chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Blepharospasm, Blister, Eye movement disorder, Varicella
Clinical narrative: blister; chicken pox; eye movement disorder; twitch of my right eye; This case was reported by a consumer via call center representative and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in late 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced blister, chickenpox, eye movement disorder and blepharospasm. On an unknown date, the outcome of the blister, chickenpox, eye movement disorder and blepharospasm were unknown.   It was unknown if the reporter considered the blister, chickenpox, eye movement disorder and blepharospasm to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose and had blisters that resembled chicken pox occur after the 2nd dose. I had a much more severe reaction resulting in a return trip to my primary care physician. They verified that the blisters appeared to be like chicken pox. Soon after had an intermittent twitch of my right eye. This eye movement has worsened over time since the 2nd part vaccine.  The reporter was concerned.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Musculoskeletal pain, Pain in extremity, Presyncope
Clinical narrative: arm pain; shoulder pain; headache; pre-syncope episode; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX795AA, expiry date unknown) for prophylaxis.   On 7th June 2019, the patient received Bexsero .5 ml. On 8th June 2019, 1 days after receiving Bexsero, the patient experienced pain in arm, shoulder pain, headache and presyncope. On an unknown date, the outcome of the pain in arm, shoulder pain, headache and presyncope were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, headache and presyncope to be related to Bexsero.  Additional details were provided as follows: The patient reported arm and shoulder pain, headache, and had a pre syncope episode the next day after receiving the vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site red; Injection site hot; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 31st May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, couple of days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The reporter has a consumer that received the Shingrix and reported that the injection site became red and hot a couple of days after receiving the vaccination. The symptoms have resolved. The reporter was unable to provide additional information because the consumer was not in pharmacy at the time of reporting.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site redness; Injection site hot; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number X39679 ?, the reported lot number does not macth with any GSK lot number, expiry date unknown) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR 13) for prophylaxis.   On 27th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and PREVNAR 13. On 28th July 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Prevnar 13 on left deltoid. The next day after getting vaccination, the injection site became red and hot and was the same at the time of reporting. The reporter was unable to provide any additional information because the consumer was not in the pharmacy at the time of the reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for 1st dose, refer case US2019AMR142228).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's sister. Additional information was not available. The reporter did not consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Cough, Dyspnoea, Periarthritis, Productive cough
Clinical narrative: Coughing up so much stuff; chest froze; shoulders froze; breathing difficult; couldn't cough up stuff / asthmatic coughing; This case was reported by a consumer via call center representative and described the occurrence of chest tightness in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lung disorder. Concomitant products included medication unknown, medication unknown (Nebulizer (Name Unknown)).   On 23rd May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd May 2019, 10 min after receiving Shingrix, the patient experienced chest tightness, frozen shoulder, difficulty breathing and cough resembling asthma. On 29th July 2019, the patient experienced productive cough. On 29th July 2019, the outcome of the chest tightness and cough resembling asthma were recovered/resolved. On an unknown date, the outcome of the frozen shoulder was recovered/resolved and the outcome of the difficulty breathing and productive cough were unknown.   It was unknown if the reporter considered the chest tightness, frozen shoulder, difficulty breathing, cough resembling asthma and productive cough to be related to Shingrix.  Additional information received were as follows: Within 10 minutes of receiving the dose, the patient's chest and both shoulders froze. The patient could not breathe well and she could not cough up stuff in her lungs, which she needed to do due to her lung problem. While the patient had some asthmatic coughing, she has not been able to cough up the stuff in her lungs. 67 days after receiving Shingrix, the patient started coughing up so much stuff. The reporter consented to follow up. The case was related to patient.
