chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of COMVAX (lot # J013884 and expiration date 19-AUG-2016, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. There was no previous temperature excursion. The temperature of the excursion was 59F and the time frame was 16 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received form a registered nurse and refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of ROTATEQ (lot # K017573 and expiration date 11-JUN-2016, lot # L013193 and expiration date 20-JAN-2017, orally, dose was not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. The temperature of the first excursion was 59F and the time frame was 16 hours. The temperature of the second excursion was 32F and the time frame was 120 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX with lot # L009205, expiry date 17-MAR-2017; dose, route of administration and anatomical location not reported). The doses of (Oka/Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, TD
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Administered Adult dose of Hep B vaccine to pediatric 11yr old. Pt was contacted following day, no adverse event noted to date.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Injection site faint redness approx 1" X 2" with mild itching.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Given MMRV on 4/6/16. On 4/7/16 started with a small area of surrounding redness and induration to the left arm @ site of injection. Increased size of redness and induration on 4/8/16.
Age: 0.17
Sex: M
Vaccine: 6VAX-F
Symptoms: Blood test, Crying, Fatigue, Injection site induration, Injection site pain
Clinical narrative: Excessive crying non stop, extreme tiredness, some pain in thighs ongoing for 2 weeks. When 4 months shots occurred bumps got bigger on thigh where the injection was received. It's very painful to the touch. The bumps are still hard and bigger then in inch in daiameter. You can see the needle point where the shot was injected.
Age: 0.17
Sex: M
Vaccine: 6VAX-F
Symptoms: Injection site swelling, Irritability, Pain in extremity
Clinical narrative: Excessive crying non stop, extreme tiredness, some pain in thighs ongoing for 2 weeks. When 4 months shots occurred bumps got bigger on thigh where the injection was received. It's very painful to the touch. The bumps are still hard and bigger then in inch in daiameter. You can see the needle point where the shot was injected.
Age: 51.0
Sex: F
Vaccine: HIBV, MENB, MNQ, PPV
Symptoms: Anion gap decreased, Blood albumin normal, Blood calcium decreased, Blood chloride normal, Blood creatinine normal
Clinical narrative: 51 year-old F with multiple medical problems. Received PPSV23, Hib, MCV4P, and MenB vaccines on 28 Jan 2016. Received Hib and PPV23 in left upper arm, and received both meningococcal vaccines in right upper arm. Within 12 hours of vaccine receipt, patient noted reaction at vaccination site; initially, redness, warmth, swelling and tenderness about 2" in diameter in left upper arm, then rapidly increased over the next 24 hours. No streaking or lymphadenopathy. Patient also felt feverish on 29 Jan and her temperatures were initially around 101. She began self-treating with Tylenol and intermittent ice packs to left upper arm. By 30 Jan (post-vaccination day 2), patient's site reaction extended from left shoulder almost to elbow and affected area was about 2/3 circumferential around area of injections. Her temperatures peaked at 103.3 and she was shivering vigorously. She also noted her heart beat was rapid, but denies palpitations. Patient denies n/v, headaches, or dyspnea; she had minor body aches. During this time, she had a runny nose, which was responsive to treatment with antihistamines. She sought evaluation on morning of 30 January at Emergency Department. Initial vital signs: T 102.5, BP 132/77, HR 113, RR 18. She was treated with IV fluids and Tylenol. Her lab work was significant for leukocytosis. She was released after approximately 2 1/2 hours of ED check in. Diagnosis: presume fever/leukocytosis secondary to vaccine administration, vital signs and lab consistent with SIRS. Patient was discharged on Tylenol as needed, not to exceed 2 grams daily. Complete resolution of symptoms within 48 hours of ER evaluation.
