chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient was vaccinated with an improperly stored M-M-R II; This spontaneous report was received from a medical assistant, regarding a 16 year old male patient. The patient's illness at the time of vaccination were reported as none. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included hepatitis B virus vaccine (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine inactivated (unspecified) and meningococcal ACYW conj vaccine (carrier unspecified).  On 27-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # R028382, expiration date 10-MAR-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The temperature was exposed to a temperature of 13.13 degree Celsius since 23-MAY-2019 to 02-OCT-2019 as recorded by a digital data logger was involved. There were no previous temperature excursions, however, on an unknown date the vaccine had a temperature excursion with a highest temperature above 9 degree Celsius (58.96 degree Celsius) for 8299 and 45 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012360: US-009507513-1910USA012981: US-009507513-1910USA012359: US-009507513-1910USA012355: US-009507513-1910USA012352: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012358: US-009507513-1910USA012351: US-009507513-1910USA012350: US-009507513-1910USA012353:
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient was vaccinated with an improperly stored M-M-R II; This spontaneous report was received from a medical assistant, regarding a 16 year old male patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included hepatitis b virus vaccine (unspecified), meningococcal acyw conj vaccine (carrier unspecified), poliovirus vaccine inactivated (unspecified) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid.   On 24-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # R027997, expiration date 01-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  No information regarding the temperature excursion was provided. A digital data logger was involved. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012355: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012360: US-009507513-1910USA012981: US-009507513-1910USA012352: US-009507513-1910USA012351: US-009507513-1910USA012240: US-009507513-1910USA007637: US-009507513-1910USA012359: US-009507513-1910USA012349: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354:
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 (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-DEC-2013, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified), as prescribed and/or administered by a healthcare provider at the clinic for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a healthcare professional for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, 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 would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Herpes zoster, Pruritus
Clinical narrative: I was told it is a shingle. Not an allergic response but a shingle; Itchy blisters, flaming red; Itchy blisters, flaming red; Itchy blisters, flaming red; flamed red; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix. On 15th October 2019, less than a day after receiving Shingrix, the patient experienced shingles, blister, pruritus, erythema and burning sensation. On an unknown date, the outcome of the shingles, blister, pruritus, erythema and burning sensation were unknown.   It was unknown if the reporter considered the shingles, blister, pruritus, erythema and burning sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and broke out on my chest. Itchy blisters, flaming red. The patient was told it was a shingle. Not an allergic response but a shingle.  The patient thinking that probably should not get the second vaccination in six months.
Sex: M
Vaccine: RAB
Symptoms: Accidental exposure to product, Exposure via skin contact, Skin laceration
Clinical narrative: Laceration of finger; Exposure via skin contact; Inadvertent exposure to vaccine; This case was reported by a consumer and described the occurrence of laceration of finger in a male patient who received Rabies NVS (RabAvert) for prophylaxis.   On 10th October 2019, the patient received RabAvert. On 10th October 2019, immediately after receiving RabAvert, the patient experienced laceration of finger, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the laceration of finger, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the laceration of finger to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The patient that was at the time of reporting very anxious about rabies, and hope you could kindly answer my question. The patient asked can the inactivated rabies viruses ever become active and infectious again under some circumstances.The patient accompanied someone else to get rabies vaccine (RabAvert). After the injection, the patient picked up the vaccine vial from the garbage can, and found there was one drop or two of the vaccine left in the vial.The patient had a wound on my hand at that time, so if the vaccine got into my wound, was it able to cause rabies to me, which led to laceration of finger, exposure via skin contact and inadvertent exposure to vaccine. The patient knows the vaccine was inactivated by -propiolactone, and it changes the structure of guanine of RNA, but the patient worried that this process was reversible and the inactivated viruses in the garbage can somehow got reactivated and became infectious again.  The patient called CDC and GlaxoSmithKline customer service, but neither of them could answer question. The doctor said the patient would be fine but am still worried. The patient really hope could the reporter answer the question. The patient struggling so much right at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on his scalp; This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received Shingrix. On 21st September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter representative reported an adverse event with Shingrix vaccine. The patient received Shingrix in the pharmacy and got a Shingles on his scalp. The reporter told her to report it to Glenmark. When asked for NDC, the reporter reported that the patient received injection in his arm. The reporter asked for the telephone number of GlaxoSmithKline and asked if we distribute the product. No additional information obtained.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling cold, Inappropriate schedule of product administration, Malaise, Pain in extremity
