chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray normal, Erythema, Induration, Local swelling, Rash
Clinical narrative: This spontaneous report was received from a Nurse refers to a 20 year old female patient. The patient's medical history included flu. On 02-JAN-2014 the patient was vaccinated with 3 dose of GARDASIL (dose, route and frequency were not reported). Concomitant medications included Birth control pill (manufacturer unspecified). On 04-Mar-2014, the patient experienced that her arm (no designation on whether it was the right or left arm) was red and swollen. The patient also indicated she had gone to the emergency room of the local hospital (unspecified date, hospital or location). The hospital completed a chest and arm x-rays for the patient. No diagnosis was made. No treatment given was specified from the hospital. The patient was released the same day. The mother (anonymous) of the patient also contacted the office to state the arm also had a rash and had become hardened. The mother took the patient to the pediatrician. The patient was prescribed a Z-PAK and steroids (manufacturer and dose unspecified). The outcome of the events was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray limb normal
Clinical narrative: This spontaneous report was received from a Nurse refers to a 20 year old female patient. The patient's medical history included flu. On 02-JAN-2014 the patient was vaccinated with 3 dose of GARDASIL (dose, route and frequency were not reported). Concomitant medications included Birth control pill (manufacturer unspecified). On 04-Mar-2014, the patient experienced that her arm (no designation on whether it was the right or left arm) was red and swollen. The patient also indicated she had gone to the emergency room of the local hospital (unspecified date, hospital or location). The hospital completed a chest and arm x-rays for the patient. No diagnosis was made. No treatment given was specified from the hospital. The patient was released the same day. The mother (anonymous) of the patient also contacted the office to state the arm also had a rash and had become hardened. The mother took the patient to the pediatrician. The patient was prescribed a Z-PAK and steroids (manufacturer and dose unspecified). The outcome of the events was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 33 year old female patient. No pertinent medical history or drug reactions/allergies were provided. On 25-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # J014401; expiry date 26-NOV-2014), 0.5 ml, subcutaneously in the arm (dose number not provided). No co-suspect or concomitant therapies were reported. After receiving PNEUMOVAX 23, approximately on 25-FEB-2014, the patient developed swelling and redness on her arm, at the injection site. The reporter did not know if the patient had received PNEUMOVAX 23 in the past. At the time of the report, the outcome of the events was unknown. It was reported that the patient may had been using an unspecified cream to treat the injection site symptoms. The patient sought medical attention by calling the office. The reporter requested a lot check. This is case is linked to case MARRS # 1403USA001361 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. The physician reported that the female pregnant patient was vaccinated with VARIVAX (Merck) (dose, route and frequency were not reported) on 11-FEB-2014. The physician stated that the patient last menstrual period was on 29-JAN-2014. No ultrasound has been performed. No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Blood heavy metal increased, Confusional state, Dizziness, Headache
Clinical narrative: Severe headaches, Trembling hands, Dizziness, Swollen Lymph Nodes, Confusion, Depleted B-12 aka B-12 Deficiency, Leg Pain, Anxiety. Etc, ETC, and it continues. Wart Removed from Nose by specialist...
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Pain in extremity, Skin papilloma, Tremor, Vitamin B12 decreased
Clinical narrative: Severe headaches, Trembling hands, Dizziness, Swollen Lymph Nodes, Confusion, Depleted B-12 aka B-12 Deficiency, Leg Pain, Anxiety. Etc, ETC, and it continues. Wart Removed from Nose by specialist...
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vitamin B12 deficiency, Wart excision
Clinical narrative: Severe headaches, Trembling hands, Dizziness, Swollen Lymph Nodes, Confusion, Depleted B-12 aka B-12 Deficiency, Leg Pain, Anxiety. Etc, ETC, and it continues. Wart Removed from Nose by specialist...
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site mass, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Lump at injection site along with swelling of arm from shoulder to elbow.  Red raised rash from shoulder to elbow.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Severe pain in right shoulder. Tingling and numbness in right hand.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site warmth, Neck pain, Skin warm
Clinical narrative: Warmth and radiation pain to left shoulder and neck. Reported 03/16/2014 at 11:00am. No treatment given.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Abasia, Back disorder, Dysstasia, Nasopharyngitis, Pyrexia
Clinical narrative: Encountered lumbar back problems and got worse over the weekend. Could not walk, stand or sit for one week. On the sixth day after the vaccination I also got symptoms of a cold with running nose and fever.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Rhinorrhoea
Clinical narrative: Encountered lumbar back problems and got worse over the weekend. Could not walk, stand or sit for one week. On the sixth day after the vaccination I also got symptoms of a cold with running nose and fever.
