chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age with hyperlipidemia. The patient's medical history included Arteriosclerotic cardiovascular disease (ASCVD). On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiry not reported). Concomitant therapies included lisinopril and ALDACTONE. On an unknown date the patient experienced allergy to with PNEUMOVAX 23. On an unknown date patient started therapy with LIPITOR 20mg/day orally for hyperlipidemia. Patient desired generic and not trade name LIPITOR. Patient desired to switch from trade name atorvastatin to generic. The outcome of allergy to with PNEUMOVAX 23 was unknown. Causality was not reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Chest pain, Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 15 April 2014. A 19 year old male subject, medical history reported as no, developed chest pain, considered mild in severity, 2 days after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on 24 March 2014 and concomitantly, an injection of TYPHOID VACCINE, (manufacturer, lot number, route, site and side not reported) on 24 March 2014. On 26 March 2014, 2 days post vaccination; the subject experienced three episodes of chest pain lasting about 30 seconds, each improved when he "paused" for a second. The subject did not take any meds for it or seek medical attention. On 08 April 2014 the Troponin I result was reported as normal, less than (<) 0.10 ng/mL. On 08 April 2014, electrocardiogram (ECG) was reported as normal. The subject was referred for care. According to reporter, no further information was expected to follow. The chest pain was considered resolved on 07 April 2014. The patient's outcome was reported as recovered. According to the investigator, the event of chest pain was considered other important medical events and possibly related to the trial product. Documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administration error, No adverse event
Clinical narrative: No adverse event noted. Misadministration only.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: Skin reaction on right ear.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Breath sounds abnormal, Diarrhoea haemorrhagic, Haematochezia, Hepatomegaly, Kidney enlargement
Clinical narrative: Skin turned yellow, diarrhea with blood, vomiting, red blood count dropped taking off formula of 5 wks, blood transfusion, white blood count down, given antibiotics, fluids, probiotics, kidneys, spleen and liver enlarged. Patient, was a ECMO patient at hospital. He was born with pulmonary hypertension, heart murmur, enlarged spleen and liver. He also swallowed the amnio fluid and his lungs were compromised so he became a ECMO patient. Was on ECMO 2-3-14 thru 2-10-14. He has been on feeding tube since 2-3-14. Patient was recovering from these illnesses. His liver and spleen were back to normal as of 2-26-14. Took off oxygen on 2-26-14. Started breast feeding with improvement each day. Doctor was going to release him to go home. On March 4 administered Hep B vac. March 5th had vomiting, bloody stools, skin yellowing, started losing weight, took off milk. Liver and spleen enlarged again, kidneys enlarged secreting protein in kidneys, had low red blood cells blood transfusion, put back on oxygen very raspy breathing, low white blood cells gave antibiotics. Since the Hep B vaccine he relapsed back at least 2 wks or more wks. As of 4-21-14 is still in hospital.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Red blood cell count decreased, Splenomegaly, Transfusion, Vomiting, Weight decreased
Clinical narrative: Skin turned yellow, diarrhea with blood, vomiting, red blood count dropped taking off formula of 5 wks, blood transfusion, white blood count down, given antibiotics, fluids, probiotics, kidneys, spleen and liver enlarged. Patient, was a ECMO patient at hospital. He was born with pulmonary hypertension, heart murmur, enlarged spleen and liver. He also swallowed the amnio fluid and his lungs were compromised so he became a ECMO patient. Was on ECMO 2-3-14 thru 2-10-14. He has been on feeding tube since 2-3-14. Patient was recovering from these illnesses. His liver and spleen were back to normal as of 2-26-14. Took off oxygen on 2-26-14. Started breast feeding with improvement each day. Doctor was going to release him to go home. On March 4 administered Hep B vac. March 5th had vomiting, bloody stools, skin yellowing, started losing weight, took off milk. Liver and spleen enlarged again, kidneys enlarged secreting protein in kidneys, had low red blood cells blood transfusion, put back on oxygen very raspy breathing, low white blood cells gave antibiotics. Since the Hep B vaccine he relapsed back at least 2 wks or more wks. As of 4-21-14 is still in hospital.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: White blood cell count decreased, Yellow skin
