chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal dreams, Injection site pain, Injection site pruritus, Limb discomfort, Lymph node pain
Clinical narrative: This case was reported by a physician and described the occurrence of injection site itching in a male patient who received SHINGRIX. On 23rd February 2018, the patient received SHINGRIX. On 23rd February 2018, 1 hr after receiving SHINGRIX, the patient experienced injection site itching, arm discomfort, limbs stiffness, abnormal dreams, pain in arm and lymph node pain. On 23rd February 2018, the outcome of the injection site itching was recovered/resolved. On an unknown date, the outcome of the arm discomfort, limbs stiffness, abnormal dreams, pain in arm and lymph node pain were unknown. It was unknown if the reporter considered the injection site itching, arm discomfort, limbs stiffness, abnormal dreams, pain in arm and lymph node pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, the vaccination with SHINGRIX felt no different than FLUARIX did. On 23rd February 2018, 1 hour after vaccination, the patient experienced a bit of local itching at the injection site and it went after 3 hours. The patient had no more local discomfort than after flu vaccination. The patient was feeling a little fullness in the patient's arm and a bit stiff, but he reported that it was no big deal and he was ready for dinner at his favorite restaurant. In February 2018, less than a week after vaccination the patient woke up from a rather weird dream in which he had developed an egg-sized tender mass at the injection site which he had named, in fact there was no mass, though his upper arm was definitely moderately tender. The patient reported that, he needed to check package insert about weird dreams. The patient's local inflammatory response check showed cell trafficking and was checked. In February 2018, less than a week after vaccination, the patient was beginning to feel slight ache in axillary nodes as antigen presenting cells begin to migrate in and do their magic. All consistent with AS01 mechanism of action. This case has been linked with case US2018GSK032395 and US2018GSK036922, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a physician and described the occurrence of injection site itching in a male patient who received SHINGRIX. On 23rd February 2018, the patient received SHINGRIX. On 23rd February 2018, 1 hr after receiving SHINGRIX, the patient experienced injection site itching, arm discomfort, limbs stiffness, abnormal dreams, pain in arm and lymph node pain. On 23rd February 2018, the outcome of the injection site itching was recovered/resolved. On an unknown date, the outcome of the arm discomfort, limbs stiffness, abnormal dreams, pain in arm and lymph node pain were unknown. It was unknown if the reporter considered the injection site itching, arm discomfort, limbs stiffness, abnormal dreams, pain in arm and lymph node pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, the vaccination with SHINGRIX felt no different than FLUARIX did. On 23rd February 2018, 1 hour after vaccination, the patient experienced a bit of local itching at the injection site and it went after 3 hours. The patient had no more local discomfort than after flu vaccination. The patient was feeling a little fullness in the patient's arm and a bit stiff, but he reported that it was no big deal and he was ready for dinner at his favorite restaurant. In February 2018, less than a week after vaccination the patient woke up from a rather weird dream in which he had developed an egg-sized tender mass at the injection site which he had named, in fact there was no mass, though his upper arm was definitely moderately tender. The patient reported that, he needed to check package insert about weird dreams. The patient's local inflammatory response check showed cell trafficking and was checked. In February 2018, less than a week after vaccination, the patient was beginning to feel slight ache in axillary nodes as antigen presenting cells begin to migrate in and do their magic. All consistent with AS01 mechanism of action. This case has been linked with case US2018GSK032395 and US2018GSK036922, reported by the same reporter.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Tendonitis, X-ray limb
Clinical narrative: Recent vaccine causing rotator cuff tendonitis.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac function test normal, Injection site pain, Joint range of motion decreased, Pain in extremity, Sleep disorder
Clinical narrative: Site of injection was sore, which was expected. But shoulder joint, upper arm pain worsened and range of motion impaired. Pain has not lessened at all and at times is intense. Cannot pick up anything heavy with left hand and cannot sleep on left side. Pain sometimes radiates down my arm. Had full cardiac work up last year and all was normal. NSAIDs help but relief does not last long.  .
