chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 88-year-old female patient who received SHINGRIX for prophylaxis. On 23rd January 2019, the patient received the 2nd dose of SHINGRIX. On 23rd January 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 24th January 2019, the patient experienced feeling unwell, appetite lost and nausea. On 25th January 2019, the patient experienced diarrhea and fatigue. On an unknown date, the outcome of the pain in arm, feeling unwell, nausea, diarrhea and fatigue were recovering/resolving and the outcome of the appetite lost was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, feeling unwell, appetite lost, nausea, diarrhea and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 87 or 88 year. The patient experienced arm soreness on Wednesday that worsened but doing better at the time of reporting. She also experienced not feeling well, no appetite and nausea on Thursday. By Friday she was sick, diarrhea and fatigue. The patient was feeling fair at time of reporting, but was unsure if it was the product or a bug she had caught. Prescribing information was reviewed for side effects and she was referred to her physician. The reporter consented to follow up.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site nodule in a 28-year-old female patient who received ENGERIX B adult (batch number J2J9R, expiry date 14th September 2021) for prophylaxis. On 23rd January 2019, the patient received the 3rd dose of ENGERIX B adult (intramuscular). On 23rd January 2019, less than a day after receiving ENGERIX B adult, the patient experienced injection site nodule, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site nodule, injection site erythema and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site nodule, injection site erythema and injection site pain to be related to ENGERIX B adult. Additional details were provided as follows: The patient received a dose of ENGERIX-B adult in left arm. The patient developed a nodule at the injection site and were still visible with a little redness in the center. It was painful when pressure was applied. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had horrible pain at the injection site and he could not move his arm and this pain was still occurring and it had been months since patient received SHINGRIX. The reporter could not remember the patient's name or demographic information since the initial reason for his call was to ask about timing of SHINGRIX vaccine in the patients receiving steroid injection, then the healthcare professional mentioned the 3 separate patients with rare side effects these patients were complaining about after receiving SHINGRIX, but healthcare professional did not remember these patient's names or demographic information. Three separate adverse events for three separate patients reported for this one healthcare professional. This case has been linked to the US2019015728 and US2019015736, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe pain and rash at the injection site. The reporter did not consent to follow-up. The reporter had limited information regarding the event and the health care professional did not want to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 25th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the injection site erythema, pain in arm and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site erythema, pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient experienced injection site redness, which was about 3.5 by 4 inches in size and lasted for a few days and resolved. The patient also experienced arm soreness and was unable to use her arm normally until about 6 weeks after the shot and it has resolved. The reporter did not consent to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue, Inappropriate schedule of product administration, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tiredness in a 63-year-old male patient who received SHINGRIX (batch number 9349T, expiry date 7th March 2021) for prophylaxis. Co-suspect products included SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. Concomitant products included SHINGRIX. On 15th October 2018, the patient received the 2nd dose of SHINGRIX. On 17th December 2018, the patient received the 3rd dose of SHINGRIX. On 15th October 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 17th December 2018, the patient experienced extra dose administered. On an unknown date, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were not recovered/not resolved and the outcome of the drug dose administration interval too short and extra dose administered were unknown. It was unknown if the reporter considered the tiredness and pain to be related to SHINGRIX. Additional details were provided as follows: On 9th October 2018, the patient received 1st dose of SHINGRIX(batch number 9349T, expiry date 7th March 2021). The patient inadvertently received 3 doses of SHINGRIX, which led to extra dose administered. The patient received 2nd dose of SHINGRIX earlier than recommended interval, which led to shortening of vaccination schedule. The patient now complained of feeling tired and achy since the last dose was administered. The batch number of SHINGRIX was updated from EH927 to EH9Z7, according to sales data sheet. Consent to follow up was given. Doctor reports that the patient's physical exam was normal. The reporter listed all 3 doses of SHINGRIX for chronology and because of the concern that the cumulative effect might be impacting the patient's symptoms. Lab Comments: On an unknown date, the patient's physical examination was normal.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital blister
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of genital blister in a 57-year-old male patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. The patient's past medical history included genital blister (the patient had history of genital blisters). On 1st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, 7 days after receiving SHINGRIX, the patient experienced genital blister. On an unknown date, the outcome of the genital blister was recovered/resolved. It was unknown if the reporter considered the genital blister to be related to SHINGRIX. Additional details were provided as follows: The patient has on history of genital blisters. The nurse reported that the patient received a dose of SHINGRIX and about 1 week after the injection the patient developed bad genital blisters that lasted for several weeks. The patient did not seek any medical treatment and had no new sexual partners. The blisters did finally resolve without treatment.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site swelling, Pyrexia
Clinical narrative: Fever, headache, swelling on shot area, joint pain.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Needle issue, Syringe issue, Underdose
Clinical narrative: Full dose wasn't given. The needle separated from the syringe (while in the child's thigh) and the immunization spilled out .
