chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site pain, Malaise
Clinical narrative: malaise; soreness at injection site; Body temperature increased; This case was reported by a consumer and described the occurrence of malaise in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise, injection site muscle pain and body temperature increased. On an unknown date, the outcome of the malaise, injection site muscle pain and body temperature increased were unknown.   It was unknown if the reporter considered the malaise, injection site muscle pain and body temperature increased to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced the symptions like the body temperature was recorded as 99.3 degree F, general malaise and muscle soreness other that the site of the injection. The patient asked how long could expect the symptions. Fore assistance the chat was directed to a Shingrix product specialist. The pharmacist asked the patient to take note that anything they chat about should not be taken as medical advice. The pharmacist refered the patient to the patient's health care provider as their primary resource for patient care.      Lab Comments: On an unknown date, the patient's body temperature was recorded to be 99.3 degree F.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Influenza like illness
Clinical narrative: Flu like symptoms; extradose; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis.   On 11th April 2019, the patient received the 3rd dose of Shingrix. On 11th April 2019, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The pharmacist reported that, the patient received a 3rd dose of Shingrix, which led to extra dose administered.   Follow up information received from pharmacist on 24th July 2019: The patient's demographic details were updated. The patient received 3 doses of Shingrix in deltoid muscle.  Prior 2 doses were in August 2018 and November 2018, in checking the patient profile it was missed. The patient received the 3rd dose of Shingrix via intramuscularly .5 ml.  On an unknown date, less than 3 months after, the patient experienced flu like symptoms that could resulted. The outcome of the flu like symptoms was unknown.  It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. The VAERS details were updated. This case was a medication error with harm
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Drug dose administration interval too long; arm swollen; redness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number M77B4, expiry date 8th February 2021) for prophylaxis.  Previously administered products included Shingrix (1st dose received in summer of 2018.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable. The patient's daughter thought that patient received 1st dose of vaccine in June of 2018 and did not receive her second dose yet, which led to incomplete course of vaccination. The daughter provided patient's information for contact instead of her own.   Follow up information received from the consumer on 22nd April 2019: VAERS information was updated.   Follow up information received from the consumer on 24th July 2019: The patient demographic details was updated. On 4th August 2018, the patient received 1st dose of vaccine intramuscularly. On 4th August 2018, less than a day after vaccination the patient experienced swollen and redness around injection site. The patient used ice packs and ibuprofen. The redness and swollen were resolved within a week on 11th August 2018. On 28th March 2019, patient received 2nd dose of vaccine intramuscularly (batch number: E3Z7E; expiry date:27th April 2019), which led to lengthening of vaccination schedule. The VAERS information was updated. The reporter considered the swelling arm and erythema to be related to Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hypotonia, Injection site pain, Limb discomfort
Clinical narrative: Vaccination site pain /Hurt so much; Joint pain; Decreased muscle tone; Arm discomfort / Arm not functioning; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, joint pain, decreased muscle tone and arm discomfort. On an unknown date, the outcome of the injection site pain, joint pain, decreased muscle tone and arm discomfort were unknown.   It was unknown if the reporter considered the injection site pain, joint pain, decreased muscle tone and arm discomfort to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but the it could be 83 or 84 years. The patient received vaccine in unknown arm. The patient received their first dose, it destroyed their arm. It described as the patient did not have a lot of muscle and when she got it, it hurt so much and it went to her joints and something happened. So the doctor said don't do it again in the arm. The patient's arm was still not functioning 100 percent. It was reported that there was no further information to provide regarding the product or event at this time. The reporter gave permission to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash over arms; This case was reported by a consumer via call center representative and described the occurrence of rash in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gastrointestinal ulcer. Previously administered products included Shingrix (1st dose received on March 2019.). Concomitant products included hydrocortisone (Topical Hydrocortisone).   In June 2019, the patient received the 2nd dose of Shingrix. In July 2019, between 3 and 4 months after receiving Shingrix, the patient experienced rash. The patient was treated with hydrocortisone. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. On 20th July 2019, the patient started to experience rash on both the arms running down the elbow.  The patient had been applying hydrocortisone cream to it. The reporter gave permission to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Product preparation issue
