chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Eustachian tube dysfunction, Facial pain, Fatigue, Hot flush, Muscle spasms
Clinical narrative: Intense pressure in ears and eustachian tubes.  Dizziness, intense thirst, hot flashes and head tightness.  Faintness and extreme fatigue and weakness.  Muscle pain and spasms throughout right arm, shoulder, and right side of neck.  Tight throat - felt like I was being choked.  Could not swallow food without extreme difficulty for 6 - 8 months.  Rapid weight loss.  After 2 weeks, developed pain along side of face and jaw and TMJ that has not gone away after 1.5 yrs.  Also currently have eustachian tube dysfunction.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Pain in jaw, Temporomandibular joint syndrome, Tension headache, Thirst
Clinical narrative: Intense pressure in ears and eustachian tubes.  Dizziness, intense thirst, hot flashes and head tightness.  Faintness and extreme fatigue and weakness.  Muscle pain and spasms throughout right arm, shoulder, and right side of neck.  Tight throat - felt like I was being choked.  Could not swallow food without extreme difficulty for 6 - 8 months.  Rapid weight loss.  After 2 weeks, developed pain along side of face and jaw and TMJ that has not gone away after 1.5 yrs.  Also currently have eustachian tube dysfunction.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Throat tightness, Weight decreased
Clinical narrative: Intense pressure in ears and eustachian tubes.  Dizziness, intense thirst, hot flashes and head tightness.  Faintness and extreme fatigue and weakness.  Muscle pain and spasms throughout right arm, shoulder, and right side of neck.  Tight throat - felt like I was being choked.  Could not swallow food without extreme difficulty for 6 - 8 months.  Rapid weight loss.  After 2 weeks, developed pain along side of face and jaw and TMJ that has not gone away after 1.5 yrs.  Also currently have eustachian tube dysfunction.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4
Symptoms: Dehydration, Pyrexia, Respiratory rate increased, Urticaria
Clinical narrative: High fever, dehydration, hives, rapid breathing.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Urticaria
Clinical narrative: Husband called to report his wife was suffering from hives all across her stomach that occurred in the past 2 days (that they appeared after her flu vaccine) and that she overall just didn't feel good.  Explained to husband that with her allergies she was unable to take the recommendation of antihistamines so therefore needed to contact her pcp on call or go to the hospital.
Age: 49.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: I have had a great deal of increasing pain in my left elbow the has radiated up into my shoulder and down into my fingers ever since having had my vaccination. Nothing I take Tylenol, Ibuprofen, Excedrin, ASA, Aleve seem to work to help the pain. I can't even hardly lift up my glass to drink.
Age: 49.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: I have had a great deal of increasing pain in my left elbow the has radiated up into my shoulder and down into my fingers ever since having had my vaccination. Nothing I take Tylenol, Ibuprofen, Excedrin, ASA, Aleve seem to work to help the pain. I can't even hardly lift up my glass to drink.
Age: 64.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Large red raised area near site of injection that was very tender and itchy. Treated symptoms with Benadryl.
Age: 1.5
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Abnormal behaviour, Crying, Dry skin, Pharyngeal erythema, Pyrexia
Clinical narrative: My son went in for his well visit on 12/19 and got his last hib shot and his chicken pox shot and by the time we got home he had spiked a 103.8 fever which I knew was from the shots so I just gave him some Motrin and kept and eye on him. Well by the next morning, 12/20 the fever was still up there but he had developed this hive and just wasn't himself. So I called the doctor. We brought him in they are telling me it's from a virus he got because his throat is a little red and his nose his runny.( which I knew it wasn't a virus because he didn't have it before the shots) she said to give him some benedryl for the hives every 6 hrs when they come and Motrin every 6 hrs for the temp because he's throws up to Tylonal so we can't alternate. So the next day comes (12/21) and I realize that after giving him milk he broke out in a hive so I'm questioning weather or not he is allergic to milk all of a sudden. So I called the dr. They told me to switch to almond milk so I did. And to stop all milk products and schedule an allergist asap and see what's going on. So then we went on the day and he had lunch and I gave him a peanut butter sandwich with some almond milk . After lunch he was tired so I put him down for a nap. Heard a strange noise on the monitor so I go to check on him and he's throwin up everywhere. So I quickly clean him up. Put him in the tub and what do ya kno more hives all over. So what is he now allergic to peanut butter to. So I called the dr. So now I have to stop all nut products and switch to lactaid and since yesterday his skin has broke out all dry, patchy and rash like and I can't put anything on it because we are seeing an allergist tomorrow. So all because of these damn shots he has had on the 19th my poor 1 year old is no longer playful, barley eats a thing and crys 24 7. This was all the week of the 19th. We saw the allergist and she put him on Zyrtec and he now still has this dry patchyness on his rear but that's it.
