chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2015US033477, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555454) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 360086) on 25 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 360086) on 24 Apr 2015. This report refers to a 49-year-old female patient. She had no known allergies. Concomitant medications were not reported. She was vaccinated with FLUVIRIN, (batch number: 1413401), along with PNEUMOVAX (other manufacturer, batch number: K009876) intramuscularly into the right arm on 17 Nov 2014. On the same day after vaccination, the patient had debilitating pain on the arm, headache, nausea, fast heartbeat and fever. The patient had an emergency room visit. The patient's lab data revealed cellulitis. The outcome of the events was condition unchanged. The events were assessed as non-serious. The causality assessment of the events was not reported. Seriousness of the event cellulitis was upgraded based on the NVS-IME list. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413401) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 360086) on 25 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 360086) on 24 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Allergy to vaccine
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 21Nov2014, this case now contains all required information to be considered valid. This is a spontaneous report from a non-clinical study program. A contactable 84-year-old female consumer reported that she received PREVNAR 13, (Lot. J90092, Expiration date: 31May2016, NDC: 00005-1971-05) 0.5ml single dose, on 14Oct2014. The patient had a soy allergy. Concomitant medication were none. On 14Oct2014, the patient had a reaction to drug excipients. The consumer stated she was extremely allergic to soy and that was not told to her that it was a component. As treatment, the patient received prednisone 10 mg (for 4 days). On 18Oct2014 the patient experienced pain in stomach, burning in lungs and extreme cold; on 19Oct2014 she could not sleep in her bed, too much pain, and passed out trying to get up; on 22Oct2014 light headedness and on an unspecified date back pain. She got pneumonia on 01Feb2015 and was very sick for 2 week. The events reaction to drug excipients and lightheadedness did not involve hospitalization. Admission to hospital was involved for the events: almost passed out trying to get up on 21Oct2014 until 30Oct2014, pain in stomach 5 day after shot for 4 weeks, couldn't sleep in her bed 3 weeks after shot, too much pain and extreme cold 4 days after shot for 3 weeks, burning in lungs 4 days after shot for 2 weeks, Back pain 4 days after for 4 weeks. Treatment received was the following: for pain in stomach prednisone 10 mg and ADVIL 3x day; for burning in lungs prednisone 10 mg (4 days); for insomnia prednisone 15 mg and she took 3 ADVIL a day; for loss of consciousness ADVIL; for extreme cold she took 3 ADVIL per day, for back pain 3 ADVIL. No treatment was received for the event almost passed out trying to get up. The patient recovered from adverse events reaction to drug excipients, pain in stomach, loss of consciousness, burning in lungs, lightheadedness, insomnia, back pain and cold on 15Nov2014. The patient did not recover from back pain. Clinical outcome of the event pain was unknown. Follow-up (22Dec2014): New information reported from the same contactable consumer includes: vaccination details (Lot and Expiration date provided), reaction data (pain, and back pain added as additional adverse event), case seriousness updated. Follow-up (28Apr2015): New information reported from a contactable consumer includes: immunization date; dosage, no concomitant medication; hospitalization; reaction to drug excipients onset date; outcome, treatments; pneumonia and very sick for 2 weeks newly added.
