chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from physician on 20-Dec-2017. This case was linked to 2017SA264640-1 (same reporter). This case involves adult patient (age and gender not reported) who was vaccinated with 0.5 ml dose (once) of FLUZONE QUADRIVALENT (Batch number, expiration date, dose and site of administration was not reported) via intramuscular route on 01 Dec 2017. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced anaphylactic reactions described as "very unusual". Patient had not seen reactions of this type. Lab data and corrective treatment were not reported. The patient's event outcome was unknown. Upon internal review, the company decided to consider the case serious because of important medical event anaphylactic reaction. List of documents held by sender: none.; Reporter's Comments: Patient experienced anaphylactic recation after vaccination. Exact time to onset is not mentioned. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, role of the vaccine cannot be assessed.; Sender's Comments: Patient experienced anaphylactic recation after vaccination. Exact time to onset is not mentioned. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from physician on 20-Dec-2017. This case was linked to 2017SA264637 (same reporter). This case involves an adult patient (age and gender not reported) who was vaccinated with 0.5 ml dose (once) of FLUZONE QUADRIVALENT (Batch number, expiration date, dose and site of administration was not reported) via intramuscular route on 01 Dec 2017. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced anaphylactic reactions described as "very unusual". Patient had not seen reactions of this type. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. Upon internal review, the company decided to consider the case serious due to important medical event anaphylactic reaction. List of documents held by sender: none.; Sender's Comments: Patient experienced anaphylactic reactions after vaccination. Exact time to onset is not mentioned. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Nasopharyngitis, White blood cell count decreased
Clinical narrative: Initial unsolicited report received from nurse on 21-Dec-2017. This case involves 51-year-old female patient who was vaccinated with a dose of FLU VACCINE (Batch number, expiration date, dose, route and site of administration was not reported) on Oct 2017. The patient had a medical history of Rheumatoid Arthritis (ongoing). Concomitant medications included KEVZARA 200 mg by subcutaneous (SQ) injection, every two weeks since 09 Oct 2017 for Rheumatoid Arthritis. On 10 Dec 2017, few months following the vaccination, the patient experienced cold and flu symptoms (unspecified). On unknown date after 13 Dec 2017, post vaccination, the patient began experiencing a low WBC. It was reported that, the patient saw her doctor on 13 Dec 2017 for the cold and flu symptoms and also had follow up appointment with her doctor on 28 Dec 2017, for the low WBC. The patient thinks her cold and flu symptoms are probably related to her allergies. Lab data includes blood test. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient reported to me (about 2 months later) that she developed swelling around the area of the injection. Patient states this area was swollen for about 4 days before going away. No long term harm from this injection site reaction.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Insomnia, Myalgia
Clinical narrative: Muscle pain resulting in loss of sleep after taking PREVNAR 13. Symptoms have lasted for 6 weeks with no signs of going away.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Fatigue, Influenza, Malaise, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 80-year-old female patient who received Influenza vaccine Quadrivalent unspecified season. Co-suspect products included BREO ELLIPTA unknown for chronic obstructive pulmonary disease. Concurrent medical conditions included heart disorder, tiredness (normally tired) and pneumonia (1 year before reporting date). Concomitant products included PROAIR. In October 2017, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, the patient started BREO ELLIPTA 1 puff(s) once daily. On 15th December 2017, less than a year after receiving Influenza vaccine Quadrivalent unspecified season and BREO ELLIPTA, the patient experienced feeling unwell. In December 2017, the patient experienced condition aggravated and tiredness. On 17th December 2017, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. The patient was treated with ondansetron hydrochloride and oseltamivir. Influenza vaccine Quadrivalent unspecified season was continued with no change. BREO ELLIPTA was continued with no change. On an unknown date, the outcome of the vaccination failure, condition aggravated and tiredness were unknown and the outcome of the influenza and feeling unwell were recovering/resolving. The reporter considered the vaccination failure, influenza, feeling unwell, condition aggravated and tiredness to be unrelated to Influenza vaccine Quadrivalent unspecified season and BREO ELLIPTA. Additional details were reported as follows: The patient had been on BREO ELLIPTA for about a year, it was been between 6 months to a year. She stated that she also got a flu shot in late October or early November at a Pharmacy. The patient did not know the manufacturer of the flu vaccine. The patient noted before last Friday she was not feeling good and tired, but was always tired. On Saturday the patient felt worse and then on Sunday she went to an outpatient care and they diagnosed her with the flu. This case was considered as suspected vaccination failure case since the laboratory test for influenza was unknown. The patient noted she almost completed the medications. The reporter does not relate any of these events to the medications. She noted she took a lot of medications on routine, but did not want to provide those. The healthcare professional declined for information and does not want him contacted. The patient denied permission to contact their physician.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX. On 21st December 2017, the patient received SHINGRIX. In December 2017, several hours after receiving SHINGRIX, the patient experienced malaise and headache. On 21st December 2017, the patient experienced injection site pain. In December 2017, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the malaise and headache were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, malaise and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a dentist who herself was the patient. Four hours after vaccination, the healthcare professional experienced pain at the injection site. The healthcare professional did not provide the date of birth, lot number and expiration date of the vaccine.
