chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pruritus, Scratch, Urticaria
Clinical narrative: I am not sure if it was the MMR II, I just know that is was the MMR vaccine. What happened was, I took my 4 year old daughter in for her four year check-up and she received four vaccines. During the vaccines the nurse crossed my daughter's arms and asked me to hold them and her still to prevent her from moving while the shots were being given. During one of her shots she jerked her leg and the needle ended up scratching her leg pretty bad and managed to poke me in the back of my right arm. (The vaccine had already been injected into her leg, I just got poked with the needle after.) At the time it kind of hurt but then started stinging pretty bad for about 5 minutes. The nurse checked my arm and it was just a tiny red dot. At the time I wasn't worried about it, and it was a total accident, and once the stinging went away I even forgot about it for a while. At home that night I was fine, but the following day my arm was a bit sore. I figured it was just from getting poked, still no big deal, and went on with my day. Sunday night (the accident happened Friday) I felt an itch on my arm, forgetting about the poke I naturally went to scratch it and that's when I felt the huge lump. It looked like a huge welt with redness in the middle and was still sore and itched. Monday morning I woke up and the lump was bigger and wider and more red. Still sore and itchy. The whole weekend I didn't feel normal and I was extra tired. I called my daughter's pediatrician to find out which vaccine I was accidently poked with and it was the MMR. I was told to go see my doctor to have him take a look and to put a cool rag on it and to take BENADRYL. My stepmom was a medical assistant and told me to report it just in case and provided this link. It was an absolute accident, just wanted to report my reaction to it.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: LOW GRADE FEVER AND SITE WARMTH AND REDNESS.
Age: 15.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: Within 15 mins itching on upper body/neck area. Within 5 hrs large welts/hives on upper body. Within 24 hrs hives/welts covered entire body (head to bottom of feet).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pallor, Vomiting
Clinical narrative: Pt left clinic without incident, Registrar received call from mother stated as patient was in auto, vomited and became pale denies rash, angioedema, respiratory difficulty, pt. coherent and responsive mother returned to lobby of building within 10 minutes evaluated by myself and RN pt responsive, oriented,  active, normal respiratory rate, pulse 88.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Malaise, Muscle spasms
Clinical narrative: At 4:30pm on day of vaccine (Saturday 3/3), patient began to feel mild flu like symptoms. By later in the same evening she has having shaking chills. Next day (sunday) she was feeling somewhat better symptoms "ebbing and flowing". By Monday she was having severe spasms in her back and significant aches in her knees and hips. Today (Tuesday) she still not feeling well. She called her doctor who asked her to report to us the pharmacy and have us report to you. MD is following up with temp checks and according to pt, her doctor does not feel this is the flu.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: At 4:30pm on day of vaccine (Saturday 3/3), patient began to feel mild flu like symptoms. By later in the same evening she has having shaking chills. Next day (sunday) she was feeling somewhat better symptoms "ebbing and flowing". By Monday she was having severe spasms in her back and significant aches in her knees and hips. Today (Tuesday) she still not feeling well. She called her doctor who asked her to report to us the pharmacy and have us report to you. MD is following up with temp checks and according to pt, her doctor does not feel this is the flu.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 55-year-old female patient who received Influenza vaccine. Previously administered products included Influenza vaccine with an associated reaction of influenza (please refer case US2018GSK037537 for a case of a dose which was administered 5 years ago.). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional details were provided as follows: The patient reported that, after taking the flu vaccine this year, she experienced the flu at the time of reporting. The patient did not report any hospitalization. At the time of this report, the patient had recovered from flu episode. The patient clarified, of all the times she had taken the vaccine, she twice got the flu anyway. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown. This case has been linked with US2018GSK037537, reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 80-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, several days after receiving SHINGRIX, the patient experienced injection site itching, injection site swelling, injection site erythema and injection site inflammation. On an unknown date, the outcome of the injection site itching, injection site swelling, injection site erythema and injection site inflammation were not recovered/not resolved. The reporter considered the injection site itching, injection site swelling, injection site erythema and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The health care professional reported that the patient experienced itching, inflammation, redness, and swelling locally at injection site a few days after receiving the SHINGRIX vaccine. The patient's symptoms had not resolved on the reporting date, but they were not getting worse.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a adult female patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. About 5 years ago from the date of reporting, the patient took the flu vaccine and experienced the flu. The patient did not report any hospitalization. At the time of this report, the patient had recovered from flu episode. The patient clarified, of all the times she had taken the vaccine, she twice got the flu anyway. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown. This case has been linked with case US2018GSK035098, (case of next dose, for the same patient).