Age: 30.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Burning sensation, Contusion, Pain, Pruritus
Clinical narrative: Starting feeling burning right after injection, about 20mins later starting feeling itchy, and body aches and bruising. No fever symptoms worsen overnight. Patient was advised by PCP to use BENADRYL for itchiness also recommended using cold pack to relieve pain and bruising.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Loss of consciousness, Muscle twitching
Clinical narrative: Approximately 2-3 minutes after receiving the vaccination, caregiver passed out while still sitting in chair. He was unconscious for approximately 3 minutes and twitched a little. Employee Health Nurse protected his airway by holding his head up right until some color returned to his cheeks and he regained consciousness. A Rapid Response was called and that team arrived within about 2 to 3 minutes. Caregiver was sitting upright, talking, joking, and drinking orange juice when the Nursing Supervisor escorted him to a place where he could lay down and recover for a while. No further adverse response was reported. Of note is the fact that the caregiver had worked all night the night before, he slept for 4 hours prior to coming for the shot. He had not eaten since the middle of the night. He reports having passed out once before while donating plasma (which he does routinely about once per month).
Age: 1.5
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Blood creatine phosphokinase normal, Full blood count normal, Influenza virus test negative, Joint swelling, Pain in extremity
Clinical narrative: Pt developed 2/28 went to peds, flu neg. Seen by me 3/1 with fever and complaint of leg pains and had normal exam. Dx with viral illness. Then on early am 3/3 went to ED for joint swelling. They did CBC, ESR, CK all normal. Came to see me in office morning of 3/3. Noted to have swelling of right knee. Advised most likely toxic synovitis. Then went back to ED later that night (seen by me at hospital) and he had swelling of both hands and feet and still the right knee, temp of 100F and diffuse urticarial rash. Dx with serum sickness. The only new med etc is the flu shot and PREVNAR vaccine. Did get MOTRIN when he had fever.
Age: 1.5
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Peripheral swelling, Pyrexia, Red blood cell sedimentation rate normal, Serum sickness, Synovitis
Clinical narrative: Pt developed 2/28 went to peds, flu neg. Seen by me 3/1 with fever and complaint of leg pains and had normal exam. Dx with viral illness. Then on early am 3/3 went to ED for joint swelling. They did CBC, ESR, CK all normal. Came to see me in office morning of 3/3. Noted to have swelling of right knee. Advised most likely toxic synovitis. Then went back to ED later that night (seen by me at hospital) and he had swelling of both hands and feet and still the right knee, temp of 100F and diffuse urticarial rash. Dx with serum sickness. The only new med etc is the flu shot and PREVNAR vaccine. Did get MOTRIN when he had fever.
Age: 1.5
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Urticaria, Viral infection
Clinical narrative: Pt developed 2/28 went to peds, flu neg. Seen by me 3/1 with fever and complaint of leg pains and had normal exam. Dx with viral illness. Then on early am 3/3 went to ED for joint swelling. They did CBC, ESR, CK all normal. Came to see me in office morning of 3/3. Noted to have swelling of right knee. Advised most likely toxic synovitis. Then went back to ED later that night (seen by me at hospital) and he had swelling of both hands and feet and still the right knee, temp of 100F and diffuse urticarial rash. Dx with serum sickness. The only new med etc is the flu shot and PREVNAR vaccine. Did get MOTRIN when he had fever.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. Between 05-MAR-2018 and 06-MAR-2018, the patient received a dose of improperly stored ROTATEQ (lot # N005617, expiry date: 03-OCT-2018) and LIQUID PEDVAXHIB (lot # N016991, expiry date: 07-MAR-2020) (product storage error). The temperature excursion ranged between 58.6 Fahrenheit (F) on an unknown date for a time frame of 4.5 hours. There was no previous temperature excursion. The call was not because of a data logger. No adverse effects were reported. Product quality complaint was not involved.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient of an unspecified ethnicity received the first dose of PREVNAR 13 (lot T88778, expiry date Mar2020, NDC 00005-1971-05) intramuscular on 06Feb2018 at approximately 12:15 at 0.5 ml single in the left deltoid for pneumococcal prevention (immunisation). No other vaccine was administered the same day. Medical history included ongoing blood pressure disorder. She was taking other unspecified concomitant medications. The patient was administered with the vaccine at the drug store, she stayed at the back area for observation for 15 minutes and did not have any issues. Then the patient went throughout the store and did the remaining of her shopping and while trying to purchase items she fainted. They had to call an ambulance and the patient was taken to the hospital where she was admitted the same day. The patient recovered on 06Feb2018. The event faint was assessed as serious as medically significant and per