chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urine analysis
Clinical narrative: Simple Febrile Seizure at home, lasting no more than 5 minutes on 7/27/18, family concerns for decreased muscle strength and coordination following seizure. Fevers of 101-103. Second ED visit around 11:45pm 7/27/18 due to fever not responding to MOTRIN and TYLENOL- patient was under-dosed, fever control discussed in length. Complex febrile seizure in ED on 7/28/18, did not last past 5 minutes- neither had focality, neurology contacted and no further work up recommended. Rash started once fever broke and seizures stopped. Family history of febrile Seizures.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site pain, Insomnia, Musculoskeletal pain, Neck pain
Clinical narrative: Pain and bruisy feeling around injection site. Used ibuprofen and moist heat throughout the day. Symptoms still occurring. Cannot sleep on right side. Pain has gone into shoulder and up into neck.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Eye swelling, Pruritus
Clinical narrative: Woke up 1/1/2019 7AM with itchy, swollen, red skin around both eyes. Went to Urgent Care on 1/2/19.  Rec'd Rxs for Medrol Dose Pack as directed and Triamcinoline 0.1% oint Apply twice a day, filled here and picked up 1/2/19 11:20AM. She said she is not allergic to vaccines and has had the flu vaccine multiple times. She said she does not know if she is allergic to eggs, she doesn't eat them. I suggested FLU-BLOK for next year. I will follow up w/ pt on Friday 1/4/19.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, Tendon disorder, Ultrasound scan normal
Clinical narrative: Pt is complaining of left upper arm pain/shoulder pain which began shortly after vaccine administration on 10/3 and has worsened over time.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Rash
Clinical narrative: Rash, redness. Given prednisone which helped w/Sx.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient in office with sibling, both receiving multiple vaccines. Accidental admin from wrong tray, resulting in patient receiving 2 doses of HPV in one day. Patient receiving total now of 4 HPV doses, 3 and 4 on same day. Patient remained in office for 15" wait after vaccines, no stated problems.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Diplopia, Dizziness, Eye pain, Facial pain
Clinical narrative: First developed pains on right side of my face including right eye. Radiated on top of my head same side. Then noticed blisters on my face  and head with severe pains. Prescribed Famcyclovir for 1 week. Presently still suffering pains on my face, head and right eye. Feel dizziness, double vision and extreme tiredness.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Full blood count, Headache, Metabolic function test, Nuclear magnetic resonance imaging brain
Clinical narrative: First developed pains on right side of my face including right eye. Radiated on top of my head same side. Then noticed blisters on my face  and head with severe pains. Prescribed Famcyclovir for 1 week. Presently still suffering pains on my face, head and right eye. Feel dizziness, double vision and extreme tiredness.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: First developed pains on right side of my face including right eye. Radiated on top of my head same side. Then noticed blisters on my face  and head with severe pains. Prescribed Famcyclovir for 1 week. Presently still suffering pains on my face, head and right eye. Feel dizziness, double vision and extreme tiredness.
Age: 43.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Pain, Pruritus, Rash generalised
Clinical narrative: Patient contacted the clinic 12/27/2018 and reports developed widespread rash all over body with itching and body aches. This was around 2 weeks after her vaccines were administered. Denied any resp symptoms. Pt was taking BENADRYL for symptoms with no improvement. Pt was advised to continue with antihistamine as needed and advised could follow up with PCP if no improvement and reviewed ER precautions. Verified with nurse practitioner at clinic that this can be a side effect of both MMR and varicella and is listed on the VIS. Pt was notified. Called patient 1/2/2019 for follow up. She reported that the symptoms completely resolved in around 2 days and currently having no symptoms.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Posture abnormal
Clinical narrative: Almost immediately following vaccine administration, patient reported feeling like she was going to faint. She was in a seated position and within 30 seconds her head and upper torso started falling forward. Her eyes closed briefly. Her airways stayed open the entire time, There was no observable foaming at the mouth or convulsions. Within a minute or two she regained full consciousness. 911 was called almost immediately. Prior to EMT arrival, we obtained a blood pressure about 5 minutes following this and it was about 100/66. At that time the patient reported only feeling a little dizzy. Upon further questioning after the event, the patient stated that a similar outcome to this occurred following a blood draw in the past. When Paramedics arrived, the patient was checked out and she declined to go to the hospital and was driven home by a family member.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was unknowingly about 12 weeks pregnancy at time of immunization. She only found out about pregnancy on 12/25/18 and is due 3/7/19. She is currently in prenatal care but no other details about health of pregnancy are known.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-APR-2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: MMRV, TDAP
Symptoms: Incorrect route of product administration, No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a 15-month-old male patient. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 19-DEC-2018 the patient was vaccinated with PROQUAD (dose, frequency, lot#, expiration date were unknown) that had been reconstituted with BOOSTRIX rather than the sterile diluent (product preparation error; wrong product administered) intramuscularly rather than subcutaneously (incorrect route of product administration) for prophylaxis. It was reported that there were no adverse effects. The outcome of product preparation error, no adverse event, incorrect route of product administration and wrong product administered was unknown.