Age: 25.0
Sex: M
Vaccine: FLU3, HPV4, PPV
Symptoms: Band neutrophil percentage, Chills, Computerised tomogram, Injection site erythema, Injection site movement impairment
Clinical narrative: Fever chills myalgias rendess and swelling left deltoid - unable to move left shoulder due to pain.
Age: 25.0
Sex: M
Vaccine: FLU3, HPV4, PPV
Symptoms: Injection site swelling, Myalgia, Neutrophil percentage increased, Pyrexia, White blood cell count increased
Clinical narrative: Fever chills myalgias rendess and swelling left deltoid - unable to move left shoulder due to pain.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Lymph node pain, Malaise, Mass, Vomiting
Clinical narrative: Pain, site of injection persisted 2 mos. General malaise 4 days. Vomiting 1 day. Large mass of sl tender soft lymph nodes neck, same side as injection.
Age: 1.01
Sex: M
Vaccine: DTPIHI, MMR, UNK
Symptoms: Pain in extremity, Pyrexia, Rash, Restlessness
Clinical narrative: Severe rash & pain on legs, 3/16 moved to arms as well a small rash on torso.  Legs & feet appear to be worse.  103 rectal Fever & restless.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Nausea, Vomiting
Clinical narrative: 24 hours after receiving vaccine pt had nausea, cramping, vomiting.
Age: 3.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report received from a physician refers to a 3 year old child (patient). On 12-MAR-2014 the patient was inadvertently vaccinated with a dose of GARDASIL, approximately 0.2 ml, subcutaneous injection. The physician had informed that ice was placed at the injection site to prevent spreading. The patient had sought medical attention by being in the doctor's office. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse via a representative refers to an 8 year old patient. On 27-NOV-2006 the patient was vaccinated with the first dose of VARIVAX (Merck), injection, (lot#, expiration date and dose unspecified). On 06-JAN-2010 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # was reported as 12314, expiration date and dose unspecified). On 22-FEB-2014 the patient was seen by the physician due to the patient experienced an unspecified rash on back and abdomen on an unknown date. The representative also reported that the nurse was unsure of "how many lesions developed on the patient". The event outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to four patients of unknown age and gender. On an unknown date, the patients were vaccinated with expired doses of ROTATEQ (lot # H012252, expiry date 29-JAN-2014), 2 ml, oral. All dose of ROTATEQ were stored properly and supported by in house data. No adverse events were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of unknown gender. On 03-MAR-2014, the patient was vaccinated with an expired dose of properly stored ROTATEQ (lot # H012252, expiry date 29-JAN-2014), 2 ml, oral. This dose was the third dose in ROTATEQ series. No adverse events were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (LVN) via a Field Representative refers to a female patient in her late 70s. In approximately 2013 (about one year ago) the patient was vaccinated with a dose of ZOSTAVAX, (lot #, expiration date and dose unspecified), Injection. On an unknown date in 2014 the patient had developed shingles "recently". The event outcome was unknown. The patient had sought medical attention via visited clinic. Additional information has been requested.
