chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic HBV infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients: 4446 infants born to 3253 HBV-positive mothers between 1197 and 2010. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors for HBV transmission, and transmission rates. Tests for HBsAg (HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012. All these 25 patients had hepatitis B immune globulin (H-BIG) and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patients had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received third dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. This is one of 25 reports from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist regarding an approximately 58 year old female patient. No information about medical history, concurrent conditions was reported. The pharmacist reported that on 17-OCT-2014 (reported as earlier today) the patient who was vaccinated with PNEUMOVAX 23 (lot#, dose and route not reported) at another pharmacy called to report that she has developed a "golf ball sized" sore lump at the injection site. The whole arm was sore. No concomitant medications reported. The pharmacist does not know which arm was affected. No lab diagnostics studies were performed. The patient sought medical attention by contacting the pharmacy. No treatment was given for the events. There was no product quality complaint. The outcome of the events was reported as not recovered. The causality was not specified. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain upper, Constipation, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from an approximately 72 years old male patient concerning himself. Patient had drug reactions/ allergies to penicillin. On 15-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 lot # K005797, expiry date 21-MAR-2015, injection. Concomitant therapy was aspirin. On 15-OCT-2014, patient developed swelling, soreness, and redness at the injection site, as well as: nausea, fever of 101, stomach pain, constipation for a day and half, and flu like symptom after receiving PNEUMOVAX 23. Patient did not seek medical attention. On an unknown date in October 2014, the outcome of events was resolved. Causality was not reported. No product quality complaint (PQC) was involved. No additional information provided. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from an approximately 72 years old male patient concerning himself. Patient had drug reactions/ allergies to penicillin. On 15-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 lot # K005797, expiry date 21-MAR-2015, injection. Concomitant therapy was aspirin. On 15-OCT-2014, patient developed swelling, soreness, and redness at the injection site, as well as: nausea, fever of 101, stomach pain, constipation for a day and half, and flu like symptom after receiving PNEUMOVAX 23. Patient did not seek medical attention. On an unknown date in October 2014, the outcome of events was resolved. Causality was not reported. No product quality complaint (PQC) was involved. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 18-AUG-2014 the patient was vaccinated with (Merck) VARIVAX (lot number: J000202 with expiry date of 09-JAN-2015) (dose, frequency and route unspecified) and MMR II (lot number: J005723 with expiry date of 08-SEP-2015) (dose, frequency and route unspecified). Concomitant medications were not reported. The reporter stated that temperatures of (Merck) VARIVAX and MMR II vaccines have not been monitored since January 2014. The reporter does not known if (Merck) VARIVAX and MMR II had any temperature excursions. No adverse symptoms were reported. The outcome of the events was unknown. The causality of the events with (Merck) VARIVAX and MMR II was not reported. This case is linked to # 1410USA010478 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 22-MAY-2014 the patient was vaccinated with (Merck) VARIVAX (lot number: J000202 with expiry date of 09-JAN-2015) (dose, frequency and route unspecified). Concomitant medications were not reported. The reporter stated that temperatures of (Merck) VARIVAX have not been monitored since January 2014. The reporter does not known if (Merck) VARIVAX had any temperature excursions. No adverse symptoms were reported. The outcome of the events was unknown. The causality of the events with (Merck) VARIVAX was not reported. This case is linked to #1410USA011166 via same reporter link. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Amnesia, Herpes zoster, Memory impairment
