chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mycobacterium test
Clinical narrative: Pt received a Hepatitis A injection in her R deltoid on 10/3/18. She has had swelling, pain, and erythema at injection site for about 6 weeks.  I&D was performed 12/13/18.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Abscess, Culture, Debridement, Fungal test, Injection site erythema
Clinical narrative: Pt received a Hepatitis A injection in her R deltoid on 10/3/18. She has had swelling, pain, and erythema at injection site for about 6 weeks.  I&D was performed 12/13/18.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Injection site pain, Mycobacterium test, Wound treatment
Clinical narrative: Pt received a Hepatitis A injection in her R deltoid on 10/3/18. She has had swelling, pain, and erythema at injection site for about 6 weeks.  I&D was performed 12/13/18.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Crying, Discomfort, Pyrexia, Rash, Sleep disorder
Clinical narrative: Fever ranging from 101.9-103.0, spots on belly, thighs and face for 5 days after shot. Lasting until 9 days later. Extreme crying, discomfort, sleep disturbance and possible throat discomfort.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal hypokinesia
Clinical narrative: Pregnancy has been normal, felt a significant decline in baby movement after vaccine.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Amnesia, Full blood count, Headache, Pyrexia, X-ray
Clinical narrative: High fever 103 + severe headache Transported to Hospital by ambulance, now having memory loss.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: Fever of 105 degrees, headache, lethargic.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complained of a very painful arm that resulted him having limited arm motion by that evening. He complained of lots of pain at night when trying to lay on that side. Patient followed up with dr 12/3/18 and was given a medrol dosepack. Patient stated pain went away and motion was almost back to normal. After stopping the dosepack, the pain returned and motion deccreased. Patient went back to doctor 12/12 and he prescribed another dosepack (based on profile). Unware of next steps doctor is taking. Also unware if injury/symptoms directly related to shot. When spoke with office they said they were going to try a steriod pack, and if that did not work the patient would follow up in office.
Age: 0.75
Sex: M
Vaccine: FLU4, HEP
Symptoms: Lip swelling, Wheezing
Clinical narrative: Flu immunization administered at 9 month well visit. Due to parent concern, was observed in office for period of 20 minutes after vaccine was administered. On the way home, approx. 45 minutes later, patient developed swollen lip and wheezing. Was taken to the Emergency Room. En route to the emergency room parents administered EPIPEN Junior. Symptoms largely improved administration. In ED was given dose of DECADRON and BENADRYL. He was observed in the ED for a couple of hours until discharged home.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Appetite disorder, Crying, Middle insomnia, Pyrexia
Clinical narrative: He was running a fever, which I expected, but has been extremely fussy and crying. He has had no interest in food the past couple days and it's been challenging even getting fluids in him. In addition, he was not sleeping. He was waking up around midnight and then staying up till 4:30am (3 nights). Last night was the first night he slept and didn't wake up. I'm not sure if his appetite has changed at this point, but I sent a message to the doctor. He's never had a reaction like this to the other rounds of shots so I'm not sure why these were different. Hopefully he has already turned the corner. And to be honest, I didn't even connect his behavior to the shots until I read the vaccine information sheet that was provided by the doctor and saw his symptoms matched what was stated as an adverse reaction.  I thought he may be getting sick again or teething, but he's never lost his appetite or not slept for several days continuously.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, aches, chills.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 17 year old patient of unknown gender. Information about concomitant medication, drug reactions/allergies and pertinent medical history was not provided. On unspecified dates, the patient received 3 doses of GARDASIL 9 (strength, route, lot# and expiration date were not reported) for prophylaxis. Then on 12-NOV-2018 the patient received the 4th dose of GARDASIL 9 (intramuscular, lot# R016971, expiration date was 22-MAR-2021; strength was not reported) for prophylaxis (extra dose administered). No adverse effects reported.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a male (reported as "his") patient of unknown age. Information about concomitant medication, drug reactions/allergies and pertinent medical history was not provided. On 09-NOV-2011, the patient received his 1st dose of VAQTA (strength was reported as 25/0.5 without unit; route, lot# and expiration date were not reported) for prophylaxis. On 23-APR-2012, the patient received his 2nd dose of VAQTA (strength was reported as 25/0.5 without unit; route, lot# and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration). The exact dose was unknown but it was a pediatric dose. No adverse effects reported.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Chills, Injection site pain, Pain