initial hospitalization. Causality assessment was possible but it was unknown if event depended also from other medications taken by the patient and other ongoing conditions. Sender's Comments: Based on the information currently available, there was not a reasonable possibility that the event fainted was related to the suspect drug PREVNAR 13, it is more likely related to underlying history of blood pressure disorder for this elder patient. This case will be re-evaluated upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a healthcare professional (patient's father) on 23-Feb-2018. This case involves a male patient (age not reported), who was vaccinated with FLUZONE QIV (batch number, expiry date, route, dose not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient was just diagnosed with influenza (based only on symptoms). It was also reported that diagnosing facility had run out of throat swabs, so they could not swab him to be able to confirm the diagnosis via laboratory test, or provide type information. Other lab test and corrective treatment were not reported. Outcome of the events were not reported. Upon internal review the case was considered as serious because of important medical event: influenza. Documents held by sender: none.; Sender's Comments: Patient developed Influenza infection post vaccination. The exact time to onset is unknown. The boy was diagnosed with Influenza based only on symptoms without any confirmatory test for starin identification. This is a poorly document case as time to onset is unknown, additional information regarding patient medical history, infectious history and lab or serological confirmation are needed to confirm vaccination failure.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient has significant swelling at injection site about 3 to 4 in round in size, warm to the touch and hard. (Normal reaction). No other symptoms. Advised to follow up with unit/PCP.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling on right thigh. BANOPHEN was prescribed.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Expanding localized erythema, induration, pruritis at the injection site, measuring 7.5cm x 7.5cm at the time of the physical exam.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Hyperhidrosis, Nausea, Peripheral swelling
Clinical narrative: Arm swelling (unusually large), sweating, dizziness, and nausea developed later in the evening the day of vaccination. The next morning the swelling "moved" down arm and formed a bubble. All symptoms resolved after a couple of days.
Age: 1.08
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Nasopharyngitis, Rash, Rash macular, Rash vesicular, Vaccination complication
Clinical narrative: Pt was evaluated by Dr. on March 7, 2018. HPI: She began with rash yesterday  -- she has had cold s/s -- no fever since yesterday -- she did receive her Varicella vaccine on 2/24/18, 10 days prior to rash developing. INTEGUMENTARY: Positive for rash. SKIN: a rash is noted on the scalp, on the face (forehead), on the chest, and on the back; the color is mainly pink and red; it is best characterized as macular and vesicular. ASSESSMENT 052.7 B01.9  Varicella -- vaccine induced DDx. PLAN: Varicella Discussed in detail -- some concern for mom who is pregnant and has not had chickenpox in the past. Recommend for mom to wear a mask around patient until lesions have resolved and to avoid touching the lesions if they open up. MEDICATIONS: Advised to take OTC TYLENOL (acetaminophen) and ibuprofen. RECOMMENDATIONS given include: increase fluids and monitor I's and O's. FOLLOW-UP: Schedule follow-up appointments on a p.r.n. basis. Patient Recommendations: For Varicella: Use acetaminophen (TYLENOL) as needed for pain or fever. Use ibuprofen (ADVIL or MOTRIN) to help with pain, fever, or swelling. Schedule follow-up appointments as needed.
Age: 1.08
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt was evaluated by Dr. on March 7, 2018. HPI: She began with rash yesterday  -- she has had cold s/s -- no fever since yesterday -- she did receive her Varicella vaccine on 2/24/18, 10 days prior to rash developing. INTEGUMENTARY: Positive for rash. SKIN: a rash is noted on the scalp, on the face (forehead), on the chest, and on the back; the color is mainly pink and red; it is best characterized as macular and vesicular. ASSESSMENT 052.7 B01.9  Varicella -- vaccine induced DDx. PLAN: Varicella Discussed in detail -- some concern for mom who is pregnant and has not had chickenpox in the past. Recommend for mom to wear a mask around patient until lesions have resolved and to avoid touching the lesions if they open up. MEDICATIONS: Advised to take OTC TYLENOL (acetaminophen) and ibuprofen. RECOMMENDATIONS given include: increase fluids and monitor I's and O's. FOLLOW-UP: Schedule follow-up appointments on a p.r.n. basis. Patient Recommendations: For Varicella: Use acetaminophen (TYLENOL) as needed for pain or fever. Use ibuprofen (ADVIL or MOTRIN) to help with pain, fever, or swelling. Schedule follow-up appointments as needed.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dyspnoea, Nausea, Urticaria, Vomiting
Clinical narrative: Nausea and vomitting, diarrhea, SOB, bodywide hives.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient had chills and a fever for 2 days.