Clinical narrative: not feeling well; fever; weak; cold; tenderness / pain when touching her arm; incorrect dosing schedule; Bruising of arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE QUADRIVALENT) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 11th September 2019, refer linked case US2019AMR189574). Concurrent medical conditions included shingles (2019).   On 15th October 2019, the patient received the 2nd dose of Shingrix. On 9th October 2019, the patient received FLUZONE QUADRIVALENT. On 15th October 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell, fever, weakness, cold, pain in arm and drug dose administration interval too short. In October 2019, the patient experienced bruising of arm. The action taken with FLUZONE QUADRIVALENT was unknown. On an unknown date, the outcome of the feeling unwell and fever were recovered/resolved and the outcome of the weakness, cold, bruising of arm and drug dose administration interval too short were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, fever, weakness, cold and pain in arm to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on her right arm. The patient had pain when touching her arm which was unresolved. The patient did not feel well. The patient had 108 degree F. fever and was not feeling well overnight. The patient's fever resolved but she still felt weak, but better overall. The patient was also unbelievably cold at night after the second injection. The patient also received Fluzone Quadrivalent shot 2019-2020 on her right arm. The patient was questioning if her symptoms were related to the flu shot or the fact that she got the Shingrix vaccine too early. The patient also reported that she received the second shot of the Shingrix in her right arm where there was a bruise remaining from her Fluzone shot in the same arm. The reporter consented to follow up. It was unknown if the reporter considered the injection site pain, feeling unwell, fever, weakness, cold, tenderness, feeling abnormal and drug dose administration interval too short to be related to Fluzone Quadrivalent shot 2019-2020 as well.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tenderness
Clinical narrative: not feeling well; fever; weak; cold; tenderness / pain when touching her arm; incorrect dosing schedule; Bruising of arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE QUADRIVALENT) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 11th September 2019, refer linked case US2019AMR189574). Concurrent medical conditions included shingles (2019).   On 15th October 2019, the patient received the 2nd dose of Shingrix. On 9th October 2019, the patient received FLUZONE QUADRIVALENT. On 15th October 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell, fever, weakness, cold, pain in arm and drug dose administration interval too short. In October 2019, the patient experienced bruising of arm. The action taken with FLUZONE QUADRIVALENT was unknown. On an unknown date, the outcome of the feeling unwell and fever were recovered/resolved and the outcome of the weakness, cold, bruising of arm and drug dose administration interval too short were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, fever, weakness, cold and pain in arm to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on her right arm. The patient had pain when touching her arm which was unresolved. The patient did not feel well. The patient had 108 degree F. fever and was not feeling well overnight. The patient's fever resolved but she still felt weak, but better overall. The patient was also unbelievably cold at night after the second injection. The patient also received Fluzone Quadrivalent shot 2019-2020 on her right arm. The patient was questioning if her symptoms were related to the flu shot or the fact that she got the Shingrix vaccine too early. The patient also reported that she received the second shot of the Shingrix in her right arm where there was a bruise remaining from her Fluzone shot in the same arm. The reporter consented to follow up. It was unknown if the reporter considered the injection site pain, feeling unwell, fever, weakness, cold, tenderness, feeling abnormal and drug dose administration interval too short to be related to Fluzone Quadrivalent shot 2019-2020 as well.
Sex: M
Vaccine: FLU3
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: severe hearing loss in his right ear; tinnitus/ringing in his ear; Initial information received on 21-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 74 years old male patient who experienced severe hearing loss in his right ear (deafness unilateral) and tinnitus/ringing in his ear (tinnitus), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2019, the patient received a single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ253AA via intramuscular route in the arm nos.  On an unknown date, the patient developed a serious severe hearing loss in his right ear (deafness unilateral) after having symptoms of tinnitus/ringing in his ear (tinnitus) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  Patient required visit to ENT specialist on the date of vaccination.  No lab test was reported.  Final diagnosis was deafness unilateral and tinnitus.   The patient was treated with 10 mg of PREDNISONE (PREDNISONE) and was put on steroids as suggested by ENT specialist.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for the events (symptoms were still ongoing at the time of reporting).; Sender's Comments: This case involves a 74 years old male patient who experienced severe hearing loss in his right ear and tinnitus/ringing in his ear post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Degeneration of inner ear structure, trauma or exposure to loud noise, infection is most common factor of hearing loss in elderly age, which need to be excluded before any conclusion can be drawn. Additional information including patient's medical history, condition at the time of vaccination, any history of trauma, lab test ruling out other etiologies is needed for further assessment of the case. Based on available information the role of vaccine cannot be assessed.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Fall, Head injury, Limb injury, Syncope
Clinical narrative: Patient fainted approximately 2 minutes after receiving flu vaccine.  He fell into a wall and bruised his forehead, shoulder and arm.