Clinical narrative: This spontaneous report as received from the consumer (the patient's daughter) refers to a 82 year old female patient. The patient pertinent medical history included allergy to surgical tape. On an unspecified date in March 2013, the patient was vaccinated with the 1st dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) and a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). On an unspecified date in March 2013, three days after receiving ZOSTAVAX and PNEUMOVAX 23, the patient experienced shingles. The patient was treated with prednisone and an unspecified antiviral medication. The consumer also explained that, on an unknown date, the patient had short term and long term memory issues. On 17-OCT-2014, the patient experienced the patient received a second dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). No adverse effects had been reported after the 2nd dose of ZOSTAVAX. The outcome of shingles and memory issues was unknown. The relatedness between the events and ZOSTAVAX and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: Immediately after the PNEUMOVAX 23 was administered IM - her arm swelled up. Ice applied. Pt. had excruciating arm pain at 3am and could not move arm - progressively got better and fine at 1:00 pm on Sunday.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Dermatitis, Eczema, Metabolic function test, Pruritus
Clinical narrative: This spontaneous report as received from patient's father concerning his son, a 15 year old male patient. Patient's concurrent conditions and relevant medical history was not reported. Approximately on an unknown date in February 2014 (also reported as March 2014), patient was vaccinated with first dose of GARDASIL (lot number, dose, frequency and route unspecified) for prevention of HPV infection. Approximately on an unknown date in August 2014 (reported as 2 and half months ago from 17-OCT-2014), the patient was vaccinated second dose of GARDASIL (lot number, dose, frequency and route unspecified) for prevention of HPV infection. Concomitant medications were not reported. On an unknown date in 2014 the patient experienced severe skin dermatitis and small red bumps after the first dose of GARDASIL. The reporter stated that initially the red bumps were only present on the hands, but now it was spreading throughout entire body and legs as well. The reporter also stated that itching was the real issue for the patient. On an unspecified date the patient has since developed the MRSA infection. The patient also has had fever when there was an infection present. The patient has also been diagnosed with Eczema. Patient has undergone full blood screening and metabolic lab test but results were not reported. The patient sought medical attention and had seen several doctors such as pediatric, dermatologist and primary cause physicians during this period. The patient has received various therapy treatments CORTISONE, Steroid based prescription creams, and over the counter topical creams without success (dose and manufacturers unspecified). The third dose of GARDASIL was not given yet. The outcome of the events was reported as not recovered/not resolved. The causality of the events with GARDASIL was not reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Staphylococcal infection
Clinical narrative: This spontaneous report as received from patient's father concerning his son, a 15 year old male patient. Patient's concurrent conditions and relevant medical history was not reported. Approximately on an unknown date in February 2014 (also reported as March 2014), patient was vaccinated with first dose of GARDASIL (lot number, dose, frequency and route unspecified) for prevention of HPV infection. Approximately on an unknown date in August 2014 (reported as 2 and half months ago from 17-OCT-2014), the patient was vaccinated second dose of GARDASIL (lot number, dose, frequency and route unspecified) for prevention of HPV infection. Concomitant medications were not reported. On an unknown date in 2014 the patient experienced severe skin dermatitis and small red bumps after the first dose of GARDASIL. The reporter stated that initially the red bumps were only present on the hands, but now it was spreading throughout entire body and legs as well. The reporter also stated that itching was the real issue for the patient. On an unspecified date the patient has since developed the MRSA infection. The patient also has had fever when there was an infection present. The patient has also been diagnosed with Eczema. Patient has undergone full blood screening and metabolic lab test but results were not reported. The patient sought medical attention and had seen several doctors such as pediatric, dermatologist and primary cause physicians during this period. The patient has received various therapy treatments CORTISONE, Steroid based prescription creams, and over the counter topical creams without success (dose and manufacturers unspecified). The third dose of GARDASIL was not given yet. The outcome of the events was reported as not recovered/not resolved. The causality of the events with GARDASIL was not reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Local swelling
