chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown.  There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 6 year old male patient. The patient was a healthy and active boy. His relevant past drug history was unknown. On 20-JUL-2010, the patient was vaccinated with the first dose of (Merck) VARIVAX (dose and route unspecified) and on 12-OCT-2015, the patient was inadvertently vaccinated with a full adult dose of ZOSTAVAX (lot # reported as L017138 exp date 13-AUG-2015) (route not reported) instead of being given his second dose of (Merck) VARIVAX. There was no concomitant medications. It was unknown if there was any relevant lab work. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician refers to unspecified female patients of unknown ages. On an unknown date, the patients were vaccinated with doses of GARDASIL (rouse and lot # not reported). The physician reported that on an unspecified dates, the patients experienced passing out in parking lot after receiving GARDASIL. At the time of the report, the patients' outcome was unknown. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: JEV1
Symptoms: Encephalitis Japanese B
Clinical narrative: Pt came in for Japanese encephalitis vaccine #2. Had received #1 on 9/22/15. Did not realize pt came 1 week too early.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Cellulitis (L) arm. Redness, hot, pain.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, Infantile spitting up, Oral administration complication
Clinical narrative: This spontaneous report has been received from a physician concerning a child patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On unspecified date, the patient received his third dose of ROTATEQ, oral (lot #, exp. date, strength and dose were not provided). The child spit up most of the dose immediately after third dose was administered. Therefore, the physician had administered an "extra"/fourth dose of ROTATEQ. At the reporting time, the outcome of infantile spitting up was not reported. This is one of several reports received from the same reporter. Additional information is not expected as the physician declined to provide any additional information.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Erythema, Feeling hot, Pruritus
Clinical narrative: 2" square area of redness. Pt feels heat and discomfort. Gave BENADRYL 25 mg and- it every 4-6 prn redness, itching. And Ice PK apply 15 min each time (off 15 min) for heat and pain. Notified family dr.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Fatigue, Influenza like illness, Local swelling, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 9-year-old female patient who received ENGERIX B pediatric (batch number unknown, expiry date 1st July 2015). On 1st October 2015, the patient received the 3rd dose of ENGERIX B pediatric. On 1st October 2015, an unknown time after receiving ENGERIX B pediatric, the patient experienced expired vaccine used. On 2nd October 2015, the patient experienced fever, sore throat, local swelling, influenza-like symptoms, pain, tiredness and feeling unwell. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, local swelling, influenza-like symptoms, pain, tiredness and feeling unwell were recovered/resolved and the outcome of the sore throat was not recovered/not resolved and the outcome of the expired vaccine used was unknown. The reporter considered the fever, sore throat, local swelling, influenza-like symptoms, pain and tiredness to be related to ENGERIX B pediatric. It was unknown if the reporter considered the feeling unwell to be related to ENGERIX B pediatric. Additional details provided were as follows: This case was previously reported to a doctor. This case was reported by the patient's mother. On 2nd October 2015, 1 day after receiving 3rd dose of ENGERIX B pediatric vaccine, the patient experienced flu-like symptoms, a fever of 102 degrees F, aches, pain, feeling tired, sore throat, and had felt a bump on the bottom of her cheek area. The patient also complained of not feeling well. The patient's mother gave her TYLENOL and between that day and the following day most of the patient's symptoms resolved although the sore throat continued. According to the patient's mother she received a call from the hospital that administered the vaccine and was informed that, the patient received an expired vaccine with an expiration of 1st July 2015. The patient's mother stated that she is very worried about the safety of her daughter and would like to speak to someone about this situation. She just learned of the expired dosing on the reporting day and she was frantically attempting to get information about what this may do to her daughter. The reporter did not wish to stay on the line to provide any further details and stated that if someone from safety would like to call her she would then provide additional information at that time. The patient's mother reported that she needed to call the hospital to see whether the patient should be revaccinated or if the patient needs to be hospitalized. The reporter only had limited information about the dosing and did not have the lot number. The patient's mother was requesting for correspondence as soon as possible.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 9-year-old female patient who received ENGERIX B pediatric (batch number unknown, expiry date 1st July 2015). On 1st October 2015, the patient received the 3rd dose of ENGERIX B pediatric. On 1st October 2015, an unknown time after receiving ENGERIX B pediatric, the patient experienced expired vaccine used. On 2nd October 2015, the patient experienced fever, sore throat, local swelling, influenza-like symptoms, pain, tiredness and feeling unwell. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, local swelling, influenza-like symptoms, pain, tiredness and feeling unwell were recovered/resolved and the outcome of the sore throat was not recovered/not resolved and the outcome of the expired vaccine used was unknown. The reporter considered the fever, sore throat, local swelling, influenza-like symptoms, pain and tiredness to be related to ENGERIX B pediatric. It was unknown if the reporter considered the feeling unwell to be related to ENGERIX B pediatric. Additional details provided were as follows: This case was previously reported to a doctor. This case was reported by the patient's mother. On 2nd October 2015, 1 day after receiving 3rd dose of ENGERIX B pediatric vaccine, the patient experienced flu-like symptoms, a fever of 102 degrees F, aches, pain, feeling tired, sore throat, and had felt a bump on the bottom of her cheek area. The patient also complained of not feeling well. The patient's mother gave her TYLENOL and between that day and the following day most of the patient's symptoms resolved although the sore throat continued. According to the patient's mother she received a call from the hospital that administered the vaccine and was informed that, the patient received an expired vaccine with an expiration of 1st July 2015. The patient's mother stated that she is very worried about the safety of her daughter and would like to speak to someone about this situation. She just learned of the expired dosing on the reporting day and she was frantically attempting to get information about what this may do to her daughter. The reporter did not wish to stay on the line to provide any further details and stated that if someone from safety would like to call her she would then provide additional information at that time. The patient's mother reported that she needed to call the hospital to see whether the patient should be revaccinated or if the patient needs to be hospitalized. The reporter only had limited information about the dosing and did not have the lot number. The patient's mother was requesting for correspondence as soon as possible.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (route of administration, anatomical location, lot number and expiration date were not provided). On 12-OCT-2015, the patient was at the healthcare worker's office to receive the second dose in the hpv series but, she/he was vaccinated with a dose of GARDASIL 9 (route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications provided. No adverse effect was reported. There was no product quality issue involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to 9 patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the 9 patients were inadvertently vaccinated with VARIVAX (Merck) (dosage, strength, route and lot# were not reported), which had been improperly stored. There was no concomitant medication reported. At the time of the report, no adverse effects was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter was not consented to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates, the patients were administered improperly stored VAQTA (lot # J005010, expiration date: 23-OCT-2015; lot # J014584, expiration date: 16-JAN-2016; lot # K000943, expiration date: 24-SEP-2016; lot # K009506, expiration date: 22-SEP-2016) (dosage, strength and route were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health care worker referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown date in September 2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # K022265, expiration date 22-OCT-2016, 5 microgram) intramuscularly. Concomitant therapies were not reported. No adverse events were reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Musculoskeletal pain, Pain in extremity, Tendonitis
Clinical narrative: Case number PHHY2015US124646 is an initial spontaneous report received via vaccine adverse events reporting system (VAERS reference number: 581843) on 05 Oct 2015. This report refers to a 56 year old female patient. Her current conditions included atrial fibrillation, gout, hypertension, hypothyroidism and allergies to DARVOCET and sulfa drugs. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1410901) intramuscularly in the left arm on 22 Oct 2014. On 24 Oct 2014, she had left shoulder/arm pain. She went to emergency room. On 16 Dec 2014, she was referred to primary care physician (PCP) for shoulder pain and left arm pain. On 21 Dec 2014, she had X-ray and cortisone injection. On 31 Dec 2014, her orthopedist reported that she had bursitis and tendonitis of the rotator cuff. On 31 Mar 2015, she had steroid shot and was referred for physical therapy and she had it for 2 weeks. On 23 Apr 2015, she had magnetic resonance imaging (MRI) and results were not reported. On 28 Apr 2015, she had left shoulder cortisone injection. On 26 May 2015, T-pack was administered. The events outcome was reported as condition unchanged. The events were reported as non-serious, but the events tendonitis and bursitis were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Case number PHHY2015US124646 is an initial spontaneous report received via vaccine adverse events reporting system (VAERS reference number: 581843) on 05 Oct 2015. This report refers to a 56 year old female patient. Her current conditions included atrial fibrillation, gout, hypertension, hypothyroidism and allergies to DARVOCET and sulfa drugs. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1410901) intramuscularly in the left arm on 22 Oct 2014. On 24 Oct 2014, she had left shoulder/arm pain. She went to emergency room. On 16 Dec 2014, she was referred to primary care physician (PCP) for shoulder pain and left arm pain. On 21 Dec 2014, she had X-ray and cortisone injection. On 31 Dec 2014, her orthopedist reported that she had bursitis and tendonitis of the rotator cuff. On 31 Mar 2015, she had steroid shot and was referred for physical therapy and she had it for 2 weeks. On 23 Apr 2015, she had magnetic resonance imaging (MRI) and results were not reported. On 28 Apr 2015, she had left shoulder cortisone injection. On 26 May 2015, T-pack was administered. The events outcome was reported as condition unchanged. The events were reported as non-serious, but the events tendonitis and bursitis were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Case number PHHY2015US124646 is an initial spontaneous report received via vaccine adverse events reporting system (VAERS reference number: 581843) on 05 Oct 2015. This report refers to a 56 year old female patient. Her current conditions included atrial fibrillation, gout, hypertension, hypothyroidism and allergies to DARVOCET and sulfa drugs. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1410901) intramuscularly in the left arm on 22 Oct 2014. On 24 Oct 2014, she had left shoulder/arm pain. She went to emergency room. On 16 Dec 2014, she was referred to primary care physician (PCP) for shoulder pain and left arm pain. On 21 Dec 2014, she had X-ray and cortisone injection. On 31 Dec 2014, her orthopedist reported that she had bursitis and tendonitis of the rotator cuff. On 31 Mar 2015, she had steroid shot and was referred for physical therapy and she had it for 2 weeks. On 23 Apr 2015, she had magnetic resonance imaging (MRI) and results were not reported. On 28 Apr 2015, she had left shoulder cortisone injection. On 26 May 2015, T-pack was administered. The events outcome was reported as condition unchanged. The events were reported as non-serious, but the events tendonitis and bursitis were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 69.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Middle insomnia, Pain in extremity
Clinical narrative: Patient had pain in arm that started after injection and has lasted 30 plus days.
Age: 69.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient had pain in arm that started after injection and has lasted 30 plus days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL, DTAPIPV
Symptoms: Injection site cellulitis, Injection site hypersensitivity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site cellulitis in a 5-year-old female patient who received KINRIX (batch number 5TD93, expiry date 10th September 2017). This case was associated with a product complaint. On 2nd October 2015, the patient received the 1st dose of KINRIX (intramuscular). On 4th October 2015, 2 days after receiving KINRIX, the patient experienced injection site cellulitis (serious criteria hospitalization and GSK medically significant), injection site erythema (serious criteria hospitalization) and injection site swelling (serious criteria hospitalization). On an unknown date, the patient experienced product complaint. The patient was treated with antibiotics. On an unknown date, the outcome of the injection site cellulitis, injection site erythema and injection site swelling were recovering/resolving and the outcome of the product complaint was unknown. It was unknown if the reporter considered the injection site cellulitis, injection site erythema, injection site swelling and product complaint to be related to KINRIX. Additional details were provided as follows: The patient presented to the physician's associate on 4th October 2015 with redness and swelling at the injection site. The patient returned and was seen on 5th October 2015 by the reporting physician and was diagnosed with cellulitis. The patient was placed on unspecified antibiotics and spent the night in the hospital. The patient was improving. A QA report was being submitted. The physician had seen an increase in injection site reaction with KINRIX and the vaccine could be suspect. As a precaution, a QA report was being submitted with the adverse event. The physician had placed one patient in the hospital for a reaction and had heard of another similar situation anecdotally from the friend of the patient's mother. No replacement, but if needed, a vial of vaccine would be available for return from the physician's office. This case was linked to 2 other cases US2015144657 and US2015144658 (reported by the same reporter).