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abdominal pain upper, Altered state of consciousness, Back pain, Burning sensation, Dizziness
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 21Nov2014, this case now contains all required information to be considered valid. This is a spontaneous report from a non-clinical study program. A contactable 84-year-old female consumer reported that she received PREVNAR 13, (Lot. J90092, Expiration date: 31May2016, NDC: 00005-1971-05) 0.5ml single dose, on 14Oct2014. The patient had a soy allergy. Concomitant medication were none. On 14Oct2014, the patient had a reaction to drug excipients. The consumer stated she was extremely allergic to soy and that was not told to her that it was a component. As treatment, the patient received prednisone 10 mg (for 4 days). On 18Oct2014 the patient experienced pain in stomach, burning in lungs and extreme cold; on 19Oct2014 she could not sleep in her bed, too much pain, and passed out trying to get up; on 22Oct2014 light headedness and on an unspecified date back pain. She got pneumonia on 01Feb2015 and was very sick for 2 week. The events reaction to drug excipients and lightheadedness did not involve hospitalization. Admission to hospital was involved for the events: almost passed out trying to get up on 21Oct2014 until 30Oct2014, pain in stomach 5 day after shot for 4 weeks, couldn't sleep in her bed 3 weeks after shot, too much pain and extreme cold 4 days after shot for 3 weeks, burning in lungs 4 days after shot for 2 weeks, Back pain 4 days after for 4 weeks. Treatment received was the following: for pain in stomach prednisone 10 mg and ADVIL 3x day; for burning in lungs prednisone 10 mg (4 days); for insomnia prednisone 15 mg and she took 3 ADVIL a day; for loss of consciousness ADVIL; for extreme cold she took 3 ADVIL per day, for back pain 3 ADVIL. No treatment was received for the event almost passed out trying to get up. The patient recovered from adverse events reaction to drug excipients, pain in stomach, loss of consciousness, burning in lungs, lightheadedness, insomnia, back pain and cold on 15Nov2014. The patient did not recover from back pain. Clinical outcome of the event pain was unknown. Follow-up (22Dec2014): New information reported from the same contactable consumer includes: vaccination details (Lot and Expiration date provided), reaction data (pain, and back pain added as additional adverse event), case seriousness updated. Follow-up (28Apr2015): New information reported from a contactable consumer includes: immunization date; dosage, no concomitant medication; hospitalization; reaction to drug excipients onset date; outcome, treatments; pneumonia and very sick for 2 weeks newly added.
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Insomnia, Loss of consciousness, Malaise, Nasopharyngitis, Pneumonia
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 21Nov2014, this case now contains all required information to be considered valid. This is a spontaneous report from a non-clinical study program. A contactable 84-year-old female consumer reported that she received PREVNAR 13, (Lot. J90092, Expiration date: 31May2016, NDC: 00005-1971-05) 0.5ml single dose, on 14Oct2014. The patient had a soy allergy. Concomitant medication were none. On 14Oct2014, the patient had a reaction to drug excipients. The consumer stated she was extremely allergic to soy and that was not told to her that it was a component. As treatment, the patient received prednisone 10 mg (for 4 days). On 18Oct2014 the patient experienced pain in stomach, burning in lungs and extreme cold; on 19Oct2014 she could not sleep in her bed, too much pain, and passed out trying to get up; on 22Oct2014 light headedness and on an unspecified date back pain. She got pneumonia on 01Feb2015 and was very sick for 2 week. The events reaction to drug excipients and lightheadedness did not involve hospitalization. Admission to hospital was involved for the events: almost passed out trying to get up on 21Oct2014 until 30Oct2014, pain in stomach 5 day after shot for 4 weeks, couldn't sleep in her bed 3 weeks after shot, too much pain and extreme cold 4 days after shot for 3 weeks, burning in lungs 4 days after shot for 2 weeks, Back pain 4 days after for 4 weeks. Treatment received was the following: for pain in stomach prednisone 10 mg and ADVIL 3x day; for burning in lungs prednisone 10 mg (4 days); for insomnia prednisone 15 mg and she took 3 ADVIL a day; for loss of consciousness ADVIL; for extreme cold she took 3 ADVIL per day, for back pain 3 ADVIL. No treatment was received for the event almost passed out trying to get up. The patient recovered from adverse events reaction to drug excipients, pain in stomach, loss of consciousness, burning in lungs, lightheadedness, insomnia, back pain and cold on 15Nov2014. The patient did not recover from back pain. Clinical outcome of the event pain was unknown. Follow-up (22Dec2014): New information reported from the same contactable consumer includes: vaccination details (Lot and Expiration date provided), reaction data (pain, and back pain added as additional adverse event), case seriousness updated. Follow-up (28Apr2015): New information reported from a contactable consumer includes: immunization date; dosage, no concomitant medication; hospitalization; reaction to drug excipients onset date; outcome, treatments; pneumonia and very sick for 2 weeks newly added.