Clinical narrative: Information has been received from a 64 year old non-pregnant female patient referring to herself. The patient had no concomitant medication, drug reactions/allergies and pertinent medical history. On 14-NOV-2018, the patient received a dose of PNEUMOVAX 23 (intramuscular, lot# was R018136, expiration date was 10-JUL-2020; strength was not reported) for prophylaxis. The patient reported that a few hours later, she took 2 TYLENOL EXTRA STRENGTH (lot number and expiration date were unknown by reporter). The patient reported that later in the day, she began to feel arm pain at the injection site, and achy all over. She began to feel chills and temperature spiked to 102.3 Fahrenheit (F) degree. She took 2 additional TYLENOL EXTRA STRENGTH. On 15-NOV-2018, she called physician to report that she experienced the adverse effects, with no report of a response by the physician. On 15-NOV-2018, she began to feel better. Treatment was given for the events. No lab test was performed. The outcome of the events was reported as recovering. The causality between the events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 2-year-old patient of an unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with the first pediatric dose of VAQTA 25/ 0.5 (units were not provided), injection for prophylaxis (exact dose, route of administration, lot # and expiration date were not provided) at 1 year, 11 months of age. On an unknown date, the patient was vaccinated with the first pediatric dose of VAQTA 25/ 0.5 (units were not provided), injection for prophylaxis (exact dose, route of administration, lot # and expiration date were not provided) at 2 years, 1 month of age. The vaccinations were scheduled earlier than schedule. No adverse effects were reported. The outcome of event was not provided. The causality assessment was not reported.
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Erythema, Peripheral swelling, Pneumonia
Clinical narrative: This spontaneous report was received from a female patient of approximately 78 years. The patient had drug reactions or allergies to celecoxib (CELEBREX), nitrofurantoin, ciprofloxacine, "Sulfa" and alendronate. The patient's concomitant therapies included levocetirizine dihydrochloride (XYZAL) and "many other medications". On an unknown date, in 2012, the patient was vaccinated with an unspecified "pneumonia shot" (manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, in 2012, on the arm she received the "pneumonia shot" (manufacturer unknown) became red and swollen (peripheral swelling and erythema). Then, on an unknown date, one week after receiving the "pneumonia shot" (manufacturer unknown), she experienced unspecified "breathing problems" and went later, on an unknown date to  an unspecified emergency room for the "breathing problems" and was diagnosed with pneumonia but was not admitted to the hospital. The patient recovered from the event on an unspecified date in 2012. On an unknown date, reported as "few years ago", the patient started therapy with mometasone furoate(ASMANEX TWISTHALER) 200 micrograms, via respiratory for chronic bronchitis (dose, frequency, lot number and expiration date were not reported). On an unknown date, in November 2018, reported as last week, the patient she took "5 doses"  of mometasone furoate(ASMANEX TWISTHALER) 200micrograms, per respiratory, with lot # R022733 with expiration date on 30-NOV-2019 with a dose counter malfunction (product quality issue) (dose and frequency were not reported) and then experienced coughing "in the mornings". At the time of this report, the patient was recovering from the event cough with a different mometasone furoate (ASMANEX TWISTHALER) (dose, frequency,  lot number and expiration date were not reported) that was started on 01-DEC-2018. The outcome of the events peripheral swelling and erythema and the causal relationship between the aforementioned events and both suspect therapies were not reported. Upon internal review, the event pneumonia was considered to be medically significant.; Sender's Comments:  US-009507513-1812USA002765:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2014, a healthcare provider administered the ZOSTAVAX (lot# and route not provided) vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related conditions. In 2016, the patient was treated by a health care provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries.  As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Chest X-ray, Influenza virus test, Pyrexia, Streptococcus test
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 12-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-NOV-2018, the patient was vaccinated with PROQUAD (lot # R020676, expiration date: 15-JAN-2020, dose and route of administration were not provided) for prevention. On 17-NOV-2018, the patient experienced fever between 102 to 104 Fahrenheit degrees after receiving PROQUAD. The patient was seen in emergency room on 24-NOV-2018. The patient received an unspecified treatment for the event. An unknown test for influenza and strep and chest x-ray were performed on an unknown date in 2018. The outcome of the fever was reported as recovered on an unknown date in 2018. The relatedness between the event and PROQUAD was not reported.