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL, DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site cellulitis in a 5-year-old female patient who received KINRIX (batch number 5TD93, expiry date 10th September 2017). This case was associated with a product complaint. On 2nd October 2015, the patient received the 1st dose of KINRIX (intramuscular). On 4th October 2015, 2 days after receiving KINRIX, the patient experienced injection site cellulitis (serious criteria hospitalization and GSK medically significant), injection site erythema (serious criteria hospitalization) and injection site swelling (serious criteria hospitalization). On an unknown date, the patient experienced product complaint. The patient was treated with antibiotics. On an unknown date, the outcome of the injection site cellulitis, injection site erythema and injection site swelling were recovering/resolving and the outcome of the product complaint was unknown. It was unknown if the reporter considered the injection site cellulitis, injection site erythema, injection site swelling and product complaint to be related to KINRIX. Additional details were provided as follows: The patient presented to the physician's associate on 4th October 2015 with redness and swelling at the injection site. The patient returned and was seen on 5th October 2015 by the reporting physician and was diagnosed with cellulitis. The patient was placed on unspecified antibiotics and spent the night in the hospital. The patient was improving. A QA report was being submitted. The physician had seen an increase in injection site reaction with KINRIX and the vaccine could be suspect. As a precaution, a QA report was being submitted with the adverse event. The physician had placed one patient in the hospital for a reaction and had heard of another similar situation anecdotally from the friend of the patient's mother. No replacement, but if needed, a vial of vaccine would be available for return from the physician's office. This case was linked to 2 other cases US2015144657 and US2015144658 (reported by the same reporter).
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Neck pain
Clinical narrative: Pain from middle of the back of my head all the way down to the back of my knees, pulsating and constricting pain, sweating and very dry mouth.  No pain on the front of my body, only in the backside.  Blood pressure shot up.  Faint headache afterwards and slight pain across the chest after pain was subsiding.  No rash.  Felt fine after released from the hospital.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Blood pressure increased, Blood test, Chest pain, Dry mouth
Clinical narrative: Pain from middle of the back of my head all the way down to the back of my knees, pulsating and constricting pain, sweating and very dry mouth.  No pain on the front of my body, only in the backside.  Blood pressure shot up.  Faint headache afterwards and slight pain across the chest after pain was subsiding.  No rash.  Felt fine after released from the hospital.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Electrocardiogram, Headache, Hyperhidrosis
Clinical narrative: Pain from middle of the back of my head all the way down to the back of my knees, pulsating and constricting pain, sweating and very dry mouth.  No pain on the front of my body, only in the backside.  Blood pressure shot up.  Faint headache afterwards and slight pain across the chest after pain was subsiding.  No rash.  Felt fine after released from the hospital.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Cough, Generalised erythema, Injection site urticaria, Nasal congestion
Clinical narrative: Started with hives at injection site, then itching all over, entire body turned red, throat itchy and feeling swollen as well as nose, wheezing cough, anaphylatic reaction.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Nasal pruritus, Pharyngeal oedema, Pruritus generalised, Throat irritation, Wheezing
Clinical narrative: Started with hives at injection site, then itching all over, entire body turned red, throat itchy and feeling swollen as well as nose, wheezing cough, anaphylatic reaction.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Coagulation time shortened, Gingival bleeding, Haemorrhage, Injection site erythema, Injection site rash
Clinical narrative: Pt. had red, raised heated rash and welt at sight of injection. Pt. was unable to run or jog. Pt. developed bleeding gums and increased bleeding, decreased clot time starting 10/2015.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Pt. had red, raised heated rash and welt at sight of injection. Pt. was unable to run or jog. Pt. developed bleeding gums and increased bleeding, decreased clot time starting 10/2015.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head abnormal, Hypoaesthesia oral, Injection site reaction, Lip discolouration, Nervousness
Clinical narrative: Information has been received from a 60 year old female patient with spinal stenosis, pinched nerve and kidney stones referring to herself. On 29-SEP-2015 the patient was vaccinated with ZOSTAVAX (1 shot, lot number was unknown) intramuscularly. There was no concomitant medication. On 12-OCT-2015 (also reported as 12-AUG-2015) at 8:30 pm the patient experienced strong itch on neck, she could not stop scratching. In addition, her right cheek was swelling and gum on bottom of mouth was numb and tingling. She stated that the swelling on her right cheek was the size of a golf ball cut in half. She was very nervous about the adverse reaction. She became pale with discolored lips from adverse reaction. In addition, she was blotchy at the injection site. She was taken to the emergency room (ER) on 12-OCT-2015. The patient was administered an intravenous (IV) with "PEPSID", BENADRYL, and "PREGNOZONE". Furthermore, in October 2015 at hospital in a doctor office the patient had a computerised axial tomogram (CAT) scan to check for an abscess tooth. She was sneezing a lot (in 2015). Test results proved that she had mucus in nasal cavity. Since adverse reaction swelling had gone down significantly. Color had come back in her face. Patient still had puffiness in cheek. She mentioned BENADRYL made her sleepy (in October 2015). She stated that it put her out like a light and was snoring. The outcome of the events (except for pale) was reported as recovering. The causality was not reported. Upon internal review, intravenously with BENADRYL for itch on neck, cheek swelling, gum numb and tingling, pale, discolored lips and injection site blotchy was considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pallor, Paraesthesia oral, Pruritus, Rash macular, Rhinorrhoea