Age: 51.0
Sex: F
Vaccine: HIBV, MENB, MNQ, PPV
Symptoms: Blood glucose normal, Blood magnesium normal, Blood phosphorus decreased, Blood sodium decreased, Blood urea normal
Clinical narrative: 51 year-old F with multiple medical problems. Received PPSV23, Hib, MCV4P, and MenB vaccines on 28 Jan 2016. Received Hib and PPV23 in left upper arm, and received both meningococcal vaccines in right upper arm. Within 12 hours of vaccine receipt, patient noted reaction at vaccination site; initially, redness, warmth, swelling and tenderness about 2" in diameter in left upper arm, then rapidly increased over the next 24 hours. No streaking or lymphadenopathy. Patient also felt feverish on 29 Jan and her temperatures were initially around 101. She began self-treating with Tylenol and intermittent ice packs to left upper arm. By 30 Jan (post-vaccination day 2), patient's site reaction extended from left shoulder almost to elbow and affected area was about 2/3 circumferential around area of injections. Her temperatures peaked at 103.3 and she was shivering vigorously. She also noted her heart beat was rapid, but denies palpitations. Patient denies n/v, headaches, or dyspnea; she had minor body aches. During this time, she had a runny nose, which was responsive to treatment with antihistamines. She sought evaluation on morning of 30 January at Emergency Department. Initial vital signs: T 102.5, BP 132/77, HR 113, RR 18. She was treated with IV fluids and Tylenol. Her lab work was significant for leukocytosis. She was released after approximately 2 1/2 hours of ED check in. Diagnosis: presume fever/leukocytosis secondary to vaccine administration, vital signs and lab consistent with SIRS. Patient was discharged on Tylenol as needed, not to exceed 2 grams daily. Complete resolution of symptoms within 48 hours of ER evaluation.
Age: 51.0
Sex: F
Vaccine: HIBV, MENB, MNQ, PPV
Symptoms: Carbon dioxide normal, Chills, Haematocrit normal, Haemoglobin normal, Heart rate increased
Clinical narrative: 51 year-old F with multiple medical problems. Received PPSV23, Hib, MCV4P, and MenB vaccines on 28 Jan 2016. Received Hib and PPV23 in left upper arm, and received both meningococcal vaccines in right upper arm. Within 12 hours of vaccine receipt, patient noted reaction at vaccination site; initially, redness, warmth, swelling and tenderness about 2" in diameter in left upper arm, then rapidly increased over the next 24 hours. No streaking or lymphadenopathy. Patient also felt feverish on 29 Jan and her temperatures were initially around 101. She began self-treating with Tylenol and intermittent ice packs to left upper arm. By 30 Jan (post-vaccination day 2), patient's site reaction extended from left shoulder almost to elbow and affected area was about 2/3 circumferential around area of injections. Her temperatures peaked at 103.3 and she was shivering vigorously. She also noted her heart beat was rapid, but denies palpitations. Patient denies n/v, headaches, or dyspnea; she had minor body aches. During this time, she had a runny nose, which was responsive to treatment with antihistamines. She sought evaluation on morning of 30 January at Emergency Department. Initial vital signs: T 102.5, BP 132/77, HR 113, RR 18. She was treated with IV fluids and Tylenol. Her lab work was significant for leukocytosis. She was released after approximately 2 1/2 hours of ED check in. Diagnosis: presume fever/leukocytosis secondary to vaccine administration, vital signs and lab consistent with SIRS. Patient was discharged on Tylenol as needed, not to exceed 2 grams daily. Complete resolution of symptoms within 48 hours of ER evaluation.
Age: 51.0
Sex: F
Vaccine: HIBV, MENB, MNQ, PPV
Symptoms: Injection site erythema, Leukocytosis, Pain, Platelet count decreased, Pyrexia
Clinical narrative: 51 year-old F with multiple medical problems. Received PPSV23, Hib, MCV4P, and MenB vaccines on 28 Jan 2016. Received Hib and PPV23 in left upper arm, and received both meningococcal vaccines in right upper arm. Within 12 hours of vaccine receipt, patient noted reaction at vaccination site; initially, redness, warmth, swelling and tenderness about 2" in diameter in left upper arm, then rapidly increased over the next 24 hours. No streaking or lymphadenopathy. Patient also felt feverish on 29 Jan and her temperatures were initially around 101. She began self-treating with Tylenol and intermittent ice packs to left upper arm. By 30 Jan (post-vaccination day 2), patient's site reaction extended from left shoulder almost to elbow and affected area was about 2/3 circumferential around area of injections. Her temperatures peaked at 103.3 and she was shivering vigorously. She also noted her heart beat was rapid, but denies palpitations. Patient denies n/v, headaches, or dyspnea; she had minor body aches. During this time, she had a runny nose, which was responsive to treatment with antihistamines. She sought evaluation on morning of 30 January at Emergency Department. Initial vital signs: T 102.5, BP 132/77, HR 113, RR 18. She was treated with IV fluids and Tylenol. Her lab work was significant for leukocytosis. She was released after approximately 2 1/2 hours of ED check in. Diagnosis: presume fever/leukocytosis secondary to vaccine administration, vital signs and lab consistent with SIRS. Patient was discharged on Tylenol as needed, not to exceed 2 grams daily. Complete resolution of symptoms within 48 hours of ER evaluation.
