chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Shot was administered in Doctor's office by a medical assistant and/or nurse. The shot was injected into the right shoulder, not into the right arm. Within 15 minutes after shot was administered, symptoms included heart palpitations, diarrhea, vomiting, dizziness, weakness and faintness. Within 12 hours of injection, pain emanating from right shoulder all the way down the arm to the fingers. Unable to sleep the first night due to discomfort from injection. Morning after, rash from right shoulder to right elbow, itchiness, swelling at site of injection and in right biceps/deltoid areas, bruising around injection site, numbness and pain - has received physical therapy to help regain motion in right shoulder/arm. Has taken pain killers including Gabapentin (300 mg X 3 times daily), Extra strength TYLENOL, Prednisone (10mg), CELEBREX, Methylprednisone (4mg dose pack).
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity, Palpitations, Product administered at inappropriate site, Vomiting
Clinical narrative: Shot was administered in Doctor's office by a medical assistant and/or nurse. The shot was injected into the right shoulder, not into the right arm. Within 15 minutes after shot was administered, symptoms included heart palpitations, diarrhea, vomiting, dizziness, weakness and faintness. Within 12 hours of injection, pain emanating from right shoulder all the way down the arm to the fingers. Unable to sleep the first night due to discomfort from injection. Morning after, rash from right shoulder to right elbow, itchiness, swelling at site of injection and in right biceps/deltoid areas, bruising around injection site, numbness and pain - has received physical therapy to help regain motion in right shoulder/arm. Has taken pain killers including Gabapentin (300 mg X 3 times daily), Extra strength TYLENOL, Prednisone (10mg), CELEBREX, Methylprednisone (4mg dose pack).
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD, lot # reported as N019282, expiration date 09-JAN-2019 and VARIVAX, lot # N021581, expiration date 09-AUG-2019 (for both strength, dose number, route and anatomical location were not provided). The vaccines were reconstituted with properly stored Merck sterile diluent. Administered dose of PROQUAD and VARIVAX experienced the temperature excursion of -9 Celsius degrees to 8 Celsius degrees (also reported as 7.3 Celsius degrees) for 1 hour and 9 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a nurse on 12-JUN-2018 and refers to a 4-year-old patient. On 12-JAN-2018, the patient was vaccinated with improperly stored dose of PROQUAD, lot # N019828 (previously reported as N019282) and VARIVAX. This is one of six reports received from the same reporter. Sender's Comments: US-009507513-1806USA007938; US-009507513-1806USA007940; US-009507513-1806USA007937; US-009507513-1806USA007936; US-009507513-1806USA007939.
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In approximately May 2018 (reported as beginning of May), the patient was vaccinated with a dose Oka/Merck VARIVAX reconstituted with sterile diluent, subcutaneous for prophylaxis. In approximately 2018 (reported as 2 weeks after first dose), the patient experienced varicella like rash. The patient called her primary care provider. No treatment was given and the rash subsided (in 2018). The outcome of rash vesicular was reported as recovered/resolved. Causality assessment was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-JAN-2015, the patient was inoculated with the ZOSTAVAX vaccine at physicians office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster, also known as shingles. Later in 2015, he was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Heart rate increased, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 63-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 1st June 2018, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site pain. In June 2018, the patient experienced headache, stomach pain, nausea and heart rate increased. The patient was treated with famotidine (Pepcid). In June 2018, the outcome of the heart rate increased was recovered/resolved. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the stomach pain, injection site erythema, injection site warmth, injection site pain and vaccine administered at inappropriate site were unknown and the outcome of the nausea and injection site swelling were recovering/resolving. The reporter considered the headache, stomach pain, nausea, heart rate increased, injection site swelling, injection site erythema, injection site warmth and injection site pain to be related to SHINGRIX. Additional information was received as follows: This case was reported by the nurse for herself. On 31st May 2018, at 1:30 pm the patient received SHINGRIX on left arm. On 1st June 2018, in the middle of the night, around 1:00 am, the patient started having a severe headache, stomach pain, nausea and fast heart rate. One day after receiving SHINGRIX the patient experienced the skin was swollen, red, hot to the touch and sore at the injection site. The patient's fast heart rate resolved about 3 days later from the time of the injection. The patient was unable to tell if her stomach pain and nausea had been resolved because she started taking Pepcid to treat that side effect and had continued to do so. The swelling, redness and soreness at the site had been gradually getting worse. The swelling at the site was as large as a softball, but as of reporting date, it was starting to look a little smaller. The patient had made her physician aware of her experience. The patient mentioned that she never had a reaction to any vaccines that she ever had. The person that gave the injection to the patient, gave it below the deltoid, which led to vaccine administered at inappropriate site. The patient was not able to speak quick enough to mention that the area where the injection should had been given was higher on her arm than it was given.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 63-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 1st June 2018, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site pain. In June 2018, the patient experienced headache, stomach pain, nausea and heart rate increased. The patient was treated with famotidine (Pepcid). In June 2018, the outcome of the heart rate increased was recovered/resolved. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the stomach pain, injection site erythema, injection site warmth, injection site pain and vaccine administered at inappropriate site were unknown and the outcome of the nausea and injection site swelling were recovering/resolving. The reporter considered the headache, stomach pain, nausea, heart rate increased, injection site swelling, injection site erythema, injection site warmth and injection site pain to be related to SHINGRIX. Additional information was received as follows: This case was reported by the nurse for herself. On 31st May 2018, at 1:30 pm the patient received SHINGRIX on left arm. On 1st June 2018, in the middle of the night, around 1:00 am, the patient started having a severe headache, stomach pain, nausea and fast heart rate. One day after receiving SHINGRIX the patient experienced the skin was swollen, red, hot to the touch and sore at the injection site. The patient's fast heart rate resolved about 3 days later from the time of the injection. The patient was unable to tell if her stomach pain and nausea had been resolved because she started taking Pepcid to treat that side effect and had continued to do so. The swelling, redness and soreness at the site had been gradually getting worse. The swelling at the site was as large as a softball, but as of reporting date, it was starting to look a little smaller. The patient had made her physician aware of her experience. The patient mentioned that she never had a reaction to any vaccines that she ever had. The person that gave the injection to the patient, gave it below the deltoid, which led to vaccine administered at inappropriate site. The patient was not able to speak quick enough to mention that the area where the injection should had been given was higher on her arm than it was given.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a elderly female patient who received SHINGRIX for prophylaxis. Concomitant products included amlodipine, acetylsalicylic acid (Aspirin), gabapentin, thyroxine sodium (Levothyroxine), metolazone, guaiphenesin (Mucinex), docusate, dorzolamide, apixaban (Eliquis), hydralazine, furosemide (Lasix), latanoprost, metoprolol and repaglinide. On 7th June 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 7th June 2018, less than a day after receiving SHINGRIX the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were provided as follows: SHINGRIX was given in right arm. The patient planned to follow-up with her physician on an unknown date.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included adalimumab (Humira). On 4th June 2018 11:00, the patient received the 1st dose of SHINGRIX. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On 11th June 2018, the patient experienced injection site warmth and injection site itching. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site warmth, injection site itching and injection site erythema were not recovered/not resolved. The reporter considered the injection site pain, injection site warmth, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in her upper left arm. The patient reported that she experienced soreness and redness at the injection site. On the reporting day, after 7 days of vaccination the redness had spread and it was large and warm to the touch as well as itchy.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Concomitant products included gabapentin, lorazepam, sodium chloride, Tamsulosin, AMITIZA and trazodone. On 9th June 2018 11:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received SHINGRIX in the left deltoid. At the time of vaccination, the patient commented that the injection was painful. The patient had not reported anything else to the pharmacy.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a female 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 week 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 provided as follows: The age at vaccination was not reported. The health care professional (HCP) reported that the patient developed active Shingles within 5 days of receiving a dose of SHINGRIX. The healthcare professional declined to provide any further details.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, intramuscularly). On an unknown date, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and intramuscular formulation administered by other route. The patient was treated with ibuprofen and non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: This case was reported by Office Manager. The reporter indicated that, they had a patient who received the 2nd dose of SHINGRIX subcutaneously, which led to incorrect route of vaccine administration. The patient's injection site was very swollen, red, and was very painful. The patient used cold compresses on the injection site. The field representative was unable to provide additional information.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 31-May-2018 regarding an unsolicited valid non-serious case received from Pfizer PCS under other manufacturer reference number- 2018197329 on 31-May-2018 and transmitted to Sanofi. This case involves an unknown age patient who experienced allergy to tetanus vaccine, while he/she received vaccine Tetanus Toxoid. 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 Tetanus Toxoid produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. The patient developed a non-serious allergy to tetanus vaccine (allergy to vaccine) following the administration of Tetanus Toxoid. Final diagnosis was allergy to tetanus vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus vaccine.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Vomiting
