chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vasculitis
Clinical narrative: vasculitis on both legs, lower abdomen, lower back and buttocks; rash; This case was reported by a physician via call center representative and described the occurrence of vasculitis in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 54A2T, expiry date 11th December 2021) for prophylaxis.   On 7th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th November 2019, 8 days after receiving Shingrix, the patient experienced vasculitis and rash. On an unknown date, the outcome of the vasculitis was recovering/resolving and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the vasculitis and rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient noticed a rash and went to visit the doctor.  The patient had vasculitis on both legs, lower abdomen, lower back and buttocks.  The reporter states that, the vasculitis was resolving, however, it was not completely resolved. The patient required emergency visit.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Pain in extremity
Clinical narrative: Arm soreness; Felt "crappy"; Fatigued; Flu-like Symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, malaise and fatigue. On an unknown date, the outcome of the pain in arm and malaise were unknown and the outcome of the influenza-like symptoms and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, malaise and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced arm  soreness that lasted a few days and the patient also felt crappy, which she described as fatigued and also experienced flu-like symptoms for 2 days.  The patient did not want to receive the 2nd dose of Shingrix, and the patient was already late for the 2nd dose but possibly would not receive it at all. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: couldn't locate a dose anywhere; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in spring 2018).   On 23rd November 2019, the patient received the 2nd dose of Shingrix. On 23rd November 2019, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were received as follows: The patient could not locate dose anywhere until the date of vaccination for 2nd dose.  The reporter did not consented to follow up. Patient said she did not want a phone call nor a letter from the company.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain at injection site; redness at injection; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On 26th September 2019, the outcome of the injection site pain, injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had injection site pain, injection site erythema and injection site swelling. The reporter did not consent to follow up. Limited information was provided. The patient wanted to remain anonymous. This case linked with US2019GSK219143, reported by same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site discomfort, Injection site erythema, Injection site pruritus, Vulvovaginal erythema
Clinical narrative: reactivation of shingles; redness; itching; uncomfortable; redness; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number N99P3, expiry date 19th October 2021) for prophylaxis.   The patient's past medical history included shingles (experienced shingles on an unknown date).   On 20th November 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, injection site erythema, injection site itching, injection site discomfort and vaginal erythema. On an unknown date, the outcome of the shingles, injection site erythema, injection site itching, injection site discomfort and vaginal erythema were unknown.   It was unknown if the reporter considered the shingles, injection site erythema, injection site itching, injection site discomfort and vaginal erythema to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient experienced a red ring, itching and discomfort at the injection site.  The patient also experienced a reactivation of shingles in her vaginal area with redness. The reporter did not provide any specific dates of onset or when the previous shingles case was.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Lethargy, Nausea
Clinical narrative: Lethargic; Difficulty sleeping; Shivering; Fever; Body aches; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced lethargy. In December 2019, the patient experienced shivering, fever, general body pain, headache, nausea and difficulty sleeping. On an unknown date, the outcome of the shivering, fever, general body pain, headache, nausea, difficulty sleeping and lethargy were unknown.   It was unknown if the reporter considered the shivering, fever, general body pain, headache, nausea, difficulty sleeping and lethargy to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient stated that she received her first dose of Shingrix vaccine and experienced shivering, fever, body ache, headache, and nausea. The patient was not able to sleep at night and was feeling lethargic. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Lethargic; Difficulty sleeping; Shivering; Fever; Body aches; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced lethargy. In December 2019, the patient experienced shivering, fever, general body pain, headache, nausea and difficulty sleeping. On an unknown date, the outcome of the shivering, fever, general body pain, headache, nausea, difficulty sleeping and lethargy were unknown.   