chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Patient report a small red raised area at injection site the day of administration. The day following administration patient report a larger red area at site of injection (approximately 3 inches in diameter), temperature of 101 and general malaise. Adverse symptoms resolved by 2/19/18.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Vaccination complication
Clinical narrative: Anaphylactic reaction due to vaccination, subs encntr on 2018-02-16.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large, red swollen area at injection site.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site reaction, Muscular weakness, Myalgia
Clinical narrative: 8 out of 10 muscle soreness and weakness at sight of injection lasting 14 days.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site of 13 x 12 cm.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Muscle atrophy, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia
Clinical narrative: 61 yo male who developed shoulder & upper arm pain (left) after receipt of IIV at flu drive. He states he was sitting and the vaccinator was a nurse, and she was standing. He states the injection site was higher than usual and he felt an immediate 'shock' electrical like pain from his shoulder to his fingers. He states it resolved but 1-3 days later he developed a dull ache in the shoulder and down the upper arm to his elbow, but does not radiate further. There was point tenderness at the upper deltoid/ lower shoulder, posterior portion in the soft tissue. It has improved over time and is now intermittent. It does not affect sleep. He has normal ROM and strength. This is his nondominant arm and he has no history of injury.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Cardiac pacemaker evaluation, Chills, Electrocardiogram normal, Headache, Pyrexia
Clinical narrative: Headache and low grade fever 1 day after vaccine. Syncope 2/16/18. Seen at ER. Still with headache and chills 1 week after vaccine.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Headache and low grade fever 1 day after vaccine. Syncope 2/16/18. Seen at ER. Still with headache and chills 1 week after vaccine.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reported severe radiating pain throughout her entire arm after receiving PNEUMOVAX 23 (within 3 hours), was in such extreme pain that she could not move out of bed (lasted for approximately 12 hours).
Age: 85.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Feeling cold, Vomiting
Clinical narrative: Extreme cold all over, vomiting 9:00 pm.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Decreased appetite, Dizziness
Clinical narrative: I received the SHINGRIX vaccine on Friday 2-16-18. I woke up about 3-4 AM the next morning with a stomach ache, I started to feel nauseous. I was able to go back to sleep eventually. When I woke up the next morning I really felt awful. My muscles hurt. Actually everything hurt, I felt like I was going to be sick and when I tried to get up I was really weak. I also had the chills. Tried to eat some breakfast but didn't really want it. I was able to eat 1/2 a banana and a sip of juice but had to go back to bed because I felt like I could faint. Truthfully, I don't remember ever feeling just all over awful. I was able to sleep for a couple of hours. I checked to see if i had a fever but I didn't. I'm not one to stay in bed so I forced myself to get up. All day it was the same feeling and if I did one thing I was exhausted. I couldn't get rid of the chills either. That's scary. Sunday my arm was really red where I got the shot and it hurt and later on in the day it started to itch. I was still so very tired but started to feel a little more human. Still no appetite. Today is Monday the 19th and I'm much improved but still so very tired and don't quite feel myself.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: I received the SHINGRIX vaccine on Friday 2-16-18. I woke up about 3-4 AM the next morning with a stomach ache, I started to feel nauseous. I was able to go back to sleep eventually. When I woke up the next morning I really felt awful. My muscles hurt. Actually everything hurt, I felt like I was going to be sick and when I tried to get up I was really weak. I also had the chills. Tried to eat some breakfast but didn't really want it. I was able to eat 1/2 a banana and a sip of juice but had to go back to bed because I felt like I could faint. Truthfully, I don't remember ever feeling just all over awful. I was able to sleep for a couple of hours. I checked to see if i had a fever but I didn't. I'm not one to stay in bed so I forced myself to get up. All day it was the same feeling and if I did one thing I was exhausted. I couldn't get rid of the chills either. That's scary. Sunday my arm was really red where I got the shot and it hurt and later on in the day it started to itch. I was still so very tired but started to feel a little more human. Still no appetite. Today is Monday the 19th and I'm much improved but still so very tired and don't quite feel myself.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: I received the SHINGRIX vaccine on Friday 2-16-18. I woke up about 3-4 AM the next morning with a stomach ache, I started to feel nauseous. I was able to go back to sleep eventually. When I woke up the next morning I really felt awful. My muscles hurt. Actually everything hurt, I felt like I was going to be sick and when I tried to get up I was really weak. I also had the chills. Tried to eat some breakfast but didn't really want it. I was able to eat 1/2 a banana and a sip of juice but had to go back to bed because I felt like I could faint. Truthfully, I don't remember ever feeling just all over awful. I was able to sleep for a couple of hours. I checked to see if i had a fever but I didn't. I'm not one to stay in bed so I forced myself to get up. All day it was the same feeling and if I did one thing I was exhausted. I couldn't get rid of the chills either. That's scary. Sunday my arm was really red where I got the shot and it hurt and later on in the day it started to itch. I was still so very tired but started to feel a little more human. Still no appetite. Today is Monday the 19th and I'm much improved but still so very tired and don't quite feel myself.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Mobility decreased, Nausea, Tinnitus, Vision blurred
