chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Hyperaesthesia, Injection site erythema, Injection site swelling, Lethargy, Pain
Clinical narrative: First 24 hours - fever TMAX of 102.3, mild diffuse rash to posterior trunk, lethargy, small area of swelling/redness around site. >24 hours - Right Arm swelling & Redness spread (shoulder down to elbow), Very Hot to the Touch, Painful, Skin Sensitivity, child denied having any "tingling" or sensation issues in hand or arm, just "hurts". 48 hours - Swelling & Redness had progressed further w/ continued pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: First 24 hours - fever TMAX of 102.3, mild diffuse rash to posterior trunk, lethargy, small area of swelling/redness around site. >24 hours - Right Arm swelling & Redness spread (shoulder down to elbow), Very Hot to the Touch, Painful, Skin Sensitivity, child denied having any "tingling" or sensation issues in hand or arm, just "hurts". 48 hours - Swelling & Redness had progressed further w/ continued pain.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Significant soreness and tenderness, mild erythema at injection site the evening she had this. Day after - soreness plus some decrease in ROM. Today came to office w/hives in deltoid area and axillary area.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Heart rate increased, Pyrexia, Swelling face
Clinical narrative: Patient called on July 17th stating that she had developed facial swelling, increased heart rate, dizziness, fever of 102 F for full 24 hrs after receiving TRUMENBA and MENACTRA on 7/13/17. Symptoms normalised after 24 hours.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Rash
Clinical narrative: Rash on arms, elbows, and hand. Pruritus.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Limb mass, Skin warm, Urticaria
Clinical narrative: Mom states child developed hives on back, arms, hands, and feet. States he also had a lump on each arm the size of 1/2 a golf ball. States she did not take his temperature, but she stated he only felt slightly warm, so she stated if he had a fever it was not a high one. Mother also stated child gets hives frequently from different things. Did have a similar reaction to a vaccine when he was younger. Mother gave child BENADRYL, but she states it has not helped. Encouraged her to contact child's doctor.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Electromyogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Nov. 11th woke up with tingling sensation in feet and hands with bad backpain and weakness. Dec 21 Had EMG with Dr. Dec 30 Had Lumbar puncture at Hospital.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Nov. 11th woke up with tingling sensation in feet and hands with bad backpain and weakness. Dec 21 Had EMG with Dr. Dec 30 Had Lumbar puncture at Hospital.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Dizziness, Eye movement disorder, Loss of consciousness, Paraesthesia
Clinical narrative: Patient complained of feeling dizzy a few minutes after receiving the HPV 9 vaccine. He then had a very brief convulsion (lasting a few seconds), his eyes rolled into the back of his head and he lost consciousness (also for a few seconds). When he awoke, he said his stomach hurt and his fingers felt tingly. We observed him in the office for 30 min and symptoms completely resolved.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Patient complained of feeling dizzy a few minutes after receiving the HPV 9 vaccine. He then had a very brief convulsion (lasting a few seconds), his eyes rolled into the back of his head and he lost consciousness (also for a few seconds). When he awoke, he said his stomach hurt and his fingers felt tingly. We observed him in the office for 30 min and symptoms completely resolved.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site irritation, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and referred to a 37 year old female patient. The patient's concurrent conditions included rhinitis allergic, iron deficiency anaemia, costochondritis, human immunodeficiency virus (HIV) infection, hyperlipidaemia, myalgia, chest pain, palpitations and osteopenia. The patient's concomitant therapies included cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate (GENVOYA) and ergocalciferol. The patient's medical history included injection site reactions (reported as reactions or allergies to unspecified drug). On 25-JUL-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX23 (dose and route of administration were not reported) (lot# N010109 with expiration date: 20-NOV-2018) for pneumococcal vaccination. On the same day, reported as "within a couple of hours", the patient experienced irritation and swelling at the unknown injection site. On 25-JUL-2017, the patient returned to the doctor's office due to a low-grade fever, swelling and redness at the injection site. The patient was seen by an unspecified physician. The pharmacist reported that the patient was diagnosed with cellulitis on 25-JUL-2017 and received a prescription for an antimicrobial (unspecified). No laboratory diagnostics studies were performed. The pharmacist requested a lot check for PNEUMOVAX23. The outcome of the events was reported as recovering. The relatedness between the events and the PNEUMOVAX23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA011278:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates, the patients were administered doses of improperly stored ROTATEQ injection (Lot# M041184, expiration date 31-MAY-2018; Lot# M044724, expiration date 13-JUN-2018) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 2 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects was reported. This is one of several reports received from the same reporter. Lot number (M044724) has been verified to be a valid lot number for ROTATEQ. Sender's Comments: US-009507513-1707USA012152: US-009507513-1707USA012415: US-009507513-1707USA012417: US-009507513-1707USA012418: US-009507513-1707USA012419.