chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Nasopharyngitis, Neck pain, Night sweats, Pain, Pleuritic pain
Clinical narrative: This is a spontaneous report obtained from a contactable consumer from a Pfizer-sponsored program. A 70 year old male patient received, on 05Sep2015, PREVNAR 13 in the right arm at single dose. Relevant medical history included ongoing Suppressed Immune System from 2012 and ongoing White Blood Count much higher than Red Blood Cells began in either Jul2015 or Aug2015. The patient previously, on an unspecified date, experienced an allergic reaction to menthol, penicillins, aspirin, LEVAQUIN and contrast dye. Concomitant medications were unknown. On an unspecified date, the patient experienced extreme fatigue/he was exhausted all the time, headache, muscle pain especially in legs, shoulder pain (lower part of his shoulder hurt), joint pain (starting at the bottom of ankle and kneecap and in the coccyx), neck pain, cold, joint range of motion decreased (limitation of arm movement), decreased appetite. On an unspecified date, the patient experienced chills, body temperature fluctuation, muscle spasms, pain, pleuritic pain (his lungs have been burning on and off like he is starting to have pneumonia) and he was feeling abnormal. The vaccine may be defective. He was feeling dizzy, his nose was clogged. The patient had pain at the injection site, and rash. On 08Sep2015 the patient experienced allergic to the suspension, got sick, spitting and coughing up blood, affecting memory, weakening his muscle tissue in legs, stumbling and falling. He also stated his leg muscle mass was decreasing. The patient noticed that his legs were not as powerful as they were, and they wobble when he first stand up. On 03Dec2015 the patient experienced night sweats, brain was being scrambled. The patient said he may have had brain damage with this product. Clinical outcome of pleuritic pain, brain injury, dizziness, nasal congestion, allergy and product quality issue was unknown. The patient did not recover from the other events at time of this report. Follow up (15Dec2015): New information from a Pfizer-sponsored program from the same contactable consumer included: new events provided, medical history.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report obtained from a contactable consumer from a Pfizer-sponsored program. A 70 year old male patient received, on 05Sep2015, PREVNAR 13 in the right arm at single dose. Relevant medical history included ongoing Suppressed Immune System from 2012 and ongoing White Blood Count much higher than Red Blood Cells began in either Jul2015 or Aug2015. The patient previously, on an unspecified date, experienced an allergic reaction to menthol, penicillins, aspirin, LEVAQUIN and contrast dye. Concomitant medications were unknown. On an unspecified date, the patient experienced extreme fatigue/he was exhausted all the time, headache, muscle pain especially in legs, shoulder pain (lower part of his shoulder hurt), joint pain (starting at the bottom of ankle and kneecap and in the coccyx), neck pain, cold, joint range of motion decreased (limitation of arm movement), decreased appetite. On an unspecified date, the patient experienced chills, body temperature fluctuation, muscle spasms, pain, pleuritic pain (his lungs have been burning on and off like he is starting to have pneumonia) and he was feeling abnormal. The vaccine may be defective. He was feeling dizzy, his nose was clogged. The patient had pain at the injection site, and rash. On 08Sep2015 the patient experienced allergic to the suspension, got sick, spitting and coughing up blood, affecting memory, weakening his muscle tissue in legs, stumbling and falling. He also stated his leg muscle mass was decreasing. The patient noticed that his legs were not as powerful as they were, and they wobble when he first stand up. On 03Dec2015 the patient experienced night sweats, brain was being scrambled. The patient said he may have had brain damage with this product. Clinical outcome of pleuritic pain, brain injury, dizziness, nasal congestion, allergy and product quality issue was unknown. The patient did not recover from the other events at time of this report. Follow up (15Dec2015): New information from a Pfizer-sponsored program from the same contactable consumer included: new events provided, medical history.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Blood test normal, Bone pain, Gait disturbance