Clinical narrative: Patient stated that after receiving the vaccine that she started experiencing dizziness/lightheadedness, especially when turning her head from side to side, nausea, ringing in he rears, some blurred vision, and states that she couldn't get out of the bed for several days to come to the doctor, she also reported these symptoms to the pharmacy where she received the vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: Patient stated that after receiving the vaccine that she started experiencing dizziness/lightheadedness, especially when turning her head from side to side, nausea, ringing in he rears, some blurred vision, and states that she couldn't get out of the bed for several days to come to the doctor, she also reported these symptoms to the pharmacy where she received the vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Patient stated that after receiving the vaccine that she started experiencing dizziness/lightheadedness, especially when turning her head from side to side, nausea, ringing in he rears, some blurred vision, and states that she couldn't get out of the bed for several days to come to the doctor, she also reported these symptoms to the pharmacy where she received the vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Mobility decreased, Nausea, Tinnitus, Vision blurred
Clinical narrative: On same day start out with headache, next day felt bad all day. Weak and no appetite. Next morning 4:00AM woke up to very severe dizziness, sick stomach, and diarrhea, throw up just green and yellow bile very bitter about 3 times lasted about all day. But dizziness stayed. Starting to lighten up next day but still have it.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: On same day start out with headache, next day felt bad all day. Weak and no appetite. Next morning 4:00AM woke up to very severe dizziness, sick stomach, and diarrhea, throw up just green and yellow bile very bitter about 3 times lasted about all day. But dizziness stayed. Starting to lighten up next day but still have it.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: On same day start out with headache, next day felt bad all day. Weak and no appetite. Next morning 4:00AM woke up to very severe dizziness, sick stomach, and diarrhea, throw up just green and yellow bile very bitter about 3 times lasted about all day. But dizziness stayed. Starting to lighten up next day but still have it.
Age: 0.5
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Patient was to be given PCV 13. Nurse prepared immunizations to be given and asked this nurse to assist with administration of immunizations. This nurse choose PNEUMOVAX 23 from the immunizations prepared by other Nurse. This nurse questioned if this was the appropriate Pneumonia vaccine for this patient for which she said yes. Vaccination was then administered to patient.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: Mom noticed at 5:30 pm on 2/20/18 3 inches of redness around left deltoid and was given BENADRYL. When patient awoke on 2/21/18 there was 5 inches, redness, warm to touch and pain with motion.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Mental status changes, Posturing, Seizure, Tonic clonic movements
Clinical narrative: Seizure (possible initial syncopal / pre-syncopal episode but followed by tonic-clonic movement, posturing and altered mental status).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema of eyelid, Eyelid oedema, Eyelid pain, Headache
Clinical narrative: I had a headache since the injection. However, it wasn't until almost two weeks later, I experienced itching of the scalp and some pain. I had difficulty removing my left contact lens at night. When I awoke in the morning, my left temple and left eyelid was sore. I had a small bump at the top of my forehead near my scalp. The following day my left eyelid became puffy and there was a red patch near the upper part of the left eyelid. I thought that I may have been too aggressive in removing my left lens the previous day. On 2/14/18, my outer left eyelid was very swollen and I went to the Immediate Care. It was there that they diagnosed Shingles and prescribed Valacyclovir HCL- 1000mg 3x day for 7 days. I then saw my ophthalmologist on the same day for an exam. He concurred with the diagnosis and medication. A follow up appointment was scheduled for 3/14/18. I do not routinely get a Flu shot. The last time I had one must have been about 10-12 years ago. At that time, within 15 minutes of the injection, I developed flu-like symptoms (sinus drainage, scratchy throat, joint pain).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Influenza like illness, Pain of skin, Paranasal sinus hypersecretion, Pruritus
Clinical narrative: I had a headache since the injection. However, it wasn't until almost two weeks later, I experienced itching of the scalp and some pain. I had difficulty removing my left contact lens at night. When I awoke in the morning, my left temple and left eyelid was sore. I had a small bump at the top of my forehead near my scalp. The following day my left eyelid became puffy and there was a red patch near the upper part of the left eyelid. I thought that I may have been too aggressive in removing my left lens the previous day. On 2/14/18, my outer left eyelid was very swollen and I went to the Immediate Care. It was there that they diagnosed Shingles and prescribed Valacyclovir HCL- 1000mg 3x day for 7 days. I then saw my ophthalmologist on the same day for an exam. He concurred with the diagnosis and medication. A follow up appointment was scheduled for 3/14/18. I do not routinely get a Flu shot. The last time I had one must have been about 10-12 years ago. At that time, within 15 minutes of the injection, I developed flu-like symptoms (sinus drainage, scratchy throat, joint pain).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Throat irritation
Clinical narrative: I had a headache since the injection. However, it wasn't until almost two weeks later, I experienced itching of the scalp and some pain. I had difficulty removing my left contact lens at night. When I awoke in the morning, my left temple and left eyelid was sore. I had a small bump at the top of my forehead near my scalp. The following day my left eyelid became puffy and there was a red patch near the upper part of the left eyelid. I thought that I may have been too aggressive in removing my left lens the previous day. On 2/14/18, my outer left eyelid was very swollen and I went to the Immediate Care. It was there that they diagnosed Shingles and prescribed Valacyclovir HCL- 1000mg 3x day for 7 days. I then saw my ophthalmologist on the same day for an exam. He concurred with the diagnosis and medication. A follow up appointment was scheduled for 3/14/18. I do not routinely get a Flu shot. The last time I had one must have been about 10-12 years ago. At that time, within 15 minutes of the injection, I developed flu-like symptoms (sinus drainage, scratchy throat, joint pain).