It was unknown if the reporter considered the shivering, fever, general body pain, headache, nausea, difficulty sleeping and lethargy to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient stated that she received her first dose of Shingrix vaccine and experienced shivering, fever, body ache, headache, and nausea. The patient was not able to sleep at night and was feeling lethargic. The patient did not consent to follow up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness at injection site; Hard area at injection site; Soreness/tenderness at injection site; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2019, 19 days after receiving Shingrix, the patient experienced injection site erythema and injection site induration. On an unknown date, the patient experienced injection site pain and headache. On an unknown date, the outcome of the injection site pain and headache were recovered/resolved and the outcome of the injection site erythema and injection site induration were unknown.   It was unknown if the reporter considered the injection site pain, headache, injection site erythema and injection site induration to be related to Shingrix.  Additional details were received as follows: The patient stated that he received the first dose of Shingrix vaccine and experienced soreness and tenderness at injection site along with a headache. On the day of reporting the patient also woke up with redness and hard area at the injection site which was circular and 1 inch by 1 inch in size. The patient did not consent to follow up.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error
Clinical narrative: medication error; Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 16 years old male patient who experienced medication error, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 17-Nov-2018, the patient received a dose  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U51808A via unknown route in unknown administration site.  The patient developed a non-serious medication error <<Unknown latency>> following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Final diagnosis was medication error.    It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Applicable for medication error.       Additional information was received on 14-Jan-2019 by << "the same reporter" or "reporter type if other reporter">>.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: Received Flu vaccine during pregnancy with no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 37 years old female patient who received a 0.25-2 mL dose of vaccine INFLUENZA VACCINE [Flu vaccine] (lot and expiry date: unknown), via unknown route, on 28-Oct-2019.  Data regarding this pregnancy were received prospectively. The date of last menstrual period was unknown. The estimated due date is 19-Dec-2019.  Relevant medical history and concomitant medication were unknown.  On 28-Oct-2019, patient Received  INFLUENZA VACCINE during pregnancy (PT: Exposure during pregnancy).  At the time of reporting, outcome of the pregnancy was not reported.  Information on the batch number was requested.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: used a 5/8 inch needle, patient had very little fat on his arms and she went in at 90 degrees, NO AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 71 years old male patient who experienced Wrong injection technique while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ301AA, exp date: 24 June 2020  via intramuscular route in the left deltoid.  It was a case of  Wrong injection technique as pharmacist used a 5/8 inch needle, when the recommendation was to use a 1 inch needle. It was also reported that patient had very little fat on his arms and pharmacist went in at 90 degrees.  At the time of the report, no adverse event was reported.  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
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Ophthalmoplegia, Paralysis
Clinical narrative: Bell's palsy; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported.   On 10-OCT-2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   On unknown date in October 2019 (reported as within approximately two weeks of receiving zoster vaccine live (ZOSTAVAX)), the patient experienced severe paralysis of her face, scalp and eye, and was diagnosed with Bell's palsy requiring extensive medical treatment. These injuries continued today and were caused by zoster vaccine live (ZOSTAVAX).   As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event Bell's palsy was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event Bell's palsy to be disability.   Upon internal review, the event Bell's palsy was determined to be medical significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional symptoms reported; improperly stored varivax; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/ allergies and concurrent conditions were not reported. The patient's concomitant therapy included sterile diluent.  On 21-NOV-2019, the patient was vaccinated with improperly stored second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dosage, route were not reported, lot# S008692  has been verified to be a valid lot number for (varicella virus vaccine live (oka/merck)), expiration date reported as 21-MAR-2021) for prophylaxis (product storage error). It was reported that the vaccine underwent temperature excursion of 6.5 Fahrenheit (F) for a time frame of 20 minutes. There was previous temperature excursion of 8.1 F for 25 minutes reported. There was involvement of data logger. No additional symptoms (no adverse event) were reported. No product quality complaint was reported. The outcome of product storage error and no adverse event was unknown.