Clinical narrative: This is a spontaneous report from a contactable consumer. A 68-year-old female patient received a single dose of PREVNAR 13, on 31Aug2015 on left arm. The patient medical history included thyroid disorder. Concomitant medication included unspecified thyroid medication. On 01Sep2015 she had severe muscular aches, pains in back, hips and thigh muscles, severe skeletal aches, she could hardly walk like her legs were not going to support her at times. She stated that she recently had to have a wheelchair in the airport and that she is terrified. She had horrible pains through her head and neck, pain in both arms. She stated these symptoms have gotten worse. She started to feel a little better, but then events reoccurred and seemed worse. Due to all the events, she went to urgent care a couple times and visited her doctor 2 to 3 times. She saw her doctor in Oct 2015 and again a week before the report. Her doctor was referring her to a rheumatologist and it will be a few weeks until she was seen. Patient stated she never had been unhealthy, and had no issues whatsoever. She had never had muscle pain before. Blood work done on an unspecified date were "perfect". Final outcome of the events was not recovered.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Loss of control of legs, Myalgia, Neck pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 68-year-old female patient received a single dose of PREVNAR 13, on 31Aug2015 on left arm. The patient medical history included thyroid disorder. Concomitant medication included unspecified thyroid medication. On 01Sep2015 she had severe muscular aches, pains in back, hips and thigh muscles, severe skeletal aches, she could hardly walk like her legs were not going to support her at times. She stated that she recently had to have a wheelchair in the airport and that she is terrified. She had horrible pains through her head and neck, pain in both arms. She stated these symptoms have gotten worse. She started to feel a little better, but then events reoccurred and seemed worse. Due to all the events, she went to urgent care a couple times and visited her doctor 2 to 3 times. She saw her doctor in Oct 2015 and again a week before the report. Her doctor was referring her to a rheumatologist and it will be a few weeks until she was seen. Patient stated she never had been unhealthy, and had no issues whatsoever. She had never had muscle pain before. Blood work done on an unspecified date were "perfect". Final outcome of the events was not recovered.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Wheelchair user
Clinical narrative: This is a spontaneous report from a contactable consumer. A 68-year-old female patient received a single dose of PREVNAR 13, on 31Aug2015 on left arm. The patient medical history included thyroid disorder. Concomitant medication included unspecified thyroid medication. On 01Sep2015 she had severe muscular aches, pains in back, hips and thigh muscles, severe skeletal aches, she could hardly walk like her legs were not going to support her at times. She stated that she recently had to have a wheelchair in the airport and that she is terrified. She had horrible pains through her head and neck, pain in both arms. She stated these symptoms have gotten worse. She started to feel a little better, but then events reoccurred and seemed worse. Due to all the events, she went to urgent care a couple times and visited her doctor 2 to 3 times. She saw her doctor in Oct 2015 and again a week before the report. Her doctor was referring her to a rheumatologist and it will be a few weeks until she was seen. Patient stated she never had been unhealthy, and had no issues whatsoever. She had never had muscle pain before. Blood work done on an unspecified date were "perfect". Final outcome of the events was not recovered.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Chills, Drug administered at inappropriate site, Erythema, Feeling hot
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 06Oct2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported for seven patients. This is the fourth of the seven reports. A 72-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 (Batch/Lot #L60103 and expiration date:Dec2016) possibly subcutaneous in left abdominal on 03Sep2015. Relevant medical history included multiple myeloma and concomitant medications were not reported. The patient experienced, on 03Sep2015, rash, pain, hot to touch, tenderness, chills, redness and cellulitis on unknown date. The events were described as follows, the patient complained of rash (7 inch diameter) in abdomen where vaccine was given, tried cold, ibuprofen was done but site getting worse with redness, pain and hot to touch. Patient come into clinic, cellulitic area in left abdomen (where patient received injection) continued to spread outside of borders. Patient received IV vancomycin, switched to oral CIPRO 500mg. The outcome of all the events was unknown. Follow-up (02DEC2015): Follow-up attempts are completed. No further information is expected. Follow-up (14Dec2015) Additional information received from the same contactable pharmacist includes age and gender of the patient, batch/Lot and expiration date, date of vaccination, events onset date and medical history. Tenderness, feeling hot, cellulitis, redness added as adverse events. Case upgraded to serious.