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Atypical haemolytic uraemic syndrome, Cytogenetic analysis normal, Plasmapheresis, Status epilepticus, Thrombotic microangiopathy
Clinical narrative: Thrombotic microangiopathy presenting as status epilepticus. Presumed atypical HUS with neg genetic tests. Treated plasma exchange, oral steroids and complement suppression.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown demographics. The patients' current condition, historical condition, historical drug, drug allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (strength, dose, unit, route and frequency not reported) (Lot#: N021171, Expiration Date: 11/01/2018) and PROQUAD (strength, dose, unit, route and frequency not reported) (Lot#: N024563, Expiration Date: 06-MAR-2019), (Lot#: N025718, Expiration Date: 17-MAR-2019) (Lot#: N023965, Expiration Date: 28-FEB-2019) and VARIVAX (strength, dose, unit, route and frequency not reported) (Lot#: N020015, Expiration Date: 17-JUL-2019), (Lot#: N020014, Expiration Date: 17-JUL-2019), (Lot#: N024566, Expiration Date: 07-SEP-2019) as prophylaxis which. No adverse effects reported. STERILE DILUENT used for reconstitution of all products was properly stored. Temperature & Timeframe was reported as 6 Fahrenheit to 14 Fahrenheit for 4 hours and 15 minutes and 15 Fahrenheit to 46 Fahrenheit for 1 hour 45 minutes. It was reported there was a previous temperature excursion. No product quality compliant (PQC) was reported.
Sex: M
Vaccine: FLU3
Symptoms: Foetal exposure during pregnancy, Shoulder dystocia
Clinical narrative: Information has been received from a physician on 14-FEB-2018, for GARDASIL 9 a Pregnancy Registry product, concerning pregnancy retrospective report. This report refers to a male Neonate. The patient's concurrent conditions and concomitant medications were not reported. The Last Menstrual Period date of the patient's mother (LMP) was reported as 27-MAR-2017. Estimated date of conception was 10-APR-2017. Estimated date of delivery( EDD) was reported as of 01-JAN-2018. The patient's mother medical history included 6 previous pregnancies and 6 full term deliveries of children with no infant complications or birth defects. The patient's mother did not have pre-term deliveries, spontaneous abortions, elective terminations or stillbirths. On 17-JUL-2017, the patient's mother had a negative result of Hepatitis C Viral RNA test (HCV RNA) and reactive Hepatitis C AB. The patient's mother diagnostic test on 17-OCT-2017, showed proteinuria. On 03-OCT-2017, the patient's mother was vaccinated with first dose of GARDASIL 9 in the left deltoid, lot number N017542 with expiration date in 21-NOV-2019 (strength and route of administration were not provided) for prophylaxis             (exposure during pregnancy). The other mother's therapies administered during pregnancy included nitrofurantoin (MACROBID) 100 mg twice a day (every 12 hours) administered for Urinary tract infection (UTI) from 15-AUG-2017 till 21-AUG-2017, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) administered on 09-NOV-2017 and influenza virus split virion 3v vaccine inactivated (AFLURIA) (reported also as flu shot) administered on 15-NOV-2017. There was no complications during pregnancy. On 28-DEC-2017 at 39 weeks gestation, the patient was delivered weighing 3628 grams (8 lbs) (live birth full term). The patient was exposed during the second and third trimesters. During delivery the patient experienced complications as shoulder distocia. It was also reported that infant was normal. The patient's APGAR scores, head circumference and length were not reported. The patient did not have congenital anomalies. The outcome of shoulder distocia was unknown. Causality was not provided by the reporter. Upon internal, review the event of shoulder distocia was considered to be medically significant. This case is linked with mother case# 1710USA001774.; Sender's Comments: US-009507513-1710USA001774:
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Eye pruritus, Pruritus