Age: 21.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Dizziness, Pallor, Paraesthesia
Clinical narrative: Following the second vaccine - Hepatitis A - became pale, stated lightheaded - no loss of consciousness. Client was seated on exam table for vaccine administration - had him lay back on table with legs elevated. BP 138/68. Client stated had tingling in arms and legs. Remained alert, oriented, skin warm and dry. Had not eaten breakfast. Was given sweet beverage to drink and hard candy. Symptoms resolved, declined further assistance 10:05 AM.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bursitis, Injection site pain
Clinical narrative: Patient began experiencing a painful left shoulder by afternoon on the day of her injection. She was diagnosed with bursitis of her left shoulder. It became progressively worse and she is currently continuing in physical therapy.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: This spontaneous report was received from a 75-year-old female patient who refers to herself. The patient's concurrent conditions included kidney disease and arthritis. The patient's medical history included rotator cuff surgery in her left shoulder 10 years ago. The patient's concomitant therapies included hydrochlorothiazide, rosuvastatin calcium (CRESTOR), levothyroxine sodium (manufacturer unknown), amlodipine and OTC supplements. The patient did not have any drug reactions or allergies. On 17-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot# N025384 and expiration date: 19-APR-2019 (dose and administration site was not reported). On 18-NOV-2017, approximately 5 hours after receiving the injection, the patient experienced pain that radiated up into her left shoulder. The patient also stated that there was no visible swelling or redness on her arm and it was not tender to the touch but when she attempted to move her arm that the pain shot into her left shoulder. The patient reported that she went to the hospital due to the pain on 18-NOV-2017 where they drew blood, gave her codeine with acetaminophen for pain and released her. On 21-NOV-2017, the patient recovered from the events. The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 09-JUL-2004, the patient was vaccinated with an improperly stored dose of M-M-R II. On 20-JUL-2004, the patient was also vaccinated with an improperly stored dose of VARIVAX. On 29-JUL-2004, the patient received the second dose of M-M-R II and VARIVAX. Both vaccines were reconstitute with a sterile diluent (STERILE DILUENT), which was unknown if was properly stored (dose, route, lot numbers and expiration dates were not reported) all for prophylaxis. No adverse effects reported.
Age: 71.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injection site discolouration, Injection site reaction, Musculoskeletal pain, Rash macular, Swelling
Clinical narrative: Per PCP note: C/O patient states that he received his PNEUMOVAX and Flu vaccines o 12/12/2017 and today he has a large black and blue and red blotches on his left arm (PNEUMOVAX) down to his elbow. Patient denies and itchiness or fever. Patient took ALEVE on the day he received his PNEUMOVAX 23 injection because of shoulder pain. Pain was improved and he was able to sleep all right. Patient presents today to document his reaction. Mild reaction to PNEUMOVAX 23. Recommend applying ice for 20min. to the affected area hourly for relief of pain and swelling. May use TYLENOL or ibuprofen for additional comfort measures. Follow up If not improved.Flu shot-Right arm and PNEUMOVAX 23-Left arm.