Clinical narrative: About 18 hrs after headache, body aches and arm swollen. Then few hrs later 100.5, chills, sore joints, nausea, vomiting and diarrhea. Fever spiked at 102 degrees. Dr said take ADVIL only. Still has symptoms now - next morning.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: About 18 hrs after headache, body aches and arm swollen. Then few hrs later 100.5, chills, sore joints, nausea, vomiting and diarrhea. Fever spiked at 102 degrees. Dr said take ADVIL only. Still has symptoms now - next morning.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 77 year old female patient with pacemaker, arrhythmia, thyroid disease (unspecified) and allergy to BIAXIN, penicillin and AVELOX (unspecified reactions). On 25-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (Lot # J013555; expiration date: 02-MAY-2015) (dose and route were not provided). Nurse reported that the patient experienced severe swelling, pain, and heat at the injection site following administration of PNEUMOVAX 23 in approximately 25-SEP-2014. Nurse reported that the patient was treated with BENADRYL (unspecified dose, frequency) and ice. There were no laboratory tests or diagnosed studies performed. The patient sought unspecified medical attention. The patient recovered on an unspecified date in 2014. This is one of several reports received from the same reproter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: 14y 7 m/o M who reports recurrent intermittent hives since GARDASIL vac on 9/9/14. Clinically dermatographia - not previously noted in patient.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 5 patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with expired doses of (Merck) VARIVAX injection administered subcutaneously at dose 0.5 ml (indication, lot# and expiry date unspecified). The physician did not have the lot number or expiration date in front of him at the time of the call, but stated that all 5 doses were given less than 14 days after the expiration date. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash generalised, Varicella virus test negative
Clinical narrative: Following varicella vaccine # 1 c/o pimple-like eruptions generalized over body x 1 week.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness and edema and pain around injection site and spreading down arm.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine administration during pregnancy in a 40-year-old female patient who received BOOSTRIX. On 18th September 2014, the patient received BOOSTRIX. The patient's last menstrual period was on an unknown date and estimated date of delivery was 15th December 2014. The patient received BOOSTRIX at week 27 of the pregnancy and during the second trimester of pregnancy. On an unknown date, 1 days after receiving BOOSTRIX, the patient experienced vaccine administration during pregnancy. On an unknown date, the outcome of the vaccine administration during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the reporter considered the vaccine administration during pregnancy to be related to BOOSTRIX. Additional details: Caller reports that she received the BOOSTRIX vaccine while pregnant. Estimated date of delivery is 12/15/2014, it was administered at 27 weeks gestation. Lot and expiration date were unknown. No AEs reported.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother states that clients right deltoid became swollen and red after receiving vaccines - no fever, no pain. Treated with ibuprofen and ice to area.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from Certified Medical Assistant refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 16-SEP-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # J006921 expiry date 09-AUG-2014 (dose and route not reported). Concomitant medication was not reported. No known adverse effects. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On 10/16/14 right deltoid and surrounding area became swollen, red, hot and itchy. She said she took ADVIL every 8 hrs, used ice packs for 15 mins on/off.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Injection site induration, Injection site joint swelling, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a physician via medical records refers to a 11 year old male patient with shellfish allergy. Prior vaccine administration on 05-SEP-2014 included FLUZONE, the fifth dose. (Patient denies medical history, past medical surgery, no smoke exposure, personal history: joint custody, living with: parents and sibling, diet: no shellfish, home smoke detector use: yes, housing: no guns in the home, pets: yes-one dog, and no travel outside of the country). On 22-SEP-2014 at 14:47, the patient was vaccinated with the second dose of GARDASIL, intramuscular, Lot # K008335 and expiration date on 23-JUN-2016, in the left arm. Other suspect therapy included the first dose of MENVEO, intramuscular, Lot # 14044, in the right arm, received on 22-SEP-2014. Concomitant therapies taken PRN included EPIPEN, SINGULAIR, albuterol sulfate (manufacturer unknown) and ORAPRED. It was received medical records from 22-SEP-2014. A routine child exam was performed. The patient's review of systems, interval History, nutrition, developmental assessment, key family checks, vital signs, and general examinations resulted normal. On that day, the second dose of GARDASIL and the first dose of MENVEO were administered. On 25-SEP-2014 the patient presented on physician's office complaining of right arm swelling beginning several hours after vaccination, extending to below the elbow. It was received