chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 8 weeks old female patient. On 07-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 8 weeks old female patient. On 07-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 3 month old female patient. On 20-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 3 month old female patient. On 20-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 month old male patient. On 13-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 month old male patient. On 13-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Immediate pain at time of injection. Shoulder pain and weakness in arm. I believe the needle went too deep. Hurts all way down arm into hand. Fingers are coded and whole arm is tingling. Everyday all day.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site nerve damage, Injection site pain, Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Immediate pain at time of injection. Shoulder pain and weakness in arm. I believe the needle went too deep. Hurts all way down arm into hand. Fingers are coded and whole arm is tingling. Everyday all day.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: Immediate pain at time of injection. Shoulder pain and weakness in arm. I believe the needle went too deep. Hurts all way down arm into hand. Fingers are coded and whole arm is tingling. Everyday all day.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 12-NOV-2014, the patient was vaccinated with a dose of ROTATEQ injection administered orally at dose 2 ml (strength, indication, lot# and expiry date unspecified), that underwent a temperature excursion. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Ct. reports immediate stinging pain in arm at vaccination site. States since then she has had stinging/pain off and on in arm. Numbness/tingling in fingers for the last 1 1/2 weeks and has difficulty lifting arm due to pain.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: Ct. reports immediate stinging pain in arm at vaccination site. States since then she has had stinging/pain off and on in arm. Numbness/tingling in fingers for the last 1 1/2 weeks and has difficulty lifting arm due to pain.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, redness and swelling at injection site and surrounding arm. Pt is going to take antihistamine for itching and swelling and use ice prn for swelling. Will monitor circumference of affected area and seek physician if condition worsens.  Not warm to the touch or other signs of infection.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood culture, Cellulitis, Erythema, Hypersensitivity, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a 55 year old female consumer with allergy to vancomycin, to LEVAQUIN, to AXID, ESTRING, to sulfa, to latex and with alpha-1 antitrypsin abnormal level. The patient's medical history included breast cancer, shingles and ventricular tachycardia (dates unknown). On 18-NOV-2014 the patient was subcutaneously vaccinated with one injection of ZOSTAVAX (exact dose, lot# and expiration date were not reported). Concomitant therapies included KLOR-CON, triamterene, hydrochlorothiazide (manufacturer unknown) reported as HCTZ, digoxin and nadolol. On 18-NOV-2014 the patient experienced a slight reaction to ZOSTAVAX as soon as it was administered (redness and mild pain). On the following day (on 19-NOV-2014), the patient experienced two red welts, pain and itching at the injection site of where she was injected with the ZOSTAVAX vaccine. The redness spread (on the following day as well, on 19-NOV-2014) from the injection site to her elbow. The areas (two separate areas) were "warm to the touch". One area was "bright red" in color in comparison to a darker red in the other areas of the outbreak. On an unknown date, in November 2014 the patient was diagnosed with cellulitis due to an allergic reaction and possibly a staph infection and or possibly MRSA (methicillin-resistant Staphylococcus aureus). The patient sought medical attention in emergency room and was admitted to hospital on an unknown date, in November 2014 and was treated with vancomycin, BENADRYL intravenous (i.v.) and with clindamycin. The patient had blood culture test and regular laboratory work performed with no results provided (date unspecified). The patient was told to follow-up with her cardiologist. At the time of the report, the outcome of the events was not recovered. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review the event of "allergic reaction" was considered to be medically significant as required treatment with BENADRYL by the intravenous route. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site urticaria
