chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised, Throat irritation
Clinical narrative: Initial unsolicited report received from a consumer (via other company Pfizer) on 05-Jan-2016. Manufacturer Report Number: 2015469563. This case involves a 68-years-old female patient, who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (batch number: unknown) via intramuscular route in left upper arm on 29-Sep-2015. Patient had medical history of asthma which was diagnosed close to 1980, allergy to adhesives in 2015 (ongoing) and allergy to formaldehyde in 1999 (ongoing). Patient had received Atorvastatin in 2014, 10 mg tablet once a day by mouth (ongoing) for prevention of cholesterol and albuterol inhaler for asthma (ongoing) as concomitant medications. On 29-Sep-2015, within an hour following vaccination, the patient experienced itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head was itching, back of her mouth had started swelling, had not been sleeping right; got less sleep and itching over whole body. The patient had an allergy to the vaccine. On an unknown date, few days after the vaccination, congestion started. On an unspecified date, in between 16-18th of Oct-2015, patient experienced early stage pneumonia. On an unknown date in 2015 (reported as started sometime after 29-Sep-2015) patient experienced heart palpitations. On an unknown date in 2015, she experienced pain in left shoulder and congestion. Patient required doctor ER/doctor visit. On 24-Oct-2015, patient was hospitalized and performed EKG test which came back funny. Repeat EKG tests were performed. On Oct 2015, the EKG was normal. Laboratory investigations included egg allergy test on Oct-2015 which was negative, on 24-Oct-2015 EKG showed slow heart rate and brachial abnormality and on an unknown date in Oct-2015 showed within normal range. On an unknown date in Nov-2015, nuclear stress test which was normal, on an unknown date in Oct-2015 enzyme level test and echocardiogram showed normal and on an unknown date in Oct-2015 X-ray of lungs which was clear. Patient had received Prednisone (it was a Methylprednisolone dose pack- 4mg tablets, oral) for allergic reactions, on 20-Oct-2015 Clarithromycin 500 mg tablet twice a day by mouth which was stopped 10 days later as it was a 10 day course and antibiotics (not specified) for pneumonia and albuterol inhaler from 29-Sep-2015 to 20-Oct-2015 as a corrective treatment. At the time of this report the patient was recovering from congestion. On 20-Oct-2015 patient recovered from itching deep in her ears, itching on the roof of her mouth, itching in her eyes, whole head itching, back of her mouth started swelling, had not been sleeping right; getting less sleep and itching over whole body. On 26-Oct-2015, she recovered from heart palpitations. On 27-Oct-2015, patient was discharged from hospital. On 30-Oct-2015 recovered from pneumonia. On an unknown date in Nov-2015 recovered from pain in left shoulder. Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: Injected limb mobility decreased, Injection site joint movement impairment
Clinical narrative: The patient states she has decreased movement and range of motion in left shoulder.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 56 year old female patient. The patient had drug allergy/reaction to aspirin and acetaminophen, VICODIN "causes her to vomit". The patient had none medical history. On 07-JAN-2016 the patient was vaccinated with ZOSTAVAX lot # L000449, expiration date 08-MAR-2016, 0.65 ml/once, subcutaneous in the left arm for preventing shingles. Concomitant therapies included FOSAMAX, SYNTHROID and PROTONIX. On 11-JAN-2016 ("today"), the patient called the pharmacy, stated she had pain, redness and swelling at the injection site. No treatment was given for the events. No lab tests was done. The outcome of the events was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from an unspecified reporter via social media referring to thousands of unspecified female patients. On unknown dates the patients were vaccinated with GARDASIL (dose, lot # and route were unknown). On unknown dates. the patients were killed and disabled by therapy with GARDASIL. Outcome of disability was unknown. It was unknown if autopsies were performed. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Bone cancer, Death, Incorrect route of drug administration
Clinical narrative: Information has been received from a physician via company representative referring to a male patient of unknown age. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, dose and strength unknown) subdermally. Later the patient died from bone cancer on an unknown date. It was unknown if autopsy was done. Causality was not provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Approximately 3 days after developed rash on trunk and shoulders. NP reported to pharmacy, treated w/MEDROL 4 mg hydrocortisone.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13, TDAP
Symptoms: Antinuclear antibody negative, Borrelia test negative, C-reactive protein normal, Injection site pain, Pain
Clinical narrative: Pain in shoulder/bicep areas- full ROM but with pain.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13, TDAP
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Pain in shoulder/bicep areas- full ROM but with pain.