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Reaction to excipient, Sleep disorder
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 21Nov2014, this case now contains all required information to be considered valid. This is a spontaneous report from a non-clinical study program. A contactable 84-year-old female consumer reported that she received PREVNAR 13, (Lot. J90092, Expiration date: 31May2016, NDC: 00005-1971-05) 0.5ml single dose, on 14Oct2014. The patient had a soy allergy. Concomitant medication were none. On 14Oct2014, the patient had a reaction to drug excipients. The consumer stated she was extremely allergic to soy and that was not told to her that it was a component. As treatment, the patient received prednisone 10 mg (for 4 days). On 18Oct2014 the patient experienced pain in stomach, burning in lungs and extreme cold; on 19Oct2014 she could not sleep in her bed, too much pain, and passed out trying to get up; on 22Oct2014 light headedness and on an unspecified date back pain. She got pneumonia on 01Feb2015 and was very sick for 2 week. The events reaction to drug excipients and lightheadedness did not involve hospitalization. Admission to hospital was involved for the events: almost passed out trying to get up on 21Oct2014 until 30Oct2014, pain in stomach 5 day after shot for 4 weeks, couldn't sleep in her bed 3 weeks after shot, too much pain and extreme cold 4 days after shot for 3 weeks, burning in lungs 4 days after shot for 2 weeks, Back pain 4 days after for 4 weeks. Treatment received was the following: for pain in stomach prednisone 10 mg and ADVIL 3x day; for burning in lungs prednisone 10 mg (4 days); for insomnia prednisone 15 mg and she took 3 ADVIL a day; for loss of consciousness ADVIL; for extreme cold she took 3 ADVIL per day, for back pain 3 ADVIL. No treatment was received for the event almost passed out trying to get up. The patient recovered from adverse events reaction to drug excipients, pain in stomach, loss of consciousness, burning in lungs, lightheadedness, insomnia, back pain and cold on 15Nov2014. The patient did not recover from back pain. Clinical outcome of the event pain was unknown. Follow-up (22Dec2014): New information reported from the same contactable consumer includes: vaccination details (Lot and Expiration date provided), reaction data (pain, and back pain added as additional adverse event), case seriousness updated. Follow-up (28Apr2015): New information reported from a contactable consumer includes: immunization date; dosage, no concomitant medication; hospitalization; reaction to drug excipients onset date; outcome, treatments; pneumonia and very sick for 2 weeks newly added.
Age: 12.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Haematochezia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of bloody stool in a 12-year-old female patient who received INFANRIX (batch number AT57M, expiry date 31st October 2016). On 22nd April 2015 09:23, the patient received the 1st dose of INFANRIX (intramuscular) .5 ml. In April 2015, several days after receiving INFANRIX, the patient experienced bloody stool (serious criteria GSK medically significant). On 22nd April 2015 09:23, the patient experienced inappropriate age at vaccine administration. In April 2015, the outcome of the bloody stool was recovered/resolved. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the bloody stool to be probably related to INFANRIX. Additional details were reported as follows: A few days after receiving INFANRIX the patient had bloody stools that lasted for 1 day. The patient was too old to receive INFANRIX. The patient was fine at the time of reporting.
Age: 12.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Drug administered to patient of inappropriate age, Haematochezia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of bloody stool in a 12-year-old female patient who received INFANRIX (batch number AT57M, expiry date 31st October 2016). On 22nd April 2015 09:23, the patient received the 1st dose of INFANRIX (intramuscular) .5 ml. In April 2015, several days after receiving INFANRIX, the patient experienced bloody stool (serious criteria GSK medically significant). On 22nd April 2015 09:23, the patient experienced inappropriate age at vaccine administration. In April 2015, the outcome of the bloody stool was recovered/resolved. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the bloody stool to be probably related to INFANRIX. Additional details were reported as follows: A few days after receiving INFANRIX the patient had bloody stools that lasted for 1 day. The patient was too old to receive INFANRIX. The patient was fine at the time of reporting.
