chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Headache, Hyperaesthesia, Injection site warmth
Clinical narrative: I expected some swelling, however (and I work out so my arm muscles are well defined).  First, the upper arm muscle was hardened and tender. By 10:15 PM, the area was surrounded by redness (and "outlined" too). By the next day (02/06/2017), the redness had spread down over the bicep muscle and it also was very sensitive. By 6:12 PM (02/06/2017) the redness and tenderness had spread around the arm slightly to the triceps, as well as down to the inner elbow. Am I going to do my workout?  Heck, no.  Also, the night of 2/05, I was slightly dizzy and had a headache. These effects are more than I expected. Along with the spread of the redness, the right arm (site of injection) is much warmer to the touch than the untouched arm.  Never had a reaction like this before.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Myosclerosis
Clinical narrative: I expected some swelling, however (and I work out so my arm muscles are well defined).  First, the upper arm muscle was hardened and tender. By 10:15 PM, the area was surrounded by redness (and "outlined" too). By the next day (02/06/2017), the redness had spread down over the bicep muscle and it also was very sensitive. By 6:12 PM (02/06/2017) the redness and tenderness had spread around the arm slightly to the triceps, as well as down to the inner elbow. Am I going to do my workout?  Heck, no.  Also, the night of 2/05, I was slightly dizzy and had a headache. These effects are more than I expected. Along with the spread of the redness, the right arm (site of injection) is much warmer to the touch than the untouched arm.  Never had a reaction like this before.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Rash and hives develop on stomach and arms.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient came in to pharmacy and showed me her arm, it was red from injection site to bend in elbow and warm to the touch, she wanted to know if it was a normal reaction, I told her no and to go see her doctor.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Tendonitis, X-ray
Clinical narrative: Shoulder pain, loss of mobility directly after shot, has turned into months of pain, deltoid tendonitis.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Anxiety, Depersonalisation/derealisation disorder, Dizziness, Feeling abnormal, Insomnia
Clinical narrative: Depersonalization, visual snow, anxiety, brain fog, dizziness, objects she looks at jump and move around (including words when she's reading), occasional weakness in legs to the point where they give out, damage to short term memory, learning difficulties (and she's a straight A student), insomnia, and tingling in hands, feet, and legs. Oh, and extreme thirst.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Learning disorder, Loss of control of legs, Memory impairment, Muscular weakness, Paraesthesia
Clinical narrative: Depersonalization, visual snow, anxiety, brain fog, dizziness, objects she looks at jump and move around (including words when she's reading), occasional weakness in legs to the point where they give out, damage to short term memory, learning difficulties (and she's a straight A student), insomnia, and tingling in hands, feet, and legs. Oh, and extreme thirst.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Thirst, Visual impairment
Clinical narrative: Depersonalization, visual snow, anxiety, brain fog, dizziness, objects she looks at jump and move around (including words when she's reading), occasional weakness in legs to the point where they give out, damage to short term memory, learning difficulties (and she's a straight A student), insomnia, and tingling in hands, feet, and legs. Oh, and extreme thirst.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Rash
Clinical narrative: Rash, non pruritic on body.  No other symptoms.  Tx with Benadryl x 2 and rash resolved.  Rash did not have the appearance of urticaria.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Cyanosis, Dyspnoea
Clinical narrative: Breathing problems: Woke up with a barking cough, couldn't get full breaths, lips with blue tinge all through the night until morning. Held her in a steamy shower to open her lungs and then in our bed with a humidifier. Was better by the following afternoon.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fall, Loss of consciousness, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 78-year-old female patient who received Influenza vaccine Quadrivalent. In December 2016, the patient received Influenza vaccine Quadrivalent. In January 2017, 30 days after receiving Influenza vaccine Quadrivalent, the patient experienced loss of consciousness (serious criteria hospitalization and GSK medically significant), fall (serious criteria hospitalization) and sickness (serious criteria hospitalization). On an unknown date, the patient experienced cough. On an unknown date, the outcome of the loss of consciousness, fall and sickness were recovering/resolving and the outcome of the cough was not recovered/not resolved. It was unknown if the reporter considered the loss of consciousness, fall and sickness to be related to Influenza vaccine Quadrivalent. The reporter considered the cough to be probably related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was reported by the patient's son. The specific brand name of the flu vaccine received by the patient was unknown. The patient experienced a barking cough following administration of vaccine. Also, the reporter initially stated that patient was currently sick. He further specified sick as meaning that patient slipped on ice and fell a week before reporting date. She was knocked out. Due to the event, she was hospitalized. The batch number of the flu vaccine was unknown. This case had been linked with case US2017014925, reported by the same reporter.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: 13 month old patient was given second dose of MMR 25 days from 1st dose. As well as second dose of varicella 25 days from 1st dose. Hep A #1 was administered as well. Pt. did not have any symptoms 15 mins after administration of vaccines. Mom was advised that extra dose was given. No further treatment needed.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Site of vaccine-whooping cough-was left arm. Achiness was noticed, but as time went on, it extended to bicep, elbow, and lower arm. Since vaccine, normal activity like lifting grandson is painful. Ache continues. Flu shot on Rt arm.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Arthralgia, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Site of vaccine-whooping cough-was left arm. Achiness was noticed, but as time went on, it extended to bicep, elbow, and lower arm. Since vaccine, normal activity like lifting grandson is painful. Ache continues. Flu shot on Rt arm.