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Anaphylactic reaction, Angioedema, Cough, Erythema, Eye pruritus
Clinical narrative: The author in the article discussed about the risk of anaphylaxis after vaccination in children and adults. This report refers to a 7-year- old male patient. Historic conditions included anaphylaxis and atopic dermatitis. Current conditions included allergy to egg and gelatin. Vaccination history included administration of trivalent influenza vaccine (TIV) (manufacturer and batch number: not reported) and other unspecified vaccines. No concomitant medication was reported. The patient was vaccinated with hepatitis A vaccine (manufacturer and batch number: not reported) along with varicella vaccine (other manufacturer, batch number: not reported) on an unknown date. Within 30 minutes to less than 60 minutes after vaccination the patient experienced angioedema, lips swelling, throat closure, red itchy eyes, cough, erythema, rash and vomiting. The patient was sent to the clinic. The emergency department doctor attributed vaccines as trigger for the events (vaccine triggered anaphylaxis). The patient was treated with epinephrine, oral antihistamine, oral H2 blocker, parenteral steroid, intravitreal injection (IVT) and bronchodilator. The patient was referred to an allergist. Final outcome of the events was reported as complete recovery. Seriousness of the events was not reported, but the event anaphylactic reaction was upgraded as medically significant based on Novartis Important Medical Events (NVS-IME) list. The author described the case as Brighton Level 1 of diagnostic certainty. The author concluded that the present study was based on a very large population receiving currently used vaccines and confirmed the rarity of post-vaccination anaphylaxis overall and after specific vaccines. Although anaphylaxis after immunization was rare; its immediate onset (usually within minutes) and life-threatening nature require that all personnel and facilities providing vaccinations have procedures in place for anaphylaxis management. Additional provider education concerning current recommendations for treatment and follow-up appears to be warranted. Upon review following corrections were done: Medical history of the patient was of allergies and anaphylaxis but the hypersensitivity to any particular product or its excipient was not reported. Event contraindication to vaccination was removed.; Reporter's Comments: Could not code IVT as treatment.
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Lip swelling, Ocular hyperaemia, Rash, Throat tightness, Vaccination complication
Clinical narrative: The author in the article discussed about the risk of anaphylaxis after vaccination in children and adults. This report refers to a 7-year- old male patient. Historic conditions included anaphylaxis and atopic dermatitis. Current conditions included allergy to egg and gelatin. Vaccination history included administration of trivalent influenza vaccine (TIV) (manufacturer and batch number: not reported) and other unspecified vaccines. No concomitant medication was reported. The patient was vaccinated with hepatitis A vaccine (manufacturer and batch number: not reported) along with varicella vaccine (other manufacturer, batch number: not reported) on an unknown date. Within 30 minutes to less than 60 minutes after vaccination the patient experienced angioedema, lips swelling, throat closure, red itchy eyes, cough, erythema, rash and vomiting. The patient was sent to the clinic. The emergency department doctor attributed vaccines as trigger for the events (vaccine triggered anaphylaxis). The patient was treated with epinephrine, oral antihistamine, oral H2 blocker, parenteral steroid, intravitreal injection (IVT) and bronchodilator. The patient was referred to an allergist. Final outcome of the events was reported as complete recovery. Seriousness of the events was not reported, but the event anaphylactic reaction was upgraded as medically significant based on Novartis Important Medical Events (NVS-IME) list. The author described the case as Brighton Level 1 of diagnostic certainty. The author concluded that the present study was based on a very large population receiving currently used vaccines and confirmed the rarity of post-vaccination anaphylaxis overall and after specific vaccines. Although anaphylaxis after immunization was rare; its immediate onset (usually within minutes) and life-threatening nature require that all personnel and facilities providing vaccinations have procedures in place for anaphylaxis management. Additional provider education concerning current recommendations for treatment and follow-up appears to be warranted. Upon review following corrections were done: Medical history of the patient was of allergies and anaphylaxis but the hypersensitivity to any particular product or its excipient was not reported. Event contraindication to vaccination was removed.; Reporter's Comments: Could not code IVT as treatment.