Sex: F
Vaccine: HEP, HEP, HEP, HEP, HEP, HEP
Symptoms: Hepatitis B surface antibody negative, Therapy non-responder, Underdose
Clinical narrative: Therapy non responder; Therapy non responder; Underdose; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 11-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On 28th August 2018, the patient received the 4th dose of Engerix B .5 ml. On 29th July 2019, the dose was .5 ml (.5 ml daily). On 29th July 2019, the patient received the 5th dose of Engerix B .5 ml. On 29th July 2019, not applicable after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Engerix B, not applicable after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Engerix B and unknown after receiving Engerix B, the patient experienced underdose. On an unknown date, the patient experienced therapy non-responder and therapy non-responder. On an unknown date, the outcome of the therapy non-responder, therapy non-responder and underdose were unknown.   It was unknown if the reporter considered the therapy non-responder and therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Engerix B.  Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. The patient could be of less than 1 year at the time of 1st vaccination. The patient received her initial 3 dose series of Hepatitis B vaccine in her first year of life. Last year in 2018, when the patient was 10 years old, she was found to have a titer level that was indeterminate, which led to non responder to therapy and hence the pediatrician decided to give her a booster dose of Engerix B 0.5 ml. This year in 2019, titer was checked again and it was still indeterminate, which led to non responder to therapy. On 29th July 2019, the patient received 2nd booster dose of Engerix B 0.5 ml, which led to underdose. As the patient was 11 years old, and the recommended booster dose for an 11 year old patient was 1 ml. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Raised; Knot; Redness on upper arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number D7797, expiry date 9th July 2021) for prophylaxis.   On 21st May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site nodule. On an unknown date, the outcome of the injection site erythema and injection site nodule were recovered/resolved and the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site nodule to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received Shingrix and experienced redness on upper arm covering area of 6 to 8 inches in size. She also experienced a raised knot in size of inch to inch and a half. It took about two weeks for the redness and knot to be resolved. No further details were provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Sore; Red; the injection site became hot; area involved increased in size; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number T9KE4, expiry date 25th September 2021) for prophylaxis.   Concomitant products included sulphamethoxazole, trimethoprim (Bactrim).   On 20th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st July 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The reporter has a consumer that received Shingrix in the left deltoid and the injection site became red, and hot and the area involved increased in size over several days. The red area was at the time of reporting and the size of her hand and it was still hot and sore. The consumer indicated that she was taking Bactrim at the time of the injection and wondered if that might had caused the reaction. The reporter was unable to provide any additional information because the consumer was not in the pharmacy at the time of the call.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Shingrix. On 23rd July 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Specific details about patient and lot number were not available by pharmacist at time of report. The patient received Shingrix in left arm. The pharmacist reported that a patient received Shingrix and experienced redness at the injection site which was lasting 7 days with no improvement. There was discrepancy between the outcome reported in the structured field (not recovered/ not resolved) and the outcome reported in the source document recovering/resolving, Also the age group was reported in the structured field as adult and the age group reported in the source document as infant.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated, Dyspnoea, Fatigue, Palpitations
Clinical narrative: Shortness of breath; Wheezing; Heart palpitations; Fatigue; asthma-like symptoms; Condition aggravated; This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis.   Concurrent medical conditions included asthma.   On 25th July 2019, the patient received the 1st dose of Shingrix. On 25th July 2019, 1 hr after receiving Shingrix, the patient experienced shortness of breath, wheezing, palpitation, fatigue, asthma-like condition and condition aggravated. On an unknown date, the outcome of the shortness of breath, wheezing, palpitation, fatigue and asthma-like condition were recovering/resolving and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the shortness of breath, wheezing, palpitation, fatigue, asthma-like condition and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about an hour to an hour and a half later started to experience asthma like symptoms that included shortness of breath and wheezing. The patient but saw an increase in symptoms after receiving the vaccine. The patient also experienced heart palpitations and extreme fatigue. The reporter spoke to the patient the day after she received the vaccine and she stated that she was feeling better, but not 100 percent. The reporter gave consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Wheezing
Clinical narrative: Shortness of breath; Wheezing; Heart palpitations; Fatigue; asthma-like symptoms; Condition aggravated; This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis.   Concurrent medical conditions included asthma.   On 25th July 2019, the patient received the 1st dose of Shingrix. On 25th July 2019, 1 hr after receiving Shingrix, the patient experienced shortness of breath, wheezing, palpitation, fatigue, asthma-like condition and condition aggravated. On an unknown date, the outcome of the shortness of breath, wheezing, palpitation, fatigue and asthma-like condition were recovering/resolving and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the shortness of breath, wheezing, palpitation, fatigue, asthma-like condition and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about an hour to an hour and a half later started to experience asthma like symptoms that included shortness of breath and wheezing. The patient but saw an increase in symptoms after receiving the vaccine. The patient also experienced heart palpitations and extreme fatigue. The reporter spoke to the patient the day after she received the vaccine and she stated that she was feeling better, but not 100 percent. The reporter gave consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: swollen; redness; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, the patient experienced redness which spread from the top of his shoulder area and down his deltoid. Symptoms began at an unknown time. The reporter did not consent to follow up. Pharmacist declined to provide more information.
