chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Polymerase chain reaction positive, Rash, Vaccination failure
Clinical narrative: Information has been received from the authors in a literature article concerning a 19 year old female with MMR vaccine (manufacturer unknown) (route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at HCA or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency (HCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at HCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (Hl), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The 19 year old patient with known exposure to measles during travel developed disease despite 3 documented MMR (manufacturer unknown) vaccine doses (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative refers to a patient of unknown age. On 30-DEC-2015, the patient was vaccinated with ZOSTAVAX, dose 1. On 24-MAR-2016, the patient was vaccinated with dose 2 of ZOSTAVAX. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Polymerase chain reaction positive, Rash, Vaccination failure
Clinical narrative: Information has been received from the authors in a literature article concerning an unknown gender 21 year old patient with MMR (manufacturer unknown) (route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at HCA or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency (HCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at HCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (Hl), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose, Product name confusion
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an one year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 10-MAR-2016, the patient was vaccinated with a dose of PROQUAD (Merck) (dose and route were not reported, lot # L046507 with expiration date 17-MAY-2017) and a dose of VARIVAX (Merck) (dose and route were not reported, lot # L041207 with expiration date 20-OCT-2017) during the same visit due to product confusion. It was reported that PROQUAD (Merck) was mistaken for which was the intended product. The reporter was not aware of any adverse effects. This is one of several report received from the same source. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Polymerase chain reaction positive, Rash, Vaccination failure
Clinical narrative: Information has been received from the authors in a literature article concerning an unknown gender 25 year old patient with MMR (manufacturer unknown) (route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at HCA or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency (HCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at HCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (Hl), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Discomfort, Hypersensitivity, Lymphadenopathy, Urticaria
Clinical narrative: Reaction/Event: significant discomfort for several days with much suffering; Case Narrative: Initial unsolicited report received from a Non-healthcare professional on 02 March 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu Vaccine) (batch number, dose, dose in series, route and site of administration was not reported) on an unspecified date. It was reported that patient was allergic to chicken feathers. Patient was not allergic to eggs. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had Extreme allergic reaction: lymph nodes very swollen in neck/upper body with hives and significant discomfort for several days with much suffering. Lab data and corrective treatments were not reported. Outcome of events was not reported. List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Burning sensation, Feeling cold, Headache, Hyperaesthesia, Nausea
Clinical narrative: Initial unsolicited report received from a nurse on 10 March 2016. This case involves a 23-year-old male patient who was vaccinated with a intramuscular dose of Adacel (batch number L-U5298, expiration date, dose was not reported) in left deltoid and first intramuscular dose of Menactra (batch number U0216AA, expiration date, dose was not reported) in left deltoid, both on 9 March 2016 at 5 P.M. Illness at time of vaccination and preexisting physician diagnosed allergies, birth defects, medical conditions was denied. Concomitant medications were denied. On 09 March 2016, at 6 P.M, one hour following the vaccination, the patient developed whole body burning sensation, body then goes cold, HA, nausea, skin sensitive. Patient had experienced fever +24 degree Celsius at age of 13. Lab data was reported none. The patient received corrective treatment with Tylenol. The patient was not recovered from events. List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 10 March 2016. This case involves a 23-year-old male patient who was vaccinated with a intramuscular dose of Adacel (batch number L-U5298, expiration date, dose was not reported) in left deltoid and first intramuscular dose of Menactra (batch number U0216AA, expiration date, dose was not reported) in left deltoid, both on 9 March 2016 at 5 P.M. Illness at time of vaccination and preexisting physician diagnosed allergies, birth defects, medical conditions was denied. Concomitant medications were denied. On 09 March 2016, at 6 P.M, one hour following the vaccination, the patient developed whole body burning sensation, body then goes cold, HA, nausea, skin sensitive. Patient had experienced fever +24 degree Celsius at age of 13. Lab data was reported none. The patient received corrective treatment with Tylenol. The patient was not recovered from events. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TD
