chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of muscle soreness in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle soreness and fever. On an unknown date, the outcome of the muscle soreness and fever were unknown. It was unknown if the reporter considered the muscle soreness and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that after receiving SHINGRIX, two patients developed sore muscles and fever after receipt of SHINGRIX. The healthcare professional would not give patient's initials or dates of birth did not have vaccine lot or expiry dates. This case has been linked with case US2018154161 and US2018154162, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccination indication. The health care professional stated that about 75 percent of patients had let them know that they experienced soreness that lasted about 3 to 7 days post vaccination (more than a couple hundred patients have received SHINGRIX). This was more than was seen with the flu vaccine (confirmed the flu vaccines were non-GSK flu vaccines).
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 79-year-old male patient who received SHINGRIX (batch number FZ23ND ?, expiry date 21st February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 22nd August 2018, the patient received the 2nd dose of SHINGRIX. On 23rd August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site reaction and malaise. On an unknown date, the outcome of the injection site reaction was not recovered/not resolved and the outcome of the malaise was unknown. It was unknown if the reporter considered the injection site reaction and malaise to be related to SHINGRIX. Additional details were provided as follows: On 24th June 2018, the patient received 1st dose of SHINGRIX on left deltoid (for tolerance to 1st dose refer linked case US2018154113). The patient received 2nd dose of SHINGRIX on left deltoid. At 12:00 hours the patient experienced injection site reaction that radiated down to his elbow and also had malaise.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a four months old female patient who was received 0.5 ml dose of PENTACEL (HIB Lot number C5506AA, Expiry date 05-Sep-2019 and DTap-IPV Lot Number C5324AC and Expiry Date 05-Sep-2019) intramuscularly in right thigh on 27-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; and ROTATEQ for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that HIB component was reconstituted with sterile diluent and given to patient. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 29-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI981AB and expiry date: 16-Mar-2019) via intramuscular route in the left arm on 29-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because FLUZONE HD given to a pediatric Patient. No AE symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: None.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 29-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown demographic patient who received a of vaccine IPOL which got expired due to temperature excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. It was unknown any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Papule, Rash generalised
Clinical narrative: Total body rash with white papules on arms and legs starting about 1 hr after injection. First course of vaccine tolerated well on 5/24/18.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Mother refer that next day of vaccination the left upper arm was red, hard and hot. The patient was vaccinated. The patient came to the clinic and was treated with Benadryl.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Lip swelling, Musculoskeletal pain, Rash
Clinical narrative: Pt describes lip swelling, a rash and shoulder pain at that time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Facial pain, Headache, Pain
Clinical narrative: Chills, fever, headache, face pain, coughing, body aches, Methylprednisolone and Bromphen/Pseudo/Dextro HBR Syrup.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever, headache, face pain, coughing, body aches, Methylprednisolone and Bromphen/Pseudo/Dextro HBR Syrup.
Age: 27.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 27-year-old male patient. Patient's concurrent conditions, pertinent medical history and allergies were not reported. On 05-JUN-2018, the patient was vaccinated with a dose of PROQUAD, lot# N035172, expiration date 09-JUN-2019 (dose of the vaccine, route of administration was unspecified) along with a dose of VARIVAX (dose of the vaccine, route of administration, #lot and expiration date were unspecified). The PROQUAD, was reconstituted with sterile diluent. No adverse event was reported.
Age: 17.0
Sex: F
Vaccine: HPV9, IPV, MMRV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a healthcare business professional and refers to a 17-year-old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 13-AUG-2018, the patient was vaccinated with and unspecified doses of PROQUAD (route of administration, lot # and expiration date were not reported), GARDASIL 9 (route of administration, lot # and expiration date were not reported) and poliovirus vaccine inactivated (manufacturer unknown) for prophylaxis. Concomitant therapies included hydrocortisone cream, clindamycin and DIFFERIN GEL. On 14-AUG-2018, the patient developed a fever of 102.7 degrees Fahrenheit. The patient did not seek medical attention. There were no lab diagnostic or studies performed and there was no treatment given for the event. The outcome of the fever was not reported. The causality assessment between the fever and suspected therapies was not reported.
