chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abnormal dreams, Headache, Insomnia, Malaise, Pain in extremity
Clinical narrative: Sick feeling; fever; Up all night because of the fever; Left arm soreness; Headache; Wild dreams; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams. On an unknown date, the outcome of the feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams were unknown.   It was unknown if the reporter considered the feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams to be related to Shingrix.  Additional information received were as follows: The nurse also stated that she administered the vaccine to other employees on the day before reporting, who she had called on the reporting date and 7 of the 10 had reported the exact same issues. The nurse did not had the specifics of the individuals other than 4 were females and 3 were males. They all received the same lot and expiration date of the product she received and it was the first dose of Shingrix for all. This case is 1 of the 8 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Sick feeling; fever; Up all night because of the fever; Left arm soreness; Headache; Wild dreams; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams. On an unknown date, the outcome of the feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams were unknown.   It was unknown if the reporter considered the feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams to be related to Shingrix.  Additional information received were as follows: The nurse also stated that she administered the vaccine to other employees on the day before reporting, who she had called on the reporting date and 7 of the 10 had reported the exact same issues. The nurse did not had the specifics of the individuals other than 4 were females and 3 were males. They all received the same lot and expiration date of the product she received and it was the first dose of Shingrix for all. This case is 1 of the 8 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abnormal dreams, Headache, Insomnia, Malaise, Pain
Clinical narrative: Sick feeling; fever; Up all night because of the fever; Left arm soreness; Headache; Wild dreams; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams. On an unknown date, the outcome of the feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams were unknown.   It was unknown if the reporter considered the feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams to be related to Shingrix.  Additional information received were as follows: The nurse also stated that she administered the vaccine to other employees on the day before reporting, who she had called on the reporting date and 7 of the 10 had reported the exact same issues. The nurse did not had the specifics of the individuals other than 4 were females and 3 were males. They all received the same lot and expiration date of the product she received and it was the first dose of Shingrix for all. This case is 1 of the 8 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sick feeling; fever; Up all night because of the fever; Left arm soreness; Headache; Wild dreams; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams. On an unknown date, the outcome of the feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams were unknown.   It was unknown if the reporter considered the feeling unwell, fever, sleeplessness, pain in arm, headache and abnormal dreams to be related to Shingrix.  Additional information received were as follows: The nurse also stated that she administered the vaccine to other employees on the day before reporting, who she had called on the reporting date and 7 of the 10 had reported the exact same issues. The nurse did not had the specifics of the individuals other than 4 were females and 3 were males. They all received the same lot and expiration date of the product she received and it was the first dose of Shingrix for all. This case is 1 of the 8 cases, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Chat with RN how long should a person wait with active shingles to get their 2nd shingrix. The reporter didn't have facts with this patient, this was only what he was telling me. The patient might be confusing the zostavax with the shingrix, the reporter would be looking into that. HCP disconnected from the chat and therefore no permission given to follow up.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a physician via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was resolved with sequelae.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: MD states he experienced slight pain following Shingrix administration in May 2019 that lasted for a day or so then subsided.  He states it was probably administered in his left arm and believes it was adminstered IM. The reporter consented to follow up.  No lot number or expiration date available.  This case has been linked with US2019165617, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoacusis, Inappropriate schedule of product administration
Clinical narrative: Hearing issue; Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of hard of hearing in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced hard of hearing and drug dose administration interval too long. On an unknown date, the outcome of the hard of hearing and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the hard of hearing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient thought she might had been over the 6 month window for her 2nd dose of Shingrix, which led to lengthening of the vaccination schedule. The patient was experiencing some issues with her hearing. The reporter was in a rush and did not want to provide any information in regards to the adverse event and address.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vaccine positive rechallenge
Clinical narrative: Nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, refer case US2019AMR167670).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's friend received dose of Shingrix and next day after vaccination experienced nausea. The nausea recovered within 1 days. The reporter did not provide additional details. This was 3rd of 4 reports provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Ligament rupture
Clinical narrative: Torn ligament in left arm; Fall; This case was reported by a pharmacist via call center representative and described the occurrence of ligament tear in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (due to that could not received injections to the right arm).   On 14th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced ligament tear and fall. On an unknown date, the outcome of the ligament tear and fall were unknown.   It was unknown if the reporter considered the ligament tear and fall to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy student. The age at vaccination was not reported. The patient received 1st dose of Shingrix on an unknown arm, but since that time, the patient fell and tore a ligament in her left arm and had been instructed to also avoid injections to the left arm. The reporter stated that, the patient did not share the date of the fall and adds the patient's arm would be out for at least 6 months. Upon call back to the pharmacy, the pharmacist came to the line and confirms details as reported by the pharmacy student. Further details not provided and specialist neglected to asked whether safety had permission to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th September 2019, the patient received the 2nd dose of Shingrix. On 13th September 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were received as follows: the patient inadvertently was administered second dose of Shingrix less than 4 week after dose one, which led to Shortening of vaccination schedule. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2018 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient not yet receive the second dose, which led to incomplete course of vaccination. The VAERS details were reported for the 1st dose.