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site bruising, Injection site haemorrhage, Thrombosis
Clinical narrative: Patient was bleeding a little more than normal. I watched it briefly and opted to put a second inject safe bandage of the first one. She called the next morning and said that she bled for 30 minutes while shopping in the store. When she removed the bandages there was a clot.  I suggested that she contact her PCP to make sure nothing more serious was going on. At the time of the exam there was slight bruising and she wasn't concerned unless severe bruising occured. They had her come in, and the provider felt that I did not push the needle in far enough, but I used a 1 inch needle and when I released the needle retraction mechanism I recall nothing unusual.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site inflammation, Injection site pain, Musculoskeletal disorder
Clinical narrative: I received a flu shot in my right arm and a pneumonia shot in my left arm. I experienced no pain in my right arm but immediately exclaimed as I was receiving the pneumonia shot that the shot in my left arm was painful. The pharmacist said it should not have hurt, but I told her it did. My arm continued to hurt and be painful for the rest of the day. By the evening, I could no longer lift my arm or use my left arm in a meaningful way.  The pain has been excruciating and I'm unable to use my left arm.  I made an appointment with a ortho doctor the next morning. I went to the doctor today.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Product administered at inappropriate site
Clinical narrative: I received a flu shot in my right arm and a pneumonia shot in my left arm. I experienced no pain in my right arm but immediately exclaimed as I was receiving the pneumonia shot that the shot in my left arm was painful. The pharmacist said it should not have hurt, but I told her it did. My arm continued to hurt and be painful for the rest of the day. By the evening, I could no longer lift my arm or use my left arm in a meaningful way.  The pain has been excruciating and I'm unable to use my left arm.  I made an appointment with a ortho doctor the next morning. I went to the doctor today.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness bilateral, Deafness neurosensory
Clinical narrative: Per the doctor's office, patient reported hearing loss in both ears the same day as he received the vaccination. The doctor reported severe sensorineural hearing loss in both right and left ears.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Pain, Pain in extremity, Paraesthesia, X-ray
Clinical narrative: Symptoms started 2 days post vaccination. Started with severe back pain then sharp shooting leg pain bilaterally with pain and tingling in arms, wrists and hands. Denies fever or runny nose. Was seen by PCP and Neurologist. Prescribed indomethacin 50 mg BID x 1 week on 10/15/19 but did help.  Administered dexamethasone 4mg/ml injection and Ketorolac 60mg/2ml on 10/16/19 and 10/18/19. Prescribed Medrol pack 10/18/19. Also prescribed Soma 250 mg and Tramadol 50 mg on 10/16/19. Most relief received after steroid injections per patient.
Age: 2.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Agitation, Analgesic drug level therapeutic, Blood alcohol normal, CSF culture negative, Computerised tomogram head normal
Clinical narrative: Altered mental status (agitation, repetitive words, fussy, active) for more than 12 hours, started "out of the blue" on 10/21 while at the grocery store with Mom. Went to ER and had full workup. Symptoms improved without spontaneously within 24 hours.
Age: 2.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Drug screen negative, Electroencephalogram normal, Full blood count normal, Gram stain, Gram stain negative
Clinical narrative: Altered mental status (agitation, repetitive words, fussy, active) for more than 12 hours, started "out of the blue" on 10/21 while at the grocery store with Mom. Went to ER and had full workup. Symptoms improved without spontaneously within 24 hours.
Age: 2.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Irritability, Magnetic resonance imaging brain normal, Mental status changes, Metabolic function test normal, Psychomotor hyperactivity
Clinical narrative: Altered mental status (agitation, repetitive words, fussy, active) for more than 12 hours, started "out of the blue" on 10/21 while at the grocery store with Mom. Went to ER and had full workup. Symptoms improved without spontaneously within 24 hours.