Sex: U
Vaccine: HPVX
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age. There was no information about the patient's medical history, concurrent condition, and concomitant medications provided. On unknown dates, the patient was vaccinated with the first and the second dose of unidentified Merck hpv vaccine administered (name and lot number not provided) It was unknown whether GARDASIL or GARDASIL 9 were administered. It was also mentioned, that the patient missed the last dose in the 3 series of GARDASIL 9. No adverse reactions was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications and drug reactions or allergies were not reported. On 16-AUG-2018, the patient was vaccinated with improperly stored dose of PROQUAD, recombinant human albumin (rHA), subcutaneously (dose was not reported), lot # R006217, expiration date 28-AUG-2019, for prophylaxis. The vaccine was reconstituted with an unspecified dose of sterile diluent. The vaccine was stored in temperature range between -14 and -10 degrees Celsius for 1 hour 15 minutes (date unspecified). There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a field representative and refers to a 11-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. The patient had blood drawn on 17-AUG-2018, prior to receiving vaccination. On 17-AUG-2018, the patient was vaccinated with GARDASIL 9 (dose, route and site of administration, lot# and expiration date were not reported) for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal vaccine (unspecified). After the vaccination, the patient reported feeling lightheaded and laid down in the unspecified office for 30 minutes. No treatment was given for the event. The patient had recovered on the same day, 17-AUG-2018. The causality assessment between the event and GARDASIL 9 was not reported.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Central nervous system lesion, Connective tissue disorder, Gastrointestinal tube insertion, Impaired gastric emptying
Clinical narrative: This spontaneous report was received from a patient's sister and refers to a 12-year-old non-pregnant female patient. There was no concurrent conditions, medical history and concomitant medications were not reported. On unspecified date in 2012 (reported as ''at the age of 12''), the patient was vaccinated with a first dose of GARDASIL to prevent human papillomavirus (HPV) (lot #, expiration date, dose, site and route of administration were not reported). On unspecified dates reported as ''within a couple of weeks after her first dose'', the patient experienced several adverse events; she had gastroparesis, a feeding tube, brain lesions near her pituitary gland, plummeting blood pressure, connective tissue problems, scars as well as continuous "flair ups". Since unspecified date in 2012 (reported as ''at the age of 12''), the patient had a gastric pacemaker implant inserted and as a result could not have children (significant disability or incapacity). In approximately 2014, (reported as ''over the past four and a half years''), the patient had numerous hospitalization at a number of unspecified hospitals due to unspecified reasons. The patient sought medical attention and treatment for adverse event was given. The outcome of the events was reported as not recovered. The causality assessment between the events and GARDASIL was not provided. Upon internal review, the events of gastroparesis and gastrointestinal tube insertion were determined to be medically significant.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Medical device implantation, Scar
Clinical narrative: This spontaneous report was received from a patient's sister and refers to a 12-year-old non-pregnant female patient. There was no concurrent conditions, medical history and concomitant medications were not reported. On unspecified date in 2012 (reported as ''at the age of 12''), the patient was vaccinated with a first dose of GARDASIL to prevent human papillomavirus (HPV) (lot #, expiration date, dose, site and route of administration were not reported). On unspecified dates reported as ''within a couple of weeks after her first dose'', the patient experienced several adverse events; she had gastroparesis, a feeding tube, brain lesions near her pituitary gland, plummeting blood pressure, connective tissue problems, scars as well as continuous "flair ups". Since unspecified date in 2012 (reported as ''at the age of 12''), the patient had a gastric pacemaker implant inserted and as a result could not have children (significant disability or incapacity). In approximately 2014, (reported as ''over the past four and a half years''), the patient had numerous hospitalization at a number of unspecified hospitals due to unspecified reasons. The patient sought medical attention and treatment for adverse event was given. The outcome of the events was reported as not recovered. The causality assessment between the events and GARDASIL was not provided. Upon internal review, the events of gastroparesis and gastrointestinal tube insertion were determined to be medically significant.