medical records from 25-SEP-2014. Interim history: Patient got his vaccines on 22-SEP-2014, Monday. The first night it was hard the next day it was hard and then it was swollen over his elbow. The patient's review of systemic and vital signs were normal. On general examination, regarding extremities, it was reported: swelling from shoulder joint down to below the right elbow, circumferential, with redness to below the elbow on the right, normal range of motion and non-tender but hard throughout to palpation, no evidence of compartment syndrome. Assessment: Cellulitis -682.9 (Primary), aseptic post immunization with MENVEO. Treatment: Start Clindamycin HCl capsule, 300 mg, 1 capsule, orally, every 8 hours, 10 days, 30, refills: 0. Start MEDROL (pak) tablet, 4mg, as directed, orally, following package instructions, 7 days, 1, refills 0. Notes: it was recommended starting clindamycin today and considering steroid in the next 1-2 days if not improving or worsening. Script sent for mom to pick up as needed. If he was getting worse, they had instructions to follow up at the physician's office. At the time of the report, the patient's outcome was not provided. The relatedness between GARDASIL and adverse events was not provided. It was reported as Allergies: MENVEO (swelling of arm to below elbow: contraindication). All available medical records will be provided upon requested. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In August 2014 the patients were vaccinated with an improperly stored GARDASIL 120 Y (dose, route, lot number and expiration date not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown age and gender. In September 2014 the patients were vaccinated with an improperly stored M-M-R II (dose, route, lot number and expiration date not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In July 2014 the patients were vaccianted with an improperly stored GARDASIL 120 Y (dose, route, lot number and expiration date not reported). No adverse effects reported. This is one of several reports received form the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Pyrexia, Rash
Clinical narrative: Complaining of rash. Started Friday July 1st with blisters, itching, and fever to 101.7.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unspecified gender and age. On 17-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (Lot number, expiration date, dose and route were not provided). Nurse reported that the patient experienced mild soreness, redness and a warm spot at the injection site following administration of PNEUMOVAX 23 in approximately 17-SEP-2014. Nurse reported that the patient was treated with ADVIL and "ice" and recovered on an unspecified date in 2014. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis developed 6 hours after vaccine. Patient went to ER and sent home. Went to pediatrician at 8:30 am 10/21/14 and was put on KEFLEX 750MG twice daily. Patient is slowly recovering.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 58 year old female patient reporting on herself without pertinent medical history, drug reactions or allergies. On 26-SEP-2014 the patient was vaccinated with ZOSTAVAX (dose, lot # and route of administration were not reported). Concomitant therapies included NEXIUM, loratadine (manufacturer unknown), zolpidem tartrate (manufacturer unknown) and MAXALT. On 26-SEP-2014, the patient experienced redness, swelling, warmth and itchiness at the injection site after receiving ZOSTAVAX. Patient stated that the redness at the injection site turned to a light brown color on unknown date in 2014 (reported as sometime over the last week). She reported that the light brown color at the injection site had a birthmark appearance. Patient did not receive any treatment for the adverse events. She sought medical attention and saw the pharmacist on 08-OCT-2014. There were not laboratory studies performed. The outcome of redness at the injection site was unknown. The outcome of itchiness, swelling and warmth at the injection site was reported as recovered/resolved on unknown date in 2014 (reported as within the first week after receiving ZOSTAVAX). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In September 2014 the patients were vaccinated with an improperly stored (Oka-Merck) PROQUAD (dose, route, lot number and expiration date not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In September 2014 the patients were vaccinated with an improperly stored (Merck) VARIVAX (dose, route, lot number and expiration date not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In September 2014 the patients were vaccinated with an improperly stored GARDASIL 120 Y (dose, route, lot number and expiration date not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Infection