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of PREVNAR 13 on an unspecified date at single dose for immunisation. Medical history included femoral neck fracture. On an unknown date (when she was recovering from femoral neck fracture), she took first dose of pneumococcal 13-val conj vaccine for immunisation. The patient inadvertently received two doses of pneumococcal 13-val conj vaccine on unknown dates, within days of separation from each other. On an unspecified date, after her second dose of the vaccine, she experienced lack of appetite with outcome of unknown. Information on the batch number has been requested.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Cognitive disorder, Decreased appetite, Fatigue, Haemorrhage, Hypertonia
Clinical narrative: I received a Hepatitis A vaccine--the 2nd shot in the series--to complete a law requirement in order to serve food. I wanted to report my experience with VAERS, just to be safe, because I experienced very strange symptoms that I've never before experienced as a result of a vaccination. I received a vaccination, and the nurse left the room to get a cracker or juice. I fainted/became unconscious. When the nurse returned to the room and found that I had fainted, she and another staff person assisted me from the chair to the bed/table. I expressed that I had nausea, but was beginning to feel better. The nurse put an ice pack on my head because after fainting, I had 3 small knots with scratches with some blood trace on my forehead. I was feeling better and recovering. But a few minutes later, and all of a sudden, pain started to course through my entire body, and I told them things were getting worse, and I could feel it in my legs and body. Then, my body (especially my arms, hands, and fingers) became so abnormally stiff/rigid/contorted that I couldn't move them. I looked like someone with hypertonia. The nurse said the abnormal stiffness was the result of a panic attack--not the vaccination. This reaction was alarming to me because I feel that I was recovering from fainting, and then began to experience the body pain and abnormal stiffness, and then panicked as a result of that reaction. I do not feel I began to experience a panic attack prior to the abnormal stiffness, and I have never experienced muscle problems or such stiffness in conjunction with a panic attack. I do not believe the abnormal stiffness that I experienced is a symptom of a panic attack--I believe that only minor stress-related muscle tension is symptomatically associated with panic attacks. The other alarming experience I had as a result of the vaccination is that for 8 days following the vaccination, my cognition was affected: I would lose blocks of time during the day, experience forgetfulness, and had difficulty with basic comprehension of routine tasks such as running my business software. I did experience minor common side effects that could be expected--I lost my appetite and thirst drive, experienced tiredness, and full arm soreness.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness, Memory impairment, Muscle rigidity, Musculoskeletal stiffness, Nausea
Clinical narrative: I received a Hepatitis A vaccine--the 2nd shot in the series--to complete a law requirement in order to serve food. I wanted to report my experience with VAERS, just to be safe, because I experienced very strange symptoms that I've never before experienced as a result of a vaccination. I received a vaccination, and the nurse left the room to get a cracker or juice. I fainted/became unconscious. When the nurse returned to the room and found that I had fainted, she and another staff person assisted me from the chair to the bed/table. I expressed that I had nausea, but was beginning to feel better. The nurse put an ice pack on my head because after fainting, I had 3 small knots with scratches with some blood trace on my forehead. I was feeling better and recovering. But a few minutes later, and all of a sudden, pain started to course through my entire body, and I told them things were getting worse, and I could feel it in my legs and body. Then, my body (especially my arms, hands, and fingers) became so abnormally stiff/rigid/contorted that I couldn't move them. I looked like someone with hypertonia. The nurse said the abnormal stiffness was the result of a panic attack--not the vaccination. This reaction was alarming to me because I feel that I was recovering from fainting, and then began to experience the body pain and abnormal stiffness, and then panicked as a result of that reaction. I do not feel I began to experience a panic attack prior to the abnormal stiffness, and I have never experienced muscle problems or such stiffness in conjunction with a panic attack. I do not believe the abnormal stiffness that I experienced is a symptom of a panic attack--I believe that only minor stress-related muscle tension is symptomatically associated with panic attacks. The other alarming experience I had as a result of the vaccination is that for 8 days following the vaccination, my cognition was affected: I would lose blocks of time during the day, experience forgetfulness, and had difficulty with basic comprehension of routine tasks such as running my business software. I did experience minor common side effects that could be expected--I lost my appetite and thirst drive, experienced tiredness, and full arm soreness.