Clinical narrative: injection site pain; inappropriate reconstitution technique; Inappropriate dose of vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose and Shingrix at an unknown dose. On an unknown date, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the diluent portion of the vaccine only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Then the patient was re-vaccinated with full dose the same day and reported pain at the injection site. The reporter had no other information available, as the reporter was calling from home. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2021) and (batch number 2792L, expiry date 27th September 2021) for prophylaxis.   Concomitant products included prednisone.   On 7th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 13th July 2019, 6 days after receiving Shingrix, the patient experienced rash. In July 2019, the patient experienced pruritus. On an unknown date, the outcome of the rash and pruritus were unknown.   It was unknown if the reporter considered the rash and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient experienced itching on her knee initially less than a week after vaccination and then developed a rash six days after receiving the Shingrix vaccine. The patient came in to get her prescription filled for Prednisone. No additional details were available. It was reported to follow-up with the pharmacist directly. The reporter gave permission to follow up. As per sales data sheet reported batch number of Shingrix adjuvant was changed from Z79ZL to 2792L.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Body ache; Fever; Swelling at injection site; Redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 19th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced general body pain, fever, injection site swelling and injection site erythema. On an unknown date, the outcome of the general body pain, fever, injection site swelling and injection site erythema were resolved with sequelae.   It was unknown if the reporter considered the general body pain, fever, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced body ache, fever, swelling and redness at injection site. The reporter stated that, the patient had recovered. No further details were provided.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Post herpetic neuralgia, Product supply issue
Clinical narrative: post herpetic neuralgia on right abdomen; pain; Product supply issue; This case was reported by a physician via call center representative and described the occurrence of post herpetic neuralgia in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 14 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced post herpetic neuralgia, pain and product supply issue. In November 2018, the outcome of the post herpetic neuralgia and pain were recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the post herpetic neuralgia and pain to be related to Shingrix.  Additional details were provided as follows: The patient is a retired neurologist. The patient reported that about 2 to 3 weeks after injection, he developed what felt like a post herpetic neuralgia on his right abdomen, about 2 inches from the mid-line. The reporter stated that wearing a t shirt or any shirt was annoying and that the pain resolved sometime in November 2018. The patient reported that due to his travel as well as unavailability of product, has yet to get the second dose and was outside the 6 month window.
Age: 66.0
Sex: M
Vaccine: PNC, VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number T9KE4, expiry date 25th September 2021) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On 24th June 2019, the patient received the 1st dose of Shingrix (intramuscular) and PREVNAR. On 6th July 2019, 12 days after receiving Shingrix, the patient experienced rash. The patient was treated with triamcinolone, hydroxyzine hydrochloride (Hydroxyzine) and methylprednisolone sodium succinate (Solu Medrol). On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and prevnar was administered in the right arm. The patient received Shingrix and Prevnar concomitantly and developed a rash on both arms, back and trunk.  The patient had the rash about two weeks before he went to the emergency room on 20th July 2019.  He was prescribed hydroxyzine, triamcinolone, and solu medrol. The rash was getting better but still not resolved.  The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Myalgia; Feels like crap; This case was reported by a physician via call center representative and described the occurrence of fever in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019 09:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd July 2019, less than an hour after receiving Shingrix, the patient experienced myalgia and feeling bad. On 23rd July 2019 22:00, the patient experienced fever and chills. The patient was treated with ibuprofen (Motrin). On 24th July 2019, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the fever and feeling bad were unknown and the outcome of the myalgia was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, myalgia and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient had the injection around 9:30am and the fever 104 degree F and chills developed around 10:00 pm. The patient also experienced a myalgia and kind of feels like crap.  The myalgia started within the first hour after the injection and was ongoing. At the time of reporting the patient had not checked for a fever, but he has been taking Motrin every 6 hours.   The patient did not have chills at the time of reporting.   The reporter consented to follow up. Lot number and expiry date was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain in extremity
Clinical narrative: flu like symptoms; sore left arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received Shingrix (intramuscular). On 24th July 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The caller reported that the adverse events on behalf of his wife.  The patient was experiencing flu like symptoms and her left arm was sore.  Did not consent to follow up. The caller declined to provide the patient treating physician's information and her date of birth. This case linked with US2019134707, reported by same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site rash, Rash