Sex: M
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: tingling on his hands and finger tips\ Tingling on the finger tips; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a male patient who received Rabies NVS (RabAvert) for prophylaxis.   On 20th November 2019, the patient received RabAvert 1 ml. In November 2019, less than a week after receiving RabAvert, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was unknown.   It was unknown if the reporter considered the tingling of extremity to be related to RabAvert.  Additional case details were reported as follows: The age at vaccination was not reported. It was unknown if the patient received RabAvert vaccination for pre or post exposure prophylaxis. The patient reported tingling on his hands and finger tips after receiving Rabavert on last Wednesday. No specific data from product was clarified.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest pain, Dyspepsia, Headache, Injection site pain
Clinical narrative: fever; headache; muscle aches; pain at injection site; heartburn; upset stomach; pain in upper chest; This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 4th November 2019, 1 days after receiving Shingrix, the patient experienced fever, headache, muscle pain, injection site pain, heartburn, upset stomach and chest pain. On 5th November 2019, the outcome of the fever, headache and muscle pain were recovered/resolved. On 6th November 2019, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the heartburn, upset stomach and chest pain were recovering/resolving.   It was unknown if the reporter considered the fever, headache, muscle pain, injection site pain, heartburn, upset stomach and chest pain to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; headache; muscle aches; pain at injection site; heartburn; upset stomach; pain in upper chest; This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 4th November 2019, 1 days after receiving Shingrix, the patient experienced fever, headache, muscle pain, injection site pain, heartburn, upset stomach and chest pain. On 5th November 2019, the outcome of the fever, headache and muscle pain were recovered/resolved. On 6th November 2019, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the heartburn, upset stomach and chest pain were recovering/resolving.   It was unknown if the reporter considered the fever, headache, muscle pain, injection site pain, heartburn, upset stomach and chest pain to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: pain at the injection site/ Achy arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Tetanus vaccine with an associated reaction of pain in extremity.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experienced pain at the injection site with an achy arm. The patient claims that her shot felt like a tetanus shot and she had an achy arm.   The patient received the vaccination in her left upper arm.   No additional details were available. This case has been linked with the case US2019GSK213839 and US2019GSK213842, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: achy feeling in her arm/ pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but she was in her 60's. The patient received Shingrix vaccine and experienced pain at the injection site with an achy feeling in her arm. The reporter consented to follow up. This case has been linked with the case US2019GSK213841, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at injection site; . This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the reporter for her neighbor. The age at vaccination was not reported. The patient received Shingrix and had injection site pain. The reporter did not consent to follow up. This case linked with US2019GSK219141, reported by same reporter.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Alphavirus test, Bacterial test negative, Borrelia test negative, Chest X-ray abnormal, Chlamydia test positive
Clinical narrative: Meningitis and encephalitis, possible Bickerstaff brainstem encephalitis
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Culture negative, Encephalitis, Haemophilus test positive, Meningitis, Serology negative
Clinical narrative: Meningitis and encephalitis, possible Bickerstaff brainstem encephalitis
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: West Nile virus test negative
Clinical narrative: Meningitis and encephalitis, possible Bickerstaff brainstem encephalitis
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reported that she had severe pain in her leg that started 6 days after the shot. She went to her doctor and received a steroid shot that did not help it at all. She then went to the emergency room after the pain was not relieved. She did not clarify what steps they took at that point. She read through the vaccine information statement and felt like her leg pain might have been a reaction. She also wanted me to add the flu shot to her list of allergies.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm redness, pain and swelling where she was injected with the vaccine
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Stomach pain; reddness at injection site; swelling at injection site; Soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of stomach pain in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced stomach pain, injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the stomach pain, injection site erythema, injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the stomach pain, injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: At the time of this report the patient was experiencing severe stomach pain. The reporter consented to follow up.
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Blood pressure increased, Hypoaesthesia oral, Hypotonia, Nausea, Pain in extremity
Clinical narrative: New employee presented to Employee Health Office for egg-free flu shot.  She endorsed hx. of prior vaccine reactions, did not have documentation.  She received Flublok injection at ~1000 am.  We asked her to stay in office for few minutes of observation.  ~ 10 min. after injection, she began to c/o her tongue feeling numb along side.  She was lucid, slid down in the chair and then said she needed to lay down.  We helped her to the floor.  She remained responsive but did have short, few seconds of non-responsiveness, appeared to go limp, but never stopped breathing.  We checked her VS.  BP was elevated, HR wnl, O2 sat 100%.  She was responsive & c/o nausea.  She did not vomit.  We attempted to administer epinephrine, first into her left deltoid, then into her left anterior thigh.  The injection didn't appear to function appropriately and much of the medication spilled onto her clothing and floor.  We called a Campus Response for assistance and then I decided we should call a Code to access more resources. The Code Team arrived and I assisted putting her on a backboard and onto gurney.  She was shaking so we applied warm blankets.  Another nurse accompanied her to the ED with a copy of the VS we had taken.  The patient never lost consciousness.  She c/o pain in her thigh where epi injection had been attempted.