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Cough
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cough aggravated in a 73-year-old male patient who received SHINGRIX. Concurrent medical conditions included cough. On 26th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced cough aggravated. On an unknown date, the outcome of the cough aggravated was not recovered/not resolved. It was unknown if the reporter considered the cough aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm. The patient had pre-existing cough that worsened after receiving SHINGRIX. The patient has denied permission to contact their physician.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Crying, Injection site pain, Mobility decreased
Clinical narrative: Child reports site very painful, unable to move next morning, trying to make her bed. So painful was crying to her mother about the pain.
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Limb discomfort, Paraesthesia, Restlessness
Clinical narrative: Tingling, restlessness, heaviness of lower legs after 2nd rabies vaccine dose. Symptoms have not improved. (Patient will finish the rabies series and receive 4th dose tomorrow). Note - patient has received rabies immunoglobulin.
Sex: U
Vaccine: HPV9, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a vaccine coordinator referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions, and allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored GARDASIL 9 (lot number: M041940 and expiration date: 28-JUN-2019) (dosage schedule and route of administration were not reported). Other suspect therapies included improperly stored ROTATEQ (lot number: L039141 and expiration date: 16-AUG-2017) and M-M-R II (lot number: M036544 and expiration date: 15-AUG-2018) which was reconstituted with properly stored sterile diluent (manufacturer unknown). All suspect therapies were administered for prophylaxis. The vaccines were exposed to a temperature between 32 to 35 Fahrenheit (34.7 Fahrenheit) for 3 days and 7 hours. Additionally, the vaccines were exposed to previous temperature excursion of 47 to 77 Fahrenheit (74.7 Fahrenheit) for 2 days and 22 hours. The reporter stated that the call was because of a data logger. No adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: General physical health deterioration
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as nurse) via field representative refers to children of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patients were vaccinated with GARDASIL 9 for prevention of HPV. The reporter mentioned that 2 friends with children who received GARDASIL 9 (lot # and expiry date were not reported) went downhill and one had to go to Clinic. The outcome of general physical health deterioration was unknown. Causality assessment was not provided by reporter. No other AE information reported. No PQC involved.
Sex: M
Vaccine: VARZOS
Symptoms: Furuncle, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. In approximately November 2017 (reported as "about four months ago"), the patient was vaccinated with ZOSTAVAX, subcutaneously, for shingles prevention (dose, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient experienced a "boil" at the injection site (Injection site abscess). The pharmacist reported that it was about the size of a pencil eraser, was not painful and was not a rash. It was unknown by the reporter if the patient received treatment for the event or if lab diagnostics or studies were performed. The patient was not recovered from the event by the time of the reporting. The reporter did not assess the causal relationship between vaccination with ZOSTAVAX and the event.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable unspecified healthcare professional via a Pfizer sales representative. A 65-year-old female patient of an unspecified ethnicity received PREVENAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history was and concomitant medications were not reported. It was reported that on an unspecified date, 1 day after the immunization, the patient was back at the office and complained of a large red area near the injection site. It was reported that the patient was given steroid (unspecified) and symptoms all resolved by the following day (unspecified date). The outcome of the event was recovered on an unspecified date. No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itchiness (not sure if it was at injection site or in throat) and severe allergies on an unspecified date with outcome of unknown. The information on the batch number has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Balance disorder, Chills, Decreased appetite, Hyperhidrosis
Clinical narrative: Beginning in afternoon on day of injection: whole body pain, weakness, minor balance problems, nausea, very thirsty, left arm pain (barely able to lift arm, rash around injection site (down to almost elbow and inside arm), minor chills, sweating, loss of appetite. Due to weakness, stayed in bed most of the day following injection. Gradually better over next few days. Mild irritability over (10 ?-day period).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site rash, Irritability, Nausea, Pain
Clinical narrative: Beginning in afternoon on day of injection: whole body pain, weakness, minor balance problems, nausea, very thirsty, left arm pain (barely able to lift arm, rash around injection site (down to almost elbow and inside arm), minor chills, sweating, loss of appetite. Due to weakness, stayed in bed most of the day following injection. Gradually better over next few days. Mild irritability over (10 ?-day period).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Thirst
Clinical narrative: Beginning in afternoon on day of injection: whole body pain, weakness, minor balance problems, nausea, very thirsty, left arm pain (barely able to lift arm, rash around injection site (down to almost elbow and inside arm), minor chills, sweating, loss of appetite. Due to weakness, stayed in bed most of the day following injection. Gradually better over next few days. Mild irritability over (10 ?-day period).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX. In February 2018, the patient received SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient received SHINGRIX about a week ago and still had swelling and a 3 inch red patch around the injection site. The reporter did not wish to provide additional information.