Age: 60.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Arthralgia, Pain in extremity, Tendon pain
Clinical narrative: Tendon and bicep area aching and pain. Inner elbow, as well-pain. Slow to heal from normal activity since vaccination, on side of vaccination which is my right arm-right arm received both shots.
Age: 60.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Arthralgia, Injection site pain, Injection site reaction, Myalgia, Pain in extremity
Clinical narrative: Tendon and bicep area aching and pain. Inner elbow, as well-pain. Slow to heal from normal activity since vaccination, on side of vaccination which is my right arm-right arm received both shots.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: Lump on the upper part of arm where shot was done.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Acne, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Pain, deltoid with erythema and mild induration. One area of pimple. (Left deltoid) Pt was seen next day at health center and told to treat symptomatically.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever to 101.9. No other Sx reported.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Irritability, Local reaction, Rash erythematous
Clinical narrative: Local reaction of 3" x 3" erythema at site of PREVNAR injection ((R) thigh) and 1" x 2" on (R) ankle. Also very fussy and had diffuse erythematous spots on trunk, face and legs. Erythema around PENTACEL inj site of 1" x 15". 3/4 tsp BENADRYL administered and cool compress applied to (R) thigh. Erythema started to resolve after approx. 15 min and almost completely resolved by 45 min.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: Seizure at approximately 03:30 am. TX includes being taken to hospital for evaluation.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product preparation error
Clinical narrative: I administered the Zoster vaccine to the patient in the presence of an LPN. Vaccine administered subcutaneously. The vaccine was reconstituted with 0.5 ml versus the entire content of the diluent provided.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Feeling abnormal, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: I administered the Zoster vaccine to the patient in the presence of an LPN. Vaccine administered subcutaneously. The vaccine was reconstituted with 0.5 ml versus the entire content of the diluent provided.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Paraesthesia, Rash pruritic
Clinical narrative: I administered the Zoster vaccine to the patient in the presence of an LPN. Vaccine administered subcutaneously. The vaccine was reconstituted with 0.5 ml versus the entire content of the diluent provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Hypoaesthesia, Joint swelling, Laboratory test
Clinical narrative: Shot administered on 1-19-17 about 2:00 p.m. by nurse. By 4:00 p.m.-1-19-17 upper arm swelled in huge knot-baseball size surrounding by red ring. Extreme pain, redness, swelling spread to complete arm, down to wrist and hand, caused numbness in fingers. Extreme pain-ER visit necessary.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: Shot administered on 1-19-17 about 2:00 p.m. by nurse. By 4:00 p.m.-1-19-17 upper arm swelled in huge knot-baseball size surrounding by red ring. Extreme pain, redness, swelling spread to complete arm, down to wrist and hand, caused numbness in fingers. Extreme pain-ER visit necessary.