Age: 1.5
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: burned going in; This is a spontaneous report from a contactable other hcp.   A 18-months-old female patient received the fourth dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number not provided) intramuscular in the thigh right on 02Aug2019 13:30 at single dose for immunisation. The patient medical history was none. On 02Aug2019 the patient received also the first dose of influenza vaccine (FLU VACCINE VII, Sanofi Lot number: UT6647JA expiry date: 30Jun2020) intramuscular in the left thigh, and the fourth dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL, Sanofi, Lot number: UJ017AAA expiry date: 26Oct2020) intramuscular in the left thigh both for immunisation. The patient previously received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (Lot number: W09943; Expiration: 30Apr2020) intramuscular in the right thigh on 02Aug2018 (a little over 2 months), the second dose (Lot number: W51762; expiry date: 30Jun2020) intramuscular in the left thigh on 03Oct2018 at 4 months old, the third dose (Lot number: X11327; expiry date: 30Sep2020) intramuscular in the right thigh on 03Dec2018 at 6 months old all at single dose; on the same dates she received also diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid all at single doses for immunisation. The medical assistant reported that a first product (Batch/lot number: AG8356, NDC number: 0005197101), Expiry Date: May2021), was not administered as the product needle was injected into the patient's leg but the whole top of the syringe was cracked so the medication shot all over the bed and the patient didn't get any of it. Reporter went to administer the vaccine, while in the child leg, whole top of syringe was cracked, defective vial, and by vial the reporter means prefilled syringe, where the needle attaches on to the top of the syringe was cracked. Reporter did not notice before placing the needle on because they have to push up to get air out, the crack must've been farther up in the syringe. The patient was successfully re-dosed and the successful dose of pneumococcal 13-val conj vac (dipht crm197 protein) burned going in. The outcome of the event was not reported. Information on the batch number has been requested.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a child under the age of 4 received the Quadracel vaccine, no adverse event; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a under four years old child patient who was vaccinated with a dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number, Exp. Date. Dose, route and site of administration not reported) on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration.  No adverse event was reported post vaccination.  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. Information on the batch number was requested.  List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MMR, MNQ, TDAP
Symptoms: Vaccination complication
Clinical narrative: Patient had adverse reaction to HPV. Vitals was taken. BP 112/78 pulse 86 RR 16 Temp 97.6 denies pain. Patient was stabilized and monitored for 30 minutes. She was discharged stable
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Blood glucose normal, Cold sweat, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient had a vasovagal syncope response upon standing after injections (both given in left deltoid, +1 inch apart. Hep A was the first given in the upper deltoid, HPV second in the lower deltoid). Writer had patient sit down, and she then passed out for 5-10 seconds. RN and provider were called into the exam room to evaluate her. Writer took her blood pressure and it was 54/34. Writer elevated patients legs on provider's chair, as she was not able/willing to transfer to the exam table. Patient was given orange juice, water, and crackers as she reported she had not eaten since noon, nor had she had anything to drink all day. Blood sugar was 102. Second blood pressure reading was 64/36. Patient then went to the restroom  with her mother, had a BM, and went back into exam room. Her final blood pressure was 94/64 and she was feeling much better, less pale and clammy. She walked to check out with RN and was given permission to go from RN and provider.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: High fever of 102 degrees F. Red bumps on cheeks and limbs two days after.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and Chills, self resolved over 24-48 hours
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, severe chills, headache, muscle aches
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dry skin, Erythema, Feeling abnormal, Peripheral swelling
Clinical narrative: Pt states she heard or "felt"  a popping ( I as the pharmacist do not recall hearing a popping) she states that she felt as if her nose was then about to bleed (this was not communicated the day of) Pt states she had chills the following tuesday (3 days later) and her arm began to swell. Pt also receives a bone marrow shot in the same arm. at presentation on friday 9/20 patient does not present with swelling, some slight redness however her skin turgor and condition of skin makes most of her skin appear dry brittle and slighlty red. Pt denies pain, limited motion, and appears to be doing fine. she states she just wanted us to know that she had a reaction. she did inform her md. I instructed her to talk with her doctor next year as to whether or not she should receive the vaccine. Pt is not angered at the pharmacy and or immunizer just wanted us to know.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Bed sharing, Blister, Chills, Cough, Decreased appetite