Age: 2.0
Sex: M
Vaccine: MNQ
Symptoms: Anaphylactic reaction, Lip swelling, Rash, Vomiting
Clinical narrative: Anaphylatic Reaction: Lip swelling, rash, vomited approximately 45 minutes after vaccine administered. Patient sent to ER VIA 911 given EPI-PEN x's 2, kept for observation. Given EPI for home use PRN.
Sex: M
Vaccine: FLU4
Symptoms: Discomfort
Clinical narrative: This case was reported by a physician and described the occurrence of discomfort in a male patient who received FLUARIX TETRA. On an unknown date, the patient received FLUARIX TETRA. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown. It was unknown if the reporter considered the discomfort to be related to FLUARIX TETRA. Additional details were provided as follows: The age at vaccination was not reported. No more local discomfort than after flu jab. This case has been linked with case US2018GSK032395 and US2018GSK032396, reported by the same reporter.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site infection, Injection site reaction
Clinical narrative: Injection site reaction- looks to be infected.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Pain
Clinical narrative: Wife and I both got the flu shot, I did not have a problem, but my wife came down with shingles 4 days after shot, it started in back of head and neck, but pain got too bad and went to our Family Dr. who prescribes a medication. The pain lasted roughly 4 weeks. The only area infected was the side/Back of head and back of neck. I have done a lot of research thru the internet and you people need to research this yourself. My wife did not need this type of agony, just thinking what she went thru really irritates me. Think how you would react if it was a family member of yours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pt called office back approximately three hours after given stating that there was a large area where the shot was given and it was now red, swollen, sore, and that she was in a lot of pain. She then called the next morning stating that it was still red, swollen and painful to touch as well as she was now nauseated and had a headache.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: C/O pain and burning in left upper arm. Complaints of burning down arm to elbow and up through neck region including near breast. Complains that she cannot 'lean' on arm and has discomfort and difficultly lifting left arm.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site warmth, Vaccination site mass
Clinical narrative: Patient states she felt a lump under the area that she had the vaccine. She had had this previously with other vaccines. This occurred on 1/17/18 with vaccination. On 3/6/18 she noticed redness and warmth at the injection site overlying the lump.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dysphoria, Feeling abnormal, Musculoskeletal chest pain, Myalgia, Pain in extremity
Clinical narrative: 3 HOURS AFTER THE INJECTION, PATIENT STARTED FEELING "BAD" OVERALL. ARM HURT AND MUSCLE SORENESS. PATIENT REPORTED FEELING DYSPHORIA. THIS FEELING LASTED ABOUT 3 DAYS. THE SECOND DAY WAS THE WORST. NO VOMITING, NO FEVER. JUST WANTED TO SIT OR LAY DOWN ALL DAY. PATIENT EXPERIENCED SHARP PAIN IN THE RIB CAGE ON RIGHT SIDE (SAME SIDE AS INJECTION) FROM DAYS 3-6 POST INJECTION. THEN BACK TO NORMAL.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Limb discomfort, Pain
Clinical narrative: She developed large red/pink area around the injection site that was about 2.75 inches across with irregular border. She woke up on 3/8/18 with just a small red area, but by noon the area increased to the 2.75 inches across and appears to be increasing in size. There is swelling that radiates from the shoulder to the elbow. The reddened area is very warm to the touch. She has discomfort if she moves her arm up and down.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Electromyogram, Grip strength decreased, Injection site pruritus, Musculoskeletal pain
Clinical narrative: Site itched much longer than normal. On or around January 23 I woke up with severe pain in my back/shoulder area and I had lost grip strength in my left hand. I still have pain and loss of grip strength.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging neck, Nuclear magnetic resonance imaging thoracic, X-ray
Clinical narrative: Site itched much longer than normal. On or around January 23 I woke up with severe pain in my back/shoulder area and I had lost grip strength in my left hand. I still have pain and loss of grip strength.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 26-FEB-2016, the patient was vaccinated with a dose of GARDASIL lot # K016966 and expiration date of 10-MAY-2017, for prophylaxis (dose and route of administration were not reported). On 26-APR-2016, the patient received a second dose of GARDASIL lot # K016966 and expiration date of 10-MAY-2017, for prophylaxis (dose and route of administration were not reported). On 31-AUG-2016, the patient was vaccinated with a dose of GARDASIL 9 lot # M009378 and expiration date of 23-APR-2018, for prophylaxis (dose and route of administration were not reported). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA003341: US-009507513-1801USA006860.