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Vomiting
Clinical narrative: The author in the article discussed about the risk of anaphylaxis after vaccination in children and adults. This report refers to a 7-year- old male patient. Historic conditions included anaphylaxis and atopic dermatitis. Current conditions included allergy to egg and gelatin. Vaccination history included administration of trivalent influenza vaccine (TIV) (manufacturer and batch number: not reported) and other unspecified vaccines. No concomitant medication was reported. The patient was vaccinated with hepatitis A vaccine (manufacturer and batch number: not reported) along with varicella vaccine (other manufacturer, batch number: not reported) on an unknown date. Within 30 minutes to less than 60 minutes after vaccination the patient experienced angioedema, lips swelling, throat closure, red itchy eyes, cough, erythema, rash and vomiting. The patient was sent to the clinic. The emergency department doctor attributed vaccines as trigger for the events (vaccine triggered anaphylaxis). The patient was treated with epinephrine, oral antihistamine, oral H2 blocker, parenteral steroid, intravitreal injection (IVT) and bronchodilator. The patient was referred to an allergist. Final outcome of the events was reported as complete recovery. Seriousness of the events was not reported, but the event anaphylactic reaction was upgraded as medically significant based on Novartis Important Medical Events (NVS-IME) list. The author described the case as Brighton Level 1 of diagnostic certainty. The author concluded that the present study was based on a very large population receiving currently used vaccines and confirmed the rarity of post-vaccination anaphylaxis overall and after specific vaccines. Although anaphylaxis after immunization was rare; its immediate onset (usually within minutes) and life-threatening nature require that all personnel and facilities providing vaccinations have procedures in place for anaphylaxis management. Additional provider education concerning current recommendations for treatment and follow-up appears to be warranted. Upon review following corrections were done: Medical history of the patient was of allergies and anaphylaxis but the hypersensitivity to any particular product or its excipient was not reported. Event contraindication to vaccination was removed.; Reporter's Comments: Could not code IVT as treatment.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint noise, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shoulder pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced shoulder pain, joint range of motion decreased and joint clicking. On an unknown date, the outcome of the shoulder pain and joint range of motion decreased were recovering/resolving and the outcome of the joint clicking was unknown. It was unknown if the reporter considered the shoulder pain, joint range of motion decreased and joint clicking to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient had severe pain that progressed in intensity starting on day 4 then over a 5 week period in the shoulder the injection was given. This pain was severe and limited movement. The patient continued the water aerobics that had been doing for years. The pain remained constant from about week 6 through week 13 where it slowly started to subside. The pain was minimal at the time of reporting, however there was a lot of popping and grinding noise and some limited movement from the affected joint area. The patient stated that, she needed the 2nd dose and asked if it would be possible to get the vaccine in the buttocks, hip or thigh area.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal tenderness, Diarrhoea, Fatigue, Gastrointestinal pain, Injection site erythema
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of injection site swelling in a 68-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included dupilumab (Dupixent). On 14th December 2018, the patient received the 2nd dose of SHINGRIX. On 14th December 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, intestinal cramps and injection site erythema. On 15th December 2018, the patient experienced nausea, abdominal tenderness, exhaustion and diarrhea. The patient was treated with ice pack (nos). On an unknown date, the outcome of the injection site swelling, injection site pain, nausea, intestinal cramps, abdominal tenderness, exhaustion, diarrhea and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling, injection site pain, nausea, intestinal cramps, abdominal tenderness, exhaustion, diarrhea and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: On 13th December 2018, the patient received Dupixent two injections subcutaneously (SQ) and was due to follow with one injection SQ every other week for allergy induced asthma. The patient received the SHINGRIX vaccine on left arm. On 14th December 2018, immediately described as 2 to 3 hours after the vaccination, the patient began to experience injection site reaction of the left arm