Age: 20.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient lost consciousness for about 5 seconds after receiving the M-M-R-II vaccine. Patient regained consciousness spontaneously without treatment. Pt reported fine after a few minutes rest. Mother mentioned that pt was afraid of needles. EMS was called. EMS checked with Pt and reported fine. No treatment given.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Myalgia
Clinical narrative: (L) sided muscle and joint pain affecting neck, shoulder, elbow, hip, knee, as reported by patient.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash
Clinical narrative: Facial rash following administration of MMR, DTaP and IPV on 01/27/17. No changes in diet or products.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Headache, Hypoaesthesia, Nausea
Clinical narrative: Pt presents to clinic with c/o reaction to immunization (8/17/16), numbness/tingling in left arm down to fingers, headache started the day she got the immunization, nausea/lightheaded, diarrhea x 3 days.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Vaccination complication
Clinical narrative: Pt presents to clinic with c/o reaction to immunization (8/17/16), numbness/tingling in left arm down to fingers, headache started the day she got the immunization, nausea/lightheaded, diarrhea x 3 days.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse drug reaction, Cough, Dizziness, Haemorrhage, Laboratory test
Clinical narrative: Rash appeared Nov. of 2015 and lasted until Nov. 2016. It would be so intense, I'd itch until I had spots that bled. It appeared from my neck to my knees and would welt up when itched. Pravastatin sodium-quit taking these for a month as Dr. recommended-Latanoprost for eyes, used every night. Losartan used up until 9-22-2015 then tried Amlodipine for a month-made me dizzy then put on Lisinopril-made me cough continually-went back on Losartan 1-6-17 rash went away in Nov. 2016-I was advised to not get flu shot  in Fall.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash appeared Nov. of 2015 and lasted until Nov. 2016. It would be so intense, I'd itch until I had spots that bled. It appeared from my neck to my knees and would welt up when itched. Pravastatin sodium-quit taking these for a month as Dr. recommended-Latanoprost for eyes, used every night. Losartan used up until 9-22-2015 then tried Amlodipine for a month-made me dizzy then put on Lisinopril-made me cough continually-went back on Losartan 1-6-17 rash went away in Nov. 2016-I was advised to not get flu shot  in Fall.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Blister, Rash, Rash pruritic
Clinical narrative: Started with mildly itchy rash/blisters on left side of torso 2/2/17.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Gianotti-Crosti syndrome, Rash
Clinical narrative: Two days after Hep A injection was given to patient and twin brother, both developed a rash that appeared similar to Gianotti Crosti syndrome.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Bradycardia, Dizziness, Visual impairment
Clinical narrative: After vaccine administer pt. had bradycardia, seeing black and dizzy.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain, Pain in extremity, Pruritus, Rash
Clinical narrative: Pt. developed redness, swelling and pain after MCV-4 immunization yesterday. Pt. states arm was painful yesterday constantly. Today arm is mostly itchy, painful with movement. H/O immunization reaction to DTaP. Mother gave ADVIL, effective. Denies wheezing or SOB. Pain has been stable. No fever noted. No other symptoms. Symptoms: Skin Rash, Urticaria Pruritus and swelling, pain. Treatment: Cetirizine 5 mg every day.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Swelling, Urticaria
Clinical narrative: Pt. developed redness, swelling and pain after MCV-4 immunization yesterday. Pt. states arm was painful yesterday constantly. Today arm is mostly itchy, painful with movement. H/O immunization reaction to DTaP. Mother gave ADVIL, effective. Denies wheezing or SOB. Pain has been stable. No fever noted. No other symptoms. Symptoms: Skin Rash, Urticaria Pruritus and swelling, pain. Treatment: Cetirizine 5 mg every day.
Age: 4.0
Sex: F
Vaccine: IPV, MMRV, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient administered Tdap vaccine rather than Dtap. No harm to patient. No reaction.
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Skin discomfort
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of paresthesia skin in a adult male patient who received Flu Seasonal TIV Dresden. In 2011, the patient received Influenza vaccine unspecified 2011-12 season. On an unknown date, an unknown time after receiving Influenza vaccine unspecified 2011-12 season, the patient experienced paresthesia skin. On an unknown date, the outcome of the paresthesia skin was unknown. It was unknown if the reporter considered the paresthesia skin to be related to Influenza vaccine unspecified 2011-12 season. Additional details were provided as follows: The age at vaccination was not reported. This case was previously not reported to anyone. The pharmacist reported that the patient experienced feeling of thorns coming out of skin when the patient received unknown manufacturer flu vaccine five years ago from the date of reporting. No further information was available on the event per pharmacist. The reporter declined to provide patient demographics and to answer all question for safety report.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Area of Men B vaccination on RT deltoid slightly erythematous and swollen (indurated) and tender. 6 x 7 cm induration.