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 58 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. It was reported that the patient had no drug reactions or allergies. On 13-FEB-2018 the patient was vaccinated with VAQTA (lot # N031940, expiry date 23-NOV-2018) (dosing regimen and frequency unknown) for prophylaxis. On 13-FEB-2018 (later that day), the patient was "was itchy on torso, eyes and ears". The nurse also reported that the patient does not have a rash and "you can't see anything on the body" (not further clarification provided). It was reported that the patient was taking BENADRYL as treatment for the itchiness. The outcome of the events was reported as recovering. The relatedness of the events to the therapy with VAQTA was unknown. There was no product quality complaint reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-JUN-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but instead the patient contracted a persistent strain of shingles. Subsequently, the patient was treated by a physician for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe shingles (onset not provided). As a direct and proximate result of ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Influenza like illness, Oropharyngeal pain, Pruritus, Respiratory tract congestion
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included asthma ongoing. The patient's concomitant medications includes Budesonide/Formoterol inhaler were not reported.  The patient experienced flu-like symptoms with runny nose, chills, congestion, sore throat, "scratchy" ears on an unspecified date, four days after vaccination with outcome of unknown.
Sex: F
Vaccine: PNC13
Symptoms: Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included asthma ongoing. The patient's concomitant medications includes Budesonide/Formoterol inhaler were not reported.  The patient experienced flu-like symptoms with runny nose, chills, congestion, sore throat, "scratchy" ears on an unspecified date, four days after vaccination with outcome of unknown.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a contactable nurse for a patient enrolled in a Pfizer-sponsored program; this report regards an event part of the medical history of the patient. A currently 24-year-old female patient received a single dose of PREVNAR 13 on an unspecified date for immunisation and INVEGA SUSTENNA, BACTRIM, CIPRODEX, MIRALAX and sulfa, all via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication. The patient's concomitant medications were not reported. The patient experienced drug allergy to PREVNAR 13, INVEGA SUSTENNA, BACTRIM, CIPRODEX, MIRALAX  and sulfa on an unspecified date with outcome of unknown. The action taken in response to the event for INVEGA SUSTENNA, BACTRIM, CIPRODEX, MIRALAX and sulfa was unknown.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Left Deltoid area where injection site developed welt 2.5x2.5cm red area raised area 0.3 cm,  Hydrocortisone 2.5 to be applied topically 2-4 times a day.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Body aches, redness and pain at injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Pain
Clinical narrative: Body aches, chills, redness and pain at injection site.
Age: 49.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Autoimmune thyroiditis, Injection site erythema, Injection site papule, Injection site reaction, Mouth ulceration
Clinical narrative: Year-old female with a history of pemphigus ulcers of oral mucous membranes and Hashimoto's who presents today for evaluation of a dermatologic adverse reaction after receipt of MMR and TWINRIX. She states the vaccines were given simultaneously to her left arm in 5-7 days later she developed a dermatologic lesion in the upper arm near the injection sites but not on either site. It started as a pin-sized papule and continued to enlarge until it developed a raised papular erythematous lesion with scale and erosions. It was nonpainful and nonpruritic. One month after vaccine receipt she returned for her MMR and TWINRIX No. 2 but declined due to continued presence of the lesion, now present approximately 3 weeks. She was treated with 7 days of oral steroid and topical clobetasol. The lesion resolved within a week of steroid therapy.
