chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to chemicals, Anaphylactic reaction, Condition aggravated, Lip swelling, Mouth swelling
Clinical narrative: Information has been received from the author in a published literature abstract. This case concerns a 73 year old female with hypertension, chronic hepatitis C and alpha gal allergy. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, the patient presented to the emergency department for near syncope after epinephrine administration for upper lip, mouth and tongue swelling, experienced 45 minutes after obtaining the zoster vaccine live (manufacturer unknown) (anaphylactic reaction). Per the authors, a review of the vaccination contents revealed use of porcine gelatin - a meat product felt to have induced an immunoglobulin E (IgE) response in the setting of alpha gal allergy. On an unspecified date, the patient was admitted to the hospital, managed with intravenous fluids, and discharged on the following morning. The outcome of anaphylactic reaction was unknown at the time of this report. As reported, this was an unusual case of alpha gal allergy with anaphylaxis induced by zoster vaccine live (manufacturer unknown) due to use of porcine gelatin. Upon internal review, the event anaphylactic reaction was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Presyncope, Swollen tongue
Clinical narrative: Information has been received from the author in a published literature abstract. This case concerns a 73 year old female with hypertension, chronic hepatitis C and alpha gal allergy. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, the patient presented to the emergency department for near syncope after epinephrine administration for upper lip, mouth and tongue swelling, experienced 45 minutes after obtaining the zoster vaccine live (manufacturer unknown) (anaphylactic reaction). Per the authors, a review of the vaccination contents revealed use of porcine gelatin - a meat product felt to have induced an immunoglobulin E (IgE) response in the setting of alpha gal allergy. On an unspecified date, the patient was admitted to the hospital, managed with intravenous fluids, and discharged on the following morning. The outcome of anaphylactic reaction was unknown at the time of this report. As reported, this was an unusual case of alpha gal allergy with anaphylaxis induced by zoster vaccine live (manufacturer unknown) due to use of porcine gelatin. Upon internal review, the event anaphylactic reaction was determined to be medically significant.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash erythematous, Rash generalised, Rash vesicular
Clinical narrative: Patient developed a varicella like rash at the injection site within 2 days of receiving the vaccine. Initial rash started to heal, then patient has developed little red dots on various places throughout her body on 4 separate occasions over the past 6 weeks.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain, Tenderness
Clinical narrative: Patient reports pain at injection site that isn't better after 2 weeks. Pain is not worse but not getting better, and sore to move and lie on that arm. Pain is dull and achy, but not sharp in nature. Spoke with patient again on 12/21/17 and patient reports pain is much improved and is experiencing only minimal tenderness/pain.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt called pharmacy morning of 12/21/17 to report adverse events to PNEUMOVAX 23 givien on 12/20/17. She stated that event began approximately 2 hours after vaccine was given. First S&S were pain, swelling, redness and hot to touch at injection site, followed soon after by dizziness and light nausea. Pt reports additional symptoms of tightness in neck, more severe nausea and swelling of entire left arm from elbow to shoulder with onset in late evening and early morning. No report of facial or neck swelling, no rash. Pt refused need to see doctor at the time. Advised pt to monitor, use NSAID or choice for pain and use diphenhydramine OTC for the next 48 hours. Also advised that pt should seek urgent / emergency medical care if S&S get worse or swelling begins to effect neck / mouth / throat area.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Pt called pharmacy morning of 12/21/17 to report adverse events to PNEUMOVAX 23 givien on 12/20/17. She stated that event began approximately 2 hours after vaccine was given. First S&S were pain, swelling, redness and hot to touch at injection site, followed soon after by dizziness and light nausea. Pt reports additional symptoms of tightness in neck, more severe nausea and swelling of entire left arm from elbow to shoulder with onset in late evening and early morning. No report of facial or neck swelling, no rash. Pt refused need to see doctor at the time. Advised pt to monitor, use NSAID or choice for pain and use diphenhydramine OTC for the next 48 hours. Also advised that pt should seek urgent / emergency medical care if S&S get worse or swelling begins to effect neck / mouth / throat area.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Middle insomnia, Pain in extremity
Clinical narrative: On the day of the shot my left arm was a little sore so I thought that's normal. After 3 to 4 days Pain persisted and right now I can't rotate my left arm, it aches, wakes me up at night and can only lift & turn my left arm to go back half way.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Swelling, itching, and redness. Tender to touch.