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (rHA) lot # M025607, expiration date 18-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 degrees Celsius for 8 hours and 26 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA002146.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Infrequent bowel movements
Clinical narrative: This spontaneous report as received from a consumer refers to a 10 week old female patient. On 24-JUL-2017 the patient was vaccinated with ROTATEQ dose 1, oral for prophylaxis. On 31-JUL-2017, the patient experienced infrequent bowel movements. The outcome of infrequent bowel movements was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 24-JUL-2017, the patient was vaccinated with an expired dose of M-M-R II (expiration date 22-JUL-2017; dose, route and lot # were unknown) reconstituted with sterile diluent (lot # and expiration date were unknown) for prophylaxis. No adverse effects were reported.
Age: 62.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 62 year old patient. On 25-JUL-2017 the patient was vaccinated with VAQTA lot # M034893, expiration date 26-MAY-2017 for prophylaxis. On 25-JUL-2017, the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M040412, expiration date 30-JUN-2019 (single doses; dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 degrees Celsius for 8 hours and 26 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA012921.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 25-JUL-2017, the patient was vaccinated with VARIVAX lot # M042495, expiry date 19-OCT-2018 for prophylaxis. Concomitant therapies included sterile diluent. On 25-JUL-2017, the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. 01-AUG-2017, the patient was vaccinated with an expired dose of GARDASIL 9 (lot # L045711, 08-MAY-2017) for prophylaxis. No adverse effect reported.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Patient describes the evening after the vaccine he developed a headache, fever 100.0F fatigue and pain at the injection site which made it difficult to move his arm.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Right arm painful, mild swelling in the evening and next day after injection. Also became dizzy and vomited morning after receiving vaccine.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Appendicitis, Dizziness, Paraesthesia
Clinical narrative: Patient developed severe abdominal pain, lightheadedness, and tingling in arms when stood up approximately 2:00am, on 8/4/17.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: SWELLING, REDNESS AND TENDERNESS TO VACCINE SITE ON DAY VACCINE WAS GIVEN. SYMPTOMS  RESOLVING ON ITS OWN.
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling on posterior left arm at site of Zoster vaccine - redness is 1.5 x 2 inches in size.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Dyskinesia, Hyperhidrosis, Loss of consciousness, Vomiting
Clinical narrative: Patient received immunizations of HPV. Pt tolerated vaccine. Ambulated self to chair against wall. Approximately 5 minutes after receiving vaccine pt was noted to have uncontrolled body movements.  Pt eyes closed. Nurse supported pt body while she appeared to be losing consciousness. Pt responded to name while being directed to keep eyes open. Pt became diaphoretic, and clammy. Respirations were even. Pt did not lose control of bladder or bowel. Pt continued to have uncontrolled body movements for approximately 3 additional minutes. Pt then continued to appear to lose consciousness, but remained alert to name and ability to follow commands. Pt had emesis x1 of clear liquid.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse who reported that improperly stored doses of VARIVAX lot #M047662, expiration date 02-DEC-2018; lot #M048200, expiration date 07-DEC-2018; lot #N012618, expiration date 21-APR-2019; lot #N008826, expiration date 12-SEP-2018; and lot #N001527, expiration date 13-JAN-2019 (dosages and routes of administration not provided), and PROQUAD lot #N008826, expiration date 12-SEP-2018; lot #N002917, expiration date 24-JUL-2018; lot #M035145, expiration date 30-JAN-2018; and lot #M048201, expiration date 05-JUN-2016 (reported as 05-JUN-2018) (dosages and routes of administration not provided) were administered on multiple unspecified dates to multiple unspecified patients (ages and genders unknown). The vaccines were reconstituted with properly stored sterile diluent (MSD) (lot number and expiration date unknown). The nurse was unable to specify which lot numbers were administered, so all improperly stored lot numbers were provided. No adverse effects were reported. Temperature: 15°F to 46°F (16°F) Time frame: 2 hours Previous temperature excursion: No Data logger involved: Yes. No additional information provided. Lot number N008826 is not a valid lot number for VARIVAX. Lot number N001527 has been verified to be a valid lot number for VARIVAX. Lot number N008826 has been verified to be a valid lot number for PROQUAD. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Rash