Clinical narrative: Skin turned yellow, diarrhea with blood, vomiting, red blood count dropped taking off formula of 5 wks, blood transfusion, white blood count down, given antibiotics, fluids, probiotics, kidneys, spleen and liver enlarged. Patient, was a ECMO patient at hospital. He was born with pulmonary hypertension, heart murmur, enlarged spleen and liver. He also swallowed the amnio fluid and his lungs were compromised so he became a ECMO patient. Was on ECMO 2-3-14 thru 2-10-14. He has been on feeding tube since 2-3-14. Patient was recovering from these illnesses. His liver and spleen were back to normal as of 2-26-14. Took off oxygen on 2-26-14. Started breast feeding with improvement each day. Doctor was going to release him to go home. On March 4 administered Hep B vac. March 5th had vomiting, bloody stools, skin yellowing, started losing weight, took off milk. Liver and spleen enlarged again, kidneys enlarged secreting protein in kidneys, had low red blood cells blood transfusion, put back on oxygen very raspy breathing, low white blood cells gave antibiotics. Since the Hep B vaccine he relapsed back at least 2 wks or more wks. As of 4-21-14 is still in hospital.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Diet refusal, Enema administration, Haematochezia, Intussusception
Clinical narrative: Fussy, crying in pain, refusing bottles, had small mucusy bloody stool the morning of 4/15. seen in the office, diagnosis obscure, had large bloody stool that evening. ED dx intussuseption. Reduced with air enema. Did well.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Mucous stools, Ultrasound scan abnormal, X-ray abnormal
Clinical narrative: Fussy, crying in pain, refusing bottles, had small mucusy bloody stool the morning of 4/15. seen in the office, diagnosis obscure, had large bloody stool that evening. ED dx intussuseption. Reduced with air enema. Did well.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: A large red circle, swollen, softball size circle.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Influenza, Malaise, Myalgia
Clinical narrative: Initial case received from a health care professional, who is also the patient, on 17 April 2014. A 73-year-old female patient, with a reported medical history of allergies to BIAXIN and epinephrine and no reported concomitant therapies, had received an intramuscular dose of FLUZONE HIGH-DOSE on the left deltoid on September 2013 (batch number not reported). She had previously received yearly flu shots. She denied any illness at the time of vaccination. On 30 December 2013, the patient stated that she woke up with headache, muscle aches, general malaise and sweats. There were no records of fever. The patient went to consult at a local emergency department on 31 December 2013 and stated to the ED physician: "I have the flu and I need a prescription for TAMIFLU". No flu test was performed to confirm the diagnosis. TAMIFLU was prescribed as per patient's request along with hydrocodone for headache and muscle aches. Patient stated that symptoms resolved in 72 hours. The patient recovered from the events. She did not report this to her own physician. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Headache, Hyperhidrosis, Palpitations
Clinical narrative: About 2 hrs. after injection I became clammy and sweating with a pulse rate of 180 with palpitations. 15 min. later I got a severe headache. Lasted 45 min. until I could take a LOPRESSOR. HR dropped to 100. Headache lasted until next day. I don't ever get headaches. Doing fine since 4-11-14.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test normal, Skin mass, X-ray normal
Clinical narrative: This spontaneous report as received from a male patient of unknown age with high blood pressure and cholesterol refers to himself. No allergies were reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot#, expiration date not reported). Concomitant therapy included unspecified medications for high blood pressure and cholesterol. On an unknown date, reported as "6 months after the shot" the patient got shingles. The patient stated that he discovered a lump on his abdomen (date unspecified). On an unknown date the patient went to the hospital, where he received several tests and X-ray that did not show anything in the lump. The patient was not admitted to the hospital. For the treatment the patient was given steroids (unspecified name and manufacturer) and TYLENOL. The outcome of adverse events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 67 year old patient. Medical history and concurrent conditions were not reported. On 21-FEB-2014, the patient was vaccinated with PNEMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 70.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 70 year old patient. Medical history and concurrent conditions were not reported. On 04-FEB-2014, the patient was vaccinated with PNEMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a 6 month old infant. Approximately on 18-APR-2014 (also reported as today), the patient was vaccinated with expired ROTATEQ (lot # H017671, expiry date: 25-MAR-2014). No concomitant medication was reported. No adverse effects reported. There was no product quality complaint. Outcome of the reported event was unknown. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 63 year old patient. Medical history and concurrent conditions were not reported. On 14-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 67 year old patient. Medical history and concurrent conditions were not reported. On 12-FEB-2014, the patient was vaccinated with PNEMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Inflammation, Injection site swelling
Clinical narrative: Local inflammation and swelling around MMRV injection site.