Age: 11.0
Sex: M
Vaccine: HEPA, IPV, MMRV
Symptoms: Fatigue, Malaise, Pharyngitis, Rash generalised
Clinical narrative: Pt presented to our office on 12/20 with a rash, fatigue/malaise, and pharyngitis. Rash was raised bumps all over body. Started 3 days after receiving the vaccine with no change as of 12/20. RTC in 2 days for recheck.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Injected limb mobility decreased, Injection site erythema, Injection site induration
Clinical narrative: Malaise, fevers and chills, loss of appetite x 2 days, very painful, hard, warm, swollen and redness from above the injection site almost to the elbow. Was unable to lift my arm for 3 days.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Malaise, fevers and chills, loss of appetite x 2 days, very painful, hard, warm, swollen and redness from above the injection site almost to the elbow. Was unable to lift my arm for 3 days.
Age: 1.17
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Swelling, hardness, redness, worsening in days after initial event.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy test, Inflammation, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: She claims she developed itching after a few hours after receiving the vaccination earlier that morning and it progressively got worse on her back and both arms. She did not seek medical treatment until 12/15/17 for a rash covering her whole body from Dr. At that appointment she had a red and inflamed rash with scars on her back from itching and marks on her arms from constantly itching. The doctors office gave her a kenalog injection and triamcinolone cream to use twice daily as needed. The doctor's office informed the pharmacy on 12/20/17 about the potential that she could have had a reaction to the PREVNAR 13 injection and that they were doing additional allergy tests to rule out other causes. On 12/21/17 the pharmacy felt they should report the incident in the event that it was indeed an allergic reaction to the vaccination.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Body temperature increased, Crying, Fear
Clinical narrative: Patient came in with parents for required school vaccinations and we also discussed the recommended vaccines. His parents approved all four vaccines, to which he expressed some reservations, but agreed to. I asked if he had eaten and they stated they were going to go eat afterwards, so I explained its best to have something to eat and fluids when receiving the vaccines and he had a bottle of water and crackers. I explained prior to giving the vaccinations that it would be best to relax his arms and not tense his muscles as it would be less sore afterwards and that it is important not to hold his breath or hyperventilate but to breathe normal as it could make him dizzy. He did fine although at one point he was hyperventilating slightly and I just reminded him and he slowed it down. I asked if he was doing alright a few minutes afterwards and he said yes, but he looked upset after a few more minutes and started to cry a little. I asked if he was feeling dizzy and he said no, that he just felt scared, and did not want to lie down. His parents informed me that he has anxiety disorder. Nurses assisted in the event of syncope, which did not happen.  His vitals were 116/83 BP, 65 HR, 98% O2 and at first his temperature was 99.6 but he didn't feel warm so we retook it and it was 98.5.  After about 5-10 minutes he said he was feeling alright and was ready to leave. We assisted him out of the chair but he was fine.  Also we recommended he take it easy and rest the remainder of the evening, take TYLENOL or MOTRIN for any fever or discomfort and that if the site were sore to apply a cool compress, as well as to stay hydrated.  They left to go to restaurant before returning home.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Musculoskeletal stiffness
Clinical narrative: PT HAD THE SHOT APPROXIMATELY AT 2:15 PM AND BY 4:30PM SHE START GETTING TIRED. PATIENT DESCRIBE SHE MAY SLEPT ON THE RIGHT ARM AT NIGHT. BY THE NEXT MORNING (ABOUT 18 HRS AFTER THE SHOT), THE INSIDE OF HER ARM IS BECOMING PINK ABOUT THE SIZE OF 6x3  AND THE MUSCLE IS REALLY STIFF (NOT AT THE INJECTION SITE). PATIENT TOOK ADVIL TWICE IN THE NEXT 24 HOURS, HER PAIN IS GONE. BY MONDAY, THE PINK IS FADED AND BY TUESDAY IT ALMOST FADED. SHE DID NOT EXPERIENCE ANY FEVER.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Rash developed 12 hours after vaccine below injection site, red raised irregular area down to elbow on left arm.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Body temperature increased, Feeling cold, Muscle twitching, Seizure