Clinical narrative: redness; rash; This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 22nd July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 24th July 2019, 2 days after receiving Shingrix, the patient experienced erythema of extremities and rash. On an unknown date, the outcome of the erythema of extremities and rash were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left arm. The patient reported that a patient received the first dose of Shingrix and this morning she noticed, approximately two inches from the injection site, redness with a rash. The reporter had consented to follow up. There was discrepancy in the age group reported in source document (infant) and in database it was elderly as per DOB, also there was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and in the database it was reported as not recovered/ not resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Hypoaesthesia, Hypoaesthesia oral, Lymphadenopathy
Clinical narrative: Tongue and cheek Numbness; Swollen glands; Chest tightness; Tongue and cheek Numbness; This case was reported by a other health professional via call center representative and described the occurrence of numbness of tongue in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   Co-suspect products included benadryl (nos) (Benadryl) for an unknown indication.   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Benadryl 100 mg at an unknown frequency. On 16th July 2019, 30 min after receiving Shingrix, the patient experienced numbness of tongue, swollen glands, chest tightness and hypoesthesia. On 16th July 2019, the outcome of the numbness of tongue, swollen glands, chest tightness and hypoesthesia were recovered/resolved.   It was unknown if the reporter considered the numbness of tongue, swollen glands, chest tightness and hypoesthesia to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix in right deltoid. The patient took 100 mg of Benadryl approximately 30 minutes prior to the injection. It was reported that approximately 30 minutes after vaccination, the patient experienced tongue and cheek numbness, swollen glands, and chest tightness.  The events lasted for a couple hours and then resolved. It was unknown if the reporter considered the numbness of tongue, swollen glands, chest tightness and hypoesthesia to be related to Benadryl as well. The reporter consented to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4359, expiry date unknown) for prophylaxis.   On 5th July 2019, the patient received Shingrix (intramuscular) .5 ml. In July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the one of his patients received the Shingrix vaccine. The patient started having arm soreness after the injection and had the soreness, even though it has been 3 weeks.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Injection site reddness; Hives on chest; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KF37, expiry date 14th April 2020) for prophylaxis.   The patient's past medical history included injection site erythema and hives. Previously administered products included Unknown vaccination.   On 24th July 2019, the patient received Shingrix. On 24th July 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and hives. On an unknown date, the outcome of the injection site erythema and hives were unknown.   It was unknown if the reporter considered the injection site erythema and hives to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that patient reported injection site redness and hives on chest after receiving Shingrix.  The patient also reported that this was typically happens after she receives vaccinations and post operation. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Pain of skin, Vaccine positive rechallenge
Clinical narrative: tiredness; joint ache; hair ache / scalp hurts; Back pain; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy. Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on 12th March 2019 and experienced adverse events, refer linked case US2019134786).   On 23rd July 2019, the patient received the 2nd dose of Shingrix. On 24th July 2019, 1 days after receiving Shingrix, the patient experienced tiredness, joint pain, scalp pain and back pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness, joint pain, scalp pain and back pain were unknown.   It was unknown if the reporter considered the tiredness, joint pain, scalp pain and back pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. On the reporting date, the patient experienced adverse events which were back pain, joint pain, tiredness, hair hurt, and scalp hurts.
Sex: F
Vaccine: HEP, HEPA, HEPAB
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Wrong vaccine administered; Interchange of Vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 53-year-old female patient who received HAB (Twinrix) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On 19th July 2019, the patient received Twinrix. On an unknown date, the patient received Hepatitis A vaccine at an unknown dose and Hepatitis B vaccine at an unknown dose. On 19th July 2019, unknown after receiving Twinrix and not applicable after receiving Hepatitis A vaccine and Hepatitis B vaccine, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown.  Additional information received were as follows: The patient received Twinrix to start the series, received Hepatitis A and Hepatitis B monovalent as the second doses in the series, which led to wrong vaccine administered. The patient received Twinrix as the third dose in the series, which led to inappropriate schedule of vaccine administered.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product complaint
Clinical narrative: Pharmaceutical product complaint; Invalid case- The only event pharmaceutical product complaint for rubber stopper of Shingrix vial.