Age: 71.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injection site discolouration, Injection site pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Per PCP note: C/O patient states that he received his PNEUMOVAX and Flu vaccines o 12/12/2017 and today he has a large black and blue and red blotches on his left arm (PNEUMOVAX) down to his elbow. Patient denies and itchiness or fever. Patient took ALEVE on the day he received his PNEUMOVAX 23 injection because of shoulder pain. Pain was improved and he was able to sleep all right. Patient presents today to document his reaction. Mild reaction to PNEUMOVAX 23. Recommend applying ice for 20min. to the affected area hourly for relief of pain and swelling. May use TYLENOL or ibuprofen for additional comfort measures. Follow up If not improved.Flu shot-Right arm and PNEUMOVAX 23-Left arm.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Vision blurred, Vomiting
Clinical narrative: Dizziness, blurred vision, vomiting 5 minutes after vaccine. Lasted about 10 minutes.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, C-reactive protein increased, Chills, Full blood count, Malaise
Clinical narrative: Pt states that following flu shot admin. he became ill with muscle and joint pain and chills. Getting progressively worse over next 2 months. Pt was seen by MD and diagnosed with polymyalgia rheumatica questionable exacerbated by flu shot.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Polymyalgia rheumatica, Red blood cell sedimentation rate increased, X-ray
Clinical narrative: Pt states that following flu shot admin. he became ill with muscle and joint pain and chills. Getting progressively worse over next 2 months. Pt was seen by MD and diagnosed with polymyalgia rheumatica questionable exacerbated by flu shot.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS, FLU4, VARZOS
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Pain at the onset of injection, decreased range of motion, "never the same since".
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to an 11 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 02-NOV-2017, the patient was vaccinated with an adult dose of VAQTA lot number M039055 and expiration date of 22-JUL-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via company representative, concerning an unspecified number of elderly patients (reported as "fewer than five patients" but "probably two patients", of 65 years old or older) of an unknown gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date in September 2017, the patients were vaccinated with one shot of PNEUMOVAX 23 injection (strength, dose number, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date in 2017, the patients experienced redness and swelling at the injection site after receiving PNEUMOVAX 23. It was unknown if patients sought medical attention or if laboratory diagnostics or studies were performed.  About one week later, on an unspecified date in 2017, the patients recovered from the adverse events. The causal relationship between the aforementioned adverse events and the PNEUMOVAX 23 was not assessed.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-DEC-2017, the patient was vaccinated with ZOSTAVAX lot number M042850 and expiration date of 18-JAN-2018, via intramuscularly route instead of the subcutaneous route for prophylaxis. No apparent adverse effects were reported in the patient.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: This spontaneous report was received from a currently 67-year-old female patient referring to herself. There was no information about the patient's concurrent conditions and concomitant therapies provided. The patient had no medical history and no drug reaction or allergy. On 25-OCT-2017, the patient was intramuscularly vaccinated with a second dose of PNEUMOVAX 23 (exact dose, lot# and expiry date were not reported) for prophylaxis. On an unknown date in 2017, reported that after receiving PNEUMOVAX 23, the patient could not lift her right arm to touch her left shoulder. She further stated that even though her arm was better, she still had pain when doing certain motions. She sought medical attention, talked with the pharmacist and was given a treatment for the events. The patient was not hospitalized. No lab diagnostic studies were performed. The outcome of the events was reported as recovering. The reporter's causality assessment between the events and the PNEUMOVAX was not reported.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's pertinent medical history included primary cholangitis. The patient did not have any drug reactions or allergies. No information regarding concomitant medications was provided. On 19-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N010105; expiry date 15-NOV-2017 (dose and route of administration were not provided). On an unknown date in December 2017 (reported as shortly after receiving the vaccination), the patient developed a cellulitis-like reaction. The patient sought medical attention by calling the office. No antibiotics or other treatment were given. No lab diagnostics or studies were performed. The outcome of the event was reported as recovered on an unknown date in December 2017 (reported as: "up to week after receiving the injection"). The causality assessment was not provided. The reporter requested a lot check for the PNEUMOVAX 23. Upon internal review, the event of the cellulitis-like reaction not under control was considered medically significant. Sender's Comments: US-009507513-1801USA000917: US-009507513-1801USA000916.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M041768, expiration date 25-JUN-2018 (dose was not reported)  for prophylaxis. No adverse effects were reported. The temperature involved was 9 to 25 degrees Celsius for 15 minutes. No previous temperature was reported, and a data logger was involved.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning an approximately 13 year old of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In 2016, the patient was vaccinated with one single dose of GARDASIL 9 (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. In approximately 2017, the patient was in the office for the second dose of GARDASIL 9. No adverse effects reported.