Clinical narrative: This spontaneous report as received from a 55 year old female consumer with allergy to vancomycin, to LEVAQUIN, to AXID, ESTRING, to sulfa, to latex and with alpha-1 antitrypsin abnormal level. The patient's medical history included breast cancer, shingles and ventricular tachycardia (dates unknown). On 18-NOV-2014 the patient was subcutaneously vaccinated with one injection of ZOSTAVAX (exact dose, lot# and expiration date were not reported). Concomitant therapies included KLOR-CON, triamterene, hydrochlorothiazide (manufacturer unknown) reported as HCTZ, digoxin and nadolol. On 18-NOV-2014 the patient experienced a slight reaction to ZOSTAVAX as soon as it was administered (redness and mild pain). On the following day (on 19-NOV-2014), the patient experienced two red welts, pain and itching at the injection site of where she was injected with the ZOSTAVAX vaccine. The redness spread (on the following day as well, on 19-NOV-2014) from the injection site to her elbow. The areas (two separate areas) were "warm to the touch". One area was "bright red" in color in comparison to a darker red in the other areas of the outbreak. On an unknown date, in November 2014 the patient was diagnosed with cellulitis due to an allergic reaction and possibly a staph infection and or possibly MRSA (methicillin-resistant Staphylococcus aureus). The patient sought medical attention in emergency room and was admitted to hospital on an unknown date, in November 2014 and was treated with vancomycin, BENADRYL intravenous (i.v.) and with clindamycin. The patient had blood culture test and regular laboratory work performed with no results provided (date unspecified). The patient was told to follow-up with her cardiologist. At the time of the report, the outcome of the events was not recovered. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review the event of "allergic reaction" was considered to be medically significant as required treatment with BENADRYL by the intravenous route. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Laboratory test, Pain, Skin warm, Urticaria
Clinical narrative: This spontaneous report as received from a 55 year old female consumer with allergy to vancomycin, to LEVAQUIN, to AXID, ESTRING, to sulfa, to latex and with alpha-1 antitrypsin abnormal level. The patient's medical history included breast cancer, shingles and ventricular tachycardia (dates unknown). On 18-NOV-2014 the patient was subcutaneously vaccinated with one injection of ZOSTAVAX (exact dose, lot# and expiration date were not reported). Concomitant therapies included KLOR-CON, triamterene, hydrochlorothiazide (manufacturer unknown) reported as HCTZ, digoxin and nadolol. On 18-NOV-2014 the patient experienced a slight reaction to ZOSTAVAX as soon as it was administered (redness and mild pain). On the following day (on 19-NOV-2014), the patient experienced two red welts, pain and itching at the injection site of where she was injected with the ZOSTAVAX vaccine. The redness spread (on the following day as well, on 19-NOV-2014) from the injection site to her elbow. The areas (two separate areas) were "warm to the touch". One area was "bright red" in color in comparison to a darker red in the other areas of the outbreak. On an unknown date, in November 2014 the patient was diagnosed with cellulitis due to an allergic reaction and possibly a staph infection and or possibly MRSA (methicillin-resistant Staphylococcus aureus). The patient sought medical attention in emergency room and was admitted to hospital on an unknown date, in November 2014 and was treated with vancomycin, BENADRYL intravenous (i.v.) and with clindamycin. The patient had blood culture test and regular laboratory work performed with no results provided (date unspecified). The patient was told to follow-up with her cardiologist. At the time of the report, the outcome of the events was not recovered. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review the event of "allergic reaction" was considered to be medically significant as required treatment with BENADRYL by the intravenous route. Additional information has been requested.