Symptoms: Dizziness, Eye movement disorder, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: Significant pain at site of injection.  Within a couple minutes feeling nauseaus, went pail, sweating profusely, feeling dizzy, eyes rolling, feeling need to vomit.  After 10 minutes these symptoms subsided but significant pain at sight of injection continued for the next 2 hours.  24 hours later injection site arm remains very sore to move the arm or touch the area.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TD
Symptoms: Pain, Pallor
Clinical narrative: Significant pain at site of injection.  Within a couple minutes feeling nauseaus, went pail, sweating profusely, feeling dizzy, eyes rolling, feeling need to vomit.  After 10 minutes these symptoms subsided but significant pain at sight of injection continued for the next 2 hours.  24 hours later injection site arm remains very sore to move the arm or touch the area.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Respiratory distress
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of respiratory distress in a infant patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced respiratory distress (serious criteria GSK medically significant). On an unknown date, the outcome of the respiratory distress was unknown. The reporter considered the respiratory distress to be possibly related to PEDIARIX. Additional details were provided as follows: The neonatologist (name unknown) informed the reporter that two patients (babies) experienced respiratory distress after vaccination with PEDIARIX. The event occurred in the previous couple of months but specific dates were unknown. The sales representative connected the reporter with agency and agency might also report additional adverse events details. This case has been linked to case US2016GSK043333, reported by the same reporter. No further details were provided.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Seasonal Influenza vaccine. Co-suspect products included VENTOLIN Hfa inhaler for chronic bronchitis and pneumonia. Concurrent medical conditions included chronic bronchitis and pneumonia. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose and VENTOLIN Hfa (inhaled) at an unknown dose and frequency. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine and not applicable after starting VENTOLIN Hfa, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria hospitalization). VENTOLIN Hfa was continued with no change. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Seasonal Influenza vaccine. The reporter considered the influenza to be unrelated to VENTOLIN Hfa. Additional details were provided as follows: The patient experienced flu when she was at home. The patient reported that she was hospitalized in January 2016 and then sent to a rehabilitation center for a month. The patient did not related VENTOLIN HFA to the adverse event experienced by her. This case was considered as suspected vaccination failure since the time to onset for the event and the lab test confirmation for the strain was unknown.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Respiratory distress
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of respiratory distress in a infant patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced respiratory distress (serious criteria GSK medically significant). On an unknown date, the outcome of the respiratory distress was unknown. The reporter considered the respiratory distress to be possibly related to PEDIARIX. Additional details were provided as follows: The neonatologist (name unknown) informed the reporter that two patients (babies) experienced respiratory distress after vaccination with PEDIARIX. The event occurred in the previous couple of months but specific dates were unknown. The sales representative connected the reporter with agency and agency might also report additional adverse events details. This case has been linked to case US2016041905, reported by the same reporter. No further details were provided.
Age: 13.0
Sex: F
Vaccine: HPVX, MENB, HPV4, MENB
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of anaphylactic reaction in a 13-year-old female patient who received BEXSERO. Previously administered products included HPV vaccine (1st dose). Concurrent medical conditions included multiple allergies. Concomitant products included HPV vaccine. On an unknown date, the patient received BEXSERO. On an unknown date, 10 min after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and difficulty breathing. The patient was treated with EPIPEN. On an unknown date, the outcome of the anaphylactic reaction and difficulty breathing were recovered/resolved. The reporter considered the anaphylactic reaction and difficulty breathing to be probably related to BEXSERO. Additional details were received as follows: The reported concomitant dose of HPV vaccine was a subsequent dose of HPV vaccine. The patient did not experience an anaphylactic reaction with first dose of HPV vaccine. The patient was monitored for one hour at vaccination center and then sent home.