Age: 0.16
Sex: F
Vaccine: HIBV
Symptoms: Injection site abscess, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 10 week old premature female patient with hydrocephalus and no drug reactions/allergies. There was no concomitant medication. On 04-MAR-2015, the patient was vaccinated with the first dose of PEDVAXHIB (lot # K015463, expiration date: 09-JUL-2017, dose and route not reported). On approximately 18-MAR-2015, reported as 2 weeks after receiving the vaccine, the patient developed abscess at the injection site. The area of the abscess was swollen and bumpy. On 22-MAR-2015, the patient was hospitalized overnight. The patient was treated with clindamycin. No labs/diagnostic studies were performed. The outcomes of the events were reported as recovered/resolved on an unknown date in 2015. The causality between the events and PEDVAXHIB was not reported. The reporter stated she would like a lot check on PEDVAXHIB that was administered. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp to 100.6 evening after imms given no site soreness no increased fussiness.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). On an unknown date the patient experienced shingles after receiving ZOSTAVAX. The patient sought medical attention. The outcome of the event was unknown. Relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A spontaneous report was received from a licensed practical nurse concerning a female who was 32 years old. On 28-APR-2015 the patient received GARDASIL as 32 years of age. No adverse effect was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Induration, Local swelling
Clinical narrative: May 5th - Red, swollen, hard in local area. May 6th area had gotten larger, hardest went away. Pt also notes sharp pain on her back directly after leaving hospital.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Right arm slightly red and slightly swollen the day following immunization. 2 days later right arm more swollen, more red with red streak going down arm, and 'itchy". Advised Mom to take child back to doctor or walk-in-clinic.
Age: 36.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Glossodynia, Oral mucosal blistering, Pyrexia
Clinical narrative: Patient c/o mouth blisters, sore tongue and fever. She did not check temperature, just felt feverish. She took Tylenol. Had doctor visit 5/6/15.
Age: 32.0
Sex: M
Vaccine: FLU3, MNQ, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pt reported symptoms began with swelling, redness, pain at injection site with increasing swelling progressing to today and accompanied by general feeling of illness.  Instructed patient to seek medical treatment at their private physician immediately.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and tenderness at injection site 4 - 5 days post injection.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site became red, swollen, painful, and itchy.  Was within two hours of injection.  Have put hot compresses on site and taken Tylenol.  (Can send picture if needed.  Give me an e-mail address to send it to.)
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and tenderness at injection site.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperaesthesia, Injection site swelling, Pain of skin, Pyrexia
Clinical narrative: Fever, bicep swelling in arm that received vaccine, generalized skin sensitivity described as pain to any kind of touch.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 07-APR-2015, the patient was vaccinated with VAQTA (25/0.5) (unspecified dose, units and route) which was expired on 25-JAN-2015 (lot # 0532AE). No adverse events were reported. There was no product quality complaints (PQC) involved. The outcome of the events was unknown. No further information was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with Sjogren's syndrome, hypothyroidism, hypercholesterolaemia and reaction to food additive. The patient had reaction, nausea, after monosodium glutamate (MSG) intake. On 14-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # K018172, expiration date 02-DEC-2015), 0.65 ml, subcutaneous in the left post-lateral triceps subcutaneously. Concomitant therapies included levothyroxine sodium (manufacturer unknown) and simvastatin (manufacturer unknown). On 17-APR-2015 (in the morning), the patient awakened with pain and swelling at her injection site (also reported that event occurred over 48 hours after receiving ZOSTAVAX). Her arm remained painful and swollen at the injection site for 4 or 5 days. The patient did not develop a rash. Lab diagnostics studies were not performed. The outcome of injection site pain and injection site swelling was reported as recovered/resolved on an unknown day in April 2015. The relatedness between pain and swelling at the injection site and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site infection, Product quality issue, Staphylococcal infection