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Nodule, Pain, Pain in extremity, Panic attack, Scratch
Clinical narrative: I received a Hepatitis A vaccine--the 2nd shot in the series--to complete a law requirement in order to serve food. I wanted to report my experience with VAERS, just to be safe, because I experienced very strange symptoms that I've never before experienced as a result of a vaccination. I received a vaccination, and the nurse left the room to get a cracker or juice. I fainted/became unconscious. When the nurse returned to the room and found that I had fainted, she and another staff person assisted me from the chair to the bed/table. I expressed that I had nausea, but was beginning to feel better. The nurse put an ice pack on my head because after fainting, I had 3 small knots with scratches with some blood trace on my forehead. I was feeling better and recovering. But a few minutes later, and all of a sudden, pain started to course through my entire body, and I told them things were getting worse, and I could feel it in my legs and body. Then, my body (especially my arms, hands, and fingers) became so abnormally stiff/rigid/contorted that I couldn't move them. I looked like someone with hypertonia. The nurse said the abnormal stiffness was the result of a panic attack--not the vaccination. This reaction was alarming to me because I feel that I was recovering from fainting, and then began to experience the body pain and abnormal stiffness, and then panicked as a result of that reaction. I do not feel I began to experience a panic attack prior to the abnormal stiffness, and I have never experienced muscle problems or such stiffness in conjunction with a panic attack. I do not believe the abnormal stiffness that I experienced is a symptom of a panic attack--I believe that only minor stress-related muscle tension is symptomatically associated with panic attacks. The other alarming experience I had as a result of the vaccination is that for 8 days following the vaccination, my cognition was affected: I would lose blocks of time during the day, experience forgetfulness, and had difficulty with basic comprehension of routine tasks such as running my business software. I did experience minor common side effects that could be expected--I lost my appetite and thirst drive, experienced tiredness, and full arm soreness.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: I received a Hepatitis A vaccine--the 2nd shot in the series--to complete a law requirement in order to serve food. I wanted to report my experience with VAERS, just to be safe, because I experienced very strange symptoms that I've never before experienced as a result of a vaccination. I received a vaccination, and the nurse left the room to get a cracker or juice. I fainted/became unconscious. When the nurse returned to the room and found that I had fainted, she and another staff person assisted me from the chair to the bed/table. I expressed that I had nausea, but was beginning to feel better. The nurse put an ice pack on my head because after fainting, I had 3 small knots with scratches with some blood trace on my forehead. I was feeling better and recovering. But a few minutes later, and all of a sudden, pain started to course through my entire body, and I told them things were getting worse, and I could feel it in my legs and body. Then, my body (especially my arms, hands, and fingers) became so abnormally stiff/rigid/contorted that I couldn't move them. I looked like someone with hypertonia. The nurse said the abnormal stiffness was the result of a panic attack--not the vaccination. This reaction was alarming to me because I feel that I was recovering from fainting, and then began to experience the body pain and abnormal stiffness, and then panicked as a result of that reaction. I do not feel I began to experience a panic attack prior to the abnormal stiffness, and I have never experienced muscle problems or such stiffness in conjunction with a panic attack. I do not believe the abnormal stiffness that I experienced is a symptom of a panic attack--I believe that only minor stress-related muscle tension is symptomatically associated with panic attacks. The other alarming experience I had as a result of the vaccination is that for 8 days following the vaccination, my cognition was affected: I would lose blocks of time during the day, experience forgetfulness, and had difficulty with basic comprehension of routine tasks such as running my business software. I did experience minor common side effects that could be expected--I lost my appetite and thirst drive, experienced tiredness, and full arm soreness.