Clinical narrative: On Tuesday, 09/03/2019 I took my healthy 1 year old daughter for her 12-month visit where she received the recommended dose of Varicella. The injection was administered by her Pediatrician to the left upper thigh. By Wednesday, 09/04 evening my daughter became febrile with a fever that spike to its highest 104°F by Thursday 09/05/2019 which was associated with shivering and loss of appetite. The fever persisted despite of oral Tylenol and Motrin given to my daughter. Finally, her pediatrician administered a rectal suppository in the office on 09/05 which helped to reduce the fever, however, it did spike again that evening. The fever lasted until Saturday 09/07 and my daughter began to show signs of improvement by Sunday 09/08. Monday 09/09 my daughter developed what I thought were cold symptoms which included cough, congestion and runny nose; this lasted a week. On Sunday 09/15/2019 I noticed some inflammation at the site of her injection which I began to keep an eye on throughout the day; by Monday 3 vesicles were formed on her left thigh and one in the center of her chest. By Monday evening the vesicles continued to appear and the swelling at the injection site became more prominent. I took my daughter to an after hour Urgent Care on Tuesday 09/17 evening to express my concerns and all they could say was its viral. Keeping in mind that my daughter did not have nor has she developed any vesicles on her hands or feet, therefore, the prognosis of coxsackie would not apply. Additionally we co-sleep and I have not developed any symptoms throughout this entire time and coxsackie is extremely contagious. It is now September 20, 2019 and finally some of the vesicles on my daughter?s body are beginning to heal especially the ones at the site of injection. I will continue to monitor and keeping a diary along with photos to further assist with any information needed regarding this matter.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site inflammation, Injection site swelling, Injection site vesicles, Nasopharyngitis, Pyrexia
Clinical narrative: On Tuesday, 09/03/2019 I took my healthy 1 year old daughter for her 12-month visit where she received the recommended dose of Varicella. The injection was administered by her Pediatrician to the left upper thigh. By Wednesday, 09/04 evening my daughter became febrile with a fever that spike to its highest 104°F by Thursday 09/05/2019 which was associated with shivering and loss of appetite. The fever persisted despite of oral Tylenol and Motrin given to my daughter. Finally, her pediatrician administered a rectal suppository in the office on 09/05 which helped to reduce the fever, however, it did spike again that evening. The fever lasted until Saturday 09/07 and my daughter began to show signs of improvement by Sunday 09/08. Monday 09/09 my daughter developed what I thought were cold symptoms which included cough, congestion and runny nose; this lasted a week. On Sunday 09/15/2019 I noticed some inflammation at the site of her injection which I began to keep an eye on throughout the day; by Monday 3 vesicles were formed on her left thigh and one in the center of her chest. By Monday evening the vesicles continued to appear and the swelling at the injection site became more prominent. I took my daughter to an after hour Urgent Care on Tuesday 09/17 evening to express my concerns and all they could say was its viral. Keeping in mind that my daughter did not have nor has she developed any vesicles on her hands or feet, therefore, the prognosis of coxsackie would not apply. Additionally we co-sleep and I have not developed any symptoms throughout this entire time and coxsackie is extremely contagious. It is now September 20, 2019 and finally some of the vesicles on my daughter?s body are beginning to heal especially the ones at the site of injection. I will continue to monitor and keeping a diary along with photos to further assist with any information needed regarding this matter.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: On Tuesday, 09/03/2019 I took my healthy 1 year old daughter for her 12-month visit where she received the recommended dose of Varicella. The injection was administered by her Pediatrician to the left upper thigh. By Wednesday, 09/04 evening my daughter became febrile with a fever that spike to its highest 104°F by Thursday 09/05/2019 which was associated with shivering and loss of appetite. The fever persisted despite of oral Tylenol and Motrin given to my daughter. Finally, her pediatrician administered a rectal suppository in the office on 09/05 which helped to reduce the fever, however, it did spike again that evening. The fever lasted until Saturday 09/07 and my daughter began to show signs of improvement by Sunday 09/08. Monday 09/09 my daughter developed what I thought were cold symptoms which included cough, congestion and runny nose; this lasted a week. On Sunday 09/15/2019 I noticed some inflammation at the site of her injection which I began to keep an eye on throughout the day; by Monday 3 vesicles were formed on her left thigh and one in the center of her chest. By Monday evening the vesicles continued to appear and the swelling at the injection site became more prominent. I took my daughter to an after hour Urgent Care on Tuesday 09/17 evening to express my concerns and all they could say was its viral. Keeping in mind that my daughter did not have nor has she developed any vesicles on her hands or feet, therefore, the prognosis of coxsackie would not apply. Additionally we co-sleep and I have not developed any symptoms throughout this entire time and coxsackie is extremely contagious. It is now September 20, 2019 and finally some of the vesicles on my daughter?s body are beginning to heal especially the ones at the site of injection. I will continue to monitor and keeping a diary along with photos to further assist with any information needed regarding this matter.