Sex: F
Vaccine: MENB
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: neck pain; swelling of lymph nodes; This case was reported by a physician via sales rep and described the occurrence of neck pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included complex regional pain syndrome.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced neck pain and enlargement of lymph nodes. On an unknown date, the outcome of the neck pain and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the neck pain and enlargement of lymph nodes to be related to Bexsero.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The batch number of Bexsero was unknown. The GlaxosmithKline employee informed by the physician that, the patient experienced neck pain and swelling of lymh nodes, but the physician did not specify. At the time of reporting, the date of therapy and onset of event was unknown. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 years patient was given Dapatacel instead of Adacel; 12 years patient was given Dapatacel instead of Adacel; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 years old patient who received vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date, route and site of administration were unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested  Documents held by sender: none.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 7 year old femal patient was given a 0.5ml dose of Quadracel vaccine on 31-Jul-19; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a seven years old female patient was given a 0.5ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]vaccine on 31-Jul-19 lot C5500CA, expiry date: 16-Aug-2020 via unknown route in the left deltoid 31 July 2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   The patient was also given Progard vaccine.  It was an actual medication error due to inappropriate age at vaccine administration.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt c/ left arm swelling and redness, hot to touch that developed around 24 hrs after receiving vaccine.  Pt given  Benadryl in office then started on Cephalexin. Pt in office for f/u on 8/9 greatly improved.
Age: 58.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Product preparation error
Clinical narrative: When giving MMR the MA accidentally used Menactra as the Diluent instead of a sterile Diluent. the combined MMR + Menactra was given to the patient
Age: 9.0
Sex: M
Vaccine: MMRV
Symptoms: Eye pain, Headache, Pyrexia, Urticaria
Clinical narrative: Severe eye pain and headache fever and hives
Age: 23.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient vaccinated on 8/7/2019.  Returned to clinic on 8/8/19 with redness and swelling at site of varicella vaccine administration.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness/swelling /warmth of upper arm below injection site, beginning a few hours after dose administered.   Per patient report to pharmacy 8/9/19,  swelling is decreased since yesterday but arm is still red and warm to the touch.  Area is about 1/2 the circumference of the arm as of now.  Patient had not yet sought medical treatment but was advised to do so.   We requested that the patient report the outcome of visit to us
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Arm swelled (2 half dollar size), red & sore to touch, black & yellow bruise, lump by injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: patient complained of soreness in the arm and that she could not raise her arm above her shoulders
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm
Clinical narrative: Redness, warm to touch
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Dizziness, Hypoacusis, Immediate post-injection reaction, Pallor
Clinical narrative: Immediately following injection, patient stated that she felt dizzy, lightheaded, and hard of hearing as if she was "underwater". She was pale and clammy. The RPh tried to take her pulse and HR but automated reader came back as "error"
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Feeling hot, Headache, Malaise, Monoplegia
Clinical narrative: 45 minutes after the shot, patient felt "sicker than a dog", puking with a headache.  Patient laid down and slept for 4 hours.  Patient woke up, her left leg was tingling with heat waves going down the left leg.  Her left side was droopy including her face and arm.  She went to the ER and they sent her to a larger hospital thinking she was having a stroke.  Symptoms resolved by the next day
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Vomiting
Clinical narrative: 45 minutes after the shot, patient felt "sicker than a dog", puking with a headache.  Patient laid down and slept for 4 hours.  Patient woke up, her left leg was tingling with heat waves going down the left leg.  Her left side was droopy including her face and arm.  She went to the ER and they sent her to a larger hospital thinking she was having a stroke.  Symptoms resolved by the next day
Age: 12.0
Sex: F