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Culture, Erythema, Fungal test, Gram stain, Mycobacterium test
Clinical narrative: Pt is a 54-year-old female who presents for evaluation of right arm injection site. Patient had flu and hepatitis injections on 10/3/18. Patient is unsure of which vaccination was given in the right arm, but states that the area above the right deltoid muscle where the injection was given has increased in size and erythema since injection. Denies drainage, fever, sweats, chills. Denies ever having a reaction like this before. States the area of the injection site on her left arm has no problems. States the pain is 8/10 at its worst. I&D performed.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Pt is a 54-year-old female who presents for evaluation of right arm injection site. Patient had flu and hepatitis injections on 10/3/18. Patient is unsure of which vaccination was given in the right arm, but states that the area above the right deltoid muscle where the injection was given has increased in size and erythema since injection. Denies drainage, fever, sweats, chills. Denies ever having a reaction like this before. States the area of the injection site on her left arm has no problems. States the pain is 8/10 at its worst. I&D performed.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Candida test, Culture, Fungal test, Gram stain, Injection site erythema
Clinical narrative: Pt is a 57-year-old female who is seen for evaluation of left arm lesion. Patient states she received an influenza injection on 10/3/18 in the left arm. Patient states the area overlying her left deltoid on her left upper extremity swells intermittently and becomes red and inflamed. Denies noticing any drainage. Denies fever, sweats, chills. States the area is worse with tender to palpation and rates pain 4/10.  I&D performed.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Mycobacterium test, Skin lesion
Clinical narrative: Pt is a 57-year-old female who is seen for evaluation of left arm lesion. Patient states she received an influenza injection on 10/3/18 in the left arm. Patient states the area overlying her left deltoid on her left upper extremity swells intermittently and becomes red and inflamed. Denies noticing any drainage. Denies fever, sweats, chills. States the area is worse with tender to palpation and rates pain 4/10.  I&D performed.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Myalgia, Pruritus generalised, Pyrexia, Torticollis
Clinical narrative: Approximately one hour after injection, she developed hives and itching generalized across body; next day they ulcerated and opened up; lasted 5 days; 10 days later she developed fever to 103 with cervical adenopathy, generalized myalgias and torticollis that lasted 3 days
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Ulcer, Urticaria
Clinical narrative: Approximately one hour after injection, she developed hives and itching generalized across body; next day they ulcerated and opened up; lasted 5 days; 10 days later she developed fever to 103 with cervical adenopathy, generalized myalgias and torticollis that lasted 3 days
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient is 2y 2m and should have received a 0.25 ml FLUZONE vaccine for patients 6-36 mo. Patient received FLUZONE 3+ (0.5ml) vaccine. Prior to entering the room, I drew up a 0.5 ml and 0.25 ml dose of the flu vaccine, as patient and his 9yo brother were both receiving the flu vaccines. I had another nurse verify my vaccines prior to entering the room. Once I was in the room, the 2yo was placed on the exam table to get his flu vaccine before his older brother. I grabbed one of the flu vaccines and administered it to the patient. After administration, I realized I gave the patient the 0.5 ml dose of the flu vaccine. I immediately left the room to notify the provider, Dr., who stated no additional adverse effects should occur. I then notified the mother who verbalized understanding and was told to call with any future concerns. The provider was in the room following the vaccine. Patient alert and oriented with no adverse effects noted. (team leader) and (practice manager) were also notified. I spoke with lady at the Health Dept who stated vaccine dose does not need to be repeated and should not expect any adverse effects from the increased dose. Also recommendation to fill out a VAERS report.