Sex: U
Vaccine: MMRV, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse referring to a 65 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-MAR-2018, the patient was inadvertently vaccinated with a dose of Oka-Merck PROQUAD (rHA), lot # N019250 with expiration date 20-DEC-2018 for prophylaxis instead of a dose of ZOSTAVAX (route of administration was not provided). Concomitant medications included sterile diluent. No adverse effect was reported. It was stated that the facility where the vaccine was administered usually stored Oka-Merck PROQUAD and ZOSTAVAX in the same container, but the nurse who administered the vaccine did not realize there was no ZOSTAVAX in that container at that time. The nurse then took a dose of Oka-Merck PROQUAD from that container without realizing it was Oka-Merck PROQUAD and did not notice this until after administration of the dose. The nurse who administered the vaccine stated that she knew the difference between both vaccines, but that she made a medication error.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 30-JUN-2016, the patient was vaccinated with a dose of GARDASIL lot # K016966 and expiration date of 10-MAY-2017, for prophylaxis (dose and route of administration were not reported). On 06-FEB-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # M009378 and expiration date of 23-APR-2018, for prophylaxis (dose and route of administration were not reported). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA003341: US-009507513-1802USA013791.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 04-JAN-2016, the patient was vaccinated with a dose of GARDASIL lot # K016966 and expiration date of 10-MAY-2017, for prophylaxis (dose and route of administration were not reported). On 06-FEB-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # M009378 and expiration date of 23-APR-2018, for prophylaxis (dose and route of administration were not reported). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA013791: US-009507513-1803USA003340.
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling, White blood cell count increased
Clinical narrative: This is a spontaneous report from contactable consumer via a Pfizer sales representative. An elderly (70, unit unknown) male patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced white blood cell count went up and arm got swollen both on an unspecified date in May2017 with outcome of unknown. The patient went to the emergency room due to the events. The information on the lot number has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscle spasms
Clinical narrative: Patient received vaccine at workplace clinic at 1:26PM. Patient sent message the following morning, reporting, "... I woke up around 3AM with my entire body cramping and severe headache as well. I'm working from home today, I'll take the ADVIL and hoping this will go away soon. It's a little better but not by much." Spoke to physician and let patient know that she may take ADVIL. Also alerted patient that symptoms should resolve within 2-3 days per SHINGRIX prescribing information sheet and CDC website. Advise patient to call if symptoms change or worsen.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, itching at injection site. Very Red and warm to touch. Ice, BENADRYL, MOTRIN. Ordered to fill Prednisone 20mg tablet if reaction worsened.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at injection site, warm to touch, swollen and red. BENADRYL, cool compresses and MOTRIN. Fill ABx if worse.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Ear infection, Pyrexia, Rash, Rash erythematous, Rash vesicular
Clinical narrative: 9 Days after vaccines were given my daughter spiked a high fever of 104 degrees Fahrenheit. I gave her TYLENOL and the fever came down. Then she maintained a temperature around 100 for the next 2 days. Then her fever spiked to 104 again and she started to get red bumps all over her chest, back and head. We took her to the Urgent Care and by the time we saw the Dr. the red dots were darker and more prominent. The Dr. said a lot of the bumps had vesicles. He diagnosed her with chicken pox and she also had a double ear infection. She was given Acyclovir 200MG and Amoxicillin 400MG. Her twin sister who had all the same shots on the same days had the same exact reactions. So both of my daughters are suffering from these reactions and they have yet to subside.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: 9 Days after vaccines were given my daughter spiked a high fever of 104 degrees Fahrenheit. I gave her TYLENOL and the fever came down. Then she maintained a temperature around 100 for the next 2 days. Then her fever spiked to 104 again and she started to get red bumps all over her chest, back and head. We took her to the Urgent Care and by the time we saw the Dr. the red dots were darker and more prominent. The Dr. said a lot of the bumps had vesicles. He diagnosed her with chicken pox and she also had a double ear infection. She was given Acyclovir 200MG and Amoxicillin 400MG. Her twin sister who had all the same shots on the same days had the same exact reactions. So both of my daughters are suffering from these reactions and they have yet to subside.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: About 3/4th of outer upper right arm had redness/swelling/red rash that felt warm to the touch. It started on 3/7/18 mid-day and worsened over the day. Patient saw MD on 3/8/18 and MD gave oral antibiotic to treat.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt is 8 YO and received DAPTACEL indicated for 7 and under--no adverse reaction noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pustule, Injection site swelling, Injection site warmth
Clinical narrative: Right arm up to shoulder swollen and hot to touch. Dime size pustule area noted over IM injection KINRIX. Referred directly to MD.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on his right inner and posterior thigh and calf. Also with two small rashes left buttock.