Age: 0.0
Sex: U
Vaccine: HPV4
Symptoms: Foetal exposure during pregnancy, Premature baby, Twin pregnancy
Clinical narrative: This spontaneous report as received from a 33 year old mother refers to her two neonates. On 27-MAR-2013 the mother received the first dose of vaccinated with GARDASIL (lot#, expiration date, dose were unknown) intramuscularly. Concomitant therapies included CELEXA. The mother found out that she was pregnant on 07-APR-2013. Last Menstrual Period (LMP) and Expected Delivery of Date (EDD) were unknown. After 31 weeks of pregnancy on an unspecified date, the mother delivered twins. The outcome of the premature was unknown. The mother had sought unspecified medical attention. Upon internal review, the event of the mother had twins that were born after 31 weeks of pregnancy were considered to be medically significant. This is one of two reports from the same reporter, the mother's information was captured in MARRS#1411USA010351. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood test abnormal, Bursa injury, Bursal fluid accumulation, Bursitis, Drug administered at inappropriate site
Clinical narrative: This spontaneous report as received from a 62 year old female registered nurse with no drug reactions or allergies, refers to herself. On 17-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intra-articular in the arm (lot number was not reported). On the same day (17-OCT-2014), the patient was concomitantly administered a dose of influenza virus vaccine (unspecified). The patient reported she had had an unspecified pneumococcal vaccine (manufacturer unknown) years ago (date not provided), could not rule out PNEUMOVAX 23. The patient stated she received her influenza virus vaccine (unspecified) and the pharmacist went to administer the PNEUMOVAX 23, on 17-OCT-2014, he stuck the needle in very high up on the shoulder and he could not inject it, so he stuck the needle a second time right next to the first location and also could not inject. On the third needle insertion, he was able to inject the PNEUMOVAX 23. The patient stated that on 17-OCT-2014, about 2 and a half hours after the vaccination, her shoulder began to have severe pain. She stated that it was throbbing and painful, so painful that she was nauseated. She stated that she took ibuprofen and BENADRYL and went to an unspecified urgent care center. She also went to her unspecified internal medicine physician who referred her to an orthopaedic surgeon, who, on an unknown date in 2014, took Magnetic Resonance Imaging (MRI) of her shoulder and found fluid in the bursa with bursitis with a small high grade superficial tear partial tear (onset date 17-OCT-2014). The patient also reported that on 17-OCT-2014 the pharmacist injected the PNEUMOVAX 23 into her shoulder joint and it was so tender and painful that she could not lie down, sleep or even put ice on it. The patient was scheduled for surgery with the orthopaedic surgeon to repair the torn ligament but the surgery had to be delayed related to unspecified problems with blood work (date unspecified in 2014). There was no treatment given for the events of fluid in the bursa with bursitis with a small high grade superficial tear partial tear, shoulder joint and it was tender and painful that she could not lie down, sleep or even put ice on it, problems with blood work and torn ligament. The outcome of the events was not recovered. Relatedness between the therapy and the events was not reported. Upon internal review, the events "shoulder joint/it was so tender and painful that she could not lie down, sleep or even put ice on it" and "could not sleep" were considered to be disabling. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Drug administration error, Injection site joint pain, Injection site pain, Injection site reaction, Insomnia
Clinical narrative: This spontaneous report as received from a 62 year old female registered nurse with no drug reactions or allergies, refers to herself. On 17-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intra-articular in the arm (lot number was not reported). On the same day (17-OCT-2014), the patient was concomitantly administered a dose of influenza virus vaccine (unspecified). The patient reported she had had an unspecified pneumococcal vaccine (manufacturer unknown) years ago (date not provided), could not rule out PNEUMOVAX 23. The patient stated she received her influenza virus vaccine (unspecified) and the pharmacist went to administer the PNEUMOVAX 23, on 17-OCT-2014, he stuck the needle in very high up on the shoulder and he could not inject it, so he stuck the needle a second time right next to the first location and also could not inject. On the third needle insertion, he was able to inject the PNEUMOVAX 23. The patient stated that on 17-OCT-2014, about 2 and a half hours after the vaccination, her shoulder began to have severe pain. She stated that it was throbbing and painful, so painful that she was nauseated. She stated that she took ibuprofen and BENADRYL and went to an unspecified urgent care center. She also went to her unspecified internal medicine physician who referred her to an orthopaedic surgeon, who, on an unknown date in 2014, took Magnetic Resonance Imaging (MRI) of her shoulder and found fluid in the bursa with bursitis with a small high grade superficial tear partial tear (onset date 17-OCT-2014). The patient also reported that on 17-OCT-2014 the pharmacist injected the PNEUMOVAX 23 into her shoulder joint and it was so tender and painful that she could not lie down, sleep or even put ice on it. The patient was scheduled for surgery with the orthopaedic surgeon to repair the torn ligament but the surgery had to be delayed related to unspecified problems with blood work (date unspecified in 2014). There was no treatment given for the events of fluid in the bursa with bursitis with a small high grade superficial tear partial tear, shoulder joint and it was tender and painful that she could not lie down, sleep or even put ice on it, problems with blood work and torn ligament. The outcome of the events was not recovered. Relatedness between the therapy and the events was not reported. Upon internal review, the events "shoulder joint/it was so tender and painful that she could not lie down, sleep or even put ice on it" and "could not sleep" were considered to be disabling. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Ligament rupture, Nausea, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This spontaneous report as received from a 62 year old female registered nurse with no drug reactions or allergies, refers to herself. On 17-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intra-articular in the arm (lot number was not reported). On the same day (17-OCT-2014), the patient was concomitantly administered a dose of influenza virus vaccine (unspecified). The patient reported she had had an unspecified pneumococcal vaccine (manufacturer unknown) years ago (date not provided), could not rule out PNEUMOVAX 23. The patient stated she received her influenza virus vaccine (unspecified) and the pharmacist went to administer the PNEUMOVAX 23, on 17-OCT-2014, he stuck the needle in very high up on the shoulder and he could not inject it, so he stuck the needle a second time right next to the first location and also could not inject. On the third needle insertion, he was able to inject the PNEUMOVAX 23. The patient stated that on 17-OCT-2014, about 2 and a half hours after the vaccination, her shoulder began to have severe pain. She stated that it was throbbing and painful, so painful that she was nauseated. She stated that she took ibuprofen and BENADRYL and went to an unspecified urgent care center. She also went to her unspecified internal medicine physician who referred her to an orthopaedic surgeon, who, on an unknown date in 2014, took Magnetic Resonance Imaging (MRI) of her shoulder and found fluid in the bursa with bursitis with a small high grade superficial tear partial tear (onset date 17-OCT-2014). The patient also reported that on 17-OCT-2014 the pharmacist injected the PNEUMOVAX 23 into her shoulder joint and it was so tender and painful that she could not lie down, sleep or even put ice on it. The patient was scheduled for surgery with the orthopaedic surgeon to repair the torn ligament but the surgery had to be delayed related to unspecified problems with blood work (date unspecified in 2014). There was no treatment given for the events of fluid in the bursa with bursitis with a small high grade superficial tear partial tear, shoulder joint and it was tender and painful that she could not lie down, sleep or even put ice on it, problems with blood work and torn ligament. The outcome of the events was not recovered. Relatedness between the therapy and the events was not reported. Upon internal review, the events "shoulder joint/it was so tender and painful that she could not lie down, sleep or even put ice on it" and "could not sleep" were considered to be disabling. 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 an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-NOV-2014"), an unspecified number of patients received ROTATEQ oral (doses, lot # and expiration dates were not reported) stored at 33F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old male patient. On 03-NOV-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016. The outcome of the event was unknown. This is one of the several reports received from the same reproter. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old male patient. On 08-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old male patient. On 08-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old male patient. On 08-OCT-2014, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # J016186 expiry date 24-OCT-2016). The outcome of the event was unknown. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old male patient. On 08-OCT-2014, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # J016186 expiry date 24-OCT-2016). The outcome of the event was unknown. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 8 weeks old male patient. On 23-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from an office manager (also reported as healthcare worker) refers to five unknown patients of unknown age and gender. On unknown dates the patients were vaccinated with a dose of ROTATEQ, oral (dose and lot number not reported). No adverse effects were reported. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 month old male patient. On 27-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 month old male patient. On 27-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 month old male patient. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # J016186 expiry date 24-OCT-2016). The outcome of the event was unknown. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 month old male patient. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # J016186 expiry date 24-OCT-2016). The outcome of the event was unknown. Additional information has been requested.