Clinical narrative: 12:55 PM patient stated she felt a seizure coming on and laid down on the chair in the office. This RN took the patient into Room 4 to lay down; vitals taken 13:04 HR 95, O2 96%, B/P 85/51, Temp 98.6 Temporal. Vitals taken at 13:14 HR 107, O2 98%, B/P 91/62, Temp 99.8 Temporal. Patient stated she was cold, a warming blanket was placed on the patient, patient was offered crackers and water numerous times, patient refused. Guardian stated patient only eats about 6 items due to her autism. Patient has been verbal appropriate and communicates with staff and guardian. At approx. 13:20 patient had instance of left hand "twitching", guardian stated that happens at times when patient is having partial seizure activity. Patient vitals taken at 13:35 HR 65, O2 95%, B/P 114/96, temp 99.8 temporal. Patient was given a piece of chocolate after patient finished chocolate guardian stated she was behaving more like normal. Patient and guardian were given vaccine records and walked to the exit, with no issues notice.
Age: 1.92
Sex: M
Vaccine: HEPA
Symptoms: Eye swelling, Injection site rash, Rash erythematous, Skin discolouration
Clinical narrative: Within a couple hours of getting vaccine, patients eyes became swollen and purple and he developed a rash on his right leg. Mom reports eyes remain purple, this Am but swelling has reduced, rash stayed the same. Small red dots on right leg only.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cough, Pyrexia, Retching, Sensation of foreign body, Speech disorder
Clinical narrative: My child had a slight fever and a cough that made her gag, like there was something in the back of her throat, which wasn't too different than after the first set of these same vaccines. The first time she got them she went from being an easily consoled, self-pacifying baby to absolutely screaming when she was tired or for no apparent reason. However, with this second set of shots she wasn't fussy like the first time, but she threw up multiple times, starting in the evening of the day the vaccines were given and continuing over the course of 3 days. When I say throw up I mean completely emptied the entire contents of her stomach to the point I was worried about wet and poopy diapers. This was not a normal reaction. She even randomly threw up once about one week post-vaccination. Also, my child has not babbled or been vocal like she was since the day she received her vaccinations.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: My child had a slight fever and a cough that made her gag, like there was something in the back of her throat, which wasn't too different than after the first set of these same vaccines. The first time she got them she went from being an easily consoled, self-pacifying baby to absolutely screaming when she was tired or for no apparent reason. However, with this second set of shots she wasn't fussy like the first time, but she threw up multiple times, starting in the evening of the day the vaccines were given and continuing over the course of 3 days. When I say throw up I mean completely emptied the entire contents of her stomach to the point I was worried about wet and poopy diapers. This was not a normal reaction. She even randomly threw up once about one week post-vaccination. Also, my child has not babbled or been vocal like she was since the day she received her vaccinations.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Flushing, Nausea, Vision blurred
Clinical narrative: Feeling flush, overheated, dizzy, slight blurred vision, nausea.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Patient developed arm pain after receiving vaccination that didn't go away. Sought medical attention and was originally treated for possible infection which resulted in no improvement. Had MRI done and was told by physician that she had tears in rotary cuff and would need to follow up with an orthopedic physician for treatment options. Physician could not say it was related to vaccination, but patient thought she should report it as a possible adverse reaction anyways.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, MMR, RV1
Symptoms: Crying, Irritability, Moaning, Vomiting projectile
Clinical narrative: A few hours after the shots he became very cranky- crying a lot, fussy at the breast. He started overheating and whimpered all night long. He was awake every thirty minutes crying and when he was sleeping he was moaning and wincing in pain. The next day (12/21) he was cranky most of the day and not his usual happy self- around 6:00 pm he started projectile vomiting multiple times. Again overheating.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Patient had a rash (red area with some pain) in the same arm as the PREVNAR injection but did not start until after 1 week from injection.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Electrocardiogram normal, Flushing
Clinical narrative: Feeling flushed and dizzy, which lasted for approximately 20 mins. EKG performed, normal. Provided environment for rest and hydration.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Rash papular, Rash pruritic
Clinical narrative: Within 9 hours of administration of vaccine the left upper arm had swelling and redness. Within 11 hours of 12 administration small erythematous rough papules were on cheeks of face. By Saturday 12-16-17 the swollen arm and bumps on face had not gone away and were itchy (no fever, no difficulty breathing, no swollen lips, no hives). Nurse advice line recommended oral diphenhydramine. It helped. By Monday 12-17-17 arm not swollen but face with bumps.