Age: 13.0
Sex: F
Vaccine: HPVX, MENB, HPV4, MENB
Symptoms: Cough, Dizziness, Dyspnoea, Pallor
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of anaphylactic reaction in a 13-year-old female patient who received BEXSERO. Previously administered products included HPV vaccine (1st dose). Concurrent medical conditions included multiple allergies. Concomitant products included HPV vaccine. On an unknown date, the patient received BEXSERO. On an unknown date, 10 min after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and difficulty breathing. The patient was treated with EPIPEN. On an unknown date, the outcome of the anaphylactic reaction and difficulty breathing were recovered/resolved. The reporter considered the anaphylactic reaction and difficulty breathing to be probably related to BEXSERO. Additional details were received as follows: The reported concomitant dose of HPV vaccine was a subsequent dose of HPV vaccine. The patient did not experience an anaphylactic reaction with first dose of HPV vaccine. The patient was monitored for one hour at vaccination center and then sent home.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Numbness to both hands, fingertips, tingling and to facial area to this date. Pain to injection site and arm (left arm). Difficulty moving arm, with pain.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Numbness to both hands, fingertips, tingling and to facial area to this date. Pain to injection site and arm (left arm). Difficulty moving arm, with pain.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: NO ADVERSE EVENT OCCURRED DUE TO ADMINISTRATION; WRONG MEDICATION/WRONG ROUTE.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Irregular shaped, red, 2 to 4 mm in diameter, non-itchy rash appeared on patient's chest and has spread to abdomen, back and under arms.
Age: 34.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 34-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions/allergies was reported. On 23-MAR-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (Merck) (dose, lot #, expiry date, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Dyspnoea, Injection site erythema, Pain in extremity
Clinical narrative: On 3/23/16 pt received a PNEUMOVAX from her PCP (11:40 am) 7 hour later, pt. presented to urgent care Dept. c/o chest pain and sob with redness and pain on injection arm site. Pt was given BENADRYL and SOLU-MEDROL IV and was transferred to hospital ED.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site reaction
Clinical narrative: 3 inches circular reaction at site of injection left arm.
Sex: U
Vaccine: HPV9
Symptoms: Adverse event, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a healthcare professional (medical assistant) via company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not provided. On unspecified dates, the patient was vaccinated with 2 doses of GARDASIL (dose, strength, route, vaccination site not provided). On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, strength, route, vaccination site not provided) to complete the third dose of HPV vaccination series. After the administration of GARDASIL 9, the patient experienced an unspecified reaction. No further information was provided. Product quality complaint (PQC) was not reported. The outcome and causality of the adverse event was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unspecified. On 06-AUG-2014, the patient received vaccination with ZOSTAVAX (lot # L035506, expiry date: 16-DEC-2016) via subcutaneous route and received it again on 29-MAR-2016 (extra dose administered). No adverse effect was reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: 3 year old with cochlear implants all other vaccines up to date with no history of reactions needed PNEUMOVAX 23 due to cochlear implants - seen 3-22-16 in good health and given vaccine. Reseen 3-29-16 with hx of red maculopapular rash since 3-25-16 on trunk and face - not itchy or painful. No other symptoms. Rash fading when seen.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No pertinent medical history, drug reaction/ allergies or concurrent conditions were reported. On 29-MAR-2016, the patient was inadvertently vaccinated with an expired dose of VARIVAX (Merck) (which had a lot of K003421 and expiration date of 06-MAR-2016; however, dose, dosage number and route of administration were not reported). This was reported supported. Nonetheless, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Dysphagia, Glossopharyngeal nerve disorder, Herpes zoster, Pain of skin
Clinical narrative: This spontaneous report was received from a 90 year old female patient reporting on herself. The patient's concurrent conditions were not provided, the patient's medical history included allergy to morphine and penicillin. The patient stated that she was part of a study in 2004 for shingles prevention. In 2004, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (strength, dose, lot number and expiration date were not provided). Concomitant therapies included CARAFATE. The patient stated that in December 2014 she was diagnosed with shingles, which was followed by a severe postherpetic neuralgia. The patient described the sensation as 'stabbing pain' shooting through her skin. In June 2015, the patient was hospitalized for four days for severe dehydration and was unable to swallow. The patient stated that the "nerve endings in her tongue and throat" made it almost impossible for her to swallow (glossopharyngeal nerve disorder). The patient received a pain management. There was no PQC involved. The outcome of herpes zoster, vaccination failure, dehydration, pain of skin, postherpetic neuralgia, glossopharyngeal nerve disorder and dysphagia was reported as not recovered. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Vaccination failure