Age: 0.56
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old female patient. On 20-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling of the shot site and radiating out 6+".  Hot to the touch, painful and itchy.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests abnormal, Anaphylactic reaction, Bladder dysfunction, Blood pressure increased, Computerised tomogram normal
Clinical narrative: 10-15-14: Sudden hearing loss (R) ear. 10-16-14: Hearing loss (R) ear and swelling face/throat -> urgent care visit that day: epi-shot given and 40 mg prednisone prescribed. 10-17-14 visit to ENT. 10-19-14 visit to ER: sudden hearing loss continued and increased swelling at face: increased steroids to 60 mg. CT scan of brain (-). Blood work taken and referred to internal medicine MD for specific MRIs as follow-up. 10-22 MRI of brain, steroid taper ordered by MD. 10-23 and 10-24 episodes anaphylaxis - treated with steroid, albuterol and BENADRYL. 10-24: Bladder control changes and trunk weakness, muscle twitching, paresthesias, hand swelling, decreased motor control, decreased short term memory, blurry vision, heart palpitations, bowel control changes -> 4 additional ER visits, 2 by ambulance for allergic reaction and anaphylaxis. Increased BP, med changes. MRI spine: T-L-S, more blood work. Referral to ENT, allergy/immunology MD, neurologist. Testing ongoing for continued problems.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness unilateral, Functional gastrointestinal disorder, Hypersensitivity, Local swelling, Memory impairment
Clinical narrative: 10-15-14: Sudden hearing loss (R) ear. 10-16-14: Hearing loss (R) ear and swelling face/throat -> urgent care visit that day: epi-shot given and 40 mg prednisone prescribed. 10-17-14 visit to ENT. 10-19-14 visit to ER: sudden hearing loss continued and increased swelling at face: increased steroids to 60 mg. CT scan of brain (-). Blood work taken and referred to internal medicine MD for specific MRIs as follow-up. 10-22 MRI of brain, steroid taper ordered by MD. 10-23 and 10-24 episodes anaphylaxis - treated with steroid, albuterol and BENADRYL. 10-24: Bladder control changes and trunk weakness, muscle twitching, paresthesias, hand swelling, decreased motor control, decreased short term memory, blurry vision, heart palpitations, bowel control changes -> 4 additional ER visits, 2 by ambulance for allergic reaction and anaphylaxis. Increased BP, med changes. MRI spine: T-L-S, more blood work. Referral to ENT, allergy/immunology MD, neurologist. Testing ongoing for continued problems.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Motor dysfunction, Muscle twitching, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: 10-15-14: Sudden hearing loss (R) ear. 10-16-14: Hearing loss (R) ear and swelling face/throat -> urgent care visit that day: epi-shot given and 40 mg prednisone prescribed. 10-17-14 visit to ENT. 10-19-14 visit to ER: sudden hearing loss continued and increased swelling at face: increased steroids to 60 mg. CT scan of brain (-). Blood work taken and referred to internal medicine MD for specific MRIs as follow-up. 10-22 MRI of brain, steroid taper ordered by MD. 10-23 and 10-24 episodes anaphylaxis - treated with steroid, albuterol and BENADRYL. 10-24: Bladder control changes and trunk weakness, muscle twitching, paresthesias, hand swelling, decreased motor control, decreased short term memory, blurry vision, heart palpitations, bowel control changes -> 4 additional ER visits, 2 by ambulance for allergic reaction and anaphylaxis. Increased BP, med changes. MRI spine: T-L-S, more blood work. Referral to ENT, allergy/immunology MD, neurologist. Testing ongoing for continued problems.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Paraesthesia, Pharyngeal oedema, Pulmonary function test, Sudden hearing loss