characterized with swelling of the left arm, the left arm being sore and had the left arm turning red. On the night of 14th December 2018, less than a day after receiving SHINGRIX, the patient began to experience severe upper intestinal cramps. One day after receiving SHINGRIX, the patient experienced nausea, intestinal cramps, lower and upper abdominal tenderness, diarrhea and exhaustion. There was no treatment for  these events. However, treatment included usage of ice for the injection site reactions on the left arm. No additional information was provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of injection site swelling in a 68-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included dupilumab (Dupixent). On 14th December 2018, the patient received the 2nd dose of SHINGRIX. On 14th December 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, intestinal cramps and injection site erythema. On 15th December 2018, the patient experienced nausea, abdominal tenderness, exhaustion and diarrhea. The patient was treated with ice pack (nos). On an unknown date, the outcome of the injection site swelling, injection site pain, nausea, intestinal cramps, abdominal tenderness, exhaustion, diarrhea and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling, injection site pain, nausea, intestinal cramps, abdominal tenderness, exhaustion, diarrhea and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: On 13th December 2018, the patient received Dupixent two injections subcutaneously (SQ) and was due to follow with one injection SQ every other week for allergy induced asthma. The patient received the SHINGRIX vaccine on left arm. On 14th December 2018, immediately described as 2 to 3 hours after the vaccination, the patient began to experience injection site reaction of the left arm characterized with swelling of the left arm, the left arm being sore and had the left arm turning red. On the night of 14th December 2018, less than a day after receiving SHINGRIX, the patient began to experience severe upper intestinal cramps. One day after receiving SHINGRIX, the patient experienced nausea, intestinal cramps, lower and upper abdominal tenderness, diarrhea and exhaustion. There was no treatment for  these events. However, treatment included usage of ice for the injection site reactions on the left arm. No additional information was provided.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle tightness, Musculoskeletal stiffness, Pain in extremity, Product complaint
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of pain in arm in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 26th December 2018 10:00, the patient received the 1st dose of SHINGRIX. On 26th December 2018 13:00, 3 hrs after receiving SHINGRIX, the patient experienced pain in arm (serious criteria hospitalization), shoulder muscle stiffness (serious criteria hospitalization) and muscle tightness (serious criteria hospitalization). On an unknown date, the patient experienced pharmaceutical product complaint. The patient was treated with tramadol and (NOS) BENADRYL. On an unknown date, the outcome of the pain in arm, shoulder muscle stiffness, muscle tightness and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the pain in arm, shoulder muscle stiffness and muscle tightness to be related to SHINGRIX. Additional details were reported as follows: After vaccination the patient experienced tightness around the shoulder and left arm, which escalated to immense pain. On the same day, the patient went to hospital on the around 5:15 PM.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 30 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 information received as follows: The age at the vaccination was not reported. The healthcare professional reported that the patient developed shingles. No further details were reported regarding the event.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: The patient experienced some headache that night after vaccines were given and pain and swelling on the vaccine site the following day. The patient was prescribed Cephalexin 250 mg x 10 days.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Vomiting
Clinical narrative: Passed out for less than 30 seconds with persistent dizziness for about 5 minutes, vomited.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Toothache
Clinical narrative: This was my 2nd dose so I was a bit more prepared but worried about how I'd feel again after the shot. This time right after I got it, I started taking 2 ADVIL every 6 hrs. It helped a tiny bit. I started getting aching and tired late in day but once again in the middle of the night felt horrible and still when I got up at 8 a.m. I had to go back to bed for several more hours to shake it off but felt better after lunch. The 1st shot caused horrible shivering, headache, weakness, nausea, muscle aches, then sweating. I could hardly walk from bed to bathroom when I thought I was going to puke. Some muscles hurt so much it felt like I had injuries and both times a sensitive tooth I had felt like a toothache for a day but both times went away. Then like after 1st shot I'm having headaches days after. I don't think I'd ever get this again if I was told I needed more shots. Luckily I did both shots when I didn't have to work the next day or I'd have to call in sick.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Crying, Fatigue, Feeling cold, Hyperhidrosis, Injection site pain