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: New employee presented to Employee Health Office for egg-free flu shot.  She endorsed hx. of prior vaccine reactions, did not have documentation.  She received Flublok injection at ~1000 am.  We asked her to stay in office for few minutes of observation.  ~ 10 min. after injection, she began to c/o her tongue feeling numb along side.  She was lucid, slid down in the chair and then said she needed to lay down.  We helped her to the floor.  She remained responsive but did have short, few seconds of non-responsiveness, appeared to go limp, but never stopped breathing.  We checked her VS.  BP was elevated, HR wnl, O2 sat 100%.  She was responsive & c/o nausea.  She did not vomit.  We attempted to administer epinephrine, first into her left deltoid, then into her left anterior thigh.  The injection didn't appear to function appropriately and much of the medication spilled onto her clothing and floor.  We called a Campus Response for assistance and then I decided we should call a Code to access more resources. The Code Team arrived and I assisted putting her on a backboard and onto gurney.  She was shaking so we applied warm blankets.  Another nurse accompanied her to the ED with a copy of the VS we had taken.  The patient never lost consciousness.  She c/o pain in her thigh where epi injection had been attempted.
Age: 53.0
Sex: F
Vaccine: RAB, VARZOS
Symptoms: Pain, Palpitations, Rash, Urticaria
Clinical narrative: Patient reports she noticed a rash of hives at approximately 4:00pm the day of the vaccination. Patient states soon after the rash she felt body aches from head to toe (so much she had to lie down) and she felt her heart race (over 100bpm). Patient states she rested the rest of that evening and when she got up the next morning, she felt fine. The patient states she feels the problematic vaccine was the Shingrix because she had received a dose of the RabAvert one week prior without any problems.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site discomfort, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Individual developed typical left deltoid area tenderness by 24 hours but has noted persistent tingling, pain into distal portion of left arm in addition to persistent discomfort at site of injection though no swelling, bruising evident on exam at time of visit to assess this 12/7/19.  No response to anti-inflammatories and topical therapies by individual.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site papule, Injection site rash
Clinical narrative: Right Shoulder rash. Multiple papules confined to R shoulder.
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chest X-ray abnormal, Condition aggravated, Cough, Decreased appetite
Clinical narrative: 10/09/2019-Patient presented to PCPs office with chief complaint of watery eyes, runny nose, cough, and SOB. Generalized weakness worsening and appetite continues to decline. Memory continues to decline, Itching in hands. Spontaneous bruising. Treatment-Add Megace for appetite, Hold Coumadin and recheck Friday, Increase Ensure to 3 times daily as tolerated, Eat greens today
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Increased tendency to bruise, International normalised ratio increased, Lacrimation increased, Memory impairment
Clinical narrative: 10/09/2019-Patient presented to PCPs office with chief complaint of watery eyes, runny nose, cough, and SOB. Generalized weakness worsening and appetite continues to decline. Memory continues to decline, Itching in hands. Spontaneous bruising. Treatment-Add Megace for appetite, Hold Coumadin and recheck Friday, Increase Ensure to 3 times daily as tolerated, Eat greens today
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Prothrombin time prolonged, Pruritus, Rhinorrhoea
Clinical narrative: 10/09/2019-Patient presented to PCPs office with chief complaint of watery eyes, runny nose, cough, and SOB. Generalized weakness worsening and appetite continues to decline. Memory continues to decline, Itching in hands. Spontaneous bruising. Treatment-Add Megace for appetite, Hold Coumadin and recheck Friday, Increase Ensure to 3 times daily as tolerated, Eat greens today
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Malaise, Pain, Pain in extremity
Clinical narrative: Arm pain by evening, next few days. Sudden low back pain (muscular?), started that evening, lasted five days. Generally not feeling well ... aches, pains, fever, chills. Still feel like I'm getting over it, six days later.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Arm pain by evening, next few days. Sudden low back pain (muscular?), started that evening, lasted five days. Generally not feeling well ... aches, pains, fever, chills. Still feel like I'm getting over it, six days later.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient complained of a sore arm at the site of injection. No swelling or redness at the site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Pain, Pain in extremity
Clinical narrative: Patient received Prevnar 13 on 11/29/19 in right deltoid muscle.  She had soreness that day and developed a rash/redness on skin in the middle of the arm.  Patient had soreness and redness which continued to persist.  Patient came to pharmacy on Sunday and pharmacist saw redness on arm and referred her to primary care.   Patient saw her primary care on 12/9/19 for another reason and asked her primary care about the red patch.  Her primary care gave her Augmentin 500 bid along with cough medication.  Patient came to pharmacy on Monday.   She showed me her arm with redness.  She said her redness was less at that time.  Today, 12/10/19, her husband came to pharmacy and told me her arm was more red and it was sore when she lifted her arm.  I contacted oversight physician, Dr. Dr. said it may be cellulitits and antibiotic may make a difference.  I contacted her primary care dr. and she asked that patient should continue on Augmentin.  Patient is to follow up in a week.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site warmth, Malaise, Pain
Clinical narrative: 12/04:  Body aches and malaise;  soreness at injection site. 12/05  Injection site is warm and largely inflamed.