Clinical narrative: Information was received on 14-JUL-2017 from a pharmacist regarding a 78 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-JAN-2012 the patient was vaccinated with ZOSTAVAX, lot # 1599AA expiration 13-JAN-203, 1 DF, subcutaneous for the prevention of shingles. Concomitant therapies included sterile diluent (lot # and expiration unknown.) The pharmacist reported that the patient has had three cases of shingles since receiving the vaccine. The patient has developed a painful rash each time the shingles occurred. The shingles episodes occurred on 25-JAN-2012, September 2014 and 30-JUN-2017. On 25-JAN-2012, the patient was treated with VALTREX 500 mg by mouth three times a day for 2 weeks. In September 2014, the patient was treated with VALTREX by mouth three times a day for 2 weeks. On 25-JUN-2017 (also reported as 30-JUN-2017), the patient was treated with VALTREX twice daily for 2 weeks and Prednisone 10mg once a day for 2 weeks. The pharmacist reported the patient saw the doctor each time she had shingles. The pharmacist reported that the patient did not have significant disability or incapacity but was very uncomfortable. The patient was not hospitalized. The outcome of herpes zoster is unknown. No additional information was available. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unspecified dates, an unspecified amount of patients received improperly stored doses of VAQTA (lot# N012324 exp 05-APR-2018), RECOMBIVAX HB, (lot# M036156, exp. 23-FEB-2019), ROTATEQ (lot# N003401 exp.13-OCT-2018), and PROQUAD (Lot# N002915, exp. 24-JUL-2018). Reconstituted with properly stored STERILE WATER DILUENT. No adverse effects reported. No further information provided. Vaccines VAQTA, RECOMBIVAX HB, ROTATEQ Temperature: 47°F to 77°F Time frame: 1 Hour 35 Minutes No previous temperature excursion Digital Data logger report was involved. Vaccines involved: PROQUAD Temperature: 6°F to 14°F Time frame: 55 Minutes No previous temperature excursion Digital Data logger report was involved. Lot number N003401 has been verified to be a valid lot number for ROTATEQ. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 7 month old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-JUL-2017, the patient was vaccinated with a second dose of ROTATEQ orally (lot # M041766, expiration date 08-MAY-2018). On 14-JUL-2017, the patient was vaccinated with a third dose of ROTATEQ orally (lot# M041766, expiration date: 08-MAY-2018). No adverse effects were reported. Additional information is not expected, no consent to contact reporter.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test negative, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a 25 year old female patient. There was no information regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. The patient was pregnant at the time of the report. On an unknown date in 2017, the patient was inadvertently vaccinated with VARIVAX for prophylaxis (lot number and expiration date were not provided). The vaccine was reconstituted with sterile diluent MRK (lot number and expiration date were not provided). The patient had pregnancy test done on 15-MAR-2017, with the negative result. Then, subsequently the patient was determined to be pregnant (unknown date in 2017). The patient had an ultrasound investigation performed, which determined conception occurred on an unknown date in mid February 2017. The ultrasound result was normal (performed in approximately 2017). The last menstrual period was calculated as approximately 01-FEB-2017 and estimated delivery date was calculated on 08-NOV-2017. The patient sought medical attention by visiting a physician's office. The pregnancy outcome was pending. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, at the age of 12 years the patient was vaccinated with GARDASIL (dose, route, batch/lot# unknown) as first dose in the Human papillomavirus vaccination series for prophylaxis. On an unknown date, at an unknown age the patient received GARDASIL 9 as second dose (dose, route, batch/lot# unknown) in the vaccination series (Interchange of vaccine products). On an unknown date, at an unknown age the patient was in the reporter's office to receive the third dose in the vaccination series with GARDASIL 9. No adverse effects were reported. Product quality complaint was not involved.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Around 9:00 PM after injection, complained of severe pain in arm around injection site. Gave Children's MOTRIN. Awoke 8:30 AM with 101 fever, red and swollen 3" mound around site. 12:00 PM gave 1/6 dose of MOTRIN (felt nausea). 2:00 PM gave remaining dose MOTRIN, fever reduced to 99. Iced bump.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Rash
Clinical narrative: Rash all over arms, legs, back and stomach.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Rash
Clinical narrative: Rash all over legs, arms, stomach and back.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: Localized reaction with cellulitis around injection site.