Clinical narrative: 10-15-14: Sudden hearing loss (R) ear. 10-16-14: Hearing loss (R) ear and swelling face/throat -> urgent care visit that day: epi-shot given and 40 mg prednisone prescribed. 10-17-14 visit to ENT. 10-19-14 visit to ER: sudden hearing loss continued and increased swelling at face: increased steroids to 60 mg. CT scan of brain (-). Blood work taken and referred to internal medicine MD for specific MRIs as follow-up. 10-22 MRI of brain, steroid taper ordered by MD. 10-23 and 10-24 episodes anaphylaxis - treated with steroid, albuterol and BENADRYL. 10-24: Bladder control changes and trunk weakness, muscle twitching, paresthesias, hand swelling, decreased motor control, decreased short term memory, blurry vision, heart palpitations, bowel control changes -> 4 additional ER visits, 2 by ambulance for allergic reaction and anaphylaxis. Increased BP, med changes. MRI spine: T-L-S, more blood work. Referral to ENT, allergy/immunology MD, neurologist. Testing ongoing for continued problems.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Vision blurred, Visual acuity tests abnormal
Clinical narrative: 10-15-14: Sudden hearing loss (R) ear. 10-16-14: Hearing loss (R) ear and swelling face/throat -> urgent care visit that day: epi-shot given and 40 mg prednisone prescribed. 10-17-14 visit to ENT. 10-19-14 visit to ER: sudden hearing loss continued and increased swelling at face: increased steroids to 60 mg. CT scan of brain (-). Blood work taken and referred to internal medicine MD for specific MRIs as follow-up. 10-22 MRI of brain, steroid taper ordered by MD. 10-23 and 10-24 episodes anaphylaxis - treated with steroid, albuterol and BENADRYL. 10-24: Bladder control changes and trunk weakness, muscle twitching, paresthesias, hand swelling, decreased motor control, decreased short term memory, blurry vision, heart palpitations, bowel control changes -> 4 additional ER visits, 2 by ambulance for allergic reaction and anaphylaxis. Increased BP, med changes. MRI spine: T-L-S, more blood work. Referral to ENT, allergy/immunology MD, neurologist. Testing ongoing for continued problems.
Age: 11.0
Sex: F
Vaccine: FLU3, HIBV, MNQ, PPV
Symptoms: Cellulitis, Chills, Hypotension, Injection site reaction, Intensive care
Clinical narrative: 11/7 - Patient presented with fever, chills, elevated WBC and low BP. Given fluid boluses and IV antibiotics - admitted to the PICU with concern for shock. Transferred to the floor on 11/8. Developed localized reaction on (R) arm (site of PPV23) with concern for possible cellulitis. Discharged on 11/13 to complete a course of oral antibiotics.
Age: 11.0
Sex: F
Vaccine: FLU3, HIBV, MNQ, PPV
Symptoms: Local reaction, Pyrexia, Shock, Vaccination complication, White blood cell count increased
Clinical narrative: 11/7 - Patient presented with fever, chills, elevated WBC and low BP. Given fluid boluses and IV antibiotics - admitted to the PICU with concern for shock. Transferred to the floor on 11/8. Developed localized reaction on (R) arm (site of PPV23) with concern for possible cellulitis. Discharged on 11/13 to complete a course of oral antibiotics.