Age: 51.0
Sex: F
Vaccine: HIBV, MENB, MNQ, PPV
Symptoms: Red blood cell count normal, Rhinorrhoea, Systemic inflammatory response syndrome, Vaccination site pain, Vaccination site swelling
Clinical narrative: 51 year-old F with multiple medical problems. Received PPSV23, Hib, MCV4P, and MenB vaccines on 28 Jan 2016. Received Hib and PPV23 in left upper arm, and received both meningococcal vaccines in right upper arm. Within 12 hours of vaccine receipt, patient noted reaction at vaccination site; initially, redness, warmth, swelling and tenderness about 2" in diameter in left upper arm, then rapidly increased over the next 24 hours. No streaking or lymphadenopathy. Patient also felt feverish on 29 Jan and her temperatures were initially around 101. She began self-treating with Tylenol and intermittent ice packs to left upper arm. By 30 Jan (post-vaccination day 2), patient's site reaction extended from left shoulder almost to elbow and affected area was about 2/3 circumferential around area of injections. Her temperatures peaked at 103.3 and she was shivering vigorously. She also noted her heart beat was rapid, but denies palpitations. Patient denies n/v, headaches, or dyspnea; she had minor body aches. During this time, she had a runny nose, which was responsive to treatment with antihistamines. She sought evaluation on morning of 30 January at Emergency Department. Initial vital signs: T 102.5, BP 132/77, HR 113, RR 18. She was treated with IV fluids and Tylenol. Her lab work was significant for leukocytosis. She was released after approximately 2 1/2 hours of ED check in. Diagnosis: presume fever/leukocytosis secondary to vaccine administration, vital signs and lab consistent with SIRS. Patient was discharged on Tylenol as needed, not to exceed 2 grams daily. Complete resolution of symptoms within 48 hours of ER evaluation.
Age: 51.0
Sex: F
Vaccine: HIBV, MENB, MNQ, PPV
Symptoms: Vaccination site warmth, White blood cell count increased
Clinical narrative: 51 year-old F with multiple medical problems. Received PPSV23, Hib, MCV4P, and MenB vaccines on 28 Jan 2016. Received Hib and PPV23 in left upper arm, and received both meningococcal vaccines in right upper arm. Within 12 hours of vaccine receipt, patient noted reaction at vaccination site; initially, redness, warmth, swelling and tenderness about 2" in diameter in left upper arm, then rapidly increased over the next 24 hours. No streaking or lymphadenopathy. Patient also felt feverish on 29 Jan and her temperatures were initially around 101. She began self-treating with Tylenol and intermittent ice packs to left upper arm. By 30 Jan (post-vaccination day 2), patient's site reaction extended from left shoulder almost to elbow and affected area was about 2/3 circumferential around area of injections. Her temperatures peaked at 103.3 and she was shivering vigorously. She also noted her heart beat was rapid, but denies palpitations. Patient denies n/v, headaches, or dyspnea; she had minor body aches. During this time, she had a runny nose, which was responsive to treatment with antihistamines. She sought evaluation on morning of 30 January at Emergency Department. Initial vital signs: T 102.5, BP 132/77, HR 113, RR 18. She was treated with IV fluids and Tylenol. Her lab work was significant for leukocytosis. She was released after approximately 2 1/2 hours of ED check in. Diagnosis: presume fever/leukocytosis secondary to vaccine administration, vital signs and lab consistent with SIRS. Patient was discharged on Tylenol as needed, not to exceed 2 grams daily. Complete resolution of symptoms within 48 hours of ER evaluation.
Age: 59.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pain, Swelling
Clinical narrative: Soreness, swelling. Saw same MD ~48h later. Treated with ice, NSAIDs and monitoring.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: I received a call 4/7/16 at about 5pm from patient's wife that he was in a hospital in ICU, he was suffering from Guillain Barre Syndrome brought on by his flu shot--this is per his doctors. I do not know when problem started.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Feeling abnormal, Guillain-Barre syndrome, Laboratory test abnormal, Mechanical ventilation, Paraesthesia
Clinical narrative: I received a call 4/7/16 at about 5pm from patient's wife that he was in a hospital in ICU, he was suffering from Guillain Barre Syndrome brought on by his flu shot--this is per his doctors. I do not know when problem started.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Peripheral coldness, Pruritus, Pyrexia, Skin irritation
Clinical narrative: I received a call 4/7/16 at about 5pm from patient's wife that he was in a hospital in ICU, he was suffering from Guillain Barre Syndrome brought on by his flu shot--this is per his doctors. I do not know when problem started.
Age: 12.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Child presented to school nurse with hives to chest and back, given 25 mg Benadryl PO at 11:45 AM.  Child went to see family physician for evaluation. At 8:00 pm hives were on face, neck, torso, both legs and arms.  On 4/7/2016 hives only on upper legs.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Malaise, Pyrexia
Clinical narrative: I HAD THE CHICKENPOX VACCINE ON MONDAY 03/28/2016 STARTED ON MONDAY NIGHT I FEEL SICK, I HAD FEVER OF 102 THE NEXT DAY  WHICH IS TUESDAY 03/29/16 IT WAS WORST AND WORST I WENT TO  WALKING CLINIC THE DOCTOR GIVING MEDICATION NOTHING WORK  AND I END UP ON EMERGENCY ROOM THE NEXT DAY AND THE DOCTOR GIVE ME MORE MED AND WANT ME TO STAY HOME FOR 5 DAYS.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red rash on left bicep with swelling and redness.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: States had pain at site of injection (left deltoid) immediately after shot; gradually worsened to "excruciating pain", not able to use arm normally, not able to raise arm, by 4/8/2016; to PCP for evaluation, Dx possible bursitis or allergic reaction; started on Prednisone PO. To check back with PCP on 4/11/2016.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Injection site pain, Pain in extremity
Clinical narrative: Injection site soreness, whole arm pain, dizziness, weakness.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash pruritic, Vaccination site induration, Vaccination site reaction
Clinical narrative: Vaccine site had 2 painful and itchy bumps appear. The next day they started merging into one bump and have a 2-3 inch red raised bump around them. Getting more itchy and painful by the day, and getting more firm.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported redness and swelling and temperature at injection site 4 days after shot.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Abnormal behaviour, Decreased appetite, Emotional distress, Hypersomnia, Injection site erythema
Clinical narrative: Fever, redness & swelling at vaccination point.  Baby slept for 2 days, would wake up screaming several times and inconsolable, lack of appetite and could not wake him to feed.  This was completely out of character for my baby.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Pyrexia, Screaming, Vaccination site swelling
Clinical narrative: Fever, redness & swelling at vaccination point.  Baby slept for 2 days, would wake up screaming several times and inconsolable, lack of appetite and could not wake him to feed.  This was completely out of character for my baby.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Lip swelling
Clinical narrative: Patient described pain on arm of injection and redness around area date above is when patient reported reaction but symptoms might had happened before patient described little swelling of lips as well.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Dizziness, Impaired work ability, Injection site pain, Injection site rash
Clinical narrative: Woke up feeling light-headed and dizzy. Called Doctor's office at 11:20 AM. Took pulse with wrist heart rate monitor, and it was 98-102 bpm. Temperature of 99.5. Couldn't bend over as would get very dizzy. Large rash the size of two silver-dollars where the injection site was. Injection site hot to touch, entire upper arm sore and tender. Laying down caused heart rate to return to normal. Doctor prescribed 6 day dose of Prednisone and taking BENADRYL in addition to already taken daily ALLEGRA dose. Had to call off work due to side effects.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Woke up feeling light-headed and dizzy. Called Doctor's office at 11:20 AM. Took pulse with wrist heart rate monitor, and it was 98-102 bpm. Temperature of 99.5. Couldn't bend over as would get very dizzy. Large rash the size of two silver-dollars where the injection site was. Injection site hot to touch, entire upper arm sore and tender. Laying down caused heart rate to return to normal. Doctor prescribed 6 day dose of Prednisone and taking BENADRYL in addition to already taken daily ALLEGRA dose. Had to call off work due to side effects.
Age: 23.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt came back to pharmacy 4/8/16 about 2p complaining of injection site redness and swelling. Both pharmacists looked at the site on the right arm and told patient to keep watch if it spreads that it did not seem serious. After patient left, pharmacists said based on injection site reaction it was possible that it might have been received intramuscularly. RPh called Merck and Merck also took information down and Merck's medical team said she would fax study showing that patient would still be able to mount a response and ADR were the same as SQ.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chills, Diarrhoea, Dyspnoea, Pyrexia
Clinical narrative: Fever, chill, nausea, vomiting x 2 days. Diarrhea x 1 week. Really weak. SOB resolved with TYELENOL and MOTRIN. As per patient she did not go to ER.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Fever, chill, nausea, vomiting x 2 days. Diarrhea x 1 week. Really weak. SOB resolved with TYELENOL and MOTRIN. As per patient she did not go to ER.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with and improperly stored dose of ZOSTAVAX (lot # reported as L029481 with expiration date of 19-NOV-2016 and lot # L012478 with expiration date of 10-JUL-2017 (anatomical route of vaccination and dose number were not provided). No adverse event was reported. The Certified Medical Assistant (C.M.A.), reported the following temperature excursion for ZOSTAVAX: -10.6 degrees C for 1 hour and 26 minutes. The vaccine underwent and additional temperature of -6.7 degrees C for 2 hours and 25 minutes on an unspecified date. No product quality issues was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored dose of PROQUAD (Merck) rHA lot # L024122 with expiration date of 30-DEC-2016 and lot # L042818 with expiration date of 26-APR-2017 (anatomical route of vaccination and dose number were not provided). No adverse event was reported at time of vaccination with PROQUAD (Merck). The Certified Medical Assistant (C.M.A), reported the following temperature excursion for PROQUAD (Merck): -10.6 degrees C for 1 hour and 26 minutes. The vaccine underwent an additional temperature excursion of -6.7 degrees C for 2 hours and 25 minutes on an unspecified date. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient, the patients were vaccinated with and improperly stored dose (Merck) VARIVAX lot # K020758 with expiration date of 31-OCT-2016, lot # L034367 with expiration date of 08-SEP-2017 and lot # L024250 with expiration date of 30-JUN-2017 (anatomical route of vaccination and dose number were not provided). No adverse event was reported at time of vaccination with (Merck) VARIVAX. The Certified Medical Assistant (C.M.A.), reported the following temperature excursion for (Merck) VARIVAX: -10.6 degrees C for 1 hour and 26 minutes. The vaccine underwent an additional temperature excursion of -6.7 degrees C for 2 hours and 25 minutes on an unspecified date. No product quality issue was involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Myalgia and Nausea Vomiting
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patient were vaccinated with LIQUID PEDVAXHIB lot number K025005, expiration date 31-JUL-2017 and lot number L042258, expiration date 18-AUG-2018 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as multiple unspecified patients received improperly stored LIQUID PEDVAXHIB. The temperature was 47.98 F and the timeframe was 63 house. No adverse event was reported. At the time of the report, the patients' status was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with GARDASIL 9 lot # L016428, expiration date 30-JUL-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as multiple unspecified patients received improperly stored GARDASIL 9. The temperature was 47.98 F and the time frame was 63 hours. No adverse event was reported. At the time of the report, the patients' status was unknown. 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 registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with ROTATEQ lot number K023532, expiration date 21-JUN-2016 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as multiple unspecified patients received improperly stored ROTATEQ. The temperature was 47.98 F and the time frame was 63 hours. No adverse event was reported. At the time of the report, the patients' status was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB lot number K010535, expiration date 27-AUG-2016 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as multiple unspecified patients received improperly stored RECOMBIVAX HB. The temperature was 47.98 F and the timeframe was 63 hours. No adverse event was not reported. At the time of the report, the patients' status was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Skin warm
Clinical narrative: Rash - about 4 inches wide - warm to touch with small central bump - noticed to be getting worse 8 days after vaccination - pt referred to PCP.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dysphagia, Fatigue, Injection site rash, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Rash around inj. site, fatigue, sore throat, facial swelling, redness of eyes, trouble swallowing.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Swelling face
Clinical narrative: Rash around inj. site, fatigue, sore throat, facial swelling, redness of eyes, trouble swallowing.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, IPV, MMR
Symptoms: Respiratory distress, Wrong drug administered
Clinical narrative: PCV was ordered, but IPV was given by mistake on 3/30/16. A week later on 4/6/16 was seen at ER for respiratory distress.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Red, warn area on (L) deltoid, with fever up to 101 degrees.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Hypoaesthesia, Lumbar puncture abnormal, Myelitis transverse, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Burning pain around back started within a few days followed by numbness in legs about a week after that. Prescribed prednisone and IV steroids. Referred to Neurology and diagnosed with Transverse Myelitis. Symptoms improved over several months, but pain and numbness persist. Adverse event onset date is date numbness started.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site rash
Clinical narrative: Client calls to report that 24 hrs after rcv'ing PPSV23, she developed a rash on the upper arm where she rcv'd the vaccine - 5 red raised areas, each the size of a silver dollar. No other reaction. Has been putting BENADRYL topically on with no worsening and rash only slightly less pronounced. Will f/u with provider if any other symptoms start or rash worsens.
Age: 0.58
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None. HAV was given earlier than recommended.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Myalgia, Pain
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding himself. No pertinent medical history and drug reactions/allergies were reported. On 09-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (strength, dose and frequency were not reported). Concomitant medications were not provided. On 12-FEB-2016 (three days after vaccination) the patient experienced "severe body aches and pains that have not let up". He has reported it to VAERS already. The outcome of pain was reported as not recovered/not resolved. Causality assessment was not provided. No further AE information was provided. Product quality complaint was not filed. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Asthenia, Pain
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding himself. No pertinent medical history and drug reactions/allergies were reported. On 09-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (strength, dose and frequency were not reported). Concomitant medications were not provided. On 12-FEB-2016 (three days after vaccination) the patient experienced "severe body aches and pains that have not let up". He has reported it to VAERS already. The outcome of pain was reported as not recovered/not resolved. Causality assessment was not provided. No further AE information was provided. Product quality complaint was not filed. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding himself. No pertinent medical history and drug reactions/allergies were reported. On 09-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (strength, dose and frequency were not reported). Concomitant medications were not provided. On 12-FEB-2016 (three days after vaccination) the patient experienced "severe body aches and pains that have not let up". He has reported it to VAERS already. The outcome of pain was reported as not recovered/not resolved. Causality assessment was not provided. No further AE information was provided. Product quality complaint was not filed. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Painful rash underneath breast and on back. Diagnosed as shingles.
Age: 30.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Abdominal cramping and loose stools which began after first dose of VIVOTIF and persisted throughout course of dosing.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Death, Influenza like illness, Pneumonia
Clinical narrative: Flu like symptoms, followed by death on Jan 19. Coroner mentioned pneumonia.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Epistaxis
Clinical narrative: Woke up with a bloody nose 12+hrs after vaccine was administered.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient experienced a red, inflamed area around the sight of injection.  It was 1 inch by 2 inches, was raised, warm, and itched.  She started loratidine on 3/25/16. On 3/26/16 she went to the ER and was given a prescription for KEFLEX and BENADRYL. The rash was gone by 4/4/2016.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Itchy at first on 8th; then red; now swollen & warm plus a larger amount of red; shape: size of tangerine & puffy.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, X-ray
Clinical narrative: Started with soreness in shoulder which progressed worse each month, until health provider contacted; then Orthopedic specialist; received steroid injection; no help or relief 6 months later.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Started with body aches, fever up to 100.5, redness, swelling, heat, to injection site. Generalized symptoms lasted two days. Injection site pain started improving over 3 days but the redness and swelling persisted and even got larger.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Started with body aches, fever up to 100.5, redness, swelling, heat, to injection site. Generalized symptoms lasted two days. Injection site pain started improving over 3 days but the redness and swelling persisted and even got larger.
Age: 0.79
Sex: F
Vaccine: HIBV
Symptoms: Gaze palsy, Seizure, Skin warm, Tremor, Unresponsive to stimuli
Clinical narrative: Acted fine at first, I was never told of a fever or anything. I (mother) was about to lay her down for a nap as I thought she was asleep. I look down and she was shaking and looking up into the left corner of her eye, I called her name a few times and she was not making contact. I yelled for my mother to come help, she picked her up as I called 911, she was still seizing until about a minute before paramedics arrived. They immediately said she felt warm. Total seize time was about 2 minutes.