Clinical narrative: Patient presented to office on 1/2. 2 days after receiving PPSV 23 vaccination because she is a smoker with throbbing pain to the right upper arm, unable to lay on the right side and hold her baby with arm. Crying with pain at times. Feels sweaty/cold at times since yesterday and very run down since vaccine given. Right upper arm with large area of splotchy redness, warm and tender to touch to lateral portion of upper arm. Afebrile at visit.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Patient presented to office on 1/2. 2 days after receiving PPSV 23 vaccination because she is a smoker with throbbing pain to the right upper arm, unable to lay on the right side and hold her baby with arm. Crying with pain at times. Feels sweaty/cold at times since yesterday and very run down since vaccine given. Right upper arm with large area of splotchy redness, warm and tender to touch to lateral portion of upper arm. Afebrile at visit.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling, severe pain at the injection site in the form a 2x3 inch rash. Patient in a lot of discomfort and tried to use ice pack to help but it provided no relief.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Pyrexia
Clinical narrative: Fever of 99.6-104 F, shortness of breath, dizziness.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Immediately after the shot was administered, she felt pain from her upper arm down to her wrist. This started as soon as the shot was given on Oct. 26th. She used ice on it but it continued to hurt, so on Nov. 8th she went to the ED and was given IV steroids. This helped for a few weeks, but then it hurt again, especially when she played her instrument or didn't get much sleep. I saw her on Dec. 6th and gave her a 12 day Prednisone taper. This helped until a few days after the treatment. Pain was not as bad as before. She came today, Jan. 2nd, and says again it hurts if she doesn't sleep or plays her instrument a long time. She was given another Prednisone taper, and told to apply ice to her right deltoid every night. When the Prednisone is finished, I've asked her to take 2 ALEVE or 3 Ibuprofen 200 mg PRN pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin lesion, Swelling
Clinical narrative: Fever for 1 day, swelling for 2-3 days, scar-like lesion remains 1/2/19.
Age: 40.0
Sex: F
Vaccine: FLUC4, PPV, FLUC4, PPV
Symptoms: Abdominal pain, Anaphylactic reaction, Asthenia, Diarrhoea, Dyspnoea
Clinical narrative: On 12/19/18, 3 minutes after receiving PNEUMOVAX and while she was receiving the flu vaccine, the patient began to have acute onset shortness of breath, so I was called out of another patient room to re-assess. She was notably flushed, tachypneic, satting 88% on room air, lungs clear, tachycardic with regular rhythm. I requested my attending physician Dr. to assist me with management at this point. She stated she had to go to the bathroom, as she was having acute-onset diarrhea. She was helped to the restroom by MA and had profuse diarrhea, she subsequently felt too weak to get off the toilet, and was then assisted to the floor. While patient was helped to the bathroom, EMS was called for concerns for anaphylactic shock. Dr. and Dr. accompanied the patient in the bathroom. Vitals were re-obtained which showed BP 70/40s with weak distal extremity pulses. Two rounds of epinephrine injection 0.3mg given at 11:31 am on R) thigh, another dose of Epinephrine given at 11:36am on L) thigh administered by Dr. epinephrine Lot No. 7FM427; Exp Jan 2019. Benadryl PO 50 mg x1 was also given, and O2 4L NC was started. EMS arrived, and she was still alert and able to answer questions, though with slowed mentation and complaining of diffuse abdominal pain. Given concern for anaphylactic shock, she was emergently transported to the ED by paramedics. At Hospital ED, she received a dose of 10 mg dexamethasone IV and famotidine 40 mg IV, though vital signs were stable upon arrival. She was prescribed an epipen at the time of discharge from the ED. She was diagnosed with anaphylaxis and discharged home in stable condition. She returned to our clinic 12/31/18 for follow-up, and was notably in stable condition. She was referred to an allergist for formal testing, though it is presumed her anaphylaxis was likely secondary to either the PNEUMOVAX vaccine (which she received first) or the flu vaccine (which she received second). I suspect the reaction was more likely secondary to the PNEUMOVAX vaccine, as her symptoms of feeling short of breath started just prior to her receiving the flu vaccine, and she has received the flu vaccine 4 years ago with no adverse effects.