Age: 18.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Feeling abnormal, Loss of consciousness, Seizure
Clinical narrative: The vaccination was administer and about 30 seconds after the administration, the pt began to loss consciousness. The pt began convulsing for about 1 minute. After 1 minute, the pt regained consciousness but was slightly dazed and didn't know what had happened.
Age: 18.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Seizure
Clinical narrative: The vaccination was administer and about 30 seconds after the administration, the pt began to loss consciousness. The pt began convulsing for about 1 minute. After 1 minute, the pt regained consciousness but was slightly dazed and didn't know what had happened.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Patient had pain after vaccination. Pain spread to elbow and hand. Patient went to Dr office and receive a steroid shot.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: Patient reports of pain in arm from when she got the vaccine for 3 weeks.
Age: 32.0
Sex: M
Vaccine: YF
Symptoms: Hyperhidrosis, Hypertension, Nausea, Pyrexia, Swollen tongue
Clinical narrative: Nausea, vomiting, vertigo, swollen tongue, sweating, fever, HTN 12 hours after the vaccine.
Age: 32.0
Sex: M
Vaccine: YF
Symptoms: Vertigo, Vomiting
Clinical narrative: Nausea, vomiting, vertigo, swollen tongue, sweating, fever, HTN 12 hours after the vaccine.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient began with swelling at the site on 3/1/2018 which has gotten larger until she presented today (3/8/2018). Area of redness approximately 8 cm  by 4 cm on upper R arm. Warm to touch, do discharge or sign of infection.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal X-ray, Abdominal pain upper, Bacterial infection, Chills, Diarrhoea
Clinical narrative: Symptoms began roughly 12 hours after vaccine was administered. Flu-like symptoms. Headache, extreme fatigue, body aches, fever, chills. For the following week, extremely watery diarrhea numerous times a day along with headaches and fatigue. Eight days later, Saturday February 3rd - symptoms progressed to vomiting, diarrhea, headache, fatigue, nausea, stomach cramps, stomach pain, dizziness. These symptoms continued until February 23rd. Blood results showed bacterial infection and an allergic response. Ultrasound normal. X Ray normal. Symptoms began to slowly improve on their own February 24th.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Headache, Hypersensitivity, Influenza like illness
Clinical narrative: Symptoms began roughly 12 hours after vaccine was administered. Flu-like symptoms. Headache, extreme fatigue, body aches, fever, chills. For the following week, extremely watery diarrhea numerous times a day along with headaches and fatigue. Eight days later, Saturday February 3rd - symptoms progressed to vomiting, diarrhea, headache, fatigue, nausea, stomach cramps, stomach pain, dizziness. These symptoms continued until February 23rd. Blood results showed bacterial infection and an allergic response. Ultrasound normal. X Ray normal. Symptoms began to slowly improve on their own February 24th.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test normal, Nausea, Pain, Pyrexia, Ultrasound abdomen normal
Clinical narrative: Symptoms began roughly 12 hours after vaccine was administered. Flu-like symptoms. Headache, extreme fatigue, body aches, fever, chills. For the following week, extremely watery diarrhea numerous times a day along with headaches and fatigue. Eight days later, Saturday February 3rd - symptoms progressed to vomiting, diarrhea, headache, fatigue, nausea, stomach cramps, stomach pain, dizziness. These symptoms continued until February 23rd. Blood results showed bacterial infection and an allergic response. Ultrasound normal. X Ray normal. Symptoms began to slowly improve on their own February 24th.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound scan normal, Vomiting, White blood cell count increased, X-ray normal
Clinical narrative: Symptoms began roughly 12 hours after vaccine was administered. Flu-like symptoms. Headache, extreme fatigue, body aches, fever, chills. For the following week, extremely watery diarrhea numerous times a day along with headaches and fatigue. Eight days later, Saturday February 3rd - symptoms progressed to vomiting, diarrhea, headache, fatigue, nausea, stomach cramps, stomach pain, dizziness. These symptoms continued until February 23rd. Blood results showed bacterial infection and an allergic response. Ultrasound normal. X Ray normal. Symptoms began to slowly improve on their own February 24th.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Induration
Clinical narrative: Palpable induration starting on day of injection that continues 4 months post injection. Afebrile. No symptoms from what we can tell given that patient is non-verbal.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT CALLED PHARMACY OF 03/08/18 TO REPORT REDNESS AND SWELLING. SHE SAID IT DID NOT BURN OR WAS NOT SORE BUT THE REDNESS AREA WAS ENLARGING SHE THOUGHT. I TOLD  HER TO TAKE A BENADRYL AND GO SEE HER DOCTOR. SHE WENT TO HER DOCTOR WHO VERIFIED IT WAS A REACTION AND INSTRUCTED HER TO TAKE BENADRYL EVERY 8 HOURS UNTIL REDNESS AND SWELLING WENT DOWN. I SAW THE PT THAT DAY AND INJECTION SITE AREA WAS RED AND SWOLLEN AND WARM TO THE TOUCH.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Developmental delay, Infantile spasms, Seizure