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects; patient administered the 1st dose of recombivax HB on 5/4/2019 and a 2nd dose on 7/8/2019; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2019, the patient was vaccinated with 1st dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dosing details not reported) for prophylaxis. On 08-JUL-2019, the patient was vaccinated with second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) ( lot/batch# R031052, expiry date # 03-JUN-2021, strength, dose and route, therapy type not reported) for prophylaxis (inappropriate schedule of product administration). There were no adverse effects. There was no product quality complaint (PQC).
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm was red; Arm was swollen; This case was reported by a consumer and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were unknown.   The reporter considered the erythema of extremities and swelling arm to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked if there any discounts/coupons that could be applied to the Shingrix vial shot for Shingles. The patient reported that she and her husband they had different insurance options. The patient received 1 of 2 shots, and she paid 45 (co-pay) and her husband paid the total cost of 170. They were still facing these costs to receive a 2nd shot in 2 to 4 months. The patient reported that her arm was red and swollen. The patient reported that it was strange that insurance did not help out with vaccinations, just the flu shot!  The patient did not want to come down with Shingles and was thankful you have a vaccination as a remedy.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a physician via sales rep and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in her 80's. It was reported that the patient experienced rash after the dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site exfoliation
Clinical narrative: Red spot at injection site; Flaky skin at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes zoster.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema and injection site exfoliation. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site exfoliation was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site exfoliation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 76 years or 77 years. Injection site had redness and flaky skin, about the size of a pencil eraser. The redness was not raised. The patient was seen by her dermatologist who prescribed a steroid cream and after treatment, the red, flaky skin resolved. At the time of reporting the patient returned to the pharmacy and states the redness recurred.  The date of recurrence was unknown to pharmacist, but as of the time of this call the redness was ongoing.  The patient denied itching and pain, and states that at the time of reporting the reddened skin was not flaky. The reporter consented to follow up. The pharmacist did not provide further details.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropathy, Balance disorder, Diplopia, Loss of consciousness, Somnolence
Clinical narrative: blacked out; vertigo; she states if was like her knees buckled; fell asleep; rubbing below her ear on her neck, slightly behind the ear and just under her skull bone, equilibrium was off; double vision; This case was reported by a consumer via call center representative and described the occurrence of blackout in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vertigo (experienced earlier before receiving Shingrix, in yoga class when she tilted her head back.). Concurrent medical conditions included multiple myeloma (received infusion treatments for the same).   On 27th August 2019, the patient received the 1st dose of Shingrix. On 28th August 2019, 1 days after receiving Shingrix, the patient experienced double vision, sleepiness and balance disorder. On 12th September 2019, the patient experienced blackout (serious criteria GSK medically significant), vertigo and joint disorder. On an unknown date, the outcome of the blackout, vertigo, joint disorder, sleepiness and balance disorder were unknown and the outcome of the double vision was recovered/resolved.   It was unknown if the reporter considered the blackout, vertigo, double vision, joint disorder, sleepiness and balance disorder to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at the infusion center where she receives her infusion treatments for multiple myeloma.  On the 2nd day after receiving Shingrix, the patient was lying on the floor with her dog. She felt asleep and when she went to get up her equilibrium was off and she had double vision for about 2 hours.  