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 06Oct2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported for seven patients. This is the fourth of the seven reports. A 72-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 (Batch/Lot #L60103 and expiration date:Dec2016) possibly subcutaneous in left abdominal on 03Sep2015. Relevant medical history included multiple myeloma and concomitant medications were not reported. The patient experienced, on 03Sep2015, rash, pain, hot to touch, tenderness, chills, redness and cellulitis on unknown date. The events were described as follows, the patient complained of rash (7 inch diameter) in abdomen where vaccine was given, tried cold, ibuprofen was done but site getting worse with redness, pain and hot to touch. Patient come into clinic, cellulitic area in left abdomen (where patient received injection) continued to spread outside of borders. Patient received IV vancomycin, switched to oral CIPRO 500mg. The outcome of all the events was unknown. Follow-up (02DEC2015): Follow-up attempts are completed. No further information is expected. Follow-up (14Dec2015) Additional information received from the same contactable pharmacist includes age and gender of the patient, batch/Lot and expiration date, date of vaccination, events onset date and medical history. Tenderness, feeling hot, cellulitis, redness added as adverse events. Case upgraded to serious.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Skin warm, Tenderness, Vaccination site rash
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 06Oct2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported for seven patients. This is the fourth of the seven reports. A 72-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 (Batch/Lot #L60103 and expiration date:Dec2016) possibly subcutaneous in left abdominal on 03Sep2015. Relevant medical history included multiple myeloma and concomitant medications were not reported. The patient experienced, on 03Sep2015, rash, pain, hot to touch, tenderness, chills, redness and cellulitis on unknown date. The events were described as follows, the patient complained of rash (7 inch diameter) in abdomen where vaccine was given, tried cold, ibuprofen was done but site getting worse with redness, pain and hot to touch. Patient come into clinic, cellulitic area in left abdomen (where patient received injection) continued to spread outside of borders. Patient received IV vancomycin, switched to oral CIPRO 500mg. The outcome of all the events was unknown. Follow-up (02DEC2015): Follow-up attempts are completed. No further information is expected. Follow-up (14Dec2015) Additional information received from the same contactable pharmacist includes age and gender of the patient, batch/Lot and expiration date, date of vaccination, events onset date and medical history. Tenderness, feeling hot, cellulitis, redness added as adverse events. Case upgraded to serious.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Malaise, Pericardial effusion, Pneumonia, Renal failure
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her father. A male patient of an unspecified age and ethnicity received on the same unspecified date PREVNAR 13, via an unspecified route of administration at 0.5 ml, single and Flu shot, at 1 DF, single both via an unspecified route of administration. The patient medical history and concomitant medications were not reported. The patient experienced double pneumonia, water around his heart, kidney fail and had been sick for over 30 days all on an unspecified date with outcome of not recovered.
Sex: F
Vaccine: PNC13
Symptoms: Death, Pneumonia pneumococcal
Clinical narrative: This is a spontaneous report from a non-contactable consumer that reported for a patient (patient's sister-in-law). A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced pneumococcal pneumonia on an unspecified date and then died. It was not reported if an autopsy was performed. No follow up attempts possible. No further information expected.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Catheterisation cardiac abnormal, Coronary arterial stent insertion, Decreased appetite, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself and from a contactable nurse. An 80-year-old female patient (height about 5 feet 6 and half inches) received PREVNAR 13 (Lot # M06899), intramuscular at 0.5 ml, single in the left deltoid on 30Oct2015 at 10:25. Medical history included ongoing blood pressure abnormal. Concomitant medication included atenolol (unknown manufacturer) at 50 mg 1x/day, amlodipine (unknown manufacturer), at 2.5 mg for blood pressure abnormal and benazepril (unknown manufacturer) at 20 mg once all started taking it a long time ago and ongoing for blood pressure abnormal. The patient experienced headache and fatigue on 10Nov2015 with outcome of not recovered, muscle weakness and decreased appetite on an unspecified date with outcome of unknown. The patient was hospitalised on 15Nov2015 for 2 days. She did not take any treatment for headaches and fatigue. The consumer mentioned that she had her last blood work done on 30Oct2015 and result was normal. the patient underwent heart catheterization with stent placement on 16Nov2015. Follow-up (15Dec2015): New information obtained from a contactable nurse includes: hospitalization, route of administration, lot # and surgical procedures.