Vaccine: HPV9, IPV, MMRV, MNQ, TDAP
Symptoms: Loss of consciousness, Presyncope, Syncope
Clinical narrative: Minutes after administration of vaccination while I was documenting the encounter, I heard yelling in the hallway and someone yelling seizure. I rushed to the scene and was the first on site within five seconds. Patient was conscious  but, I sent my coworker to get the nearest doctor. I layed the patient down to help ensure her safety. Doctor arrived and helped treat patient. It was then determined through the patients mom that she actually passed out and was mistaken in her assumption of a seizure. Vitals were ran by Assistant and was determined by Doctor that it was a vasovagal reaction and syncope. Patient continued lying down for 20 minutes as we monitored her condition before they left.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: It was the wrong vaccine. Patient was requesting to get meningitis vaccine, but the pharmacist who was working gave M-M-R. Talked to patient he was okay and had no adverse side effects.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: A day after my Shingrix vaccination I had nerve twinges, on and off  on the left side of my head, for a few days.  (I was vaccinated on my left arm.)  I have had terrible pain in my upper arm for 6 weeks and 4 days.  In addition to icing, I have taken ibuprofen and Aleve, but it does not make a difference.  I hurts when I raise my arm half-way up in front of me.  It hurts when I put my arm behind my back.  It is painful to get dressed, take a shower, dry myself, do my hair, drive, put dishes in the cupboard, make a left-hand turn in my car with my left arm.  I could go on and on.  It is terrible and I am trying to be optimistic that it will go away.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: Patient reported Fever/Nausea and hives and welts on arm, face, and eyebrows.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient had developed a circular rash later the day she got the vaccine. The rash was 1-inch in diameter and approximately 2-3 inches lower than injection site. Patient describes that as itchy and warm to touch, but denies fever. The next day, the rash grew slightly bigger to ~3-inch in diameter but it was not as warm as previous day.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Skin mass
Clinical narrative: patient presented to the pharmacy today (8-9) and stated that one week after she received her Tdap vaccine, she started to get hard nodules that felt like marbles under her skin. She believes this is a vaccine reaction. She also got a tattoo around the same time. The lumps I felt were above her tattoo but she stated that started at the injection site and moved down her arm and then to her other arm. Her doctor is referring her to a specialist but she has not had that appt yet.
Age: 13.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Blood test normal, Dyspnoea, Muscle contractions involuntary, Muscle spasms, Urine analysis normal
Clinical narrative: Severe back spasms, shortness of breath, unable to sit or lie down, body contorted, visit to the ER
Age: 13.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: X-ray normal
Clinical narrative: Severe back spasms, shortness of breath, unable to sit or lie down, body contorted, visit to the ER
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abnormal behaviour, Binocular eye movement disorder, Confusional state, Dizziness, Dysarthria
Clinical narrative: After vaccination, patient became very nauseated and felt sick. She also felt hot, dizzy. She was made to lay down. She complained of not being able to feel her right arm but was able to move it on her own when commanded to do so. Then she started to act confused and "out of it", and acted as if falling asleep with her eyes open and her eyes kept crossing medially. During this time she was still able to answer questions appropriately (she was oriented to place and person) and was able to follow commands ("look at me", squeeze my fingers, etc), but her speech was slurred and she would immediately return to her confused state with eyes crossing again, and she would just lay there. She was resting comfortably and breathing comfortably but intermittently would take very slow and deep breaths. Vital signs (BP, HR, RR) were checked and stable, and heart and breath sounds via auscultation were normal. Then she started foaming at the mouth, at first a small amount intermittently and then it became excessive. Then she started having all over body twitching, especially noted in her lower extremities. She continued to remain responsive throughout all of this, responding to questions and following commands. The entire series of events happened over the course of about an hour after receiving the vaccines. EMS was called when she began foaming excessively and twitching.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Feeling hot, Foaming at mouth, Hyperventilation, Malaise