Age: 81.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Herpes zoster, Swelling
Clinical narrative: My mother had a shingles outbreak near left eye.  It was red and swollen.  in the evening, looking much worse the next morning.  My sister took my mother to a walk in clinic and they diagnosed Singles and wanted her to go to eye doctor.  She was given aclovir for 10 days, which cleared up the shingles outbreak.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site vesicles, Purulent discharge
Clinical narrative: Patient had a reaction at the injection site which blistered and had white pus. Pt followed up with her provider which initiated valcylovir  and clindamycin
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported. On or about 09-APR-2013, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, route of administration, anatomical location, lot number and expiration date were not provided), as prescribed and/or administered by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, she was treated by a physician at the physician office for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the pt had not recovered from herpes zoster. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was considered as related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 03-JUN-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date (subsequent to inoculation), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. By the time of this report, the patient had not recovered from shingles. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain to arm during injection, radiating down the arm
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate increased
Clinical narrative: Rapid heart rate (over 100 BPM) experienced for approximately two hours before sleep. I had not been exercising or consuming carbohydrates for three hours before the symptoms started. For reference, my resting heart rate is approximately 42 BPM. When I woke the following morning, there were no symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Neck pain, Pain
Clinical narrative: Chills, shaking, body aches, tired, sore neck, head ache for 36 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Chills, shaking, body aches, tired, sore neck, head ache for 36 hours.
Age: 58.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Allergy to vaccine, Hypersensitivity, Inflammation, Monoplegia, Pain in extremity
Clinical narrative: Patient states she had partial arm paralysis of right arm(proximal) for 2.5 hours after leaving the store. She also experienced pain and inflammation in the distal right arm. She went to the emergency room where she was diagnosed as having an allergic reaction to the Prevnar 13 vaccine. No further treatment. Patient has since recovered completely.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Still extremely sore muscles in arm, very painful to move, feels like was just given the shot today but its been 3 weeks. Arm throbs, but no external markings, or bruises, or coloration.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain to injection site immediately after injection
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Acupuncture, Chiropractic, Dizziness, Feeling hot, Headache
Clinical narrative: I went to the doctor because I thought I had strep throat. A culture was taken and it was confirmed I had strep throat. The nurse suggested I get the Tetanus shot as it had been a long time since I had one. I said sure, not knowing it was multiple shots in one AND you are NEVER supposed to give a shot when someone is sick! I didn't know this information at the time of the shot. Immediately after the shot I felt hot and sweaty and sick. I asked to use the restroom and barely made it there. I fainted in the restroom. After I woke up I yelled for the nurse to come and help me. She walked me back to the room where I was given the shot. The doctor came back in and placed cold presses on my body to help me. After about 30 minutes I was able to stand up and walk out. I've not felt the same since that Tdap shot that day! My memory has been horrible since that day, I get dizzy very easily and constant headaches. I've had to do acupuncture and chiropractic care to help heal myself from the Tdap shot.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Malaise, Memory impairment, Syncope
Clinical narrative: I went to the doctor because I thought I had strep throat. A culture was taken and it was confirmed I had strep throat. The nurse suggested I get the Tetanus shot as it had been a long time since I had one. I said sure, not knowing it was multiple shots in one AND you are NEVER supposed to give a shot when someone is sick! I didn't know this information at the time of the shot. Immediately after the shot I felt hot and sweaty and sick. I asked to use the restroom and barely made it there. I fainted in the restroom. After I woke up I yelled for the nurse to come and help me. She walked me back to the room where I was given the shot. The doctor came back in and placed cold presses on my body to help me. After about 30 minutes I was able to stand up and walk out. I've not felt the same since that Tdap shot that day! My memory has been horrible since that day, I get dizzy very easily and constant headaches. I've had to do acupuncture and chiropractic care to help heal myself from the Tdap shot.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: generalized maculopapular (mildly itchy) rash starting on right foot, now on trunk and all extremities, sparing face and oral mucosa. No localized reaction on deltoid.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red large swallow injection site