Age: 1.5
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Rash, Rhinorrhoea, Urticaria, Viral infection, Vomiting
Clinical narrative: My son went in for his well visit on 12/19 and got his last hib shot and his chicken pox shot and by the time we got home he had spiked a 103.8 fever which I knew was from the shots so I just gave him some Motrin and kept and eye on him. Well by the next morning, 12/20 the fever was still up there but he had developed this hive and just wasn't himself. So I called the doctor. We brought him in they are telling me it's from a virus he got because his throat is a little red and his nose his runny.( which I knew it wasn't a virus because he didn't have it before the shots) she said to give him some benedryl for the hives every 6 hrs when they come and Motrin every 6 hrs for the temp because he's throws up to Tylonal so we can't alternate. So the next day comes (12/21) and I realize that after giving him milk he broke out in a hive so I'm questioning weather or not he is allergic to milk all of a sudden. So I called the dr. They told me to switch to almond milk so I did. And to stop all milk products and schedule an allergist asap and see what's going on. So then we went on the day and he had lunch and I gave him a peanut butter sandwich with some almond milk . After lunch he was tired so I put him down for a nap. Heard a strange noise on the monitor so I go to check on him and he's throwin up everywhere. So I quickly clean him up. Put him in the tub and what do ya kno more hives all over. So what is he now allergic to peanut butter to. So I called the dr. So now I have to stop all nut products and switch to lactaid and since yesterday his skin has broke out all dry, patchy and rash like and I can't put anything on it because we are seeing an allergist tomorrow. So all because of these damn shots he has had on the 19th my poor 1 year old is no longer playful, barley eats a thing and crys 24 7. This was all the week of the 19th. We saw the allergist and she put him on Zyrtec and he now still has this dry patchyness on his rear but that's it.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Peripheral swelling, Throat tightness
Clinical narrative: Patients arm was swollen with a huge rash around the injection site. She also noted her throat felt like it was closing but not as bad as her usual allergic reactions.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Feeling abnormal, Hypoaesthesia, Injection site haemorrhage
Clinical narrative: Arm sore and trouble moving, later redness, feverish, and very painful even to the touch, felt sick.  The sickness last one full day.  Redness, feverish, painful lasted about 3 days, 15th - 18th, after that started improving, very itchy and still painful to the touch.  About 11 days after vaccination, the limited movement changed and I started get severe pain when I moved my arm from the shoulder down through my arm into my hand. This was a pain that felt like a rubber band was snapping apart.  In a few days the pain changed again.  I could move my shoulder fairly well, but the pain in my forearm hurt when I moved it with a burning, painful sensation.  Sometimes it feel like something squiggly inside my forearm.  I have developed a numbness in my forearm, but still get the burning, painful, and squiggly feelings when I move certain ways.  I have not gone to the Doctor as I am hoping this will pass.  Just a note, there was a blood pool under the skin a little bigger than a quarter from one of the injections.  If it doesn't improve I will going to a doctor.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Mobility decreased, Pain, Pain in extremity, Pruritus
Clinical narrative: Arm sore and trouble moving, later redness, feverish, and very painful even to the touch, felt sick.  The sickness last one full day.  Redness, feverish, painful lasted about 3 days, 15th - 18th, after that started improving, very itchy and still painful to the touch.  About 11 days after vaccination, the limited movement changed and I started get severe pain when I moved my arm from the shoulder down through my arm into my hand. This was a pain that felt like a rubber band was snapping apart.  In a few days the pain changed again.  I could move my shoulder fairly well, but the pain in my forearm hurt when I moved it with a burning, painful sensation.  