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 27Apr2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer who reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age and ethnicity received PREVNAR 13 (Lot # 31687, expiration date and NDC number unknown), via an unspecified route of administration on an unspecified date at single dose. Medical history and concomitant medications were not reported. The patient was administered a vaccine that had an issue and got staph infection at the injection site on an unspecified date. The outcome of the events was unknown. The reporter mentioned that she wanted information regarding safety and quality of this vaccine which they could extend to the patient and she wanted some information to ensure that this vaccine was unable to contain live staph infection.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Pain, Rash, Skin burning sensation, Skin exfoliation
Clinical narrative: Hospitalized for 3 days with dehydration-loss of weight. I went down to 71 lbs. Burning rash up and down my arms and chest area - pain - peeling skin on inside of my hands and arms - some pain took 3 weeks to completely cover - started on left side - went to right side.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: Hospitalized for 3 days with dehydration-loss of weight. I went down to 71 lbs. Burning rash up and down my arms and chest area - pain - peeling skin on inside of my hands and arms - some pain took 3 weeks to completely cover - started on left side - went to right side.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain, Peripheral swelling, X-ray normal
Clinical narrative: 7/10 Pain; Localized swelling as well as in the distal phalanges of the right arm; No numbness.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Seizure, Staring, Vomiting
Clinical narrative: Fever, minor seizure (staring), followed by vomiting.
Sex: U
Vaccine: PNC13
Symptoms: Injection site infection, Product quality issue, Staphylococcal infection
Clinical narrative: The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 27Apr2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer, who reported similar events for 2 patients. This is the 2nd of two reports. An elderly patient of an unspecified ethnicity and gender received PREVNAR 13 (Lot # 31687), via an unspecified route of administration on an unspecified date at 0.5 ml, single. Medical history and concomitant medications were not reported. The patient was administered a vaccine that had an issue and got staph infection at the injection site on an unspecified date. The outcome of the events was unknown. The reporter inquired if there are other reports of this lot producing staph infections. They gave the prefilled vaccine and they wore gloves. The reporter also inquired if staph have been obtained from within the assisted living facility or could the medication cause this.
Sex: M
Vaccine: PNC13
Symptoms: Hypertension, Septic shock
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A male patient of an unspecified age and ethnicity received on 29Apr2015 PREVNAR 13, via an unspecified route of administration at single dose. Relevant medical history and concomitant medications were not reported. The patient behaved hypertensive on 29Apr2015, two hours later the vaccination and he was hospitalized. The patient was in septic shock in Apr2015. The outcome of the events was unknown.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Cardiac arrest, Death, Resuscitation, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable physician. An 88-year-old female patient received PREVNAR 13 (Lot # L36485, Exp. date 01Oct2016, NDC code 00005197101), via an unspecified route of administration at 0.5 ml, single on 28Apr2015. Medical history included congestive heart failure, hypertension, hyperlipidemia, coronary artery disease and stroke. The patient had these medical conditions for at least 10-20 years. Patient was bedbound or wheelchair bound prior to receiving the vaccine. Blood work revealed elevated white blood cell count. Reporter said that she broke her hip, wasn't able to stand on the scale, and had lost a lot of weight. The patient's concomitant medications were not reported. On 28Apr2015, the patient experienced cardiac arrest. Therapeutic measures were taken as a result of cardiac arrest. The patient died on 29Apr2015. It was not reported if an autopsy was performed. The event was described as follows: about a half an hour after the vaccination, she had a cardiac arrest. Reporter did not witness the event. Patient had an arrest, and emergency was called. They resuscitated her and brought to the ER. She arrested again in the ER. Patient just saw reporter for a follow-up visit and reporter decided to give her the vaccine. The reporter called because she was wondering if it was an anaphylactic reaction to the PREVNAR or if there have been any similar reports, she stated she can't prove or disprove that is what happened, but it is a possibility.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm erythema over triceps no signs of infection or cellulitis, swelling and 3 cm hard nodule is TTP and easily moveable at injection site, under skin. Tender to touch pain scale 8/10. No lymphadenopathy of submandibular, axillary or trochlear areas.