Age: 0.42
Sex: F
Vaccine: RVX
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a consumer referring to his daughter, a 5 months old premature female patient. The patient had no drug reactions/allergies or concomitant medications. In April 2013, the patient was vaccinated with one shot of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), injection, for prophylaxis (strength, dosage schedule, lot number and expiration date were not reported). The patient developed a high fever on the date of administration after having received the vaccine. As a result of the fever, the patient was taken to the emergency room for medical attention, but she was not admitted to the hospital. The patient was treated during the emergency room visit with intravenous fluids and tylenol. No studies or diagnostic laboratories were carried out. The outcome of pyrexia was reported as recovered on an unspecified date. Causality assessment was not provided. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1809USA000752 :
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Inappropriate schedule of product administration, Peripheral swelling, Swelling
Clinical narrative: I am the school nurse caring for this child. His first Hep A immunization was 03/21/2018. When student enrolled at our school father was instructed to get the 2nd immunization on or after 9/21/2018. Father took child to mobile clinic on 8/18 to get a Varicella and child was also given the Hepatitis A. Father gave staff all recs. I have contacted the  manager of the mobile clinic and left a message. I have not heard back. I then contacted Hospital and left a message. I have not heard back. Immunization was given early. Father states child had swelling to arm and groin area.  Redness to arm as well. Will student have to repeat Hep A in 6 months?
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Muscle spasms
Clinical narrative: Severe leg cramps off and on from 4AM TO 9Pm on Friday August 31, 2018. Also felt extremely cold, fatigued and headachy during those hours. I experience leg cramps and medicate for them. These were of the longest duration and greatest severity of my life.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscle spasms
Clinical narrative: Severe leg cramps off and on from 4AM TO 9Pm on Friday August 31, 2018. Also felt extremely cold, fatigued and headachy during those hours. I experience leg cramps and medicate for them. These were of the longest duration and greatest severity of my life.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Muscle spasms
Clinical narrative: Cramping from knees to the tips of his toes starting on 8/31/18 4:00 a.m. to 9:00 p.m.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscle spasms
Clinical narrative: Cramping from knees to the tips of his toes starting on 8/31/18 4:00 a.m. to 9:00 p.m.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Capillary nail refill test, Dry skin, Injection site bruising, Injection site rash, Injection site swelling
Clinical narrative: Rash. Additional comments: outside L thigh, x3 days, same spot MMRV was given 8/28/18, no itching, no discharge, no fever, has not spread.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash maculo-papular, Skin warm
Clinical narrative: Rash. Additional comments: outside L thigh, x3 days, same spot MMRV was given 8/28/18, no itching, no discharge, no fever, has not spread.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Chills, Malaise, Nausea, Periarthritis, Pyrexia
Clinical narrative: Pt describes fever, chills, nausea, frozen shoulder, and overall feeling of sickness.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Patient had soreness and hardness at injection site.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Given adult dose instead of adolescent dose.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Eye swelling, Feeling hot, Joint swelling, Swelling
Clinical narrative: Pt developed, swelling elbow, and R side of neck, R eye, 3 days after vaccination and states she felt hot, but no fever detected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4 cm area of erythema with "quarter" sized swelling in right arm surrounding injection site. 2x3cm area of erythema with "dime" sized swelling in left arm surrounding injection site. Diphenhydramine 4.6ml given orally. Swelling in left arm resolved, but unchanged in right arm 10-15 minutes later.