Clinical narrative: Information has been received from a 60 year old female patient with spinal stenosis, pinched nerve and kidney stones referring to herself. On 29-SEP-2015 the patient was vaccinated with ZOSTAVAX (1 shot, lot number was unknown) intramuscularly. There was no concomitant medication. On 12-OCT-2015 (also reported as 12-AUG-2015) at 8:30 pm the patient experienced strong itch on neck, she could not stop scratching. In addition, her right cheek was swelling and gum on bottom of mouth was numb and tingling. She stated that the swelling on her right cheek was the size of a golf ball cut in half. She was very nervous about the adverse reaction. She became pale with discolored lips from adverse reaction. In addition, she was blotchy at the injection site. She was taken to the emergency room (ER) on 12-OCT-2015. The patient was administered an intravenous (IV) with "PEPSID", BENADRYL, and "PREGNOZONE". Furthermore, in October 2015 at hospital in a doctor office the patient had a computerised axial tomogram (CAT) scan to check for an abscess tooth. She was sneezing a lot (in 2015). Test results proved that she had mucus in nasal cavity. Since adverse reaction swelling had gone down significantly. Color had come back in her face. Patient still had puffiness in cheek. She mentioned BENADRYL made her sleepy (in October 2015). She stated that it put her out like a light and was snoring. The outcome of the events (except for pale) was reported as recovering. The causality was not reported. Upon internal review, intravenously with BENADRYL for itch on neck, cheek swelling, gum numb and tingling, pale, discolored lips and injection site blotchy was considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Sneezing, Snoring, Somnolence, Swelling face
Clinical narrative: Information has been received from a 60 year old female patient with spinal stenosis, pinched nerve and kidney stones referring to herself. On 29-SEP-2015 the patient was vaccinated with ZOSTAVAX (1 shot, lot number was unknown) intramuscularly. There was no concomitant medication. On 12-OCT-2015 (also reported as 12-AUG-2015) at 8:30 pm the patient experienced strong itch on neck, she could not stop scratching. In addition, her right cheek was swelling and gum on bottom of mouth was numb and tingling. She stated that the swelling on her right cheek was the size of a golf ball cut in half. She was very nervous about the adverse reaction. She became pale with discolored lips from adverse reaction. In addition, she was blotchy at the injection site. She was taken to the emergency room (ER) on 12-OCT-2015. The patient was administered an intravenous (IV) with "PEPSID", BENADRYL, and "PREGNOZONE". Furthermore, in October 2015 at hospital in a doctor office the patient had a computerised axial tomogram (CAT) scan to check for an abscess tooth. She was sneezing a lot (in 2015). Test results proved that she had mucus in nasal cavity. Since adverse reaction swelling had gone down significantly. Color had come back in her face. Patient still had puffiness in cheek. She mentioned BENADRYL made her sleepy (in October 2015). She stated that it put her out like a light and was snoring. The outcome of the events (except for pale) was reported as recovering. The causality was not reported. Upon internal review, intravenously with BENADRYL for itch on neck, cheek swelling, gum numb and tingling, pale, discolored lips and injection site blotchy was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a new article via a journalist in a website referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. Overall, 6.2 percent of the reported problems were considered serious. The exact adverse events were not reported. The outcome of the events was not reported. It was reported that these types or reports could not determine whether adverse events were caused by the vaccine or just a coincidence. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Malaise, Pain in extremity
Clinical narrative: Extreme pain at site of injection. Raised red area 3" in diameter around site of injection; raising arm above shoulder level is excruciating. All of this is still ongoing as of two days later. I've gotten flu shots every year and never had local site pain this bad. I don't know if it's just something specific to the pneumoccocal vaccine but this a really, really lousy side effect. I also had a severe headache the evening after the vaccination and general malaise the next day, but I don't know whether those had anything to do with the vaccination. The arm pain, though, seems pretty obviously connected.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Arthralgia, Body temperature increased, Chest X-ray, Electrocardiogram, Full blood count