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Axillary pain, Breast pain, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Pain in upper arm, originally originating from injection site, later to shoulder, armpit, and upper breast area. I have difficulty in dressing, holding items, (dog leash), even the motion of driving (steering)  an cause pain. Pain is worse when sleeping or first thing in the morning.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site reaction, Insomnia
Clinical narrative: On 2/5/19, around 0200, I awoke with severe pain to my left shoulder, left scapula, left deltoid, and left armpit (6/10 pain scale). This was alleviated with NAPROSYN 500mg and brought pain down to a 3/10. At 0600, when I got up, I noticed lymphadenopathy to my left armpit and left breast. The injection site was slightly reddened, tender to palpation, but the majority of the pain continued to surround the same areas as mentioned above. Lifting my arm in any direction is extremely painful. At 1600 I noticed 7 red welts (approx. 1-2cm in diameter each) surrounding the injection area. Welt symptoms only included erythema. At 2000 the pain was severe and I used an ice pack in addition to NAPROSYN and ULTRAM.    On 2/6/19, I awoke again at 0200 to similar pain from the previous night.  I was unable to sleep on my left side due to the pain.  Lifting my arm in any direction remains extremely painful.  The lymphadenopathy remained, especially in my left armpit.  The welts combined into one giant welt approx. 8x8cm with three 1-2cm satellite welts.  Welt symptoms remain only with erythema.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Musculoskeletal pain, Pain, Urticaria
Clinical narrative: On 2/5/19, around 0200, I awoke with severe pain to my left shoulder, left scapula, left deltoid, and left armpit (6/10 pain scale). This was alleviated with NAPROSYN 500mg and brought pain down to a 3/10. At 0600, when I got up, I noticed lymphadenopathy to my left armpit and left breast. The injection site was slightly reddened, tender to palpation, but the majority of the pain continued to surround the same areas as mentioned above. Lifting my arm in any direction is extremely painful. At 1600 I noticed 7 red welts (approx. 1-2cm in diameter each) surrounding the injection area. Welt symptoms only included erythema. At 2000 the pain was severe and I used an ice pack in addition to NAPROSYN and ULTRAM.    On 2/6/19, I awoke again at 0200 to similar pain from the previous night.  I was unable to sleep on my left side due to the pain.  Lifting my arm in any direction remains extremely painful.  The lymphadenopathy remained, especially in my left armpit.  The welts combined into one giant welt approx. 8x8cm with three 1-2cm satellite welts.  Welt symptoms remain only with erythema.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Chills, Headache, Influenza like illness, Pain in extremity
Clinical narrative: Flu-like symptoms. Headache, chills, fever, upset stomach, very sore arm for 24 hours. TYLENOL helped with the fever.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Flu-like symptoms. Headache, chills, fever, upset stomach, very sore arm for 24 hours. TYLENOL helped with the fever.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, MMRV, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There was no adverse event with this patient. However, on this day, other nurse's were completing inventory and were in the room where the freezer is located, making it congested. When the vaccine was replaced (post inventory), the two vaccines on this shelf were switched from their normal location. I reached in to grab the varicella from its normal location and instead grabbed the MMRV and gave it to the patient. I did call the parent to make her aware of the fact that her child had received both the MMR and the MMRV on this day. During the call, I made her aware of the need to watch her for increased temperature and reminded her of the possibility of the rash in that 5-12 day period. The mother voiced an understanding and thanked me for the phone call. The vaccine was also re-positioned on this day to its normal location in the freezer. To our knowledge, no physician visit was required.