Age: 4.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING OF LEFT ARM ABOUT THE SIZE OF A QUARTER
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Amnesia, Headache, Pyrexia
Clinical narrative: Fever for 2 days, severe HA for 5 days, mother reports increase in his known short-term memory loss.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: PATIENT SAID THAT 4 DAYS LATER HE DEVELOPED A MILD RASH ON HIS RIGHT ARM, ALSO A MILD RASH ON THE RIGHT SIDE OF HIS TORSO. HE SAID IT BEGAN WITH BUMPS THAT MAY HAVE BEEN FLUID FILLED AND WAS A LITTLE ITCHY. HE SAID THAT HE WASN'T USING ANYTHING ON THE RASH BUT THAT IT WAS GETTING BETTER AS OF 8/4/17. HE COULD NOT CONFIRM IF THE RASH WAS OR WAS NOT FROM POISON IVY OR SOMETHING ELSE. HE ALSO SAID HE HADN'T SEEN THE DOCTOR AS OF YET BECAUSE IT WAS GETTING BETTER AND HE WANTED TO WAIT UNTIL MONDAY. IF IT WASN'T GONE BY THEN OR IF IT WAS GETTING WORSE HE WOULD CALL THE DR THEN.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever developed late afternoon on 8/1 around 4 pm ET. Fever continued through morning of 8/3, fever broke around 10 am ET on 8/3. Fever temperature presented around 101.8 and increased to 103 (rectal temperature). Temperature ranged between those two points from 8/1 to 8/3 unless medication / pain reliever was given. Child was giving children's Motrin at a dose per the age/weight instructions (5 ml). Dose d given once on 8/1, twice on 8/2 and once on 8/3. About 6 hours after fever broke, a rash was noticed on the child's butt cheeks.  Rash appeared as muted red spots approx. 5 millimeters in diameter. Rash spread to back, chest, stomach, neck and cheeks/face the following day (today - day of reporting of incident). Called the clinical line of my doctor's office (doctor noted in this form). Doctor's office advised rash was likely either related to the MMR shot or possibly Roseola (may also be related to MMR shot). Dr. cannot see patient today, and advises to monitor through the weekend and come in on Monday (8/7) if symptoms persist.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator and refers multiple patients of unknown ages. On unknown dates, the patients were vaccinated with VARIVAX lot # M035141 or lot # M048200 for prophylaxis. Concomitant therapies included sterile diluent. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA001720.