Sometimes it feel like something squiggly inside my forearm.  I have developed a numbness in my forearm, but still get the burning, painful, and squiggly feelings when I move certain ways.  I have not gone to the Doctor as I am hoping this will pass.  Just a note, there was a blood pool under the skin a little bigger than a quarter from one of the injections.  If it doesn't improve I will going to a doctor.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Arm sore and trouble moving, later redness, feverish, and very painful even to the touch, felt sick.  The sickness last one full day.  Redness, feverish, painful lasted about 3 days, 15th - 18th, after that started improving, very itchy and still painful to the touch.  About 11 days after vaccination, the limited movement changed and I started get severe pain when I moved my arm from the shoulder down through my arm into my hand. This was a pain that felt like a rubber band was snapping apart.  In a few days the pain changed again.  I could move my shoulder fairly well, but the pain in my forearm hurt when I moved it with a burning, painful sensation.  Sometimes it feel like something squiggly inside my forearm.  I have developed a numbness in my forearm, but still get the burning, painful, and squiggly feelings when I move certain ways.  I have not gone to the Doctor as I am hoping this will pass.  Just a note, there was a blood pool under the skin a little bigger than a quarter from one of the injections.  If it doesn't improve I will going to a doctor.
Age: 28.0
Sex: M
Vaccine: FLU4, HEP, PPV, TDAP
Symptoms: Dizziness, Headache, Influenza like illness, Malaise, Nausea
Clinical narrative: Patient went to bed on 1/14/17 at around 11pm after receiving his vaccines around 1:30pm that afternoon. He noted that he did not feel too well at that point, with explaining he had mild flu-like symptoms. Around 4:30am, he woke from his sleep feeling dizzy, faint, nausea, headache, pain around the temples, and vomiting. He went to the emergency room where they administed IV saline solution and zofran. The patient was then released home shortly thereafter, and today (1/15/17 at 4pm) is feeling much better, but still having pain around the temples.
Age: 28.0
Sex: M
Vaccine: FLU4, HEP, PPV, TDAP
Symptoms: Vomiting
Clinical narrative: Patient went to bed on 1/14/17 at around 11pm after receiving his vaccines around 1:30pm that afternoon. He noted that he did not feel too well at that point, with explaining he had mild flu-like symptoms. Around 4:30am, he woke from his sleep feeling dizzy, faint, nausea, headache, pain around the temples, and vomiting. He went to the emergency room where they administed IV saline solution and zofran. The patient was then released home shortly thereafter, and today (1/15/17 at 4pm) is feeling much better, but still having pain around the temples.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At site of injection patient's arm became swollen, red, hot and tender. Patient came and reported to pharmacy 1/16/2017.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site pain, Pruritus, Skin irritation
Clinical narrative: Pain at site of shot, irritation, itching, swelling, redness, headache.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pain at site of shot, irritation, itching, swelling, redness, headache.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Abnormal behaviour, Acute stress disorder, Eye swelling, Fatigue, Hypersensitivity
Clinical narrative: Thought to be allergic reaction to something. Extreme runny nose, swollen eyes, extreme fatigue. Gave Benedryl and child went to bed (at 5:30 pm). Major restlessness, sleeplessness, verbal tics and outbursts and negative behavior ensued for the next 10 days. Extreme sensitivity to stress and stimulation continues.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Insomnia, Restlessness, Rhinorrhoea, Tic
Clinical narrative: Thought to be allergic reaction to something. Extreme runny nose, swollen eyes, extreme fatigue. Gave Benedryl and child went to bed (at 5:30 pm). Major restlessness, sleeplessness, verbal tics and outbursts and negative behavior ensued for the next 10 days. Extreme sensitivity to stress and stimulation continues.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Adult living facility, doctor, pharmacist unaware patient previously vaccinated 11/24/2014. Called doctor who ordered the vaccination.