Clinical narrative: Throat swelling x 2 minutes starting immediately after administration. Severe body aches including muscles, skin and joints. Temperature rose to a max of 102.5. Syncopal episode.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Immediate post-injection reaction, Influenza virus test, Metabolic function test, Myalgia, Pain
Clinical narrative: Throat swelling x 2 minutes starting immediately after administration. Severe body aches including muscles, skin and joints. Temperature rose to a max of 102.5. Syncopal episode.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pain of skin, Pharyngeal oedema, Syncope
Clinical narrative: Throat swelling x 2 minutes starting immediately after administration. Severe body aches including muscles, skin and joints. Temperature rose to a max of 102.5. Syncopal episode.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Arthralgia, Blood test normal, Body temperature increased, Chest X-ray normal, Chills
Clinical narrative: Throat swelling x 2 minutes starting immediately after administration. Severe body aches including muscles, skin and joints. Temperature rose to a max of 102.5. Syncopal episode.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Electrocardiogram normal, Full blood count normal, Headache, Hypersensitivity, Immediate post-injection reaction
Clinical narrative: Throat swelling x 2 minutes starting immediately after administration. Severe body aches including muscles, skin and joints. Temperature rose to a max of 102.5. Syncopal episode.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Influenza virus test negative, Loss of consciousness, Migraine, Myalgia, Pain
Clinical narrative: Throat swelling x 2 minutes starting immediately after administration. Severe body aches including muscles, skin and joints. Temperature rose to a max of 102.5. Syncopal episode.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pain of skin, Pharyngeal oedema, Seizure, Urine analysis normal, Vomiting
Clinical narrative: Throat swelling x 2 minutes starting immediately after administration. Severe body aches including muscles, skin and joints. Temperature rose to a max of 102.5. Syncopal episode.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a new article via an journalist in a website referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. There were 8.2 reports of fainting per 100,000 doses and 0.2 blood clots per 100,000 doses, the study shows. Other problems included nausea, headache, a skin reaction at the injection site, an allergic or hypersensitive reaction, skin rash, and autoimmune reactions such as Guillain-Barre syndrome, a potentially life-threatening condition in which the body's immune system attacks part of the nervous system. The outcome of event was not reported. The causality was unknown. Upon internal review, Guillain-Barre syndrome was considered to be medically significant event. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Eye pain, Injection site erythema, Injection site inflammation, Injection site urticaria
Clinical narrative: Injection site very red, inflamed, hot, and large wheal. Pt having pain behind left eye and under left breast (like when she has had shingles previously). NO rash yet, but called pt on 10-9-15 and stated having rash under breast at that time.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash
Clinical narrative: Injection site very red, inflamed, hot, and large wheal. Pt having pain behind left eye and under left breast (like when she has had shingles previously). NO rash yet, but called pt on 10-9-15 and stated having rash under breast at that time.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site urticaria, Pruritus, Skin warm, Swelling
Clinical narrative: Hive started at injection site. Swelling, itching, warmth, red skin. Lasting until current >12 hrs even with Benadryl taken.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives starting under right breast, by Thursday 10/15/2015 AM was all over trunk/abodmen/back. Already taking Zyrtec, added Pepcid and Benadryl. Urgent care added steroid injection IM and prednisone 20mg BID * 4 days. Hives have not reduced or gone away as of today 10/16/2015.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Death, Meningococcal sepsis, Myocarditis, Neisseria test positive
Clinical narrative: Patient died with the cause of death being reported as Acute Myocarditis. Due to: Neisseria Meningitis Septicemia. Isolate tested as Group Y. Being reported as a breakthrough case.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Pyrexia
Clinical narrative: Headache and fever.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pain of skin, Pyrexia, Vomiting
Clinical narrative: Severe fever (103), chills, muscle pain, skin hurt, vomiting.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Nausea, Pallor
Clinical narrative: Experienced light headedness, cold pale moist facial skin, slight nausea, and had to lie down on floor to prevent fainting for a 10 minutes. Husband came into room and lifted head slightly and give me a piece of banana and a grape for sugar. We took blood pressure with calibrated machine and it was extremely low at 76 over 46. Husband walked me to bed and gave me some salt, felt better in 20 more minutes and BP recovered to 109 over 70.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Headache
Clinical narrative: HEAD ACHE - IF I HAD THE CHOICE OF PNEUMONIA OR HEAD ACHE I TAKE HEAD ACHE FELT LIKE MY HEAD WAS GOING TO EXPLODE.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Originally, I had severe itching which lead to hives on my entire torso.