Sex: M
Vaccine: MMR, TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a male patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II. Dose and lot information were not provided. Other suspect therapies included Tdap (manufacturer unknown). On an unknown date the patient who was administered both the vaccines on an unspecified date, experienced anaphylactic reaction. The outcome of anaphylactic reaction was reported as resolved. The patient had sought medical attention of unknown type. The pharmacy student was unable to provide any further details. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a approximately 60 year old male physician referring to himself. The patients medical history included angioedema and shingles. Current conditions included multiple sclerosis and cardiovascular disease. No drug reactions or allergies were reported. On 22-JUN-2011, the patient was vaccinated with ZOSTAVAX dose, route not reported. No concomitant medication reported. On an unknown date in January 2014 (also reported as 6 weeks ago), the patient experienced shingles. The reporter also stated that he had developed shingles in his 30s and compared to his previous case of shingles this case of shingles was very tolerable. Laboratory diagnostics studies were not performed. The physician self prescribed himself acyclovir and LYRICA for treatment. The physician reported that for the last week he has been ok. Causality between ZOSTAVAX and the event shingles was not reported. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a 35 year old male patient. Medical history, drug allergy were none. The patient was vaccinated with first dose of M-M-R II during childhood on an unknown date and received a booster dose of M-M-R II for work related vaccination on an unknown date in January 2013. Dosage and lot information was not provided for either doses. Concomitant medications were none. The physician had called to report that this patient had presented with negative titers for measles on 04-MAR-2014 even after receiving first dose of the vaccine in child hood and a booster dose last year. The outcome of event negative titers for measles was reported as not recovered/not resolved. The patient had sought medical attention by seeing the physician. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. No concomitant medication reported. On an unknown date, the patient experienced redness at the injection site after receiving ZOSTAVAX. The outcome of redness at the injection site was not reported. Causality between ZOSTAVAX and redness at the injection site was not reported. Product quality issue was not reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Case number PHHY2012US111115 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 465501) web site on 04 Dec 2012, with the follow-up received from Quality Assurance Department (reference number: 210170) on 13 Mar 2014. This report refers to a 51-year-old female patient. Her current conditions included allergy to epinephrine and antihistamines and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204201) intramuscularly on to left arm on 18 Sep 2012. On the same day, she felt hot and experienced pressure in chest, difficulty in breathing, tachycardia and elevated blood pressure. She went to emergency room. Echocardiogram and electrocardiography (EKG) were performed and the results were not reported. The outcome of the events was reported as complete recovery as of 19 Sep 2012. Based on the investigation performed, QA department stated that, the FLUVIRIN vaccine (batch number: 1204201) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 210170) on 13 Mar 2014: Updated batch review report.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Tachycardia
Clinical narrative: Case number PHHY2012US111115 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 465501) web site on 04 Dec 2012, with the follow-up received from Quality Assurance Department (reference number: 210170) on 13 Mar 2014. This report refers to a 51-year-old female patient. Her current conditions included allergy to epinephrine and antihistamines and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204201) intramuscularly on to left arm on 18 Sep 2012. On the same day, she felt hot and experienced pressure in chest, difficulty in breathing, tachycardia and elevated blood pressure. She went to emergency room. Echocardiogram and electrocardiography (EKG) were performed and the results were not reported. The outcome of the events was reported as complete recovery as of 19 Sep 2012. Based on the investigation performed, QA department stated that, the FLUVIRIN vaccine (batch number: 1204201) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 210170) on 13 Mar 2014: Updated batch review report.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Echocardiogram abnormal, Pain, Pericardial effusion, Pericarditis
Clinical narrative: Case number PHHY2013US056733 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 487556) web site on 05 Jun 2013, with the follow-up received from Quality Assurance Department (reference number: 233528) on 13 Mar 2014. This report refers to a 17-year-old female patient. Her medical history included hives due to amoxicillin and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204201) on 05 Dec 2012. On 06 Dec 2012, her chest started hurting and it got worse throughout the day. It was reported that the same thing happened next day. The pain was worse with activity especially at dance class. She went to emergency room. It was reported that echocardiograms showed effusion in the tissues and the cardiologist diagnosed it as pericarditis. She was advised rest with no activity and was treated with anti-inflammatory medications: NAPROSYN and MOTRIN. The reporter assessed the event as life-threatening. The outcome of the events was reported as condition unchanged. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204201) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 233528) on 13 Mar 2014: Updated batch review report.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial fibrillation
Clinical narrative: Case number PHHY2014US012653 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 513595) on 03 Feb 2014 and a follow up received from the Quality Assurance Department (QA, reference number: 280232) on 13 Mar 2014. This report refers to a 64-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly in the right arm on 07 Oct 2013. On the same date, one hour after vaccination, he experienced atrial fibrillation which lasted for two days. the patient did not have atrial fibrillation for several years. The outcome was reported as complete recovery. The seriousness and causality of the event were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1309401) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number; 280232) on 13 Mar 2014: Updated batch review report.