Age: 14.0
Sex: U
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Hunger, Pallor, Pulse abnormal
Clinical narrative: 12 1245 `/15/17 pt complained of hunger; dizziness. Per pt spent the night at friends house; had not eaten/ Since, pt displayed muscle convulsions, pale skin, weak pulse; clammy skin, local fire department responded and pt was taken care of.
Age: 14.0
Sex: U
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: 12 1245 `/15/17 pt complained of hunger; dizziness. Per pt spent the night at friends house; had not eaten/ Since, pt displayed muscle convulsions, pale skin, weak pulse; clammy skin, local fire department responded and pt was taken care of.
Age: 74.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Burning sensation, Immediate post-injection reaction, Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Shoulder pain, limited ROM, tenderness, burning, burning from shoulder to wrist immediately post injection, constant ache, stiffness, Physical Therapy.
Age: 74.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, Tenderness
Clinical narrative: Shoulder pain, limited ROM, tenderness, burning, burning from shoulder to wrist immediately post injection, constant ache, stiffness, Physical Therapy.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Fatigue, Impaired work ability, Injection site reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 59-year-old male patient who received BOOSTRIX (batch number ED2EN, expiry date 3rd December 2017). Concomitant products included Levothyroxine, loratadine, NORCO and HYTRIN. On 27th May 2016, the patient received BOOSTRIX. In May 2016, several days after receiving BOOSTRIX, the patient experienced fever (serious criteria hospitalization), fatigue (serious criteria hospitalization), weakness (serious criteria hospitalization) and joint pain (serious criteria hospitalization). On 27th May 2016, the patient experienced injection site reaction (serious criteria hospitalization). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the fatigue, weakness and joint pain were not recovered/not resolved and the outcome of the injection site reaction was recovering/resolving. The reporter considered the fever, fatigue, injection site reaction, weakness and joint pain to be almost certainly related to BOOSTRIX. Additional details were provided as follows: The concomitant medications included vitamins. On 27th May 2016, less than a day after receiving BOOSTRIX, the patient experienced injection site reactions which were not specified. The patient did not receive other vaccines on the day of vaccination. In May 2016, less than a week after receiving BOOSTRIX, the patient experienced joint pain, arthralgia, weakness, and fatigue. The patient was admitted to the hospital from 8th August 2016 to 10th August 2016. All laboratory tests were normal and negative. The patient had an infectious disease and rheumatology consult which were found to be unremarkable. At the time of reporting, the patient was no longer to work. The physician reported this case to Center of Disease Control (CDC) and VAERS. The physician was seeking a medical guidance on how to proceed or if there was any data related to this events. The physician transferred information to medical information after the adverse event report.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Laboratory test normal, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 59-year-old male patient who received BOOSTRIX (batch number ED2EN, expiry date 3rd December 2017). Concomitant products included Levothyroxine, loratadine, NORCO and HYTRIN. On 27th May 2016, the patient received BOOSTRIX. In May 2016, several days after receiving BOOSTRIX, the patient experienced fever (serious criteria hospitalization), fatigue (serious criteria hospitalization), weakness (serious criteria hospitalization) and joint pain (serious criteria hospitalization). On 27th May 2016, the patient experienced injection site reaction (serious criteria hospitalization). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the fatigue, weakness and joint pain were not recovered/not resolved and the outcome of the injection site reaction was recovering/resolving. The reporter considered the fever, fatigue, injection site reaction, weakness and joint pain to be almost certainly related to BOOSTRIX. Additional details were provided as follows: The concomitant medications included vitamins. On 27th May 2016, less than a day after receiving BOOSTRIX, the patient experienced injection site reactions which were not specified. The patient did not receive other vaccines on the day of vaccination. In May 2016, less than a week after receiving BOOSTRIX, the patient experienced joint pain, arthralgia, weakness, and fatigue. The patient was admitted to the hospital from 8th August 2016 to 10th August 2016. All laboratory tests were normal and negative. The patient had an infectious disease and rheumatology consult which were found to be unremarkable. At the time of reporting, the patient was no longer to work. The physician reported this case to Center of Disease Control (CDC) and VAERS. The physician was seeking a medical guidance on how to proceed or if there was any data related to this events. The physician transferred information to medical information after the adverse event report.