Sex: U
Vaccine: RV1
Symptoms: Accidental underdose, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a infant patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a day after receiving ROTARIX, the patient experienced vomiting and accidental underdose. On an unknown date, the outcome of the vomiting and accidental underdose were unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details were reported as follows: The age at vaccination was not reported. After receiving ROTARIX vaccine, the patient vomited the vaccine, which led to accidental underdose. The healthcare professional did not have patient or product infection. The reporter had very limited information. The healthcare professional was informed that someone might reach out for additional information.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Nausea, Presyncope, Tinnitus
Clinical narrative: Mother called and stated child almost passed out about 10 min after inj. Also c/o ringing in ears, nausea and stomach ache - As I was talking to her his symptoms were resolving. Provider on that day also spoke to mom.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Approximately 20 hours of chills, fatigue, headache, and muscle aches. No temperature was taken.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: Approximately 20 hours of chills, fatigue, headache, and muscle aches. No temperature was taken.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: This is my second entry for a single adverse effect to SHINGRIX, edited only to add the physician's name and relevant phone numbers. I have had a very minor problem with pain in my nose for the past two months. The pain is exclusively on the right side of my nose, but its location has moved over time from the upper side of my nose to the bridge/top of my nose and then, most recently, to the side of my right nostril. One health-care provider suggested that the pain might be caused by shingles, even though there is NO rash. If I do indeed have pain caused by shingles, my pain may be minor because I received the shingles vaccine (Zostavax?) about four years ago.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: This is my second entry for a single adverse effect to SHINGRIX, edited only to add the physician's name and relevant phone numbers. I have had a very minor problem with pain in my nose for the past two months. The pain is exclusively on the right side of my nose, but its location has moved over time from the upper side of my nose to the bridge/top of my nose and then, most recently, to the side of my right nostril. One health-care provider suggested that the pain might be caused by shingles, even though there is NO rash. If I do indeed have pain caused by shingles, my pain may be minor because I received the shingles vaccine (Zostavax?) about four years ago.