Age: 40.0
Sex: F
Vaccine: FLUC4, PPV, FLUC4, PPV
Symptoms: Flushing, Mental impairment, Pulse abnormal, Tachycardia, Tachypnoea
Clinical narrative: On 12/19/18, 3 minutes after receiving PNEUMOVAX and while she was receiving the flu vaccine, the patient began to have acute onset shortness of breath, so I was called out of another patient room to re-assess. She was notably flushed, tachypneic, satting 88% on room air, lungs clear, tachycardic with regular rhythm. I requested my attending physician Dr. to assist me with management at this point. She stated she had to go to the bathroom, as she was having acute-onset diarrhea. She was helped to the restroom by MA and had profuse diarrhea, she subsequently felt too weak to get off the toilet, and was then assisted to the floor. While patient was helped to the bathroom, EMS was called for concerns for anaphylactic shock. Dr. and Dr. accompanied the patient in the bathroom. Vitals were re-obtained which showed BP 70/40s with weak distal extremity pulses. Two rounds of epinephrine injection 0.3mg given at 11:31 am on R) thigh, another dose of Epinephrine given at 11:36am on L) thigh administered by Dr. epinephrine Lot No. 7FM427; Exp Jan 2019. Benadryl PO 50 mg x1 was also given, and O2 4L NC was started. EMS arrived, and she was still alert and able to answer questions, though with slowed mentation and complaining of diffuse abdominal pain. Given concern for anaphylactic shock, she was emergently transported to the ED by paramedics. At Hospital ED, she received a dose of 10 mg dexamethasone IV and famotidine 40 mg IV, though vital signs were stable upon arrival. She was prescribed an epipen at the time of discharge from the ED. She was diagnosed with anaphylaxis and discharged home in stable condition. She returned to our clinic 12/31/18 for follow-up, and was notably in stable condition. She was referred to an allergist for formal testing, though it is presumed her anaphylaxis was likely secondary to either the PNEUMOVAX vaccine (which she received first) or the flu vaccine (which she received second). I suspect the reaction was more likely secondary to the PNEUMOVAX vaccine, as her symptoms of feeling short of breath started just prior to her receiving the flu vaccine, and she has received the flu vaccine 4 years ago with no adverse effects.
Age: 40.0
Sex: F
Vaccine: FLUC4, PPV, FLUC4, PPV
Symptoms: Vaccination complication
Clinical narrative: On 12/19/18, 3 minutes after receiving PNEUMOVAX and while she was receiving the flu vaccine, the patient began to have acute onset shortness of breath, so I was called out of another patient room to re-assess. She was notably flushed, tachypneic, satting 88% on room air, lungs clear, tachycardic with regular rhythm. I requested my attending physician Dr. to assist me with management at this point. She stated she had to go to the bathroom, as she was having acute-onset diarrhea. She was helped to the restroom by MA and had profuse diarrhea, she subsequently felt too weak to get off the toilet, and was then assisted to the floor. While patient was helped to the bathroom, EMS was called for concerns for anaphylactic shock. Dr. and Dr. accompanied the patient in the bathroom. Vitals were re-obtained which showed BP 70/40s with weak distal extremity pulses. Two rounds of epinephrine injection 0.3mg given at 11:31 am on R) thigh, another dose of Epinephrine given at 11:36am on L) thigh administered by Dr. epinephrine Lot No. 7FM427; Exp Jan 2019. Benadryl PO 50 mg x1 was also given, and O2 4L NC was started. EMS arrived, and she was still alert and able to answer questions, though with slowed mentation and complaining of diffuse abdominal pain. Given concern for anaphylactic shock, she was emergently transported to the ED by paramedics. At Hospital ED, she received a dose of 10 mg dexamethasone IV and famotidine 40 mg IV, though vital signs were stable upon arrival. She was prescribed an epipen at the time of discharge from the ED. She was diagnosed with anaphylaxis and discharged home in stable condition. She returned to our clinic 12/31/18 for follow-up, and was notably in stable condition. She was referred to an allergist for formal testing, though it is presumed her anaphylaxis was likely secondary to either the PNEUMOVAX vaccine (which she received first) or the flu vaccine (which she received second). I suspect the reaction was more likely secondary to the PNEUMOVAX vaccine, as her symptoms of feeling short of breath started just prior to her receiving the flu vaccine, and she has received the flu vaccine 4 years ago with no adverse effects.