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Extreme pain in arm after shot, could not move for several days; pain went away in arm but stayed in shoulder; better with aspirin, pain with movements like putting on jacket, putting on deodorant; lateral arm movements. Saw school nurse but not PCP.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Pain where shot was given, Redness where shot was given, Muscle pain. Feeling tired and weak, headache, shivering, upset stomach, I developed a sore on the roof of my mouth. I had pain in my left leg for a week. The sore on the roof of my mouth has finally healed after 4 weeks.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain in extremity, Stomatitis
Clinical narrative: Pain where shot was given, Redness where shot was given, Muscle pain. Feeling tired and weak, headache, shivering, upset stomach, I developed a sore on the roof of my mouth. I had pain in my left leg for a week. The sore on the roof of my mouth has finally healed after 4 weeks.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2012, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2014, the patient was treated by a physician at a hospital for shingles (not specified whether admitted; considered Emergency Room visit until follow-up is received). The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: FLUX, MENB
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative. An adolescent female patient received TRUMENBA (Lot number and expiration date were not reported) and influenza vaccine; both on the arm, with route of administration and therapy dates unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had redness, heat and swelling in the upper arm. The outcome of the events, 'redness, heat and swelling in the upper arm', was not recovered.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pain after vaccine administration; could not move arm after shot and hurt; Pain lasted 3-4 days; still hurts when changing shirt, lateral arm movement; has DR's apt on 12/17/18.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Skin exfoliation, Swelling
Clinical narrative: Redness in a palm-sized area, slight swelling lasting about 8 days, minor skin peeling after 10 days. No treatment, symptoms resolved without treatment.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Malaise
Clinical narrative: Beginning about 24 hours after receiving the vaccine, began to develop high fever (max of 103), chills, malaise, fatigue, all body ache, and bad headache. Malaise, body ache, and HA had begun about 8 hours before that, but fever kicked in at the 24 hour point, and lasted about 8-10 hours, including heavy sweating in bed. Still some residual symptoms at 72 hours post vaccination, but fever, HA, myalgia, have receded. Should be noted that the exact same profile of symptomatology also occurred for the first dose of the vaccination series, but was not reported to VAERS at the time.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Beginning about 24 hours after receiving the vaccine, began to develop high fever (max of 103), chills, malaise, fatigue, all body ache, and bad headache. Malaise, body ache, and HA had begun about 8 hours before that, but fever kicked in at the 24 hour point, and lasted about 8-10 hours, including heavy sweating in bed. Still some residual symptoms at 72 hours post vaccination, but fever, HA, myalgia, have receded. Should be noted that the exact same profile of symptomatology also occurred for the first dose of the vaccination series, but was not reported to VAERS at the time.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Tenderness
Clinical narrative: Soreness in upper shoulder area and tender since 11-1-18,  patient notices it more when he does outside work.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Computerised tomogram head, Differential white blood cell count, Foaming at mouth, Full blood count, Immediate post-injection reaction
Clinical narrative: 12/12/2018 - Mother reported that child became fussy and seemed to be in pain immediately after receiving Hep A vaccine and kept stiffening up. Mother took child to ER where it was reported that she appeared to be foaming at the mouth.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Irritability, Musculoskeletal stiffness, Pain