Sex: M
Vaccine: VARZOS
Symptoms: Prostate cancer
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Concurrent conditions and medical history were not reported. The pharmacist reported that on an unknown date in 2007, the patient may had received a dose of ZOSTAVAX (Lot number, expiration date, dose and route were not provided). Concomitant medication was not reported. Recently, on an unknown date, the patient was diagnosed with prostate cancer and was being treated with finasteride (manufacturer unknown) dose unspecified (MARRS#1604USA005910). The outcome of prostate cancer was unknown at the time of the report. The reporter did not assess the relatedness between ZOSTAVAX and prostate cancer. Upon internal review prostate cancer was considered a medically significant event. This is one of two reports from the same patient. 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 medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored (temperature: 34 degrees Fahrenheit and 51 degrees Fahrenheit for 14 hours; no previous excursion was reported) doses of VAQTA lot # L023936 and expiration date: 15-MAR-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 16-FEB-2016, the patient was vaccinated with an improperly stored (temperature: 58 degrees Fahrenheit (F), time frame: 1 hour and 30 minutes; no previous temperature excursion was reported) dose of MMR II lot # L007217, expiration date 03-MAR-2017 (albumin status, dose and route of administration were not specified). No adverse effect was reported. This is one of several reports received from the same reporter. 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 certified medcal assistant (C.M.A) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 06-APR-2016, the patient was inadvertently vaccinated with an expired dose of VAQTA injection, lot # K002831, expiration date 15-JAN-2016 (dose, and route of administration were not provided). No adverse effect was reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a medical assistant via agency referring to a 13 year old female patient. The patient did not have any medical history, concurrent conditions and past drug history. On 14-MAR-2016, the patient was vaccinated with an adult dose of VAQTA (1 ml, once, lot # L017757, expiry date: 08-APR-2018, route unknown). No concomitant therapies were reported. There was no relevant lab work done. Additional information has been requested. It has been determined, that the initial version of case # US-009507513-1603USA007143 was sent with wrong aware date. The report should have been submitted with aware date of 14-MAR-2016 instead of 15-MAR-2016. Therefore, case # US-009507513-1603USA007143 is being deleted from our files on hepatitis a vaccine, inactivated and a new case # US-009507513-1604USA002092 is created to replace MARRS # US-009507513-1603USA007143.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursion. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored (temperature: 34 degrees Fahrenheit and 51 degrees Fahrenheit for 14 hours; no previous excursion was reported) doses of RECOMBIVAX HB lot # K021444 and expiration date: 17-SEP-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored (temperature: 34 degrees Fahrenheit and 51 degrees Fahrenheit for 14 hours; no previous excursion was reported) doses of GARDASIL 9 lot # L044475 and expiration date: 12-MAY_2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX vial (19400 plaque-forming unit (PFU, dose, route of administration, lot# and expiration date were not reported) and on an unknown date, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). It was reported that doses of ZOSTAVAX and PNEUMOVAX 23 were administered 4 weeks apart. On an unknown date, the patients experienced injection site reactions. The pharmacist noticed that more patients (unspecified number) experienced injection site reactions when ZOSTAVAXC and PNEUMOVAX 23 were administered concomitantly (captured in MARRS# 1604USA000233), than wen ZOSTAVAX and PNEUMOVAX 23 were administered 4 weeks apart. The outcome of injection site reactions was not reported. Causality assessment was not provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old patient (also reported as a child) of unknown gender. The patient's concurrent conditions. medical history and concomitant medications were not provided. On 06-APR-2016 (also reported as today), the patient was inadvertently vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) injection (lot # L017997, expiration date 19-MAY-2017, in the left arm) and PROQUAD (Merck) (lot # reported as L051102, expiration date 17-JUN-2017, dose, route of administration and anatomical location were not specified). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-FEB-2016, the patient was vaccinated with an improperly stored (temperature: 58 degrees Fahrenheit (F), time frame: 1 hour and 30 minutes; no previous temperature excursion was reported) dose of M-M-R II lot # L007217, expiration date 03-MAR-2017 (albumin status, dose and route of administration were not specified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site exfoliation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via agency employee and refers to a patient (age reported as under 65 years old) of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, exact dose and route of administration were not reported). On an unknown date, the patient experienced injection site pain, injection site peeling of skin, injection site warmth and injection site swelling. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of 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 as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient received improperly stored (temperature: 34 degrees Fahrenheit and 51 degrees Fahrenheit for 14 hours; no previous excursion was reported) doses of oral ROTATEQ lot # L029618 and expiration date: 20-MAY-2017 (dose was not reported, route of administration defaulted to oral). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006393, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.