Age: 1.17
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Fluid intake reduced, Irritability, Pyrexia
Clinical narrative: Low grade fever for past 3 days, irritable, not taking in much fluids.
Age: 1.75
Sex: F
Vaccine: DTAP, FLU4, HEP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site movement impairment
Clinical narrative: Mother called 02/06/19 at 8:03AM stating that daughter awoke from a nap on 02/05/19 and refused to stand of walk. Nurse asked if mother had moved daughter's legs, and mother states that she did, and gave her acetaminophen, but no relief noted. Nurse checked with supervisor and called mother back, stating to follow up with pediatrician. Mother called nurse back at 11:05AM and stated that her daughter is now started to stand and walk.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling
Clinical narrative: Swelling arm.
Age: 10.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Parent called after hours nurse on 01/25/2019 that patient c/o redness and soreness at injection site. Patient seen in office on 01/26/2019, sent home on supportive care. Presented to clinic on 01/272019 with pain, redness and numbness at injection site and temp of 102. Dx with cellulitis, sent home on clindamycin. Seen in office on 01/28/2019 with same symptoms, increased clindamycin. Presented to ED on 01/28/2019 at 1843, admitted as inpatient with dx of cellulitis to left arm, discharged on 01/31/2019.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pharyngeal swelling, Rash, Restlessness, Urticaria
Clinical narrative: Patient reports getting hives, throat swelling, and restlessness (couldn't sleep) all beginning at about 9pm on the same day as the shot was administered. She states the hives (with raised bumps) resolved within 1 day, however the rash associated with it lasted approximately 3 days. Throat swelling was better by the next morning, so only lasted about 12 hours. The restlessness lasted for 3 nights.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Vaccine was given in the arm close to the elbow not in the deltoid. My daughter was complains of numbness and the sight was swollen and red for two days. I applied Ice for two days to get the swollen down.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Headache, muscle aches, shivering and chills, fatigue, sore arm. Symptoms began about 12 hours after injection and began to lessen after about 5 hours. It has now been 20 hours since vaccine, and I still have mild symptoms of headache, muscle aches, and sore arm.
Age: 35.0
Sex: F
Vaccine: FLU4, MMR, TDAP
Symptoms: Abscess, Incisional drainage, Inflammation
Clinical narrative: Received call from Dr. that this patient had seen in his office on 01-31-19 for a physical and complained of abscess and inflammation on right arm. Dr. called our office and left a voice message on 01-31-19 to notify our office. Our office was closed for a training 01-31-19 & 02-01-19. Contact was made by phone to Dr. on 02-04-19. He stated that he had seen patient and lanced and drained affected area. Patient was prescribed an antibiotic. Made contact with husband of patient to follow up 02-04-19. Husband stated that wife's affected area is healing well and she is taking antibiotic as prescribed, applying hydrogen peroxide, and applying pressure around area to cleanse wound as doctor instructed him to do. Husband self reported that patient had previously received vaccines given August 2018 but no paperwork or record available for verification of vaccines. It is unknown to spouse as to type of vaccines received in past by patient.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Hypoaesthesia, Malaise, Pain
Clinical narrative: Severe aching all over body, fever, general sickness for 4 days then one month later an identical reaction necessitating an emergency room visit. I lost 70% of the strength in my arms and hands for 2 weeks. I now have partial numbness and parenthesis in hands and feet.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Severe aching all over body, fever, general sickness for 4 days then one month later an identical reaction necessitating an emergency room visit. I lost 70% of the strength in my arms and hands for 2 weeks. I now have partial numbness and parenthesis in hands and feet.
Age: 13.0
Sex: M
Vaccine: MENB, PPV
Symptoms: Condition aggravated, Injection site pain, Pyrexia, Sickle cell disease
Clinical narrative: Patient began experiencing pain in right deltoid evening of vaccination 2/4/2019. Patient became febrile through the night and temp continued to rise. Patient was given ibuprofen when temp was 100.2. Pain continued to increase at injection site without erythema.Temp increased to 102.9 and was directly admitted to hospital d/t sickle cell diagnosis for monitoring /pain control/hydration.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Soreness in upper arm at injection site, General fatigue, feeling chilled, other body aches, headache.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 23-JAN-2019, the patient was vaccinated with a dose of improperly stored VARIVAX, lot # R022113, expiry date: 02-AUG-2020 or lot # R017639, expiry date: 20-JUN-2020 (strength, dose number, dose, units, route and anatomical location were not reported) for prophylaxis which was reconstituted with properly stored diluent. The vaccine with the lot # R022113 and lot # R017639 experienced temperature excursion from 6ºF to 14ºF (7ºF) for 30 minutes. Previous temperature excursion was reported to be from 6ºF to 14ºF (12ºF) for 8 hours and 15 minutes. The call was not due to digital data logger. At the time of the call it was unspecified which lot # of the vaccine was administered to the patient. No adverse effects were reported. The outcome of product storage error was unknown. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of headache in a 50-year-old male patient who received SHINGRIX for prophylaxis. In December 2017, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient did not know lot number or expiry date. The side effect reported headache on second day. For tolerance of 2nd dose of SHINGRIX, refer case US2019GSK017827.
Sex: F
Vaccine: MENB
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a week after receiving BEXSERO, the patient experienced fever, stiff neck and headache. The patient was treated with methylprednisolone sodium succinate (Solu-Medrol). On an unknown date, the outcome of the fever, stiff neck and headache were recovered/resolved. It was unknown if the reporter considered the fever, stiff neck and headache to be related to BEXSERO. Additional details were provided as follows: The patient was 18 or 19 year old. The patient received her 1st dose of BEXSERO and within 72 hours, developed fever, stiff neck, and headache. The symptoms lasted for approximately 5 days. The patient was seen in the emergency room and was treated with solu-medrol. The reporter did not have any additional details regarding the event and the emergency room visited was visit required. The reporter agreed to follow up from GSK.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, tenderness and itch, 4x5cm/around shot site x3 weeks.
Age: 48.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Unevaluable event
Clinical narrative: Use ice topically.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient reported severe pain in injected deltoid which radiates throughout the arm beginning soon after injection and to this date 2/6/19. She mentioned she will be going to see her physician soon regarding this.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Flu-like symptoms (fever, chills), soreness at injection site.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Acute respiratory distress syndrome, Back pain, Chills, Crying, Headache
Clinical narrative: Fever.  No other localizing symptoms up to 102.5. Rigors. No N/V/D. Ate a sandwich yesterday. Mild LBP with fever and HA with fever otherwise no HA. No contractions. Active baby. No ROM, VB.  No dysuria. Daughter had a fever, up to 101 a week ago - ? viral not treated. Husband has congestion. On exam pulse 120, RR 20, rigors, Gen - crying, tearful, shaking. Ch - CTA bilaterally, no retractions, No increase in work of breathing. Will send to L&D for admission and eval. Went into ARDS.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tearfulness, Tremor
Clinical narrative: Fever.  No other localizing symptoms up to 102.5. Rigors. No N/V/D. Ate a sandwich yesterday. Mild LBP with fever and HA with fever otherwise no HA. No contractions. Active baby. No ROM, VB.  No dysuria. Daughter had a fever, up to 101 a week ago - ? viral not treated. Husband has congestion. On exam pulse 120, RR 20, rigors, Gen - crying, tearful, shaking. Ch - CTA bilaterally, no retractions, No increase in work of breathing. Will send to L&D for admission and eval. Went into ARDS.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Fatigue, Myalgia, Nasal congestion