Sex: F
Vaccine: ANTH
Symptoms: Exposure during pregnancy, Incomplete course of vaccination
Clinical narrative: Received literature article on 09JAN2017. The article notes a woman potentially exposed to Bacillus anthracis while in another country, and noted to be pregnant at some unknown date, was medically advised to transition from ciprofloxacin to amoxicillin. No adverse event to either BIOTHRAX vaccination or antibiotics was reported. Additional information was received from epidemiologist, one of the co-authors of the article, on 09JAN2017: The reporter indicated that the subject had received prior BIOTHRAX vaccination, but was not up to date per standards. On an unknown date, following potential exposure to B. anthracis, she received 1 dose of BIOTHRAX vaccine as a booster and was prescribed 60 days of antibiotics. After 30 days, for an unknown reason, she was advised to switch drugs from ciprofloxacin to amoxicillin. The subject's date of conception in relation to the timing of events is unknown. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reported for herself. A 82-year-old female patient received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)  at single dose on unknown date for immunization. Relevant medical history and concomitant medications were unknown. The patient experienced pneumonia on Dec2017 with outcome of recovering. Information on the batch number has been requested. Pfizer is Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Nuclear magnetic resonance imaging normal, Pain, X-ray normal
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date three years ago, at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain at the injection site that within 2 or 3 days it was getting more and more painful. Three years later she was still in pain every day. The patient underwent lab tests and procedures which included nuclear magnetic resonance imaging and x-ray on unspecified date: there was nothing to see. The events were non serious with outcome of unknown.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: Pt received 2nd HPV-did not eat breakfast prior but was given OJ in office prior. No previous reactions. Pt became Pale and vomited-mild dizziness -pt given sucker and cool pack on head-laid down and monitored x 30 min-Pt color returned, alert and left with mom. Will F/U on Pt tomorrow.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Grip strength decreased, Immediate post-injection reaction, Impaired driving ability, Muscular weakness, Paraesthesia
Clinical narrative: I had a strange reaction to my flu shot (not certain which flu vaccine it was, but I know it was egg free), not the typical symptoms listed on the handout flyer. It began a few minutes after receiving the shot and fully resolved about 6 hours later. Weakness in my calf muscles immediately following the shot and also in my hands a couple hours later. Difficult to open jars/grip items and difficult to even press the gas peddle, I couldn't do more than a few single leg calf raises at a time for a couple of hours. Just a weird weakness and tingling sensation in both calf muscles and hands.  I reported to my work's employee health department who administered the shot and was advised to report my experience to VAERS.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Bronchial disorder, Influenza, Malaise, Upper respiratory tract infection
Clinical narrative: I have been sick each month since receiving this flu shot. I have symptoms of URI, flu, achy joints and other signs of illness. I have never been sick over the years, and tolerate flu vaccines just fine. If anything, I have gotten one flu during the entire year and it was mild as a result of my being vaccinated. I have a collection of symptom - ranging from low level to serious bronchial distress each month since the day I got the shot from this clinic. I'm not sure if the needles were contaminated or the vaccine or both.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Eyelid oedema, Pruritus, Urticaria
Clinical narrative: Hives on face and arms, mild eyelid swelling. Some itching. BENADRYL given.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Pt was given ZOSTAVAX when they should have received a Varicella.
Age: 87.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Right arm redness, warmth, fluid build up. We referred him to his doctor.
Age: 36.0
Sex: F
Vaccine: HIBV, MMR, YF
Symptoms: Confusional state, Dizziness, Eye movement disorder, Fatigue, Feeling drunk
Clinical narrative: Started having blurry vision, rapid eye movement, dizziness, vertigo on 1/1/2017, it has been getting worse and confusion is added.. tiredness. Feels like, I'm drunk, but without the actual being drunk part.