Clinical narrative: Initial information received on 04-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a patient (gender and age not reported) who experienced excessive redness at injection site and vomiting within 24 hour, after receiving vaccine QUADRACEL. 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 QUADRACEL (lot number and expiration date not reported) via unknown route in unknown administration site. On an unspecified date (latency not reported), following vaccination, the patient developed excessive redness at injection site and vomiting within 24 hour. No complementary investigations were reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for excessive redness at injection site and as unknown for vomiting within 24 hour. List of document held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case from a Pharmacist. This case involves a patient (gender and age not reported) who received a dose of HIB VACCINE on an unspecified date (manufacturer, batch number, expiry date, route and site of administration were not reported). This is an actual medication error case as the product was reconstituted with water instead of diluent (product preparation error). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination not reported. No adverse event was reported. Lab data and corrective treatment: not reported. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Initial information received on 25-May-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 67 years old male patient who experienced bursitis, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatments, vaccinations and family history were not provided. At the time of the event, the patient had ongoing Neuropathy peripheral. The patient did not have any known drug allergy. Concomitant medications included Gabapentin for Neuropathy peripheral and supplements (not specified). On 27-Aug-2017, the patient received a dose of Influenza USP Trival A-B High Dose Subvirion Vaccine (lot number, expiry date and dose not reported) via intramuscular route in the right deltoid. On an unknown date, few hours post vaccination, the patient developed a non-serious event of decrease in range of motion in his right arm, pain in his right arm and SIRVA (shoulder injury related to vaccine administration) with the diagnosis of bursitis. Relevant tests were not reported. Final diagnosis was bursitis. The patient was treated with Cortisone injection on 17-May-2018. The patient was not recovered from the pain in his right arm and outcome of the other events was reported as unknown. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Patient complained of low grade fever (99) and myalgias and headache. Patient instructed to give ALEVE 2 tablets twice a day for 3 days. If fever greater than 101 or if having no relief in symptoms after 5 days--office visit recommended.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Chills, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Within hours both arm muscles very weak and extremely aching. Could barely lift arms above chest. 2 more hours pass and start feeling body aches, weakness, shivering, chills and low grade fever. Start taking ibuprofen but this lasts all night till early morning. Next day somewhat better. Back to normal by day 3. Never had any vac. reactions like this prior with flu, tetanus etc. Really don't want to do the second dosage now (maybe try again when I'm in my late 60's?) We'll see......
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Within hours both arm muscles very weak and extremely aching. Could barely lift arms above chest. 2 more hours pass and start feeling body aches, weakness, shivering, chills and low grade fever. Start taking ibuprofen but this lasts all night till early morning. Next day somewhat better. Back to normal by day 3. Never had any vac. reactions like this prior with flu, tetanus etc. Really don't want to do the second dosage now (maybe try again when I'm in my late 60's?) We'll see......
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Middle insomnia, Mobility decreased, Myalgia
Clinical narrative: Patient woke up around 2 AM having chills, ran fever, muscle pain, injection site is sore, and hard to lift arm up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient woke up around 2 AM having chills, ran fever, muscle pain, injection site is sore, and hard to lift arm up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: RASH AND RED SPOTS ON BOTH UPPER LEGS IN LOCALIZED AREA.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Rash
Clinical narrative: Aching muscles, headache, chills, fatigue- all beginning about 8 hours after injection. A few days later, a rash appeared on my lower legs.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 66 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 13 year old male patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 31-AUG-2016, the patient was vaccinated with GARDASIL for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On 10-FEB-2018, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial unsolicited report received from nurse on 11 Nov 2018. This case involves patient (age and gender not reported) who was vaccinated with a dose of IPOL and TUBERSOL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as patient received doses of open product exposed to 1.4C. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module of the 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: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from pharmacist on 08 Jun 2018. This case involves a patient (age and gender not reported) who was vaccinated with expired dose of MENACTRA (expiration date: April, batch number, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Exposure during pregnancy, Gestational diabetes, Stillbirth
Clinical narrative: Daughter was stillborn at 35 weeks on 4/28/15, she was 5 pounds 9 ounces and 17 3/4 long. Pregnancy was pretty normal, diagnosis of gestational diabetes, but that is a questionable diagnosis.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy, red rash areas all over back and small area on right side of face--currently taking LYRICA, hydroxyzine, gabapentin and valacyclovir.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: Shortness of breath, dizziness, headache chills. Whole body felt weak.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised, Rash pruritic, Rash vesicular, Scab
Clinical narrative: PATIENT HAD RASH OUTBREAK SIMILAR TO CHICKEN POX ON HER WHOLE BODY, THE RASH WAS  ITCHY AND BLISTER LIKE. TODAY SHE HAS SCABS OVER THE AREAS WHERE SHE PREVIOUSLY HAD RASH ALTHOUGH COMPLAINING OF ITCHING.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Hours after vaccine given, right arm became painful, erythematous and edematous. Symptoms worsened overnight prompting patient to come to the Clinic for evaluation.