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself and from a contactable nurse. An 80-year-old female patient (height about 5 feet 6 and half inches) received PREVNAR 13 (Lot # M06899), intramuscular at 0.5 ml, single in the left deltoid on 30Oct2015 at 10:25. Medical history included ongoing blood pressure abnormal. Concomitant medication included atenolol (unknown manufacturer) at 50 mg 1x/day, amlodipine (unknown manufacturer), at 2.5 mg for blood pressure abnormal and benazepril (unknown manufacturer) at 20 mg once all started taking it a long time ago and ongoing for blood pressure abnormal. The patient experienced headache and fatigue on 10Nov2015 with outcome of not recovered, muscle weakness and decreased appetite on an unspecified date with outcome of unknown. The patient was hospitalised on 15Nov2015 for 2 days. She did not take any treatment for headaches and fatigue. The consumer mentioned that she had her last blood work done on 30Oct2015 and result was normal. the patient underwent heart catheterization with stent placement on 16Nov2015. Follow-up (15Dec2015): New information obtained from a contactable nurse includes: hospitalization, route of administration, lot # and surgical procedures.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 24-year-old female patient who received FLUARIX Quadrivalent (batch number 329TN, expiry date 30th June 2016). Concomitant products included ADDERALL, LEXAPRO and Birth Control. On 4th December 2015, the patient received FLUARIX Quadrivalent (intramuscular) .5 ml. On 4th December 2015, less than a day after receiving FLUARIX Quadrivalent, the patient experienced injection site pain (serious criteria disability), shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, shoulder pain and injected limb mobility decreased were not recovered/not resolved. The reporter considered the injection site pain, shoulder pain and injected limb mobility decreased to be probably related to FLUARIX Quadrivalent. Additional details were provided as follows: The pharmacist reported that the patient was experiencing pain in her upper arm and shoulder where she received her vaccination. The pain was so bad she was not able to pick up anything and it was limiting her range of motion. It hurt for her to  move the arm at all. The pain started the same day she received the vaccine and has gotten progressively worse.
Age: 72.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Pruritus, Pyrexia, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 72-year-old female patient received of PREVENAR 13 and Flu, both on 18Nov2015 at single dose. Medical history and concomitant medications were not provided. Patient took pneumonia vaccine in the past. The patient's arm was itchy and she had a little fever on an unknown date after the vaccination. She also had some tenderness and redness. Patient was hospitalized due to fever, tenderness and redness. The consumer was treated with acetaminophen for pruritus, no treatment given for fever, tenderness and redness. Events resolved on an unknown date.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 15-OCT-2015 the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Peripheral swelling, Red blood cell sedimentation rate normal
Clinical narrative: Swelling, redness at injection site, resolved now. Persistent bilateral hand and foot pain/swelling since the injection 6 months ago.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient reported a painful arm from elbow up to shoulder and red bands of discoloration on arm as well.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient reported a painful arm from elbow up to shoulder and red bands of discoloration on arm as well.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Exposure to vaccinated person, Malaise, Pneumonia, Urine analysis abnormal
Clinical narrative: My mom received Prev 13 Shot and she got sick, gave it to everybody, me her son got it as well now I'm home from hospital they also said I got pneumonia from her getting the shot, I feel horrible, I was in hospital, I'm on all kinds of medicine, all due to her getting that shot, I'm found all kinds of information on that shot and can't find anybody talking good about it, even says that the shot can cause the bacteria to spread. What do I do?