Clinical narrative: After vaccination, patient became very nauseated and felt sick. She also felt hot, dizzy. She was made to lay down. She complained of not being able to feel her right arm but was able to move it on her own when commanded to do so. Then she started to act confused and "out of it", and acted as if falling asleep with her eyes open and her eyes kept crossing medially. During this time she was still able to answer questions appropriately (she was oriented to place and person) and was able to follow commands ("look at me", squeeze my fingers, etc), but her speech was slurred and she would immediately return to her confused state with eyes crossing again, and she would just lay there. She was resting comfortably and breathing comfortably but intermittently would take very slow and deep breaths. Vital signs (BP, HR, RR) were checked and stable, and heart and breath sounds via auscultation were normal. Then she started foaming at the mouth, at first a small amount intermittently and then it became excessive. Then she started having all over body twitching, especially noted in her lower extremities. She continued to remain responsive throughout all of this, responding to questions and following commands. The entire series of events happened over the course of about an hour after receiving the vaccines. EMS was called when she began foaming excessively and twitching.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Muscle twitching, Nausea, Respiratory rate decreased, Sensory loss
Clinical narrative: After vaccination, patient became very nauseated and felt sick. She also felt hot, dizzy. She was made to lay down. She complained of not being able to feel her right arm but was able to move it on her own when commanded to do so. Then she started to act confused and "out of it", and acted as if falling asleep with her eyes open and her eyes kept crossing medially. During this time she was still able to answer questions appropriately (she was oriented to place and person) and was able to follow commands ("look at me", squeeze my fingers, etc), but her speech was slurred and she would immediately return to her confused state with eyes crossing again, and she would just lay there. She was resting comfortably and breathing comfortably but intermittently would take very slow and deep breaths. Vital signs (BP, HR, RR) were checked and stable, and heart and breath sounds via auscultation were normal. Then she started foaming at the mouth, at first a small amount intermittently and then it became excessive. Then she started having all over body twitching, especially noted in her lower extremities. She continued to remain responsive throughout all of this, responding to questions and following commands. The entire series of events happened over the course of about an hour after receiving the vaccines. EMS was called when she began foaming excessively and twitching.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Posturing, Seizure, Syncope
Clinical narrative: fainting vs mild seizure, recovered in less than 1 minute, but had 2 brief episodes of stiffening/posturing during that time (occurred about a minute after vaccines were given)
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Muscle twitching
Clinical narrative: pt passed out with little twitching for 5-6 seconds
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Severe nausea and vomiting. Chills/fever/fatigue. This is the second dose and family realized that the first time he recieved the dose had a similar incident and had to go to ER.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain, Paraesthesia oral, Skin warm
Clinical narrative: First dose of Shingrix was given at 4:49 pm on 8/3/2019. Patient stayed in the area for about 15 minutes and as she was leaving, she said the sides of the tongue were tingling. However, since the symptoms did not get worse, she left for home. She was called about 2 hours later and the tingling was gone, but she had developed a headache that lasted a couple of hours. She returned to the pharmacy on 8/9/2019 stating that her arm was still red and hot to the touch. The first couple of days she said the area was hot to the touch and painful. A call was made to the doctor alerting the office to the reaction. Patient said she was taking Fexofenadine 1 qd to help counteract the reaction.  It is unknown what the outcome with the doctor is.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV9, MNQ
Symptoms: Face injury, Fall, Loss of consciousness, Seizure, Tremor
Clinical narrative: About 5 min. After shot, we walked to lab waiting room, sat down, within 3 min. He began to seize up and shake, causing him to fall out of the chair, hitting his cheek. I screamed something was wrong. I was told he passed out and would be fine. He laid down and got a cold compress and fan, as well as some juice. 10 min later he finished his eye and ear test and we left. The dr.  Said as I was checking out, next dose we would have him stay laying down for 15 min. But I worry it was a seizure and he shouldn't have the 2nd!