Age: 27.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant.
Age: 46.0
Sex: M
Vaccine: FLUC3
Symptoms: Dizziness, Feeling abnormal, Flushing, Heart rate increased, Muscle fatigue
Clinical narrative: Felt flush and had a strange feeling. Took Tylenol at 11:00 am. Felt some better but still felt strange. At 06:00pm felt rapid heart rate and dizziness. At 11:00 pm rapid heart rate was gone but still felt dizziness and nausea. On 10/16/15 06:30 am feeling dizziness and muscle fatigue with muscle aches, and just an overall strang feeling in my face and head. I went to employee health and informed them of the symptoms. I took 25mg diphenhydramin P.O. at 10:15 10/16/15 feeling some what better but still have a weird hard to describe feeling.
Age: 46.0
Sex: M
Vaccine: FLUC3
Symptoms: Myalgia, Nausea
Clinical narrative: Felt flush and had a strange feeling. Took Tylenol at 11:00 am. Felt some better but still felt strange. At 06:00pm felt rapid heart rate and dizziness. At 11:00 pm rapid heart rate was gone but still felt dizziness and nausea. On 10/16/15 06:30 am feeling dizziness and muscle fatigue with muscle aches, and just an overall strang feeling in my face and head. I went to employee health and informed them of the symptoms. I took 25mg diphenhydramin P.O. at 10:15 10/16/15 feeling some what better but still have a weird hard to describe feeling.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at the injection site.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain, erythema, swelling at injection site. Swelling spreading to upper arm and down to elbow. Fevers as high as 101.4. Headaches.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RED, SWOLLEN, WARM TO TOUCH DOWN TO HER ELBOW.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Nausea, Tremor
Clinical narrative: Mild nausa. Severe chills and shakes. Weakness.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Pt reports arm where injection was became inflamed, red, hot to touch. She believes it was due to the Pneumonia vaccine she received.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Blindness, Disability, Dyskinesia, Generalised tonic-clonic seizure, Hallucination
Clinical narrative: A report has been received from a consumer concerning a 9 years old Female patient. No relevant history and concomitant diseases were reported. The patient had been receiving FLUMIST quadrivalent (intranasal), 0.2 millilitres, as one/single administration during Aug-2013. It was reported that three days after her daughter received the vaccine she began losing her vision and her head began a ticking motion to the left. She was later diagnosed with migraine with auras. Five months after the vaccination was given, in Jan 2014, she had a Grand mal seizure. Reporter stated that since that time her seizures have increased, her migraines have increased, and she now had hallucinations. The reporter's mother stated that her daughter could no longer attend public school due to these health issues. The daughter of the consumer was declared to be disabled. Action taken with FLUMIST quadrivalent was unknown. The outcome of the events of losing vision, Grand mal seizure, head began a ticking motion to the left, migraine with auras and hallucinations was unknown. The company physician considered the events of losing vision and Grand mal seizure as serious due to criteria of Important medical event and disability.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Migraine with aura, Tic
Clinical narrative: A report has been received from a consumer concerning a 9 years old Female patient. No relevant history and concomitant diseases were reported. The patient had been receiving FLUMIST quadrivalent (intranasal), 0.2 millilitres, as one/single administration during Aug-2013. It was reported that three days after her daughter received the vaccine she began losing her vision and her head began a ticking motion to the left. She was later diagnosed with migraine with auras. Five months after the vaccination was given, in Jan 2014, she had a Grand mal seizure. Reporter stated that since that time her seizures have increased, her migraines have increased, and she now had hallucinations. The reporter's mother stated that her daughter could no longer attend public school due to these health issues. The daughter of the consumer was declared to be disabled. Action taken with FLUMIST quadrivalent was unknown. The outcome of the events of losing vision, Grand mal seizure, head began a ticking motion to the left, migraine with auras and hallucinations was unknown. The company physician considered the events of losing vision and Grand mal seizure as serious due to criteria of Important medical event and disability.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Fatigue, pain at injection site (left arm), spreading to head and down leg. 800 mg Ibuprofen at 7pm. 10/16: Tingling in scalp on left side, face, down to knee, increased soreness in shoulder and neck.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Fatigue, pain at injection site (left arm), spreading to head and down leg. 800 mg Ibuprofen at 7pm. 10/16: Tingling in scalp on left side, face, down to knee, increased soreness in shoulder and neck.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain, Paraesthesia, Swelling