Age: 44.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 44 year old patient. Medical history and concurrent conditions were not reported. On 27-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Paralysis
Clinical narrative: Initial case received from a consumer, who is also the patient, via another manufacturer under reference number 20800281403USA013674 on 15 April 2014. A 64-year-old female patient received tetanus toxoid vaccine (manufacturer and lot number not reported) on an unspecified date, and later experienced the reaction of "paralyze from top waist for ten days". The consumer reported this reaction as an allergy to tetanus. No additional information was reported, and outcome was unknown. Of note, the primary reporter (consumer) did not provide any contact information; as a result, no follow-up requests will be sent. The other manufacturer (Merck) has agreed to forward any additional information received. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Musculoskeletal discomfort, Peripheral coldness, Sensation of foreign body
Clinical narrative: Hep B IM (R) deltoid - after developed cold sensation (R) arm and shoulder - also "like chicken bone stuck in throat" - no hives no rash no SOB - just "uncomfortable when swallow" called PHN - told if SOB -> to ER. As day progressed cold sensation subsided. Left some discomfort (R) shoulder blade increased with movement. F/U call 4/18/14 states still some discomfort (R) scapula increased with movement. N/C at injection site - feeling in throat gone. Client has not contacted physician. PHN advised to call with any change and seek medical eval. if discomfort persists.
Age: 84.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 84 year old patient. Medical history and concurrent conditions were not reported. On 05-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 55 year old patient. Medical history and concurrent conditions were not reported. On 31-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Vomiting
Clinical narrative: PT VOMITED AND PALE AFTER IMMUNIZATIONS.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Abscess, Cellulitis, Pain, Rash, Skin warm
Clinical narrative: Swelling, rash, warm to touch, sore--diagnosed with cellulitis/abscess in office.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Swelling
Clinical narrative: Swelling, rash, warm to touch, sore--diagnosed with cellulitis/abscess in office.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Dysphagia, Dyspnoea, Eye swelling, Hypersensitivity
Clinical narrative: Vaccine was given on 11/06/2013, 12/18/2013 & 04/08/2014. On the morning of 04/09/2014 after the 3rd vaccination I went to the emergency room with symptoms of an allergic reaction (difficulty breathing and swallowing felt like my throat was closing, swelling eyes and face, hives rash and tingling burning sensation on the skin).
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Skin burning sensation, Swelling face, Throat tightness, Urticaria
Clinical narrative: Vaccine was given on 11/06/2013, 12/18/2013 & 04/08/2014. On the morning of 04/09/2014 after the 3rd vaccination I went to the emergency room with symptoms of an allergic reaction (difficulty breathing and swallowing felt like my throat was closing, swelling eyes and face, hives rash and tingling burning sensation on the skin).
Age: 1.39
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Feeling hot, Productive cough, Rash, Rhinorrhoea
Clinical narrative: He received the jab at 4:30 pm, by 7pm or 8 he started coughing, the next morning he had a runny nose with a cough and it has continued up to this day. Sunday I called the Dr to tell her about it and she said it was not the vaccine. Sunday, Monday and Tuesday along with the mucus and cough he felt hot to the touch but th en thermometers keep reading a normal temperature of 77 or 78. By Wednesday afternoon he developed a rash on the back of his neck, and today Thursday that is the 7th day after the vaccine the rash seems to be spreading to the chest.
Age: 1.39
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: He received the jab at 4:30 pm, by 7pm or 8 he started coughing, the next morning he had a runny nose with a cough and it has continued up to this day. Sunday I called the Dr to tell her about it and she said it was not the vaccine. Sunday, Monday and Tuesday along with the mucus and cough he felt hot to the touch but th en thermometers keep reading a normal temperature of 77 or 78. By Wednesday afternoon he developed a rash on the back of his neck, and today Thursday that is the 7th day after the vaccine the rash seems to be spreading to the chest.
Age: 1.64
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Convulsion, Foaming at mouth, Gaze palsy, Unresponsive to stimuli
Clinical narrative: Episode concerning for seizure in the absence of seizure. Her mother found her unresponsive and her eyes deviated upwards and spitting at the mouth.  Mom stated she was unresponsive until arriving at the ER at 5:54 PM.
Age: 37.0
Sex: M
Vaccine: MMR, SMALL
Symptoms: Erythema, Mobility decreased, Pain in extremity, Pruritus, Swelling
Clinical narrative: Anthrax Vaccination (booster) developed redness, itch and pain Right upper arm spreading distally, reported limitation in ROM. Began after taking hot shower the night of vaccine adm. Phy. exam: Afebrile, erythemia,swelling and tenderness below site of vaccination.  No lymphadenopathy. Assessment: Reaction consistent with subcutaneous adm of vaccination.  Plan:  NSAID's, antihistamine, elevation of arm.  Quarters for 24 hrs. RV for assessment 2 days.