The day before reporting, she was at her counter, and reached up to put something away and then she felt like her knees buckled and she was not sure but believed she might have been blacked out.  The patient remembered thinking like what had happened.  The patient also experienced vertigo the night before the date of reporting. The patient rubbed below her ear on her neck, slightly behind the ear and just under her skull bone when she experienced vertigo. The patient was encouraged to continue to express the events to her physician. On the day of receiving Shingrix, the patient was in the infusion center having her port flushed, which was because she received infusion treatments for Multiple Myeloma. The reporter consented to follow up. The reporter was willing to get authorization form. She notified her PCP via email about the events, but she was under the care of her hematologist/ oncologist who was the doctor that recommended her to receive Shingrix.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: blacked out; vertigo; she states if was like her knees buckled; fell asleep; rubbing below her ear on her neck, slightly behind the ear and just under her skull bone, equilibrium was off; double vision; This case was reported by a consumer via call center representative and described the occurrence of blackout in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vertigo (experienced earlier before receiving Shingrix, in yoga class when she tilted her head back.). Concurrent medical conditions included multiple myeloma (received infusion treatments for the same).   On 27th August 2019, the patient received the 1st dose of Shingrix. On 28th August 2019, 1 days after receiving Shingrix, the patient experienced double vision, sleepiness and balance disorder. On 12th September 2019, the patient experienced blackout (serious criteria GSK medically significant), vertigo and joint disorder. On an unknown date, the outcome of the blackout, vertigo, joint disorder, sleepiness and balance disorder were unknown and the outcome of the double vision was recovered/resolved.   It was unknown if the reporter considered the blackout, vertigo, double vision, joint disorder, sleepiness and balance disorder to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at the infusion center where she receives her infusion treatments for multiple myeloma.  On the 2nd day after receiving Shingrix, the patient was lying on the floor with her dog. She felt asleep and when she went to get up her equilibrium was off and she had double vision for about 2 hours.  The day before reporting, she was at her counter, and reached up to put something away and then she felt like her knees buckled and she was not sure but believed she might have been blacked out.  The patient remembered thinking like what had happened.  The patient also experienced vertigo the night before the date of reporting. The patient rubbed below her ear on her neck, slightly behind the ear and just under her skull bone when she experienced vertigo. The patient was encouraged to continue to express the events to her physician. On the day of receiving Shingrix, the patient was in the infusion center having her port flushed, which was because she received infusion treatments for Multiple Myeloma. The reporter consented to follow up. The reporter was willing to get authorization form. She notified her PCP via email about the events, but she was under the care of her hematologist/ oncologist who was the doctor that recommended her to receive Shingrix.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: pain in arm; a fever of 103 degrees; received 1st dose of Trumenba in 2018/nurse reported the incident late in the afternoon on 17Sep2019 and has requested information regarding the completion of the Trumenba series; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA; lot number and expiration date were unknown), via an unspecified route of administration on 2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The nurse reported that the patient received the 1st dose of meningococcal group b rlp2086 in 2018, and within 48 hours the patient complained of pain in arm and reported a fever of 103 degrees to the office. The nurse reported the incident late in the afternoon on 17Sep2019 and has requested information regarding the completion of the meningococcal group b rlp2086 series. The nurse was asking if it was safe and recommended to complete the series with this patient following the adverse events that occurred following the first dose in 2018. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: hot red and swollen arm after receiving vaccine in the same arm, patient was seen in a walk in and received an antibiotic scipt
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Influenza like illness, Myalgia, Pruritus
Clinical narrative: I had flu like symptoms (fatigue, muscles aches) the evening of the shot and most of the following day. Then 3 days after the shot, I developed a line of burning/itching at the base of my neck on the left side. This was intermittent for about a week. I would call them flares that were very intense for about 30 seconds and then the feeling would stop.  It was in a line about 4 inches long. I looked for a rash but I could not see anything on the skin. I had no symptoms after my 1st Shingrix shot. I am a pharmacist.
Age: 5.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Crying, Fall, Headache, Lethargy, Pallor
Clinical narrative: Patient received MMR, Varicella, and Influenza vaccines at Public Health Immunization Clinic. Patient tolerated vaccines well, returned to the waiting room to wait while sister's immunizations were drawn up, and per patient's mom and aunt, fainted.  Per patient's mother, patient was standing in front of her as she was seated in a chair, complained of a headache, and then started to fall forward. Mother caught patient before he fell and no injury sustained. Patient then had moments of lethargy, whining, and crying for three to four minutes. No difficulty breathing. Face pale according to vaccinating nurse.  Patient was laid supine on mom and aunt's laps for a couple minutes, when it was determined he had not eaten in 7 hours.  A small candy bar, a bottle of Boost drink, and a bottle of water given. No prior history of syncope. Patient's sister reacted in same manner on 9/17/19 (VAERS report also submitted) with two short seizures afterwards (this child with history of Epilepsy). Reassessment after candy and Boost started showed improvement in color, activity, and symptoms.  Patient and family remained in the waiting area for another 10 minutes without further incidence. Instructed mother and aunt that children to be vaccinated with PCP for a more controlled environment.
Age: 5.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Patient received MMR, Varicella, and Influenza vaccines at Public Health Immunization Clinic. Patient tolerated vaccines well, returned to the waiting room to wait while sister's immunizations were drawn up, and per patient's mom and aunt, fainted.  Per patient's mother, patient was standing in front of her as she was seated in a chair, complained of a headache, and then started to fall forward. Mother caught patient before he fell and no injury sustained. Patient then had moments of lethargy, whining, and crying for three to four minutes. No difficulty breathing. Face pale according to vaccinating nurse.  Patient was laid supine on mom and aunt's laps for a couple minutes, when it was determined he had not eaten in 7 hours.  A small candy bar, a bottle of Boost drink, and a bottle of water given. No prior history of syncope. Patient's sister reacted in same manner on 9/17/19 (VAERS report also submitted) with two short seizures afterwards (this child with history of Epilepsy). Reassessment after candy and Boost started showed improvement in color, activity, and symptoms.  Patient and family remained in the waiting area for another 10 minutes without further incidence. Instructed mother and aunt that children to be vaccinated with PCP for a more controlled environment.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient said she was shopping later on that day and passed out. Didn't feel that way at all right after vaccine for earlier in the day. No signs of allergic rxn, simply fainted then was fine.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Give Meningoccal immunization on 09/17/2019. Immunization was not due until 11/12/2019 which is slightly under 2 months from now.  Last Dose 06/25/2015 - No adverse reactions
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Blister, Injection site erythema, Injection site swelling, Pyrexia, Skin warm
Clinical narrative: Starting the following day of the injections given, swelling and warmth began along with slight fever. Tylenol was given for fever and cool wash cloth was used for swelling. Next day Thursday the 19th of September 2019 around 8:30 am I noticed extreme swelling and blisters forming.  I called office and they said to bring him in. They saw him and prescribed antibiotics, steroids, pain reliever, and a cream for the site. Also drew a line surrounding the swollen site and said if swelling went outside of border to take baby to the ER or if a fever of 100.4 or higher was present. Made follow up visit for 1 week. Later in that same day around 6:00 pm the swelling had worsened and went outside of lines. Took baby to ER and and said to give double dose of antibiotics and to bring him back the following day to check up.  It is the 20th day of September while I write this and still early in the morning. The swelling has gone even farther outside of the line almost wrapping around the entire thigh but redness has slightly subsided.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Swelling
Clinical narrative: Starting the following day of the injections given, swelling and warmth began along with slight fever. Tylenol was given for fever and cool wash cloth was used for swelling. Next day Thursday the 19th of September 2019 around 8:30 am I noticed extreme swelling and blisters forming.  I called office and they said to bring him in. They saw him and prescribed antibiotics, steroids, pain reliever, and a cream for the site. Also drew a line surrounding the swollen site and said if swelling went outside of border to take baby to the ER or if a fever of 100.4 or higher was present. Made follow up visit for 1 week. Later in that same day around 6:00 pm the swelling had worsened and went outside of lines. Took baby to ER and and said to give double dose of antibiotics and to bring him back the following day to check up.  It is the 20th day of September while I write this and still early in the morning. The swelling has gone even farther outside of the line almost wrapping around the entire thigh but redness has slightly subsided.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Swelling, tender, large knot at injection site
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Glossodynia, Headache, Nausea
Clinical narrative: Pt received Shingrex vaccination on Monday, Sept. 16, 2019 at pharmacy.  (pt originally reported she received the vaccination on the 17th, pharmacy then pt confirmed it was Monday, Sept 16, 2019).  Pt called her doctor's office on Friday, Sept. 20, 2019 to report her symptoms.  Reports by noon on the day she received the vaccine noted left arm soreness, by mid afternoon developed chills, excessive thirst, nausea, fatigue, required sips of water to help her swallow.  Symptoms continued all night, next AM awoke with headache, chills continued with nausea, and excessive fatigue. Tylenol relieved the headache. Next day chills decreased, fatigue started to improve, arm soreness left. Next day developed sores and pain under her tongue, developed bumps on her tongue.  Symptoms continued to improve, except for tongue and mouth sores and spots.  Chills were gone on day 4, fatigues improving, no nausea and thirst improved.   Today, Friday 9-20-19 chills, fatigue gone, soreness remains in mouth and tongue.  Denies ever experiencing a rash, itching, difficulty breathing or chest pressure/pain, no facial swelling.   First Shingrex received was at pharmacy (same) on 7-9-19 and experienced no adverse reactions.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Thirst, Tongue disorder, Tongue ulceration
Clinical narrative: Pt received Shingrex vaccination on Monday, Sept. 16, 2019 at pharmacy.  (pt originally reported she received the vaccination on the 17th, pharmacy then pt confirmed it was Monday, Sept 16, 2019).  Pt called her doctor's office on Friday, Sept. 20, 2019 to report her symptoms.  Reports by noon on the day she received the vaccine noted left arm soreness, by mid afternoon developed chills, excessive thirst, nausea, fatigue, required sips of water to help her swallow.  Symptoms continued all night, next AM awoke with headache, chills continued with nausea, and excessive fatigue. Tylenol relieved the headache. Next day chills decreased, fatigue started to improve, arm soreness left. Next day developed sores and pain under her tongue, developed bumps on her tongue.  Symptoms continued to improve, except for tongue and mouth sores and spots.  Chills were gone on day 4, fatigues improving, no nausea and thirst improved.   Today, Friday 9-20-19 chills, fatigue gone, soreness remains in mouth and tongue.  Denies ever experiencing a rash, itching, difficulty breathing or chest pressure/pain, no facial swelling.   First Shingrex received was at pharmacy (same) on 7-9-19 and experienced no adverse reactions.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Fever (100.6) for 2 days, chills, sore arm, redness at injection site
Age: 75.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Chills, Condition aggravated, Fatigue, Glaucoma, Headache
Clinical narrative: The night of the injection the patient had a violent 12 hour reaction to the shingles shot. Dry heaves, teeth chattering chills, headache, body aches, nausea and vomiting. The next day she was very exhausted. She coincidentally had an appointment with Dr., her ophthalmologist, glaucoma specialist on 8/8/2019. Her eye pressures had soared from 10 each to 15 and 24.  Due to the high IOP she was placed on numerous medications. She was seen again on 8/22/2019 by Dr as a followup to her 8/8/19 appointment.