Age: 72.0
Sex: M
Vaccine: FLUX, TDAP, TDAP
Symptoms: Injection site pain, Muscle spasms, Muscle twitching
Clinical narrative: Initial unsolicited report received from a Physician (consumer) on 09 January 2017. This case involves a 72-year-old male patient who was vaccinated with a dose ADACEL (batch number: U5468AA, expiration date: 30 September 2018) intramuscularly in the left shoulder area and a dose INFLUENZA VACCINE (Flu) (manufacturer: SEQUIRUS, batch number and expiration date not reported) intramuscularly in the right arm (dose was not reported for both vaccines) on 29 October 2016. Patient's medical history and concomitant medications were not reported. On 29 October 2016, same day following the vaccination, the patient developed left shoulder pain, muscle spasms and twitching. Lab data was not reported. Patient was recommended massage therapy as corrective treatment. Outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 72.0
Sex: M
Vaccine: FLUX, TDAP, TDAP
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Initial unsolicited report received from a Physician (consumer) on 09 January 2017. This case involves a 72-year-old male patient who was vaccinated with a dose ADACEL (batch number: U5468AA, expiration date: 30 September 2018) intramuscularly in the left shoulder area and a dose INFLUENZA VACCINE (Flu) (manufacturer: SEQUIRUS, batch number and expiration date not reported) intramuscularly in the right arm (dose was not reported for both vaccines) on 29 October 2016. Patient's medical history and concomitant medications were not reported. On 29 October 2016, same day following the vaccination, the patient developed left shoulder pain, muscle spasms and twitching. Lab data was not reported. Patient was recommended massage therapy as corrective treatment. Outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: RUDENESS, SWELLING, pain at injection site. Now is about 6 inches by 6 inches in rudeness and swelling. Hot to touch. Itchy. Using ice topically to reduce the itch.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On 12-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (subcutaneous, lot # L032402, expiration date 26-NOV-2016, 0.65 ml) for prophylaxis. No symptoms reported.     Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot # M035147, expiration date 25-OCT-2017, dose and route of administration were not reported) reconstituted with expired sterile diluent (lot # L002440, expiration date 15-JAN-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an unspecified health care professional, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients were vaccinated with an improperly stored doses of PROQUAD lot # M032496 and expiration date 02-JAN-2018 (dose, administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The vaccine had one temperature excursion of 7.1 Fahrenheit (F) for 1 hour and a previous excursion of 6.4 (F) for 3 hours; with a data logger involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted. Sender's Comments: US-009507513-1701USA001223: US-009507513-1701USA001224.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly VAQTA lot # M030598, expiration date: 13-OCT-2017, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 46.5 Fahrenheit degrees for 20 minutes. A previous excursion of 46.5 Fahrenheit degrees for 20 minutes was reported. Data logger was involved. It was reported a total time out of range of 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA001262: US-009507513-1701USA001263: US-009507513-1701USA001264: US-009507513-1701USA001265: US-009507513-1701USA001266: US-009507513-1701USA001267:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.   On 23-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L034724, expiration date 09-DEC-2016) (strength and dose were not reported) subcutaneously for prophylaxis. No side effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014176:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 07-DEC-2016, the patient received a dose of unexpired ZOSTAVAX (dose, lot # and expiration date were not reported) that was prepared with expired sterile diluent  (manufacturer unknown) (lot# L001646, expiration date 20-DEC-2015) subcutaneously for prophylaxis. No known adverse effects. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014392: US-009507513-1612USA014391: US-009507513-1612USA014393.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 06-DEC-2016, the patient received a dose of unexpired ZOSTAVAX (dose, lot # and expiration date were not reported) that was prepared with expired sterile diluent  (manufacturer unknown) (lot# L001646, expiration date 20-DEC-2015) subcutaneously for prophylaxis. No known adverse effects. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014392: US-009507513-1612USA014393: US-009507513-1612USA014321.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 16-DEC-2016, the patient received a dose of unexpired ZOSTAVAX (dose, lot # and expiration date were not reported) that was prepared with expired sterile diluent  (manufacturer unknown) (lot# L001646, expiration date 20-DEC-2015) subcutaneously for prophylaxis. No known adverse effects. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014393: US-009507513-1612USA014391: US-009507513-1612USA014321.