Age: 0.55
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old male patient. On 27-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old male patient. On 27-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old male patient. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # J016186 expiry date 27-OCT-2014). The outcome of the event was unknown. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old male patient. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # J016186 expiry date 27-OCT-2014). The outcome of the event was unknown. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old female patient. On 21-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspepsia, Eyelid oedema, Respiratory tract congestion
Clinical narrative: Approx 6:15pm began feeling what I first thought was heartburn. Approx 8-8:15pm severe congestion and swelling in both eyes. Right eye swelled almost closed. BENADRYL relieved the congestion, but eye swelling wasn't entirely gone until the second morning.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed rash on the injection area and surrounding area including the inner part of the left arm. Also it is painful, warm and swollen. She went to the physician two days later to vacccination (11/12/14) and diagnosis was cellulitis. He prescribed CIPRO 500 mg tabs.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Severe pain at time og TDAP shot. Pain lasted from Oct. 9 thru Nov 19 and beyond. Dr prescribed ibuprofen, heat, ice and physical therapy. I am not pain free (Nov 19) yet and can't sleep on left shoulder. Dr said my rotary cuff is damaged.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Large indurated, erythematous painful area around injection site-5 smaller areas over upper arm. KEFLEX 500 mg BID x 7d.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of heaviness
Clinical narrative: Pt reports diaphoresis associated with leg "heaviness" and arm "heaviness". Denies SOB, hives or urticaria. Vitals: BP 145/83 P92 R16 T 36.5 P.O. 100%. Given BENADRYL 50 mg PO at 0100. Recheck at 0115 with no change in symptoms. Recheck at 0200 continues to deny SOB, hives or urticaria.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: I got the vaccine on the 10/22/2014. I only want to take the flu shot every other year. This time the news of ebola, made feel I have to take it. About 45 min to 1 hour my arm's were itching bad I was shopping. Got home looked at my body at that time I didn't know what it was. My doc said it was hives.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: The shot was given at the top of my arm. The following morning I could not move my arm without extreme pain. I called the pharmacy and was told I could take MOTRIN and use ice. It didn't get better, so I saw my dr on 11-13-14. He prescribed prednisone 20 mg. One tablet 2x dat for 5 days.
Sex: U
Vaccine: RV5
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 an unknown date unspecified number of patients were vaccinated with a dose of ROTATEQ (lot number expiration date, dose were not reported), route default as oral for prophylaxis that underwent post supported temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Site of Menactra administration became raised with mild pruritis.  Sx only lasted for 5 min, then resolved completely.  Since then, every week give or take a few days, the site becomes raised again with similar pruritus, and again resolves after a few minutes.  No treatment up to this point.  Pt returned for his final Gardasil dose and has had the same reaction occur at this new administration site.  Have now suggested to the pt to apply Hydrocortisone and Benadryl cream bid for 2 wks to see if this resolves sx completely.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Fall, Hyperhidrosis, Nausea
Clinical narrative: Donor had blurred vision, dizziness, light-headedness, nausea, pale, sweaty, felt faint & weak, then fell on the floor in bathroom.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor, Vision blurred
Clinical narrative: Donor had blurred vision, dizziness, light-headedness, nausea, pale, sweaty, felt faint & weak, then fell on the floor in bathroom.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: EMPLOYEE DID NOT HAVE INITIAL REACTION AFTER 15 MINUTES OF RECEIVING VACCINE. EMPLOYEE COMPLAINED OF ADVERSE SYMPTOMS TO STAFF APPROXIMATELY 2-3 HOURS LATER. NO VAERS COMPLETED AT TIME. EMPLOYEE STATED TO MANAGEMENT 11/26/2014 THAT SHE DID NOT WISH TO RECEIVE ANOTHER VACCINE DUE TO HAVING A REACTION FROM THE PREVIOUS. EMPLOYEE STATED THAT AFTER VACCINE WAS GIVEN ON 10/20/2014 SHE EXPERIENCED SLIGHT SWELLING IN HER HANDS, ARMS, AND FACIAL AREA. EMPLOYEE STATED THAT SHE WAS ADVISED TO TAKE SOME BENADRYL AFTERWARDS SHE STATED THE SYMPTOMS SUBSIDED ABOUT AN HOUR AFTER.