Age: 25.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site pain, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Headache, high fever, pain injection site swelling, vomiting three times.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Fatigue, Peripheral swelling, Tenderness
Clinical narrative: Chills, fatigue, and very tender and swollen arm-started 1 1/2 days after IZ -> treated with ice, PERCOCET.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Fridge temp out of range 1-10-17. No adverse reaction. No re-vax recommended due to age.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Fridge temp out of range 1-9-17. No adverse reaction. No re-vax recommended.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Fridge temp out of range 1-9-17. No adverse reaction. Re-vax recommended: ROTATEQ only.
Age: 1.92
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Fridge temp out of range 1-9-17. No adverse reaction. Re-vax recommended by clinic.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: 17 yr. old patient received her third HPV shot. Arm was sore for 2 days resolved. Two weeks and two days later the arm got severe swollen, MD visit found cellulitis.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 17 yr. old patient received her third HPV shot. Arm was sore for 2 days resolved. Two weeks and two days later the arm got severe swollen, MD visit found cellulitis.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Acute kidney injury, Blood bilirubin increased, Blood creatinine increased, Blood pressure decreased, Blood smear test normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 30-Jan-2017. This case involves a 73 year old male patient, who was vaccinated with YELLOW FEVER VACCINE (batch number, expiry date, dose and route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had infection at the injection site. Lab test and corrective treatment was not reported. On 30-Dec-2016 patient died at hospital. It was unknown that autopsy was performed or not. Documents held by sender: none. Sender's Comments: This is a poorly documented death case of a 73-y.o. man who died on 30 Dec 2016, an unknown time after administration of YELLOW FEVER VACCINE. The cause of death is suspected as infection at the injection site. No information is provided on time to onset, symptoms and their evolution, results of etiological investigations, patient's medical history including previous vaccinations (YF and others), concomitant vaccinations and medications, and autopsy results. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: infection at the injection site.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Cardiac arrest, Chills, Chronic kidney disease, Clostridium test negative, Diarrhoea
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 30-Jan-2017. This case involves a 73 year old male patient, who was vaccinated with YELLOW FEVER VACCINE (batch number, expiry date, dose and route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had infection at the injection site. Lab test and corrective treatment was not reported. On 30-Dec-2016 patient died at hospital. It was unknown that autopsy was performed or not. Documents held by sender: none. Sender's Comments: This is a poorly documented death case of a 73-y.o. man who died on 30 Dec 2016, an unknown time after administration of YELLOW FEVER VACCINE. The cause of death is suspected as infection at the injection site. No information is provided on time to onset, symptoms and their evolution, results of etiological investigations, patient's medical history including previous vaccinations (YF and others), concomitant vaccinations and medications, and autopsy results. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: infection at the injection site.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Endotracheal intubation, Headache, Hypophagia, Hypotension, Influenza like illness
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 30-Jan-2017. This case involves a 73 year old male patient, who was vaccinated with YELLOW FEVER VACCINE (batch number, expiry date, dose and route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had infection at the injection site. Lab test and corrective treatment was not reported. On 30-Dec-2016 patient died at hospital. It was unknown that autopsy was performed or not. Documents held by sender: none. Sender's Comments: This is a poorly documented death case of a 73-y.o. man who died on 30 Dec 2016, an unknown time after administration of YELLOW FEVER VACCINE. The cause of death is suspected as infection at the injection site. No information is provided on time to onset, symptoms and their evolution, results of etiological investigations, patient's medical history including previous vaccinations (YF and others), concomitant vaccinations and medications, and autopsy results. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: infection at the injection site.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Jaundice, Life support, Malaise, Metabolic acidosis, Multiple organ dysfunction syndrome