Age: 37.0
Sex: M
Vaccine: MMR, SMALL
Symptoms: Tenderness
Clinical narrative: Anthrax Vaccination (booster) developed redness, itch and pain Right upper arm spreading distally, reported limitation in ROM. Began after taking hot shower the night of vaccine adm. Phy. exam: Afebrile, erythemia,swelling and tenderness below site of vaccination.  No lymphadenopathy. Assessment: Reaction consistent with subcutaneous adm of vaccination.  Plan:  NSAID's, antihistamine, elevation of arm.  Quarters for 24 hrs. RV for assessment 2 days.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at injection site. Symptoms began in morning of 4/24/2014, advised to put warm compress on area.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: PT REPORTED SEVERE PAIN AT INJECTION SITE AND LINGERING MUSCLE STIFFNESS IN SHOULDER AND UPPER ARM. SHE STILL HAS LIMITED MOTION AND STIFFNESS IN THAT UPPER ARM.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Confusional state, Cyanosis, Dyskinesia, Fall, Head injury
Clinical narrative: Fainting with no apparent distress or anxiety beforehand. Not conscious for a couple of minutes, jerking movements. Multiple red spots on upper arms and chest. Pallor and circumoral cyanosis. These symptoms resolved in a few minutes without intervention. Head injury from fall to the floor, resulting in slight confusion for a couple of hours and headache up to a week. Red sore raised area at the site of injection for several days.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site rash, Loss of consciousness
Clinical narrative: Fainting with no apparent distress or anxiety beforehand. Not conscious for a couple of minutes, jerking movements. Multiple red spots on upper arms and chest. Pallor and circumoral cyanosis. These symptoms resolved in a few minutes without intervention. Head injury from fall to the floor, resulting in slight confusion for a couple of hours and headache up to a week. Red sore raised area at the site of injection for several days.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Pallor, Rash erythematous, Syncope
Clinical narrative: Fainting with no apparent distress or anxiety beforehand. Not conscious for a couple of minutes, jerking movements. Multiple red spots on upper arms and chest. Pallor and circumoral cyanosis. These symptoms resolved in a few minutes without intervention. Head injury from fall to the floor, resulting in slight confusion for a couple of hours and headache up to a week. Red sore raised area at the site of injection for several days.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Lymphadenitis, Lymphadenopathy
Clinical narrative: Lymphadenopathy, especially submandibular and occipital lymph nodes. Did not have fourth DTaP injection
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Local swelling, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Swollen left arm extending to wrist, temperature, pain, called MD after 2 weeks ,was told to wait two more weeks, at present left arm has limitations and pain.
Age: 75.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Rash, Rash erythematous, Rash pustular
Clinical narrative: Shortly after receiving the VARIVAX, noted feeling more achy on a daily basis. Then on 4/7/14, noted outbreak of non-pruritic red bumps on her trunk. Exam on 4/7/14 showed: "scattered erythematous pustules over trunk w/ surrounding erythema, no clear vesicles".
Age: 80.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 80 year old patient. Medical history and concurrent conditions were not reported. On 31-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 64 year old patient. Medical history and concurrent conditions were not reported. On 30-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 71 year old patient. Medical history and concurrent conditions were not reported. On 24-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 80 year old patient. Medical history and concurrent conditions were not reported. On 04-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hot flush, Hyperhidrosis
Clinical narrative: Pt reported some shortness of breath about one hour after receiving GARDASIL (2nd in series). Mother reported pt. was having something like hot flashes and sweating spells. Mom took her to ER at 8:30 pm where she was treated with DECADRON and BENADRYL by mouth and mom states within 10 mins she was better. Mom thinks dau. felt panic and got scared. Reports O2 was 100% heart rate normal. Went to school today (4/24/).
Age: 1.01
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site discolouration, Injection site induration, Injection site reaction, Rash macular, Skin lesion
Clinical narrative: Blotchy, hyperpigmented lesions on right thigh with some induration at injection site.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 102.7.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 75 year old patient. Medical history and concurrent conditions were not reported. On 12-MAR-2014, the patient was vaccinated with PNEMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.76
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Pyrexia
Clinical narrative: Hep B shot given at 1 PM. 7 PM developed fever - 101.9 (R), "not herself" quiet - hard spot where shot given. Fever x 48 hours.
Age: 74.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 74 year old patient. Medical history and concurrent conditions were not reported. On 12-MAR-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 64 year old patient. Medical history and concurrent conditions were not reported. On 14-MAR-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.