Age: 1.33
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Postictal state, Pyrexia, Seizure like phenomena, Somnolence, Tremor
Clinical narrative: Description from ED: 16mo girl presenting for two seizure-like episodes today. She had generalized shaking with no focality noticed by the parents. The first episode lasted about three minutes and then she had another brief episode in the car on the way here. She was sleepy in between the episodes and did not return to baseline. Parents deny cyanosis or apnea. She continues to be sleepy at the time of the evaluation. Parents did notice some low-grade fever today following her immunizations (mom believes she received HepB and PREVNAR vaccines). However, she has not had cough, vomiting, diarrhea, or other symptoms of illness.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 13 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. The patient initially started on a 2 dose regimen for GARDASIL 9 then was shifted to a 3 dose regimen as schedule was off for 2 dose regimen. On 19-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiry date were not reported), on 21-SEP-2016 with the second dose and on 18-JAN-2018 with third dose. No adverse effects were reported.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 04-FEB-2018, the patient was potentially vaccinated with a properly stored but expired dose of (wistar ra 27-3) M-M-R II, expiration date 20-JAN-2018, subcutaneously, for prophylaxis (lot # was not reported). Concomitant therapies included STERILE DILUENT which was properly stored too. No adverse effects were reported.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Feeling abnormal, Headache, Respiratory tract congestion
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on behalf of her husband. A 73-year-old male patient of unknown race received PREVNAR 13 on 27Feb2018 10:30 via unspecified route in the left upper arm at single dose. Relevant medial history included Blood disorder, Blood cholesterol abnormal, allergic to shellfish, and nuts, the patient cannot take Calcium or Fish oil because he has had reactions to them. Concomitant medications included Hydroxyurea 500mg every other day he takes 2, and the opposite days he takes one for blood disorder, ongoing and Gemfibrozil 600mg takes one half of a tablet by mouth once a day, for blood cholesterol abnormal and ongoing. The patient had a regular pneumonia shot about 5 years ago and had no symptoms whatsoever. The patient did not know if he took 23 or 13. On 27Feb2018 the patient felt like he had full blown pneumonia, totally congested and very back headache. All events were recovering.  Information on the batch number has been requested.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from contactable healthcare professional received via Pfizer Sales Representative. A 16-year-old female patient received TRUMENBA on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not reported. In the night of vaccination the patient experienced pain, nausea, vomiting, headache, fever, lasted 2 days. The final outcome of the events was unknown. Information on the batch number has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Palpitations, Rash
Clinical narrative: This is a spontaneous report from a contactable healthcare professional (physician assistant), via a Pfizer sale representative. A 16-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on 22Feb2018 at 0.5 ml, single for MENACTRA, intramuscular on 22Feb2018 at unknown dose and frequency for serogroup B meningococcal disease prevention. Medical history included ongoing Sulfa allergy, ongoing CIPRO allergy and had ongoing oral birth control (Taking Riboflavin). Concomitant medications included ongoing EPIPEN from 2014, and ongoing riboflavin for birth control. On 22Feb2018, the patient experienced palpitations. The patient also had a rash on her face and neck on unspecified date. On 25Feb2018, 3 days after receiving the doses, the patient went to the emergency department. She was not admitted to the hospital. The patient was treated with BENADRYL and Hydroxyzine and recovered completely the same day. The patient thinks the cause of her palpitations and rash was the meningococcal group b rlp2086 because it was her first dose and she had previously had a dose of the meningococcal vaccine a/c/y/w conj (dip tox). The reporter did not indicate causality for either vaccine. The patient was seen at the doctor's office on 27Feb2018 by the reporter and an additional physician assistant at the office. It was now flagged on the patient's chart to not give her a second dose of meningococcal group b rlp2086. The outcome of the events was recovered on 25Feb2018.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rcd. vaccine 2/10/18 broke out in a rash 3 days later on 2/13/18.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: Patient received vaccine 2/22/18, complained about adverse fevers starting 2/25/18. Sunday, swelling, arm redness, itching, body ache, tingling sensation in arm. Swelling has gotten worse and is visiting MD today (3/1/18).
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Patient received vaccine 2/22/18, complained about adverse fevers starting 2/25/18. Sunday, swelling, arm redness, itching, body ache, tingling sensation in arm. Swelling has gotten worse and is visiting MD today (3/1/18).