Sex: F
Vaccine: HPVX
Symptoms: Death
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. The physician reported that an unspecified patient stated that daughter of a friend, on an unknown date, vaccinated with either GARDASIL 9 or GARDASIL (dose, route, batch/Lot # unknown) for prophylaxis. Subsequently, on an unknown date the patient died. The cause of death was not reported. It was unknown if an autopsy was performed. Causality assessment was not provided. No PQC filed. The physician was not able to provide any further details. Reported Cause(s) of Death: unknown cause of death.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to an unspecified patient of unknown age and gender. Information on concomitant medication, medical history, concurrent condition, drug allergies/reactions were unknown by reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, lot# and expiration date were unknown by reporter) for immunisation. The reporter stated that an unspecified patient experienced pain and swelling at the injection site after receiving ZOSTAVAX and patient also experienced fever which lasted about 4 days. The outcome of injection site pain, pyrexia and injection site swelling were reported as recovered on an unspecified date. No product quality complaint (PQC) was involved. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date, "10 days" after vaccination, the patient experienced "unconfirmed shingles rash on her neck". The patient sought medical attention and was treated. The outcome of herpes zoster was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from an administrator and refers multiple patients of unknown ages. On unknown dates, the patients were vaccinated with PROQUAD lot # M022402 or lot # M044720 for prophylaxis. Concomitant therapies included sterile diluent. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA005904.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal discomfort, Headache, Pain in extremity
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 01Aug2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A report was received via a sales representative. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot R45100), intramuscular in left deltoid on 31May2017 at 0.5 ml, single for immunisation. The patient medical history was not reported. Concomitant medication included MENACTRA (Lot U5514AB) received on 31May2017 intramuscular in right deltoid at 0.5 ml for immunisation. On 31May2017 the patient experienced severe headache, upset stomach, pain in lf arm x3 days. The outcome of the events was recovered.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in Apr2017 at single dose for immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced nauseous, chills, joint pain, muscle pain, been feeling really bad, had a cough in the morning when she got up, very tired and no appetite, all on an unspecified date with outcome of unknown. The events were described as following. She had no fever, no vomiting but she was nauseous and had chills. The joint pain and muscle pain was what was most bothersome to her at the current time and did not know if it was related to her rheumatoid arthritis or the vaccination. She planned to discuss this further with her physician. The patient wondered if she should have received the vaccine because she already had an autoimmune disease called rheumatoid arthritis.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in Apr2017 at single dose for immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced nauseous, chills, joint pain, muscle pain, been feeling really bad, had a cough in the morning when she got up, very tired and no appetite, all on an unspecified date with outcome of unknown. The events were described as following. She had no fever, no vomiting but she was nauseous and had chills. The joint pain and muscle pain was what was most bothersome to her at the current time and did not know if it was related to her rheumatoid arthritis or the vaccination. She planned to discuss this further with her physician. The patient wondered if she should have received the vaccine because she already had an autoimmune disease called rheumatoid arthritis.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site pain, Peripheral swelling, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent) via a Pfizer sales representative. A 17-year-old female patient of an unspecified race/ethnicity received TRUMENBA, via an unspecified route of administration at single dose on 10Jan2017 (first dose) in the right arm and on 26Apr2017 (second dose) in the left arm for prevention of invasive Neisseria meningitis. The patient medical history and concomitant medications were not reported. The patient experienced severe headache, vomiting 12 times, severe pain at injection site, swollen arm, after each dose. The events were described as follows: Severe headache and vomiting started around the next day after receiving the first and second dose, started initially soon after 10Jan2017 but not on the 10Jan2017. These took longer to resolve then the pain and swelling. They also lasted another two days after the first dose, resolved but then the patient experienced it again with the second dose. Starting soon after the 26Apr2017 but not on the same day and they resolved another two days or so later. Severe pain at injection site and swollen arm started after receiving first dose on 10Jan2017. Lasted for a couple of days after first injection, resolved. Patient experienced these events again on 26Apr2017 after receiving second dose of product. Both resolved a couple of days later sometime in Apr2017. Swollen arm was the one she received injection in.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received, on an unknown date, PREVNAR 13 at single dose and quadrivalent influenza vaccine (QIV), both for immunization. Relevant medical history and concomitant medications were unknown. On 03Aug2016, the patient's hand was swelling and rainbow color to skin. BACTRIM was given as treatment by physician. Clinical outcome of the events was unknown at time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site dryness, Injection site pain, Injection site reaction, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable pharmacist, via a Pfizer sales representative. A patient of an unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. After the use of the product, on 02Aug2016, the patient complained of injection site being really tender and the skin around the injection site was dry and peeling. The outcome of the events was unknown.