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: Breathing difficulties; allergy; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 82-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, 2 hrs after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced difficulty breathing and allergy. On an unknown date, the outcome of the difficulty breathing and allergy were unknown.   It was unknown if the reporter considered the difficulty breathing and allergy to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The reporter had no information on the manufacturer of the vaccine or when the adverse events occurred. The case was filed for FluLaval and Fluarix Quadrivalent 2018-2019 season, however, no information was provided which vaccine caused the adverse events. Two to four hours after receiving Flu vaccine, the patient had to visit the emergency room with breathing difficulties. The reporter had no specific details about the agent that caused allergy to the patient, but the patient could eat eggs. The reporter consented to follow up.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: HPV vaccince to left delt on 8/1   developed generalized urticaria the next morning
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Asthma, Condition aggravated, Cough, Eczema, Insomnia
Clinical narrative: Around 1;00 a.m. patient started coughing and was unable to sleep; which continued for over a month. For the next month his eczema got worse and worse. Rough patches appeared all around his face. His asthma and coughing  also got worse and worse; resulting in hospitalization. Currently he is still struggling with his asthma, sleeping and eczema.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Rash papular
Clinical narrative: Left arm redness inflammtion no pain itchy and papular rash around the site of injection
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Pain in extremity
Clinical narrative: Patient developed pain, numbess and tingling in left arm from her shoulder to her fingers. Of note, she previously had two doses of Trumemba, this was her first dose of Bexsero
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia
Clinical narrative: Patient developed pain, numbess and tingling in left arm from her shoulder to her fingers. Of note, she previously had two doses of Trumemba, this was her first dose of Bexsero
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Contusion, Fall, Headache, Loss of consciousness, Nausea
Clinical narrative: Patient walked outside after getting shots and passed out on ground. Girlfriend found him lying in parking space unconscious, easily aroused and got Health Department staff. Nurse went out an assessed patient B/P 142/88, P 88, Neuro checks completed and all within normal limits, patient alert and oriented to person, place, and time. Contusion noted back of head and left elbow.  Assisted to sit in truck in air conditioning, given water and candy. Patient reports felt sick on stomach and head hurt but just thought he was hungry due to not eating since early AM. RN advised patient to go to ER for further evaluation due to hitting head and concussion symptoms multiple times, patient refused. Girlfriend called back later to advise patient letting her take him to Hospital ER, for evaluation due to extreme headache and emesis.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Vomiting
Clinical narrative: Patient walked outside after getting shots and passed out on ground. Girlfriend found him lying in parking space unconscious, easily aroused and got Health Department staff. Nurse went out an assessed patient B/P 142/88, P 88, Neuro checks completed and all within normal limits, patient alert and oriented to person, place, and time. Contusion noted back of head and left elbow.  Assisted to sit in truck in air conditioning, given water and candy. Patient reports felt sick on stomach and head hurt but just thought he was hungry due to not eating since early AM. RN advised patient to go to ER for further evaluation due to hitting head and concussion symptoms multiple times, patient refused. Girlfriend called back later to advise patient letting her take him to Hospital ER, for evaluation due to extreme headache and emesis.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Full blood count, Pain, Pyrexia
Clinical narrative: chills,body aches,fever,cellulitis,elevated wbc
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: chills,body aches,fever,cellulitis,elevated wbc
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Muscular weakness, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pain and weakness in arm continues after 1.5 weeks, doesn?t respond to ibuprofen or acetaminophen. Feels like a bad bruise with pain radiating up the shoulder, no marks, redness, or swelling.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Uveitis
Clinical narrative: uveitis in left eye, shingles
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Fever of 102.5, headache, dizziness, slight nausea, stayed in bed for most of day after booster vaccine.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Myalgia
