering, pain in arm, erythema and pain were recovered/resolved. It was unknown if the reporter considered the headache, shivering, pain in arm, erythema and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced shivering, soreness, redness, pain and a headache. All those side effects listed lasted overnight, but the sore arm lasted about three days. For tolerence of 2nd dose refer case, US2018177101 reported by the same reporter for the same patient.
Age: 1.5
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 months old patient who received a dose of 0.5 ml QUADRACEL (frequency once) lot number: UT6259KA, expiration date: 30-Jun-2019 via intramuscular route in right arm on 28-Sep-2018. The patient's medical history was not reported. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; PREVNAR 13 for Immunisation; and HEPATITIS A VACCINE for Immunisation. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that the patient did not experience any adverse event. 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. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 71 years old male patient who experienced the patient felt that he did not receive the entire 0.5ml dose and little bit leaked out of the injection site (right deltoid) and ran down his arm, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ038AA via unknown route in the right deltoid. It was also a case of actual medication error due to Vaccine underdose and exposure via skin contact. (Other relevant tests included No lab test). Final diagnosis was little bit leaked out of the injection site (right deltoid) and ran down his arm and the patient felt that he did not receive the entire 0.5ml dose. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for little bit leaked out of the injection site (right deltoid) and ran down his arm and as Not Applicable for the patient felt that he did not receive the entire 0.5ml dose. 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.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 76 years old female patient who experienced fluzone hd given to one patient two times in one day, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Oct-2018, the patient received a twice 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ029AB via intramuscular route in the left deltoid. It was a case of actual medication error due to extra dose administered. The patient outcome is reported as Not Applicable for FLUZONE HD given to one patient two times in one day. 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. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Cardiac stress test, Chest pain, Echocardiogram, Electrocardiogram, Laboratory test
Clinical narrative: Pain behind sternum and pain on inhalation 4 days after receiving flu vaccine. Went to hospital and had multiple test done. 6 different pills daily plus a blood thinner while in hospital. Hospital results are waiting on transcription.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Painful respiration, Pulmonary function test
Clinical narrative: Pain behind sternum and pain on inhalation 4 days after receiving flu vaccine. Went to hospital and had multiple test done. 6 different pills daily plus a blood thinner while in hospital. Hospital results are waiting on transcription.
Age: 88.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Electrocardiogram, Laboratory test
Clinical narrative: Patient reported she got flu shot Friday 10/5 at store. Then preceded to have dizziness the following mornings after that.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain
Clinical narrative: Developed pain in left shoulder day after administration, also radiating to her neck and was worse at night and upon waking up in the morning. And she's still having pain, as pain increased days after receiving it.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Left hand pain at injection site,limited mobility due to pain left arm. No infection. No brachial plexus weakness or injury but also could be neuritis. Too early to tell as she has pain and weakness is sec to pain or real neuritis, unknown. Start ibuprofen 800 mg tablet 1 tablet 3 times a day as needed for 7 days. Start predniSONE 10 mg tablet 1 tablet every day for 5 days.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain
Clinical narrative: Neck pain on left side.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Dysphonia, Fatigue
Clinical narrative: Bad dizziness, hoarseness, muscle weakness, headaches, muscle aches, feeling tired, nausea, loose stools, loss of appetite.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Muscular weakness, Myalgia, Nausea