Clinical narrative: This spontaneous report was received from a 90 year old female patient reporting on herself. The patient's concurrent conditions were not provided, the patient's medical history included allergy to morphine and penicillin. The patient stated that she was part of a study in 2004 for shingles prevention. In 2004, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (strength, dose, lot number and expiration date were not provided). Concomitant therapies included CARAFATE. The patient stated that in December 2014 she was diagnosed with shingles, which was followed by a severe postherpetic neuralgia. The patient described the sensation as 'stabbing pain' shooting through her skin. In June 2015, the patient was hospitalized for four days for severe dehydration and was unable to swallow. The patient stated that the "nerve endings in her tongue and throat" made it almost impossible for her to swallow (glossopharyngeal nerve disorder). The patient received a pain management. There was no PQC involved. The outcome of herpes zoster, vaccination failure, dehydration, pain of skin, postherpetic neuralgia, glossopharyngeal nerve disorder and dysphagia was reported as not recovered. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood test normal, Chest X-ray normal, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Baby started losing color and turning pale. Then went completely limp. He wouldn't open his eyes or respond to anything. It came on quickly, within 2 minutes from totally normal to pale and limp.  No warnings whatsoever. Called 911 and taken by ambulance to hospital. Probably within about 30 minutes he was coming back to normal. He was admitted and observed overnight. Had his oxygen monitored the entire time. Had 2 X-rays, an echo, and EKG, EEG, and lots of blood work. Everything came back normal.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypotonia, Pallor, Unresponsive to stimuli
Clinical narrative: Baby started losing color and turning pale. Then went completely limp. He wouldn't open his eyes or respond to anything. It came on quickly, within 2 minutes from totally normal to pale and limp.  No warnings whatsoever. Called 911 and taken by ambulance to hospital. Probably within about 30 minutes he was coming back to normal. He was admitted and observed overnight. Had his oxygen monitored the entire time. Had 2 X-rays, an echo, and EKG, EEG, and lots of blood work. Everything came back normal.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Musculoskeletal pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: High fever of 102, nausea, vomiting, severe pain in arm, back and shoulders.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: High fever of 102, nausea, vomiting, severe pain in arm, back and shoulders.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Started to note then pain and swelling in the area at the area of the shot;  following day she noted increased swellingand pain, redness to about 15 cm diameter, and it has abated 3/31/2016 AM with less redness and swelling.  No fevers chills; no facial swelling, breathing issues or tongue and lip swelling.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia
Clinical narrative: Fever- gave Tylenol to reduce fever and he got better.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Faeces discoloured, Haematochezia, Irritability, Mucous stools, Vomiting
Clinical narrative: The day after the vaccine was administered the patient had a large vomit and then had a blood stool.  Only one episode of bloody stool.  The patient was also fussy and her stools have been green and mucus.
Age: 32.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain and tenderness at the site of injection in my left shoulder started around midnight on 3/31/16. I woke up later in the AM on the same date to severe pain and tenderness at the site of injection in my left shoulder. I have difficulty moving my arm where the shot was given. It has not improved at all.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Urticaria
Clinical narrative: Localized rash to injection site followed by hives outbreak over entire body 3 hours after onset.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Decreased appetite, Diarrhoea, Headache, Muscular weakness, Pain
Clinical narrative: Started vomiting day after vaccine administration. Two days after administration headache, fever, body aches, muscle weakness, diarrhea, and lack of appetite.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: Started vomiting day after vaccine administration. Two days after administration headache, fever, body aches, muscle weakness, diarrhea, and lack of appetite.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Warm rash on arm at injection site, patient visited her doctor and was checked out and released.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site warmth