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 22-DEC-2016, the patient received a dose of unexpired ZOSTAVAX (dose, lot # and expiration date were not reported) that was prepared with expired sterile diluent (manufacturer unknown) (lot# L001646, expiration date 20-DEC-2015) subcutaneously for prophylaxis. No known adverse effects. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014392: US-009507513-1612USA014321: US-009507513-1612USA014391.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an unspecified health care professional, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the multiple unspecified patients were vaccinated with an improperly stored doses of ZOSTAVAX lot # M032638 and expiration date 04-OCT-2017 (dose, administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The vaccine had one temperature excursion of 7.1 Fahrenheit (F) for 1 hour and a previous excursion of 6.4 (F) for 3 hours; with a data logger involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted.; Sender's Comments: US-009507513-1701USA001224: US-009507513-1612USA010151:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L027733, expiration date: 13-SEP-2017 and lot M000442, expiration date: 31-MAR-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 46.5 Fahrenheit degrees for 20 minutes. A previous excursion of 46.5 Fahrenheit degrees for 20 minutes was reported. Data logger was involved. It was reported a total time out of range of 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA001263: US-009507513-1701USA001264: US-009507513-1701USA001265: US-009507513-1701USA001266: US-009507513-1701USA001267: US-009507513-1612USA012399:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (rHA) lot # M008589 , expiration date: 16-FEB-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 46.5 Fahrenheit degrees for 20 minutes. A previous excursion of 46.5 Fahrenheit degrees for 20 minutes was reported. Data logger was involved. It was reported a total time out of range of 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA012399: US-009507513-1701USA001262: US-0095713-1701USA001263: US-009507513-1701USA001264: US-009507513-1701USA001267: US-009507513-1701USA001266:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M014318, expiration date: 30-SEP-2017 and lot # M006112, expiration date: 16-NOV-2017, orally, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion of 46.5 Fahrenheit degrees for 20 minutes. A previous excursion of 46.5 Fahrenheit degrees for 20 minutes was reported. Data logger was involved. It was reported a total time out of range of 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA012399: US-009507513-1701USA001262: US-009507513-1701USA001263: US-009507513-1701USA001264: US-009507513-1701USA001265: US-009507513-1701USA001267:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M006922, expiration date: 21-JUN-2017, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 46.5 Fahrenheit degrees for 20 minutes. A previous excursion of 46.5 Fahrenheit degrees for 20 minutes was reported. Data logger was involved. It was reported a total time out of range of 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA012399: US-009507513-1701USA001262: US-009507513-1701USA001263: US-009507513-1701USA001264: US-009507513-1701USA001265: US-009507513-1701USA001266.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M031802 exp date 09-NOV-2017) (dose not reported) orally. The detail of the storage was a temperature excursion to 35 F for 24 hours. No adverse effects were reported.       This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA006147: US-009507513-1701USA006148:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unknown number of patients of unknown gender and age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. In September 2016, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L016428, expiration date: 30-JUL-2017) intramuscularly for prophylaxis. No adverse effects noted. No product quality complaint was involved. The medical assistant reported that the vaccine reached 9 C degrees for 8 hours. There were no prior excursions. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004349.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Occupational exposure to product, Product quality issue
Clinical narrative: This spontaneous report was received from a nurse referring to a physician, a male patient of unknown age. The physician's medical history, concurrent conditions or concomitant medications were not reported. In December 2016, reported as within the last week, while 3 babies (2 age 4 months and one aged 2 months with not specified genders) were vaccinated with a dose of ROTATEQ (orally, Lot # M022373, expiration date: 20-FEB-2018; dose not reported) for prophylaxis; and after they experienced an adverse event (projectile vomiting), the reporter filed a product quality complaint  because the ROTATEQ in all three cases seemed more viscous. To be sure that the ROTATEQ was not a bad batch, the physician put a few drops of the ROTATEQ on his fingers and then tasted the vaccine occupational exposure to product). He reported that this vaccine was fine and he did not experience an adverse effect. This is one of the 4 cases reported