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. On 21-APR-2015, the patients were vaccinated with doses of GARDASIL (dose, route of administration, anatomical location, lot# and expiration date were not reported), which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Information has been received from a nurse referring to her 1 year old son. No concurrent or historical conditions were reported. On 17-FEB-2015, the patient was vaccinated with MMR II and his first dose of (Merck) VARIVAX (both strength, route, dose, lot# and expiration dates unknown). On an unspecified date in April 2015, patient developed 7 to 8 vesicles on his back, 2 vesicles on his chest and 2 vesicles on his belly. Medical attention was sought by visiting the office of an unspecified physician on an unspecified date. Patient was diagnosed by physician with "atypical chickenpox". No treatment was given. All vesicles resolved on an unspecified date. This is one of several reports from the same source. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash vesicular, Scab
Clinical narrative: Information has been received from a 52 year old male physician referring to himself. The patient had high cholesterol, depression and aspirin (multiple unspecified manufacturers) allergy (the patient developed hives 10-15 years ago after aspirin use, and he recovered on an unspecified date). In April 2013 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, lot# and dose were unknown). Concomitant therapies included atorvastatin and LEXAPRO. On approximately 21-APR-2015, about 2 weeks ago the patient developed shingles with a "V1 ophthalmic distribution on the right side of the nose and right eyelid and on the forehead. There were 5 scabbed vesicular spots on the forehead. The affected area had a burning feeling." The patient went to see a physician for medical attention. There were no lab diagnostics studies performed. The patient started valacyclovir therapy (manufacturer unspecified) for the shingles on 02-MAY-2015. The "burning feeling" was recovering. The shingles were recovering. The relationship of the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 15 year old female patient. No concurrent or historical conditions were reported. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (strength, route and dose unknown, lot # K008931 and expiration date 04-MAR-2017). No adverse effects reported. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Expired product administered, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 28 year old female patient with no drug reactions or allergies and with no medical history. No concomitant medications were reported. On 09-APR-2015, the patient was inadvertently vaccinated with an expired dose of M-M-R II, subcutaneous, lot number: J003790, expiration date 28-MAR-2015, dose 0.5 ml (injection site was not reported). Other suspect therapies included ENGERIX-B, intramuscular, (dose, lot number, expiration date and injection site not reported). On 09-APR-2015, the patient experienced a little bit of pain around injection site. The patient did not seek medical attention. No lab diagnostic studies were performed. The reporting pharmacist believed that the pain reported was mostly due to intramuscular administration of ENGERIX-B. The outcome of the pain around injection site was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Gluteal shingles.
Age: 0.35
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Pyrexia, Rash generalised, Urticaria
Clinical narrative: Started as a couple small spots of rash/hives. Later in the evening he was covered in hives/rash from neck to toe. Were itchy. Had slight fever.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. On 21-APR-2015, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, route of administration, anatomical location, lot# and expiration date were not reported), which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Blood culture negative, Full blood count normal, Injection site erythema, Injection site swelling
Clinical narrative: Swelling of arm with redness. No tenderness or limitation of movement.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Discomfort, Headache, Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: At 1140 on 5/5/15, pt returned to MD office with c/o Left arm swelling, mild discomfort, irritation, LGF, itching and redness where vaccine was administered.  Pt also had headache.  Pt had no other symptoms. MD instructed pt to apply ice to the area on arm affected, take acetaminophen prn for pain and take Claritin 10mg PO q12h prn for itching.  Pt was instructed to return to MD office if symptoms worsen or fail to improve.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pyrexia, Skin irritation
Clinical narrative: At 1140 on 5/5/15, pt returned to MD office with c/o Left arm swelling, mild discomfort, irritation, LGF, itching and redness where vaccine was administered.  Pt also had headache.  Pt had no other symptoms. MD instructed pt to apply ice to the area on arm affected, take acetaminophen prn for pain and take Claritin 10mg PO q12h prn for itching.  Pt was instructed to return to MD office if symptoms worsen or fail to improve.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Headache, Skin reaction
Clinical narrative: At 1140 on 5/5/15, pt returned to MD office with c/o Left arm swelling, mild discomfort, irritation, LGF, itching and redness where vaccine was administered.  Pt also had headache.  Pt had no other symptoms. MD instructed pt to apply ice to the area on arm affected, take acetaminophen prn for pain and take Claritin 10mg PO q12h prn for itching.  Pt was instructed to return to MD office if symptoms worsen or fail to improve.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site bruising
Clinical narrative: Gradual onset and worsening of bruise starting at the site of injection then spreading distally to elbow.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: I gave the 4th dose of DTaP too early. 3rd dose given 11/11/2014. I administered DTaP on 5/6/2015.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a male patient of unknown age. On 06-MAY-2013, the patient was vaccinated with his first dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported). On 09-JUL-2013, the patient was vaccinated with his second dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported). On 19-AUG-2013, the patient was too early vaccinated with his third dose of GARDASIL (dose 0.5 ml, intramuscular, expiration date 25-FEB-2016, lot# was not reported). No adverse effects were reported. Product quality complain (PQC) was not involved. Additional information is not expected because a physician did not wish to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. On 21-APR-2015, the patients were vaccinated with doses of RECOMBIVAX HB (dose, route of administration, anatomical location, lot# and expiration date were not reported), which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Night that she got Tdap she developed pain in index finger of left arm. The pain worsened overnight and felt like she had to rub to straighten 2nd finger. Now with pain>paresthesias 2nd finger (L) hand.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome 4/29/15.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies were reported. On 21-APR-2015, the patients were vaccinated with doses of VAQTA (dose, route of administration, anatomical location, lot# and expiration date were not reported), which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. On 21-APR-2015, the patients were vaccinated with doses of ROTATEQ (route of administration defaulted to oral; dose, lot# and expiration date were not reported), which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age with no drug reactions or allergies. No medical history was provided. On 25-APR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (strength, dose, route and site of administration, lot# and expiry date unspecified). No concomitant medications were reported. On 26-APR-2015, the patient developed a red, hot area below the injection site. The patient sought medical attention, she came to pharmacy and received the treatment, as per pharmacist suggestion, the patient applied cold compresses to the area and took an unspecified antihistamine. No laboratory test were performed. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information is not expected as the reporting pharmacist did not grant permission to perform follow up contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 3, intramuscular. The patient received an improperly stored dose of GARDASIL (lot K010574, expiration 04/08/2017). The patient received her dose, which was her third in the series, on 04/08/2015. No adverse effect reported. No additional information provided. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a first dose of GARDASIL (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. The nurse practitioner stated that unspecified number of patients returned to the office on unspecified dates over 1 year later after receiving a first dose of GARDASIL to receive a second dose of GARDASIL. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 3, intramuscular. The patient received an improperly stored dose of GARDASIL (lot K010574, expiration 04/08/2017). The patient received her dose, which was her third in the series, on 04/14/2015. No adverse effect reported. No additional information provided. This is one of two reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a male patient of unknown age. The patient received a dose of (Merck) VARIVAX injection. The healthcare worker reported that one dose of (Merck) VARIVAX injection (lot # K011082, expiration date 08/08/2016), which was exposed to a temperature outside of the recommended range, was administered to the patient yesterday, on 22APR2015. No adverse effect has been observed or reported. The outcome of incorrect storage and no adverse event is unknown. No additional information was provided. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Chills, Headache, Neck pain