Clinical narrative: Bad dizziness, hoarseness, muscle weakness, headaches, muscle aches, feeling tired, nausea, loose stools, loss of appetite.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt's mother brought pt to ER on night of 9/26/18 stating he was having allergic reaction to injection. Pt's left thigh was found to be red, warm to touch and swollen. Pt was given PRELONE 15mg/5mL 24mg po in ER and certirizine 2.5mg. script for PRELONE 15mg/5mL, 5 mL po QD x 5 days at home. Instructed to f/u with PCP in 10-14 days or sooner. Cool compresses as needed. Pt came to clinic on 9/27/18 and clinic nurses observed some redness and swelling. Mother states it is much better. Redness was marked with marker for mother and told to notify us if redness went out past lines.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Asthenia, Condition aggravated, Hypersensitivity, Pain
Clinical narrative: I have a patient that got the FLUZONE QUADRIVALENT on Oct 1, 2018 and 3 hours later she developed hives and swelling of face. She took some over the counter medications and the next day was still swollen. She took prednisone and ATARAX and after 6 hours without antihistamines she still had tightness in throat. She went to the Clinic, ER, with hives in chest and neck. Diagnosed with anaphylaxis, allergic reaction and urticaria. She has never had issues in the past. Now on Oct 5 she is in the doctors ofc for a follow up and she still feels weak and has pain, but is much improved.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Throat tightness, Urticaria
Clinical narrative: I have a patient that got the FLUZONE QUADRIVALENT on Oct 1, 2018 and 3 hours later she developed hives and swelling of face. She took some over the counter medications and the next day was still swollen. She took prednisone and ATARAX and after 6 hours without antihistamines she still had tightness in throat. She went to the Clinic, ER, with hives in chest and neck. Diagnosed with anaphylaxis, allergic reaction and urticaria. She has never had issues in the past. Now on Oct 5 she is in the doctors ofc for a follow up and she still feels weak and has pain, but is much improved.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Exposure to communicable disease, Exposure via partner
Clinical narrative: Information has been received from a 26 year old male patient, referring to himself. The patient had no concomitant therapy, pertinent medical history or drug reactions/allergies. In 2005 or 2006 when the patient was about 12 year old, the patient was vaccinated with first dose of GARDASIL (3 dose regimen, route was reported as "in the arm", strength, lot #, expiration date unknown) for prophylaxis (reported as "for HPV protection"). On an unknown date, the patient's current partner was recently diagnosed with Human Papillomavirus type 16. The patient said he was certain he was exposed to Human Papillomavirus (HPV) 16 within the past 8 months. The patient said he planned to "get checked" for Human Papillomavirus (HPV) by a physician as a precaution. No treatment was given for the events. No lab diagnostics or studies were performed for the events. The patient had not sought medical attention.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant therapies were not provided. On 27-SEP-2017, the patient was vaccinated with a first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided) for prevention of human papilloma virus (HPV). On an unknown date, the patient developed diarrhea that persisted for 10 months after receiving her first and only dose of GARDASIL 9. The patient sought medical attention. Stool culture was performed but the results were unknown. She was referred to gastroenterologist. On an unknown date in 2018, the patient recovered from diarrhea. The relatedness between diarrhea and the GARDASIL 9 was not provided.
Age: 1.75
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever was 105 and I was alternating MOTRIN and TYLENOL and also giving lukewarm baths. Injection site swelled up to 5-6 inches and was hot to the touch. This went on for 3 days. Fever finally broke and his leg swelling started to go down
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Patient woke up the following day with blotchy rash and swelling of thigh. Thigh was warm to touch.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Pruritus, Throat irritation, Urticaria
Clinical narrative: **I do not know which influenza vaccine I had, I just chose one from the list*** I had a flu shot at work around 11am. I have never before had a flu shot, but didn't expect any issues. By 2pm I was very anxious and felt very itchy. I had on cheap jeans so i just attributed my itchy legs to that and the anxiety was attributed to being at work on a beautiful Friday afternoon. Once i got home from work around 5pm and changed, i noticed i had hives all over my knees. My throat was also a little itchy, but that isn't uncommon for me. foods/drinks/seasonal allergies give me an itchy/swollen throat alot. I went to urgent care and they gave me a steroid shot. The hives were gone within minutes and my throat was also clear again.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Myalgia, Pain