Age: 1.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site erythema, Injection site macule
Clinical narrative: Rec'd Varicella #1 and Flu #1 at 1yr check up on 12/08/17. On 12/20/17 Mom brought Pt. to office for sick O.V. and reported (L) post arm with "spot a few days after vaccines given." Provider on 12/20/17 noted oval pink, semi-firm macule app 2cm at site. No fever, warmth, tenderness or streaking. No Tx; (+) monitor.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Presyncope
Clinical narrative: 'Near-syncope' event after - few minutes after phlebotomy and then vaccines, and while watching younger sib get vaccines, the patient suddenly felt lightheaded, nauseous got pale, diaphoretic, then vomited. No LOC. Sat/rested and was fine within few minutes, discharged to home, VS remained stable.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Vomiting
Clinical narrative: 'Near-syncope' event after - few minutes after phlebotomy and then vaccines, and while watching younger sib get vaccines, the patient suddenly felt lightheaded, nauseous got pale, diaphoretic, then vomited. No LOC. Sat/rested and was fine within few minutes, discharged to home, VS remained stable.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema
Clinical narrative: Patient made F/U apt for EVAL of increased redness around (R) thigh vaccine site. Vaccines administered 12-18-17- Mild redness per parent after shots that worsened overnight. No D/C or swelling observed on assessment. Limbs move without difficulty.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Injection site pain, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: She noted fever (above 102), myalgias and arm pain about 14 hours after her vaccines. On exam about 24 hours after the vaccines, the anterior injection site was more tender and slightly edematous. This was the site of the pneumovax vaccine. When viewed the next day, the upper arm was slightly edematous, but not warm an no erythema.
Age: 14.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse effect; improperly stored vaccine adminstered; This spontaneous report was received from a medical assistant regarding a 14-year-old patient of unknown gender. The patient's medical history, concomitant medication and concurrent conditions were not reported.  On 26-JUL-2017, the patient was vaccinated with a dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # M037770, expiry date: 01-JUN-2019 for prophylaxis. No adverse effects reported.   The reporter confirmed the temperature excursions on 12-JUN-2017 at 8:00 am and 13-JUN-2017 at 8:00 am. On these days, the temperature in storage unit dropped down to 35 degree Fahrenheit for about 15 minutes each day. The minimum temperature was reported as 35 degree Fahrenheit on both days and maximum temperature 41 degree Fahrenheit on 12-JUN-2017 and 43 degree Fahrenheit on 13-JUN-2017, room temperature when discovered was 72 degree Fahrenheit on both days. The reporter contacted manufacturer, they were able to use vaccines, she adjusted the temperature on the storage unit, there had been no other problems. It was also reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was improperly stored before with cumulative timeframe of 32 to 35 degrees Fahrenheit for 1 hour and 20 minutes. The temperature excursion was detected by digital data logger.  All telephone attempts to obtain follow-up information have been unsuccessful. This is one of a few reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA007096: US-009507513-1707USA007097: US-009507513-1707USA005936: US-009507513-1712USA010535: US-009507513-1712USA010548:
Age: 14.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No adverse effect; improperly stored vaccine adminstered; This spontaneous report was received from a medical assistant regarding a 14-year-old patient of unknown gender. The patient's medical history, concomitant medication and concurrent conditions were not reported.  On 26-JUL-2017, the patient was vaccinated with a dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # M037770, expiry date: 01-JUN-2019 for prophylaxis. No adverse effects reported.   The reporter confirmed the temperature excursions on 12-JUN-2017 at 8:00 am and 13-JUN-2017 at 8:00 am. On these days, the temperature in storage unit dropped down to 35 degree Fahrenheit for about 15 minutes each day. The minimum temperature was reported as 35 degree Fahrenheit on both days and maximum temperature 41 degree Fahrenheit on 12-JUN-2017 and 43 degree Fahrenheit on 13-JUN-2017, room temperature when discovered was 72 degree Fahrenheit on both days. The reporter contacted manufacturer, they were able to use vaccines, she adjusted the temperature on the storage unit, there had been no other problems. It was also reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was improperly stored before with cumulative timeframe of 32 to 35 degrees Fahrenheit for 1 hour and 20 minutes. The temperature excursion was detected by digital data logger.  All telephone attempts to obtain follow-up information have been unsuccessful. This is one of a few reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA007096: US-009507513-1707USA007097: US-009507513-1707USA005936: US-009507513-1712USA010535: US-009507513-1712USA010548:
Age: 1.83
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood alkaline phosphatase increased
Clinical narrative: Initial unsolicited report received from a nurse on 07-Dec-2017. This case involves a two-years old female patient who was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (batch number: UT5897MA, expiry date: 30-Jun-2018, form, route, dose in series was not reported) in left thigh on 01-Nov-2017. Patient's medical history were not reported. No other immunizations were administered at that time. On an unknown date, following the vaccination, patient had increased alkaline phosphatase 5129 (high) showed after the lab test done on 17-Nov-2017 and a repeat test on 01-Dec-2017 showed alkaline phosphatase (3704). Other lab tests were not reported. Corrective treatment were not reported. The event outcome was unknown. List of documents held by sender: none.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to a 47 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions. The patient's concomitant therapies included sterile diluent (DILUENT MRK). On 10-NOV-2017, the patient was inadvertently vaccinated with PROQUAD subcutaneously, lot # N002917 and expiration date on 24-JUL-2018 (dose was not reported) for prophylaxis; instead of VARIVAX (dose, route lot number and expiration date was not reported) for prophylaxis (wrong drug administered) (drug administered to patient of inappropriate age).    The reporter stated that, the patient did not experienced any adverse event.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2017, the patient was vaccinated with PROQUAD (dose, route of administration, site of administration, lot#, expiration date were not reported) for prophylaxis. On the same day, patient was vaccinated with second dose of PROQUAD subcutaneously, lot # N019826, expiration date 09-JAN-2019 (dose, site of administration were not reported) for prophylaxis. Second dose of vaccine was reconstituted with sterile diluent (MERCK) (lot # and expiration date were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to 3 female patients of unknown ages. Information concerning the patients' medical history, concurrent conditions and concomitant medications, was not reported. On an unknown date, the patients were vaccinated with unspecified doses of GARDASIL 9 to prevent Human Papilloma Virus (HPV) (dosage schedule, route, lot number and expiration date were not reported). On an unknown date, the patients developed severe injection site pain. The physician did not state how many doses each patient received in the GARDASIL 9 series, however the physician mentioned that the patient's injection site pain increased as subsequent doses were administered in the vaccine series. The patient's outcome was unknown.  The causal relationship between therapy with GARDASIL 9 and the severe injection site pain, was not reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 67-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N024384 with expiration date on 18-MAY-2019. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308 :
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 75-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N024384 with expiration date on 18-MAY-2019. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 73-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N024384 with expiration date on 18-MAY-2019. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 86-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N024384 with expiration date on 18-MAY-2019. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number N019250 with expiration date in 20-DEC-2018 (strength, anatomical location, dose number and route of administration were not provided), for prophylaxis. A properly stored sterile water diluent (DILUENT MRK) (lot number and expiration date were not provided) was used to reconstitute the vaccine. The vaccine was exposure to a temperature excursion; the data logger registered a temperature range between 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 20 minutes. There was no previous temperature excursion. No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash morbilliform
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a female patient of about 1 year-old. The patient's relevant medical history, drug  reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with M-M-R II, subcutaneously, for prophylaxis (strength, dosage schedule, lot number and expiration date were not reported). On an unknown date, two weeks after vaccination, the patient developed measles-like rash on the abdomen area. It was unknown by the reporter whether the patient received treatment to the aforementioned event or if any laboratory tests were carried out. The reporter informed that the patient visited the physician's office on an unknown date. The patient fully recovered of measles-like rash on an unspecified date. The relatedness between M-M-R II and measles-like rash was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Acute kidney injury, Glomerulonephritis minimal lesion, Herpes zoster, Nephrotic syndrome, Oedema