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging spinal abnormal, Pain, Paraesthesia
Clinical narrative: Three-week history of body aches and progressive paresthesias.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Rash
Clinical narrative: Localized rash, edema, and erythema.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Local reaction, Rash generalised
Clinical narrative: Within 24 hrs of immuniza. with large local reaction: redness and swelling of entire deltoid. Then 24-48 hours generalized itchy rash. 5 days after immuniza, rash on deltoid and swelling from mid upper arm over the AC joint.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Rash pruritic
Clinical narrative: Within 24 hrs of immuniza. with large local reaction: redness and swelling of entire deltoid. Then 24-48 hours generalized itchy rash. 5 days after immuniza, rash on deltoid and swelling from mid upper arm over the AC joint.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to an 18 year-old patient of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 23-DEC-2015, the patent was intramuscularly administered the first dose of both an adult formulation of VAQTA injection (50/1.0 U/ml; lot # L018499 with an expiration date 25-FEB-2017; dose was not provided) as well as a pediatric/adolescent formulation of VAQTA injection 25./0.5 (Lot # L027757 with expiration date 08-APR-2018; dose was not provided). This was an outside the labeled recommendations in the prescribing information. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F; In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (Lot # L018499, exp. date: 25-FEB-2017)(route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp, date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L028666, exp. date: 04-NOV-2016) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperatures was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperatures was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 16-JAN-2015, the patient was vaccinated with the first dose of VAQTA (Lot#, expiration date, dose and route of administration were not reported). On 26-JUN-2015, the patient was vaccinated with a second dose of VAQTA (Lot#, expiration date, dose and route of administration were not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Underdose, Vomiting
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On 22-DEC-2015, less than the recommended dose of ROTATEQ (lot number, expiration date and dose unknown) was administered to the patient orally. Concomitant medications were unspecified. Then the patient proceeded to vomit on the same day. The outcome of the events was unknown. The causality between vomiting and oral, ROTATEQ was unspecified. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On 22-OCT-2015 at 6:58pm, vaccine alarm was received, then the worker came into clinic and found freezer out of range. She reported (storage unit temperature at the time was 7.3F, room temperature at the time was 72.0F). She reported to supervisor, and the supervisor called the reporting nurse. As the showed alarm, the supervisor and the nurse discussed whether or not to move vaccine. On the time they were on the phone, the temp reading came down to 5.9 degrees F in 10 min, so the reporter felt confident it would be back within range in a matter of minutes and told the supervisor to leave vaccine in freezer and the reporter would review and submit data next morning. Upon arrival Friday morning 23-OCT-15, freezer was within range. The reporter put X on doses for which this was the first temperature excursion, and put XX on doses that were also involved on out of range incident in October 2015. On unknown dates the patients were vaccinated with doses of these improperly stored PROQUAD (Merck) (20 doses of lot # L032759 with expiration 24-FEB-2017, 5 doses of lot# L024125 with expiration 30-DEC-2016, dose, frequency and route were not reported). This is one of several cases received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 4 year old male patient who was with no pertinent medical history or drug reactions/allergies. On 09-AUG-2012 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (injection, dose and route not reported, lot# G016512, expired date 23-NOV-2013). On 29-JUL-2015 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX (injection, dose and route not reported, Lot L005298, Expiration date unspecified). There was no concomitant medication. The patient presented to office on 13-DEC-2015 (reported as 5 days ago), with lesions that appeared to be chickenpox. There was no treatment. The outcome of the patient was reported as not recovered/not resolved. Causality was not reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 6 year old female patient who was with no pertinent medical history or drug reactions/allergies. On 23-SEP-2010 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (dose, route and lot# not reported). On 16-OCT-2013 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX (dose and route not reported, Lot J005429, Expiration date unspecified). There was no concomitant medication. On 18-DEC-2015 the patient developed chicken pox. The patient was seen in the office on 18-DEC-2015 and presented with spots, multiple lesions that appeared to be chickenpox. There was no treatment. The outcome of the patient was reported as not recovered/not resolved. Causality was not reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram head normal, Full blood count normal, Hyporesponsive to stimuli, Hypotonic-hyporesponsive episode, Lethargy
Clinical narrative: Baby woke up with a high pitched scream. It wasn't really a cry. But a scream, then he would lie there. Then scream again. Also has altered mental status. Lethargic and didn't respond well to stimulation. Mom called 911 and child taken to ED for evaluation. Then admitted to Hospital. By around 6am he was at his baseline. I'm suspicious for hypotonic hyporesponsive episode. Also screaming.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Mental status changes, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal, Screaming, Urine analysis normal
Clinical narrative: Baby woke up with a high pitched scream. It wasn't really a cry. But a scream, then he would lie there. Then scream again. Also has altered mental status. Lethargic and didn't respond well to stimulation. Mom called 911 and child taken to ED for evaluation. Then admitted to Hospital. By around 6am he was at his baseline. I'm suspicious for hypotonic hyporesponsive episode. Also screaming.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling at injection site. Hydrocortisone cream, ice and oral allergy medications.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV9
Symptoms: Immediate post-injection reaction, Presyncope
Clinical narrative: Immediately after receiving HPV9 (second dose) as well as intranasal flu vaccine, pt experienced near syncope and fully recovered at clinic.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt had a rash on the arms and trunk that lasted for about 5 days.