Age: 51.0
Sex: M
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 51 year old male patient. Relevant medical history and concomitant medication were not provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneously in the left arm. Dose and frequency were not provided. Other suspect therapies included ZOSTAVAX lot # J011338, subcutaneously in the left arm and BOOSTRIX (GlaxoSmithKline) intramuscularly in the right deltoid. Dose and frequency were not provided. On 17-DEC-2013, the patient experienced flu like symptoms. The outcome of flu like symptoms was reported as recovered/resolved. The reporter causality was unknown. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2014US019834 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518242) website on 17 Feb 2014 with a follow up information received from a quality assurance department (QA reference number: 282038) on 13 Mar 2014. This report refers to a 09-year-old male child. It was reported that he suffered from seasonal allergies and attention deficit-hyperactivity disorder. His concomitant medication included CONCERTA and multivitamin. He was still undergoing antibiotic treatment. On 31 Dec 2013, he was vaccinated with FLUVIRIN (batch number: not reported). On 02 Jan 2014 at 11:30 am, physician diagnosed him with cellulitis measuring (6x6.5) around flu vaccine injection site. The physician prescribed him with Cephalexin for treatment of cellulitis. It was reported that, on an unknown date, he had visited the emergency room. The final outcome of the event was reported as condition unchanged as of 02 Jan 2014. The seriousness and causality of the event was not reported. Upon follow up receipt from the quality assurance department (reference number: 282038), it was reported that since the batch number was not reported, a batch specific review could not be performed. Based on the review of the Annual Product Reviews (APRs) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems were effective in supporting the compliant production, testing and supply processes for FLUVIRIN. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow up information received from a quality assurance department (QA reference number: 282038) on 13 Mar 2014: Batch summary updated.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling hot, Joint effusion, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Received pneumonia shot 2-14 pain left shoulder. 2-15 went back to Dr. TYLENOL w/codeine much severe pain. 2-24 went again to Dr. gave Diclofenac 3 X-rays ordered, MRI. Mobility and range of motion issue - still pain. Joint swell in and out fluid in joint. 2-27 orthopedic MRI results did a steroid shot in left shoulder follow up 3-4.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rotator cuff syndrome, Swelling, X-ray limb
Clinical narrative: Received pneumonia shot 2-14 pain left shoulder. 2-15 went back to Dr. TYLENOL w/codeine much severe pain. 2-24 went again to Dr. gave Diclofenac 3 X-rays ordered, MRI. Mobility and range of motion issue - still pain. Joint swell in and out fluid in joint. 2-27 orthopedic MRI results did a steroid shot in left shoulder follow up 3-4.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Joint range of motion decreased, Joint swelling, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Received pneumonia shot 2-14 pain left shoulder. 2-15 went back to Dr. TYLENOL w/codeine much severe pain. 2-24 went again to Dr. gave Diclofenac 3 X-rays ordered, MRI. Mobility and range of motion issue - still pain. Joint swell in and out fluid in joint. 2-27 orthopedic MRI results did a steroid shot in left shoulder follow up 3-4.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Ultrasound scan
Clinical narrative: Received pneumonia shot 2-14 pain left shoulder. 2-15 went back to Dr. TYLENOL w/codeine much severe pain. 2-24 went again to Dr. gave Diclofenac 3 X-rays ordered, MRI. Mobility and range of motion issue - still pain. Joint swell in and out fluid in joint. 2-27 orthopedic MRI results did a steroid shot in left shoulder follow up 3-4.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Gait disturbance, Micturition urgency, Musculoskeletal stiffness
Clinical narrative: Case number PHEH2014US004885, is a combined initial and follow up spontaneous report from a physician received on 07 Mar 2014 and 10 Mar 2014 respectively. This report refers to a 57-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1310201) intramuscularly on 18 Nov 2013. On 19 Nov 2013, she woke up in the morning with pain in joints, body aches, stiffness, light-headed and unable to walk up and down the stairs. However she had no fever. The symptoms continued for six weeks. Approximately six weeks after vaccination with FLUVIRIN, she developed sciatica, night-time urgency with a frequency of up to seven times per night and urinary incontinence. She consulted a physician three weeks ago. The final outcome of the event sciatica was condition unchanged; urinary incontinence was condition improving and urination was occurring only during the night; pain in joint was complete recovery and outcome of the rest of the events was unknown. The seriousness and causality of the events were not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pollakiuria, Sciatica, Urinary incontinence