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history and concomitant medications were not provided. On or about 06-JUL-2015, the patient was inoculated with ZOSTAVAX (dose, route and lot # not provided). The vaccine did not prevent shingles and caused the patient to contract a persistent strain of herpes zoster (onset date not specified). Shortly after receiving ZOSTAVAX, the patient began to experience episodes of edema, weight gain, and symptoms suggestive of kidney dysfunction. Thereafter, on 02-NOV-2015, the patient presented to a hospital where she was diagnosed with minimal change disease and nephrotic syndrome secondary to minimal change disease and acute kidney injury. 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, pain and suffering, and other damages. The outcome of the events were unknown. Causality assessment was considered related. Upon internal review, nephrotic syndrome and minimal change disease were considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Renal impairment, Weight increased
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history and concomitant medications were not provided. On or about 06-JUL-2015, the patient was inoculated with ZOSTAVAX (dose, route and lot # not provided). The vaccine did not prevent shingles and caused the patient to contract a persistent strain of herpes zoster (onset date not specified). Shortly after receiving ZOSTAVAX, the patient began to experience episodes of edema, weight gain, and symptoms suggestive of kidney dysfunction. Thereafter, on 02-NOV-2015, the patient presented to a hospital where she was diagnosed with minimal change disease and nephrotic syndrome secondary to minimal change disease and acute kidney injury. 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, pain and suffering, and other damages. The outcome of the events were unknown. Causality assessment was considered related. Upon internal review, nephrotic syndrome and minimal change disease were considered medically significant. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Dizziness, Feeling hot
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable Healthcare professional and from patient for himself. This male patient of unknown age and race/ethnicity received at 9:30 AM on 11Dec2017 a single dose of PREVNAR 13 for immunization. The patient did not have a history of low blood pressure or hypertension medication use. Concomitant medications if any were not reported. On the following morning after vaccination, on 12Dec2017, when patient woke up, he felt lightheaded as if the room was spinning around him. Since then, he felt lightheaded 6 to 8 times in the past week. He also stated he felt slightly hot in the head and may have a decreased appetite (Dec2017). Outcome was unknown.
Sex: M
Vaccine: DTAP, IPV
Symptoms: Swelling face, Urticaria
Clinical narrative: Initial unsolicited report received from a Physician on 06-Dec-2017. This case involves five-year-old male patient who was vaccinated once with a 0.5 ml dose of  IPOL (batch number- M1231C) and once with 0.5 ml DTAP (batch number- C5041BA) (expiry date, Dose, Dose in series, and site of administration were not reported for both the vaccines) intramuscularly on an unknown date of 2016. Medical history and concomitant medications were not reported. On an unspecified date of 2013, previously patient was vaccinated with INFLUENZA VACCINE (batch no: V4488EA).On an unknown date, following the vaccination, the patient had hives and facial swelling. Laboratory investigations and corrective treatment were not reported. Outcome of the events were unknown. List of documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Joint range of motion decreased
Clinical narrative: Initial unsolicited report received from nurse on 08-Dec-2017. This case involves an 83-year-old female patient who was vaccinated with 0.5 ml dose once of FLUZONE HD (Batch number: UI892AA, expiration date: 06 Jun 2018, dose, route was not reported) in left deltoid on 13 Nov 2017. The patient's medical history was not reported. Patient did not receive any other vaccines at the time. It was reported that patient has no known drug allergy (NKDA). On an unspecified date, few days following the vaccination, the patient flare up of her arthritis, especially in her Left shoulder, had limited range of motion, and generalized joint pain. Lab data was not reported. The patient received corrective treatment with Prednisone. On an unspecified date, after 2 week, the patient recovered from events. List of documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Urticaria
Clinical narrative: Red raised welt on arm.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Hepatitis-A vaccine was ordered, but Hepatitis-B vaccine was given in error; patient received an extra dose of Hepatitis-B vaccine.