by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010135: US-009507513-1612USA010136: US-00950713-1612USA010099:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates since 01-AUG-2016, the unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX lot # L033343 with expiration date 13-SEP-2017 for prophylaxis (dose and route were not reported). It was stated that the temperature excursion was between 32 and 36 Fahrenheit degrees for 4 days. No previous temperature excursion was reported. No adverse effect had been reported. A product quality complaint (PQC) was not involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA004138: US-009507513-1701USA001682:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unknown number of patients of unknown gender and age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. In September 2016, the patients were vaccinated with improperly stored ROTATEQ (lot # L008997, expiration date: 04-DEC-2016) orally for prophylaxis. No adverse effects noted. No product quality complaint was involved. The medical assistant reported that the vaccine reached 9 C degrees for 8 hours. There were no prior excursions. This is one of the two reports received from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1701USA003143:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 Lot # M038216, expiration date: 09-MAY-2018  and Lot # M042599 17-JUN-2018 (strength, dose, route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was between >8C - 25C, for a time frame of 5 hours, 30 minutes. There were no previous temperature excursions. The call was  because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004701: US-009507513-1701USA004702: US-009507513-1701USA004703: US-009507513-1701USA004704.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M016193, expiration date: 24-APR-2018 (strength, dose, route were not reported) for prophylaxis (incorrect product storage).Adverse effects were reported. The temperature was between >8C - 25C, for a time frame of 5 hours, 30 minutes. There were no previous temperature excursions. The call was  because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004386: US-009507513-1701USA004702: US-009507513-1701USA004703: US-009507513-1701USA004704.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL lot # K006191, expiration date: 02-FEB-2017 (strength, dose, route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was between >8C - 25C, for a time frame of 5 hours, 30 minutes. There were no previous temperature excursions. The call was  because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004386: US-009507513-1701USA004701: US-009507513-1701USA004703: US-009507513-1701USA004704.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. the patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L027076, expiration date: 25-MAY-2017 (strength and dose were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was between >8C - <25C, for a time frame of 5 hours, 30 minutes.  There were no previous temperature excursions. The call was  because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004386: US-009507513-1701USA004701: US-009507513-1701USA004702: US-009507513-1701USA004704.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. the patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was between >-9C - <8C,  for a time frame of 2 hours, 45 minutes.  There were no previous temperature excursions. The call was because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004386: US-009507513-1701USA004701: US-009507513-1701USA004702: US-009507513-1701USA004703.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a 78 year old female patient referring to herself who was pre-diabetes and had many unspecified reactions/allergies. In December 2016 the patient was vaccinated with ZOSTAVAX (one dose, subcutaneous, lot# not reported) as prevent shingles. Concomitant therapies included CYMBALTA, SYNTHROID and ATIVAN. It was reported that the patient developed shingles across her back, a week after receiving the ZOSTAVAX vaccine (in 2016 or 2017). There was unspecified treatment given for the event. Thyroid check was performed. The patient was talking with the physician to seek medical attention. The outcome of the event was recovering. The causality was not reported. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified multiple patients of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified dates, the patients were vaccinated with a dose of improperly stored PROQUAD lot # M004895, expiration date of 26-JUL-2017 (strength, dose number, and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 63 hours: >5 degrees Fahrenheit but < 14 degrees Fahrenheit; the highest temperature was 6 degrees Fahrenheit. Reportedly, there had been no previous temperature excursions. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested Sender's Comments: US-009507513-1701USA005959.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of M-M-R II (strength, dose number, route, frequency, lot number and expiration date were not provided)  for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005965: US-009507513-1701USA005966: US-009507513-1701USA005968: US-009507513-1701USA005969: US-009507513-1701USA005964: US-009507513-1701USA005967: