chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: AFTER THE VACCINES (GIVEN 10/28/15), THERE WAS NO LOCAL OR ANAPHYLACTIC RXN.  ON 10/31/15, THE PATIENT'S LEFT ARM WAS RED AT THE SITES OF INJECTION AND HE SAID IT WAS PAINFUL TO THE TOUCH.  HE SAID WITHIN THE FIRST 24 HOURS AFTER THE SHOTS HE HAD A FEVER AND WAS SHIVERING.  ON OUR 10/31/2015 VISIT, I TOLD THE PATIENT THAT IF THE REDNESS AND PAIN IN HIS LEFT ARM DID NOT GET BETTER OR GOT WORSE IN THE NEXT COUPLE DAYS THAT HE SHOULD GO TO HIS DOCTOR. I GAVE THE PATIENT A COPY OF HIS VACCINE QUESTIONAIRE WITH RECORD OF THE VACCINES ADMINISTERED IN CASE HE NEEDED TO SEE A DR. ON 11/05/2015, HIS WIFE REPORTED THAT HIS ARM WAS STILL RED AND SORE AT THE IMMUNIZATION SITES.  WHEN I ASKED HIS WIFE IF HE HAD SEEN A DR, SHE SAID HE HAD NOT AND SAID THAT HIS LEFT ARM WAS IMPROVING.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Cough, Diarrhoea, Diarrhoea haemorrhagic, Headache
Clinical narrative: Initially started out with a headache, by the next morning (11/5) I had a cough, runny nose and congestion. All the respiratory symptoms lasted for about 3 1/2 days. On 11/8, I had stomach cramping, nausea and diarrhea that contained frank blood. I continue to have a headache.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Initially started out with a headache, by the next morning (11/5) I had a cough, runny nose and congestion. All the respiratory symptoms lasted for about 3 1/2 days. On 11/8, I had stomach cramping, nausea and diarrhea that contained frank blood. I continue to have a headache.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Left deltoid area red, swollen, painful. Warm to touch fever 101.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Several hours after vaccine administration, patient's arm begin to hurt and continued the next day as well it got better, but 2 days later the pain returned and has been getting worse there is no redness, swelling or hardness at the injection site, no fever or chills to report. It hurts to raise his arm, but the pain does get better after taking an ALEVE the patient is concerned that the pain has been present for 2 weeks now.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Body temperature increased, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Mom reported the following morning after immunizations child had oral temp of 102 with redness and swelling in LUA. Seen in office on 10/4/15 when mild swelling and redness was noted and marked. Child had minimal discomfort. Mom will give MOTRIN.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Dysgeusia, Headache, Impaired work ability, Nausea, Pain in extremity
Clinical narrative: Within 15 min of receiving FLUCELVAX patient c/o bad taste in mouth, tongue felt heavy. Later that day LT arm pain, tingling, severe headache, nausea. The next day at work I called 911 and she was taken to ER. She is still out of work. She had all childhood vaccines and Hep B series with out events.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Paraesthesia, Tongue disorder
Clinical narrative: Within 15 min of receiving FLUCELVAX patient c/o bad taste in mouth, tongue felt heavy. Later that day LT arm pain, tingling, severe headache, nausea. The next day at work I called 911 and she was taken to ER. She is still out of work. She had all childhood vaccines and Hep B series with out events.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no drug reactions or allergies, patient's medical history or concomitant medications reported. On an unspecified date in May 2014, the patient was vaccinated with a first dose in series of vaccinations of GARDASIL (strength, route, administration site, LOT#, expiration date were not reported). On an unspecified date in Aug 2015, patient was vaccinated with GARDASIL 9, (dose number, strength, route, administration site, LOT#, expiration date were not provided), (inappropriate schedule of drug administration and interchange of vaccine products). No adverse effects were reported and the patient did not seek medical attention. The outcome of interchange of vaccine products was unknown. The causality between interchange of vaccine products and suspect vaccines was not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (a certified medical assistant) referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot# also reported L005297 with expired date 17-AUG-2016) (dosing regimen and route unknown). No concomitant medications were provided. No adverse effects were reported. Lot verification result has been received on 10-JUL-2015 and lot number L005297 with an expiry date of 17-AUG-2016 has been validated for PROQUAD (Merck). All telephone attempts to obtain follow-up information on 03-AUG-2015 have been unsuccessful. Follow-up information has been received from a telephone call on 05-AUG-2015. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On 20-JUL-2015, the patient was vaccinated with a dose of PROQUAD (Merck) Lot # was confirmed to be L005297. This is one of several reports received from the same reporter. Additional information has been requested. Patient's details, product, event information and narrative were updated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an adult patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 04-NOV-2015 the patient was vaccinated with a pediatric dose of RECOMBIVAX HB, instead of an adult dose. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to an unspecified number of patients of unknown age. The patients medical histories and concurrent conditions were not reported. The patients were each administered a total of three doses of PNEUMOVAX 23 on separate unspecified dates, (lot number, expiration date, dose and route of administration were not reported). Each unspecified patient received two doses of PNEUMOVAX 23 before age 65 years, then a third dose of PNEUMOVAX 23 at age 65 years or older. No adverse effect reported. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (a certified medical assistant) referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or drug allergies were reported. On 18-JUN-2015 the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (lot# also reported as L005297 with expired date 17-AUG-2016) (dosing regimen and route unknown). No concomitant medications were provided. No adverse effects were reported. Lot verification result has been received on 10-JUL-2015 and lot number L005297 with an expiry date of 17-AUG-2016 has been validated for (Oka-Merck) PROQUAD. All telephone attempts to obtain follow-up information on 03-AUG-2015 have been unsuccessful. Follow up information has been received from a telephone call on 05-AUG-2015. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On 30-JUL-2015, the patient was vaccinated with a dose of (Oka-Merck) PROQUAD, lot # was confirmed to be L005297. This is one of several reports received from the same reporter. Additional information has been requested. Patient's details, product, event information and narrative were updated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored MMR II lot # L000458, expiration date: 06-JAN-2017, therapy type: rHA (dose, route and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old female patient with unspecified allergies. On 20-OCT-2015, the patient was vaccinated with PNEUMOVAX23 (L029113/Exp:27-MAR-2017). No other co-suspects were reported. Concomitant medications included unspecified hypertension and choelsterol medications. No medical history was reported. On 22-OCT-2015, the pharmacist stated that the patient called the pharmacy and reported following the administration of PNEUMOVAX23, she experienced warmth and "red patches" that developed above and below the injection site. No treatment was given for the events of warmth and "red patches" that developed above and below the injection site. No laboratory diagnostic studies were performed. The outcome of the events was reported as not recovered/not resolved. The causality of the events was not reported. No additional informaiton was provided. Additional informaiton has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot #K021444, expiration date: 17-SEP-2016 (dose, route and anatomical location were not reported) or RECOMBIVAX HB lot # L006231, expiration date: 06-OCT-2016 (dose, route and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # K023328, expiration date: 23-JUN-2015 (dose, route and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report has been received from a pharmacist referring to unspecified number of patients. On unknown dates the patients were vaccinated with GARDASIL (first dose, dose, frequency, route and lot# not reported). It was reported that the patients received either their second or third dose of GARDASIL late on unspecified dates. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report has been received from a pharmacist referring to unspecified number of patients. On unknown dates the patients were vaccinated with GARDASIL 9 (first dose, dose, frequency, route and lot# not reported). It was reported that the patients received earlier their second or their third dose of GARDASIL 9 late on unspecified dates. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were inadvertently administered doses of RECOMBIVAX HB (lot number J004700 and expiration date 26-NOV-2015, lot number L010595 and expiration date 12-NOV-2016, dose and route of administration were not reported) that had been improperly stored. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to four patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with oral, ROTATEQ (dose, dose number and lot# were not reported), which was improperly stored. No adverse effects were reported. On 19-OCT-2015, a telephone call was placed to the registered nurse, who was unable to provide the patients' identifiers at that time. Follow-up information has been received from the registered nurse on 20-OCT-2015. A 6-month-old patient (gender unknown) was vaccinated with an improperly stored dose of oral, ROTATEQ lot# K016261, on 31-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2015, the patient, who was on therapy with an unspecified dose of methotrexate (manufacturer unknown) was inadvertently administered a dose of VARIVAX (Merck) instead of ZOSTAVAX, (dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received form a medical assistant refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were inadvertently administered doses of COMVAX (lot number J013884 and expiration date 19-AUG-2016, dose and route of administration were not reported) that had been improperly stored. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were inadvertently administered doses of M-M-R II (lot number K024035 and expiration date 26-NOV-2016, lot number K024825 and expiration date 02-DEC-2016, dose and route of administration were not reported) that had been improperly stored. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were inadvertently administered doses of oral, ROTATEQ (lot number K011948 and expiration date 07-JUN-2016, dose was not reported) that had been improperly stored. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L019286, expiration date: 14-SEP-2015 (dose, route and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Informatino has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Peritnent medical history and drug reactions/allergies were not reported. On multiple unspecified dates the patients were administered with doses of improperly stored PEDVAXHIB (lot # was reported as L012837, expiration date was reported as 11-MAR-2018, dose and route were not reported). Concomitant drug was not reported. This is one of several reports from the same reporter. Adidtional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from nurse regarding multiple unspecified patients of unknown age and gender. The patients concurrent condition and medical history were not reported. On unspecified date in October 2015 ranging from 20-OCT-2015 to 28-OCT-2015 the patient was vaccinated with improperly GARDASIL 9 (lot # L016428, Expiry date: 30-JUL-2017) (strength, dose and frequency not reported). No adverse events were reported. This Case is one of 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to the multiple patients of unknown age and gender. On an unspecified date in 2015, starting from August 2015 and continued through October 2015, the nurse reported that unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K019561 and expiry date 22-APR-2016 and L011531; expiry: 07-JAN-2017). Concomitant medications were not reported. No symptoms were reported. No PQC were involved and no further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On multiple unspecified dates the patients were administered with doses of improperly stored GARDASIL 9 (lot # L013429, expiration date 21-JUL-2017, dose and route were not reported). Concmitant drug was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On multiple unspecified dates the patients were administered with doses of improperly stored M-M-R II (lot # was reported as L003858, expiration date was reported as 05-FEB-2017; lot # was reported as L01528, expiration date was reported as 03-APR-2017; therapy type, dose and route were not reported). Concomitant drug was not reported. This is one of several reports 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 has been received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients concurrent condition and medical history were not reported. On unknown date in October 2015 ranging from 20-OCT-2015 to 28-OCT-2015, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L014429, Expiry date: 15-MAR-2018) (strength, dose and frequency not reported). No adverse events were reported. This case is one of 2 reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or drug allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route were unknown). No information on patients' concomitant medications was provided. No adverse effects were reported. Lot number L003775 had been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. All telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received on 05-AUG-2015. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015. The patient was 12 month old. The patient was vaccinated with improperly stored dose of VARIVAX (Merck) on 15-SEP-2015. This is one of the several reports received from the same reporter. Additional information has been requested. Patient, event, product and narrative information was updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to 9 unspecified patients of unknown of age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of (Oka/Merck) VARIVAX (Lot#L008271; expiration date 11-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. Follow up information was received on 23-OCT-2015 from a certified medical assistant. The medical assistant noted that the number of patients who were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (Lot# L008271) was 8, not 9 as previously reported. Follow-up information has been received on 27-OCT-2015 from the certified medical assistant. The reporter provided that the patient of unknown age and gender was vaccinated with the improperly stored dose of (Oka/Merck) VARIVAX on 20-SEP-2015. It was reported that the vaccine was 2112 hours out of range. Additional information has been requested. Patient, product and event details and analysis were updated.