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Seizure, Syncope
Clinical narrative: This spontaneous report was received from a registered nurse via company representative, concerning a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 for prophylaxis (dose #, route of administration, lot # and expiration date were unknown). Concomitant medications were not reported. On an unknown date (reported as "later that same day"), the patient had passed out and had a seizure. The patient was taken to unspecified emergency room for treatment. At the time of reporting, the outcome of seizure and syncope was unknown. The causality assessment between the adverse events and GARDASIL 9 was not provided. Upon internal review, seizure was determined to be a medically significant event.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Paralysis, Pyrexia
Clinical narrative: Pt rcvd both SHINGRIX (left arm) and PNEUMOVAX 23 (right arm) - patient experienced fever and partial paralysis and severe weakness - said she had to roll on the floor to move - was hospitalized and put on IV antibiotics - right side injection site - recovered.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Rash vesicular
Clinical narrative: Fever to 102 degrees F and vesicular zoster-like rash on (L) volar forearm (injection was given (L) deltoid). Body aches.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: Fever to 102 degrees F and vesicular zoster-like rash on (L) volar forearm (injection was given (L) deltoid). Body aches.
Age: 37.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Borrelia test negative, Rash, Rash pruritic
Clinical narrative: 6/11/18 Pt has rash on chest and then to arms, legs, thighs, is painful, itchy, and left wasn't painful.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chills, Feeling abnormal
Clinical narrative: Nerve pain in foot, then moved to knee, followed by severe knee pain and swelling. Headache, neck pain, chills, upset stomach, flu-like symptoms, weakness, sore arm at site of injection, followed by a painful rash on my arm by the 3rd day. I am on day 4 and my knee is still painful and swollen. The arm rash is better w/less discomfort and itching. I still feel ill, and not back to normal.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Joint swelling, Malaise
Clinical narrative: Nerve pain in foot, then moved to knee, followed by severe knee pain and swelling. Headache, neck pain, chills, upset stomach, flu-like symptoms, weakness, sore arm at site of injection, followed by a painful rash on my arm by the 3rd day. I am on day 4 and my knee is still painful and swollen. The arm rash is better w/less discomfort and itching. I still feel ill, and not back to normal.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Neuralgia, Pruritus, Rash
Clinical narrative: Nerve pain in foot, then moved to knee, followed by severe knee pain and swelling. Headache, neck pain, chills, upset stomach, flu-like symptoms, weakness, sore arm at site of injection, followed by a painful rash on my arm by the 3rd day. I am on day 4 and my knee is still painful and swollen. The arm rash is better w/less discomfort and itching. I still feel ill, and not back to normal.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, swelling at injection site hours after injection was given.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Head injury, Loss of consciousness, Pallor, Syncope
Clinical narrative: Vaccines were administered by nurse. Patient walked out to the lobby and fainted. Hit her head against the frame of door/wall. Caught by mother. There was loss of consciousness. Within minutes, patient was back to normal. Denies any head pain. No palpable or visible abrasions/bruising. After laying on bed for 10 min and given orange juice, patient's facial color returned to normal. Patient was slightly pale prior to that. After a few minutes of rest, patient was discharged to home.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza, Malaise, Nasopharyngitis, Pyrexia, Vision blurred
Clinical narrative: Cold/flu symptoms, malaise, blurred vision, trouble, fever.
Age: 32.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Extreme pain to upper R arm, predominately to R bicep area. Associated symptoms include subjective fever, body aches, headache.