Clinical narrative: Case number PHEH2014US004885, is a combined initial and follow up spontaneous report from a physician received on 07 Mar 2014 and 10 Mar 2014 respectively. This report refers to a 57-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1310201) intramuscularly on 18 Nov 2013. On 19 Nov 2013, she woke up in the morning with pain in joints, body aches, stiffness, light-headed and unable to walk up and down the stairs. However she had no fever. The symptoms continued for six weeks. Approximately six weeks after vaccination with FLUVIRIN, she developed sciatica, night-time urgency with a frequency of up to seven times per night and urinary incontinence. She consulted a physician three weeks ago. The final outcome of the event sciatica was condition unchanged; urinary incontinence was condition improving and urination was occurring only during the night; pain in joint was complete recovery and outcome of the rest of the events was unknown. The seriousness and causality of the events were not reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, an unspecified number of patients may have been vaccinated with an unknown number of doses of PROQUAD (dose, route, lot number and expiration date were not reported) that were exposed to temperatures outside of those specified in the prescribing information. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, an unspecified number of patients may have been vaccinated with an unknown number of doses of VARIVAX (Merck) (dose, route, lot number and expiration date were not reported) that were exposed to temperatures outside of those specified in the prescribing information. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with an unknown number of doses of GARDASIL (dose, route, lot number and expiration date were not reported) that were exposed to temperatures outside of those specified in the prescribing information (improperly stored). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date, patient was vaccinated with a dose of PROQUAD (dose, strength, lot number, expiration date and route not provided). Co-suspect or concomitant therapies were not reported. The PROQUAD vaccine that the patient received was previously exposed to out of range temperatures. The PROQUAD vaccine was supported by in-house stability data. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with an unknown number of doses of ROTATEQ (dose, route, lot number and expiration date were not reported) that were exposed to temperatures outside of those specified in the prescribing information (improperly stored). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unkonwn demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with an unknown number of doses of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) that were exposed to temperatures outsides of those specified in the prescribing information (improperly stored). No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given injection on 3/12/14 at 1:00 pm. Came on 3/17/14 with antibiotic script for bacteria infection on site of injection. Further questioning revealed that MD thought it might be a bacteria infection. Upon examining, area looks warm, non purulent swelling.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient received vaccine on March 13 and visited the pharmacy on March 15 with a arm cellulitis.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a receptionist refers to a unspecified number of patients of unknown age and gender. On unspecified dates since 27-DEC-2013, an unknown number of patients were vaccinated with ROTATEQ (lot#, expiry not reported) after exposure to temperature outside prescribing information. No adverse events were reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient experiencing severe pain in arm vaccine was given. Patient believes they require physical therapy.
Sex: U
Vaccine: HPV4
Symptoms: Amenorrhoea, Menstruation irregular
Clinical narrative: This spontaneous report as received from a physician refers to his 16 year old daughter. The patient was vaccinated with the first dose of GARDASIL (strength, dose, route and lot # were unknown) on an unspecified date about a year ago (approximately in March 2013), after which her menstrual periods became sparse. After the patient was administered a second dose of GARDASIL on an unspecified date the patient's regular menstrual periods stopped completely. The outcome of events was unknown. The relationship of events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a receptionist refers to a unspecified number of patients of unknown age and gender. On unspecified dates since 27-DEC-2013, an unknown number of patients were vaccinated with GARDASIL (lot#, expiry not reported) after exposure to temperature outside prescribing information. No adverse events were reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ROTATEQ (Lot # not reported) (2 ml, oral route) that was exposed to a low temperature of 34 degrees Fahrenheit for an unspecified number of times over a period of 7 days (168 hours). Concomitant therapy was not reported. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a receptionist refers to a unspecified number of patients of unknown age and gender. On unspecified dates since 27-DEC-2013, an unknown number of patients were vaccinated with VAQTA (lot#, expiry not reported) after exposure to temperature outside prescribing information. No adverse events were reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Mother reports that right arm became red right after vaccine was given on 3-14-14. Next morning pt had a temp of 100.6. Arm was sore, red and swollen and hot to the touch. 3-17-14 - Mom reports to health dept and schedule an appointment with her primary care provider.