Age: 12.0
Sex: F
Vaccine: FLUN4, MNQHIB
Symptoms: Dizziness, Syncope
Clinical narrative: While waiting for elevator, my daughter said she felt light headed and she leaned against me and fainted. I called for help and medical personnel came over. She was taken to observation room for a few minutes until she fell better.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt presented shortly after (aprox 15 minutes) injection with a red, round, raised area around where shot was given.  I asked if she was having any trouble breathing, shortness of breath or itchy throat.  She did not - we talked about a dose of benadryl and I gave her one dose from my ER kit.  I asked her to follow up with me.  She came by pharmacy this morning, it was still raised and sore.  I gave her small packs of aceaminophen, ibuprofen, diphenhydramine and an ice pack.  I instructed her to use either the pain reliever and try to ice pack to see if that helped.  I will follow up with her again.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Erythema, Headache
Clinical narrative: At home: closed throat, shortness of breath, cough, fever up to 102 F, headache, tachycardia, reddened eyes, hands/fingers swollen and red. At emergency room: acute fever, generalized allergic reaction secondary.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Influenza A virus test negative, Influenza virus test negative, Local swelling, Ocular hyperaemia
Clinical narrative: At home: closed throat, shortness of breath, cough, fever up to 102 F, headache, tachycardia, reddened eyes, hands/fingers swollen and red. At emergency room: acute fever, generalized allergic reaction secondary.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Streptococcus test negative, Tachycardia, Throat tightness
Clinical narrative: At home: closed throat, shortness of breath, cough, fever up to 102 F, headache, tachycardia, reddened eyes, hands/fingers swollen and red. At emergency room: acute fever, generalized allergic reaction secondary.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: PT DEVELOPED A RED, HARD, WARM SPOT ON BACK OF ARM WHERE VACCINE WAS ADMINISTERED.  I TOLD PT TO TRY TAKING BENADRYL AND IF IT DOESN'T RESOLVE, GO GET IT CHECKED OUT AT WALK-IN CLINIC.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm swollen and red at site of injection.
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Anxiety, Insomnia, Muscle spasms, Nausea, Tension
Clinical narrative: The patient stated that he experienced nausea, tense/ anxiety, muscle spasms of his hands and feet (lasted about 2 days) and insomnia. He said the other symptoms lasted about 3 days. The patient did got to the doctor. They did not prescribe anything for his reaction.
Age: 52.0
Sex: M
Vaccine: YF
Symptoms: Blood test, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Woke up wed morning and right foot was numb. It stayed like that until Thur. Called my doc. She told me to go to emergency room. She thought it might be blood clot. Went to emergency room. They said it was not. Another week went by no better. Went to emergency. They done blood test. No results. Another week no better. Went to another emergency. They diagnosed me with GBS.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Woke up Wed morn. Right foot was numb. Hardly any feeling. Called doc. Thursday she said go to emergency room. Sounded like I had a blood clot. Went to ER. They said no clots. Sat had same symptoms in left foot up left leg and in my hands a week later went to ER. They done blood work and stool sample test. Still no better. A week later went to ER. Said I had GBS. They did a spinal tap. Then started IVIG infusion took it for five days.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Stool analysis
Clinical narrative: Woke up Wed morn. Right foot was numb. Hardly any feeling. Called doc. Thursday she said go to emergency room. Sounded like I had a blood clot. Went to ER. They said no clots. Sat had same symptoms in left foot up left leg and in my hands a week later went to ER. They done blood work and stool sample test. Still no better. A week later went to ER. Said I had GBS. They did a spinal tap. Then started IVIG infusion took it for five days.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose, Syncope
Clinical narrative: Patient fainted approximately 10 minutes after receiving the vaccine.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pain, Swelling
Clinical narrative: Got a huge reaction to the Pneumovax starting Wednesday afternoon with soreness in left shoulder and 3 really tender spots and red spots with pain lifting arm and swollen LN.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, VIIth nerve paralysis
Clinical narrative: Diagnosed with Bell's Palsy in 29th week of pregnancy. Was seen and diagnosed in the Emergency Room.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm; aching all thru body; 3 degree fever started around 3 PM.  Took acetaminophen & rested.  All symptoms lasted until 11/15/2014.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood test, Burning sensation, Erythema, Headache, Injected limb mobility decreased
Clinical narrative: Extreme soreness at injection site, couldn't move arm, bulging out swelling, redness, burning, itching, fever, headache.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Pruritus, Pyrexia, Swelling, Ultrasound scan
Clinical narrative: Extreme soreness at injection site, couldn't move arm, bulging out swelling, redness, burning, itching, fever, headache.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Extreme soreness at injection site, couldn't move arm, bulging out swelling, redness, burning, itching, fever, headache.