Sex: F
Vaccine: MENB
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a contactable health care professional via Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fatigue 3 days after 1st vaccine dose with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Erythema, Insomnia, Peripheral swelling
Clinical narrative: Red and swollen right arm that spread down to the elbow from the shoulder area. Per the patient, very uncomfortable and had difficulty sleeping. Patient took Naproxen to alleviate the pain. Patient was seen by the PCP and was given Amoxicillin/potassium 875/125 mg, ZYRTEC 10 mg and Probiotics.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Malaise, Pallor
Clinical narrative: Patient in the office for 11 year well visit. Received MENACTRA and TDaP vaccines. Child walked out of the exam room and into the waiting room to leave the office and told mom she didn't feel well. Mom stating that she turned around as patient was starting to feel weak. Mom lowered her to the ground so she didn't fall and hit her head. Mom stating that child never blacked out but was very dizzy. Did pick her up and put her in a chair in the waiting room and this is when I got upfront to check her. Child looked very pale and C/O dizziness. Otherwise ok. Pt denies falling and hitting her head. Acting well. Alert and oriented. Dr carried pt back to an exam room where we had her lay down for a little while. She was given cool cloths and water to drink. Patient felt better almost immediately but we had family wait 10 mins to make sure she was ok. Mom to F/U with any changes/concerns.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient received PREVNAR 13 and ZOSTAVAX on 7/13/2017. Patient reports that he experienced pain and numbness in arm on following day. Pain and numbness continues on 8/4/17, which is date patient reports adverse event to myself.
Age: 18.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given PROQUAD and since patient is over 12 years old patient should have had MMR and Varicella given as separate vaccines. Patient has not had any side effects. We found out that patient was given wrong vaccine when insurance would not pay for the PROQUAD. Patient has not had any side effects from the vaccine. Patient's mom was notified that this vaccine will count toward the completion of MMR and Varicella vaccine series.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Full blood count normal, Injection site erythema, Injection site warmth
Clinical narrative: 17 cm x 17 cm red and hot area of left thigh started 08/04/2017 in the morning per patient's mom.  Patient treated with Prednisolone Syrup 15 mg/5 ml - Give 2 tsp PO with food daily for 3 days.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event happened. PT was given MMR at 2 months of age, which is early. The CDC recommended at the time that MMR be given at the age of 1 years old.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Mobility decreased, Pruritus
Clinical narrative: The patients arm became itchy and hard to move the first night. The second through approximately 5th day, she developed a large red rash/hives down her left arm ending at the elbow.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Urticaria
Clinical narrative: The patients arm became itchy and hard to move the first night. The second through approximately 5th day, she developed a large red rash/hives down her left arm ending at the elbow.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Oedema peripheral, Pain
Clinical narrative: After the immunizations on Wednesday, the patient stated pain in the right arm where the MCV4 vaccine was administered. On 8/3, patient ate dinner but was feeling sore and tired. By 1 AM on 8/4, she woke up feeling badly. Her temperature was checked by her mom and was 103.7 F. Mom administered 3 tsp. of children's TYLENOL. She also developed swelling of the right axilla. By morning, patient was feeling better but still had a fever of 99.5 to 100 degrees and the swelling continued (mom states she when patient raises her arms, the visible swelling is around 2 to 2.5 inches in diameter). Today (8/4) patient has been home with her father. At around 12:30, her temperature came up to 102.5. Mom had her take an additional TYLENOL dose. Mom is trying to bring her in to seek medical care though there are no appointments available. She was advised by Dr. at the Clinic to go to the ER if mom felt it was necessary. At this time, she will wait with her daughter at home to see if the symptoms improve. The temperature is responding to the TYLENOL and she is drinking and eating well. Mom will keep an eye on her over the weekend and seek care if s/s do not improve or worsen.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: After the immunizations on Wednesday, the patient stated pain in the right arm where the MCV4 vaccine was administered. On 8/3, patient ate dinner but was feeling sore and tired. By 1 AM on 8/4, she woke up feeling badly. Her temperature was checked by her mom and was 103.7 F. Mom administered 3 tsp. of children's TYLENOL. She also developed swelling of the right axilla. By morning, patient was feeling better but still had a fever of 99.5 to 100 degrees and the swelling continued (mom states she when patient raises her arms, the visible swelling is around 2 to 2.5 inches in diameter). Today (8/4) patient has been home with her father. At around 12:30, her temperature came up to 102.5. Mom had her take an additional TYLENOL dose. Mom is trying to bring her in to seek medical care though there are no appointments available. She was advised by Dr. at the Clinic to go to the ER if mom felt it was necessary. At this time, she will wait with her daughter at home to see if the symptoms improve. The temperature is responding to the TYLENOL and she is drinking and eating well. Mom will keep an eye on her over the weekend and seek care if s/s do not improve or worsen.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Rash, Skin warm
Clinical narrative: This patient contacted us two days after receiving her ZOSTAVAX reporting a raised rash that increased from 3" to 3"x6" and was hot to touch. She also had chills. The next day the rash spread to her elbow and she reported a slight headache.