Age: 0.9
Sex: U
Vaccine: HEPA
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous report as received from a medical receptionist (healthcare worker) refers to a 9 months old patient of unknown gender. On 12-MAR-2014 the patient was inadvertently administered a 0.5ml dose of VAQTA (lot# unspecified) ("injection 25/0.5 U/ml" as reported) location and frequency unspecified, route as intramuscular. No adverse event reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 month old male patient. On 10-MAR-2014, the patient was vaccinated with M-M-R II lot# H017027, expiry date 14-SEP-2014, 0.5 ml, subcutaneous. Other suspect therapies included VARIVAX (Merck) (lot # J007021 expiry date 05-JUN-2015) and MENACTRA (lot # U4418BA, expiry date 21-MAY-2014). On 10-MAR-2014, 1 day after onset of therapy the patient received M-M-R II and VARIVAX that were inadvertently reconstituted with MENACTRA. In March 2014, the patient experienced no adverse effect. The outcome of patient received M-M-R II and VARIVAX that were inadvertently reconstituted with MENACTRA and no adverse effect were unknown. The reporter did not assess the relationship between the events and M-M-R II and VARIVAX (Merck). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin test
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient with allergy to vaccine. On an unknown date of October 2013, patient was vaccinated with FLUVIRINE (strength, dose number, route, lot number and expiry date unknown). On 14-OCT-2013, patient experienced similar injection site reactions after vaccination with FLUVIRINE as ZOSTAVAX. Patient had no other pertinent medical history or drug allergic reactions. On 06-MAR-2014 the patient was vaccinated with ZOSTAVAX (strength, dose number, route, lot number and expiry date unknown). Concomitant therapies included warfarin sodium (manufacturer unknown), atorvastatin (manufacturer unknown) and methocarbamol (manufacturer unknown). On an unknown date of March 2014, after vaccination with ZOSTAVAX the patient developed injectio site reaction. She has redness around the injection site that measures approximately 40mm by 50mm. Patient contacted pharmacist for medical attention. Patient took BENADRYL and the area did not get larger, once BENADRYL was taken. The outcome of injection site reaction and she has redness was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an unknown number of patients of unknown gender. On an unknown date the patients were vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patients were diagnosed with shingles. The outcome of shingles was unknown. The action taken with the therapy with ZOSTAVAX was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. It was reported that no VZV pack was offered to the physician since the physician stated that he did not want to be contacted regarding the adverse event. This case is related to case number 1403USA007399 via same reporter link. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Expired drug administered, Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old female patient with allergy to amoxicillin. The reporter stated that the patient exhibits an elevated temperature 'every time' the patient receives an unspecified vaccine. On 19-NOV-2013 the patient was vaccinated with VARIVAX (merck) (lot # J003528, expiration date: 25-MAR-2015) (dose not reported). Concomitant therapies included CLARITIN. The reporter stated that VARIVAX (merck) was administered after the expiration date (verified expiration date for lot # J003528 is 25-MAR-2015). The reporter stated that VARIVAX (merck) had been improperly stored (based on a documented temperature excursion) and was only supported, using extended stability, until 01-NOV-2013. On 20-NOV-2013, reported as '24 hours after receiving VARIVAX (merck)', the patient experienced an elevated temperature. The reporter stated that the patient's temperature rose of 103.9 F and lasted 'on and off' throughout the week after the VARIVAX (merck) was administered. The patient was taken to an unspecified emergency room however the patient was not admitted to the hospital. The outcome of the event was reported as recovered on an unspecified date. The relatedness between VARIVAX (Merck) and the event was not reported. Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 80 year old patient of unknown gender. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced very bad shingles. The outcome of very bad shingles was unknown. The action taken with the therapy with ZOSTAVAX was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. This case is related to case number 1403USA007543 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PEDVAXHIB (reported as PEDVAX HIB) (lot #, expiry date, route, dose, strength and indication not reported). The reporter stated that the unspecified number of patients received PEDVAX HIB at intervals of 2, 4, 6 and 12 months. No adverse symptoms reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Cellulitis, Flushing, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Child's arm became swollen, tender and flushed. Bicep circumference (left) where KINRIX was given was 22 cm, compared to 17 cm on the right side. Child also developed cellulitis and is being treated with antibiotics.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients with unknown ages and genders. On an unknown date the patients were vaccinated with ZOSTAVAX, subcutaneous (lot #, expiry date, dose unknown). The pharmacist reported that he received a phone call from a physician's office in which a medical assistant was administering with ZOSTAVAX and telling patients to rub the injection site. These unspecified number of patients were reporting that they were experiencing more irritation at the injection site after they rubbed the area. No treatment was given for the event. The outcome of the event was unknown. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Pyrexia, Rash, Respiratory tract congestion, Sinusitis