Age: 15.0
Sex: F
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Burning sensation, Cellulitis, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Mother states that patient had large red bump on left arm where had vaccine on 11/18/2015. Mother states took patient to ER and they diagnosed with cellulitis and gave antibiotic. Patient states left arm was red/itchy/burning for 1 1/2 weeks after vaccination on 11/18/15. Vaccine given in this arm was documented to be Meningitis vaccine (MCV4, Menactra) given in left deltoid.
Age: 15.0
Sex: F
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Pruritus
Clinical narrative: Mother states that patient had large red bump on left arm where had vaccine on 11/18/2015. Mother states took patient to ER and they diagnosed with cellulitis and gave antibiotic. Patient states left arm was red/itchy/burning for 1 1/2 weeks after vaccination on 11/18/15. Vaccine given in this arm was documented to be Meningitis vaccine (MCV4, Menactra) given in left deltoid.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Extremely sore arm, swollen upper left arm that turned red and hot to touch, lasted from 1-6-1; starting to clear up by 1-14-16.
Age: 46.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Polymerase chain reaction, Skin lesion, Varicella virus test negative, Viral test negative
Clinical narrative: Varicella vaccine administered 12/7/15 client developed lesions over arms and torso 1/3/16.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Feeling abnormal, Nasopharyngitis, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of device use error in a 76-year-old female patient who received ADVAIR Diskus unknown (batch number 5ZP1526, expiry date February 2017) for drug use for unknown indication. On 19th November 2015, the patient started ADVAIR Diskus (unknown) 100/50 ug at an unknown dose at unknown dosing. On 20th November 2015, 1 day after starting ADVAIR Diskus, the patient experienced device use error. The action taken with ADVAIR Diskus was unknown. On an unknown date, the outcome of the device use error was unknown. Additional details included that the patient reported that she used ADVAIR for the first time "yesterday". It went well and she reported that she felt it really helped her. On the morning of reporting, when she tried to use the device, she could not get it open. She was trying to flip the light purple section up to expose the mouthpiece. She had forgotten that the inhaler needed to be twisted to expose the mouthpiece. She was attempting to use the product incorrectly. Follow up received by a consumer on 4th December 2015 and 17th December 2015: The reporter stated that, the patient started the course with ADVAIR Diskus on 18th November 2015, and she might have received a dose of Flu vaccine on the same day. On 1st December 2015, 13 days after receiving the Flu vaccine and ADVAIR Diskus, the patient experienced cold symptoms, sniffles and cough. The patient thought that, she had flu. The patient visited back the doctor, who confirmed that she did not have the flu, but sinusitis instead. She was prescribed an antibiotic. In November 2015, less than a month after vaccination and after receiving ADVAIR Diskus, the patient never felt good (malaise), at some point felt nauseated, wheezing and trouble breathing while walking. On 17th December 2015, the patient was still wheezing. It was unknown if the events were related to Flu vaccination. The patient would talk to her doctor about taking ADVAIR twice per day instead of once per day, which has let to an underdose. The patient denied permission to contact her physician.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea, Sinusitis, Wheezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of device use error in a 76-year-old female patient who received ADVAIR Diskus unknown (batch number 5ZP1526, expiry date February 2017) for drug use for unknown indication. On 19th November 2015, the patient started ADVAIR Diskus (unknown) 100/50 ug at an unknown dose at unknown dosing. On 20th November 2015, 1 day after starting ADVAIR Diskus, the patient experienced device use error. The action taken with ADVAIR Diskus was unknown. On an unknown date, the outcome of the device use error was unknown. Additional details included that the patient reported that she used ADVAIR for the first time "yesterday". It went well and she reported that she felt it really helped her. On the morning of reporting, when she tried to use the device, she could not get it open. She was trying to flip the light purple section up to expose the mouthpiece. She had forgotten that the inhaler needed to be twisted to expose the mouthpiece. She was attempting to use the product incorrectly. Follow up received by a consumer on 4th December 2015 and 17th December 2015: The reporter stated that, the patient started the course with ADVAIR Diskus on 18th November 2015, and she might have received a dose of Flu vaccine on the same day. On 1st December 2015, 13 days after receiving the Flu vaccine and ADVAIR Diskus, the patient experienced cold symptoms, sniffles and cough. The patient thought that, she had flu. The patient visited back the doctor, who confirmed that she did not have the flu, but sinusitis instead. She was prescribed an antibiotic. In November 2015, less than a month after vaccination and after receiving ADVAIR Diskus, the patient never felt good (malaise), at some point felt nauseated, wheezing and trouble breathing while walking. On 17th December 2015, the patient was still wheezing. It was unknown if the events were related to Flu vaccination. The patient would talk to her doctor about taking ADVAIR twice per day instead of once per day, which has let to an underdose. The patient denied permission to contact her physician.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient reported reaction to pharmacy on 1/14/16. She had redness and swelling down her left arm and hand.