Age: 32.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Erythema, Joint range of motion decreased, Myalgia, Pyrexia
Clinical narrative: Extreme pain to upper R arm, predominately to R bicep area. Associated symptoms include subjective fever, body aches, headache.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and tenderness at injection site.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dehydration, Headache
Clinical narrative: Dehydration, extreme shivering lasting for about an hour, headache.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Myalgia
Clinical narrative: Pt came in today 6/19/2018 saying has had muscle pain like being on a statin, numbness in legs and shoulder.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: FEVER, CHILLS, BAD HEADACHE-FEVER AND CHILLS LASTED MOST OF THE NIGHT. HEADACHE PERSISTED FOR 2 1/2 DAYS.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of injection site and spread about the width of a soft ball, warm to touch and painful.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site movement impairment, Injection site pain, Vomiting
Clinical narrative: Vomiting after vaccines. C/O of redness and site soreness. Is not moving his arm. Red area is the size of a sand dollar, afebrile. Was seen in ED and given Ibuprofen with improvement of symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Left upper lateral arm with cellulitis, pt reported pain to site and erythema x 24 hours. Treatment Clindamycin
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Muscle spasms
Clinical narrative: Chills, cramps, leg pain, dizzy, shortness of breath, headache.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Chills, cramps, leg pain, dizzy, shortness of breath, headache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Herpes simplex, Oral herpes, Paraesthesia
Clinical narrative: Developed a cold sore (herpes simplex) on my left lower lip after a sun exposure on 6/10/18.  Typically these are very self limiting. In this case the next day I developed pain radiating up the left mandible into my left ear. This progressed through the night to severe ear pain, paresthesias of left side of tongue and entire left side of face (similar to novocaine feeling).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: Developed a cold sore (herpes simplex) on my left lower lip after a sun exposure on 6/10/18.  Typically these are very self limiting. In this case the next day I developed pain radiating up the left mandible into my left ear. This progressed through the night to severe ear pain, paresthesias of left side of tongue and entire left side of face (similar to novocaine feeling).
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthropod bite, Blister, Paraesthesia, Rash generalised, Rash pruritic
Clinical narrative: Complications: Next morning after SHINGRIX shot I found a engorged deer tick on inside of left arm above elbow. I immediately took one Doxycyline tablet. It was shortly after that, that I started feeling a tingling pin prick sensation over my back. I went to the Walk-in clinic mentioned above and Dr thought it was the a reaction to the doxycycline. This, despite, having taken doxycycline (years) before without adverser reaction. The tingling sensation turned into a rash expression of hives, polka dots all over my body, very itchy, with a blister on my right hand. Now taking prednisone at 2-20 mg  (first day) which seems to be doing something. Redness seems to be receding.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Complications: Next morning after SHINGRIX shot I found a engorged deer tick on inside of left arm above elbow. I immediately took one Doxycyline tablet. It was shortly after that, that I started feeling a tingling pin prick sensation over my back. I went to the Walk-in clinic mentioned above and Dr thought it was the a reaction to the doxycycline. This, despite, having taken doxycycline (years) before without adverser reaction. The tingling sensation turned into a rash expression of hives, polka dots all over my body, very itchy, with a blister on my right hand. Now taking prednisone at 2-20 mg  (first day) which seems to be doing something. Redness seems to be receding.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever up to 102, chills, improved the next AM with temp to 100. Spoke with doctor on phone. Told to call or go to ER if worsening reaction. Take extra strength TYLENOL as needed.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Patient felt achy, tired, and believes she had a low grade fever the day after receiving first dose of SHINGRIX IM. Lasted until that evening when she took an OTC pain reliever.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait inability, Pain in extremity, Paraesthesia
Clinical narrative: Pt believes he has Guillian-Barre. Pt was admitted to hospital unable to walk with tingling pain in legs. Hospital was unable to clearly diagnose his conditon, possible infection.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Fall, Gait disturbance, Lumbar puncture, Spinal myelogram
Clinical narrative: Pt believes he has Guillian-Barre. Pt was admitted to hospital unable to walk with tingling pain in legs. Hospital was unable to clearly diagnose his conditon, possible infection.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Walking aid user
Clinical narrative: Pt believes he has Guillian-Barre. Pt was admitted to hospital unable to walk with tingling pain in legs. Hospital was unable to clearly diagnose his conditon, possible infection.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HPV9, PNC13, RV1
Symptoms: Wrong drug administered
Clinical narrative: Nurse pulled wrong immunization other nurse drew up and gave wrong immunization. Provider notified and explained and discussed with mother. Mother states understanding and ok. Correct immunization given. Mother informed to call clinic with any questions or problems.
