chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Palpitations, Tremor, Urine analysis, Urine odour abnormal, Vomiting
Clinical narrative: This happened as soon as the shot was given. Burning in arm from shot. Went up my arm to the top of my head (numbness). I started to shake my face got white my ears red. Then a lot of sweating and bad headache. Sick to stomach and throwing up, lasted 2 days. Bad taste at back of tongue. Chills started that night lasted 2 days. Now I still have weakness, light headed, headache, trouble walking. Urine smells and orange color. Heart pounds (sometimes). Breathing a little shallow (sometimes).
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Swelling of entire tricep (general injection site on left arm); area hot to the touch. For 4 days following injection, experienced severe joint pain in knees, lower back, elbows, and shoulders. Experienced flu-like symptoms.  8 days following injection went to urgent care facility and was diagnosed with prostatitis and prescribed Cipro.  I suspect a massive generalized autoimmune inflammatory event was precipitated by the Zostavax.  Joint swelling and associated pain subsided within 6 days of date of injection; severe prostatitis continues to persist.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth, Prostate infection
Clinical narrative: Swelling of entire tricep (general injection site on left arm); area hot to the touch. For 4 days following injection, experienced severe joint pain in knees, lower back, elbows, and shoulders. Experienced flu-like symptoms.  8 days following injection went to urgent care facility and was diagnosed with prostatitis and prescribed Cipro.  I suspect a massive generalized autoimmune inflammatory event was precipitated by the Zostavax.  Joint swelling and associated pain subsided within 6 days of date of injection; severe prostatitis continues to persist.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Prostatitis
Clinical narrative: Swelling of entire tricep (general injection site on left arm); area hot to the touch. For 4 days following injection, experienced severe joint pain in knees, lower back, elbows, and shoulders. Experienced flu-like symptoms.  8 days following injection went to urgent care facility and was diagnosed with prostatitis and prescribed Cipro.  I suspect a massive generalized autoimmune inflammatory event was precipitated by the Zostavax.  Joint swelling and associated pain subsided within 6 days of date of injection; severe prostatitis continues to persist.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Autoinflammatory disease, Influenza like illness, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of entire tricep (general injection site on left arm); area hot to the touch. For 4 days following injection, experienced severe joint pain in knees, lower back, elbows, and shoulders. Experienced flu-like symptoms.  8 days following injection went to urgent care facility and was diagnosed with prostatitis and prescribed Cipro.  I suspect a massive generalized autoimmune inflammatory event was precipitated by the Zostavax.  Joint swelling and associated pain subsided within 6 days of date of injection; severe prostatitis continues to persist.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Joint swelling, Prostatitis
Clinical narrative: Swelling of entire tricep (general injection site on left arm); area hot to the touch. For 4 days following injection, experienced severe joint pain in knees, lower back, elbows, and shoulders. Experienced flu-like symptoms.  8 days following injection went to urgent care facility and was diagnosed with prostatitis and prescribed Cipro.  I suspect a massive generalized autoimmune inflammatory event was precipitated by the Zostavax.  Joint swelling and associated pain subsided within 6 days of date of injection; severe prostatitis continues to persist.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Injection site nodule, Peripheral swelling, Skin discolouration
Clinical narrative: Information has been received from a licensed practitioner nurse referring to herself who was a 57 year old female patient. The patient's medical history included colon cancer which was diagnosed 3 years ago and cancer was removed (unspecified date) and the patient stated that "she was now cancer free, that was all before getting ZOSTAVAX)". The patient had no drug reactions/allergies. On 09-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose, dose#, lot# and vaccination site not reported). Concomitant therapies included clonidine and diazepam (manufacturer unknown). After receiving ZOSTAVAX, on an unspecified date in 2015, the patient developed swelling, a rash and itching at the injection site and the skin on her forearm "up to her elbow" (unspecified arm), her inner thigh (unspecified thigh) and her right buttock was moulting. The nurse stated the "inside of both her legs was black and blue, her arms are red and white, her hands were extremely cold and she felt cold all the time". The nurse stated she was seen by the physician on 13-APR-2015 and "all sorts of tests" were performed. The nurse stated a "metabolic panel, complete blood count (CBC), C-reaction protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count" all showed to be "normal". No treatment was given for the events. The outcome of all the events was reported as not recovered. Causality was not assessed by the reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: C-reactive protein normal, Erythema, Feeling cold, Full blood count normal, Injection site pruritus