Age: 76.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Rash generalised
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a 76-year-old male patient who received ENGERIX B adult (batch number 92M2J, expiry date 3rd November 2017. Concomitant products included CIPRO, Hep A vaccine and radioembolization. On 30th November 2015, the patient received ENGERIX B adult, .5 ml. In December 2015, 12 days after receiving ENGERIX B adult, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovering/resolving. It was unknown if the reporter considered the generalized rash to be related to ENGERIX B adult. Additional details provided were as follows: The patient received CIPRO and Radio-emobilization two days prior experiencing rash. The patient experienced generalized rash 12 days after receiving ENGERIX B vaccine. The reporter was unsure if the rash was actually related to the vaccination with ENGERIX B, The patient required an emergency room visit. No further information was reported regarding the event.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Body temperature increased, Cough, Headache, Inappropriate schedule of drug administration, Injection site oedema
Clinical narrative: Case number PHEH2015US018912, is a combined initial spontaneous report from a medical assistant on 23 Sep 2015. This report refers to a 15-year-old female patient. Past medical history and concomitant medication were not reported. She received two doses of MENVEO (batch number: A14099/A15019, expiry date: 31 Sep 2016) on 27 Aug 2015 and 03 Sep 2015 respectively within a 7 days period. No adverse event was reported following this administration error. Follow-up information received on 5 November 2015 from physician: Previously administered products included DTaP (4th dose - Previous doses: 1st dose on 18 May 2000, 2nd dose on 7 September 2000 and 3rd dose on 2 November 2000), hepatitis B vaccine (3rd dose - Previous doses: 1st dose on 18 March 2000and 2nd dose on 7 May 2000), MMR vaccine (3rd dose - Previous doses: 1st dose on 14 December 2000 and 2nd dose on 18 July 2001) and polio vaccine (4th dose - Previous doses: 1st dose on 18 March 2000, 2nd dose on 18 May 2000, 3rd dose on 22 June 2000 and 4th dose on 7 September 2000). Concurrent medical conditions included iodine allergy. Concomitant products included MENVEO, PNEUMO 13, VARIVAX and BOOSTRIX. On 3rd September 2015, the patient received the 2nd dose of MENVEO (injection) 1 dosage form(s) 7 days after receiving the 1st dose which leads to an inappropriate schedule. On 4th September 2015, the patient experienced injection site edema. On 2nd October 2015, the patient experienced slight temperature, cough nonproductive, headache, spasms and rhinorrhea. On 5th September 2015, the outcome of the injection site edema was recovered/resolved. On 9th October 2015, the outcome of the slight temperature, cough nonproductive, headache, spasms and rhinorrhea were recovered/resolved. It was unknown if the reporter considered the inappropriate schedule of vaccine administered, injection site edema, slight temperature, cough nonproductive, headache, spasms and rhinorrhea to be related to MENVEO.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Muscle spasms, No adverse event, Rhinorrhoea
Clinical narrative: Case number PHEH2015US018912, is a combined initial spontaneous report from a medical assistant on 23 Sep 2015. This report refers to a 15-year-old female patient. Past medical history and concomitant medication were not reported. She received two doses of MENVEO (batch number: A14099/A15019, expiry date: 31 Sep 2016) on 27 Aug 2015 and 03 Sep 2015 respectively within a 7 days period. No adverse event was reported following this administration error. Follow-up information received on 5 November 2015 from physician: Previously administered products included DTaP (4th dose - Previous doses: 1st dose on 18 May 2000, 2nd dose on 7 September 2000 and 3rd dose on 2 November 2000), hepatitis B vaccine (3rd dose - Previous doses: 1st dose on 18 March 2000and 2nd dose on 7 May 2000), MMR vaccine (3rd dose - Previous doses: 1st dose on 14 December 2000 and 2nd dose on 18 July 2001) and polio vaccine (4th dose - Previous doses: 1st dose on 18 March 2000, 2nd dose on 18 May 2000, 3rd dose on 22 June 2000 and 4th dose on 7 September 2000). Concurrent medical conditions included iodine allergy. Concomitant products included MENVEO, PNEUMO 13, VARIVAX and BOOSTRIX. On 3rd September 2015, the patient received the 2nd dose of MENVEO (injection) 1 dosage form(s) 7 days after receiving the 1st dose which leads to an inappropriate schedule. On 4th September 2015, the patient experienced injection site edema. On 2nd October 2015, the patient experienced slight temperature, cough nonproductive, headache, spasms and rhinorrhea. On 5th September 2015, the outcome of the injection site edema was recovered/resolved. On 9th October 2015, the outcome of the slight temperature, cough nonproductive, headache, spasms and rhinorrhea were recovered/resolved. It was unknown if the reporter considered the inappropriate schedule of vaccine administered, injection site edema, slight temperature, cough nonproductive, headache, spasms and rhinorrhea to be related to MENVEO.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Skin fissures