Age: 40.0
Sex: F
Vaccine: FLUC4, PPV, FLUC4, PPV
Symptoms: Anaphylactic shock
Clinical narrative: On 12/19/18, 3 minutes after receiving PNEUMOVAX and while she was receiving the flu vaccine, the patient began to have acute onset shortness of breath, so I was called out of another patient room to re-assess. She was notably flushed, tachypneic, satting 88% on room air, lungs clear, tachycardic with regular rhythm. I requested my attending physician Dr. to assist me with management at this point. She stated she had to go to the bathroom, as she was having acute-onset diarrhea. She was helped to the restroom by MA and had profuse diarrhea, she subsequently felt too weak to get off the toilet, and was then assisted to the floor. While patient was helped to the bathroom, EMS was called for concerns for anaphylactic shock. Dr. and Dr. accompanied the patient in the bathroom. Vitals were re-obtained which showed BP 70/40s with weak distal extremity pulses. Two rounds of epinephrine injection 0.3mg given at 11:31 am on R) thigh, another dose of Epinephrine given at 11:36am on L) thigh administered by Dr. epinephrine Lot No. 7FM427; Exp Jan 2019. Benadryl PO 50 mg x1 was also given, and O2 4L NC was started. EMS arrived, and she was still alert and able to answer questions, though with slowed mentation and complaining of diffuse abdominal pain. Given concern for anaphylactic shock, she was emergently transported to the ED by paramedics. At Hospital ED, she received a dose of 10 mg dexamethasone IV and famotidine 40 mg IV, though vital signs were stable upon arrival. She was prescribed an epipen at the time of discharge from the ED. She was diagnosed with anaphylaxis and discharged home in stable condition. She returned to our clinic 12/31/18 for follow-up, and was notably in stable condition. She was referred to an allergist for formal testing, though it is presumed her anaphylaxis was likely secondary to either the PNEUMOVAX vaccine (which she received first) or the flu vaccine (which she received second). I suspect the reaction was more likely secondary to the PNEUMOVAX vaccine, as her symptoms of feeling short of breath started just prior to her receiving the flu vaccine, and she has received the flu vaccine 4 years ago with no adverse effects.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given a combination DTaP/Polio (KINRIX) instead of separate vaccines.
Age: 39.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a 39 year old patient, the gender was not reported. Concurrent conditions included that the patient was HIV positive. Historical drugs included that the patient received the first dose of PREVNAR 13 in July 2017. Information regarding medical history or concomitant medication was not provided. On 28-NOV-2018, the patient received the second dose of PREVNAR 13 (route, anatomical site of administration, lot number and expiration date were not reported). Subsequently, on 19-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (route, anatomical site of administration, lot number and expiration date were not reported) for prophylaxis. No adverse effects reported.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse regarding to a 30-year-old female patient. The patient's concurrent conditions, historical conditions, past drugs were unknown. Drug reactions/allergies were none. Concomitant medications included unspecified prenatal vitamin. On 17-DEC-2018 the patient came to receive her diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) vaccine and was instead vaccinated with a dose of GARDASIL 9 (dose, frequency, lot# and expiration date were unknown) intramuscularly for prophylaxis (wrong product administered). The patient sought medical attention (office visit). The patient was currently 31 weeks of pregnant (exposure during pregnancy). The mistake was discovered on 18-DEC-2018, when the patient back to the office and was vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) vaccine. The nurse explained that she was unsure if the patient had any history of receipt of GARDASIL or GARDASIL 9 prior to the event. There were no specific adverse symptoms (no adverse event) being reported. No treatment was given for events. The LMP and EDD was not known. The outcome of wrong product administered, no adverse event and exposure during pregnancy was unknown.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product contamination physical
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 31-DEC-2018, the patient was not able to received first dose of GARDASIL 9 due to  particulates being noted with lot# N001533 with expiration date on 16-OCT-2019 after the vial was agitated for prophylaxis (product quality issue). However, no adverse effects were reported. The causal relationship and the outcome of the event product quality issue was not reported.