Clinical narrative: very sore injection site and mustle pain (like Flu)
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Drooling, Glassy eyes, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: At approximately 10 am on 8/2/19 MA gave HPV & Menveo in R arm.  Then, she gave Tdap in L arm.  Patient began becoming stiff, glassy eyes and unresponsive to name, & started drooling after receiving Tdap . MA laid patient down & then gave ammonia inhalant & then patient began responding.  I was called to the room after this.  Patient was  sitting up on table and answering basic questions with mom and MA at her side. Pt laid down for 10 minutes & then mini neuro exam done: CN 2-12 intact, FTN intact, EOMI intact, 2 + patellar reflexes, able to walk on toes and heels, min mental status exam done- pt knew name, age, and could answer basic questions such as favorite shows that mom watches, what she likes to do- anime & drawing, what happened yesterday (grandfathers 2 year death anniversary). Pt had difficulty with spelling world backwards and counting backwards from 100 by 7 (answered 92 first, then 91).  Pt given water & left after 30 minutes.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Posture abnormal, Skin discolouration
Clinical narrative: Pt was given Bexsero in right upper arm around 3:30 pm while sitting upright on exam table.  Within 5 minutes he fell to the right and laid sideways on the exam table.  He had LOC for 30 sec, pale, green in color and diaphoretic.  He was able to sit up and sip water and cool cloth to forehead.  Oreinted x 3 within 2 mintes after vaccine.  Alert and and no distress the rest of the time in office.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Developed shingles-type rash on back of left leg, radiating to front of knee.  Blistering rash became itchy within a few days of onset.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site swelling, Injection site vesicles
Clinical narrative: Patient described and provided pictures of a red, swollen, hot, lump with tiny blisters around the injection site accompanied by a fever and headache. Patient took Aleve and applied an ice pack. Patient reported on 8/2/19 that her headache and fever had resolved.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Patient described and provided pictures of a red, swollen, hot, lump with tiny blisters around the injection site accompanied by a fever and headache. Patient took Aleve and applied an ice pack. Patient reported on 8/2/19 that her headache and fever had resolved.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient's right deltoid was swollen and warm to touch extended to just above the elbow.  Child c/o soreness to touch, denied inability to move extremity. Instructed mother to administer tylenol and place cold compress on arm.
Age: 4.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: No adverse effects reported; The patient was administered only half to three quarters of a dose of PROQUAD due to the needle leaking; The patient was administered only half to three quarters of a dose of PROQUAD due to the needle leaking; some of the vaccine may have gotten on the patient's leg; some of the vaccine may have gotten on the patient's leg; This spontaneous report was received from a medical assistant referring to a 4 year old patient of an unknown gender. Information regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies were not reported.  On 25-JUL-2019, the patient was administered only half to three quarters of a dose (underdose) of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) with lot number R008203 and expiration date on 16-SEP-2019; and the sterile diluent for the reconstitution with lot number N008379 and expiration date on 14-NOV-2019, both administered subcutaneously in the left thigh, for prophylaxis (dose and dose number were not reported, due to the needle leaking (needle issue). Also was reported, that some of the vaccine may have gotten on the patient's leg (exposure via skin contact and accidental exposure to product). No adverse effects were reported.  At the time of the report, the outcome of the event and the causality assessment between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and sterile diluent with the needle issue were not reported.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Staphylococcus test
Clinical narrative: PATIENT COMPLAINED OF PAIN, WARM AND RASH AT THE INECTION SITE. PATIENT IS TAKING DOXYCYLINE HYCLATE 100 MG TWICE DAILY
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Pyrexia, Rash
Clinical narrative: Fever, rash and erratic behavior approximately 10 days after the vaccine given.  Symptoms lasted for about a week.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyskinesia, Dyspnoea, Hyperhidrosis, Malaise, Pallor