Clinical narrative: Persistent and continuing coughing for over a  month,fatigue, some  sore  throat, muscle aches, some stuffy nose, some difficulty breathing, and could not sleep well due to the continuous coughs.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Poor quality sleep, Viral infection
Clinical narrative: Persistent and continuing coughing for over a  month,fatigue, some  sore  throat, muscle aches, some stuffy nose, some difficulty breathing, and could not sleep well due to the continuous coughs.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient accidentally received a 3rd dose of flu vaccine.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Pain, Pyrexia
Clinical narrative: Persistent fever, irritability and pain.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: Patient reported pain after flu vaccine was administered, pain has not resolved. Has been treating at Occ Health since 11/15/18- present, treatment has consist of the following: Medrol dose pack, prednisone 20mg po daily x 10days, dexamethasone patch provided through physical therapy.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea, nausea and vomiting.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain, Asthenia, Chills, Erythema, Feeling cold
Clinical narrative: Painful swelling, and redness expanding daily, for the past week. General weakness, severe headaches, pain in abdomen, shivering, feeling cold when room is warm.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Pain, Swelling
Clinical narrative: Painful swelling, and redness expanding daily, for the past week. General weakness, severe headaches, pain in abdomen, shivering, feeling cold when room is warm.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Impetigo, Oral candidiasis, Oral mucosal eruption, Pyrexia, Vomiting
Clinical narrative: Monday 6 m WCC, shots at clinic. Tuesday fever (101.5) vomiting, fever improved and stopped vomiting back to daycare this morning (Wednesday) but now has white spots on mouth and rash around mouth. Eating/drinking okay. Mood is good. Strep going around daycare. Family members healthy. Not giving any medication at this time for symptoms. Is it related to vaccines? Only new one was influenza otherwise normal 6 month shots, which he had already at 4 mo check up. I am not sure whether his vomiting/fever the day after immunizations was related, so I am sending this along. Then 2 days after immunizations was seen in my facility for separate issues. **Note, I am at a different health care facility than where he gets well child care so I do not have access to that information. Today, Wednesday 2/6/19 I diagnosed him with oral thrush and impetigo on his chin/cheeks and started him on medications.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Patient experienced fever (tactile, value unknown), emesis, and diarrhea 2-3 days after each set of vaccinations at 2 months, 4 months, and 6 months. The vaccines in common given at these visits were PEDIARIX and PREVNAR. While a fever is a common reaction to these, the GI symptoms of emesis and diarrhea are not typically seen, and therefore, the provider wished to make you aware.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Hypotension, Incomplete course of vaccination, Muscle tightness
Clinical narrative: APPROXIMATELY 12 HOURS AFTER VACCINE PATIENT EXPERIENCED DIZZINESS, NAUSEA, HYPOTENSION, SHAKINESS, HEADACHE AND NECK TENSION. SHE WENT TO HER PCP AND HE PRESCRIBED ZOFRAN AND PREDNISONE AND ADVISED THAT SHE DOESN'T RECEIVE SECOND DOSE.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Tremor
Clinical narrative: APPROXIMATELY 12 HOURS AFTER VACCINE PATIENT EXPERIENCED DIZZINESS, NAUSEA, HYPOTENSION, SHAKINESS, HEADACHE AND NECK TENSION. SHE WENT TO HER PCP AND HE PRESCRIBED ZOFRAN AND PREDNISONE AND ADVISED THAT SHE DOESN'T RECEIVE SECOND DOSE.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU4
Symptoms: No adverse event
Clinical narrative: No signs or symptoms.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Patient reports throbbing pain/soreness at injection site 84 days following injection. No radiating pain or pain elsewhere. Will follow up with PCP at upcoming scheduled appointment.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fevers and chills overnight.
Age: 1.75
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Approximately 2-1-19 patient started with redness around shot site. Redness increased to about 2 inches and blisters appeared in clusters about pea sized. No fever. Pt. seen in our office 2-4-19. No fever. Round area of mild erythema was noted with cluster of dried vesicles. No swelling, but seems tender to touch. Pictures available to view.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Skin warm
Clinical narrative: Employee stated she felt numbness to arm of injection and warmth, symptoms are outside of common side effects listed on vaccine insert.