Age: 0.75
Sex: M
Vaccine: DTAPIPV, HEP, MMR, PPV
Symptoms: Aphasia, Crying, Injection site induration, Injection site pain, Irritability
Clinical narrative: Information has been downloaded from Agency (US-GlaxoSmithKline-A0868814B). This spontaneous report was received from a health professional refers to a 9 month old male patient. At one-and-a-half months of age the patient experienced an undetermined neurological problem, and appeared to be nonresponsive. He was evaluated by an ophthalmologist who stated his eyes were okay. The cause of the neurological problem was undeterminded and the condition resolved spontaneously with no recurrence. His immunizations were withheld during the course of the episode. Concomitant therapies included 2 doses of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, 2 doses of poliovirus vaccine inactivated (unspecified), hepatitis b virus vaccine (unspecified), 2 doses of hib conj vaccine (ompc)(+) hepatitis b virus vaccine rhbsag (yeast), 2 doses of pneumococcal vaccine (unspecified). The patient's concurrent conditions were not reported. On 02-AUG-2005 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, and hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc). All vaccines were administered at a dose of 1 (unit not provided), injection, per unknown route, for prophylaxis (strength, dosage schedule, anatomical location, lot # and expiry date were not provided). On an unspecified date in 2005, the patient experienced aphasia and speech disorder. On 05-AUG-2005, the patient experienced myositis, irritability, weight bearing difficulty and crying. On an unspecified date in August 2005, the patient experienced injection site induration and injection site tenderness (injection site pain). The outcome of aphasia, speech disorder and myositis was reported as recovered. The outcome of crying, injection site pain, injection site induration, irritability and weight bearing difficulty was unknown. The reporter considered myositis to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown). The reporter's causality assessment between pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) with aphasia, speech disorder, irritability, weight bearing difficulty, crying, injection site induration and injection site pain was not reported. The agency considered aphasia, speech disorder, myositis, irritablity, weight bearing difficulty, crying, injection site induration and injection site pain to be medically significant.
Age: 0.75
Sex: M
Vaccine: DTAPIPV, HEP, MMR, PPV
Symptoms: Myositis, Speech disorder, Weight bearing difficulty
Clinical narrative: Information has been downloaded from Agency (US-GlaxoSmithKline-A0868814B). This spontaneous report was received from a health professional refers to a 9 month old male patient. At one-and-a-half months of age the patient experienced an undetermined neurological problem, and appeared to be nonresponsive. He was evaluated by an ophthalmologist who stated his eyes were okay. The cause of the neurological problem was undeterminded and the condition resolved spontaneously with no recurrence. His immunizations were withheld during the course of the episode. Concomitant therapies included 2 doses of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, 2 doses of poliovirus vaccine inactivated (unspecified), hepatitis b virus vaccine (unspecified), 2 doses of hib conj vaccine (ompc)(+) hepatitis b virus vaccine rhbsag (yeast), 2 doses of pneumococcal vaccine (unspecified). The patient's concurrent conditions were not reported. On 02-AUG-2005 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, and hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc). All vaccines were administered at a dose of 1 (unit not provided), injection, per unknown route, for prophylaxis (strength, dosage schedule, anatomical location, lot # and expiry date were not provided). On an unspecified date in 2005, the patient experienced aphasia and speech disorder. On 05-AUG-2005, the patient experienced myositis, irritability, weight bearing difficulty and crying. On an unspecified date in August 2005, the patient experienced injection site induration and injection site tenderness (injection site pain). The outcome of aphasia, speech disorder and myositis was reported as recovered. The outcome of crying, injection site pain, injection site induration, irritability and weight bearing difficulty was unknown. The reporter considered myositis to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown). The reporter's causality assessment between pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) with aphasia, speech disorder, irritability, weight bearing difficulty, crying, injection site induration and injection site pain was not reported. The agency considered aphasia, speech disorder, myositis, irritablity, weight bearing difficulty, crying, injection site induration and injection site pain to be medically significant.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Immunology test normal, Pain, Urticaria
Clinical narrative: Migrating local soreness, decreasing after 1 week. Migrating uriticaria treated orally with antihistamines & topically with clobetasol. Continued symptoms 60+ days, back to baseline mid-December. Broke out with shingles early September, treated orally with valacyclovir. Pain relieved with two 325mg acetaminophen tablets.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given a DTAP-HIB-IPV and a HIB at the same time. No reaction documented.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: The patient's arm was hot to touch a few hours after the injection at the injection site and extended down almost to her elbow the next day. She discussed the situation with us and then decided to make an appointment with her primary care doctor. The doctor said that she had never seen a reaction to this extent from a PNEUMOVAX 23 injection. The doctor gave her a Prednisone 10 mg 6 day dosepack. The symptoms started and to resolve after she starting taking the dosepack and completely resolved in a day or two on the Prednisone.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Dtap-IPV-HIB and the HIB vaccine were both given- no reaction noted.