Clinical narrative: Client began to have neck and back pain.  Headache and chills developed overnight. Her primary doctor was called in am of 05/07/2015, with instruction to go to the ER where she was treated and released.  Spouse was instructed to call Public Health and county so that a VAERS report can be made.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Swelling
Clinical narrative: Swelling started within 20 minutes of receiving vaccine. Area is red, itchy, warm for about 3 inches in diameter. C/o sharp, stabbing pains in the area, very tender to touch.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Eructation, Hyperhidrosis, Nausea, Retching
Clinical narrative: (5/2) Next day.. 5 pm-felt sick to stomach/belching. 8pm-chills/shaking/sweating. 11pm-felt like vomiting (dry heaves) by next am (5/3) all resolved. Pt asked me to documeny as she thinks symptoms from vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Tremor
Clinical narrative: (5/2) Next day.. 5 pm-felt sick to stomach/belching. 8pm-chills/shaking/sweating. 11pm-felt like vomiting (dry heaves) by next am (5/3) all resolved. Pt asked me to documeny as she thinks symptoms from vaccine.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Throat scratchy, diarrhea, and whelps with throat later becoming tight.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Dysphagia, Fatigue, Oropharyngeal pain, Sensation of foreign body
Clinical narrative: After 4 hour post vaccination patient had extreme fatigue, went to sleep, woke up at 2 am with sore throat and said it was difficult to swallow because golf ball size feeling in throat. She said her voice was raspy and sore for 2 more days. Claims to be highly allergic to latex products. No latex or natural rubber in the prefilled syringe product.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Dizziness, Dysphonia, Ear pain
Clinical narrative: At first began to hives, which I am still having problems with. Around the same time developed hoarseness, and high blood pressure (149-178), dizziness, swelling, and weakness. A month after began to have earaches, and headaches.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Headache, Hypertension, Swelling, Urticaria
Clinical narrative: At first began to hives, which I am still having problems with. Around the same time developed hoarseness, and high blood pressure (149-178), dizziness, swelling, and weakness. A month after began to have earaches, and headaches.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Erythema, swelling at the injection site.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, left upper arm. No tenderness. No fever. Full ROM. Ice 20 minutes out of every hour for evening (5/4/15). Ice 5/5/15 as often as possible.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Blood iron decreased, Chest discomfort, Dizziness, Dyspnoea, Hypotension
Clinical narrative: Dizziness, shortness of breath, tight chest, pain up back of neck.  Took to ER. Low BP. Low iron. Given fluids sent home. Was fine for four days. Symptoms now back and worse. Neck tingle has been constant.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Neck pain, Paraesthesia
Clinical narrative: Dizziness, shortness of breath, tight chest, pain up back of neck.  Took to ER. Low BP. Low iron. Given fluids sent home. Was fine for four days. Symptoms now back and worse. Neck tingle has been constant.
Age: 1.39
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Reddened area approx. 8 1/2 x 5 cm, warm to touch surrounding injection site of left thigh.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness at injection site.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and tenderness at injection site.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: REDNESS/INFLAMMATION 2 TO 3 INCHES WIDE AROUND INJECTION SITE ON LEFT ARM. PATIENT REPORTS NO PAIN. IT WAS ONLY NOTICED BECAUSE SHE LOOKED IN THE MIRROR.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Myalgia
Clinical narrative: The Patient states she received a flu vaccine in early October, approximately four weeks after, the patient noted extreme muscle weakness. Her upper extremities, lower extremities, and left arm seemed to be the most affected. The patient was subsequently evaluated by a neurologist who thought there was no neurological condition. The patient was subsequently referred to a rheumatologist who made a diagnosis of polymyalgia.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm swollen, red, warm, and itchy at site of injection. Treated with oral Benadryl and ice to site.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Menstruation delayed
Clinical narrative: Missed menstrual period following vaccine. Period was expected April 17 and as of May 7, 2015 has not started. Not due to pregnancy.
Age: 33.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Wrong drug administered
Clinical narrative: NONE NOTED, PATIENT WAS GIVEN WRONG VACCINE. ADMINISTERED PROQUAD TO AN ADULT INSTEAD OF THE SEPERATE MMR AND VARICELLA VACCINES.
Age: 33.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NONE NOTED, PATIENT WAS GIVEN WRONG VACCINE. ADMINISTERED PROQUAD TO AN ADULT INSTEAD OF THE SEPERATE MMR AND VARICELLA VACCINES.