Clinical narrative: Child received 2 month vaccines, within days of receiving those vaccines the child began having infantile spasms. Since that began the child has been in and out of the hospital, developmentally significantly delayed and has received multiple drugs in order to try to combat the severe seizure disorder.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Broke out in hives to back. No respiratory involvement. No swelling to face. Occurred about an hour after injections. Father stated that he had not eaten anything after shots were given.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Haematochezia, Irritability, Ultrasound abdomen
Clinical narrative: Increased fussiness, irritability and bloody jelly like stools.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patients arm turned red all the way down the arm, but not directly around injection site. She also got a swollen bubble of fluid about the size of a quarter down by her elbow. Applied ice and swelling and redness gradually receding.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, X-ray
Clinical narrative: Pt had severe arm pain that started following day that has persisted since the vaccination was given.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; Only a few hours then returned to normal.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: REDNESS AROUND VACCINATED AREA.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, tenderness, swelling.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site movement impairment, Injection site pain, Middle insomnia, Myalgia, Pain
Clinical narrative: The vaccine was administered on Thursday, February 22nd. Left arm was sore on Friday. On Saturday morning, the 24th, the arm could not be raised higher than the waist and was extremely painful. After several days the movement was easier, but movement was still painful. I wake in the night to extreme pain which will not improve without getting out of bed and moving around. The pain is located in the left shoulder and into the back and neck muscles adjacent to the shoulder.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, X-ray limb
Clinical narrative: The vaccine was administered on Thursday, February 22nd. Left arm was sore on Friday. On Saturday morning, the 24th, the arm could not be raised higher than the waist and was extremely painful. After several days the movement was easier, but movement was still painful. I wake in the night to extreme pain which will not improve without getting out of bed and moving around. The pain is located in the left shoulder and into the back and neck muscles adjacent to the shoulder.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Started itchy then became red and painful for 3 days.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient had radiating pain in shoulder and down arm. He though he was having a heart attack. Went to the emergency room on the morning of 3/7/18. MD gave him a injection of anti inflammatory and said that the injection was put into the shoulder joint instead of the deltoid.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Joint noise, Limb discomfort, Musculoskeletal pain, Neck pain
Clinical narrative: Patient had radiating pain in shoulder and down arm. He though he was having a heart attack. Went to the emergency room on the morning of 3/7/18. MD gave him a injection of anti inflammatory and said that the injection was put into the shoulder joint instead of the deltoid.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient had radiating pain in shoulder and down arm. He though he was having a heart attack. Went to the emergency room on the morning of 3/7/18. MD gave him a injection of anti inflammatory and said that the injection was put into the shoulder joint instead of the deltoid.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Blister, Erythema, Pain, Pruritus, Secretion discharge
Clinical narrative: Redness swelling (softball size) itching, painful to move, oozing, blistered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Swelling
Clinical narrative: Redness swelling (softball size) itching, painful to move, oozing, blistered.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Urticaria
Clinical narrative: Patient developed hives all over body. Symptoms began a few hours after shot was given, symptoms include not feeling well. MEDROL dose pak was given, 4 mg.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fatigue, Nausea, Pallor, Pyrexia, Respiratory tract congestion
Clinical narrative: Pt. had TRU and MCV yesterday then went to school, felt feverish (not taken) and nauseous after that, also noted to be pale at school; tired after and slept 12 hrs; has congestion and ST this AM, still feeling tired and fever, no SOB, no V/D, no cough.