Age: 10.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP
Symptoms: Allodynia, Blood test, Bronchitis, Dizziness, Dyspnoea
Clinical narrative: I noticed after the last dose of HPV my daughter started to catch virus after virus. I kept getting the yearly FLUMIST to avoid the flu. In 2015 she came home with respiratory symptoms and a hive. The hives and respiratory stuff got worse. The doctor said she had bronchitis with hives. Few days later I had her in the ER she had trouble catching her breath. There they gave her a breathing treatment and steroids for hives. She never recovered. I repeatedly took her to the doctor and they tested her for mono and strep. Mono came back positive. But later found out it was false positive. Over a course of a month, she had headaches, dizziness, hives, sore throat, fatigue, pain and nausea. Then each joint would start to swell. Then she had severe allodynia in her knees along with all the symptoms I mentioned. Her symptoms keep getting worse. The pain affects her nerves as well, she can't stand in the shower because she has trouble regulating her body temp and she gets dizzy.
Age: 10.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP
Symptoms: Dysstasia, Echocardiogram, Electrocardiogram, False positive investigation result, Fatigue
Clinical narrative: I noticed after the last dose of HPV my daughter started to catch virus after virus. I kept getting the yearly FLUMIST to avoid the flu. In 2015 she came home with respiratory symptoms and a hive. The hives and respiratory stuff got worse. The doctor said she had bronchitis with hives. Few days later I had her in the ER she had trouble catching her breath. There they gave her a breathing treatment and steroids for hives. She never recovered. I repeatedly took her to the doctor and they tested her for mono and strep. Mono came back positive. But later found out it was false positive. Over a course of a month, she had headaches, dizziness, hives, sore throat, fatigue, pain and nausea. Then each joint would start to swell. Then she had severe allodynia in her knees along with all the symptoms I mentioned. Her symptoms keep getting worse. The pain affects her nerves as well, she can't stand in the shower because she has trouble regulating her body temp and she gets dizzy.
Age: 10.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP
Symptoms: Headache, Joint swelling, Loss of personal independence in daily activities, Mononucleosis heterophile test, Nausea
Clinical narrative: I noticed after the last dose of HPV my daughter started to catch virus after virus. I kept getting the yearly FLUMIST to avoid the flu. In 2015 she came home with respiratory symptoms and a hive. The hives and respiratory stuff got worse. The doctor said she had bronchitis with hives. Few days later I had her in the ER she had trouble catching her breath. There they gave her a breathing treatment and steroids for hives. She never recovered. I repeatedly took her to the doctor and they tested her for mono and strep. Mono came back positive. But later found out it was false positive. Over a course of a month, she had headaches, dizziness, hives, sore throat, fatigue, pain and nausea. Then each joint would start to swell. Then she had severe allodynia in her knees along with all the symptoms I mentioned. Her symptoms keep getting worse. The pain affects her nerves as well, she can't stand in the shower because she has trouble regulating her body temp and she gets dizzy.