Clinical narrative: Approximately one minute after patient received the Shingrix vaccine he started to become very pale and sweaty. He stated not feeling well . Next he started gasping for air and jerking his body.  Patient drop his head and continue gasping for air. One dose of Epinephrine 0.3 mg was administered to his right upper leg immediately.  Patient then started to breath normal again and started to talk normal. 911 was contacted and paramedics arrived about 10 minutes after later. Patient was taken to the emergency room from where he was release home several hours later.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Posture abnormal
Clinical narrative: Approximately one minute after patient received the Shingrix vaccine he started to become very pale and sweaty. He stated not feeling well . Next he started gasping for air and jerking his body.  Patient drop his head and continue gasping for air. One dose of Epinephrine 0.3 mg was administered to his right upper leg immediately.  Patient then started to breath normal again and started to talk normal. 911 was contacted and paramedics arrived about 10 minutes after later. Patient was taken to the emergency room from where he was release home several hours later.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient had a reddened area on her left arm (about 1/3 of the area of her upper left arm). Patient reports that this red area has gone down slightly since receiving the vaccine  3 days ago. The area was not raised and patient reports that it has not gotten bigger. Patient reports that the red area is slightly below the area of the injection site.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Head injury, Headache, Nausea, Syncope
Clinical narrative: About 10 minutes after receiving immunizations, patient developed a stomachache, felt like he was going to vomit, headache, then fainted and hit his head
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Headache, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Developed headache starting 7/31; on August 1 it became severe, and she developed fever and swelling at the site of injection
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Influenza virus test negative, Injection site swelling, Neutrophil percentage increased, Pyrexia, Urine analysis normal
Clinical narrative: Developed headache starting 7/31; on August 1 it became severe, and she developed fever and swelling at the site of injection
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Developed headache starting 7/31; on August 1 it became severe, and she developed fever and swelling at the site of injection
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling, started within two days after dose was given. Loratadine and Ibuprofen.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient reported muscle pain at the site of injection that began 2 days after receiving the vaccine. The pain has persisted for almost 2 weeks with little relief with ibuprofen 800 mg at bedtime. Patient reports the pain is sharp and radiates down the arm and up the neck and that pain intensifies when pressure is applied. Patient is unable to lay on the arm and described his arm as "numb" when lifting his arm for extended period of times. No redness or swelling at the injection site, denies other signs of infection such as fever.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Vaccine was given today at 4:30 pm. The parents were notified to observe for possible adverse reaction. No adverse reactions were reported from the parents.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Hypersensitivity, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Patient had swelling and pain in right arm near injection site that began the evening of the vaccination (approximately 8 pm?).   The condition did not resolve by following morning and she went to urgent clinic for evaluation.    They determined that she had a local allergic reaction, probably to the pneumovax 23 which was administered in that arm.    She stopped by the pharmacy to inform us of the resolution this afternoon (8/2) and her treatment plan (benadryl + ranitidine).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Celulitis surrounding injection site as diagnosed by prescriber
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: 10 DAYS AFTER IMMUNIZATION BROKE OUT IN RASH OVER ALL SKIN ON BODY
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: Patient got the shingrix shot on July 23nd, 2019. Left upper arm is red and pain for 7-10 days after vaccination, lost of feeling for both hands and finger,fore arms. Both legs and feet are tingling. Head ache for 7-10 days. On August 1st, patient has been sent to the Hospital and stayed in ER overnight.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: After nurse administered Tdap & MCV4 on Lt. Deltoid at 10:45 am, found patient's face turn pale, c/o dizziness, alert , O x 3 so nurse instructed patient to put head down, then use wheelchair to transfer & assisted patient with patient's mother & other clinic RN to lie on the examination bed with both legs elevated at 10:50 am. Nurse checked BP 85/56, P 65 R 18 at 10:53 am. Nurse stayed with patient & assessed patient. Patient can answered question, responsive & awake, warm to touch. Patient denies any dizziness & no other discomfort. Nurse re-checked BP 82/49 P 58 at 11:01 am. Assisted patient to sit up at the side of bed for 3 minutes, then assisted pt. to sit on the chair. Continue to monitor pt. until 11: 27. Pt left with mother without acute distress & no discomfort.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: HIGH FEVER (101.1), GENERAL BODY ACHE AND PAIN AT INJECTION SITE