Clinical narrative: This spontaneous report as received from a female consumer of unknown age. Pertinent medical history, drug reactions or allergies were unspecified. On 30-SEP-2014 (also reported as 2 days prior), the patient "fell into gravel and dirt, cutting her leg". On 02-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. On an unknown date in October 2014 the patient's physician informed her that the cut was infected (also reported as "it is infected"). BACTRIM was given as treatment for the adverse event. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected because no reporter details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. On 09-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX lot # J007211, expiration date 20-SEP-2014, 0.65 ml, subcutaneous (dose number was unspecified). No adverse effects reported. Concomitant therapies were not reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a two unspecified patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. On 10-OCT-2014, the two unspecified patients were vaccinated with expired PNEUMOVAX23 (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were known. Concomitant therapies were not reported. The outcome of the events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, soreness, swelling, and warmth at injection site accompanied by headache 7/10. Administered Acetaminophen 1,000 mg and Ibuprofen 600 mg PO. Applied Hydrocortisone ointment topically to direct area of concern. Covered with Ice and secured with COBAN.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 20-OCT-2014 the patient was vaccinated with an expired dose of M-M-R II, dose 0.5 ml, subcutaneous, (lot # H015829 and expiration date 24-AUG-2014). No adverse effects was reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Cyanosis, Dyspnoea, Local swelling, Swelling face, Tongue dry
Clinical narrative: Client received Tdap at 10 am. Returned to clinic complaining of difficulty breathing and swelling to hands and face at 1:40 pm hives to (L) cheek below eye. Nail beds blue. C/O "tongue feeling dry". Epinephrine administered. Transferred to Emergency room by ambulance. Phone call 10/13/14 to client. Client reports returned to ER 10/11/14 for hives, difficulty breathing and continues to have swelling to arms and hands as of 10/13/14.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Client received Tdap at 10 am. Returned to clinic complaining of difficulty breathing and swelling to hands and face at 1:40 pm hives to (L) cheek below eye. Nail beds blue. C/O "tongue feeling dry". Epinephrine administered. Transferred to Emergency room by ambulance. Phone call 10/13/14 to client. Client reports returned to ER 10/11/14 for hives, difficulty breathing and continues to have swelling to arms and hands as of 10/13/14.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR
Symptoms: Eye swelling, Malaise, Wheezing
Clinical narrative: Clerk voiced pt's uncle called that pt felt sick, her eyes were swelling, clerk spoke to pt and voiced pt sound like she was wheezing. Pt was told to go to hospital. On 10/22/14 RN called pt unable to speak to pt uncle-in-law voiced pt was treated at hospital and felt much better.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received vaccine on 10/18/19 complained of injection site soreness, redness, fever and chills. Said it is gradually getting better over the past few days. The redness and swelling extended on the back of her right arm to her elbow. Recommended she try BENADRYL for allergic reaction. She also complained of itching.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Pyrexia
Clinical narrative: Patient received vaccine on 10/18/19 complained of injection site soreness, redness, fever and chills. Said it is gradually getting better over the past few days. The redness and swelling extended on the back of her right arm to her elbow. Recommended she try BENADRYL for allergic reaction. She also complained of itching.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness (R) thigh area.
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose, route not reported). Concomitant medications were not provided. The pharmacist reported that on an unspecified date the patient experienced numbness in the arm and that his arm was "virtually unusable for about a day", after receiving PNEUMOVAX 23. The patient did not seek medical attention. Outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Within the last week, in September 2014, the patient was inadvertently vaccinated with a dose of ZOSTAVAX five days after the expiration date (expiration date in September 2014). No adverse effects reported. Additional information is not expected because there is no reporter's contact information provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients. On an unknown date of 2014 (also reported  as since 29-SEP-2014), the patients was vaccinated with RECOMBIVAX HB which was improperly stored, injection 10/1.0 microgram/ml, (strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient. On an unknown date of 2014 (also reported as since 08-AUG-2014), the patient was vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: YF, YF
Symptoms: Asthenia, Loss of consciousness, Nausea, Tremor, Urinary incontinence
Clinical narrative: 10/7/14 received YF vaccine at clinic. 10/10/14 felt nauseated then felt faint while at dinner with friends. 10/14/14 reported incident to clinic providers.