Clinical narrative: Pt went to sleep and woke up the following morning with chills, fever, fatigue, muscle aches, pain, redness, swelling for 2-3 days. Symptoms fully resolved. Patient did not have any of the above reaction to the second dose.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Pt went to sleep and woke up the following morning with chills, fever, fatigue, muscle aches, pain, redness, swelling for 2-3 days. Symptoms fully resolved. Patient did not have any of the above reaction to the second dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Dyskinesia, Febrile convulsion, Loss of consciousness, Postictal state
Clinical narrative: Child woke up during the night on 10-4-18 around 12;30 am having jerky movements in bed and was unconscious. Mom called 911 seizure lasted 3-4 minutes post ictal about 2 hrs. Temperature was up to 102.8 and diagnosed with febrile seizure and post-vaccine seizure.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Seizure
Clinical narrative: Child woke up during the night on 10-4-18 around 12;30 am having jerky movements in bed and was unconscious. Mom called 911 seizure lasted 3-4 minutes post ictal about 2 hrs. Temperature was up to 102.8 and diagnosed with febrile seizure and post-vaccine seizure.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Muscular weakness, Myalgia
Clinical narrative: Starting evening of 10/02/18, started with muscle soreness /weakness in left hand (injection site was right arm) and spread to arms and legs and back. Condition improved. (22 Weeks pregnant) Seen by OB doctor.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Exposure during pregnancy, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Starting evening of 10/02/18, started with muscle soreness /weakness in left hand (injection site was right arm) and spread to arms and legs and back. Condition improved. (22 Weeks pregnant) Seen by OB doctor.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Muscular weakness, Myalgia
Clinical narrative: Minimal soreness @ injection site day of and after. However, starting with the evening of the injection left hand (muscular) began hurting and by the time I woke up on 10/4, all body muscles (neck/arms/back/abs/legs/feet) were very sore. The hand soreness has since resolved, but the rest have continued to be sore all day daily since then. I was 21 weeks 6 days pregnant at the time and am currently 22 weeks 6 days pregnant (2nd pregnancy) with an estimated due date of 2/6/19. Flu shot was taken during 1st pregnancy in 2015 with no side effects.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Exposure during pregnancy, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Minimal soreness @ injection site day of and after. However, starting with the evening of the injection left hand (muscular) began hurting and by the time I woke up on 10/4, all body muscles (neck/arms/back/abs/legs/feet) were very sore. The hand soreness has since resolved, but the rest have continued to be sore all day daily since then. I was 21 weeks 6 days pregnant at the time and am currently 22 weeks 6 days pregnant (2nd pregnancy) with an estimated due date of 2/6/19. Flu shot was taken during 1st pregnancy in 2015 with no side effects.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Haemoglobin normal, Hypotension, Vomiting
Clinical narrative: Patient Started vomiting clear liquids within the 15 min wait time. Vitals were taken immediately (B/P 72/51; Temp 98.4; Hgb 12.5), 30 minutes after the first B/P 78/57. Patient was sent to the ER for low B/P.
Age: 0.08
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Child was inadvertently given a Hepatitis A vaccine in lieu of the Hepatitis B vaccine. No complications were reported at this time.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Cold sweat, Facial pain, Headache, Injection site swelling
Clinical narrative: Adverse events started at about 10 PM that night after receiving injection. Right side of face slightly swollen, face felt like it was going to explode from pressure/pain. Vomitted soon after; also had cold sweats and weakness. Next day (10/8/18) experienced congestion, injection site swelling, headache, runny nose, drip down throat. Still experiencing these symptoms but has improved (10/9/18).
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Respiratory tract congestion, Rhinorrhoea, Swelling face, Upper-airway cough syndrome, Vomiting
Clinical narrative: Adverse events started at about 10 PM that night after receiving injection. Right side of face slightly swollen, face felt like it was going to explode from pressure/pain. Vomitted soon after; also had cold sweats and weakness. Next day (10/8/18) experienced congestion, injection site swelling, headache, runny nose, drip down throat. Still experiencing these symptoms but has improved (10/9/18).