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist, who reported the same event for 2 patients. This is the second of two reports. A male patient of unspecified age and ethnicity received a single dose of PREVNAR 13 (Lot L625074, Expiry date 30Nov2016) in the arm on 26Oct2015. Medical history and concomitant medications were not reported. The patient had a cellulitis type of reaction on the same day. The outcome of the event was unknown. The pharmacist believed that the cellulitis occurred after having shot of PREVNAR 13 as it was at same arm as the injection site.
Sex: U
Vaccine: PNC13
Symptoms: Cerebrovascular accident, Disability
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for a patient. A patient of an unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml single. Medical history and concomitant medications were not reported. The consumer reported that someone she knew complained of stroked out and become disabled after the injection on an unspecified date. The outcome of the event was unknown.
Age: 25.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Fatigue, Feeling abnormal, Haemoglobin decreased, Malaise, Transfusion
Clinical narrative: This is a spontaneous report from a contactable nurse (the patient). A 25 year-old female patient of unspecified ethnicity received PREVNAR 13 at a single dose and flu vaccine (manufacturer unknown) at an unknown dose both via an unspecified route of administration on arm, on an unspecified date in 2015. Relevant medical history included myelodysplastic syndrome and she was immunosuppressed both ongoing. Somewhere the patient had received transfusion every 6-8 weeks. Concomitant medications were not reported. The day after the vaccination in 2015, the patient did not feel well, she felt terrible and sick. She had extreme exhaustion to the point where she could barely put one foot in front of the other. The patient underwent blood work and the hemoglobin went from 8.7 to 6.9 (unit unspecified) and she was transfused. The outcome of the events was unknown. Causality was not available.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Hypoaesthesia, Injection site hypersensitivity, Mobility decreased, Pain
Clinical narrative: This is a spontaneous report from a consumer (medical assistant), from a contactable other HCP (healthcare professional), from a contactable physician and from a contactable consumer reporting for herself. A 74-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot number J20347, Expiration date Jun2016, NDC number 0005197101) on 02Apr2015 at 0.5 ml single in the right deltoid. Relevant medical history included high blood pressure, hyperlipidemia, mild diabetes, and vitamin D deficiency. The patient received in the past an unspecified pneumococcal vaccine. Concomitant medications included ongoing potassium, ongoing metformin, ongoing losartan, ongoing Aspirin, CRESTOR, ongoing hydrochlorothiazide, and ongoing Vitamin D. On an unspecified date in 2015, the patient had an allergic reaction due to PREVNAR 13 injection. The patient stated that the event was in the arm where the vaccine was administered. The medical assistant mentioned that patient did not receive any treatment in response to the event and no laboratory tests were performed. Also the patient developed side effects from the vaccination, such as numbness, tingling and discomfort on unknown date in 2015. Additionally, the patient added that she was having so much pain and her arm was practically paralyzed on unknown date in 2015. Treatment of pain included unspecified pills. All the events were not recovered and she is having so much pain in 2 fingers at night. According to the consumer she was hospitalized for the events allergic reaction in arm where the vaccine was administered, numbness, having so much pain, discomfort and tingling. The other HCP, on behalf of the physician, reported that the patient did not require hospitalization in response to the event, and also considered that the vaccine had a causal effect to the adverse event. Follow-up (13Jul2015): New information received other HCP on behalf of a physician: includes: clinical course, reporter's comment on causality assessment. Follow-up (09Sep2015): New information obtained from a contactable physician includes: additional events (numbness, tingling and discomfort). Follow-up attempts completed. No further information expected. Follow up (14Oct2015): New information received from a contactable consumer reporting for herself includes: additional events (having so much pain and her arm was practically paralyzed), treatment, past vaccine history and outcome. Follow up (02Nov2015): New information received from a contactable consumer reporting for herself includes: details on concomitant medications, outcome and seriousness criteria for the events. Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Paraesthesia, Pseudoparalysis