Clinical narrative: Patient experienced swelling and soreness.  Patient began noticing tingling as week has gone on.  Now her shoulder is numb and throbbing.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash around injection site. About size of 50-cent piece.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Patient was given 3 flu shots by accident. Patient came in with his Mother, and Sister; to all receive their flu shots. Patient was also getting his 4 year old immunizations. (Varicella, DTaP, MMR, and IPV-plus the flu shot- in total 4 shots). MA drew up all of the shots, asked another MA, for assistance to give patient 2 of his shots, and she would give his other 2 shots. MA grabbed the wrong 2 shots from the wrong pocket and gave them to the patient. The incident was recognized immediately, MA asked other MA to step out with her and it was reported to the Dr immediately, and practice administer. The Mother was made aware and was not upset or alarmed at all. She even jokingly stated that he would be protected from the flu for sure this flu season. An incident report was drew up, and MA discussed with Dr., practice administrator, and her fellow MA's what to do to prevent this from happening again.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Grip strength decreased, Injection site swelling, Injection site warmth, Sensory loss
Clinical narrative: Same side as vaccine administered, face and arm have decreased sensation, moderate to severe joint pain, hand grip strength decreased, mild localized swelling around injection site, mild warmth around injection site, no redness noted.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Fatigue, Mobility decreased, Pyrexia
Clinical narrative: Felt immobilized, extreme fatigue, slight fever, loss of appetite, and chills. Symptoms lasted about 24-36 hours after vaccination.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Chills and Fever. Muscle Ache, Sore Throat, Chest congestion, Coughing. Temperture few days later reached 100.0 F. Symptoms continued over a week and still have all symptons. Treated with cough medicine from doctor and decongestant pills.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Chills and Fever. Muscle Ache, Sore Throat, Chest congestion, Coughing. Temperture few days later reached 100.0 F. Symptoms continued over a week and still have all symptons. Treated with cough medicine from doctor and decongestant pills.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Abnormal behaviour, Aggression, Anger, Screaming
Clinical narrative: Behavior changes. Rage, screaming, kicking walls, hitting. Previously very mellow child with no history of such behavior.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Headache, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Sudden onset nausea, headache, dizziness, paleness, diaphoresis.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue
Clinical narrative: Patient stated that night of getting flu shot around 8:00pm she starting feeling very chilly and fatigued, which continued through all day the following day. She has since recovered.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: I experienced fever, chills, body aches, scratchy throat, headache and fatigue from 10/13/2015 (the evening of the day I received the vaccine) until the morning of 10/16/2015 when these symptoms eased.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Throat irritation
Clinical narrative: I experienced fever, chills, body aches, scratchy throat, headache and fatigue from 10/13/2015 (the evening of the day I received the vaccine) until the morning of 10/16/2015 when these symptoms eased.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Neck pain, Pain, Pain in extremity
Clinical narrative: The vaccine was injected on my left arm. In the afternoon, I began feeling pain on the left side of my back side of my body from my neck to my lower back. It was painful and uncomfortable to move my arm and move my neck and back.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction. red rash, itching, hot to touch. Lasted 4 hours. Returned next day. Resolving itself.