Age: 37.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Pyrexia, Seizure
Clinical narrative: Symptoms: high fever 101.9 for  4 hrs. Non responsive to  ibuprofen 400 mg. Finally started decreasing to 99 with core cooling technique ice pad on  stomach. Also, 2 seizures within 24 hrs post vaccination.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site erythema, Rash generalised, Rash maculo-papular
Clinical narrative: MOTHER REPORTS ON 09 DEC 17, PATIENT STARTED WITH REDDENED RAISED REGION AT PEDIARIX VACCINATION SITE. RASH THEN SPREAD OVER A 24 HOUR PERIOD FROM VACCINATION SITE ACROSS ENTIRE BODY. NO OTHER SYMPTOMS ASSOCIATED WITH RASH. RASH RESOLVED ON OWN OVER 36 TO 48 HOUR PERIOD WITH NO COMPLICATIONS. MOTHER HAS PICTURES OF RASH AND SHOWED THEM TO RN. RASH NONTOXIC MACULOPAPULAR IN APPERANCE.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from an administrator and refers to a 6 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-NOV-2017, the patient was vaccinated with ROTATEQ orally, 1 dose, lot # N003984, expiration date 19-NOV-2018 or lot # M044397, expiration date 20-JUN-2018. The specific lot number of vaccine administered to the patient was unknown by reporter. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion at or above 32 degrees Fahrenheit (F) up to 35 F (35.4F) for 45 minutes. Digital data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 74-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N024384 with expiration date on 18-MAY-2019. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308:
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 from lot # M037770 with expiry: 01-JUN-2019.  No adverse effects reported. The vaccine was exposed to a temperature of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from a medical assistant. The patient's identifiers were provided. This report refers to a 15-year-old patient of unknown gender, who on 25-JUL-2017 was vaccinated with a dose of improperly stored GARDASIL 9 lot # M037770, expiry date: 01-JUN-2019 for prophylaxis. The reporter confirmed the temperature excursions on 12-JUN-2017 at 8:00 am and 13-JUN-2017 at 8:00 am. On these days, the temperature in storage unit dropped down to 35 degree Fahrenheit for about 15 minutes each day. The minimum temperature was reported as 35 degree Fahrenheit on both days and maximum temperature 41 degree Fahrenheit on 12-JUN-2017 and 43 degree Fahrenheit on 13-JUN-2017, room temperature when discovered was 72 degree Fahrenheit on both days. The reporter contacted manufacturer, they were able to use vaccines, she adjusted the temperature on the storage unit, there had been no other problems. It was also reported that GARDASIL 9 was improperly stored before with cumulative timeframe of 32 to 35 degrees Fahrenheit for 1 hour and 20 minutes. This is one of a few reports received from the same reporter.; Sender's Comments: US-009507513-1707USA007096: US-009507513-1707USA007097: US-009507513-1712USA010536: US-009507513-1712USA010548: US-009507513-1707USA005936:
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable physician reporting for the daughter. A 22-year-old-female patient of unspecified race/ethnicity received TRUMENBA, via an unspecified route of administration, on 15Dec2017, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced redness, swelling, and pain at injection site, malaise and headache all on unspecified date with outcome of unknown. The information on the lot number has been requested.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Itching, redness, warm to touch.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Ear swelling, Rash generalised, Swelling face, Urticaria
Clinical narrative: Approximately 33 hours after the vaccines were administered he had an all over body rash, hives and swelling of the face and ears. Seen in the ER and given BENADRYL. Still having swelling of the ears. Advised to follow up today with Primary Care Provider.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Developed full clinical sx of chicken pox.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth at injection site, (L) delt.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site vesicles, Lymphadenopathy
Clinical narrative: Rash at injection site, swollen lymph node in neck and behind ear. (One to two vesicles with induration and erythematous area locally at site.)