Age: 12.0
Sex: M
Vaccine: HPV9, IPV, MMRV, MNQ, TDAP
Symptoms: Limb discomfort, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Deltoid region swollen, warm to the touch, itching with some discomfort. Denies S.O.B.  No hives noted, no difficulty swallowing  or  other swelling noted. No elevated body temp. Parent gave 2 - 25mg tabs of Benadryl approximately 10 minutes before calling. No other medications given. Advised mother if condition worsens please call 911 or take child to E.D. Mother states father is a Paramedic and will watch for any worsening symptoms.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site pain, Administration site warmth
Clinical narrative: Extremely sore and painful arm (feels hot) below the site of administration (deltoid).  Per patient, applied cold compress the night of 8/1 and is feeling better the evening of 8/2
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: PATIENT REPORTS REDNESS, KNOT UNDER THE SKIN, AND WARMTH AROUND THE INJECTION SITE
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Cold sweat, Decreased appetite, Injection site erythema, Injection site vesicles, Malaise
Clinical narrative: redness starting at the site of injection and moved to biceps, bubble on biceps, hot and cold sweats during the night, loss of appetite , clammy, malaise
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Night sweats
Clinical narrative: redness starting at the site of injection and moved to biceps, bubble on biceps, hot and cold sweats during the night, loss of appetite , clammy, malaise
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Dizziness, Headache, Hyperacusis
Clinical narrative: Chills, sweats, muscle aches, headache, nausea, my BP is slightly elevated, some dizziness, unable to tolerate loud noises
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Chills, sweats, muscle aches, headache, nausea, my BP is slightly elevated, some dizziness, unable to tolerate loud noises
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Feeling hot, Generalised tonic-clonic seizure, Tunnel vision
Clinical narrative: Tunnel vision & entire body became hot prior to <10 second tonic clonic seizure.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: patient complain that her arm started to feel hot, swollen, and red about 6 hours after vaccination.  After two days, the swelling  has gotten worse and she went to her doctor who diagnose her with cellulitis and prescribe her cephalexin.  As of today(2 days) after the vaccination, her arm is still swollen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Induration, Influenza like illness, Insomnia
Clinical narrative: I received the vaccine at about 2:15 pm, and that night my arm hurt quite a lot and I had a hard time sleeping. I felt OK the next morning though. At my desk at work 24 hours after I received the vaccine, I felt very ill. It came on pretty suddenly. I had a headache and extreme chills, and felt like I had a bad flu. I was slightly nauseous. I spent 6 1/2 hours lying on my office floor, only getting up to use the restroom. I felt unsafe to drive home. I stayed home from work for the next 2 days. My arm is still hard and hurts quite a bit 77 hours after the vaccination. I was never warned that many patients have a reaction like this, where they are unable to conduct their normal activities. I think medical personnel should be trained to explain this to people so that we can take this into consideration when scheduling the vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Nausea, Pain in extremity
Clinical narrative: I received the vaccine at about 2:15 pm, and that night my arm hurt quite a lot and I had a hard time sleeping. I felt OK the next morning though. At my desk at work 24 hours after I received the vaccine, I felt very ill. It came on pretty suddenly. I had a headache and extreme chills, and felt like I had a bad flu. I was slightly nauseous. I spent 6 1/2 hours lying on my office floor, only getting up to use the restroom. I felt unsafe to drive home. I stayed home from work for the next 2 days. My arm is still hard and hurts quite a bit 77 hours after the vaccination. I was never warned that many patients have a reaction like this, where they are unable to conduct their normal activities. I think medical personnel should be trained to explain this to people so that we can take this into consideration when scheduling the vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Patient received vaccine on 07/31/19 and came in on 08/02/2019 with a slight bruise on her arm and a red spot (looked similar to cellulitis) about 3-4 inches away from the injection site.  She complained that it was painful and sensitive to touch.  The size of the area was about the size of a 50 cent piece.