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, X-ray of pelvis and hip
Clinical narrative: Flu like
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms; administered an expired dose; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about patient's concurrent condition, concomitant medication, medical history, drug allergy/reaction was not reported. On 06-DEC-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) 50/1.0 U/milliliter, lot # R031045, expiration date: 18-NOV-2019 via intramuscular route for prophylaxis (dose number, anatomical location was not reported) (expired product administered). The patient experienced no symptoms (no adverse events). No product quality complaint was involved.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: COMPLIAN OF PAIN AND DECRESED RANGE OF MOTION TO LEFT ARM
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: CHILD WAS SENT BACK TO THE CLINIC WITH REDDNESS AND ITCHING FROM TOP OF SHOULDER TO ELBOW ON THE ARM WHERE SHE GOT THE INJECTION.  BENADRYL WAS ADMINISTERED BY SCHOOL NURSE PER SCHOOL POLICY
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Febrile convulsion, Hypertension, Pyrexia
Clinical narrative: 104 fever 3 days, febrile seizure, high blood pressure. he was able to  sit by himself, crawl and pull himself up onto couch before vaccination and now he can barely do it
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Pt was given a expired Dtap vaccine.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site atrophy
Clinical narrative: Atrophy in the left thigh overlying the injection site.  Mother states she noticed this when patient was 10 months old.  Clinically I appreciated the changes when he came in for a flu vaccine in October 2019.   Initially I did not believe the changes were related to vaccines.  In November, when I saw patient for his 12-month Well Check, I began considering the possibility of atrophy of the subcutaneous fatty tissue.  I referred him to pediatric dermatology for further evaluation.   Diagnosis from Dr. (pediatric dermatologist) is not certain, possibilities include lipoatrophy secondary to immunization.  Presumably since mother reports noticing these changes by 10 months old, the most recent injection on the affected thigh would be the Pediarix dose given on May 8, 2019.  Dr. states she has seen this adverse reaction from steroid injections, but never seen it secondary to immunizations.   Other possible causes of the skin changes on the left thigh include morphea and anetoderma (per Dr.'s note).  Unknown if this will cause permanent damage or disability yet.
Age: 22.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient reports left shoulder pain following vaccine administration. States that he is unable to lift left arm past shoulder height; has moderate pain with attempts. Has been referred for physical therapy.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Fever to 104, rigor/chills Significant pain, erythema, induration and tenderness over left upper arm
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Patient had a golf ball diameter sized welt at the injection site, which was warm to the touch, and felt achy for a few days.
Age: 28.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Fall, Loss of consciousness, Seizure like phenomena
Clinical narrative: Pt was fine after receiving both immunizations. After immunizations were complete, he stood at the counter waiting for me to make copies of the immunization forms for school. While standing at the counter, he passed out and fell to the ground. Another patient in the waiting area said it looked like he was seizing. Seconds later, I was notified he passed out and was on the ground, so I ran to grab my emergency bag and out to the waiting room. He was already talking and saying he was fine. I had pulled out an Epi-Pen in case I needed to administer, and he declined the need for administering it. I asked how he was feeling and he stated he felt fine, but wanted to continue to lay on the floor, just in case. I did grab him some water. 911 was called but the patient declined the need for them to come. Our store manager sat with him in the waiting area for another 15 minutes to make sure he was fine. The patient left on his own, walking, just fine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Frequent bowel movements, Headache, Nausea, Pollakiuria
Clinical narrative: Typical as listed until night time. I woke up five tomes to pee and poo. Then the nausea kept me up for several hours vomiting (dry heaves and bile.) Lost my appetite. Drumming headache. I almost forgot, I also took 12-hour guafenosin at 11:28 am on 12/09 as directed for the sinusitis. Today I have a headache but it isn?t a sinus type.