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 30-Jan-2017. This case involves a 73 year old male patient, who was vaccinated with YELLOW FEVER VACCINE (batch number, expiry date, dose and route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had infection at the injection site. Lab test and corrective treatment was not reported. On 30-Dec-2016 patient died at hospital. It was unknown that autopsy was performed or not. Documents held by sender: none. Sender's Comments: This is a poorly documented death case of a 73-y.o. man who died on 30 Dec 2016, an unknown time after administration of YELLOW FEVER VACCINE. The cause of death is suspected as infection at the injection site. No information is provided on time to onset, symptoms and their evolution, results of etiological investigations, patient's medical history including previous vaccinations (YF and others), concomitant vaccinations and medications, and autopsy results. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: infection at the injection site.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Myalgia, Pain, Platelet count decreased, Pulmonary congestion, Pulseless electrical activity
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 30-Jan-2017. This case involves a 73 year old male patient, who was vaccinated with YELLOW FEVER VACCINE (batch number, expiry date, dose and route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had infection at the injection site. Lab test and corrective treatment was not reported. On 30-Dec-2016 patient died at hospital. It was unknown that autopsy was performed or not. Documents held by sender: none. Sender's Comments: This is a poorly documented death case of a 73-y.o. man who died on 30 Dec 2016, an unknown time after administration of YELLOW FEVER VACCINE. The cause of death is suspected as infection at the injection site. No information is provided on time to onset, symptoms and their evolution, results of etiological investigations, patient's medical history including previous vaccinations (YF and others), concomitant vaccinations and medications, and autopsy results. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: infection at the injection site.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Pyrexia, Renal tubular necrosis, Sinus tachycardia, Thrombocytopenia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 30-Jan-2017. This case involves a 73 year old male patient, who was vaccinated with YELLOW FEVER VACCINE (batch number, expiry date, dose and route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had infection at the injection site. Lab test and corrective treatment was not reported. On 30-Dec-2016 patient died at hospital. It was unknown that autopsy was performed or not. Documents held by sender: none. Sender's Comments: This is a poorly documented death case of a 73-y.o. man who died on 30 Dec 2016, an unknown time after administration of YELLOW FEVER VACCINE. The cause of death is suspected as infection at the injection site. No information is provided on time to onset, symptoms and their evolution, results of etiological investigations, patient's medical history including previous vaccinations (YF and others), concomitant vaccinations and medications, and autopsy results. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: infection at the injection site.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Death, Injection site infection
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 30-Jan-2017. This case involves a 73 year old male patient, who was vaccinated with YELLOW FEVER VACCINE (batch number, expiry date, dose and route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had infection at the injection site. Lab test and corrective treatment was not reported. On 30-Dec-2016 patient died at hospital. It was unknown that autopsy was performed or not. Documents held by sender: none. Sender's Comments: This is a poorly documented death case of a 73-y.o. man who died on 30 Dec 2016, an unknown time after administration of YELLOW FEVER VACCINE. The cause of death is suspected as infection at the injection site. No information is provided on time to onset, symptoms and their evolution, results of etiological investigations, patient's medical history including previous vaccinations (YF and others), concomitant vaccinations and medications, and autopsy results. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: infection at the injection site.
Age: 56.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Herpes zoster, Laboratory test, Neuralgia, Rash
Clinical narrative: Rash later diagnosed as shingles.
Age: 56.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash later diagnosed as shingles.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Sore/pain at injection site (difficulty sleeping). Red and swollen abscess at injection site.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives all over body starting 2/3/17 and worsening 2/6/17.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Injection site pain, Myalgia, Pain
Clinical narrative: Chills, fever, body aches, muscle pain, soreness at sight of injection,  joint pain.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Chills, fever, body aches, muscle pain, soreness at sight of injection,  joint pain.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 19-JAN-2017, the patient was vaccinated with a dose of PROQUAD (dose and route unknown, lot # M034692, expiration date: 24-JAN-2018) which was improperly stored, for prophylaxis. The vaccine was stored in 6.3 Fahrenheit degree for 11 hours. There was no previous temperature excursion. The call was not because of a data logger. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Nausea, Neck pain