Age: 44.0
Sex: F
Vaccine: YF, YF
Symptoms: Dizziness, Nausea
Clinical narrative: 10/7/14 received YF vaccine at clinic. 10/10/14 felt nauseated then felt faint while at dinner with friends. 10/14/14 reported incident to clinic providers.
Age: 77.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Excessive pain when injected on highest part of arm at tip of shoulder. Upper arm and shoulder pain getting more intense over the next 4 weeks. No relief with Tramadol, Aleve; Mobic. Began Methylprednisolone tabs today.  MRI is scheduled today as requested by an Orthopedic Surgeon.
Age: 77.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, X-ray
Clinical narrative: Excessive pain when injected on highest part of arm at tip of shoulder. Upper arm and shoulder pain getting more intense over the next 4 weeks. No relief with Tramadol, Aleve; Mobic. Began Methylprednisolone tabs today.  MRI is scheduled today as requested by an Orthopedic Surgeon.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. Patient's concurrent conditions included drug reactions/allergies to penicillin. Other relevant medical history was not reported. On 14-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot number: K008883 with expiry date of 20-SEP-2015) (dose unspecified), subcutaneously. Concomitant medications were not reported. On an unknown date in October 2014 the patient developed four lesions across her back which were three or four inches wide. The patient went to the emergency room but was not admitted. On 20-OCT-2014, patient called the pharmacist and reported about the adverse event. Legal issue was involved as adverse event was sent to legal. The outcome of the event was reported as not recovered/not resolved. The causality of the event with ZOSTAVAX was not reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Foetal disorder, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous prospective pregnancy report as received from a 32 year old female patient who is also a licensed practical nurse. On 27-MAR-2014 the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date was unknown) dose 1. The patient has no relevant medical history and takes no concomitant medications. On an unknown date in 2014, she had low progesterone levels and was started on progesterone at an unknown dose. She conceived a few days before or after 07-APR-2014 and became pregnant with identical twin girls. The patient took an unknown dose of progesterone for her first 12 weeks of pregnancy and it was discontinued on her 13th week of pregnancy. On an unknown date, she was started on a probiotic, vitamin D, and a prenatal vitamin which she took during her pregnancy and continues to take during her pregnancy at this time. On an unknown date in 2014 during her pregnancy, she was diagnosed with bacterial vaginosis and was treated with oral FLAGYL at an unknown dose on an unknown date in 2014, clindamycin vaginal cream at an unknown dose on an unknown date in 2014, and terconazole vaginal cream at an unknown dose on an unknown date. The FLAGYL, clindamycin vaginal cream and terconazole vaginal cream were discontinued on an unknown dates in 2014. As of 17-OCT-2014, the patient no longer gets the GARDASIL injection and the outcome of the low progesterone levels and the bacterial vaginosis was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Foetal disorder, Foetal malformation
Clinical narrative: This spontaneous prospective pregnancy report as received from a 32 year old female patient who is also a licensed practical nurse. On 27-MAR-2014 the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date was unknown) dose 1. The patient has no relevant medical history and takes no concomitant medications. On an unknown date in 2014, she had low progesterone levels and was started on progesterone at an unknown dose. She conceived a few days before or after 07-APR-2014 and became pregnant with identical twin girls. The patient took an unknown dose of progesterone for her first 12 weeks of pregnancy and it was discontinued on her 13th week of pregnancy. On an unknown date, she was started on a probiotic, vitamin D, and a prenatal vitamin which she took during her pregnancy and continues to take during her pregnancy at this time. On an unknown date in 2014 during her pregnancy, she was diagnosed with bacterial vaginosis and was treated with oral FLAGYL at an unknown dose on an unknown date in 2014, clindamycin vaginal cream at an unknown dose on an unknown date in 2014, and terconazole vaginal cream at an unknown dose on an unknown date. The FLAGYL, clindamycin vaginal cream and terconazole vaginal cream were discontinued on an unknown dates in 2014. As of 17-OCT-2014, the patient no longer gets the GARDASIL injection and the outcome of the low progesterone levels and the bacterial vaginosis was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Progesterone decreased, Vaginitis bacterial