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Crying, Screaming
Clinical narrative: She received all vaccines as needed on time at her 2 month checkup on 1/9/19. She initially cried when vaccines were given, of course. Most babies do. The nurse went over "normal" behaviors after vaccines with me and when to call, etc. Around 2 PM 1/9/19 she woke up from a nap with an inconsolable cry/scream. I tried everything to get her to calm down. Nothing would work. I knew something didn't seem right due to her being a very happy baby and rarely ever crying. She most definitely has never screamed like that without being able to be calmed down. I called her doctor's office and told them what was happening. I took her in. The doctor checked her out, legs (injection site), head, other body parts and she said everything looked fine but this was definitely not a normal reaction. She was still screaming at this point. They gave her TYLENOL and we sat in the office for roughly 30-35 minutes. She was still crying but I did get her a little more calm to eat. It was around 5 PM when we finally were leaving. I called the doctor back the next day or so (can't remember the date) and she proceeded to let me know this was not a normal vaccine reaction again. I was at work with her while all of this took place so there were multiple people at my work as well as her doctor's office who witnessed this.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm red, swollen and hot to touch. Temp 102.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Chills, Diarrhoea, Headache
Clinical narrative: Patient reported: Around 10pm that night, patient noticed swelling/redness site of injection, redness radiated down to her underarm. Swollen lymph nodes under her arm, weakness. Nausea, body aches, headache, muscle pains in legs. Watery diarrhea. Shaking chills, reports she felt "deathly sick" and almost called the ambulance. T 101.5.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Patient reported: Around 10pm that night, patient noticed swelling/redness site of injection, redness radiated down to her underarm. Swollen lymph nodes under her arm, weakness. Nausea, body aches, headache, muscle pains in legs. Watery diarrhea. Shaking chills, reports she felt "deathly sick" and almost called the ambulance. T 101.5.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Tremor
Clinical narrative: Patient reported: Around 10pm that night, patient noticed swelling/redness site of injection, redness radiated down to her underarm. Swollen lymph nodes under her arm, weakness. Nausea, body aches, headache, muscle pains in legs. Watery diarrhea. Shaking chills, reports she felt "deathly sick" and almost called the ambulance. T 101.5.
Age: 48.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The patient presented to the pharmacy for 2 immunizations (BOOSTRIX and Flu shot). They were asked if they wanted 1 shot in either arm and they stated that they wanted them in both arms.  They were advised of the side effects and still wanted both shots in the same arm.  The patient called the pharmacy on 2/3/19 and stated that on 1/2/19 they experienced pain, hotness, and redness at the injection site.  They went to see a doctor and were prescribed and antibiotic and pain medicine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pain in extremity, Rash pruritic
Clinical narrative: I had the usual  flu like symptoms that evening past the 2nd injection, but there was also unusual aches and erratic shooting pains in my limbs. I was pretty much over this by the end of the next day. However, I began breaking out in a raised itchy/stingy/raw or burning type rash on the exact sites that the leaflet shows where you would normally have shingles rashes. It is not severe, but nevertheless unusual and continues to be bothersome. Wondering if I don't have a case of the shingles??
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Autopsy, Brain death, Death, Decreased activity
Clinical narrative: Over the next 4 days, showed a lack of smiling/laughing/playing, markedly increased sleep, began making bubbles. Slightly improving on 5th to 6th day, but still longer sleep patterns. On day 6, made "cooing" noise while being burped, then became unresponsive. Transported to the hospital and brain death pronounced the next day. Cause of death unknown.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Histology, Hypersomnia, Mechanical ventilation, Right ventricular hypertrophy, Toxicologic test
Clinical narrative: Over the next 4 days, showed a lack of smiling/laughing/playing, markedly increased sleep, began making bubbles. Slightly improving on 5th to 6th day, but still longer sleep patterns. On day 6, made "cooing" noise while being burped, then became unresponsive. Transported to the hospital and brain death pronounced the next day. Cause of death unknown.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Over the next 4 days, showed a lack of smiling/laughing/playing, markedly increased sleep, began making bubbles. Slightly improving on 5th to 6th day, but still longer sleep patterns. On day 6, made "cooing" noise while being burped, then became unresponsive. Transported to the hospital and brain death pronounced the next day. Cause of death unknown.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: Chills, violent shivering, fever, headache, body ache, general malaise, fatigue.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, violent shivering, fever, headache, body ache, general malaise, fatigue.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Abnormal behaviour, Asthenia, Choking, Fatigue, Pallor
Clinical narrative: 2y6m old pt here on nurse schedule for influenza vaccine dose #2. He did fine with dose #1 which was his first flu shot ever. Brother had a clinic appt and was being seen while said event occurred. Pt had been noted to be eating candy that mom brought along while exam of sibling took place. At approx 440-442, mom looked over and pt was slouched down by the chair, kneeling. She picked him up, said something is wrong. He had candy in his hands. Mouth was open and looked straight faced. Denies hx of food allergy, egg allergy. This was a rather sudden onset of change in behavior-along with the candy in his hand and the appearance of mouth open and lack of immediate breath suggested that he was choking. Back thrusts were given and child picked up his head, took a big breath and said "ok". I thought he had cleared his airway and he seemed improved but still "tired". Altered behavior involving weakness, palor, possible choking on candy began about 40 min post flu immun #2 with no hx of reaction to flu #1. Further evaluation took place, pt. monitored and provided repeat evaluations of over the course of 1 hour after this began. Vitals remained stable with BP stable, no desats, no angioedema, no rash or hives. Main symptoms were vomiting, palor, weakness. Improved after large amount of emesis x 1. Was able to drink water. Small sips.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Posture abnormal, Vomiting
Clinical narrative: 2y6m old pt here on nurse schedule for influenza vaccine dose #2. He did fine with dose #1 which was his first flu shot ever. Brother had a clinic appt and was being seen while said event occurred. Pt had been noted to be eating candy that mom brought along while exam of sibling took place. At approx 440-442, mom looked over and pt was slouched down by the chair, kneeling. She picked him up, said something is wrong. He had candy in his hands. Mouth was open and looked straight faced. Denies hx of food allergy, egg allergy. This was a rather sudden onset of change in behavior-along with the candy in his hand and the appearance of mouth open and lack of immediate breath suggested that he was choking. Back thrusts were given and child picked up his head, took a big breath and said "ok". I thought he had cleared his airway and he seemed improved but still "tired". Altered behavior involving weakness, palor, possible choking on candy began about 40 min post flu immun #2 with no hx of reaction to flu #1. Further evaluation took place, pt. monitored and provided repeat evaluations of over the course of 1 hour after this began. Vitals remained stable with BP stable, no desats, no angioedema, no rash or hives. Main symptoms were vomiting, palor, weakness. Improved after large amount of emesis x 1. Was able to drink water. Small sips.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid function disorder, Facial paralysis, Headache, Neck pain, Pain
Clinical narrative: I awoke with facial paralysis on the Right side of my face (could not close my eye, my mouth was drooping and I could not talk well or eat/drink).  A trip to the emergency room ruled out a stroke, and Dr. determined it was Bell's Palsy. I was given prescriptions for Prednisone, Acyclovir, White petrolatum mineral eye ointment and Artificial Tears, and was told to take OTC pain medication for the pain and headaches. Improvement began after approximately 4 weeks and is slowly improving, though I still cannot close my eye, mouth droops, and I wake with terrible headaches and pain on the right side of my head and neck.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder
Clinical narrative: I awoke with facial paralysis on the Right side of my face (could not close my eye, my mouth was drooping and I could not talk well or eat/drink).  A trip to the emergency room ruled out a stroke, and Dr. determined it was Bell's Palsy. I was given prescriptions for Prednisone, Acyclovir, White petrolatum mineral eye ointment and Artificial Tears, and was told to take OTC pain medication for the pain and headaches. Improvement began after approximately 4 weeks and is slowly improving, though I still cannot close my eye, mouth droops, and I wake with terrible headaches and pain on the right side of my head and neck.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Generalised erythema, Seizure, Swelling, Swelling face
Clinical narrative: Pt says after about 2 hours she had a seizure, she went to ER and stayed in hospital overnight. Pt also states head, face is swollen and she was flourescent red all over for about 20 hours.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Generalised erythema, Seizure, Swelling
