chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient should have received flucelvax instead of fluad due to age. no issues as of yet
Age: 20.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; on 19/08/19 a 20 year old patient received a dose of PROQUAD; This spontaneous report was received from a health professional and refers to a 20-year-old patient of unknown gender. No information regarding patient's concurrent conditions, medical history and concomitant medications was reported. On 19-AUG-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot #S003861, expiration date 08-AUG-2020 (dose, route of administration, anatomical site of injection were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patient received second dose in VARIVAX series that was improperly stored; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent condition and medical history were unknown. The patient's concomitant medication included steril diluent. On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (frequency, route of administration, lot # and expiry date unspecified) for prophylaxis. On 09-SEP-2019, the patient received second dose of varicella virus vaccine live (oka/merck)(VARIVAX) series (of lot # R020650 with expiry date 18-JUL-2020) that was improperly stored(product storage error). Sterile diluent was properly stored. On an unknown date in April 2019, the vaccine was exposed to 7.7 Fahrenheit (F) for 30 minutes. Previous temperature excursion was at 6 F to 14 F for 188 minutes. Data logger was involved. No adverse effects reported (no adverse event). The outcomes of the events were unknown.
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Breath holding, Cyanosis, Pallor
Clinical narrative: Patient was here for well visit and vaccines. During vaccinations, patient started having breath holding spells where she turned white and blue around the mouth. Did not give the 4th vaccination after this was noted. We picked baby up to stimulate her to breathe. Had the physician check her after the episode and had the parent wait in the office for 30 + minutes until she was back to her normal self. Tried to contact mom this morning to follow up and make sure the baby didn't have any problems throughout the night. Unable to contact parent. Phone rang, never went to voicemail
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, IPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction was seen 15 min after vaccine was administered
Age: 62.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Cold sweat, Laboratory test normal, Lethargy, Nausea, Pulse abnormal
Clinical narrative: After receiving both shots, the patient fainted for 15 seconds. She came to feeling lethargic and nauseated. She was awake but closed her eyes. Her skin became cool and clammy. Pulse was weak. After about 20 minutes, 911 was called.
Age: 62.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Syncope
Clinical narrative: After receiving both shots, the patient fainted for 15 seconds. She came to feeling lethargic and nauseated. She was awake but closed her eyes. Her skin became cool and clammy. Pulse was weak. After about 20 minutes, 911 was called.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Tremor, Vision blurred
Clinical narrative: maybe or maybe not related: Elevated Blood Sugar 3 hrs post IM influenza pt reports "I felt like I was crashing". Pt had breakfast and 10 units of humalog earlier. She started to experience blurred vision and shakiness. Pt took blood glucose Reading and it was 275. She reports never has blood glucose that high so she repeated and was 276. Pt took 10 more units of Humalin and ate lunch. Symptoms resolved that evening and got a blood sugar of 94. The only thing different from her normal routine was the vaccination. She believes that it is somehow related to this event.
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: Headache; Fever; Joint Ache; Chills; Flu Like Symptoms
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash, Rash erythematous, Urticaria
Clinical narrative: Received vaccines on 09/04/2019.   At 9 am on 09/05/2019 mother woke baby and noted red rash left thigh.   Arrived to office and rash had spread over body.   Diagnosis urticaria.   No wheezing, coughing or difficulty breathing.   Playing as usual.   No recent change inn soaps lotions, detergents,etc.   Dad sprayed Febreeze on their bedding last night when cleaning but father comments baby exposed to the same Febreeze when 3 yo sprayed it on him before and no reaction at that time.   Mild reaction at visit - parents counseled t observe for signs of anaphylaxis and present to ED if noted.   Prescribed Cetirizine HCL 5mgm/5ml oral solution - take 2.5 ml daily prn rash and itching.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Feeling abnormal, Vomiting
Clinical narrative: pt reported dizziness, falling, vomiting and overall feeling terrible.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Injected limb mobility decreased, Injection site joint effusion, Injection site pain
Clinical narrative: At  2 p.m, after a nap awoke with severe left arm pain and swelling adjacent to injection site but primarily a joint effusion left shoulder, so painful could hardly move it. one hour later, 3 p.m. faintness, unresponsive to wife's  questions, very "white", called EMT, around 3:15, arrived, bp 80/46.  Had large soft b.m., bp in ambulance up to 150. Taken to ER.  Tired but responsive, bp around 135-50. Lab tests all neg,  urinalysis neg.  Given fluid, discharged after 3 hours, diagnosis presyncope.  Main problem persisting is severe left should pain and swelling. On 9/4-- very tired but no fever.  Area  of swelling - soft, no redness or tenderness.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Laboratory test normal, Pallor, Presyncope, Troponin normal
Clinical narrative: At  2 p.m, after a nap awoke with severe left arm pain and swelling adjacent to injection site but primarily a joint effusion left shoulder, so painful could hardly move it. one hour later, 3 p.m. faintness, unresponsive to wife's  questions, very "white", called EMT, around 3:15, arrived, bp 80/46.  Had large soft b.m., bp in ambulance up to 150. Taken to ER.  Tired but responsive, bp around 135-50. Lab tests all neg,  urinalysis neg.  Given fluid, discharged after 3 hours, diagnosis presyncope.  Main problem persisting is severe left should pain and swelling. On 9/4-- very tired but no fever.  Area  of swelling - soft, no redness or tenderness.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Unresponsive to stimuli, Urine analysis normal
Clinical narrative: At  2 p.m, after a nap awoke with severe left arm pain and swelling adjacent to injection site but primarily a joint effusion left shoulder, so painful could hardly move it. one hour later, 3 p.m. faintness, unresponsive to wife's  questions, very "white", called EMT, around 3:15, arrived, bp 80/46.  Had large soft b.m., bp in ambulance up to 150. Taken to ER.  Tired but responsive, bp around 135-50. Lab tests all neg,  urinalysis neg.  Given fluid, discharged after 3 hours, diagnosis presyncope.  Main problem persisting is severe left should pain and swelling. On 9/4-- very tired but no fever.  Area  of swelling - soft, no redness or tenderness.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site pain, Administration site swelling, Chills, Injection site erythema, Injection site induration
Clinical narrative: Moderately severe aches of large muscle groups, bilaterally, of the trunk and limbs and left neck (unilaterally). Chills, no detectable fever when checked with thermometer. Vaccine administration site swelling, peak approximately 2x3cm diameter at 24-30hrs post-administration, induration with mild redness. Symptoms persisted approximately 48 hrs; residual administration site soreness persists as of 1355CST on 5Sep19. Self-care:  bed-rest 8hrs, limited activities for 2days, and 1600mg motrin divided into 4 doses on 3-4Sep19. Have received most vaccines, from Anthrax to Japanese Encephalitis, and Rabies to Yellow Fever as an adult; the 2nd dose of Shingrix was associated with the most marked adverse event I've ever experienced, and the first one I've ever reported on myself-- although VAERS reporting was part of my job for years.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Moderately severe aches of large muscle groups, bilaterally, of the trunk and limbs and left neck (unilaterally). Chills, no detectable fever when checked with thermometer. Vaccine administration site swelling, peak approximately 2x3cm diameter at 24-30hrs post-administration, induration with mild redness. Symptoms persisted approximately 48 hrs; residual administration site soreness persists as of 1355CST on 5Sep19. Self-care:  bed-rest 8hrs, limited activities for 2days, and 1600mg motrin divided into 4 doses on 3-4Sep19. Have received most vaccines, from Anthrax to Japanese Encephalitis, and Rabies to Yellow Fever as an adult; the 2nd dose of Shingrix was associated with the most marked adverse event I've ever experienced, and the first one I've ever reported on myself-- although VAERS reporting was part of my job for years.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: severe pain/tenderness, swelling, and erythema of skin of right upper arm.  Treated with augmentin for presumed infection for 10 days.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Rash
Clinical narrative: States she was shivering, low grade fever (described as 98.3 temp), rash around her ankles with peeling skin, arm was extremely painful and was very very tired which lasted 2 days.  She states she received the rash when she got the Shingrix injection which was on 8/29/19 and still has it today (9/5/2019). She is using antibiotic ointment on the rash and states that the rash is responding to treatment.  I have notified her physician and they will be calling her to follow-up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: States she was shivering, low grade fever (described as 98.3 temp), rash around her ankles with peeling skin, arm was extremely painful and was very very tired which lasted 2 days.  She states she received the rash when she got the Shingrix injection which was on 8/29/19 and still has it today (9/5/2019). She is using antibiotic ointment on the rash and states that the rash is responding to treatment.  I have notified her physician and they will be calling her to follow-up.
Age: 1.92
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Tdap given to patient instead of Dtap, no adverse response at this time
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Had previous flu vaccines without incident.   This was a required vaccination given at the hospital that I worked in on Friday morning 11.9.2018 at approximately 8am.   Vaccination site without incident.   The following day, on Saturday 11.10.2018, I started experiencing severe joint pain in my elbows, shoulders, hips and knees.   I was barely able to walk to perform ADL's for the entire day as well as Sunday.   Severe pain continued and was medicated with alternating Tylenol and Motrin; ice packs and other comfort measures.  I was seen at the Urgent Care on 11.12.2018 and was prescribed prednisone for the condition and returned to work later that week.    Never previously nor since has joint pain been a  condition that I have suffered from.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Malaise, Pruritus
Clinical narrative: Systemic redness, itching, malaise;  1 Benadryl given priod to injection due to reaction to flu shot 2018
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and the patient regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2016, the patient (pt) was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (date unspecified) and was treated by a health care professional, and was hospitalized due to the event (date unspecified).  As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Malaise
Clinical narrative: body reactions; This case was reported by a consumer and described the occurrence of adverse reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. It was reported that the patient experienced body reaction after the vaccination. The patient was still experiencing the after effects ever since, it was worse every day. The patient actually feeling worse now even though it's been a few days. The reporter asked how long it should take. The reporter stated that side effects should have lasted 2 to 3 days. The patient's wife experiencing sore throat, difficult to swallow, conjusted sinuses and headache, but she had never received Shingrix shots. The pharmacist stated that Shingrix was not a live vaccine, it could not cause shingles or sore throat. The reporter asked whether the patient could develop virus that could spread to me. The pharmacist stated the patient could develop a virus but that would be unrelated to Shingrix. In the clinical trials, the most common adverse reactions were pain, redness, and swelling at the injection site. The most common general adverse events were myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms. The reporter asked whether 5 day reaction was uncommon.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Shingle like rash by injection site; Shingle like rash by injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site rash and vesicular rash. On an unknown date, the outcome of the injection site rash and vesicular rash were unknown.   It was unknown if the reporter considered the injection site rash and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that, provided the following statement and was wondering if shingrix is known to cause shingle like rash by injection site. The reporter did not consent to follow up. No further details was provided.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Infectious mononucleosis
Clinical narrative: Mononucleosis; This case was reported by a other health professional via call center representative and described the occurrence of mononucleosis in a 37-year-old female patient who received HBV (Engerix B adult) (batch number FT42N, expiry date 3rd February 2021) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Engerix B adult. In August 2019, 30 days after receiving Engerix B adult, the patient experienced mononucleosis. On an unknown date, the outcome of the mononucleosis was unknown.   It was unknown if the reporter considered the mononucleosis to be related to Engerix B adult.  Additional details were provided as follows: The pharmacy technician stated the patient who received Engerix B series and at the time of reporting has mono. No further details provided on the call. The pharmacy technician consents to follow up from safety. Adverse event submitted after call was completed. There was no second suspect vaccine. The reporter clicked on new vaccine rather than save and could not delete the second vaccine. Only the Engerix B was suspect.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm
Clinical narrative: Diagnosed with a tumor after receiving the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of neoplasm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced neoplasm. On an unknown date, the outcome of the neoplasm was recovering/resolving.   It was unknown if the reporter considered the neoplasm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient diagnosed with a tumor after vaccination.  The patient has been treated and now not immunocompromised. The reporter consented to follow up. On 29th August 2018, the patient received second dose of the Shingrix vaccine that to be administered. The patient came in for the second dose of Shingrix, been one year.   Lot number 3HX44 and expiry date  15th November 2021 , reported for 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Fatigue, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Redness; Pain; Swelling; Fatigue; Nausea; Vomiting; Chest Pain; Neck Pain; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced fatigue, nausea, vomiting, chest pain and neck pain. On 18th August 2019, the patient experienced injection site erythema, injection site pain and injection site swelling. On 22nd August 2019, the outcome of the injection site erythema, injection site pain and injection site swelling were recovered/resolved. On an unknown date, the outcome of the fatigue, nausea, vomiting, chest pain and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, fatigue, nausea, vomiting, chest pain and neck pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The case was reported by patient's husband. The patient received 1st dose Shingrix vaccine and had immediate pain, redness and swelling at the injection site that lasted approximately 3 to 4 days.  Since then the patient had significant fatigue, nausea and vomiting, anterior chest pain around her collar bones, and generalized neck pain that had not resolved. The reporter consented to follow up. The reporter to provide further information (initials and DOB).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Neck pain, Vomiting
Clinical narrative: Redness; Pain; Swelling; Fatigue; Nausea; Vomiting; Chest Pain; Neck Pain; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced fatigue, nausea, vomiting, chest pain and neck pain. On 18th August 2019, the patient experienced injection site erythema, injection site pain and injection site swelling. On 22nd August 2019, the outcome of the injection site erythema, injection site pain and injection site swelling were recovered/resolved. On an unknown date, the outcome of the fatigue, nausea, vomiting, chest pain and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, fatigue, nausea, vomiting, chest pain and neck pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The case was reported by patient's husband. The patient received 1st dose Shingrix vaccine and had immediate pain, redness and swelling at the injection site that lasted approximately 3 to 4 days.  Since then the patient had significant fatigue, nausea and vomiting, anterior chest pain around her collar bones, and generalized neck pain that had not resolved. The reporter consented to follow up. The reporter to provide further information (initials and DOB).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy, Non-Hodgkin's lymphoma
Clinical narrative: slow growing Non-Hodgkin's lymphoma; This case was reported by a pharmacist via call center representative and described the occurrence of non-hodgkin's lymphoma in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th March 2019, the patient received the 1st dose of Shingrix. In March 2019, 14 days after receiving Shingrix, the patient experienced non-hodgkin's lymphoma (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the non-hodgkin's lymphoma was unknown.   It was unknown if the reporter considered the non-hodgkin's lymphoma to be related to Shingrix.  Additional case details were provided as follows: Two weeks after the 1st dose of Shingrix, the patient was diagnosed with slow growing Non-Hodgkin's lymphoma.  The patient started chemotherapy one month later and received chemotherapy once monthly. The reporter stated that, since the patient received 1st vaccine at another pharmacy, the information regarding the responsible practitioner or vaccine given was not available. The reporter consented to follow up.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Impaired driving ability, Nausea
Clinical narrative: About 30 minutes after the shot got an episode of lightheadedness and nausea that lasted a few minutes.  It came in waves, but was bad enough that he was afraid to drive home.  These 'episodes' continued to happen for the next two days at least once per day for about 30 seconds.   On Friday, 8/30/19, patient had 3 'episodes' with the last one lasting about 30 minutes in which time his wife drove him to the ER.  He had another 'episode' at the ER waiting room.  Many tests were run at the ER of which I am not privy to, but the patient said labs were drawn, an x-ray was done, and a Cat Scan.  All tests came back normal and ruled out any issues.  He had a follow up appointment with Dr. today, 9/5/19, of which not much was mentioned.  He is feeling back to his self now.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray normal
Clinical narrative: About 30 minutes after the shot got an episode of lightheadedness and nausea that lasted a few minutes.  It came in waves, but was bad enough that he was afraid to drive home.  These 'episodes' continued to happen for the next two days at least once per day for about 30 seconds.   On Friday, 8/30/19, patient had 3 'episodes' with the last one lasting about 30 minutes in which time his wife drove him to the ER.  He had another 'episode' at the ER waiting room.  Many tests were run at the ER of which I am not privy to, but the patient said labs were drawn, an x-ray was done, and a Cat Scan.  All tests came back normal and ruled out any issues.  He had a follow up appointment with Dr. today, 9/5/19, of which not much was mentioned.  He is feeling back to his self now.
Age: 9.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child was given DtaP/IPV at 9 yrs of age.  Vaccine is not licensed for use at this age.  Per conversation with mother no adverse effects noted.
Age: 58.0
Sex: F
Vaccine: FLUR4
Symptoms: Body temperature increased, Chills, Myalgia
Clinical narrative: Had injection later afternoon and a few hours later bad chills and all muscles aching everywhere. Temperature of 99.8 . Normally I'm a night owl put myself to bed and literally stayed in bed the next day. No temperature next day but muscle aches all day. Next day felt better about 80% but by end of day 100%. Never had any reaction ever before.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Headache, Memory impairment
Clinical narrative: PATIENT STATES SHE GOT A HEADACHE SO BAD SHE WENT TO THE EMERGENCY ROOM, AT THE EMERGENCY ROOM THEY DID A CAT SCAN, PATIENT DOESN'T REMEMBER HAVING CAT SCAN DONE, THE DISCHARGE HER ON PAIN MEDS, SHE IS STILLING SAYING SHE HAS THE HEADACHE TODAY.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blister infected
Clinical narrative: patient presented with blisters on both ankles 48 hours post vaccine, they later became infected. her podiatrist feels they are and adverse reaction to the vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Musculoskeletal pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Extreme pain in arm and shoulder.  Flu like symptoms X 24 hours.  Fever of 101.3, rash on right side of chest.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Urticaria
Clinical narrative: Pt broke out in hives within a few minutes of administering vaccines.   Pt was also crying during vaccine administration.  Pt was given benadryl and  prelone.  Hives resolved about 20 mins after prelone - 45 minutes after onset.  No DIB.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza, Nausea, Pyrexia
Clinical narrative: Fever nausea headaches flu symptoms
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Localized redness, swelling, pain
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Nervousness
Clinical narrative: Patient experienced chest tightness  and felt "shaky" starting about 20 minutes after vaccine administration.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Vomiting,  muscle aches, headache and nausea
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nasal congestion, Pain
Clinical narrative: headache, body aches, stuffy nose
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; A patient received 1 dose of PNEUMOVAX 23 on Friday 8/30/2019; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 30-AUG-2019, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis, lot number S004548 with expiration date in 12-AUG-2020 (strength and anatomical location not reported).  The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 47 Fahrenheit (°F) (51 F) for the time frame of 7 hours. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.      On or around 28-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was hospitalized due to the event. On an unspecified date, the patient was treated by a physician for shingles. At the reporting time, the patient had not recovered from shingles. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Rheumatoid arthritis
Clinical narrative: Patient has rheumatoid arthritis. He reported that after his Shingrix dose his arthritis pain was very great/apparent for about 3 days after.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Injection site erythema
Clinical narrative: Had pretty severe pain, swelling, redness at injection site.  Next day had fever of 102.4, pain in joints in my whole body, shivering, fatigue, stomach pain, nausea.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Had pretty severe pain, swelling, redness at injection site.  Next day had fever of 102.4, pain in joints in my whole body, shivering, fatigue, stomach pain, nausea.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Rotavirus was given as an intramuscular injection, and it is supposed to be given orally.  The amount of immunization injected exceeded 1 ml/one site.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Headache, Visual impairment
Clinical narrative: 9/4/19 patient began to complain of occipital headache, dizziness, and visual changes.  He was seen in the Medical Center Emergency Department the same day (symptoms had resolved at that point)and then the next day at this pediatric office because symptoms were continuing intermittently.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: Patient developed red rash on 8/21/19 and went to urgent care on 8/28/19 and  diagnosed  with  shingles.  Patient is still under treatment.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Rash, Swelling
Clinical narrative: swollen, red, rash
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient reports rash and pain at injection site that evening. Message provider 2 days later.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING, REDNESS, WARMTH TO THE AREA OF INJECTION (4 INCHES IN DIAMETER AROUND THE SITE) THE NIGHT OF THE VACCINATION.  TREATED WITH ICE PACK AND ZYTREC.  THE NEXT DAY WAS STILL THE SAME.   A CIRCLE WAS DRAWN AROUND IT TO SEE IF IT WOULD SPREAD.   THE REDNESS AND SWELLING SPREAD OUTSIDE OF THE  LINE SO PATIENT WENT TO THE DR. OFFICE.  THEY SAID THEY THOUGHT IT WAS A REACTION TO THE VACCINE, AND THEY PRESCRIBED TRIAMCINOLONE CREAM AND CEPHALEXIN CAPSULES ON 9/5/19
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Skin warm
Clinical narrative: patient has red area to the right thigh. patient states that there is no pain or trouble bearing weight. Pt leg warm to the touch. Mom advised to ice, ibuprofen and benedryl.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Pain
Clinical narrative: Two hours after patient felt dizzy, nausea and ached all over on 9/2/19 it resolved.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Patient developed local injection site reactions, bruise, redness, swelling overnight. Tender to touch.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Hypersensitivity, Rash pruritic
Clinical narrative: The patient developed and allergic reaction. She had a bumpy Itchy  rash that was spreading.  She took benadryl and motrin and stated that she is feeling better.  She also stated  that the reaction has subsided
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: pain in shoulder/arm , limited mobility, numbness and tingling that radiates down from shoulder into forearm and wrist
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood thyroid stimulating hormone, Full blood count, Laboratory test, Metabolic function test, Rash erythematous
Clinical narrative: Small red dots all over arm that received vaccination. Patient denied any swelling, pain, tenderness or soreness.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Thyroid function test
Clinical narrative: Small red dots all over arm that received vaccination. Patient denied any swelling, pain, tenderness or soreness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Patient complained of a metallic after taste starting the day after the vaccine and lasting 3 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Patient complained of a metallic after taste starting the day after the vaccine and lasting 3 days.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache
Clinical narrative: Severe headache
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient returned to pharmacy tonight after having received a flu and shingles vaccine this morning.  She complained that her arm was very sore and that she could not move it very well.  Upon examination, it did appear that the bandaids were a little highup on her arm closer to her shoulder.  I advised her to take Ibuprofen and benadryl to help with pain and sleep.  She had stated she had taken Aleve with no result and had been applying heat to the site.  I advised her to switch to ice instead of heat.  I told her she could go to the emergency room if she wanted too, but that it was common for pain to occur after immunization.  I advised that if she was still having pain after 1-2 days that she should contact us as well as her primary care doctor to be seen.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles, Rash
Age: 75.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Within an hour or two the Patient reported severe pain and swelling and inability to move her arm. We advised her to call or see her Doctor which she did the next day.
Age: 75.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity, Periarthritis
Clinical narrative: Within an hour or two the Patient reported severe pain and swelling and inability to move her arm. We advised her to call or see her Doctor which she did the next day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Pt received Shingrix immunization on 9/3/19.  On the morning of 9/4/19, she states that she began to have redness on the arm of the immunization.  She stated that her arm was warm on 9/4/19.  She states the warm feeling was better on 9/5/19 but it was still present.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood glucose increased, C-reactive protein increased, Carbon dioxide normal, Crying, Emotional distress
Clinical narrative: Approximately 21 hours after receiving vaccines, pt developed inconsolable crying at home. The patient was brought into the clinic approximately 28 hours after receiving vaccines, was afebrile, with normal exam except for appeared to be in significant distress and inconsolably crying. She had only taken approximately 4 ounces of formula in the previous 12 hours and had decreased urine output. There was no rash, no fever, no bulging fontanelle, no seizure activity, and no signs of trauma. She was sent to the Emergency Room at Hospital. She was admitted to the hospital overnight, where she received IV hydration, Acetaminophen and Benadryl, and was discharged after less than 24 hours admission. After discharge, the patient has been well and has not suffered any neurologic sequelae. She has not yet received her 6-month shots (not due until next month), but we plan to give all scheduled vaccines except DTaP will be deferred.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count, Hypophagia, Metabolic function test, Platelet count normal, Procalcitonin normal
Clinical narrative: Approximately 21 hours after receiving vaccines, pt developed inconsolable crying at home. The patient was brought into the clinic approximately 28 hours after receiving vaccines, was afebrile, with normal exam except for appeared to be in significant distress and inconsolably crying. She had only taken approximately 4 ounces of formula in the previous 12 hours and had decreased urine output. There was no rash, no fever, no bulging fontanelle, no seizure activity, and no signs of trauma. She was sent to the Emergency Room at Hospital. She was admitted to the hospital overnight, where she received IV hydration, Acetaminophen and Benadryl, and was discharged after less than 24 hours admission. After discharge, the patient has been well and has not suffered any neurologic sequelae. She has not yet received her 6-month shots (not due until next month), but we plan to give all scheduled vaccines except DTaP will be deferred.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine output decreased, White blood cell count increased
Clinical narrative: Approximately 21 hours after receiving vaccines, pt developed inconsolable crying at home. The patient was brought into the clinic approximately 28 hours after receiving vaccines, was afebrile, with normal exam except for appeared to be in significant distress and inconsolably crying. She had only taken approximately 4 ounces of formula in the previous 12 hours and had decreased urine output. There was no rash, no fever, no bulging fontanelle, no seizure activity, and no signs of trauma. She was sent to the Emergency Room at Hospital. She was admitted to the hospital overnight, where she received IV hydration, Acetaminophen and Benadryl, and was discharged after less than 24 hours admission. After discharge, the patient has been well and has not suffered any neurologic sequelae. She has not yet received her 6-month shots (not due until next month), but we plan to give all scheduled vaccines except DTaP will be deferred.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: PT CAME TO GET FLU SHOT ON 9/4/2019 AND REPORTED THAT WHEN SHE GOT HER 2ND DOSE OF SHINGRIX 8/15/2019 THEN NEXT DAY HER ARM WAS VERY SORE. STATED THAT SHE BEGAN TO BECOME LIGHT HEADED AND HAD A LITTLE NAUSEA. STATED HER ARM GOT SORE TO POINT WHERE SHE DIDN'T WANT TO USE IT FOR ROUGHLY 48 HOURS. SAW HER MD AND HER DOCTOR TOLD HER TO REPORT IT TO US (DR.) MD STATED IT MAY HAVE BEEN MYALGIA PER PT REPORT
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site swelling, Pain, Pyrexia
Clinical narrative: 12 Hours after administration Patient had very strong chills and fever and had to take ibuprofen Body aches especially local for 7 days site swelling 6 days slept the whole day (drowsy all day long) headaches on and off. These reactions were similar to those reported at first dose, but of a stronger intensity
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: 12 Hours after administration Patient had very strong chills and fever and had to take ibuprofen Body aches especially local for 7 days site swelling 6 days slept the whole day (drowsy all day long) headaches on and off. These reactions were similar to those reported at first dose, but of a stronger intensity
Age: 51.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Feeling hot, Flushing, Malaise
Clinical narrative: Patient Received Hepatitis A (Havarix ) vaccine IM in right arm, followed by Hepatitis B (Engerix B) vaccine in right arm. Following 2nd vaccine patient was flushed, stated not feeling well, and warm.  Patient fanned and given ice pack. Feeling much better after 20 minutes in store. Patient disclosed following incident that she had given plasma that morning, and the plasma center could not return her blood back to her like usual. She appeared much better after 20 minutes and went home following incident.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blister, Feeling hot, Pain, Secretion discharge
Clinical narrative: Pain, heat, and blisters with drainage  started 0500 next morning
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash, Rash erythematous, Skin warm
Clinical narrative: Pt came into pharmacy on 9/5/2019 and reported soreness, redness, and warm to the touch the night of vaccination on 8/27/19. She took Aleve and it went away after 3 days. Then she developed red spots from her ankle going up her knees. She was not itching  or in pain.  Recommended Benadryl also just to see if it could be an allergic reaction. She will take 25 to 50mg every 4 to 6 hours. If it doesn't get better, she will see a doctor.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Nausea, Pain
Clinical narrative: Local reaction at injection site redness and swelling, low grade fever nausea aches following HD fluzone lasted 4 to 5 days  ice to injection site OTC pain and fever reducers  fluids
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Local reaction at injection site redness and swelling, low grade fever nausea aches following HD fluzone lasted 4 to 5 days  ice to injection site OTC pain and fever reducers  fluids
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Screaming
Clinical narrative: High-pitched screaming for almost 12 hours afterwards.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Scab
Clinical narrative: Patient reported having red splotches on her skin that crust over and also rise up a little bit. They last for a few days and then disappear. Spots keep coming up in other places on the body. This has happened since she got her shot. Patient does not report any other adverse events and is going to see PCP tomorrow.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Skin reaction, Swelling
Clinical narrative: Skin reaction/redness and swelling.  Treated with smz-tmp ds (Bactrim ds) and cephalexin 500mg.  Outcome = resolution of inflammation.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received Pneumovax 23 on 9/3/19. patient has severe redness and swollen at the injection site on 9/4/19. patient went to Urgent care to seek treatment. Patient received prescriptions prednisone 10mg and Tylenol OTC. Patient presented to the pharmacy on 9/5/19. The injection site is still red and swollen.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Loss of consciousness, Presyncope, Syncope, Tremor
Clinical narrative: WHILE GIVING VARICELLA VACCINE PATIENT WAS SITTING ON THE CHAIR AND AND HE FAINTED AND PASSED OUT ON FLOOR ON FACE AND GOT SOME TREMOR . MEANWHILE VACCINE WAS GIVEN COMPLELTY BUT HE FAINTED WHILE I WAS STILL GIVING THE VACCINE. NEEDELE HAS BEEN REMOVED. THERE WAS A NURSE IN CLINIC NEXT TO PHARMACY AND ME CHECKED ON HIM AND FOUND HIS BLOOD PRESSURE WAS 80/60 VASOVAGAL RESPONSE CAUSED THIS. WE GAVE HIM WATER AND JUICE AND TOOK SOME REST IN PHARMACY UNTIL FEEL OK
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Chills, Feeling hot, Muscle contractions involuntary, Pruritus, Tremor
Clinical narrative: Patient had NEVER received a vaccine prior to this vaccine. Patient had received multiple lidocaine injections by the dentist within 1 hour prior to being given vaccine. Youth developed body shaking, shivering, sensation of being hot and itchy  about 2 hours after the vaccine. Brought to medical unit of the facility where patient residing. Patient started scratching her face and arms. No rash was seen anywhere on her body. Afebrile. BP 120/88 during shaking. Clenching hands and sometimes toes. Eyes closed. Able to open eyes when asked to open eyes. Responded to and answered all questions. Fully oriented. Able to walk however when sitting or on exam table, curls over and shakes. Denied anxiety.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Feeling abnormal, Muscle twitching, Piloerection, Pruritus, Tremor
Clinical narrative: Patient had NEVER received a vaccine prior to this vaccine. Patient had received multiple lidocaine injections by the dentist within 1 hour prior to being given vaccine. Youth developed body shaking, shivering, sensation of being hot and itchy  about 2 hours after the vaccine. Brought to medical unit of the facility where patient residing. Patient started scratching her face and arms. No rash was seen anywhere on her body. Afebrile. BP 120/88 during shaking. Clenching hands and sometimes toes. Eyes closed. Able to open eyes when asked to open eyes. Responded to and answered all questions. Fully oriented. Able to walk however when sitting or on exam table, curls over and shakes. Denied anxiety.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Muscle spasms, Pain, Vaccination complication
Clinical narrative: Patient complained of uncontrolled spasms in shoulder, arms, legs 8-9 hours after getting flu shot. Lasted for 8-10 hours.  Also, got chills, headache, body aches.  Went to see Dr on 9/5/19 to make certain he was OK.  Dr said the adverse events are likely due to flu shot.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: Shingrix vaccine was reconstituted with sterile water for injections diluent (used for Merck live vaccines such as Zostavax) instead of the diluent provided in the Shingrix box.  Patient has not experienced any adverse effects.  Patient will return for a correctly reconstituted vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test positive, Facial paralysis, Herpes simplex test negative
Clinical narrative: I received my initial Shingrix vaccination on 8/20/19 and on 8/29/19 I developed a right sided Bell's palsy. My HSV IgG titer is negative, VSV IgG is positive (I've had chicken pox as a child) with IgM titers pending. I'm a physician by the way. Thank you.