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 70-year-old female patient with no pertinent medical history and no drug reactions or allergies. On 14-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (lot number not provided) for shingles prevention. There were no concomitant medications. On an unknown date, the patient experienced "general" dry skin (unspecified location) and "a more serious" case of dry skin on the heels of her feet, the skin was actually cracking. The patient sought medical attention, she spoke with the pharmacist on 13-JAN-2016. Unspecified topical steroid cream was given for the events. No laboratory studies were performed. Outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, 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. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated orally with unknown doses of oral, ROTATEQ (lot # L008053, expiry date 30-NOV-2016), which were improperly stored - under temperature of 57.7F for 1 hour and 46.1F for 1 hour (cumulative 57.7F for 2 hours). There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had no pertinent medical history and did not use any concomitant medication. On 11-JAN-2016 at 17:00, the patient was vaccinated with a dose of ZOSTAVAX, lot # L012476, expiry date: 10-JUL-2016, dose: 0.65 ml, subcutaneously in the left arm. On 11-JAN-2016, the patient called the pharmacy to report that she was experiencing "palm-sized redness, shooting pain and itching" at her ZOSTAVAX injection site (onset date of adverse events was in January 2016). The patient did not mention whether or not she was developing a rash and she has not notified her primary healthcare provider. No treatment was given for the adverse events and no lab diagnostics studies were performed. The patient did not recover from the events. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Influenza like illness, Injection site pain, Myalgia, Respiratory tract congestion
Clinical narrative: Flu like symptoms.  Sore shoulders joints, hip joints, knee joints.  Muscle aches in upper torso and thighs.  Scratchy throat (started on day 2), tired, I just want to sleep.  Mild congestion at night.  No determinable elevation in temperature. Soreness at injection site.   Symptoms are still present 44 hours after injection.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Somnolence, Throat irritation
Clinical narrative: Flu like symptoms.  Sore shoulders joints, hip joints, knee joints.  Muscle aches in upper torso and thighs.  Scratchy throat (started on day 2), tired, I just want to sleep.  Mild congestion at night.  No determinable elevation in temperature. Soreness at injection site.   Symptoms are still present 44 hours after injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site, becoming increasingly larger every day until going to doc 01/14/2016.  Also headache.  Site is warm to touch, swollen and around 2" diameter.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The patient received both vaccines on 11/12/2015. She was in on 01/07/2016 and stated that her arm was still sore.  She was having a hard time lifting her arm completely.  It has become more mobile with less pain, but it still was a little sore.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report has been received from an 85 year old female consumer reporting on herself. The patient's concurrent conditions including hypertension and emphysema using oxygen and nebulizer. As past medical history the patient had a drug reaction of rash. On an unspecified date, the patient was vaccinated with the first dose of ZOSTAVAX (strength, dose, route, anatomical location, lot # and expiration date unspecified by the reporter). On an unspecified date in December 2015 the patient was vaccinated with a second shot of ZOSTAVAX (strength, dose, route, anatomical location, lot # and expiration date not provided). Concomitant therapies included aspirin and high blood pressure medicine (unspecified). On approximately 10-DEC-2015 (reported as 3 weeks ago) the patient developed shingles after receiving the second dose of ZOSTAVAX. It was described as a rash that would move on body; the patient reported that it would itch and burn like hell. Patient sought for medical attention and was seen by a physician. She was prescribed with VALTREX 3 times daily and hydrocortisone cream. The patient stated that the physician told her that it might take a long time to heal. The patient reported, that the pharmacist contacted her to see, if she wanted to received a third dose of ZOSTAVAX but the physician stated that he would not recommend to get an additional