Age: 1.08
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Product preparation error
Clinical narrative: HAVRIX was accidentally drawn up with Sterile Diluent (sterile water) and given. We contacted the CDC and will revaccinate. They suggested we report it to VAERS. L Thigh seems more red than usual at injection site (PREVNAR 13 and VARIVAX were given on that thigh), otherwise baby is doing fine.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, redness, pain, warm to touch, chills, vomiting. Patient called back 9/3/18 reporting it is getting  better, redness has become yellow.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting, Yellow skin
Clinical narrative: Swelling, redness, pain, warm to touch, chills, vomiting. Patient called back 9/3/18 reporting it is getting  better, redness has become yellow.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Blister, Erythema
Clinical narrative: Patient complained of vesicles down entire leg with erythema. Pt given Hydrocortisone cream.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: Mom said patient is "scared" of needles. She was a little nervous. I gave the shot and she sat down on the bench. She said she was dizzy so I went to get a cool paper towel for her face. When I came back she fainted. She was out for about 1 to 2 minutes. We gave her some Sprite to drink. Mom said she has low blood sugar often. We think the low blood sugar may have contributed to her fainting. I also gave her a glucose tablet to bring her blood glucose up. After about 5 minutes she felt fine.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient came in as a Nursing visit. I looked at previous well child visit for vaccination orders. I also checked with Provider to double check the orders were correct. Pt was given Dtap (PEDIARIX) instead of Dtap (INFANRIX).
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt received a FLUZONE QUAD injection at about 10:30 AM. Returned to pharmacy around 4PM c/o swollen/warm area around injection site.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Malaise, Musculoskeletal stiffness
Clinical narrative: 8/15 by evening left upper arm was swollen and extremely painful. Took 1000mg acetaminophen and applied ice. Kept ice on all night. 8/16 general malaise, headache, queasy stomach. Took 2 more acetaminophen. Kept ice on all day. 8/16 decided to try B-12 complex sublingual liquid, 1 ml, at lunch time to try to feel better. It seemed to help. (Would have gone to doctor if it had not!). 8/17 repeated B-12, 1 ml at noon. 8/17 feeling a little better less soreness in arm. Began to feel tender skin spots on head; also had mild stiff neck. 8/18 headache and tender skin on head. 8/18 headache. Tender skin spots gone. 8/19 symptoms gone. Note: I only had mild soreness in upper arm when I had first shot, that is normal for me. I decided to report it because it was unusual for me to have that much pain after a shot. It had me concerned enough that I never even thought to take my temperature. If B-12 hadn't helped, I would have gone to E.R.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pain of skin, Tenderness
Clinical narrative: 8/15 by evening left upper arm was swollen and extremely painful. Took 1000mg acetaminophen and applied ice. Kept ice on all night. 8/16 general malaise, headache, queasy stomach. Took 2 more acetaminophen. Kept ice on all day. 8/16 decided to try B-12 complex sublingual liquid, 1 ml, at lunch time to try to feel better. It seemed to help. (Would have gone to doctor if it had not!). 8/17 repeated B-12, 1 ml at noon. 8/17 feeling a little better less soreness in arm. Began to feel tender skin spots on head; also had mild stiff neck. 8/18 headache and tender skin on head. 8/18 headache. Tender skin spots gone. 8/19 symptoms gone. Note: I only had mild soreness in upper arm when I had first shot, that is normal for me. I decided to report it because it was unusual for me to have that much pain after a shot. It had me concerned enough that I never even thought to take my temperature. If B-12 hadn't helped, I would have gone to E.R.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in 9/4/18 complaining that that am redness, swelling and warmth at injection site occurred.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Swollen, red area about 2-2 1/2 inches wide by about 4 inches long extending from injection site. This occurred about a day after the shot. It occurred below injection site. I had slight pain on arm for several evenings. The redness and swelling were all gone on. I just waited for the symptoms to go away. The redness, swelling and any pain were all gone on 08/26/2018.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular, Swelling face
Clinical narrative: Patient developed facial swelling on 8-23-18 and a shingles-like rash on the right ear and extending down the neck and upper arms. Patient describes rash as pink, painful, itchy, and blister-like. No fever or chills reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 13-AUG-2018, the patient was vaccinated with one dose of improperly stored ROTATEQ orally (lot # R002513, expiration date: 05-JUN-2019, dose was not provided) for prophylaxis. No adverse effect reported; one dose of improperly stored ROTATEQ was administered. This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 13-AUG-2018, the patient was vaccinated with one dose of improperly stored ROTATEQ orally (lot # R002513, expiration date: 05-JUN-2019, dose was not provided) for prophylaxis. Administered dose of vaccine experienced temperature excursion between 2-8 degrees Celsius (1.8 degrees Celsius) for 10 hours. There was previous temperature excursion between 0-1 degrees Celsius for 45 minutes. Digital data logger was involved. No adverse effects were reported. This is one of two cases reported be the same reporter. Sender's Comments: US-009507513-1808USA008009: Administered dose of vaccine experienced temperature excursion between 2-8 degrees Celsius (1.8 degrees Celsius) for 10 hours. There was previous temperature excursion between 0-1 degrees Celsius for 45 minutes. Digital data logger was involved. No adverse effects were reported. This is one of two cases reported be the same reporter. Sender's Comments: US-009507513-1808USA008009.