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Redness, and Pain at injection site. Fever. S/S for 24 hours. No cellulitis.
Age: 0.75
Sex: M
Vaccine: DTAP, HEPA
Symptoms: No adverse event, Wrong drug administered, Wrong patient received medication
Clinical narrative: MEDICAL ASSISTANT GAVE THE WRONG VACCINES TO PATIENT. VACCINES WERE ORDERED FOR ANOTHER PT WITH SAME FIRST NAME. NO KNOWN ADVERSE EVENTS JUST REPORTING VACCINES ADMIN ERROR.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Nausea, Retching
Clinical narrative: During the night the patient woke up with nausea and gagging. Called the on call Pediatric triage nurse who gave her supportive therapy. Called the office in the am and there was no vomiting or any other symptoms. PCP was not sure if this was related to the vaccines but wanted to file a VAERS report just in case.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Myalgia
Clinical narrative: SORENESS IN THE MUSCLE.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 26-NOV-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # M024673 with an expiration date in 17-NOV-2017), for prophylaxis (dose, frequency, route and strength were not provided). No adverse effects were reported and no product quality complaint (PQC) was involved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 15-DEC-2017, the patient was intramuscularly vaccinated with a dose GARDASIL 9 0.5 ml/once, lot # N022584, expiry date 15-JUN-2020, for prophylaxis. The patient inadvertently received the third dose in the vaccination series two months early. No adverse effects were reported. Lot number N022584 has been verified to be a valid lot number for GARDASIL 9.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large, red circle around injection site with swelling and pain. Pt went to MD office. Not cellulitis. MD determined topical reaction resolved on own, no treatment.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Limb injury, Mobility decreased, Monoplegia, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Paralysis of arm/shoulder for 24-48 hours, limited movement after and pain, which persists to this day. Treatment with high-dosage ibuprofen and physical-therapy.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Paralysis of arm/shoulder for 24-48 hours, limited movement after and pain, which persists to this day. Treatment with high-dosage ibuprofen and physical-therapy.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Pain, swelling, tenderness, warmth, erythema-left arm. Given methylprednisolone 80 mg IM.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Inflammation, Musculoskeletal pain, Neck pain
Clinical narrative: Redness, swelling, and pain in shoulder on day after PNEUMOVAX administration. Pain extending from elbow through neck; inflamed and warm to the touch. Temperature = 99.4F. Received cephalexin at an urgent care facility on evening of 11/18/17 for potential cellulitis. Presented at Pulmonary clinic on 11/19/17 and was referred to the ED for evaluation. ED physician evaluated, and ruled out cellulitis; cephalexin discontinued. Advised warm compresses. Administered diphenhydramine 50 mg oral and ketorolac 60 mg IM. Patient educated to return to ED if symptoms worsened. On follow-up call on 11/20/17 patient was still in pain, but symptoms had not worsened.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Redness, swelling, and pain in shoulder on day after PNEUMOVAX administration. Pain extending from elbow through neck; inflamed and warm to the touch. Temperature = 99.4F. Received cephalexin at an urgent care facility on evening of 11/18/17 for potential cellulitis. Presented at Pulmonary clinic on 11/19/17 and was referred to the ED for evaluation. ED physician evaluated, and ruled out cellulitis; cephalexin discontinued. Advised warm compresses. Administered diphenhydramine 50 mg oral and ketorolac 60 mg IM. Patient educated to return to ED if symptoms worsened. On follow-up call on 11/20/17 patient was still in pain, but symptoms had not worsened.