Clinical narrative: Information has been received from a licensed practitioner nurse referring to herself who was a 57 year old female patient. The patient's medical history included colon cancer which was diagnosed 3 years ago and cancer was removed (unspecified date) and the patient stated that "she was now cancer free, that was all before getting ZOSTAVAX)". The patient had no drug reactions/allergies. On 09-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose, dose#, lot# and vaccination site not reported). Concomitant therapies included clonidine and diazepam (manufacturer unknown). After receiving ZOSTAVAX, on an unspecified date in 2015, the patient developed swelling, a rash and itching at the injection site and the skin on her forearm "up to her elbow" (unspecified arm), her inner thigh (unspecified thigh) and her right buttock was moulting. The nurse stated the "inside of both her legs was black and blue, her arms are red and white, her hands were extremely cold and she felt cold all the time". The nurse stated she was seen by the physician on 13-APR-2015 and "all sorts of tests" were performed. The nurse stated a "metabolic panel, complete blood count (CBC), C-reaction protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count" all showed to be "normal". No treatment was given for the events. The outcome of all the events was reported as not recovered. Causality was not assessed by the reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site swelling, Metabolic function test normal, Peripheral coldness, Platelet count normal
Clinical narrative: Information has been received from a licensed practitioner nurse referring to herself who was a 57 year old female patient. The patient's medical history included colon cancer which was diagnosed 3 years ago and cancer was removed (unspecified date) and the patient stated that "she was now cancer free, that was all before getting ZOSTAVAX)". The patient had no drug reactions/allergies. On 09-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose, dose#, lot# and vaccination site not reported). Concomitant therapies included clonidine and diazepam (manufacturer unknown). After receiving ZOSTAVAX, on an unspecified date in 2015, the patient developed swelling, a rash and itching at the injection site and the skin on her forearm "up to her elbow" (unspecified arm), her inner thigh (unspecified thigh) and her right buttock was moulting. The nurse stated the "inside of both her legs was black and blue, her arms are red and white, her hands were extremely cold and she felt cold all the time". The nurse stated she was seen by the physician on 13-APR-2015 and "all sorts of tests" were performed. The nurse stated a "metabolic panel, complete blood count (CBC), C-reaction protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count" all showed to be "normal". No treatment was given for the events. The outcome of all the events was reported as not recovered. Causality was not assessed by the reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Red blood cell sedimentation rate normal, Skin discolouration, Skin exfoliation
Clinical narrative: Information has been received from a licensed practitioner nurse referring to herself who was a 57 year old female patient. The patient's medical history included colon cancer which was diagnosed 3 years ago and cancer was removed (unspecified date) and the patient stated that "she was now cancer free, that was all before getting ZOSTAVAX)". The patient had no drug reactions/allergies. On 09-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose, dose#, lot# and vaccination site not reported). Concomitant therapies included clonidine and diazepam (manufacturer unknown). After receiving ZOSTAVAX, on an unspecified date in 2015, the patient developed swelling, a rash and itching at the injection site and the skin on her forearm "up to her elbow" (unspecified arm), her inner thigh (unspecified thigh) and her right buttock was moulting. The nurse stated the "inside of both her legs was black and blue, her arms are red and white, her hands were extremely cold and she felt cold all the time". The nurse stated she was seen by the physician on 13-APR-2015 and "all sorts of tests" were performed. The nurse stated a "metabolic panel, complete blood count (CBC), C-reaction protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count" all showed to be "normal". No treatment was given for the events. The outcome of all the events was reported as not recovered. Causality was not assessed by the reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin swelling