Age: 36.0
Sex: F
Vaccine: HIBV, MMR, YF
Symptoms: Vertigo, Vision blurred
Clinical narrative: Started having blurry vision, rapid eye movement, dizziness, vertigo on 1/1/2017, it has been getting worse and confusion is added.. tiredness. Feels like, I'm drunk, but without the actual being drunk part.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Client reports L deltoid area has been sore and achy since shortly after receiving vaccine. No swelling, bruising, lumps/bumps noted. No infection noted.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Injection site swelling, Mouth swelling, Pruritus, Wheezing
Clinical narrative: After Flu vaccine was given @9:56am, pt presented with swelling @ injection site. Pt. was AOx3. BENADRYL 20ml given as ordered by mouth. Pt stable and was being closely monitored by (RN, MA) for  any s/s of allergic reaction to vaccine. At  10:17am pt. c/o wheezing, dizziness, and itchiness. MD  notified and pt. was assessed by MD. Emergency 911 was called @10:20am by MA. Pt. AOx3 at this time, but also began to show signs of swelling of the mouth. Prednisone 15ml given as ordered by mouth, EPIPEN 0.15mg given as ordered IM in Left thigh, and breathing treatment started via nebulizer using Albuterol Sulfate 2.5mg as ordered by MD. Vitals taken @ 10:30am: T: 98.0; BP: 119/76; P: 86. Rescue arrived @ 10:30am. Pt. was AOx3 with no s/s of allergic reaction. Pt transported to Hospital via stretcher for further evaluation; accompanied by mother.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. Approximately in October 2017 (reported as 10/20), the patient was administered with an inappropriate storage dose of ZOSTAVAX 19400 PFU for prophylaxis, lot # N021170, expiration date 27-OCT-2018. The dose, frequency, anatomical location and route of administration were not provided. Other concomitant products included sterile diluent, for which no information was provided.  It was reported that at the morning before the administration, approximately on 19-OCT-2017 (reported as 10/19), the reporter realized that the freezer was out of range and after reporting the incidence to the manufacturer, she was advised that the product was still stable until the expiration date. No adverse effects were reported after de administration of the vaccines.   The vaccines underwent a temperature excursion of 15F to 46F during a time frame of 9 hours and 30 minutes. The pharmacist also reported that there were previous temperature excursions of 6F to 14F for 5 hours and 10 minutes and 15F to 46F for 5 hours and 30 minutes. The call was due to a data logger.  This is one of two reports received from the same reporter (MARRS # 1712USA003368); Sender's Comments:  US-009507513-1712USA003368:
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 24 year old female patient. The patient did not have any medical history, drugs allergies, or concurrent conditions; and was not taking any concomitant medications. On 15-DEC-2017, an unspecified patient was vaccinated with her first dose of GARDASIL 9 intramuscularly, lot # N018273, expiration date 17-JUN-2019, for human papillomavirus (HPV) vaccination (strength, dose and frequency were not reported). On 02-JAN-2018, the patient was called for an unspecified reason and the patient explained that on an unspecified date, after receiving GARDASIL 9, an itchy rash on face developed. The medical assistant reported that the patient was informed to call back if hives developed or rash worsened. The patient sought medical attention and she did not receive any treatment for the adverse events. Diagnostic laboratories were not performed. At the time of reporting, the outcome of itchy rash on face and hives was unknown. Additionally, the causality assessment between itchy rash on face and hives with GARDASIL 9 was not provided.
Sex: U
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Initial unsolicited report received from a nurse on 06-Nov-2017. This case involves a six patients (gender and age were not reported) who were vaccinated with a FLUZONE HIGH-DOSE (batch number, expiry date, dose, route and site of administration was not reported), on an unknown date. The patients' medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced parkinson's like shaking. Three or four of the patients had dialysis on the same day they received the flu vaccine. Lab data and corrective treatment was not reported. The outcome of the event was unknown. These patients received vaccination over the last 30 days. Details surrounding each situation were unclear. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Pt had never had influenza injections. Pediatric 0.25ML dose was given on 01/03/18. Mother returned with Pt to get 0.5ML dose on 01/04/18 per CDC guidelines.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Patient received DTaP and began to vomit 30 minutes later. Patient Rx ZOFRAN and checked vitals before sending home. Followed up with patient.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Heart rate irregular, Laboratory test, Muscle spasms
Clinical narrative: A few minutes after receiving the vaccine pt became lightheaded and pale, did not lose consciousness, and condition resolved after a snack and fluids, since this time has remained dizzy and weak, heart beating irregular and rapid, leg spasms, weight loss.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Weight decreased
Clinical narrative: A few minutes after receiving the vaccine pt became lightheaded and pale, did not lose consciousness, and condition resolved after a snack and fluids, since this time has remained dizzy and weak, heart beating irregular and rapid, leg spasms, weight loss.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Borrelia test, Cerebrovascular accident, Diplegia, Ear congestion