Age: 10.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP
Symptoms: Neuralgia, Oropharyngeal pain, Pain, Respiratory symptom, Streptococcus test
Clinical narrative: I noticed after the last dose of HPV my daughter started to catch virus after virus. I kept getting the yearly FLUMIST to avoid the flu. In 2015 she came home with respiratory symptoms and a hive. The hives and respiratory stuff got worse. The doctor said she had bronchitis with hives. Few days later I had her in the ER she had trouble catching her breath. There they gave her a breathing treatment and steroids for hives. She never recovered. I repeatedly took her to the doctor and they tested her for mono and strep. Mono came back positive. But later found out it was false positive. Over a course of a month, she had headaches, dizziness, hives, sore throat, fatigue, pain and nausea. Then each joint would start to swell. Then she had severe allodynia in her knees along with all the symptoms I mentioned. Her symptoms keep getting worse. The pain affects her nerves as well, she can't stand in the shower because she has trouble regulating her body temp and she gets dizzy.
Age: 10.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP
Symptoms: Temperature regulation disorder, Urticaria, Viral infection, X-ray
Clinical narrative: I noticed after the last dose of HPV my daughter started to catch virus after virus. I kept getting the yearly FLUMIST to avoid the flu. In 2015 she came home with respiratory symptoms and a hive. The hives and respiratory stuff got worse. The doctor said she had bronchitis with hives. Few days later I had her in the ER she had trouble catching her breath. There they gave her a breathing treatment and steroids for hives. She never recovered. I repeatedly took her to the doctor and they tested her for mono and strep. Mono came back positive. But later found out it was false positive. Over a course of a month, she had headaches, dizziness, hives, sore throat, fatigue, pain and nausea. Then each joint would start to swell. Then she had severe allodynia in her knees along with all the symptoms I mentioned. Her symptoms keep getting worse. The pain affects her nerves as well, she can't stand in the shower because she has trouble regulating her body temp and she gets dizzy.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Asthenia, Electrocardiogram, Presyncope
Clinical narrative: Weakness, near syncope.
Age: 39.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Dizziness, Nausea
Clinical narrative: After administering the Fluzone and then the Engerix B the patient started complaining that she was feeling dizzy and nauseous. After observation for a few minutes the patients condition did not seem to be improving and 911 was called. After evaluation, the emergency responders made the determination to take the patient to the hospital. Attempts to reach the patient for a status update have been unsuccessful so far.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm swelled for about 7 days, was red and hot.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature, Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Pt began having body aches and temperature on 7/31/17 after receiving the vaccine on 7/28/17. Pt's arm started becoming red, swollen, and itchy on 8/3/17.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Arthralgia, Back pain, Chest X-ray, Malaise, Nasopharyngitis
Clinical narrative: He complained of back and knee pain. Then he didn't feel well. He could not get over this constant cold. Then he developed pneumonia. His knee and back pain became worse. The pain has not went away but it is tolerable he said.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Pneumonia
Clinical narrative: He complained of back and knee pain. Then he didn't feel well. He could not get over this constant cold. Then he developed pneumonia. His knee and back pain became worse. The pain has not went away but it is tolerable he said.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood test normal, Dyskinesia, Electroencephalogram, Generalised tonic-clonic seizure, Lumbar puncture normal
Clinical narrative: Parents noticed altered LOC x 1 day later in car ride. Child was watching a movie in the car 7/9/2017: ER---admitted. Summary: Patient is a 11 Y male presented to the emergency room with altered mental mental status earlier and then had a tonic-clonic seizure in the emergency room. There was some concern that he was having abnormal movements in the car on the way up here. He was moving his head wasn't following commands appropriately. Patient was sedated in the ER because of the seizures Procedures done: MRI was normal lumbar pressure was normal blood work was normal.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Mental status changes, Nuclear magnetic resonance imaging normal
Clinical narrative: Parents noticed altered LOC x 1 day later in car ride. Child was watching a movie in the car 7/9/2017: ER---admitted. Summary: Patient is a 11 Y male presented to the emergency room with altered mental mental status earlier and then had a tonic-clonic seizure in the emergency room. There was some concern that he was having abnormal movements in the car on the way up here. He was moving his head wasn't following commands appropriately. Patient was sedated in the ER because of the seizures Procedures done: MRI was normal lumbar pressure was normal blood work was normal.