Clinical narrative: Information has been received from a licensed practitioner nurse referring to herself who was a 57 year old female patient. The patient's medical history included colon cancer which was diagnosed 3 years ago and cancer was removed (unspecified date) and the patient stated that "she was now cancer free, that was all before getting ZOSTAVAX)". The patient had no drug reactions/allergies. On 09-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose, dose#, lot# and vaccination site not reported). Concomitant therapies included clonidine and diazepam (manufacturer unknown). After receiving ZOSTAVAX, on an unspecified date in 2015, the patient developed swelling, a rash and itching at the injection site and the skin on her forearm "up to her elbow" (unspecified arm), her inner thigh (unspecified thigh) and her right buttock was moulting. The nurse stated the "inside of both her legs was black and blue, her arms are red and white, her hands were extremely cold and she felt cold all the time". The nurse stated she was seen by the physician on 13-APR-2015 and "all sorts of tests" were performed. The nurse stated a "metabolic panel, complete blood count (CBC), C-reaction protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count" all showed to be "normal". No treatment was given for the events. The outcome of all the events was reported as not recovered. Causality was not assessed by the reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Hot red swollen cellutltis upper arm. Itchy. Spreading in arm. Given at pharmacy, went to see my physician the next day.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Hot red swollen cellutltis upper arm. Itchy. Spreading in arm. Given at pharmacy, went to see my physician the next day.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Hot red swollen cellutltis upper arm. Itchy. Spreading in arm. Given at pharmacy, went to see my physician the next day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and redness at injection site, sore, itchy and aches from shoulder joint to elbow, started ~ 12 hours after injection and continues 40 hours later, not resolved.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Induration, Oedema, Skin warm
Clinical narrative: Erythema, Edema, hard and warm to touch.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling at injection site, red, tender, itching, large as a goose egg.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Abasia, Asthenia, Chest X-ray abnormal, Cough, Feeling abnormal
Clinical narrative: This spontaneous report as received from an approximately 70 year old male consumer via Pfizer refers to himself. The patient's concurrent conditions included high blood pressure. No medical history was reported. On 17-DEC-2014, the patient was inappropriately vaccinated with a single shot of PNEUMOVAX 23 (dose, frequency, lot number, expiration date, route and administration site were not reported) instead of PREVNAR 13. Concomitant therapies included metoprolol succinate, amlodipine, chlorthalidone (also reported as Water pill) and simvastatin (manufacturer unknown). On 25-DEC-2014, the patient developed first sign of getting sick, cough, and was bad for another week. The patient mentioned that it was pneumonia after he went to the doctor. As reported "it kept getting worse and worse and worse and worse" and that was the point the patient could not even walk. The patient reported that it was terrible, he felt like he was going to die, for two weeks he couldn't walk more than two steps and was so weak he lost forty pounds. The patient sought medical attention via visiting the doctor. Antibiotics (unspecified by the reporter) were given for the treatment. The patient mentioned that he had never had pneumonia in seventy years and he got it after few days he took the shot of PNEUMOVAX 23 that he thought was a big coincidence. On an unspecified date, X-rays were performed and showed that there were some scarring and fluid in the bottom of one of the patient's lungs, that is hoped to go away the day he will cough it out. The outcome of pneumonia, inability to walk and weight decreased was reported as still recovering at the time of the report. According to the patient, was much much better at the time of the report but still had something in his lungs. As reported he will go back in a month to take an X-ray to see if it's gone away. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pleural effusion, Pneumonia, Pulmonary fibrosis, Weight decreased
Clinical narrative: This spontaneous report as received from an approximately 70 year old male consumer via Pfizer refers to himself. The patient's concurrent conditions included high blood pressure. No medical history was reported. On 17-DEC-2014, the patient was inappropriately vaccinated with a single shot of PNEUMOVAX 23 (dose, frequency, lot number, expiration date, route and administration site were not reported) instead of PREVNAR 13. Concomitant therapies included metoprolol succinate, amlodipine, chlorthalidone (also reported as Water pill) and simvastatin (manufacturer unknown). On 25-DEC-2014, the patient developed first sign of getting sick, cough, and was bad for another week. The patient mentioned that it was pneumonia after he went to the doctor. As reported "it kept getting worse and worse and worse and worse" and that was the point the patient could not even walk. The patient reported that it was terrible, he felt like he was going to die, for two weeks he couldn't walk more than two steps and was so weak he lost forty pounds. The patient sought medical attention via visiting the doctor. Antibiotics (unspecified by the reporter) were given for the treatment. The patient mentioned that he had never had pneumonia in seventy years and he got it after few days he took the shot of PNEUMOVAX 23 that he thought was a big coincidence. On an unspecified date, X-rays were performed and showed that there were some scarring and fluid in the bottom of one of the patient's lungs, that is hoped to go away the day he will cough it out. The outcome of pneumonia, inability to walk and weight decreased was reported as still recovering at the time of the report. According to the patient, was much much better at the time of the report but still had something in his lungs. As reported he will go back in a month to take an X-ray to see if it's gone away. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from an approximately 70 year old male consumer via Pfizer refers to himself. The patient's concurrent conditions included high blood pressure. No medical history was reported. On 17-DEC-2014, the patient was inappropriately vaccinated with a single shot of PNEUMOVAX 23 (dose, frequency, lot number, expiration date, route and administration site were not reported) instead of PREVNAR 13. Concomitant therapies included metoprolol succinate, amlodipine, chlorthalidone (also reported as Water pill) and simvastatin (manufacturer unknown). On 25-DEC-2014, the patient developed first sign of getting sick, cough, and was bad for another week. The patient mentioned that it was pneumonia after he went to the doctor. As reported "it kept getting worse and worse and worse and worse" and that was the point the patient could not even walk. The patient reported that it was terrible, he felt like he was going to die, for two weeks he couldn't walk more than two steps and was so weak he lost forty pounds. The patient sought medical attention via visiting the doctor. Antibiotics (unspecified by the reporter) were given for the treatment. The patient mentioned that he had never had pneumonia in seventy years and he got it after few days he took the shot of PNEUMOVAX 23 that he thought was a big coincidence. On an unspecified date, X-rays were performed and showed that there were some scarring and fluid in the bottom of one of the patient's lungs, that is hoped to go away the day he will cough it out. The outcome of pneumonia, inability to walk and weight decreased was reported as still recovering at the time of the report. According to the patient, was much much better at the time of the report but still had something in his lungs. As reported he will go back in a month to take an X-ray to see if it's gone away. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pruritus, Nausea
Clinical narrative: W/in 2d of vaccine nausea/loose stool and fatigue. Resolved w/in 24h followed by an itchy, expanding erythema (R) deltoid.
Age: 80.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: On 4/16/15, pt came into to report that she had severe nausea, dizziness and weakness starting 4/9/15. Vaccine given 4/8/15. On 4/10/15, pt went to ER. Pt returned to care on 4/16/15.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent condition were not reported. The medical assistant reported that 5 doses of improperly stored ROTATEQ (strength, dose and lot # unknown) were administered to patients of unspecified days. Concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, doses of improperly stored GARDASIL (dose, lot# and route were not reported) were administered to these patients. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, doses of improperly stored RECOMBIVAX HB (dose, lot# and route were not reported) were administered to these patients. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a 9 and a half months old infant patient of unknown gender. On an unknown date the patient was vaccinated with a dose of ROTATEQ orally (lot#, expiration date, dose and strength were not reported). On an unknown date the patient received their third dose of ROTATEQ at "9 and a half months" of age (considered as inappropriate schedule of drug administration). No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: HEP, HEPA, HIBV, HPV4, MMRV, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the improperly stored VAQTA, GARDASIL, PEDVAXHIB, PNEUMOVAX 23, RECOMBIVAX HB, ROTATEQ, PROQUAD (Merck) or VARIVAX (Merck) were administered to the patients. No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 4 month old patient of unknown gender. On 10-APR-2015, the patient was vaccinated with doses of M-M-R II (subcutaneous, strength, lot#, dose were unknown) and (Oka/Merck) VARIVAX (subcutaneous, strength, lot#, dose were unknown) (inappropriate scheduled of drug administration). No adverse experience reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, doses of improperly stored VAQTA (dose, lot# and route were not reported) were administered to these patients. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. 