Age: 49.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Pemphigus, Skin lesion
Clinical narrative: Year-old female with a history of pemphigus ulcers of oral mucous membranes and Hashimoto's who presents today for evaluation of a dermatologic adverse reaction after receipt of MMR and TWINRIX. She states the vaccines were given simultaneously to her left arm in 5-7 days later she developed a dermatologic lesion in the upper arm near the injection sites but not on either site. It started as a pin-sized papule and continued to enlarge until it developed a raised papular erythematous lesion with scale and erosions. It was nonpainful and nonpruritic. One month after vaccine receipt she returned for her MMR and TWINRIX No. 2 but declined due to continued presence of the lesion, now present approximately 3 weeks. She was treated with 7 days of oral steroid and topical clobetasol. The lesion resolved within a week of steroid therapy.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anaphylactic reaction, Oxygen saturation decreased, Stridor, Swelling face, Swollen tongue
Clinical narrative: Pt with anaphylaxis, swollen face, tongue, tachycardia, low 02 saturation, stridor and wheezing. Rx started 8-10 min after administration and treated with EPIPEN x2 oxygen and 911 called with transport to hospital.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Tachycardia, Wheezing
Clinical narrative: Pt with anaphylaxis, swollen face, tongue, tachycardia, low 02 saturation, stridor and wheezing. Rx started 8-10 min after administration and treated with EPIPEN x2 oxygen and 911 called with transport to hospital.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dyspnoea, Eye irritation, Pruritus, Stridor, Throat tightness
Clinical narrative: Pt with anaphylaxis, swollen face, tongue, tachycardia, low 02 saturation, stridor and wheezing. Rx started 8-10 min after administration and treated with EPIPEN x2 oxygen and 911 called with transport to hospital.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Wheezing
Clinical narrative: Pt with anaphylaxis, swollen face, tongue, tachycardia, low 02 saturation, stridor and wheezing. Rx started 8-10 min after administration and treated with EPIPEN x2 oxygen and 911 called with transport to hospital.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anaphylactic reaction, Oxygen saturation decreased, Stridor, Swelling face, Swollen tongue
Clinical narrative: Itching, eyes burning, throat tightness, wheezing, SOB, stridor started within 15min. EPIPEN given, oxygen, then 911 called. Additional EPIPEN given before transport. Albuterol nebulizer started by EMS and transported to local ER.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Tachycardia, Wheezing
Clinical narrative: Itching, eyes burning, throat tightness, wheezing, SOB, stridor started within 15min. EPIPEN given, oxygen, then 911 called. Additional EPIPEN given before transport. Albuterol nebulizer started by EMS and transported to local ER.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dyspnoea, Eye irritation, Pruritus, Stridor, Throat tightness
Clinical narrative: Itching, eyes burning, throat tightness, wheezing, SOB, stridor started within 15min. EPIPEN given, oxygen, then 911 called. Additional EPIPEN given before transport. Albuterol nebulizer started by EMS and transported to local ER.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Wheezing
Clinical narrative: Itching, eyes burning, throat tightness, wheezing, SOB, stridor started within 15min. EPIPEN given, oxygen, then 911 called. Additional EPIPEN given before transport. Albuterol nebulizer started by EMS and transported to local ER.
Age: 0.33
Sex: F
Vaccine: MNQ, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: MENACTRA was administerd instead of PENTACEL (DTAP, IPV, HIB). No reported adverse events or symptoms.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Myelitis transverse, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Lower body paresthesia and numbness in saddle area, extending to bilateral legs, thigh and trunk. Followed up. Transverse myelitis after MRI with T4 dorsal lesion. Doctor documented possible post vaccine.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized redness and swelling at insertion site; smaller raised areas at insertion site.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Grip strength decreased, Injection site swelling, Paraesthesia, Swelling
Clinical narrative: The same day I had swelling in my right shoulder I went into the clinic and they said it was normal..today I have tingling in my fingers there is a noticeable lump on my right shoulder and I am having severe pain. I went into the office again today and he said it's all in my head. The right side of my upper body is swollen (shoulder & collar bone) my fingers are tingling I am unable to hold a piece of bread in my right hand. SOMETHING IS VERY VERY WRONG WITH ME AND IT IS NOT AN IMAGINATION.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Redness, pain and swelling developed on 1/25/2018 she came to urgent care for evaluation on 1/26 Dx cellulitis. 3X3 red, swollen and painful area noted. Treated with KEFLEX 500mg 3times daily for 7 days.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Dyspnoea, Dysstasia
Clinical narrative: Mid back pain difficult to take a deep breath or stand up straight. Pain started about 5 PM day of shot. Lt. side greater than Rt. side.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. On or about 05-APR-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but instead contracted a persistent strain of shingles. On or about 11-MAY-2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as shingles. She was prescribed VALTREX for management of her painful symptoms. On or about 23-MAY-2016, the patient sought subsequent treatment from a physician for shingles. She was prescribed AVEENO ANTI-ITCH for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. On or about 16-JUN-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but instead the patient contracted a persistent strain of shingles. On or about 15-JUN-2015, the patient was treated for the onset of a severe vesicular-patterned rash and was prescribed VALTREX for management of her painful symptoms. On or about 09-JUL-2015, the patient was treated for follow-up of her painful rash and the onset of post-herpetic neuralgia and was prescribed gabapentin and oxycodone for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Gait inability, Headache, Muscle disorder, Muscle spasms
Clinical narrative: After the shot 2 weeks ago I start feeling headaches, muscle problems in my back, neck and foot and leg left side. Also a circulation problem my veins left leg are affected my left foot sore I can not walk cramps difficulty to breath.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral vascular disorder
Clinical narrative: After the shot 2 weeks ago I start feeling headaches, muscle problems in my back, neck and foot and leg left side. Also a circulation problem my veins left leg are affected my left foot sore I can not walk cramps difficulty to breath.