Clinical narrative: Sick with Respiratory symptoms, laryngitis, weakness, excruciating  flank pain, UTI-like symptoms, high fever. Collapsed and husband called 911, Stroke-like symptoms=partial paralysis especially right side and legs, decreased breathing rate. Hospitalized for almost 2 weeks. Unable to get out of bed, extremely weak. Physical Therapy eventually assisted and noted Proprioception issues. Unable to detect pain, hot or cold sensation although pressure sensation intact. Ears plugged up and unable to hear well intermittently.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Flank pain, Flavivirus test, Hemiplegia, Hypoacusis, Laboratory test
Clinical narrative: Sick with Respiratory symptoms, laryngitis, weakness, excruciating  flank pain, UTI-like symptoms, high fever. Collapsed and husband called 911, Stroke-like symptoms=partial paralysis especially right side and legs, decreased breathing rate. Hospitalized for almost 2 weeks. Unable to get out of bed, extremely weak. Physical Therapy eventually assisted and noted Proprioception issues. Unable to detect pain, hot or cold sensation although pressure sensation intact. Ears plugged up and unable to hear well intermittently.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Laryngitis, Loss of proprioception, Lumbar puncture, Malaise, Mobility decreased
Clinical narrative: Sick with Respiratory symptoms, laryngitis, weakness, excruciating  flank pain, UTI-like symptoms, high fever. Collapsed and husband called 911, Stroke-like symptoms=partial paralysis especially right side and legs, decreased breathing rate. Hospitalized for almost 2 weeks. Unable to get out of bed, extremely weak. Physical Therapy eventually assisted and noted Proprioception issues. Unable to detect pain, hot or cold sensation although pressure sensation intact. Ears plugged up and unable to hear well intermittently.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Mycobacterium tuberculosis complex test, Pyrexia, Respiratory rate decreased, Respiratory symptom, Syncope
Clinical narrative: Sick with Respiratory symptoms, laryngitis, weakness, excruciating  flank pain, UTI-like symptoms, high fever. Collapsed and husband called 911, Stroke-like symptoms=partial paralysis especially right side and legs, decreased breathing rate. Hospitalized for almost 2 weeks. Unable to get out of bed, extremely weak. Physical Therapy eventually assisted and noted Proprioception issues. Unable to detect pain, hot or cold sensation although pressure sensation intact. Ears plugged up and unable to hear well intermittently.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Unresponsive to stimuli, Urinary tract infection
Clinical narrative: Sick with Respiratory symptoms, laryngitis, weakness, excruciating  flank pain, UTI-like symptoms, high fever. Collapsed and husband called 911, Stroke-like symptoms=partial paralysis especially right side and legs, decreased breathing rate. Hospitalized for almost 2 weeks. Unable to get out of bed, extremely weak. Physical Therapy eventually assisted and noted Proprioception issues. Unable to detect pain, hot or cold sensation although pressure sensation intact. Ears plugged up and unable to hear well intermittently.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Inflammation, Injection site pain, Joint injection, Limb injury, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Noticed pain at site, left deltoid, when injection given. Persisted unchanged for 3 weeks and sought care. Ibuprofen x 1 week without help. MRI showed inflammation of section of biceps tendon. Performed physical therapy as with his right shoulder that recently had surgery. After 3 months, saw Ortho who injected the joint with steroid--2 days ago. No change yet today when he was seen in Allergy Clinic. Rec he continue with PT for left shoulder pain, SIRVA, take NSAID routinely for 4 weeks, cold compress, given my phone # and VICP info. To return in Aug and call prn.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Shoulder operation
Clinical narrative: Noticed pain at site, left deltoid, when injection given. Persisted unchanged for 3 weeks and sought care. Ibuprofen x 1 week without help. MRI showed inflammation of section of biceps tendon. Performed physical therapy as with his right shoulder that recently had surgery. After 3 months, saw Ortho who injected the joint with steroid--2 days ago. No change yet today when he was seen in Allergy Clinic. Rec he continue with PT for left shoulder pain, SIRVA, take NSAID routinely for 4 weeks, cold compress, given my phone # and VICP info. To return in Aug and call prn.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: The night the patient got the vaccine, patient started getting soreness in the left arm. the next day, the pain was better, but now there is a swelling in the left arm with an area about the size of an egg.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal, Throat tightness, Urticaria
Clinical narrative: 2 hours after receiving the flu vaccine, this employee states she developed 1 hive on her hand then her "throat started to close."  She started to feel dizzy and "felt funny".  She states she took a Zyrtec "one full pill" and then about 2 hours after the Zyrtec, it resolved. She did not have to seek medical treatment but is going to review with her primary physician.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Headache, Hyperhidrosis, Nasal congestion
Clinical narrative: The vaccine received was Influenza, but I don't have the information about the brand name and manufacturer. Adverse reactions: shivers, temperature (102F), nausea, headaches, nasal congestion, profuse sweating.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: The vaccine received was Influenza, but I don't have the information about the brand name and manufacturer. Adverse reactions: shivers, temperature (102F), nausea, headaches, nasal congestion, profuse sweating.