Clinical narrative: This is a spontaneous report from a consumer (medical assistant), from a contactable other HCP (healthcare professional), from a contactable physician and from a contactable consumer reporting for herself. A 74-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot number J20347, Expiration date Jun2016, NDC number 0005197101) on 02Apr2015 at 0.5 ml single in the right deltoid. Relevant medical history included high blood pressure, hyperlipidemia, mild diabetes, and vitamin D deficiency. The patient received in the past an unspecified pneumococcal vaccine. Concomitant medications included ongoing potassium, ongoing metformin, ongoing losartan, ongoing Aspirin, CRESTOR, ongoing hydrochlorothiazide, and ongoing Vitamin D. On an unspecified date in 2015, the patient had an allergic reaction due to PREVNAR 13 injection. The patient stated that the event was in the arm where the vaccine was administered. The medical assistant mentioned that patient did not receive any treatment in response to the event and no laboratory tests were performed. Also the patient developed side effects from the vaccination, such as numbness, tingling and discomfort on unknown date in 2015. Additionally, the patient added that she was having so much pain and her arm was practically paralyzed on unknown date in 2015. Treatment of pain included unspecified pills. All the events were not recovered and she is having so much pain in 2 fingers at night. According to the consumer she was hospitalized for the events allergic reaction in arm where the vaccine was administered, numbness, having so much pain, discomfort and tingling. The other HCP, on behalf of the physician, reported that the patient did not require hospitalization in response to the event, and also considered that the vaccine had a causal effect to the adverse event. Follow-up (13Jul2015): New information received other HCP on behalf of a physician: includes: clinical course, reporter's comment on causality assessment. Follow-up (09Sep2015): New information obtained from a contactable physician includes: additional events (numbness, tingling and discomfort). Follow-up attempts completed. No further information expected. Follow up (14Oct2015): New information received from a contactable consumer reporting for herself includes: additional events (having so much pain and her arm was practically paralyzed), treatment, past vaccine history and outcome. Follow up (02Nov2015): New information received from a contactable consumer reporting for herself includes: details on concomitant medications, outcome and seriousness criteria for the events. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist, who reported the same event for 2 patients. This is the second of two reports. A patient of unspecified age, ethnicity and gender received a single dose of PREVNAR 13 (Lot L99271, Expiry date 31Mar2017) in the arm on 07Oct2015. Medical history and concomitant medications were not reported. The patient had a cellulitis type of reaction on the same day. The outcome of the event was unknown. The pharmacist believed that the cellulitis occurred after having shot of PREVNAR 13 as it was at same arm as the injection site.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient states she has a raised red hard area 3"x3" on her upper left arm where the ZOSTAVAX was given. It stayed that way for 3 days. Today s he states it is not as hard or as large.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Eye pain, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: 103.6 fever 15 hrs after admin of FLUMIST congestion, eye pain, lt leg pain briefly.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Fall, Unresponsive to stimuli
Clinical narrative: Approximately 3 minutes after vaccine given was standing fell into wall, slump to floor not responsive approximately 15 seconds, responsive when PHN and mom picked up able to walk to chair. FU TC 11/5/15 child fine, normal activity.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased
Clinical narrative: Pt. states that after 1 wk, the arm is immobile - tx not known - instructed to call MD.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Flushing
Clinical narrative: Nurse gave flu shot. Provider in to see patient minutes after shot administered. Pt c/o difficulty breathing, flushing. Provider ordered BENADRYL 50 mg IM. Patient was monitored in exam room for 30 min. Symptoms not improved with BENADRYL. Provider instructed mother to take patient to local ER for evaluation, continued monitoring.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Lethargy, Malaise, Pain in extremity, Pyrexia
Clinical narrative: High fever 104 degrees. Severe arm/back pain. 48 hours of lethargy/malaise.
Age: 44.0
Sex: M
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Cold sweat, Dizziness, Dyskinesia, Hypotonia, Nausea
Clinical narrative: Upon completion of last injection (TWINRIX) patient stated he felt nauseated and he was about to faint. Patient began jerking upper extremities and then became limp. Skin pale and clammy. Last approx 20 sec.-1 min and regained stability. Approx 3 min later began jerking again as well as vomiting. Patient assisted to floor, turned on side. Shortly regained stability. EMT escorted to ED.