Clinical narrative: 12/12/2018 - Mother reported that child became fussy and seemed to be in pain immediately after receiving Hep A vaccine and kept stiffening up. Mother took child to ER where it was reported that she appeared to be foaming at the mouth.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test, Computerised tomogram, Foaming at mouth, Musculoskeletal stiffness, Pain
Clinical narrative: 12/12/2018 - Mother reported that child became fussy and seemed to be in pain immediately after receiving Hep A vaccine and kept stiffening up. Mother took child to ER where it was reported that she appeared to be foaming at the mouth.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Screaming, Seizure, Tremor
Clinical narrative: 12/12/2018 - Mother reported that child became fussy and seemed to be in pain immediately after receiving Hep A vaccine and kept stiffening up. Mother took child to ER where it was reported that she appeared to be foaming at the mouth.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Myocarditis/Pericarditis.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Chills, Cough, Full blood count, Malaise
Clinical narrative: Patient became ill the day after the vaccine with severe cough, chills and fever and was diagnosed with pneumonia today, one week after the vaccine administration and treated with an antibiotic.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Patient became ill the day after the vaccine with severe cough, chills and fever and was diagnosed with pneumonia today, one week after the vaccine administration and treated with an antibiotic.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Haematoma, Haemorrhage
Clinical narrative: Pregnant patient about 30 weeks came in for Tdap as recommended by her OB/GYN. After administration, the patient bled for a moment and a small hematoma developed under the skin after applying pressure.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Rash erythematous
Clinical narrative: The next morning after the vaccine I noticed a really red rash in my armpits. I didn't panic because I had a similar rash after taking some supplements last year; when I stopped taking them the rash went away within a week. I also have had a rash a few times after getting a flu shot similar to how this rash developed but not in the armpits and much lighter. PLEASE NOTE THAT I CANNOT ANSWER THE QUESTION ON THE NEXT PAGE -ITEM 22/23-ABOUT REACTIONS TO PREVIOUS FLU VACCINES.-I DO NOT HAVE THAT SPECIFIC INFORMATION. Within a day I had a full blown deep red 'ruby' rash from my armpits, down my sides, some between my breast and quite a bit down my back-like an hourglass from the top of my shoulders down to my sacrum. I did not go to the doctor, but called the pharmacist instead and got direction from him. That direction was to report the reaction to the Agency, my doctor and take BENADRYL if needed, which I did not take. It took about a week for the rash to go away. The next day after the vaccine I also had extreme fatigue and some chills which I undertand are normal. The pharmacist also said that I will need direction from the CDC and my doctor before I take the second vaccine, which will be after Jan. 12th.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hot flush, Injection site pain, Muscle rigidity
Clinical narrative: Soreness at injection site early in the day and a bit of rigidity. Muscle pain started in arm, neck, lower back, legs at 8:30 along with hot and cold flashes. By 12:30 am, I was shaking so violently my husband held me down  and went from getting me ice packs for my headache and heaping covers on me, getting socks etc. I felt like I was going to throw up, but luckily I did not and by 2:00 I stopped shaking and teeth stopped chattering  enough to rest and sleep. I had been taking ibuprofen 500mg all day as directed. I was exhausted and sore on 12/13, but today feel fine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Tremor
Clinical narrative: Soreness at injection site early in the day and a bit of rigidity. Muscle pain started in arm, neck, lower back, legs at 8:30 along with hot and cold flashes. By 12:30 am, I was shaking so violently my husband held me down  and went from getting me ice packs for my headache and heaping covers on me, getting socks etc. I felt like I was going to throw up, but luckily I did not and by 2:00 I stopped shaking and teeth stopped chattering  enough to rest and sleep. I had been taking ibuprofen 500mg all day as directed. I was exhausted and sore on 12/13, but today feel fine.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warm to touch and pain at injection site.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports that her arm is swollen from the top to the elbow, and is very sore.