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to an 11-year-old male patient. The patient had no concomitant medications, pertinent medical history or known drug reactions and allergies. On 02-AUG-2018, the patient was vaccinated with GARDASIL 9, intramuscularly (dose, lot number and expiration date were not reported) for prevention of human papillomavirus (HPV). On the same date, within 5 minutes after receiving GARDASIL 9, the patient experienced dizziness and lightheadedness. The patient sought medical attention, no lab diagnostics were performed and the patient was treated with cold compress, drinking water and a popsicle. The outcome of the event was reported as recovered (on the same date, 30 minutes later). Causality assessment was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 08/24/18: The evening after getting vaccine in left deltoid employee stated arm felt warm and turned red and muscle swelled up (bicep). Saturday 8/25/18 upper arm was swollen, red and warm to touch. Saw on Monday 8/27/18 bicep area swollen - not deltoid area. Less swollen than over the weekend.
Sex: F
Vaccine: HPVX
Symptoms: Infertility female
Clinical narrative: This spontaneous report was derived from an article published in a local newspaper and refers to a group of female patients of unspecified age. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, route of administration, lot number and expiration date were not provided) and CERVARIX. Based on the information published, in the group of patients described above, the rate of infertility problem was higher when compared to the group that did not receive the human papilloma virus (HPV) vaccine. The reporter considered the events to be related to the administered vaccines. Sender's Comments: US-009507513-1809USA001053.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Menorrhagia
Clinical narrative: This spontaneous report was received from a physician via company representative concerning a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient received, as stated "GARDASIL 9 and MENACTRA concomitantly" (dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported). Other suspect therapies included MENACTRA (dosage schedule, route, anatomical location, lot number and expiration date were not reported), which was administered concomitantly with GARDASIL 9. On an unknown date the patient experienced prolonged menses. The outcome of the event was unknown. The reporter did not provide the causality assessment between menorrhagia and the suspect therapies. No further information provided.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Syncope, Vomiting
Clinical narrative: This spontaneous case was reported from a consumer, concerning a 15 years old, female patient. The patient's concurrent conditions, historical conditions and drug reactions or allergies were not provided. The patient's concomitant medication were birth control pill and ACCUTANE. On 23-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 series for routine vaccination prophylaxis (dose, route, anatomical side of injection, lot# and date of expiration were not reported). On the same date, the patient went home and started felt dizzy and fainted. Later in that evening she felt nauseated and vomited. It was unknown if the patient received any treatment for the adverse events. The reporter specified that no laboratory diagnostic studies were performed. The outcome of dizziness, vomiting, nausea and syncope was reported as recovered/resolved. At the reporting time, the causality assessment between of GARDASIL 9 and the aforementioned adverse event was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Loss of personal independence in daily activities, Muscle disorder
Clinical narrative: This spontaneous report was received from a registered nurse, via company representative and refers to her sister's babysitter's daughter of unknown age. Information regarding concomitant medication, pertinent medical history and drug allergies/drug reactions was unknown by reporter. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscular for vaccination (dose, lot number and expiration date were not reported). On an unknown date, the patient developed muscular issues. The event was reported as a debilitating condition as the patient no longer participated in sport activities. The outcome of the event muscle disorder and the causal relationship between the event and therapy with GARDASIL 9 were not reported. Upon internal review the event muscle disorder was determined to be significant disability.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills
Clinical narrative: This is a spontaneous report from a contactable Nurse via a Pfizer sales representative. A 16-year-old male patient received TRUMENBA and MENACTRA, both via an unspecified route of administration on 28Aug2018 at 12:30 pm at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any documented allergies. The patient experienced shivering on 28Aug2018 after use of the product, with no fever or any other symptom and within two hours, symptoms improved and symptoms were gone for the most part. The outcome of the event was recovering. Information on the batch number has been requested.