dose. At the time of the report the outcome of shingles was reported not recovered, although the shingles improved on prescribed therapy, the relatedness between the events and the suspect therapy was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to unspecified number of patients of an unknown age. The patients' concurrent conditions, medical history and concomitant medications were not reported. The physician stated that the patients were vaccinated with improperly stored ROTATEQ (lot # L002717, expiry date 02-JUN-2017 and Lot # L013192, expiry date 19-JAN-2017) (34 F for 4 hours) between 24-DEC-2015 and 12-JAN-2016. No adverse events were reported. This is one of the several reports receive from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to unspecified number of patients of an unknown age. The patients' concurrent conditions, medical history and concomitant medications were not reported. The physician stated that the patients were vaccinated with improperly stored VAQTA (lot # L030442, expiry date 19-DEC-2016) (34 F for 4 hours) between 24-DEC-2015 and 12-JAN-2016. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to unspecified number of patients of an unknown age. The patients' concurrent conditions, medical history and concomitant medications were not reported. The physician stated that the patients were vaccinated with improperly stored GARDASIL (lot # K011562, expiry date 08-APR-2017) (34 F for 4 hours) between 24-DEC-2015 and 12-JAN-2016. No adverse events were reported. This is one of the several reports receive from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to unspecified number of patients of an unknown age. The patients' concurrent conditions, medical history and concomitant medications were not reported. The physician stated that the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L025738, expiry date 14-AUG-2017) (34 F for 4 hours) between 24-DEC-2015 and 12-JAN-2016. No adverse events were reported. This is one of the several reports receive from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative referring to a patient of unknown age. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route and lot# not reported). Concomitant therapy was not reported. On an unknown date the patient experienced shingles. It was unspecified if the patient sought medical attention. The outcome of shingles was unknown. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report has been received from an unspecified person via social media referring to unspecified number of patients. On unknown date the patients were vaccinated with M-M-R II (dose, frequency, route and lot# not reported). It was reported that if CDC authors had published the truth in 2004, if they hadn't cooked the books, if they hadn't thrown away vital documents in the garbage, everybody would now know the M-M-R II had a connection to causing autism. The outcome of autism was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 12-JAN-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L027287, dose and route of administration not provided. No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 12-JAN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K010016, dose and route of administration was not provided). No concomitant therapy was reported. No adverse symptoms were reported. The pharmacist stated that the vaccine in question did not had any previous temperature excursions. The outcome of the event was unknown. No product quality issue was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L007560, expiration date 01-JU-2017 or lot # L013429, expiration date 21-JUL-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 48 degrees Fahrenheit for 89 hours. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L025738, expiration date 14-AUG-2017 or lot # L029631, expiration date 14-AUG-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 48 degrees Fahrenheit for 89 hours. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # L039659, expiration date 15-MAR-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 48 degrees Fahrenheit for 89 hours. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates (reported as since 31-DEC-2015), the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L020003, expiration date 02-JUN-2017, exact doses and route of administration were not reported). It was reported that the vaccines were exposed to the temperature of 8F for an unspecified time frame. A defrost cycling was considered. The reason of the report was data logger. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates (reported as since 31-DEC-2015), the patients were vaccinated with improperly stored doses of PROQUAD (lot # L026728, expiration date 15-JAN-2017, exact doses and route of administration were not reported). It was reported that the vaccines were exposed to the temperature of 8F for an unspecified time frame. A defrost cycling was considered. The reason of the report was data logger. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified patients of unknown age and gender. On an unknown dates, the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported, lot #L013428 with expiration date: 03-FEB-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site induration