Clinical narrative: Redness at injection site, which spread.  Hard and warm to touch after injection.  Progressively got worse.  On 3/31/16, patient called pharmacy to report reaction.  Patient was told to come in to be examined by nurse practitioner on site.  Diagnosis:  probably infection at injection site.  Treated with Cephalexin 500mg qid for 10 days.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness at injection site, which spread.  Hard and warm to touch after injection.  Progressively got worse.  On 3/31/16, patient called pharmacy to report reaction.  Patient was told to come in to be examined by nurse practitioner on site.  Diagnosis:  probably infection at injection site.  Treated with Cephalexin 500mg qid for 10 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Inflammation, Pain in extremity
Clinical narrative: Patient came to pharmacy.  Her left arm was inflamed, red, painful (according to patient) and has blisters.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Localized reaction at injection site--swelling, pain, erythema.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown dates, the patients were vaccinated orally with improperly stored doses of ROTATEQ lot # L013204, expiry date 28-JAN-2017 and lot # L029617, expiry date 09-MAY-2017 (dose was not specified). The administered doses of ROTATEQ underwent temperature excursion at 49 Fahrenheit degrees for 15 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Blindness
Clinical narrative: Exact date of vaccine and adverse event is not known. Pt recalls sometime in Nov-Jan 1991-1992. At the time of her first influenza vaccine in 1991 pt was feeling well and had no initial problems with the vaccination. Approx. 12-16 hrs. post vaccination, while bending forward to brush her teeth she developed total blindness in both eyes. Denied pain, discomfort or headaches. Her sight returned by the end of the day and she has had no reoccurrence. She did seek medical evaluation but did not undergo any formal diagnostic testing. She was never given a diagnosis and has not received the influenza vaccine since that incident. She has received other vaccinations to include the pneumonia vaccine without problems.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unspecified. Pharmacist reported that the patient visited the pharmacy on 21-MAR-2016 with orders regarding series of RECOMBIVAX HB 40 microgram, intramuscular injection and administered the first dose on the same day (reported as day 0). The patient administered second dose on 28-MAR-2016 (reported as day 7) and third dose was yet to be administered on day 14. Pharmacist reported that the patient was on a list for a lung transplant, which was reason for the altered dose schedule of vaccination (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 16 year old female patient. There was no concurrent condition or medical history reported. On 24-MAR-2016 the patient was inadvertently administered a dose of the adult formulation of VAQTA (lot # L031196, expiration date 05-FEB-2017) (dosage and strength unknown) intramuscularly. This was outside the labeled recommendation in the VAQTA prescribing information. This was the only dose of VAQTA this patient had ever been administered. No adverse effect was required. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Rash
Clinical narrative: Raised bumps on the abdomen 1 day after injection.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant medications were not reported. On unknown dates, the patients received improperly stored VARIVAX (Merck) lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Flank pain, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a 40 year old female patient regarding herself. The patient's concurrent conditions included asthma. It was reported that the patient had received BOOSTRIX, BEXSERO and RECOMBIVAX HB in the past. It was reported that the patient had no drug reactions or allergies. On 14-MAR-2016 at 7 or 7:30 in the morning the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, once intramuscularly. The patient stated that on the day she was given PNEUMOVAX 23 they attempted to do a blood draw from her left arm before giving her the vaccine but they could not do it, so they took the blood from her other arm. The patient was not taking any medications concomitantly. On 14-MAR-2016, within 2 hours of getting the vaccination patient developed a lot of pain and swelling, the swelling went about 7 inches down her arm and it went around the entire circumference of her and the entire area of the swelling was a light red color. On 14-MAR-2016 the patient was also unable to lift her arm more than a couple inches from a sitting position. The pain was severe and it hurt to have clothing touch it. It was reported that the pain reached its peal at around 10:00 on the day the patient received the PNEUMOVAX 23. The patient also stated that it took about 36 hours before she was able to lift her arm more than couple from a seated position. On approximately 15-MAR-2016 (also reported as yesterday) the patient was able to left her arm to shoulder height and an approximately 16-MAR-2016 (reported as today) she has full motion. On an unknown date approximately in March 2016 after receiving PNEUMOVAX 23 the patient experienced pain in her left side and in the left side of her neck, but didn't specify the status of those pains or when they began. The patient did not undergo any lab diagnostics studies. There was no treatment given for the events. The action taken with the therapy with PNEUMOVAX 23 was unknown. The outcome of injection site pain, hypokinesia, erythema, peripheral swelling, swelling and injection site swelling was reported as recovering. The outcome of the event pain in her left side and in the left side of her neck was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain
Clinical narrative: This spontaneous report as received from a 40 year old female patient regarding herself. The patient's concurrent conditions included asthma. It was reported that the patient had received BOOSTRIX, BEXSERO and RECOMBIVAX HB in the past. It was reported that the patient had no drug reactions or allergies. On 14-MAR-2016 at 7 or 7:30 in the morning the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, once intramuscularly. The patient stated that on the day she was given PNEUMOVAX 23 they attempted to do a blood draw from her left arm before giving her the vaccine but they could not do it, so they took the blood from her other arm. The patient was not taking any medications concomitantly. On 14-MAR-2016, within 2 hours of getting the vaccination patient developed a lot of pain and swelling, the swelling went about 7 inches down her arm and it went around the entire circumference of her and the entire area of the swelling was a light red color. On 14-MAR-2016 the patient was also unable to lift her arm more than a couple inches from a sitting position. The pain was severe and it hurt to have clothing touch it. It was reported that the pain reached its peal at around 10:00 on the day the patient received the PNEUMOVAX 23. The patient also stated that it took about 36 hours before she was able to lift her arm more than couple from a seated position. On approximately 15-MAR-2016 (also reported as yesterday) the patient was able to left her arm to shoulder height and an approximately 16-MAR-2016 (reported as today) she has full motion. On an unknown date approximately in March 2016 after receiving PNEUMOVAX 23 the patient experienced pain in her left side and in the left side of her neck, but didn't specify the status of those pains or when they began. The patient did not undergo any lab diagnostics studies. There was no treatment given for the events. The action taken with the therapy with PNEUMOVAX 23 was unknown. The outcome of injection site pain, hypokinesia, erythema, peripheral swelling, swelling and injection site swelling was reported as recovering. The outcome of the event pain in her left side and in the left side of her neck was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling 6" x 4" on upper left deltoid.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash. Dexamethasone 4 mg once.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 30-MAR02916, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (which had a lot # of K009874 and expiration date of 19-MAR-2016; however, dose, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 40 year old patient of unknown gender. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unspecified. Reporting nurse stated that the patient was indicated for vaccination with M-M-R II and VARIVAX (Merck), but was administered with one dose of PROQUAD (Merck) (lot # L040415, expiry date: 13-APR-2017) instead (inappropriate schedule of drug administration). There was no product confusion. No adverse effect was reported. It was reported that M-M-R II and VARIVAX (Merck) appeared on the product list, but were not administered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On an unspecified date in October 2014, the patient was vaccinated with the first dose of GARDASIL, later on December 2014 the second dose of the series was administered (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. On 30-MAR-2016, the patient went to the office to receive the third dose of the vaccination series (inappropriate schedule of drug administration). No adverse effect were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pt received immunizations 3-30-16. Mom noticed immunization site, red, swollen in AM before sending child to school. After returning from school ice applied, swelling increased (L) arm pain noted. Warmth to site.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None at this time. Tdap dose given to 5 yr old.
Age: 72.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, sore, swollen left arm only. I spoke to PCP office's nurse. They were going to set up an appointment today. Nurse believes it's cellulitis from description of the injection site.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patient of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. Since 30-OCT-2015, the patients were vaccinated with PROQUAD subcutaneous, lot # L030592 (expiration date 12-FEB-2017) (dose, dose number and frequency were not provided) that were stored at 5 Celsius degrees for 24 hours. Concomitant medications were not reported. No adverse events were reported. This is one of two reports from the same source. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Feeling hot, Hyperhidrosis, Odynophagia, Pain
Clinical narrative: 3-30-16  at 8pm - feeling hot tired. 3-31-16 at 4am - felt sweaty; patient notices bumps on face and swollen face, reddish face bumps on lips and the whole body hurts and swallowing.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Swelling face
Clinical narrative: 3-30-16  at 8pm - feeling hot tired. 3-31-16 at 4am - felt sweaty; patient notices bumps on face and swollen face, reddish face bumps on lips and the whole body hurts and swallowing.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Oedema, Pain
Clinical narrative: Rec'd MENVEO #1 at WCE in office on 3/24/16 in AM. S/S began same day - PM. (+) edema; c/o pain with movement and slight pink area at site (Lt upper arm). BENADRYL and ibuprofen with little relief. On exam, pink area approximately 6 x 8 cm. TX = cont. ibuprofen 400 mg po q 6-8 hours; BENADRYL PRN and ice pack 20 min. on 3-4 x/d.