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Eye pruritus, Eye swelling
Clinical narrative: Woke up the next morning with swelling to eyes and itching. Stated she had some increase in SOB. She was seen and treated with Steroids. She started felling better on the afternoon of 10/06/18.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient stated at time of administration there was slight pressure; no indication of allergic rxn during administration; patient stated swelling and redness occurred that evening; she took APAP that day and again the next day; iced down the arm as well on 2 days. Went to the MD on Tuesday, October 9th. Doxycycline 100mg bid x 7 days written for and filled on 10-7-18; Saw her arm--redness had gone down the arm and to the inside of the arm; hot to touch.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Malaise, Nausea, Vomiting
Clinical narrative: Pt called me 10/8/18 to notify me just in case there were others with similar S/S after receiving the influenza vaccine. She C/O N/V that evening, followed by feeling tired and "just not feeling well" the next day. She made a full recovery of S/S.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Urticaria
Clinical narrative: High fever with uncontrollable shivering. The fever broke by morning followed by a headache.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Conjunctival haemorrhage, Corneal abrasion, Eye pain, Intraocular pressure increased, Ophthalmological examination abnormal
Clinical narrative: Severe right eye pain and severe subconjunctival hemorrhage followed by moderate uveitis, corneal abrasion, blurring of vision, increased floaters and flashing. Now one month later. Rx: TOBRADEX ointment QID, DUREZOL drops BID. Vision 80% restored right eye. Flashing continues, Cornea healing.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Photopsia, Uveitis, Vision blurred, Vitreous floaters
Clinical narrative: Severe right eye pain and severe subconjunctival hemorrhage followed by moderate uveitis, corneal abrasion, blurring of vision, increased floaters and flashing. Now one month later. Rx: TOBRADEX ointment QID, DUREZOL drops BID. Vision 80% restored right eye. Flashing continues, Cornea healing.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Within 24 hours flu like symptoms, redness at injection site, headache, chills. The swelling and redness of right arm continued to worsen through end of week. I tried TYLENOL, ibuprofen, hydrocortisone cream and BENADRYL. Through weekend before redness subsided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Within 24 hours flu like symptoms, redness at injection site, headache, chills. The swelling and redness of right arm continued to worsen through end of week. I tried TYLENOL, ibuprofen, hydrocortisone cream and BENADRYL. Through weekend before redness subsided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: I received it last Wednesday at noon. By that afternoon my arm was marked by a super painful three-inch circle of hot, bright red. I was overcome by great fatigue and spent the day resting. During the night I started shaking to the point that my teeth chattered, and I had a terrible headache and great nausea. I called my doctor on Thursday and she sent me to the ER or an Urgent Care center; I chose Urgent Care. They gave me Zofran and Advil and ice for the arm and said I was having a severe allergic reaction to the vaccine. The doctor at the Urgent Care said to have the second shot anyway, in two to six months. But the doctor who gave me the shot, said next time could be even worse and she would NOT administer a second shot. Today is six days post-vaccine, and I am just starting to feel normal, but my arm still hurts and I'm still feeling kind of queasy and tired and weird. The headache is finally gone, as of yesterday. Do you have an opinion on getting the second shot? Without it I don't get the preventive benefit of the vaccine. With it I likely will get this sick or sicker.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Nausea, Pain in extremity, Skin warm, Tremor
Clinical narrative: I received it last Wednesday at noon. By that afternoon my arm was marked by a super painful three-inch circle of hot, bright red. I was overcome by great fatigue and spent the day resting. During the night I started shaking to the point that my teeth chattered, and I had a terrible headache and great nausea. I called my doctor on Thursday and she sent me to the ER or an Urgent Care center; I chose Urgent Care. They gave me Zofran and Advil and ice for the arm and said I was having a severe allergic reaction to the vaccine. The doctor at the Urgent Care said to have the second shot anyway, in two to six months. But the doctor who gave me the shot, said next time could be even worse and she would NOT administer a second shot. Today is six days post-vaccine, and I am just starting to feel normal, but my arm still hurts and I'm still feeling kind of queasy and tired and weird. The headache is finally gone, as of yesterday. Do you have an opinion on getting the second shot? Without it I don't get the preventive benefit of the vaccine. With it I likely will get this sick or sicker.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: I received it last Wednesday at noon. By that afternoon my arm was marked by a super painful three-inch circle of hot, bright red. I was overcome by great fatigue and spent the day resting. During the night I started shaking to the point that my teeth chattered, and I had a terrible headache and great nausea. I called my doctor on Thursday and she sent me to the ER or an Urgent Care center; I chose Urgent Care. They gave me Zofran and Advil and ice for the arm and said I was having a severe allergic reaction to the vaccine. The doctor at the Urgent Care said to have the second shot anyway, in two to six months. But the doctor who gave me the shot, said next time could be even worse and she would NOT administer a second shot. Today is six days post-vaccine, and I am just starting to feel normal, but my arm still hurts and I'm still feeling kind of queasy and tired and weird. The headache is finally gone, as of yesterday. Do you have an opinion on getting the second shot? Without it I don't get the preventive benefit of the vaccine. With it I likely will get this sick or sicker.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Started that night after supper with nausea and vomiting violently per mom, also had chills during the night and both visits continued into this morning