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Night sweats
Clinical narrative: patient said the day after her vaccination she got flu like symptoms, chills and night sweats. Those effects only lasted one day then she was fine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Pain, Redness, soreness, swelling at injection site, Headaches, muscle aches, shivering, fatigue,, dizziness and weakness
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Pain, Redness, soreness, swelling at injection site, Headaches, muscle aches, shivering, fatigue,, dizziness and weakness
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Feeling abnormal, Seizure, Tremor
Clinical narrative: Patient was given both Shingrex and Prevnar on 08/08/19. Patient is on Keppra due to stroke. Pharmacist on duty contacted patient's doctor to receive approval for immunizations to be given and approval was received. In the evening of 08/08/19, the patient had what appeared to be a mini seizure per the patient's wife. He shook once and turned his head to the right and appeared out of it for a few minutes then returned to baseline. Patient's wife then called 911 and had him transported to Hospital. At the hospital all values were normal and patient was release to go home. Patient's wife says he appears fine today. They have informed his doctor of the incident.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash that itches and is erythematous and in different size patches, on the trunk and extremities and some on face child has no fever and no problems with swallowing and appetite is not decreased she has been given Benadryl which helped her get a little relief from the itching
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Decreased appetite, Headache, Nausea
Clinical narrative: High fiber, headache, joints pain, nausea, lost of appetite, general weakness.  Treatment:  Tylenol 500mg
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Pyrexia
Clinical narrative: High fiber, headache, joints pain, nausea, lost of appetite, general weakness.  Treatment:  Tylenol 500mg
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 8/5/2019 6:36PM PT HAD INJECTION SITE PAIN RIGHT AWAY.  HOWEVER, 8/6/2019 PT FOUND REDNESS PATCH ERYTHEMA AT LOWER LEVEL OF INJECTION SIDE AND MORE TOWARD TO THE BACK OF UPPER ARM IN THE MORNING.  THE ERYTHEMA SIZE WAS ABOUT 1X1 INCH.  PT'S INJECTION SITE IS CLEAR AND NO REDNESS. THE ERYTHEMA WAS ITCH AND PAIN.  ALSO PT'S RIGHT WRIST LATERAL SIDE HAD ONE BLISTER LIKE A BEAN SIZE. PT REPORTED TO US ON 8/7/2019 IN THE EVENING.  I RECOMMENDED PT TO SEE HER DR.  SHE MADE AN APPT AND NEVER SAW HER DR.  8/8/2019 I FOLLOWED UP WITH PT.  PT SAID SHE FELT A LOT BETTER.  PT NEVER HAD FEVER OR CHILLS.  PT'S HUSBAND TOLD ME THIS DETAILED INFORMANTION .
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: pt states she sometimes feels that her arm is not as strong as it was prior to imz, not all the time, just ocassionally.  when asked if it was problematic enough for her to avoid the second shingrix, she said no, she definitely wants the second shot.
Age: 53.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash
Clinical narrative: rash
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Headache, Hyperhidrosis, Nausea, Pain of skin
Clinical narrative: PT CALLED AT 08:54 TODAY (8-9-19) C/O BAD REACTiON TO 2ND GARDASiL. SHOT (GiVEN AT 08:30-8-8-19) & PT STATES APPX 16-17:00 JOiNTS HURTING, HAiR HURT, NAUSEA, SWEATY, BAD HADACHE. MUCH BETTER TODAY
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Blood glucose normal, Bradycardia, Electrocardiogram normal, Fall
Clinical narrative: After 8 minutes of administering vaccine and pt stated he was thirsty, instructed to remain on exam table, father sitting 2 feet in front of him. He told his father of not feeling well and he turned to side and fell off exam table, hitting his head on floor. Father not sure if he had syncope episode. Pt was found on floor by staff and father and staff assisting pt to chair and was lethargic, diaphoretic, brady-cardic upon placing O2 Sat probe and then when up to 60's and hypotensive 88/40. Opening eyes on ammmonia inhalant. Neuro checks within normal limits. Started intravenous fluids with normal saline one liter. Father states patient had not eaten all day due to pending appointment with dental In same clinic. Ice pack to head applied. After 7min pt more alert and taking fluids and eating cookies and crackers. No trauma, bruise or bump to head. Moving all extremities but stated feeling weak. Instructions given to parent on discharge to watch for any mental changes, dizziness, nausea, vomiting, severe headache, high temperature and to call clinic or take patient to nearest ER or call 911.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperhidrosis, Hypotension, Lethargy, Malaise, Neurological examination normal