Age: 60.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: VARIVAX was accidently diluted with Gardasil instead of sterile diluent. No adverse reaction is expected.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Gastrointestinal disorder, Muscle spasms, Nausea, Rash
Clinical narrative: Skin rash, intestinal issues, constant cramping and nausea. All started within a month and continues to this date 2-21-2018.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Chills, Fatigue, Irritability, Pyrexia
Clinical narrative: High fever up to 103.1 recorded, vomiting 2-3 times a day for a little more than 24 hours, irritable and tired. She had abdominal pain and at one point was shivering. She was given children's acetaminophen, children's ibuprofen, tepid baths, fluids and rest.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: High fever up to 103.1 recorded, vomiting 2-3 times a day for a little more than 24 hours, irritable and tired. She had abdominal pain and at one point was shivering. She was given children's acetaminophen, children's ibuprofen, tepid baths, fluids and rest.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Swelling and inflammation at injection, tender to the touch. Joint pain, fatigue. Started a few hours after injection.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Injection site swelling, Paraesthesia
Clinical narrative: Swelling and inflammation at injection, tender to the touch. Joint pain, fatigue. Started a few hours after injection.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Erythema, Induration, Pain
Clinical narrative: Redness and induration and pain; x 2 weeks; treated w/ BENADRYL and ibuprofen.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within 24 hours of vaccination, the site became red, swollen, and warm to touch measuring 8 cm in size. Site was also painful.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: The patient said that after she was given the shot she couldn't move her arm and it got stiff. She said the next day that she had to get her daughter to move her arm. She lifts freight at work and she says her hand and arm get stiff and there are shooting pains that go down her left arm. The patient is going to make an appointment with her doctor so he can check out her arm.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Dysphonia, Pharyngeal oedema
Clinical narrative: Symptoms included facial burning and throat swelling. Exam of mouth, throat, neck revealed swollen throat and hoarseness. No shortness of breath, no wheezing, no cough. Lungs clear to auscultation. She was given IV BENADRYL and Methylprednisolone - one dose of each. Symptoms improved and she was discharged with tapering dose of Prednisone.
Age: 33.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Palindromic rheumatism, Polyarthritis, Rheumatoid factor positive, X-ray
Clinical narrative: Palindromic rheumatism might be related to the anthrax immunizations. Migrating arthritis with positive RA factor.
Age: 56.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event or reaction. Wrong dose of vaccine given. Pt will be informed of dosage error and will get additional dose.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Ejection fraction normal, Myocarditis, Troponin increased
Clinical narrative: Myocarditis.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 22 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, at the age of 1 year and 5 years, the patient was vaccinated with first and second dose of (Wistar RA 27-3) M-M-R II (dose, lot number, expiration date not reported) in sterile diluent (manufacturer unknown) via subcutaneous route for prophylaxis. On an unknown date in May 2017 and July 2017, the patient was vaccinated with third and fourth dose of (Wistar RA 27-3) M-M-R II (dose, lot number, expiration date not reported) in sterile diluent (manufacturer unknown) via subcutaneous route for prophylaxis. The patient was vaccinated at unspecified facilities. On an unspecified date, after receiving four doses of (Wistar RA 27-3) M-M-R II, the patient received a negative titer for measles. No adverse effect was reported. The outcome of measles antibody negative was unknown. The reporter did not provide the causality of measles antibody negative with both suspect therapies. No product quality complaint (PQC) was present.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 15-FEB-2018, the patient was vaccinated with an expired dose of M-M-R II recombinant Human albumin (rHA), lot # L024265 with expiration date 01-JUL-2017, for prophylaxis (route of administration was not reported). Concomitant therapies included sterile diluent (MRK). No adverse effects were reported.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Anti-thyroid antibody, Basedow's disease, Biopsy thyroid gland, Blood thyroid stimulating hormone decreased, Condition aggravated