Age: 44.0
Sex: M
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Pallor, Vomiting
Clinical narrative: Upon completion of last injection (TWINRIX) patient stated he felt nauseated and he was about to faint. Patient began jerking upper extremities and then became limp. Skin pale and clammy. Last approx 20 sec.-1 min and regained stability. Approx 3 min later began jerking again as well as vomiting. Patient assisted to floor, turned on side. Shortly regained stability. EMT escorted to ED.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Area of redness, tenderness at injection site started 1-2 days after injection; symptoms reported to office on 11/02/2015.  Pt examined by physician on 11/02/2015, Dx: Papule.  Rx: Cephalexin.  Advised to return if sx worsen or don't improve.  Follow-up call to pt done 11/09/2015: sx improved, pt did not take antibiotic.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Cheilitis, Cough, Dyspnoea, Eye swelling
Clinical narrative: At 2:30 Anaphylaxis began with minor difficulty breathing and a cough, symptoms felt similar to having a chest cold.  At this point I did not realize I was having an allergic reaction;  By 3:30 my throat and my tongue started to swell, my lips and eyes were red and swollen and I was wheezing;  I took 24 mg of powdered Diphenhydramine, the symptoms immediately started to subside.  I could breathe normally by 4:00PM; I did need to continue 25mg of Benadryl every 6 hours for 24 hours or the symptoms would return.  By 11/08/2015 at 2:00 PM I dicontinued Benadryl, but the my eyes were still swollen and a red rash remained over my eye lids. I did not seek medical attention because the Benadryl seemed to take care of the reaction.  My mother is a RN and was monitoring me.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid rash, Hypersensitivity, Lip swelling, Lower respiratory tract infection, Ocular hyperaemia
Clinical narrative: At 2:30 Anaphylaxis began with minor difficulty breathing and a cough, symptoms felt similar to having a chest cold.  At this point I did not realize I was having an allergic reaction;  By 3:30 my throat and my tongue started to swell, my lips and eyes were red and swollen and I was wheezing;  I took 24 mg of powdered Diphenhydramine, the symptoms immediately started to subside.  I could breathe normally by 4:00PM; I did need to continue 25mg of Benadryl every 6 hours for 24 hours or the symptoms would return.  By 11/08/2015 at 2:00 PM I dicontinued Benadryl, but the my eyes were still swollen and a red rash remained over my eye lids. I did not seek medical attention because the Benadryl seemed to take care of the reaction.  My mother is a RN and was monitoring me.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal oedema, Rash erythematous, Swollen tongue, Wheezing
Clinical narrative: At 2:30 Anaphylaxis began with minor difficulty breathing and a cough, symptoms felt similar to having a chest cold.  At this point I did not realize I was having an allergic reaction;  By 3:30 my throat and my tongue started to swell, my lips and eyes were red and swollen and I was wheezing;  I took 24 mg of powdered Diphenhydramine, the symptoms immediately started to subside.  I could breathe normally by 4:00PM; I did need to continue 25mg of Benadryl every 6 hours for 24 hours or the symptoms would return.  By 11/08/2015 at 2:00 PM I dicontinued Benadryl, but the my eyes were still swollen and a red rash remained over my eye lids. I did not seek medical attention because the Benadryl seemed to take care of the reaction.  My mother is a RN and was monitoring me.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash generalised
Clinical narrative: Rash entire body fingers swollen both hands per patient.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Left upper arm pain since patient received flu vaccination. She was seen 11/5/15 with continued pain. PT ordered, ice, Ibuprofen 400mg, 3x/day.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Dizziness postural, Headache, Hyperhidrosis, Nausea
Clinical narrative: Dizzy getting worse as time progresses, Nauseous for two hours, Light-Headed when standing, Headaches throughout, Sweating for thirty minutes.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Sharp severe pain in right upper arm at injection site. Constant pain which has not resolved but has worsened and pain to lift items with her right hand or sleep on that arm. Seen 11/5/15 with cont. symptoms as above.