Age: 22.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports hard, red bump on VARIVAX location, which by the next day had doubled in size to %1/2 inches by 3 inches. She reported extreme itching and redness which had begun to fade by 1/2/18.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Extra dose administered
Clinical narrative: CHILD RECEIVED AND EXTRA DOSE OF ROTAVIRUS.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Erythema, Rash macular, Throat irritation
Clinical narrative: Complained of scratchy throat and frequent coughing 15 minutes after administering vaccine. Has blotchy red areas on right arm. No laryngeal edema, swelling of lips or tongue, or difficulty breathing. Lungs clear. Given 50 mg of BENADRYL PO. Relief of symptoms reported within 20 minutes of administering BENADRYL.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Drug administered at inappropriate site, Joint injection, Musculoskeletal pain, Pain
Clinical narrative: I received a flu shot in November at pharmacy. I pulled my sleeve up as high as I've ever had to in the past and the pharmacist insisted it wasn't high enough. Rather than remove my shirt, I yanked on the sleeve to get it to raise higher. He proceeded to inject the flu shot extremely high and in my shoulder. The medicine burned going in and a short while later I felt a sharp pain in my shoulder. A week later when it hurt to even move the shoulder I went to an orthopedic shoulder specialist who diagnosed the pain as tendonitis/Bursitis and put me on an ice and OTC anti-inflammatory regimen. Two weeks later, when that treatment didn't work, he gave me a steroid injection. That's been two weeks now and the pain is still as bad as ever. He says I need an MRI next. I was fine before the flu shot and now I can hardly lift or move my arm due to the sharp piercing pain.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Tendonitis, X-ray limb
Clinical narrative: I received a flu shot in November at pharmacy. I pulled my sleeve up as high as I've ever had to in the past and the pharmacist insisted it wasn't high enough. Rather than remove my shirt, I yanked on the sleeve to get it to raise higher. He proceeded to inject the flu shot extremely high and in my shoulder. The medicine burned going in and a short while later I felt a sharp pain in my shoulder. A week later when it hurt to even move the shoulder I went to an orthopedic shoulder specialist who diagnosed the pain as tendonitis/Bursitis and put me on an ice and OTC anti-inflammatory regimen. Two weeks later, when that treatment didn't work, he gave me a steroid injection. That's been two weeks now and the pain is still as bad as ever. He says I need an MRI next. I was fine before the flu shot and now I can hardly lift or move my arm due to the sharp piercing pain.
Age: 86.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Injected limb mobility decreased, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 08-Nov-2017. This case involves an 86-year-old male patient who was vaccinated with 0.5 ml dose of FLUZONE HD (batch number: UI887AA, expiry date, dose, site of administration was not reported), intramuscularly on 07-Nov-2017 and also was vaccinated with PNEUMOVAX in left deltoid on an unknown date. The patient's medical history included hypertension, heart issues. The patient had no known drug allergies (NKDA) and was not sick at the time of vaccination. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient couldn't sleep last night due to left arm pain, developed swelling and pain of the upper left arm, and can't lift the arm, this morning had nausea and diarrhea. No other symptoms reported. Lab data and corrective treatment was not reported. The patient had not recovered from the events. List of documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain in extremity
Clinical narrative: Initial unsolicited report received from a healthcare professional on 08-Nov-2017. This case involves an 86-year-old male patient who was vaccinated with 0.5 ml dose of FLUZONE HD (batch number: UI887AA, expiry date, dose, site of administration was not reported), intramuscularly on 07-Nov-2017 and also was vaccinated with PNEUMOVAX in left deltoid on an unknown date. The patient's medical history included hypertension, heart issues. The patient had no known drug allergies (NKDA) and was not sick at the time of vaccination. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient couldn't sleep last night due to left arm pain, developed swelling and pain of the upper left arm, and can't lift the arm, this morning had nausea and diarrhea. No other symptoms reported. Lab data and corrective treatment was not reported. The patient had not recovered from the events. List of documents held by sender: none.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: Patient reported on 1/03/18 to pharmacist on duty that he experienced pain in the upper left arm and sometimes tingling approximately 2 weeks following the flu shot administration on 9/10/2017. He continues to feel pain. He has been doing 6 weeks of acupuncture and 2 physical therapy treatments. His cardiologist advised him to rest, exercise the area, and take pain relievers. He continues to feel pain.