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 55 year old male patient. on 17-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX, (lot#, expiry date, dose and route not reported). The medical assistant informed that on an unspecified date the patient developed "a chicken pox like rash at the injection site" where ZOSTAVAX was administered on 17-FEB-2014. The patient returned to see the physician assistant on 19-FEB-2014 and the rash was noted along with a fever, vomiting and congestion. The patient was diagnosed with a sinus infection and given unspecified antibiotics (manufacturer unknown). The medical assistant also stated that on 19-FEB-2014 the physician assistant noted in the patient's file that he was "allergic to ZOSTAVAX". VZVIP packet faxed. The outcome of the events was unknown. The patient had sought medical attention by going to see physician assistant. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 55 year old male patient. on 17-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX, (lot#, expiry date, dose and route not reported). The medical assistant informed that on an unspecified date the patient developed "a chicken pox like rash at the injection site" where ZOSTAVAX was administered on 17-FEB-2014. The patient returned to see the physician assistant on 19-FEB-2014 and the rash was noted along with a fever, vomiting and congestion. The patient was diagnosed with a sinus infection and given unspecified antibiotics (manufacturer unknown). The medical assistant also stated that on 19-FEB-2014 the physician assistant noted in the patient's file that he was "allergic to ZOSTAVAX". VZVIP packet faxed. The outcome of the events was unknown. The patient had sought medical attention by going to see physician assistant. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. In July 2013 the patients were vaccinated once with doses of GARDASIL (lot number and expiration date at the time of report not available) 0.5 ml injection, intramuscularly which were exposed (date unspecified) to 25 Fahrenheit for cumulative total of 205 hours. No patient data was available at the time of report. No adverse effects reported.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Apnoea, Apparent life threatening event, Blood test normal, Chest X-ray normal, Electroencephalogram normal
Clinical narrative: ALTE - acute onset of limp/apnea 24 hours after vaccines, 10 hours after eating. Hosp w/u, incl. blood, urine, chest nl. EEG nl without movement artifact. H/O benign sleep movement d/o 6/13, with (-) o/a EEG.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Hypotonia, Laboratory test normal, Urine analysis normal
Clinical narrative: ALTE - acute onset of limp/apnea 24 hours after vaccines, 10 hours after eating. Hosp w/u, incl. blood, urine, chest nl. EEG nl without movement artifact. H/O benign sleep movement d/o 6/13, with (-) o/a EEG.
Age: 3.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dermatitis exfoliative, Oedema peripheral, Papule, Pruritus, Urticaria
Clinical narrative: Hives on posterior thighs: multiple itching excavated papules. On anterior thighs erythroderma patches and pretibular areas similar patches mod edema knees. I noted areas pretibial above ankles.
Age: 15.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: Stomach ache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Full blood count, Petechiae
Clinical narrative: Petechiae noted around eyes, hairline, forehead, ears. One line of petechiae noted on (R) shoulder. Developed petechiae 2 hours after vaccines.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Left arm, hot to the touch. Hard/swollen red spot. About 7 inches wide and 5 1/2 inches long.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Swelling and redness at injection site, fussiness left thigh.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: ITCHING AND REDNESS AT INJECTION SITE. GAVE PATIENT BENADRYL AND PUT HYDROCORTISONE CREAM AT SITE AND MONITORED PATIENT FOR 30 MINUTES BEFORE SHE LEFT.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Rash papular, Rash pruritic
Clinical narrative: Developed mildly pruritic rash of erythematous papules mostly on hands and feet. Some with central vesicles.
Age: 13.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: School Nurse called 3/13/14 to report pain in childs left upper arm, redness, hardness, and warmth. Appx size of silver dollar, swelling extending from top of arm to elbow measureing 6x4 inches.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability, Screaming
Clinical narrative: Fussiness and crying nonstop for over 3 hours-family called MD at 5:20 on 03/14/2014 to report nonstop crying and screaming uncontrollably since shots were administered.