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative referring to herself, a 58 year old female patient. The patient's medical history and concurrent condition were not provided. In approximately November 2015 (reported as more than a month ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot #, route, dose, concentration and anatomical location were not provided). Concomitant medications were not reported. In approximately November 2015  (reported as 24 to 48 hours after receiving the vaccine), the patient experienced vaccination site induration in an unspecified location in an unspecified arm in which the ZOSTAVAX was received. On an unspecified date in 2015, the patient sought medical attention by seeing the physician. The outcome of vaccination site induration was unknown. The primary reporter did not provide the causality between ZOSTAVAX and vaccination site induration. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L020861, expiration date 25-JAN-2017 (dose was not reported). Administered doses of vaccines experienced the temperature excursion of 48 degrees Fahrenheit for 89 hours. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Nausea
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, dose#, lot# and route unknown). On an unspecified time after receiving ZOSTAVAX, the patient became nauseous and developed a "mosquito-like bite" and redness at the injection site. The outcome of the events was unknown. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse referring to a 5 months old patient of unknown gender. On 28-OCT-2015 the patient was vaccinated with a first dose of oral, ROTATEQ (lot # L002042, expiration 28-JUL-2016, dose was not reported) orally (Inappropriate schedule of vaccine administered). The patient received the first dose of oral, ROTATEQ at an age that was older than what is specified in the oral, ROTATEQ Pl. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a Licensed Visiting Nurse (LVN) referring to multiple unspecified patients. The patient's pertinent medical history and concomitant therapies were not reported. On unspecified dates, the patients were administered improperly stored ZOSTAVAX (dose, frequency and route of administration were not reported, lot # L021608, expiration date 10-SEP-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a Licensed Visiting Nurse (LVN) referring to multiple unspecified patients. The patients' pertinent medical history and concomitant therapies were not reported. On unspecified dates, the patients were administered improperly stored (Oka/Merck) VARIVAX (dose, frequency and route of administration were not reported, lot # L015048, expiration date 29-APR-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a Licensed Vocational Nurse (LVN) referring to multiple unspecified patients. The patients' pertinent medical history and concomitant therapies were not reported. On unspecified dates, the patients were administered improperly stored PROQUAD (dose, frequency and route of administration were not reported, lot # L007229, expiration date 03-SEP-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.18
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Peripheral swelling, Urticaria
Clinical narrative: Received phone call from mother stating child was broken out in whelps, swollen hands, and running low grade temp. Injection site was clear with no redness or inflammation. PCP thinks it is from the vaccine and ordered DECADRON and BENADRYL.
Sex: F
Vaccine: HPV9
Symptoms: Antinuclear antibody, Blood folate, Blood iron, Blood lactate dehydrogenase, Blood thyroid stimulating hormone
Clinical narrative: Dizziness and tingling legs 4 days after receiving immunization - progressive symptoms muscle weakness, fatigue resolution paresthesias continues with increased tiredness, proximal muscle weakness (insists seen at ER and specialists - PT). Headaches.
Sex: F
Vaccine: HPV9
Symptoms: Borrelia test, C-reactive protein, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness and tingling legs 4 days after receiving immunization - progressive symptoms muscle weakness, fatigue resolution paresthesias continues with increased tiredness, proximal muscle weakness (insists seen at ER and specialists - PT). Headaches.
Sex: F
Vaccine: HPV9
Symptoms: Iron binding capacity total, Laboratory test, Metabolic function test, Muscular weakness, Paraesthesia
Clinical narrative: Dizziness and tingling legs 4 days after receiving immunization - progressive symptoms muscle weakness, fatigue resolution paresthesias continues with increased tiredness, proximal muscle weakness (insists seen at ER and specialists - PT). Headaches.