Age: 82.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Feeling hot, Injection site nodule, Rash, Swelling
Clinical narrative: Pt said she had rash develop for about a week before reporting it to RPh on 12/24/15 she said that on 12/23/15 it had swollen but it had gone done by 12/24 even though she said she could still feel a knot where it had been administered.  She said the rash had heat to it.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting projectile
Clinical narrative: Projectile vomiting during sleep, after eating or drinking anything, including water. Child has not vomited again as of 12:00pm 12/24/2015. Child vomited a total 9 times in 10 hours.
Age: 0.4
Sex: F
Vaccine: PNC13
Symptoms: Crying, Poor quality sleep, Respiratory tract congestion, Tremor
Clinical narrative: No longer sleeping well at night, would cry inconsolably and shake her head as if she was trying to get relief from something. Also congested.  This went on for several days, I took her to the doctor after 3 days.
Age: 0.75
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Constipation, Crying, Functional gastrointestinal disorder, Haemorrhoids, Respiratory tract congestion
Clinical narrative: She is congested again, crying and shaking her head with no fever. Bad wheezing. Began having bowel issues, constipation, and hemorrhoids.
Age: 0.75
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Tremor, Wheezing
Clinical narrative: She is congested again, crying and shaking her head with no fever. Bad wheezing. Began having bowel issues, constipation, and hemorrhoids.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Large red lump on arm at injection site.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Influenza, Nasopharyngitis
Clinical narrative: CHILLS. FLU/COLD SYMPTOMS.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On 22-OCT-2015 at 6:58pm, vaccine alarm was received from Security, then the worker came up into clinic and found freezer out of range (storage unit temperature at the time was 7.3F, room temperature at the time was 72.0F). She reported to Supervisor, and the supervisor called the reporting nurse. As LogTag also showed alarm, the supervisor and the nurse discussed whether or not to move vaccine. On the time they were on the phone, the temp reading came down to 5.9 degrees F in 10 min, so the reporter felt confident it would be back within range in a matter of minutes and told the supervisor to leave vaccine in freezer and the reporter would review and submit data next morning. Upon arrival Friday morning 23-OCT-15, freezer was within range. The reporter put X on doses for which this was the first temperature excursion, and put XX on doses that were also involved in out of range incident in October 2015. On unknown dates in 2015, the patients were vaccinated with 16 doses of these improperly stored (Oka/Merck) VARIVAX (lot # L018002, expiration 19-MAY-2017, dose, frequency and route were not reported). This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-DEC-2015 (today), the patient was vaccinated with expire dose of VAQTA lot # L001627 with expiry date of 11-NOV-2015 (unknown route, dose and strength). No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Presyncope, Syncope
Clinical narrative: The patient exhibited a vagal response to the Flu Vaccine, whereby he felt woozy, and biefly fainted, but quickly regained consciousness.  The patient was walked to a chair, elevated his legs, and was given water and cookies.  No medications were warranted.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Usual soreness/stiffness post-shot began evening of shot and has continued since.  Pain and restriction of movement began about a week after shot and have been increasing since.  Full-range of arm motion not possible.  Unable to do "push-ups.