Sex: U
Vaccine: MEN, MENB
Symptoms: Headache, Lumbar puncture, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. This nurse reported similar events for two patients. This is the first of two reports. A 16-year-old patient of an unspecified gender received TRUMENBA and meningococcal vaccine a/c/y/w (MCV4), both via unspecified route of administration on unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was given meningococcal group b rlp2086 and MCV4 on the same visit at different locations. The patient ended up having severe headaches and vomiting and needed to be hospitalized and ended up getting a spinal tap on an unspecified date. It was reported that the events took place after the use of the products. The outcome of the events was unknown. The information on the batch/lot number and expiration date has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect drug trumenba contributed to the development of the reported events headaches and vomiting .,Linked Report(s) : US-PFIZER INC-2018350877 Same reporter/drug/event, different patient.
Sex: U
Vaccine: MEN, MENB
Symptoms: Headache, Lumbar puncture, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for two patients. This is the second of two reports. A 17-year-old patient of an unspecified gender received TRUMENBA and  meningococcal vaccine A/C/Y/W (MCV4); both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was given meningococcal group b rlp2086 and MCV4 on the same visit at different locations. The patient ended up having severe headaches and vomiting and needed to be hospitalized and ended up getting a spinal tap on an unspecified date. It was reported that the events took place after the use of the products. Outcome of the events was unknown. Information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect drug trumenba contributed to the development of the reported events severe headaches and vomiting.,Linked Report(s) : US-PFIZER INC-2018350846 Same reporter / drug / event, different patients.
Sex: U
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia, Fatigue
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old patient of unspecified gender received PREVNAR 13 and SHINGRIX, both via an unspecified routes of administration in Jul2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced knee pain and fatigue on an unspecified date. The outcome of the events was unknown. Information on batch number has been requested.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Foreign travel, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer-sales representative. A female patient of an unspecified age received PREVNAR 13 at a single dose; and PNEUMOVAX 23 at an unknown dose; both via an unspecified routes of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date after both shots and after visiting a foreign country. The outcome of the event pneumonia was unknown. Information on batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 3 patients. This is second of 3 reports. A patient of unspecified age and gender received TRUMENBA, (lot #: s58879), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness at injection site, fever, body ache, nausea all took place after use of product on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2018352648 Same reporter/product, partial same event, different patient; US-PFIZER INC-2018352982 Same reporter/product, and event, different patient.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from contactable Physician via Pfizer Sales Representative. This Physician reported similar events for 3 patients. This is 3rd of 3 reports. A 16-year-old female patient received TRUMENBA, (lot number: S58879), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness at injection site on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2018352636 Same reporter/product, partial same event, different patient.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 3 patients. This is first of 3 reports. A 16-year-old female patient received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced redness at injection site, fever, body ache, nausea all took place after use of product on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2018352636 Same reporter/product, and events, different patient; US-PFIZER INC-2018352648 Same reporter/product, partial same event, different patient.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This is a spontaneous report from a contactable Licensed Practical Nurse communicated to a sales representative, reported for a 16-year-old female patient. A 16-year-old female patient received TRUMENBA (lot number: T52806, Expiry Date: Dec2019), via an unspecified route of administration at right arm on 28Aug2018 at 0.5 ml, single for routine vaccine for Meningococcal B. The patient's medical history was not reported. Concomitant medication included MENACTRA at left arm on 28Aug2018 at single dose for immunization. An LPN, (name withheld) called from the doctor's office and reported to him that a patient who received the meningococcal group b rlp2086  vaccine pre-filled syringe on 28Aug2018 experienced a localized site reaction in Aug2018. The patient had redness, hot, and swelling in the right arm where the vaccine was given. The patient is a sixteen year old female in good health. The outcome of the events was unknown.