Clinical narrative: Information has been received from a 67 year old female consumer concerning herself. The patient's concurrent condition included gastrooesophageal reflux disease (GERD), osteoporosis and liver enzymes and cholesterol elevated (all other lab tests were OK) but did not require medication. The patient's medical history included flu shot. The patient concomitant therapies included PRILOSEC OTC and "ROLAIDS" or TUMS. On 20-JAN-2017 about 14:00 EST, the patient was vaccinated with ZOSTAVAX, 19400 units (one time) (lot#, expiration date and route were not reported) in the right arm and was vaccinated with PNEUMOVAX 23 (strength was reported as 1/25microgram/0 injection, dose was reported as 1/25microgram/0 injection, one time) (lot#, expiration date and route were not reported) in the left arm for prevention. On 21-JAN-2017 about 03:00, she woke up and felt nausea. On the same day, she also experienced soreness/pain at the base of her neck, across her shoulder area which went left to right, and it hurt when she turned her head, though she could turn her head. The pain and soreness was worsening. She also experienced swelling and soreness at the site of her PNEUMOVAX 23 injection. She was experiencing constant pain and had not done anything to treat the pain but was considering taking ALEVE PM or TYLENOL PM. She also reported soreness when she walked and felt like the pain was muscle or joint pain. There was no relevant laboratory data. On 21-JAN-2017, the patient was continued to experience worsening soreness/pain at the base of her neck, soreness/pain across her shoulder area, it hurt when she turned her head, swelling and soreness at the site of her PNEUMOVAX 23 injection and soreness when she walked however the nausea had resolved. Causality between the events, ZOSTAVAX and PNEUMOVAX 23 was unknown. Additional information is not expected as there was no consent for follow up.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a 67 year old female consumer concerning herself. The patient's concurrent condition included gastrooesophageal reflux disease (GERD), osteoporosis and liver enzymes and cholesterol elevated (all other lab tests were OK) but did not require medication. The patient's medical history included flu shot. The patient concomitant therapies included PRILOSEC OTC and "ROLAIDS" or TUMS. On 20-JAN-2017 about 14:00 EST, the patient was vaccinated with ZOSTAVAX, 19400 units (one time) (lot#, expiration date and route were not reported) in the right arm and was vaccinated with PNEUMOVAX 23 (strength was reported as 1/25microgram/0 injection, dose was reported as 1/25microgram/0 injection, one time) (lot#, expiration date and route were not reported) in the left arm for prevention. On 21-JAN-2017 about 03:00, she woke up and felt nausea. On the same day, she also experienced soreness/pain at the base of her neck, across her shoulder area which went left to right, and it hurt when she turned her head, though she could turn her head. The pain and soreness was worsening. She also experienced swelling and soreness at the site of her PNEUMOVAX 23 injection. She was experiencing constant pain and had not done anything to treat the pain but was considering taking ALEVE PM or TYLENOL PM. She also reported soreness when she walked and felt like the pain was muscle or joint pain. There was no relevant laboratory data. On 21-JAN-2017, the patient was continued to experience worsening soreness/pain at the base of her neck, soreness/pain across her shoulder area, it hurt when she turned her head, swelling and soreness at the site of her PNEUMOVAX 23 injection and soreness when she walked however the nausea had resolved. Causality between the events, ZOSTAVAX and PNEUMOVAX 23 was unknown. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of improper stored PNEUMOVAX 23 (dose, frequency and route were unknown; lot number was M036728 with expiration date 20-MAY-2018) for prophylaxis. No adverse effect was reported. The temperature of storage was between 32 F and 36 F with duration 24 hours. There was no previous temperature excursion. Data logger issue was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse via a company representative, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with the first dose of GARDASIL 9 (strength, dose, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis; and on unspecified dates more than 12 months after the first dose the patients received the second dose of GARDASIL 9 (strength, dose, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact for follow-up. Sender's Comments: US-009507513-1702USA002433.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 23 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 26-JUL-2016, the patient was vaccinated with a first dose of GARDASIL 9 lot # L045711, expiration date 08-MAY-2017, intramuscularly (dose was not reported). On 27-JAN-2017, the patient showed in the office for the second dose. Product quality complaint (PQC) was not involved. No adverse effects were noted. Additional information is not expected, as there was no consent to contact a physician.
Age: 0.42
Sex: M
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-JAN-2017, the patient was vaccinated with improperly stored doses of ROTATEQ lot# M031650, expiration date 16-MAR-2018 orally; (dose was not reported) and PEDVAXHIB lot# M034187, expiration date 17-MAY-2019 (dose and route of administration were not reported). There was no adverse effect reported. No product quality complaint was involved. Administered doses of vaccines experienced the temperature excursion with temperature above 8 degrees Celsius and below 25 degrees Celsius for 1 hour and 11 minutes. Data logger was involved. There was no previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000235.