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (R) arm, deltoid was red 12 x 13 cm, mild tender and warm, no D/C. Ice and clindamycin.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Irritability, Rash, Rash papular
Clinical narrative: 24 hours after receiving vax - Mom discovered papular rash on trunk and pt. was fussy. No fever. Seen Monday afternoon at Drs. office. Rash still present - no new symptoms.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Joint swelling, Lip swelling, Urticaria
Clinical narrative: Had MENACTRA vaccine Sat. morning. Woke up with hives on Sunday and swollen elbow, joints, lips. Went to urgent care, had a DECADRON shot. No hives on Monday. Woke up Tuesday the 2/27/18 with hives again and swollen lips.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Injection site pain, Pain
Clinical narrative: 33 yr. old female noting right arm pain from injection site, referred pain down the lateral side of her left arm and into her hand as well as numbness in part of her hand and fingers. Afebrile, VSS Ext: left arm shows puncture site from SQ injection over left deltoid. Arm strength appears symmetrical and 4/5 in both arms. Grip strength is also symmetrical and 4/5 in both hands. Left arm is able to be fully extended up over head and behind back. No obvious reaction at the injection site. Reviewed the anatomy with her to show her where the major nerves are located in the upper arm and how far away they are from her injection site. She seemed very reassured by this. Recommend taking some Ibuprofen 600 mg every 8.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Patient experiences body pain, swelling of arm, fever, and rash on arm of injection. The patient is taking ADVIL for fever and pain relief.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Patient came in 1 month later and said she is still experiencing pain in her left arm. She said that her arm feels weak and when she lifts her arm up (like to put on a shirt) she has a sharp pain in her arm. She said she also has pain when she lifts her arms in front of her. The pain has slowly decreased over time, but she is still experiencing pain. She said she typically gets her flu shot and has not experienced this before. Usually her arm does not hurt the next day unless she pushed on the area, but this one has been much more painful.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Immediate post-injection reaction, Injection site cellulitis, Pain in extremity
Clinical narrative: Pt reported she received Pneumococcal shot on 03/02/18. She had it in the left deltoid. Pt reported she felt pain right after the shot. Pt was told is a common adverse reaction. On Friday night states very painful in the left arm. She went to the doctor on Saturday and the provider looked at it and was red. Pt was instructed to come back if becomes worse. Reports over the weekend, she is getting worse. Pain and redness increased. States, "worse pain of her life' and extremely fatigued. She went into ED this morning and was diagnosed with Cellulitis of left upper arm. Pt was treated with KEFLEX 500mg. Pt is upset that she has cellulitis from the PNA shot.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Lethargy, Pyrexia, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Papular, round, red pruritic rash on body accompanied by fever and lethargy. Fever and lethargy resolved after 72 hours. Rash has been slowly resolving.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: 03/05/18 approximately 2 PM, SHINGRIX was reconstituted with Sterile Water (LOT M004656 expiration 8/13/18 from Merck) and administered to patient instead of the Adjuvant. GlaxoSmithKline was contacted and said they had no studies to provide with sterile diluent. I then contacted the CDC where they stated that the vaccine was ineffective and to re-vaccinate patient (sent e-mail as documentation). I then contacted patient to have her aware of the situation and she was understanding and had no reaction. 03/06/18 Dr. was contacted and made aware of the situation and said to re-vaccinate patient. Our District manager and Health Supervisor are also aware of what had happened.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUET. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK). No adverse effect was reported. No product quality complaint was involved.  This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about May 2011, the patient was vaccinated at physician office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, he developed severe and painful rashes on the right side of his face, which radiated upward onto his right ear and scalp. He presented to his primary care physician and was diagnosed with shingles. Thereafter, he presented to a neurologist and was diagnosed with post herpetic neuralgia in the right trigeminal distribution. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 01-MAR-2018 the patient was inadvertently vaccinated with expired dose of VARIVAX lot # M000998, expiry date: 07-JAN-2018) for prophylaxis. Other suspect therapies included sterile diluent. No adverse effects reported. No product quality complaint involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 02-FEB-2018 (also reported as 08-FEB-2018), the patient was vaccinated with improperly stored dose of ROTATEQ 1 DF (lot # M035456, expiry date: 01-MAY-2018) orally for prophylaxis. No adverse effects reported. The vaccine had undergone a temperature of 1.2 degree Celsius to 1.9 degree Celsius for a duration of 816 hours from 11-JAN-2018 to 14-FEB-2018. No previous temperature excursions reported. There was a digital data logger involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1803USA002218.