Age: 2.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Repetitive speech, Scan with contrast normal
Clinical narrative: Altered mental status (agitation, repetitive words, fussy, active) for more than 12 hours, started "out of the blue" on 10/21 while at the grocery store with Mom. Went to ER and had full workup. Symptoms improved without spontaneously within 24 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Injection site pain, Injection site warmth
Clinical narrative: severe lower back pain, pain at the injection site,  heat at the injection site, pain under arm in arm pit
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Differential white blood cell count normal, Dizziness, Electrocardiogram normal, Full blood count normal, Injection site pain
Clinical narrative: Arrives in the Emergency Department with complaint that after receiving immunization today developed red blotchy rash, pain from elbow up into neck,dizziness and lightheadedness lasting hours improved after receiving Tylenol and Benadryl.  MD orders included ECG, Lab work BMP, CBCD and troponin all testing came back within normal limits. Patient discharge home diagnosis Adverse effect of vaccine.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test normal, Neck pain, Rash erythematous, Rash macular, Troponin normal
Clinical narrative: Arrives in the Emergency Department with complaint that after receiving immunization today developed red blotchy rash, pain from elbow up into neck,dizziness and lightheadedness lasting hours improved after receiving Tylenol and Benadryl.  MD orders included ECG, Lab work BMP, CBCD and troponin all testing came back within normal limits. Patient discharge home diagnosis Adverse effect of vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Injection site reaction, Injection site swelling
Clinical narrative: Patient came in to show her right arm had a red rash going down to her elbow and there was a little swelling. She went in to her Dr. this morning ( did not know the Doctor's name) and she was given a steroid shot and will be on oral prednisone for the next few days. She is feel very tired and lethargic and has been having chills and a loss of appetite since the shot was given on 10/22/19. At the time of the shot, she was also given Pneumovax  in the same arm and Fluad in the other arm. Could have potentially caused more of a reaction as well.  The doctor she saw this morning said it was most likely due to the Shingrix.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Rash erythematous
Clinical narrative: Patient came in to show her right arm had a red rash going down to her elbow and there was a little swelling. She went in to her Dr. this morning ( did not know the Doctor's name) and she was given a steroid shot and will be on oral prednisone for the next few days. She is feel very tired and lethargic and has been having chills and a loss of appetite since the shot was given on 10/22/19. At the time of the shot, she was also given Pneumovax  in the same arm and Fluad in the other arm. Could have potentially caused more of a reaction as well.  The doctor she saw this morning said it was most likely due to the Shingrix.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pain in the arm, soreness, some swelling the following morning (10/23/19). Decreased movement leading to immobilization of the arm about 2.5 days after receiving vaccination(10/25/19). Patient had contacted physician this morning and was referred to pharmacy, I then informed the patient that this was not a usual reaction and the patient should be evaluated by physician because I suspect pharmacotherapy may be required to treat symptoms such as an anti-inflammatory medication (NSAID or steroid).
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hot flush, Hyperhidrosis, Rash, Thirst
Clinical narrative: Rash all over the body, redness, hot flashes, thirsty, scratchy throat, sweating
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Rash all over the body, redness, hot flashes, thirsty, scratchy throat, sweating
Age: 70.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site pain, Injection site swelling, Somnolence
Clinical narrative: At the injection sight, right arm,  there was swelling, redness, and pain for 72 hours.  I was also very drowsy and sleepy.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Asthenia, Balance disorder, Chest discomfort, Chest pain
Clinical narrative: Pt came into office on 10/24/19 c/o chest pain, tachycardia, heaviness in chest, hard to breath, hurts to breath, pupils dilated, falling, off balance, light headed, bad joint pain, severe headache, body aches, eyes hurt, weak, light sensitive, and nausea.    (per Dr Note) Only vaccine given on 10/23/19  patient has headache, nausea, weak with joint and muscle aches, but had chest pain ,SOB and heart racing all of which are gone, no redness at injection site.  Still has headache, mild aches and fever which is better. All symptoms gone and feels much better.  No chest pain or SOB now.  Looks active and  good.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Dyspnoea, Eye pain, Fall, Headache
Clinical narrative: Pt came into office on 10/24/19 c/o chest pain, tachycardia, heaviness in chest, hard to breath, hurts to breath, pupils dilated, falling, off balance, light headed, bad joint pain, severe headache, body aches, eyes hurt, weak, light sensitive, and nausea.    (per Dr Note) Only vaccine given on 10/23/19  patient has headache, nausea, weak with joint and muscle aches, but had chest pain ,SOB and heart racing all of which are gone, no redness at injection site.  Still has headache, mild aches and fever which is better. All symptoms gone and feels much better.  No chest pain or SOB now.  Looks active and  good.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Myalgia, Mydriasis, Nausea, Pain, Painful respiration
Clinical narrative: Pt came into office on 10/24/19 c/o chest pain, tachycardia, heaviness in chest, hard to breath, hurts to breath, pupils dilated, falling, off balance, light headed, bad joint pain, severe headache, body aches, eyes hurt, weak, light sensitive, and nausea.    (per Dr Note) Only vaccine given on 10/23/19  patient has headache, nausea, weak with joint and muscle aches, but had chest pain ,SOB and heart racing all of which are gone, no redness at injection site.  Still has headache, mild aches and fever which is better. All symptoms gone and feels much better.  No chest pain or SOB now.  Looks active and  good.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Palpitations, Photophobia, Pyrexia, Tachycardia
Clinical narrative: Pt came into office on 10/24/19 c/o chest pain, tachycardia, heaviness in chest, hard to breath, hurts to breath, pupils dilated, falling, off balance, light headed, bad joint pain, severe headache, body aches, eyes hurt, weak, light sensitive, and nausea.    (per Dr Note) Only vaccine given on 10/23/19  patient has headache, nausea, weak with joint and muscle aches, but had chest pain ,SOB and heart racing all of which are gone, no redness at injection site.  Still has headache, mild aches and fever which is better. All symptoms gone and feels much better.  No chest pain or SOB now.  Looks active and  good.
Age: 10.0
Sex: M
Vaccine: IPV, TDAP, IPV, TDAP
Symptoms: Blindness, Cyanosis, Loss of consciousness, Pallor, Vomiting
Clinical narrative: Approximately 2 minutes after both vaccines were administered, patient turned pale with blue lips and said he couldn't see anything.  He completely passed out, awaking about 30 seconds later and began vomiting.  This all happened in the office.
Age: 10.0
Sex: M
Vaccine: IPV, TDAP, IPV, TDAP
Symptoms: Loss of consciousness, Pulse abnormal, Vomiting
Clinical narrative: Approximately 2 minutes after both vaccines were administered, patient turned pale with blue lips and said he couldn't see anything.  He completely passed out, awaking about 30 seconds later and began vomiting.  This all happened in the office.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored vaccine administered; possibly administered outside of the guidelines of the prescribing information/ 18 month dose; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 07-OCT-2019, the patient was vaccinated with one dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter, lot # S000351, expiration date 10-OCT-2021 (injection site and route of administration were not reported) for prophylaxis. The nurse reported that it was the "18 month dose" and the vaccine was possibly administered outside of the guidelines of the prescribing information. Administered dose of vaccine experienced the temperature excursion of 56.0 degrees Fahrenheit for 8 hours and 30 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There was no adverse effect reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effects; a patient received a dose of MMRII via the intramuscular route; This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 18-OCT-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II), lot # S012944, expiration date 28-APR-2021, for prophylaxis, via intramuscular route (incorrect route of product administration). There were no adverse effects reported. The outcome of incorrect route of product administration and no adverse event was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was administered a dose of improperly stored VARlVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.  On 17-OCT-2019, the patient was vaccinated with improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S015460, expiration date 20-MAY-2021; vaccine dosage detail not reported) subcutaneously for prophylaxis which was reconstituted with sterile diluent, it could not be determined if the sterile  diluent was properly stored. Temperature was - 11 .5 degree Celsius for 76 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaints (PQC) was reported. Data logger was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Dysarthria, Gait inability, Hemiparesis, Mental status changes
Clinical narrative: acute cerebrovascular accident; transient ischemic attack; Painful lesions on his right thigh; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. In or around 27-SEP-2017, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), Plaintiff suffered left-sided weakness, slurred speech along with altered mental status. Plaintiff was admitted to the hospital where he was diagnosed with acute cerebrovascular accident. On an unspecified date, plaintiff was admitted to the hospital a second time with symptoms of being unable to walk,recurrent nausea and vomiting and was diagnosed with a transient ischemic attack. Plaintiff also experienced painful lesions on his right thigh. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), Plaintiffs symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of Zostavax, the pt sustained severe and permanent personal injuries. The pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The outcome of the events was not recovered.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling as the pt suffered  serious, progressive, permanent, and incurable injuries.  Upon internal review, acute cerebrovascular accident and transient ischemic attack were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Skin lesion, Transient ischaemic attack, Vomiting
Clinical narrative: acute cerebrovascular accident; transient ischemic attack; Painful lesions on his right thigh; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. In or around 27-SEP-2017, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), Plaintiff suffered left-sided weakness, slurred speech along with altered mental status. Plaintiff was admitted to the hospital where he was diagnosed with acute cerebrovascular accident. On an unspecified date, plaintiff was admitted to the hospital a second time with symptoms of being unable to walk,recurrent nausea and vomiting and was diagnosed with a transient ischemic attack. Plaintiff also experienced painful lesions on his right thigh. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), Plaintiffs symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of Zostavax, the pt sustained severe and permanent personal injuries. The pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The outcome of the events was not recovered.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling as the pt suffered  serious, progressive, permanent, and incurable injuries.  Upon internal review, acute cerebrovascular accident and transient ischemic attack were determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects; Inadvertently received a third dose of VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapies were not reported.  On 16-OCT-2019, the patient inadvertently received third dose of varicella virus vaccine live (oka/merck) (VARIVAX) (extra dose administered) (strength, dose, route were not reported, lot # S019462 and expiration date 24-JUN-2019) for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain
Clinical narrative: Pain under armpit; This case was reported by a nurse and described the occurrence of axillary pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles last October presented with severe pain under armpit and got rash upper left back). Previously administered products included antiviral and prednisone.   On 25th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced axillary pain. On an unknown date, the outcome of the axillary pain was unknown.   It was unknown if the reporter considered the axillary pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was anxious to get the Shingrix vaccine to lessen the chance of ever get Shingles.  The patient received Shingrix and experienced the pain under my armpit. For tolerances of 2nd dose, refer case US2019AMR190710, reported by same reporter for the same patient.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Rash pruritic, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Rash on left shoulder as well as left side/ original rash; Rash on left shoulder as well as left side/ original rash; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hepatic cirrhosis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several weeks after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, red rash and itchy rash. The patient was treated with betamethasone dipropionate + clotrimazole (Clotrimazole And Betamethasone Dipropionate Cream). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, red rash and itchy rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, red rash and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had the 1st shot of Shingrix in April 2019.  Within a few weeks, the patient developed a red, itchy rash on left lower back.  The itching was intense.  The patient stated, the primary physician prescribed a cream, Clotrimazole-betamethasone and the patient used 3 tubes in a week and a half and the rash finally eased and started to dry up. The patient had Cirrhosis, so consulted with liver specialist and she said it was not shingles and the patient should receive the 2nd Shingrix shot. The patient's primary physician also agreed, as like hematologist but the patient's neurologist thought the patient had shingles. The patient received 2nd Shingrix shot and after the shot, the original rash returned and now was on patient's left shoulder as well as on left side. The patient used more of the cream and it slowly subsided. The day before the reporting date, the patient saw the dermatologist and she said the patient had shingles and also stated we could not list this as a possible side effect. The patient suggested that, Shingrix vaccine should not be recommended for someone who had Cirrhosis since the patient thought that this product was not suitable for some of them.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Suspected vaccination failure; Shingles; Rash on left shoulder as well as left side/ original rash; Rash on left shoulder as well as left side/ original rash; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hepatic cirrhosis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several weeks after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, red rash and itchy rash. The patient was treated with betamethasone dipropionate + clotrimazole (Clotrimazole And Betamethasone Dipropionate Cream). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, red rash and itchy rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, red rash and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had the 1st shot of Shingrix in April 2019.  Within a few weeks, the patient developed a red, itchy rash on left lower back.  The itching was intense.  The patient stated, the primary physician prescribed a cream, Clotrimazole-betamethasone and the patient used 3 tubes in a week and a half and the rash finally eased and started to dry up. The patient had Cirrhosis, so consulted with liver specialist and she said it was not shingles and the patient should receive the 2nd Shingrix shot. The patient's primary physician also agreed, as like hematologist but the patient's neurologist thought the patient had shingles. The patient received 2nd Shingrix shot and after the shot, the original rash returned and now was on patient's left shoulder as well as on left side. The patient used more of the cream and it slowly subsided. The day before the reporting date, the patient saw the dermatologist and she said the patient had shingles and also stated we could not list this as a possible side effect. The patient suggested that, Shingrix vaccine should not be recommended for someone who had Cirrhosis since the patient thought that this product was not suitable for some of them.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Sore arm / Arm soreness was at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included postnasal drip.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th August 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a sore arm within that day. She states this arm soreness was at the injection site and resolved within 24-hours. The reporter consented to follow up. For tolerances of 2nd dose, refer case US2019190823, reported by same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatic; This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 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, 15 days after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). On an unknown date, the outcome of the polymyalgia rheumatica was unknown.   It was unknown if the reporter considered the polymyalgia rheumatica to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Last year (in 2018), the patient received first dose of Shingrix.   The company advised against getting the second shot. The patient asked if she would get a reaction getting FLUAD because she had developed polymyalgia rheumatic with Shingrix. The reporter did not consent to follow-up.