Age: 0.33
Sex: F
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-JAN-2017, the patient was vaccinated with improperly stored doses of ROTATEQ lot# M031650, expiration date 16-MAR-2018 orally; (dose was not reported) and PEDVAXHIB lot# M034187, expiration date 17-MAY-2019 (dose and route of administration were not reported). There was no adverse effect reported. No product quality complaint was involved. Administered doses of vaccines experienced the temperature excursion with temperature above 8 degrees Celsius and below 25 degrees Celsius for 1 hour and 11 minutes. Data logger was involved. There was no previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000223.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a male patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant therapies reported. On 30-JAN-2016, the patient was vaccinated with an improperly stored ZOSTAVAX lot number M036643 with expiration date of 19-NOV-2017 (strength, dose, dosage schedule, anatomical location and route of administration were not provided) for prophylaxis, and the administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 20 hours (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000880:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004883, expiration date: 02-OCT-2017 and lot# M019690, expiration date: 02-NOV-2017) (orally, dose was not provided). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion above 46 degrees Fahrenheit and less than 77 degrees Fahrenheit (the highest temperature: 46.81 degrees Fahrenheit) for 90 minutes. Data logger was involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA010895: US-009507513-1702USA002226: US-009507513-1702USA002227:
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Acute hepatic failure, Acute kidney injury, Bronchopulmonary aspergillosis, Coagulopathy, Death
Clinical narrative: Information had been received on 06-FEB-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that female (age unknown) received ZOSTAVAX on 03-DEC-2015 for prevention of shingles. Within a matter of days, patient experienced yellowing skin and eyes. Patient was hospitalized and diagnosed with acute liver failure, acute hypoxic respiratory failure, coagulopathy and liver disease. It was reported that a known complication of shingles is that it can attack the liver. Patient also experienced rashes, seizures and headaches (dates not reported). Patient underwent a liver transplant but the new liver was rejected (date not reported). Patient experienced aspergillosis pneumonia and acute renal failure (dates not reported). On 05-FEB-2015, patient passed away (conflicting information as this date is prior to when patient was vaccinated). As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, patient sustained severe and fatal personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress and loss of enjoyment of life. Patient incurred medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Patient sustained serious personal injuries and related losses including, but not limited to, the following: required healthcare and services, incurred medical and related expenses and suffered mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages up to and including death. Upon internal review, acute liver failure requiring liver transplant, acute hypoxic respiratory failure, seizures, aspergillosis pneumonia, acute renal failure, new liver was rejected and passed away were considered to be medically significant events. Additional information has been requested. Reported Cause(s) of Death: death.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Emotional distress, Headache, Liver disorder, Liver transplant, Liver transplant rejection
Clinical narrative: Information had been received on 06-FEB-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that female (age unknown) received ZOSTAVAX on 03-DEC-2015 for prevention of shingles. Within a matter of days, patient experienced yellowing skin and eyes. Patient was hospitalized and diagnosed with acute liver failure, acute hypoxic respiratory failure, coagulopathy and liver disease. It was reported that a known complication of shingles is that it can attack the liver. Patient also experienced rashes, seizures and headaches (dates not reported). Patient underwent a liver transplant but the new liver was rejected (date not reported). Patient experienced aspergillosis pneumonia and acute renal failure (dates not reported). On 05-FEB-2015, patient passed away (conflicting information as this date is prior to when patient was vaccinated). As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, patient sustained severe and fatal personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress and loss of enjoyment of life. Patient incurred medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Patient sustained serious personal injuries and related losses including, but not limited to, the following: required healthcare and services, incurred medical and related expenses and suffered mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages up to and including death. Upon internal review, acute liver failure requiring liver transplant, acute hypoxic respiratory failure, seizures, aspergillosis pneumonia, acute renal failure, new liver was rejected and passed away were considered to be medically significant events. Additional information has been requested. Reported Cause(s) of Death: death.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Ocular icterus, Pain, Quality of life decreased, Rash, Respiratory failure
Clinical narrative: Information had been received on 06-FEB-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that female (age unknown) received ZOSTAVAX on 03-DEC-2015 for prevention of shingles. Within a matter of days, patient experienced yellowing skin and eyes. Patient was hospitalized and diagnosed with acute liver failure, acute hypoxic respiratory failure, coagulopathy and liver disease. It was reported that a known complication of shingles is that it can attack the liver. Patient also experienced rashes, seizures and headaches (dates not reported). Patient underwent a liver transplant but the new liver was rejected (date not reported). Patient experienced aspergillosis pneumonia and acute renal failure (dates not reported). On 05-FEB-2015, patient passed away (conflicting information as this date is prior to when patient was vaccinated). As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, patient sustained severe and fatal personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress and loss of enjoyment of life. Patient incurred medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Patient sustained serious personal injuries and related losses including, but not limited to, the following: required healthcare and services, incurred medical and related expenses and suffered mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages up to and including death. Upon internal review, acute liver failure requiring liver transplant, acute hypoxic respiratory failure, seizures, aspergillosis pneumonia, acute renal failure, new liver was rejected and passed away were considered to be medically significant events. Additional information has been requested. Reported Cause(s) of Death: death.