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Immediate post-injection reaction, Loss of personal independence in daily activities, Mobility decreased, Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 70-year-old female patient received the 1st dose of PREVNAR 13 (lot number, expiration date NDC number unknown) via an unspecified route of administration at single dose at left deltoid on 16Feb2018 15:00 as booster to pneumonia vaccine for immunisation, administered at MD office (not military facility). The patient stated that it was her booster shot from her last pneumonia shot she had 5 years before. No additional vaccines administered on same date. Medical history included arthritis (She usually did not take anything for this. At most she will take one regular strength TYLENOL), she had a history of having bad pneumonia, that is why she got the shot. She had a sensitivity to NSAIDS. There were no concomitant medications. No relevant family medical history. No prior vaccinations (within 4 weeks). No adverse effect occurred following prior vaccinations. As soon as the patient was vaccinated on 16Feb2018, her arm ballooned up and it hurt for 3-4 days afterwards with outcome of unknown. The patient also experienced joint pain on 21Feb2018 reported as worsened (not recovered), muscle pain on 21Feb2018 reported as worsened (not recovered), muscle spasms/today (28Feb2018) her neck and shoulders are in total spasms/had getting horrible leg cramps in Feb2018 with outcome of unknown, she had a hard time getting out of bed due to the pain on 21Feb2018 with outcome of unknown. She was practically non-functional. Her normal activities were hard to do, some were impossible. She could not pick things up if they fall on the floor. This has been a full week since she felt this kind of pain. She started thinking what in the world. She never has had this before. Treatments that she tried that did not work. No testing/investigations. The patient was not hospitalized. She had an appointment with the nurse practitioner on 28Feb2018 as results of the events. A Product Complaint was filed. The information on the batch number has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 70-year-old female patient received the 1st dose of PREVNAR 13 (lot number, expiration date NDC number unknown) via an unspecified route of administration at single dose at left deltoid on 16Feb2018 15:00 as booster to pneumonia vaccine for immunisation, administered at MD office (not military facility). The patient stated that it was her booster shot from her last pneumonia shot she had 5 years before. No additional vaccines administered on same date. Medical history included arthritis (She usually did not take anything for this. At most she will take one regular strength TYLENOL), she had a history of having bad pneumonia, that is why she got the shot. She had a sensitivity to NSAIDS. There were no concomitant medications. No relevant family medical history. No prior vaccinations (within 4 weeks). No adverse effect occurred following prior vaccinations. As soon as the patient was vaccinated on 16Feb2018, her arm ballooned up and it hurt for 3-4 days afterwards with outcome of unknown. The patient also experienced joint pain on 21Feb2018 reported as worsened (not recovered), muscle pain on 21Feb2018 reported as worsened (not recovered), muscle spasms/today (28Feb2018) her neck and shoulders are in total spasms/had getting horrible leg cramps in Feb2018 with outcome of unknown, she had a hard time getting out of bed due to the pain on 21Feb2018 with outcome of unknown. She was practically non-functional. Her normal activities were hard to do, some were impossible. She could not pick things up if they fall on the floor. This has been a full week since she felt this kind of pain. She started thinking what in the world. She never has had this before. Treatments that she tried that did not work. No testing/investigations. The patient was not hospitalized. She had an appointment with the nurse practitioner on 28Feb2018 as results of the events. A Product Complaint was filed. The information on the batch number has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient presented with a red, swollen upper arm. The upper arm was warm to the touch and injection site looked good. Recommended ice and BENADRYL. Called patient later that day who reported it was subsided a bit in redness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Cough, Hyperhidrosis, Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Pt stated child had adverse reaction to vaccines the next day in the morning. Per mother child woke up with a swollen right hand and right side of his face was also puffy and hot to the touch. Per mother child develop a 102 fever and sweating badly and the area where child got KINRIX vaccine (right side) was red and painful. Cold compresses were applied on area per mother. On 2/23/2018 Mother took child to see PCP again due to congestion, a bad cough and wheezing. Pt hx of asthma. On 2/26/2018 Mother took child to PCP again due still symptomatic. Per mother, child no medicine was helping and at night pt was vomiting from coughing too much. Mother of child stated albuterol was not helping. PCP instructions cool compress QID. Observe and follow up 2 days, sooner if concerns. MOTRIN was prescribed q 8hrs x 3 days and then q 8 hrs prn for pain. PCP instructed to follow up in 2 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia, Respiratory tract congestion, Skin warm, Swelling face, Vaccination complication