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 nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were vaccinated with that does of ROTATEQ (unspecified dose and route) lot 1000425 expiry date 21-JUN-2016. On an unspecified date the vaccine had been improperly stored.The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified amount of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with improperly stored doses of GARDASIL injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified amount of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant medications were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Concurrent condition, medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck) Lot # K010797 expiry 04-FEB-2016 (dose, frequency, route of administration and indication were not provided). No adverse experiences reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Concurrent condition, medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, lot # K005429, expiry 15-APR-2016 (dose, frequency, route of administration and indication were not provided). No adverse experiences reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. 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 as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, over last 3.5 years, the patients were vaccinated with PROQUAD (Merck) that had been improperly stored (most current lot information included: lot # K019102 and expiry: 15-APR-2016; dose and route not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certificate medical assistant refers to a unspecified number of patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date, the patients were vaccinated with doses of incorrectly storage (Oka/Merck) VARIVAX (doses and routes were not reported) lot # K002928 expiration date 26-FEB-2016 and lot # K005429 expiration date 15-APR-2016. No adverse effects reported by any patient. Secondary suspects and concomitant therapies were not reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, over last 3.5 years, the patients were vaccinated with (Oka/Merck) VARIVAX that had been improperly stored (0.5 ml; subcutaneous; most current lot information include: lot # J006161 and expiry: 20-MAY-2015; lot# K007979 and expiry: 03-JUN-2016; lot # J012379 and expiry: 03-OCT-2015). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: Information has been received from a pharmacist referring to a 67 year old female patient with allergic reaction to "sulfa drugs". The patient had no pertinent medical history. On 03-APR-2015 the patient was vaccinated with 0.65 ml dose of ZOSTAVAX (lot # K023622, expiration date 20-FEB-2016, subcutaneous in right arm). There was no concomitant medication. On 03-APR-2015, shortly after the vaccination, the patient developed left and right sided neck stiffness. the patient visited unspecified chiropractor for "a couple adjustments as that typically works but did not this time". The patient also tried to use heat and cold to affected area and that did not help. In addition, ibuprofen was also used but did not provide relief. The patient sought medical attention by contacting the pharmacist and no lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Double dose of Tdap given, not adverse event. Patient reportedly "okay."
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: N/A  Called patient and informed.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Concurrent condition, medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) Lot # J012378, expiry 03-OCT-2015, (dose, frequency, route of administration and indication were not provided). No adverse experiences reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. 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 as received from a certificate medical assistant refers to a unspecified number of patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date, the patients were vaccinated with a doses of incorrectly storage PROQUAD (Merck) (doses and routes were not reported) lot # K012919 expiration date 28-FEB-2016 and lot # reported as K013867 expiration date 05-MAR-2016. Secondary suspects and concomitant therapies were not reported. No adverse effects reported by any patient. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has received from a healthcare worker (Certified Medical Assistant) referring to a patient of unknown age and gender. On 09-MAR-2015 the patient was received an expired dose of M-M-R II (rHA, batch# H018948, lot # 1646AA, expiration ate: 18-OCT-2014, 0.5 ml, subcutaneous). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were vaccinated with that doses of GARDASIL (unspecified dose and route) lot K008931 expiry date 04-MAR-2017. On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were vaccinated with that doses of LIQUID PEDVAXHIB (unspecified dose and route) (lot K019700 expiry date 16-JUL-2017). On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from nurse practitioner via company representative refers to a patient of unknown age. No information regarding current condition, medical history or drug allergies were reported. On 10-APR-2015 the patient was vaccinated with ROTATEQ suspension 2 (strength, dose, lot number, expiry date and indication unknown) oral. No concomitant therapy was reported. On 10-APR-2015, patient immediately spit up or vomited after administration of a dose of ROTATEQ. The patient was in office and neither treatment nor laboratory test were performed. The patient was administered another dose of ROTATEQ at that same office visit. The outcome of event was reported as recovered/resolved on same day. The causality of event to ROTATEQ was unknown. No further information provided. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were vaccinated with that doses of LIQUID PEDVAXHIB (unspecified dose and route) (lot K016964 expiry date 16-JUL-2017). On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received 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 nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were vaccinated with that doses of RECOMBIVAX HB (unspecified dose and route) lot K010216 expiry date 17-SEP-2016. On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Drug administered at inappropriate site