Clinical narrative: 06/06/2017 Received routine vaccine. 06/09/2017 Severe allergies symptoms began, including sneezing, runny nose, itchy eyes/skin, eczema flare ups, and wheezing. These symptoms are not completely, uncommon, however came out of nowhere even though allergies had been previously controlled. The allergies symptoms continued through the month. I believe the symptoms were due to the vaccine I received on 6/6/17. A sinus infection began towards the end of June. 07/3/2017 Dr  diagnosed Sinus Infection which was treated with 875 mg Amoxicillin. 7/13/17 Began to notice heart palpitations, racing heart, shaking hands. These symptoms have never been experienced before. 7/27/17 to 8/1/17 started noticing eyes were more puffy than normal. 8/2/17 Dr. Appointment for swollen eyes. 8/3/17 Lab results showed: Free T4 above high normal, TSH Sensitive Below normal  8/4/17 Was sent to hospital to have a thyroid ultrasound. 8/10/17 Referred to Endocronologist, Dr.  8/16/17 Thyroid Uptake and Scan- Confirmed Diagnosed of Grave Disease. 9/8/17 Dr Endocronologist, follow up for Graves Disease treatment, needle biopsy of Thyroid. 9/22/17 Dr. for treatment of Graves Eye Disease. 11/3/17 Dr, Endocronologist follow up for Graves Disease Treatment. 1/12/18 Dr.  Endocronologist, Follow up for Graves Disease Treatment. Diagnosis:  Graves Disease and Graves Eye Disease.  Long term medical care required.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Differential white blood cell count, Eczema, Eye disorder, Eye pruritus, Eyelid oedema
Clinical narrative: 06/06/2017 Received routine vaccine. 06/09/2017 Severe allergies symptoms began, including sneezing, runny nose, itchy eyes/skin, eczema flare ups, and wheezing. These symptoms are not completely, uncommon, however came out of nowhere even though allergies had been previously controlled. The allergies symptoms continued through the month. I believe the symptoms were due to the vaccine I received on 6/6/17. A sinus infection began towards the end of June. 07/3/2017 Dr  diagnosed Sinus Infection which was treated with 875 mg Amoxicillin. 7/13/17 Began to notice heart palpitations, racing heart, shaking hands. These symptoms have never been experienced before. 7/27/17 to 8/1/17 started noticing eyes were more puffy than normal. 8/2/17 Dr. Appointment for swollen eyes. 8/3/17 Lab results showed: Free T4 above high normal, TSH Sensitive Below normal  8/4/17 Was sent to hospital to have a thyroid ultrasound. 8/10/17 Referred to Endocronologist, Dr.  8/16/17 Thyroid Uptake and Scan- Confirmed Diagnosed of Grave Disease. 9/8/17 Dr Endocronologist, follow up for Graves Disease treatment, needle biopsy of Thyroid. 9/22/17 Dr. for treatment of Graves Eye Disease. 11/3/17 Dr, Endocronologist follow up for Graves Disease Treatment. 1/12/18 Dr.  Endocronologist, Follow up for Graves Disease Treatment. Diagnosis:  Graves Disease and Graves Eye Disease.  Long term medical care required.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Full blood count, Hypersensitivity, Iodine uptake abnormal, Metabolic function test, Palpitations
Clinical narrative: 06/06/2017 Received routine vaccine. 06/09/2017 Severe allergies symptoms began, including sneezing, runny nose, itchy eyes/skin, eczema flare ups, and wheezing. These symptoms are not completely, uncommon, however came out of nowhere even though allergies had been previously controlled. The allergies symptoms continued through the month. I believe the symptoms were due to the vaccine I received on 6/6/17. A sinus infection began towards the end of June. 07/3/2017 Dr  diagnosed Sinus Infection which was treated with 875 mg Amoxicillin. 7/13/17 Began to notice heart palpitations, racing heart, shaking hands. These symptoms have never been experienced before. 7/27/17 to 8/1/17 started noticing eyes were more puffy than normal. 8/2/17 Dr. Appointment for swollen eyes. 8/3/17 Lab results showed: Free T4 above high normal, TSH Sensitive Below normal  8/4/17 Was sent to hospital to have a thyroid ultrasound. 8/10/17 Referred to Endocronologist, Dr.  8/16/17 Thyroid Uptake and Scan- Confirmed Diagnosed of Grave Disease. 9/8/17 Dr Endocronologist, follow up for Graves Disease treatment, needle biopsy of Thyroid. 9/22/17 Dr. for treatment of Graves Eye Disease. 11/3/17 Dr, Endocronologist follow up for Graves Disease Treatment. 1/12/18 Dr.  Endocronologist, Follow up for Graves Disease Treatment. Diagnosis:  Graves Disease and Graves Eye Disease.  Long term medical care required.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Pruritus, Rhinorrhoea, Sinusitis, Sneezing, Thyroid gland scan abnormal