Sex: U
Vaccine: FLU4
Symptoms: Food allergy, Influenza
Clinical narrative: Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Child patient (age and gender not reported), who experienced egg allergy for her son with FLUZONE, nurses reported "getting the flu" and egg allergy for her son with FLUZONE QUADRIVALENT while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date (on 2018-2019, reported about her family's flu vaccination), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported (expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious egg allergy for her son with FLUZONE (food allergy) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious nurses reported "getting the flu" following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious egg allergy for her son with FLUZONE QUADRIVALENT (contraindication to vaccination) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also a case of contraindication to vaccination as egg allergy leads to hypersensitivity following administration of the vaccination. Other relevant tests included No Lab data was reported. Final diagnosis was egg allergy for her son with FLUZONE QUADRIVALENT, nurses reported "getting the flu" and egg allergy for her son with FLUZONE. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for egg allergy for her son with FLUZONE, as Unknown for nurses reported "getting the flu" and as Not Applicable for egg allergy for her son with FLUZONE QUADRIVALENT. List of documents held by the sender: None.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age patient who experienced due to temp excursion product was not acceptable for use, while he/she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a  dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine lot number not reported. It was a case of medication error due to product storage error. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age patient who experienced due to temp excursion product was not acceptable for use, while he/she received vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine lot number not reported. It was case of medication error due to product storage error. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Initial information received on 24-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age female patient who experienced rash, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date, dose, route and site of administration were not reported). On an unknown date the patient developed a non-serious rash, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that the patient had rash for days after receiving Flu shot.  Relevant tests were not reported.   Final diagnosis was rash.   It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  List of documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site urticaria
Clinical narrative: Patient returns to the clinic with hives at the site of the Tdap injection (right deltoid) approximately 11:20am. No respiratory symptoms. Upon exam, alert in no apparent distress. Chest CTA. BENADRYL Allergy liquid suspension 5 mL given to patient at 11:29am, by 11:45am hives are less noticeable and less redness.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pruritus
Clinical narrative: Pain and itchiness in joints, knuckles.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: Muscle soreness at the injection site, low grade fever, fatigue. The patient states she has improved after 4 days, but is still not 100%.
Sex: U
Vaccine: VARZOS
Symptoms: Abnormal faeces, Arthralgia, Diarrhoea, Headache, Pain
Clinical narrative: RECURRING POUNDING HEADACHE - TOOK 800 MG. IBUPROFEN FOR THREE DAYS - HEADACHE WENT AWAY ON THIRD DAY. EXTREME BODY/JOINT PAIN - TOOK 800 MG. IBUPROFEN FOR THREE DAYS AND BEDREST- STARTED FEELING BETTER ON DAY THREE. CHILLS AND FEVER - FEVER DIMINISHED AFTER DAY TWO - CHILLS DIMINISHED BY DAY THREE. DIARREAH - TOOK IMODIUM FOR ONE DAY - DIARREAH RESOLVED AFTER FIRST DAY. UNPLEASANT ODIR OR SMELL IN MY NOSE - NO TREATMENT -STILL HAVE IT THREE DAYS AFTER RECEIVING VACCINE.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: RECURRING POUNDING HEADACHE - TOOK 800 MG. IBUPROFEN FOR THREE DAYS - HEADACHE WENT AWAY ON THIRD DAY. EXTREME BODY/JOINT PAIN - TOOK 800 MG. IBUPROFEN FOR THREE DAYS AND BEDREST- STARTED FEELING BETTER ON DAY THREE. CHILLS AND FEVER - FEVER DIMINISHED AFTER DAY TWO - CHILLS DIMINISHED BY DAY THREE. DIARREAH - TOOK IMODIUM FOR ONE DAY - DIARREAH RESOLVED AFTER FIRST DAY. UNPLEASANT ODIR OR SMELL IN MY NOSE - NO TREATMENT -STILL HAVE IT THREE DAYS AFTER RECEIVING VACCINE.