Clinical narrative: Information has been received from a physician referring to his 63 year old wife with mild hypertension and allergic to cats. On an unknown date in approximately February 2015 (reported as "about a month ago") the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot number, expiration date unknown), 0.65 ml, intramuscularly in the triceps area of her left arm (subcutaneous injection formulation administered by other route). The reporter was not certain how much time passed after the vaccination, when the patient developed "what looked like a cellulitis" which lasted "about a week". No lab diagnostic studies were performed. The patient did not seek any medical attention for the "cellulitis", and she used an occasional ice pack on the effected area as needed. The "cellulitis" resolved within two weeks on an unspecified date approximately in 2015 and the patient was fully recovered. The causality between ZOSTAVAX and the event was unknown. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: RED, SORENESS, SWELLING.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site pain, Neck pain, Pain
Clinical narrative: Developed pain around the injection site but more around the backside of the shoulder and extending to the left side of her neck.  Pain is worse with movement. No swelling or redness or heat at injection site. Tips of fingers have felt numb at times with movement.  Resolves with rest.  Denies nausea, vomiting, shortness of breath or wheezing.  No weakness in this arm.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Injection site erythema, Rash macular, Urticaria
Clinical narrative: Patient developed erythema at the site of the shots, patient also had blotchy erythema on other parts of body, continued to evolve into erythema with hives, no respiratory difficulty.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Injection site pain (baseball size) itching.
Age: 1.25
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Juvenile idiopathic arthritis, Musculoskeletal stiffness
Clinical narrative: Stiffness in leg, red swollen bump at site of injection, fever, rash dx of Juvenile Idiopathic Arthritis (polyarticular).
Age: 1.25
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Stiffness in leg, red swollen bump at site of injection, fever, rash dx of Juvenile Idiopathic Arthritis (polyarticular).
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Blood potassium increased, Blood pressure abnormal, Feeling hot, Influenza like illness, Injection site pain
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 66 year-old female patient received, on an unspecified date, intramuscular PREVNAR 13 single dose. Relevant medical history included high blood pressure and potassium low. Concomitant medications included NORVASC, losartan, PREMARIN, tablet and trazodone. The patient mentioned that she experienced the side effects, in February 2nd (unspecified year), when she received PREVNAR 13. After the vaccination, her left arm got hurt at injection site and possibly like cellulitis, and she had pain at injection site also. The patient was put on antibiotic cephalexin. She was feeling sick like she had the flu, she was hot, had nausea, her blood pressure was abnormal ("she can't control her blood pressure") and her potassium value raised up. The patient did not recover from the events at time of this report. The patient mentioned that her doctor recommended her to take the shots as she had strains of pneumonia.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Nausea
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 66 year-old female patient received, on an unspecified date, intramuscular PREVNAR 13 single dose. Relevant medical history included high blood pressure and potassium low. Concomitant medications included NORVASC, losartan, PREMARIN, tablet and trazodone. The patient mentioned that she experienced the side effects, in February 2nd (unspecified year), when she received PREVNAR 13. After the vaccination, her left arm got hurt at injection site and possibly like cellulitis, and she had pain at injection site also. The patient was put on antibiotic cephalexin. She was feeling sick like she had the flu, she was hot, had nausea, her blood pressure was abnormal ("she can't control her blood pressure") and her potassium value raised up. The patient did not recover from the events at time of this report. The patient mentioned that her doctor recommended her to take the shots as she had strains of pneumonia.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a non clinical study program from a contactable nurse who reported for two patients. This is the second report for different patient, same vaccine (same lot number) and different adverse reactions. A 79-year-old female patient received PREVNAR 13 (lot J04196), via an unspecified route of administration on 09Apr2015 at 0.5 ml single. The patient medical history was not reported. The patient was taking other unspecified medications. On an unspecified date the patient got cellulitis of the arm, due to which she was hospitalized from 11Apr2015. The event was still ongoing and the patient was still in the hospital.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, X-ray limb normal