Clinical narrative: 06/06/2017 Received routine vaccine. 06/09/2017 Severe allergies symptoms began, including sneezing, runny nose, itchy eyes/skin, eczema flare ups, and wheezing. These symptoms are not completely, uncommon, however came out of nowhere even though allergies had been previously controlled. The allergies symptoms continued through the month. I believe the symptoms were due to the vaccine I received on 6/6/17. A sinus infection began towards the end of June. 07/3/2017 Dr  diagnosed Sinus Infection which was treated with 875 mg Amoxicillin. 7/13/17 Began to notice heart palpitations, racing heart, shaking hands. These symptoms have never been experienced before. 7/27/17 to 8/1/17 started noticing eyes were more puffy than normal. 8/2/17 Dr. Appointment for swollen eyes. 8/3/17 Lab results showed: Free T4 above high normal, TSH Sensitive Below normal  8/4/17 Was sent to hospital to have a thyroid ultrasound. 8/10/17 Referred to Endocronologist, Dr.  8/16/17 Thyroid Uptake and Scan- Confirmed Diagnosed of Grave Disease. 9/8/17 Dr Endocronologist, follow up for Graves Disease treatment, needle biopsy of Thyroid. 9/22/17 Dr. for treatment of Graves Eye Disease. 11/3/17 Dr, Endocronologist follow up for Graves Disease Treatment. 1/12/18 Dr.  Endocronologist, Follow up for Graves Disease Treatment. Diagnosis:  Graves Disease and Graves Eye Disease.  Long term medical care required.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Thyroid stimulating immunoglobulin, Thyroxine free increased, Tremor, Tri-iodothyronine free, Ultrasound thyroid abnormal
Clinical narrative: 06/06/2017 Received routine vaccine. 06/09/2017 Severe allergies symptoms began, including sneezing, runny nose, itchy eyes/skin, eczema flare ups, and wheezing. These symptoms are not completely, uncommon, however came out of nowhere even though allergies had been previously controlled. The allergies symptoms continued through the month. I believe the symptoms were due to the vaccine I received on 6/6/17. A sinus infection began towards the end of June. 07/3/2017 Dr  diagnosed Sinus Infection which was treated with 875 mg Amoxicillin. 7/13/17 Began to notice heart palpitations, racing heart, shaking hands. These symptoms have never been experienced before. 7/27/17 to 8/1/17 started noticing eyes were more puffy than normal. 8/2/17 Dr. Appointment for swollen eyes. 8/3/17 Lab results showed: Free T4 above high normal, TSH Sensitive Below normal  8/4/17 Was sent to hospital to have a thyroid ultrasound. 8/10/17 Referred to Endocronologist, Dr.  8/16/17 Thyroid Uptake and Scan- Confirmed Diagnosed of Grave Disease. 9/8/17 Dr Endocronologist, follow up for Graves Disease treatment, needle biopsy of Thyroid. 9/22/17 Dr. for treatment of Graves Eye Disease. 11/3/17 Dr, Endocronologist follow up for Graves Disease Treatment. 1/12/18 Dr.  Endocronologist, Follow up for Graves Disease Treatment. Diagnosis:  Graves Disease and Graves Eye Disease.  Long term medical care required.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Wheezing
Clinical narrative: 06/06/2017 Received routine vaccine. 06/09/2017 Severe allergies symptoms began, including sneezing, runny nose, itchy eyes/skin, eczema flare ups, and wheezing. These symptoms are not completely, uncommon, however came out of nowhere even though allergies had been previously controlled. The allergies symptoms continued through the month. I believe the symptoms were due to the vaccine I received on 6/6/17. A sinus infection began towards the end of June. 07/3/2017 Dr  diagnosed Sinus Infection which was treated with 875 mg Amoxicillin. 7/13/17 Began to notice heart palpitations, racing heart, shaking hands. These symptoms have never been experienced before. 7/27/17 to 8/1/17 started noticing eyes were more puffy than normal. 8/2/17 Dr. Appointment for swollen eyes. 8/3/17 Lab results showed: Free T4 above high normal, TSH Sensitive Below normal  8/4/17 Was sent to hospital to have a thyroid ultrasound. 8/10/17 Referred to Endocronologist, Dr.  8/16/17 Thyroid Uptake and Scan- Confirmed Diagnosed of Grave Disease. 9/8/17 Dr Endocronologist, follow up for Graves Disease treatment, needle biopsy of Thyroid. 9/22/17 Dr. for treatment of Graves Eye Disease. 11/3/17 Dr, Endocronologist follow up for Graves Disease Treatment. 1/12/18 Dr.  Endocronologist, Follow up for Graves Disease Treatment. Diagnosis:  Graves Disease and Graves Eye Disease.  Long term medical care required.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Blood calcium decreased, CSF protein increased, Guillain-Barre syndrome, Plasmapheresis
Clinical narrative: I was diagnosed with GBS (Guillain-Barre) on Feb. 7, 2018. Treatment of Plasma Freeze aka Exchange began Feb. 8, 2018. Inpatient Treatment complete FEB. 18, 2018. Follow up Physical Therapy cycle begins Feb. 23, 2018 to remedy to greatest degree possible symptoms of pins, needles, numbness, balance problems, coordination problems, loss of small motor skills, strength loss, overall fatigue.