Sex: F
Vaccine: HPV9
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Serum ferritin, Thyroxine, Vitamin B12
Clinical narrative: Dizziness and tingling legs 4 days after receiving immunization - progressive symptoms muscle weakness, fatigue resolution paresthesias continues with increased tiredness, proximal muscle weakness (insists seen at ER and specialists - PT). Headaches.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2015, the patient was vaccinated with improperly stored RECOMVBIVAX HB (lot # K010216, expiration date 17-SEP-2016, (strength, dose and route were unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nursing assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On 12-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L016429, expiration date 09-AUG-2017, dose and route were unknown). The GARDASIL 9 was stored at 31.1 F for 1.5 hours. There was no previous temperature excursion. It was called because of a "data logger". No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # K010216, expiration date 17-SEP-2016, (strength, dose and route were unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # K010216, expiration date 17-SEP-2016, (strength, dose and route unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.09
Sex: M
Vaccine: HEP
Symptoms: Breath holding, Crying, Dyspnoea, Electrocardiogram normal, Pain
Clinical narrative: 1-15-16 - Yesterday, about 5 min after the vaccine, child developed central apnea, not breathing for 10-15 sec at a time, and then gasping. He cried with stimuli but quickly went back into the apneic breathing pattern when it was stopped. Color was pale. Infant was very still. I repeated the painful stimuli (fingers in axillae) about 7 times. He had intermittent periods of breathing spontaneously which lasted 1-2 min at a time, and then recurred with the central apnea. We fed 1 ounce of formula with a dropper. No dramatic change. Color improved. Gave oxygen and put pulse ox on him, pulse ox was 100%. Called 911. They arrived about 15 min later, and by that point, the infant was breathing spontaneously and regularly. Spoke to hospital at time of discharge today and they reported that ECG was normal, no abnormalities found, final dx likely breath holding from the pain of the vaccine.
Age: 0.09
Sex: M
Vaccine: HEP
Symptoms: Pallor, Sleep apnoea syndrome
Clinical narrative: 1-15-16 - Yesterday, about 5 min after the vaccine, child developed central apnea, not breathing for 10-15 sec at a time, and then gasping. He cried with stimuli but quickly went back into the apneic breathing pattern when it was stopped. Color was pale. Infant was very still. I repeated the painful stimuli (fingers in axillae) about 7 times. He had intermittent periods of breathing spontaneously which lasted 1-2 min at a time, and then recurred with the central apnea. We fed 1 ounce of formula with a dropper. No dramatic change. Color improved. Gave oxygen and put pulse ox on him, pulse ox was 100%. Called 911. They arrived about 15 min later, and by that point, the infant was breathing spontaneously and regularly. Spoke to hospital at time of discharge today and they reported that ECG was normal, no abnormalities found, final dx likely breath holding from the pain of the vaccine.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # K010216, expiration date 17-SEP-2016, (strength, dose and route was unknown). No adverse effects were reported. No product quality (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Exercise tolerance decreased, Hypoaesthesia, Inflammation, Injected limb mobility decreased
Clinical narrative: Small round lump swollen at site of injection. Sore and achy to the touch, but not red. Slight soreness and ache within the shoulder joint hours later. Swelling within the shoulder jointfollwed with pain. Increasing unexplained pain within the shoulder joint. Great pain within shoulder joint and inability to raise or turn or twist left arm to normal range. Unable to bear weight or sleep well or exercise or swim. Exeriencing numbness and tingling in fingers of left hand. Aching down my arm to elbow and to mid-forearm. Continued aching and great pain within the shoulder joint. See below for treatment.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site joint pain, Injection site joint swelling, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Small round lump swollen at site of injection. Sore and achy to the touch, but not red. Slight soreness and ache within the shoulder joint hours later. Swelling within the shoulder jointfollwed with pain. Increasing unexplained pain within the shoulder joint. Great pain within shoulder joint and inability to raise or turn or twist left arm to normal range. Unable to bear weight or sleep well or exercise or swim. Exeriencing numbness and tingling in fingers of left hand. Aching down my arm to elbow and to mid-forearm. Continued aching and great pain within the shoulder joint. See below for treatment.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia, Weight bearing difficulty
Clinical narrative: Small round lump swollen at site of injection. Sore and achy to the touch, but not red. Slight soreness and ache within the shoulder joint hours later. Swelling within the shoulder jointfollwed with pain. Increasing unexplained pain within the shoulder joint. Great pain within shoulder joint and inability to raise or turn or twist left arm to normal range. Unable to bear weight or sleep well or exercise or swim. Exeriencing numbness and tingling in fingers of left hand. Aching down my arm to elbow and to mid-forearm. Continued aching and great pain within the shoulder joint. See below for treatment.