Age: 22.0
Sex: F
Vaccine: ADEN_4_7, FLU3, HEPAB, IPV, MEN, TDAP, VARCEL
Symptoms: Biopsy kidney, Nephrotic syndrome, Serology test, Tubulointerstitial nephritis, Ultrasound kidney
Clinical narrative: Acute membranous glomerulonephritis with nephrotic syndrome complicated by acute interstitial nephritis.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle spasms, Vomiting
Clinical narrative: Extreme cramps in lower gut with vomiting for 8 hours.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: REDNESS, WARM AND HARD TO THE TOUCH.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Abscess sterile, Erythema, Swelling
Clinical narrative: Likely sterile abscess. Notable swelling with some redness. Non tender.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Cerebral infarction, Cerebrovascular accident, Echocardiogram normal, Electroencephalogram abnormal, Facial paralysis
Clinical narrative: STROKE. Patient presented with left hemiplegia and facial droop with MRI/MRA for large acute/subacute right MCA infarct. He was afebrile, normotensive, without any electrolyte derangement. He had recurrent seizure activities on 11/23 and 11/24, for which he received Keppra and fosphenytoin. He was weaned of the fosphenytoin on 11/28 and continues on Keppra. Left hospital for inpatient rehabilitation for 2 weeks. After, at home with outpatient physical and occupational therapy 3x week.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Hemiplegia, Nuclear magnetic resonance imaging brain abnormal, Seizure
Clinical narrative: STROKE. Patient presented with left hemiplegia and facial droop with MRI/MRA for large acute/subacute right MCA infarct. He was afebrile, normotensive, without any electrolyte derangement. He had recurrent seizure activities on 11/23 and 11/24, for which he received Keppra and fosphenytoin. He was weaned of the fosphenytoin on 11/28 and continues on Keppra. Left hospital for inpatient rehabilitation for 2 weeks. After, at home with outpatient physical and occupational therapy 3x week.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Pallor, Tremor
Clinical narrative: Following vaccine administration (pt had received 5 vaccines), patient turned pale and went unconscious, while seated in a chair. LOC 5 seconds. Patient briefly shook and then awoke. Pt was fasting. Symptoms spontaneously resolved. Patient received final vaccine and waited in office at least 30 min. following. No further symptoms. No hx of vaccine reactions. Upon d/c, mom reports that while unconscious, patient's entire body was shaking. Discussed further with RN's who witnessed event. No seizure activity reported.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Aphasia, Gait inability
Clinical narrative: He was talking, walking and acting normal and progressing, and after the shots he couldn't walk or speak at all....
Age: 30.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Pain in extremity, Vaginal haemorrhage
Clinical narrative: I felt some soreness as expected in my left upper arm. That did not alarm me at all but I was shocked to see the following day that I had vaginal bleeding. I am not scheduled to have my period to the 20th of Jan so this would be very early. I have now urinated a second time and am still spotting when I pee.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac stress test, Electrocardiogram, Fall, Loss of consciousness, Nuclear magnetic resonance imaging heart
Clinical narrative: At home, I blacked out and fell against a door frame. I was immediately sent to hospital. My doctors are still testing me to determine the cause of the blackout one day after receiving flu vaccine.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: On of diarrhea, emesis, decrease appetite to all foods and liquids about 6 hours after the vaccines. No rashes, no new wheezing and no blood in stool. No seizures.