Clinical narrative: This spontaneous prospective pregnancy report as received from a 32 year old female patient who is also a licensed practical nurse. On 27-MAR-2014 the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date was unknown) dose 1. The patient has no relevant medical history and takes no concomitant medications. On an unknown date in 2014, she had low progesterone levels and was started on progesterone at an unknown dose. She conceived a few days before or after 07-APR-2014 and became pregnant with identical twin girls. The patient took an unknown dose of progesterone for her first 12 weeks of pregnancy and it was discontinued on her 13th week of pregnancy. On an unknown date, she was started on a probiotic, vitamin D, and a prenatal vitamin which she took during her pregnancy and continues to take during her pregnancy at this time. On an unknown date in 2014 during her pregnancy, she was diagnosed with bacterial vaginosis and was treated with oral FLAGYL at an unknown dose on an unknown date in 2014, clindamycin vaginal cream at an unknown dose on an unknown date in 2014, and terconazole vaginal cream at an unknown dose on an unknown date. The FLAGYL, clindamycin vaginal cream and terconazole vaginal cream were discontinued on an unknown dates in 2014. As of 17-OCT-2014, the patient no longer gets the GARDASIL injection and the outcome of the low progesterone levels and the bacterial vaginosis was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Premature delivery, Twin pregnancy, Urinary tract infection, Vaginitis bacterial
Clinical narrative: This spontaneous prospective pregnancy report as received from a 32 year old female patient who is also a licensed practical nurse. On 27-MAR-2014 the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date was unknown) dose 1. The patient has no relevant medical history and takes no concomitant medications. On an unknown date in 2014, she had low progesterone levels and was started on progesterone at an unknown dose. She conceived a few days before or after 07-APR-2014 and became pregnant with identical twin girls. The patient took an unknown dose of progesterone for her first 12 weeks of pregnancy and it was discontinued on her 13th week of pregnancy. On an unknown date, she was started on a probiotic, vitamin D, and a prenatal vitamin which she took during her pregnancy and continues to take during her pregnancy at this time. On an unknown date in 2014 during her pregnancy, she was diagnosed with bacterial vaginosis and was treated with oral FLAGYL at an unknown dose on an unknown date in 2014, clindamycin vaginal cream at an unknown dose on an unknown date in 2014, and terconazole vaginal cream at an unknown dose on an unknown date. The FLAGYL, clindamycin vaginal cream and terconazole vaginal cream were discontinued on an unknown dates in 2014. As of 17-OCT-2014, the patient no longer gets the GARDASIL injection and the outcome of the low progesterone levels and the bacterial vaginosis was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Vertigo
Clinical narrative: Vertigo.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Inflammation, Musculoskeletal pain, Neck pain, Swelling
Clinical narrative: Pain in whole shoulder and side of neck. Also swollen, ibuprofen to help w/ pain and inflammation, but it isn't working. It was administered on Monday and it is now Thursday and the pain has worsened. I will be making a ER visit today.