Clinical narrative: Pt stated child had adverse reaction to vaccines the next day in the morning. Per mother child woke up with a swollen right hand and right side of his face was also puffy and hot to the touch. Per mother child develop a 102 fever and sweating badly and the area where child got KINRIX vaccine (right side) was red and painful. Cold compresses were applied on area per mother. On 2/23/2018 Mother took child to see PCP again due to congestion, a bad cough and wheezing. Pt hx of asthma. On 2/26/2018 Mother took child to PCP again due still symptomatic. Per mother, child no medicine was helping and at night pt was vomiting from coughing too much. Mother of child stated albuterol was not helping. PCP instructions cool compress QID. Observe and follow up 2 days, sooner if concerns. MOTRIN was prescribed q 8hrs x 3 days and then q 8 hrs prn for pain. PCP instructed to follow up in 2 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Vomiting, Wheezing
Clinical narrative: Pt stated child had adverse reaction to vaccines the next day in the morning. Per mother child woke up with a swollen right hand and right side of his face was also puffy and hot to the touch. Per mother child develop a 102 fever and sweating badly and the area where child got KINRIX vaccine (right side) was red and painful. Cold compresses were applied on area per mother. On 2/23/2018 Mother took child to see PCP again due to congestion, a bad cough and wheezing. Pt hx of asthma. On 2/26/2018 Mother took child to PCP again due still symptomatic. Per mother, child no medicine was helping and at night pt was vomiting from coughing too much. Mother of child stated albuterol was not helping. PCP instructions cool compress QID. Observe and follow up 2 days, sooner if concerns. MOTRIN was prescribed q 8hrs x 3 days and then q 8 hrs prn for pain. PCP instructed to follow up in 2 days.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Pt received vaccine, advised parent before at check-in and after vaccination that pt needs to wait in immunizations clinic wait area 20 minutes post-vaccination. Patient/parent did not wait, proceeded to leave wait area and walk to clinic pharmacy. Several minutes later in pharmacy wait area, patient experienced a syncope episode, rapid response team was called and responded.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site discomfort, Mobility decreased, Pain in extremity
Clinical narrative: I got the 2017 flu shot. My arm has been sore ever since. Its hard to lift anything or hold me weight up (doing planks, etc.). There feels like there's a "bunch" in my arm where the shot was given.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Pharyngeal oedema, Swelling face
Clinical narrative: Per patient- at 1200 about 45 minutes after receiving influenza vaccine she began to feel swelling in throat and face, palms became sweaty. She took oral BENADRYL and the symptoms went away about an hour later. That same day about 5-6pm she had another episode of the same symptoms and again took oral BENADRYL with relief of symptoms.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric dose given when adult dose should have been given. No adverse outcome.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Angioedema, Muscular weakness, Urticaria, Viral infection
Clinical narrative: Hives covering body. Angioedema (eyes, mild on hands and feet, briefly lips). Leg weakness for 48 hours.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm is still sore after 3 weeks. Patient states "it hurts to use her arm" and "the pain is comparable to a toothache". Arm is not swollen or red.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Itchy red blustery bumps appeared gradually over about 6 hours. They were on my arms, legs, neck and collar Rea and scalp. The next morning they were receded and no longer itching.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness over injection site where DTaP-IPV given. Patient was started on oral antibiotics for possible cellulitis.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient said that the initial injection was more painful than previous IM vaccines she has received. Pain at site of injection continued the rest of the day but improved slightly on the next day. Injection site swelled almost immediately. There is a 3 inch diameter hard area around injection site and a 1 inch diameter bruise. On 3/6/18 patient returned to show that she now has slight redness that expands to about a 6 inch diameter. Pain is still improving, but the area is slightly warm to the touch. Patient has full range of movement in arm and shoulder.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient said that the initial injection was more painful than previous IM vaccines she has received. Pain at site of injection continued the rest of the day but improved slightly on the next day. Injection site swelled almost immediately. There is a 3 inch diameter hard area around injection site and a 1 inch diameter bruise. On 3/6/18 patient returned to show that she now has slight redness that expands to about a 6 inch diameter. Pain is still improving, but the area is slightly warm to the touch. Patient has full range of movement in arm and shoulder.