Age: 35.0
Sex: F
Vaccine: HEP, RAB
Symptoms: Chest pain, Cough, Dyspnoea
Clinical narrative: Patient reported the event to her supervisor by email on 6-19-18. I was notified at 4pm on 6-19-18 of the email and contacted the patient by phone. She reported that she began having symptoms at around 9am on 6-18-18 which were "chest hurting", and cough. She stated that she did not have difficulty breathing but it was harder to breath than normal. She stated she was no longer having pain, but still coughing a little. The cough sounded dry and hoarse. She denied all other symptoms. I instructed that she see a physician to be evaluated and she declined. She agreed to go to Clinic if pain returned or cough did not continue to improve. Instructed to call back with any questions or concerns or go to Clinic if after our hours.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2013, the patient was vaccinated with the first dose of ZOSTAVAX subcutaneously for prophylaxis (dose, lot# and expiration date were not reported). On 22-MAY-2018, the patient received a second dose of ZOSTAVAX subcutaneously for prophylaxis (dose, lot# and expiration date were not reported). No adverse effects were reported.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a non-pregnant 17 year old female patient. The patient did not have medical history, concurrent conditions, drug reactions or allergies. Her concomitant medications included an unspecified birth control method. On 04-JAN-2017, 19-JUN-2017 and 24-JAN-2018, the patient received doses of GARDASIL 9 (strength, lot #, expiration date not provided), administered intramuscularly to prevent human papillomavirus (HPV). On 06-JUN-2018, she was vaccinated with an extra dose of GARDASIL 9 through the same route and for the same indication. On 07-JUN-2018, the patient developed soreness at the site of the last GARDASIL 9 injection (injection site pain), so she sought medical attention by calling a nurse but no treatment was given for the event and no laboratory diagnostic studies were performed. She had not recovered from the event at the time of this report. The causal relationship between the injection site pain and GARDASIL 9 was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Pain in extremity, Protein urine present, Pyrexia, Vaginal lesion
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 12 year old female patient. The patient's medical history included eczema. Information regarding the patient's drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 08-AUG-2017, the patient was vaccinated with the first dose GARDASIL 9 0.5 ml, by intramuscular route (strength, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-JUN-2018, the patient received the second dose GARDASIL 9 lot # N022583 with expiration date of 20-JUN-2020 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of drug administration). On an unknown date, the patient developed "vaginal lesion", "a fever, a sore arm, and blisters and lesions in the vaginal area" (vaginal lesion, genital blister, pain in extremity, pyrexia and vaginal lesion). On 11-JUN-2018, a "urine dipstick" was performed which identified "2+ protein", and a "genital swab for HSV (herpes simplex virus)" (results were not provided) (genital disorder female and protein urine present). The outcome of vaginal lesion, genital blister, pain in extremity, pyrexia, protein urine present and genital disorder female was reported as not resolved. The causality assessment between therapy with GARDASIL 9 and the events was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Vaginal mucosal blistering
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 12 year old female patient. The patient's medical history included eczema. Information regarding the patient's drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 08-AUG-2017, the patient was vaccinated with the first dose GARDASIL 9 0.5 ml, by intramuscular route (strength, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-JUN-2018, the patient received the second dose GARDASIL 9 lot # N022583 with expiration date of 20-JUN-2020 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of drug administration). On an unknown date, the patient developed "vaginal lesion", "a fever, a sore arm, and blisters and lesions in the vaginal area" (vaginal lesion, genital blister, pain in extremity, pyrexia and vaginal lesion). On 11-JUN-2018, a "urine dipstick" was performed which identified "2+ protein", and a "genital swab for HSV (herpes simplex virus)" (results were not provided) (genital disorder female and protein urine present). The outcome of vaginal lesion, genital blister, pain in extremity, pyrexia, protein urine present and genital disorder female was reported as not resolved. The causality assessment between therapy with GARDASIL 9 and the events was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report was received from the patient's mother, via a company representative, and refers to a female patient of unknown age. The patient had no pertinent medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unspecified date in 2016, reported as "two years ago", the patient was vaccinated with one dose of GARDASIL 9 0.5 mL, injection, intramuscular as human papillomavirus (HPV) prevention (dose, anatomical location, lot number and expiration date were not reported). On an unknown date, reported as "after the injection", the patient experienced a fever (pyrexia) and sore arm (pain in extremity). It was reported that the patient did not seek for medical attention and no laboratory diagnostics or studies were performed, however, she was placed under therapy treatment with acetaminophen (TYLENOL) and after 24 hours she recovered from the fever and, on an unknown date, she recovered form her sore arm. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the patient's fever and sore arm.