Age: 1.01
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Injection site mass
Clinical narrative: Mother noticed a lump to right and left arms at vaccine site after infant received vaccines on 9/8/15. Mother stated she took the child to a General Doctor last week and that she was told the lumps would soon go away. Mother was concerned that the lump on left arm had gotten bigger. Referred client to pediatrician for evaluation and clearance for other vaccines.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Informatino has been received from a clinical medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories or drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L006392 with expiration date 25-MAY-2016; dose and route were not reported). No adverse effects were reported. This is one of the several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories or drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (lot # L007225 with expiration date 03-MAR-2017; dose and route were not reported). No adverse effects were reported. This is one of the several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of improperly stored MMR II (lot # K024824 with expiration date of 02-DEC-2016; strength, dosage, frequency and route unspecified) or RECOMBIVAX HB (lot# K016005 with expiration date of 27-AUG-2016; strength, dosage, frequency and route unspecified). No adverse effects were reported. Additional information has been requested.
Age: 0.67
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare provider concerning an approximately 9 month old (reported as 8 months and 30 days age) patient of unknown gender. The patient's pertinent medical history and concomitant therapy were not provided. On 21-OCT-2015, the patient was vaccinated with a dose of M-M-R II (lot # K021950 with expiration date 10-NOV-2016, dose and route unspecified) and a dose of VARIVAX (Merck) (lot # L019999 with expiration date 02-JUN-2017, dose and route unspecified) at the same visit (inappropriate schedule of vaccine administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were inadvertently administered doses of VAQTA (lot number L018499 and expiration date 25-FEB-2017, dose and route of administration were not reported) that had been improperly stored. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (lot# L020002, expiration date 02-JUN-2017; lot# K007982, expiration date 03-JUN-2016; lot # J014152, expiration date 07-NOV-2015, route not provided). No adverse events were reported. Product quality complaint was not involved. This is one of the several reports from the same reporter. 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 multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date the patients were vaccinated with GARDASIL (lot # K010215, expiration date 05-MAY-2017) (dosage, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one if several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to a female patient of unknown age. No information on her medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (route and site of vaccination, lot# and expiration date not reported). On an unknown date, the patient experienced headaches for one week. She did not seek medical attention. The outcome of headaches was unknown. The reporting physician did not assess the causal relationship between the event of headaches and vaccination with GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to 9 unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (Merck) (Lot# L008271; expiration date 11-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. Follow up information was received on 23-OCT-2015 from a certified medical assistant. The medical assistant noted that the number of patients who were vaccinated with the improperly stored doses of VARIVAX (Merck) (Lot# L008271) was 8, not 9 as previously reported. Follow-up information has been received on 27-OCT-2015 from the certified medical assistant. The reporter provided that the patient of unknown age and gender was vaccinated with the improperly stored dose of VARIVAX (Merck) on 28-SEP-2015. It was reported that the vaccine was 2304 hours out of range. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product and event details and analysis were updated.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Angiogram, Blood gases, Chest X-ray, Dyspnoea, Hyperventilation
Clinical narrative: Providers feel pt was experiencing an URI/panic attack. In the ED she was given KENALOG, BENADRYL, and ZOFRAN. She experienced hyperventilation (most likely 2/2 panic disorder) and kept overnight for observation. Rash and dyspnea, injection site pain, nasal discharge, swelling, water eyes. Triamcinolone, diphenhydramine, ondansetron.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Lacrimation increased, Panic attack, Panic disorder, Rash
Clinical narrative: Providers feel pt was experiencing an URI/panic attack. In the ED she was given KENALOG, BENADRYL, and ZOFRAN. She experienced hyperventilation (most likely 2/2 panic disorder) and kept overnight for observation. Rash and dyspnea, injection site pain, nasal discharge, swelling, water eyes. Triamcinolone, diphenhydramine, ondansetron.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Rhinorrhoea, Swelling, Upper respiratory tract infection
Clinical narrative: Providers feel pt was experiencing an URI/panic attack. In the ED she was given KENALOG, BENADRYL, and ZOFRAN. She experienced hyperventilation (most likely 2/2 panic disorder) and kept overnight for observation. Rash and dyspnea, injection site pain, nasal discharge, swelling, water eyes. Triamcinolone, diphenhydramine, ondansetron.