Age: 30.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse regarding to a 30-year-old patient of unknown gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 30-NOV-2018 the patient was inadvertently administered a dose of ZOSTAVAX (lot#, expiration date, dose, frequency and route were unknown) instead of second dose of VARIVAX (wrong product administered) for prophylaxis. The patient had no adverse effects (no adverse event). The outcome of events was unknown.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's concomitant medication, medical history, concurrent condition and drug reactions/allergies were unknown. On an unknown date, the patient was vaccinated with M-M-R II via intramuscular route (incorrect route of product administration) (lot# and expiry date were not reported) for prophylaxis. No adverse symptoms reported (no adverse event). No product quality complaint was reported. No further information provided. This was non-valid case due to lack of patient identifiers.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2017, the patient's healthcare provider at health care facility administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2017, the patient was treated by his healthcare provider at the same facility for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A male patient in the 4 decade received PREVNAR 13, at single dose and, influenza vaccine (FLU SHOT), both via an unspecified route of administration in the same arm on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient received both shots in one arm and experience soreness on an unspecified date with outcome of recovered. Clinical course was as follows. The gentleman was in his late 30's and got flu and PREVNAR 13 shot. Got both shots in one arm. The patient called the next day and reported soreness. The pharmacist could not determine which shot caused the soreness. He spoke to the gentleman the next day and he said that he didn't feel soreness at that time. The next day, he was fine. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. Pharmacist reported with PREVNAR 13 there is more pain than other vaccinations. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Swelling, Tenderness, Upper respiratory tract infection
Clinical narrative: Vaccine given 121118 Tuesday. Increased redness and swelling noted Thursday Patient is on antibiotic for URI. 5x9 Erythema increased tenderness notes Friday.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Bone marrow oedema, Bursitis, Full blood count normal, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: On 10/03/2018 ~1100 I had my flu shot administered in my left deltoid. The injection made my left hand numb during administration and then the numbness resolved once the needle was removed. The injection site and my left arm were sore for about 2 days, then the discomfort become slightly better. On the follow Monday, 10/8/18, my left shoulder began to have pain when I would move my left arm across my body. The pain has only become worse and I am experience limited range of motion and muscle weakness in my left arm. I have tried taking Ibuprofen but it no longer is easing the pain. I cannot lift my arm over the height of my shoulder or move it behind my back or across my body without shooting pain.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Limb discomfort, Limb injury, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: On 10/03/2018 ~1100 I had my flu shot administered in my left deltoid. The injection made my left hand numb during administration and then the numbness resolved once the needle was removed. The injection site and my left arm were sore for about 2 days, then the discomfort become slightly better. On the follow Monday, 10/8/18, my left shoulder began to have pain when I would move my left arm across my body. The pain has only become worse and I am experience limited range of motion and muscle weakness in my left arm. I have tried taking Ibuprofen but it no longer is easing the pain. I cannot lift my arm over the height of my shoulder or move it behind my back or across my body without shooting pain.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity, Red blood cell sedimentation rate normal, Rotator cuff syndrome
Clinical narrative: On 10/03/2018 ~1100 I had my flu shot administered in my left deltoid. The injection made my left hand numb during administration and then the numbness resolved once the needle was removed. The injection site and my left arm were sore for about 2 days, then the discomfort become slightly better. On the follow Monday, 10/8/18, my left shoulder began to have pain when I would move my left arm across my body. The pain has only become worse and I am experience limited range of motion and muscle weakness in my left arm. I have tried taking Ibuprofen but it no longer is easing the pain. I cannot lift my arm over the height of my shoulder or move it behind my back or across my body without shooting pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Nausea, Pain in extremity
Clinical narrative: The next morning there was nausea, dizziness, extreme fatigue and chills. I had to spend the day in bed under an electric blanket. I was unable to do anything. Miraculously, the next morning I was fine except for a sore arm.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: Patient experienced swelling that went down her arm, pain, sensitivity, headache, and tingling in her hands. Patient took TYLENOL for pain and used ice. Provider recommended a low dose of Benadryl for further treatment.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Chronic fatigue syndrome, Cognitive disorder, Disturbance in attention, Headache
Clinical narrative: Chronic Fatigue Syndrome. Cognitive dysfunctions. Headache. Myalgia. Asthenia. Orthostatic intolerance. Excessive sweating. Memory and concentration impairment. Low grade fever.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperhidrosis, Memory impairment, Myalgia, Orthostatic intolerance, Pyrexia
Clinical narrative: Chronic Fatigue Syndrome. Cognitive dysfunctions. Headache. Myalgia. Asthenia. Orthostatic intolerance. Excessive sweating. Memory and concentration impairment. Low grade fever.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Patient developed Gallium Barre Syndrome. Needs to receive IVIG therapy to reduce symptoms and cure.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging brain
Clinical narrative: Patient developed Gallium Barre Syndrome. Needs to receive IVIG therapy to reduce symptoms and cure.