Clinical narrative: After 8 minutes of administering vaccine and pt stated he was thirsty, instructed to remain on exam table, father sitting 2 feet in front of him. He told his father of not feeling well and he turned to side and fell off exam table, hitting his head on floor. Father not sure if he had syncope episode. Pt was found on floor by staff and father and staff assisting pt to chair and was lethargic, diaphoretic, brady-cardic upon placing O2 Sat probe and then when up to 60's and hypotensive 88/40. Opening eyes on ammmonia inhalant. Neuro checks within normal limits. Started intravenous fluids with normal saline one liter. Father states patient had not eaten all day due to pending appointment with dental In same clinic. Ice pack to head applied. After 7min pt more alert and taking fluids and eating cookies and crackers. No trauma, bruise or bump to head. Moving all extremities but stated feeling weak. Instructions given to parent on discharge to watch for any mental changes, dizziness, nausea, vomiting, severe headache, high temperature and to call clinic or take patient to nearest ER or call 911.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Thirst
Clinical narrative: After 8 minutes of administering vaccine and pt stated he was thirsty, instructed to remain on exam table, father sitting 2 feet in front of him. He told his father of not feeling well and he turned to side and fell off exam table, hitting his head on floor. Father not sure if he had syncope episode. Pt was found on floor by staff and father and staff assisting pt to chair and was lethargic, diaphoretic, brady-cardic upon placing O2 Sat probe and then when up to 60's and hypotensive 88/40. Opening eyes on ammmonia inhalant. Neuro checks within normal limits. Started intravenous fluids with normal saline one liter. Father states patient had not eaten all day due to pending appointment with dental In same clinic. Ice pack to head applied. After 7min pt more alert and taking fluids and eating cookies and crackers. No trauma, bruise or bump to head. Moving all extremities but stated feeling weak. Instructions given to parent on discharge to watch for any mental changes, dizziness, nausea, vomiting, severe headache, high temperature and to call clinic or take patient to nearest ER or call 911.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: Patient started to experience itching on the lower left side of his back and thought he saw a rash so quickly went in to see the doctor. The doctor told him it is a localized Shingles reaction from the Shingrix vaccination he received and it should not spread any more from where it is now. Patient is experiencing pain and has been prescribed Valacyclovir for 7 days and Norco as needed to treat the reaction and help with the pain. the patient has a follow up visit with the doctor today and the doctor says he will keep the patient and our pharmacy up to date of the treatment.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: Next day patient called to report severe pain to R upper arm, radiating to neck area. Came in to be seen by provider. Received Toradol 60mg IM injection to gluteal area. Pt very sore, no erythema, no drainage from site seen, no fever. Guarding area and complained of much pain when moving arm. Followed up with patient next day and had less soreness and advised to take over the counter Tylenol or Motrin.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash, Urticaria
Clinical narrative: Pt received Pneumovax on 7/24/19. On 7/26/19, she called, stating approx. 24 hrs later, she had a rash "bubblu-like hive" rash on arm injection had been given from elbow to wrist. Minimal rxn @ injection site. patient instructed to be evaluated & to call back. Pt never called back. PCP unsure if rxn is from vaccine or other
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Head injury, Syncope
Clinical narrative: Patien fainted after receiving all 3 vaccines, Hit his head (R) side. 1st time experience this with the patient. Tdap HPV MCV4
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Decreased appetite, Headache, Nausea
Clinical narrative: high fever (103) headache loss of appetite general weakness chills
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Pyrexia
Clinical narrative: high fever (103) headache loss of appetite general weakness chills
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, UNK
Symptoms: Developmental regression, Electrocardiogram, Electroencephalogram, Gene mutation identification test, Head banging
Clinical narrative: My son began having focal seizures after getting the dtap vaccine. He had major regression and stared into space and changed from my happy smiley boy to baby who had a blank stare and looked like the kight shut off in his eyes.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, UNK
Symptoms: Partial seizures, Speech disorder, Staring
Clinical narrative: My son began having focal seizures after getting the dtap vaccine. He had major regression and stared into space and changed from my happy smiley boy to baby who had a blank stare and looked like the kight shut off in his eyes.
Sex: F
Vaccine: UNK
Symptoms: Abnormal behaviour, Allergy to animal, Asthenia, Dairy intolerance, Dust allergy
Clinical narrative: The day she received the vaccine in January 12, 2016, she was very sleepy immediately after. Once she awoke about 4 hours after, she was very low energy. Not herself. The next day she had the same low energy & started to show signs of an allergic reaction by eczema on her face & then developing on her arms & legs. We took her into the doctors office on Jan 14, 2016 & explained to them that she was having an allergic reaction to the vaccines that were administered a few days prior. We received confirmation that it in fact was a vaccine reaction.