Clinical narrative: Pt says after about 2 hours she had a seizure, she went to ER and stayed in hospital overnight. Pt also states head, face is swollen and she was flourescent red all over for about 20 hours.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 15 year old patient, of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On an unknown date, when the patient was 14 years old, the patient was vaccinated with the fist dose of GARDASIL 9 (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. Subsequently, 13 months after receiving the first dose,the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided), at the age of 15 years old (inappropriate schedule of product administration). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were unknown. It was unknown if the reporter considered the fever and myalgia to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The reporter did not know the date of birth of patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Patient reports that 2 days after her vaccines she experienced pains and swelling at the injection site. She reports that 5 days out the redness is larger and itchy.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bundle branch block right, Disorientation, Dizziness, Electrocardiogram abnormal, Fatigue
Clinical narrative: Patient had 3 episodes of dizziness @ 9-9:30 am, 11:30-12 pm and 6:30 pm. 61 y/o female played tennis at 9 am, tried some bread, minutes later, felt dizziness, (didn't feel like it was vertigo); felt better, and played tennis, at 1130 ate bread, and again felt dizzy, sat down, then felt disoriented, felt tired, unsure if passed out, went upstairs and showered, went out and ran errands, 630 pm felt dizziness, called husband and found to be seated on chair and hand shaking for 5 sec, fell asleep on sofa, couldn't sleep well; did wake up with headache and resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Poor quality sleep, Syncope, Tremor
Clinical narrative: Patient had 3 episodes of dizziness @ 9-9:30 am, 11:30-12 pm and 6:30 pm. 61 y/o female played tennis at 9 am, tried some bread, minutes later, felt dizziness, (didn't feel like it was vertigo); felt better, and played tennis, at 1130 ate bread, and again felt dizzy, sat down, then felt disoriented, felt tired, unsure if passed out, went upstairs and showered, went out and ran errands, 630 pm felt dizziness, called husband and found to be seated on chair and hand shaking for 5 sec, fell asleep on sofa, couldn't sleep well; did wake up with headache and resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Disorientation, Dizziness, Fatigue, Nausea, Syncope
Clinical narrative: Patient had 3 episodes of dizziness @ 9-9:30 am, 11:30-12 pm and 6:30 pm. 61 y/o female played tennis at 9 am, tried some bread, minutes later, felt dizziness, (didn't feel like it was vertigo); felt better, and played tennis, at 1130 ate bread, and again felt dizzy, sat down, then felt disoriented, felt tired, unsure if passed out, went upstairs and showered, went out and ran errands, 630 pm felt dizziness, called husband and found to be seated on chair and hand shaking for 5 sec, fell asleep on sofa, couldn't sleep well; did wake up with headache and resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: Patient had 3 episodes of dizziness @ 9-9:30 am, 11:30-12 pm and 6:30 pm. 61 y/o female played tennis at 9 am, tried some bread, minutes later, felt dizziness, (didn't feel like it was vertigo); felt better, and played tennis, at 1130 ate bread, and again felt dizzy, sat down, then felt disoriented, felt tired, unsure if passed out, went upstairs and showered, went out and ran errands, 630 pm felt dizziness, called husband and found to be seated on chair and hand shaking for 5 sec, fell asleep on sofa, couldn't sleep well; did wake up with headache and resolved.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt. received vaccine on 02/04/2019 stated on 02/05/2019 she woke up and it was tender 02/06/2019 it was red with a rash and hot to touch and swollen. Pt. was seen in clinic by staff who told pt. to ice her arm and take antihistamine. She also told pt. if it does not get any better an a couple of days to come back and been seen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Hot, Red and swollen at the site of injection.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Rash erythematous, Swelling, Throat irritation, Vomiting
Clinical narrative: Pt stated that after receiving the flu vaccine on 2/4 that she started having nausea and vomiting the evening of 2/5/19. Pt states today she is still having nausea and vomiting. Pt also states that this morning she woke up with a red rash to the right side of her face with some swelling and her throat burned. Pt denied any itching, difficulty swallowing, or fever. Pt did appear to have a rash on the right side of her face with very small non-raised red spots. Pt stated swelling went away and that her rash had gotten better throughout the day, but is concerned that it was an allergy to the flu vaccine.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site warmth, Pain in extremity, Paraesthesia
Clinical narrative: The patient stated he experienced arm soreness, tingling, sweating, and redness at the injection site the day after receiving the immunization. The patient stated he was feeling better two days following the immunization. Redness and heat was isolated to the deltoid area of the left arm. The patient was advised to follow up with his primary care doctor if he had any further symptoms or felt more comfortable seeing the physician.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: 2 days after receiving SHINGRIX vaccine patient developed a itchy, papular rash on the opposite arm.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Pallor, Tremor
Clinical narrative: Dizziness, nausea, lost color in face, shaking.