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood test, Cellulitis, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous consumer report (initial receipt: 09-Oct-2014) concerns a 79-year-old female patient. The patient had medical history of diabetes, atrial fibrillation and penicillin allergy. Her concomitant medications included warfarin sodium, rosuvastatin, metoprolol, metformin, losartan, digoxin, diltiazem, sulfamethoxazole/trimethoprim, fish oil and vitamins. On 29-Sep-2014, the patient received AFLURIA (batch number not reported) in the left arm and PNEUMOVAX 23 injection (batch number: H018608) in the right arm. On 29-Sep-2014, in the evening, the patient complained of soreness in the right arm. She had a restless night trying to sleep. On 30-Sep-2014, the patient's arm was red just below the injection site for about 6 inches down including the elbow which was swollen. The redness was about 3 inches wide. The next day, the redness turned purple. The patient was advised to go to the emergency room. Blood works were done for diabetes. The patient was diagnosed with cellulitis and was injected antibiotic. Other treatments included stool softener, pain pills and an antibiotic (all unspecified). The patient felt better. There was no problem in the left arm. The outcome was reported as recovering, however the arm was still red.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Poor quality sleep
Clinical narrative: This spontaneous consumer report (initial receipt: 09-Oct-2014) concerns a 79-year-old female patient. The patient had medical history of diabetes, atrial fibrillation and penicillin allergy. Her concomitant medications included warfarin sodium, rosuvastatin, metoprolol, metformin, losartan, digoxin, diltiazem, sulfamethoxazole/trimethoprim, fish oil and vitamins. On 29-Sep-2014, the patient received AFLURIA (batch number not reported) in the left arm and PNEUMOVAX 23 injection (batch number: H018608) in the right arm. On 29-Sep-2014, in the evening, the patient complained of soreness in the right arm. She had a restless night trying to sleep. On 30-Sep-2014, the patient's arm was red just below the injection site for about 6 inches down including the elbow which was swollen. The redness was about 3 inches wide. The next day, the redness turned purple. The patient was advised to go to the emergency room. Blood works were done for diabetes. The patient was diagnosed with cellulitis and was injected antibiotic. Other treatments included stool softener, pain pills and an antibiotic (all unspecified). The patient felt better. There was no problem in the left arm. The outcome was reported as recovering, however the arm was still red.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood test, Cellulitis, Injection site erythema, Injection site joint swelling, Pain in extremity
Clinical narrative: This spontaneous consumer report (initial receipt: 09-Oct-2014) concerns a 79-year-old female patient. The patient had medical history of diabetes, atrial fibrillation and penicillin allergy. Her concomitant medications included warfarin sodium, rosuvastatin, metoprolol, metformin, losartan, digoxin, diltiazem, sulfamethoxazole/trimethoprim, fish oil and vitamins. On 29-Sep-2014, the patient received AFLURIA (batch number not reported) in the left arm and PNEUMOVAX 23 injection (batch number: H018608) in the right arm. On 29-Sep-2014, in the evening, the patient complained of soreness in the right arm. She had a restless night trying to sleep. On 30-Sep-2014, the patient's arm was red just below the injection site for about 6 inches down including the elbow which was swollen. The redness was about 3 inches wide. The next day, the redness turned purple. The patient was advised to go to the emergency room. Blood works were done for diabetes. The patient was diagnosed with cellulitis and was injected antibiotic. Other treatments included stool softener, pain pills and an antibiotic (all unspecified). The patient felt better. There was no problem in the left arm. The outcome was reported as recovering, however the arm was still red.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Injection site reaction, Myalgia, Pharyngeal oedema
Clinical narrative: Muscle pain in arm of injection about an hour after injection (~2pm); about 3 hours after injection, coughing (~4pm); about 3.5 hours after injection, wheezing and swelling of throat-- I could not swallow. This was shortly after I had called my doctor's office. (~4:30pm). Ambulance called at ~4:45 and emergency treatment received.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Muscle pain in arm of injection about an hour after injection (~2pm); about 3 hours after injection, coughing (~4pm); about 3.5 hours after injection, wheezing and swelling of throat-- I could not swallow. This was shortly after I had called my doctor's office. (~4:30pm). Ambulance called at ~4:45 and emergency treatment received.
Age: 32.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: REDNESS AT THE SITE OF PNEUMOVAX SPREADED DOWN TOWARD THE ELBOW. RED AND INFLAMED.