Age: 61.0
Sex: M
Vaccine: DTP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: 12/04/17 clinic note: Report of tetanus shot pain x2 weeks. Pt increased oxycodone/APAP from 1x to 2-3x/week for (R) arm tetanus shot pain. Pain is 4/10 right deltoid injection. Pt was instructed to RTC if pain persisted.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia, Rash macular
Clinical narrative: Patient reported on 3/8/18 arm is red, swollen, and tender to the touch. Redness is also blotchy. patient was advised to take BENADRYL and Ibuprofen and to call MD. Also stated she had slight fever and chills on day of vaccination.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient reported on 3/8/18 arm is red, swollen, and tender to the touch. Redness is also blotchy. patient was advised to take BENADRYL and Ibuprofen and to call MD. Also stated she had slight fever and chills on day of vaccination.
Age: 0.83
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash at injection site, swollen and hard, warm to touch.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: Complaints of numbness and tingling in all four extremities, back pain, reduced range of motion of back. Referred to physical therapy. Currently seeing physical therapy weekly. Patient does not report improvements of symptoms.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's spouse reported patient's arm is slightly red and swollen. Advised to take BENADRYL and TYLENOL and call MD.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Cranial nerve disorder, Eye pain, Headache, Hypoaesthesia oral, Musculoskeletal pain
Clinical narrative: This serious spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 730001), concerns a 52-year-old adult female patient. The patient's historical conditions included dumping syndrome, peptic ulcer disease, femoral neck cyst, drug induced pancreatitis and drug induced seizures (lidocaine). Historical drugs with adverse events included: ALFENTA (severe itching, vomiting and nausea) for which the patient was treated with 75 mg BENADRYL (75mg) and was in post-anaesthesia care unit (PACU), TEQUIN (severe abdominal pain, nausea and vomiting), Clindamycin (rash, nausea and vomiting), Gabapentin (chest pains), SUFENTA (severe itching) (scratched skin off), MIDRIN and PAMPRIN (pancreatitis), STADOL and Nickel (contact dermatitis), lidocaine (seizures), LAMICTAL (severe abdominal pains), COMPAZINE (Bell's palsy), CELEBREX (truncal rash on right side of body), MAXALT (weakness, mouth blisters, severe malaise), Niacin (projectile vomiting and chest pain), DONNATAL, TAGAMET, and acetyl salicylic acid (ASA) (Hives for which hospitalization had occurred), DEMEROL (anaphylaxis requiring intubation), Latex (respiratory distress and contact dermatitis), sulfa drug (rash), Penicillin (PCN) delayed reaction then truncal rash which lasted for 10 days. The patient's current conditions included asthma, migraines, Raynaud's disease, bil polyneuropathy UE, carpal tunnel syndrome, hypoglycaemia, Meckel's diverticulum, right Piriformis syndrome, Sphincter of Oddi dysfunction (unsuccessful ERCP), Fibromyalgia, cold sore (3 weeks prior), C3-C6 disc problem and right snapping hip syndrome (since unspecified dates). The patient was allergic to REGLAN, NUBAIN, VICODIN, PHENERGAN, TIGAN, TOFRANIL, MOTRIN, TORADOL, bil, Morphine, codeine, Penicillin, sulfa drugs, food (cantaloupe, monosodium glutamate (MSG), chocolate, caffeine, milk) and Latex, adhesive (EKG pads, tape band-aids-contact dermatitis). It was reported that fentanyl and MARCAINE showed positive skin test and the patient had seasonal allergies. The patient's concomitant medications included ASTELIN, SINGULAIR, ZYRTEC, Vitamin E, Vitamin D, Nitrofurantoin, VESICARE, Mirabegron, TYLENOL, Sinus, PROTONIX, BIOTENE, Calcium and Vitamin D, IMITREX and ZOFRAN for an unknown indication. On 01-Dec-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On the same day, after the administration of vaccine, the patient was taken to the emergency room as she experienced blurred vision, severe headache, numbness in tongue that deviated to left cranial nerve 7, 9, 12 involvement. The patient experienced pain behind right ear that extend into jaw and eye and down into neck and shoulder. The outcome of the events (cranial nerve disorder, shoulder pain, vision blurred, eye pain and headache) was reported as not recovered.