Age: 10.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Abdominal pain upper
Clinical narrative: Stomach pains.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Cough, Decreased appetite, Headache
Clinical narrative: Pt. administered influenza high dose at 10:42 12/23/15 and at 4 pm c/o cough, sore throat x 3 hrs, joint pains at neck, knot in stomach (left) x 10 hrs and felt like vomiting, decreased appetite, chills, slight headache. pt says her headaches and neck pain are better now. (Pt denies fever, no diarrhea, no chest pain, no swelling of hips, tongue or throat, no shortness of breath). Offered appointment and pt declined. Discussed urgent care of ER if symptoms or worsen or fail to improve.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Neck pain, Oropharyngeal pain
Clinical narrative: Pt. administered influenza high dose at 10:42 12/23/15 and at 4 pm c/o cough, sore throat x 3 hrs, joint pains at neck, knot in stomach (left) x 10 hrs and felt like vomiting, decreased appetite, chills, slight headache. pt says her headaches and neck pain are better now. (Pt denies fever, no diarrhea, no chest pain, no swelling of hips, tongue or throat, no shortness of breath). Offered appointment and pt declined. Discussed urgent care of ER if symptoms or worsen or fail to improve.
Age: 1.75
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Dyskinesia, Emotional distress, Injection site urticaria, Loss of consciousness, Pyrexia
Clinical narrative: Patient received her vaccinations and became inconsolable for 1 hour and passed out with some jerking motions. Regained consciousness on her own. Mom reported child having a fever for 30 hours total, as high as 104.8 with small relief from acetaminophen. Mother was able to manage child's condition at home without Dr or ER visit. Mother also reports a welt 1 inch in diameter around the DTaP injection site.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Dyspnoea, Hypoaesthesia oral, Throat tightness
Clinical narrative: After approximately 5 minutes post injection, patient complained of numbness in tongue, trouble swallowing, and trouble breathing. He said his throat felt like it was getting smaller. At that point he was given an EPIPEN and transported to ER.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: 1 day progressive erythema w/itch. Dense. Warm to touch.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema
Clinical narrative: (L) arm red - AUGMENTIN.
Age: 41.0
Sex: F
Vaccine: FLUC3
Symptoms: Cough, Influenza like illness, Pain, Pharyngeal erythema, Pharyngitis
Clinical narrative: Patient states every time she receives a flu injection she becomes ill - apparently received injection on 12/16/2015. Seen in acute care on 12/18/2015 for increased cough congestion along with pharyngitis, body aches and low-grade fever. Exam showed throat erythema with cobblestone appearance. Because of appearance, she was treated with amoxil. She was subsequently seen in the ER on 12/21 for flu like symptoms, discharged to home.
Age: 41.0
Sex: F
Vaccine: FLUC3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Patient states every time she receives a flu injection she becomes ill - apparently received injection on 12/16/2015. Seen in acute care on 12/18/2015 for increased cough congestion along with pharyngitis, body aches and low-grade fever. Exam showed throat erythema with cobblestone appearance. Because of appearance, she was treated with amoxil. She was subsequently seen in the ER on 12/21 for flu like symptoms, discharged to home.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Hypersensitivity, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient presents for swelling and redness around vaccine site on left arm. The swelling began the night after the vaccination on 12/17/2015, became worse and associated with low grade fevers and chills per patient that lasted 48 hours. No swelling of lips or tongue, no breathing difficulty. She followed up on 12/21/2015 and showed me the site, which was red from shoulder to elbow. Did no appear infected and patient reassured that it was a localized allergic reaction. Again, no signs of anaphylaxis. Patient presents again today, this time specifically for this pain and swelling. It is "profoundly different". The swelling is now just around the injection site, it is painful and there is now an area of discoloration. No fever, no difficulty breathing.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient presents for swelling and redness around vaccine site on left arm. The swelling began the night after the vaccination on 12/17/2015, became worse and associated with low grade fevers and chills per patient that lasted 48 hours. No swelling of lips or tongue, no breathing difficulty. She followed up on 12/21/2015 and showed me the site, which was red from shoulder to elbow. Did no appear infected and patient reassured that it was a localized allergic reaction. Again, no signs of anaphylaxis. Patient presents again today, this time specifically for this pain and swelling. It is "profoundly different". The swelling is now just around the injection site, it is painful and there is now an area of discoloration. No fever, no difficulty breathing.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.9 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L028666, exp. date: 04-NOV-2016) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L023936, exp. date: 15-MAR-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.9 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.