Clinical narrative: Intense pain in left wrist (same arm as vaccine administered).  After five months pain is close to being gone.  Light pain left hip.  Only noticeable when lying down.  Pain almost gone.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Nausea, Pain in extremity, Swelling
Clinical narrative: Pain to upper arm, redness, swelling, nausea.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia
Clinical narrative: Pain in left shoulder joint-becomes worse when I move my left arm. No treatment.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Cellulitis, Pain, Peripheral swelling
Clinical narrative: Patient reported a severely swollen arm (size of a football), pain interfering with activities of daily living (dressing, etc). Patient received care through walk in clinic/ER and was treated for cellulitis (antibiotic).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Fever stated around 4/7/15. Rash developed on trunk and face 4/11/15. Ibuprofen and BENADRYL have been used for comfort.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Patient came in office with redness to upper left thigh.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Angiogram, Balance disorder, Bowel movement irregularity, Fall, Gait disturbance
Clinical narrative: Diagnosed with Transverse Myelitis.  Experienced the following symptoms: Significant reduction in sensation from my lower chest all the way through my legs. Weakness in my legs to the point I can only walk short distances, in the past I have experienced times when I was unable to rise from a chair because my legs would not respond at all.? Loss of balance, I have fallen a number of times and now walk with a walker or forearm crutches. Continued disruption in both urination and bowel movements. Positional pain, when I am lying or setting in a reclined position there is little or no pain, when I stand or set up straight, the pain increases over time until I have to recline to avoid it.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Lumbar puncture, Micturition disorder, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Diagnosed with Transverse Myelitis.  Experienced the following symptoms: Significant reduction in sensation from my lower chest all the way through my legs. Weakness in my legs to the point I can only walk short distances, in the past I have experienced times when I was unable to rise from a chair because my legs would not respond at all.? Loss of balance, I have fallen a number of times and now walk with a walker or forearm crutches. Continued disruption in both urination and bowel movements. Positional pain, when I am lying or setting in a reclined position there is little or no pain, when I stand or set up straight, the pain increases over time until I have to recline to avoid it.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Sensory loss, Walking aid user
Clinical narrative: Diagnosed with Transverse Myelitis.  Experienced the following symptoms: Significant reduction in sensation from my lower chest all the way through my legs. Weakness in my legs to the point I can only walk short distances, in the past I have experienced times when I was unable to rise from a chair because my legs would not respond at all.? Loss of balance, I have fallen a number of times and now walk with a walker or forearm crutches. Continued disruption in both urination and bowel movements. Positional pain, when I am lying or setting in a reclined position there is little or no pain, when I stand or set up straight, the pain increases over time until I have to recline to avoid it.
Age: 56.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Axillary mass, Erythema, Pain in extremity, Skin warm
Clinical narrative: Arm was sore, with redness spreading down her left arm with a hot sensation. Also said that a lump was under her armpit about the size of a quarter. Once she removed the bandage she stated that it looked like gel.
Age: 56.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Axillary mass, Erythema, Injection site reaction, Pain in extremity, Skin warm
Clinical narrative: Arm was sore, with redness spreading down her left arm with a hot sensation. Also said that a lump was under her armpit about the size of a quarter. Once she removed the bandage she stated that it looked like gel.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Both upper arms were slightly swollen and red. pt. felt achy and had fever x 1 day. No other concerns.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Mass, Pain, Skin warm
Clinical narrative: Softball sized redness, hard, lump, warmth to touch, painful.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Given in upper arm. Redness, swelling to elbow, pain and fever of 100.8.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever - 100.4. Dizziness. Vomiting. Soreness on arm. No medication given.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Pain at injection site lasting for the last 5 months. Difficulty moving arm. Painful to touch/sleep on.