chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abnormal behaviour, Drug screen negative, Inappropriate affect
Clinical narrative: 45 min after vaccines  , patient started  laughing for no reason , throwing his goose and says fly fly , he acted  like a  high mood person , lasted  for  couple hours before he is back to him self
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle pain, fever, tired, dizzy
Age: 72.0
Sex: M
Vaccine: FLUA4, FLUA4, TDAP
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Suture insertion
Clinical narrative: Patient called pharmacy the week after his flu shot and stated he felt dizzy/light headed the day after receiving his vaccine. Patient stated that he had his shot Friday 8/28/20  and the incident happened Saturday 8/29/2020 - flu shot was actually administered on 8/27/2020. Patient stated that he passed out and hit his head, which required a visit to an emergency room. Patient stated that he received several stitches to his head. I asked the patient if the hospital made any mention what the cause of the dizziness/fall was (did the mention the flu shot?) and patient said they did not. Patient seemed unclear on many of the details. I told the patient to follow up with us if he had any more information or concerns. Patient stated he would be returning to doctor for a follow-up visit to have the sutures removed.
Age: 72.0
Sex: M
Vaccine: FLUA4, FLUA4, TDAP
Symptoms: Blood test, Computerised tomogram, Dizziness, Head injury, Loss of consciousness
Clinical narrative: Patient called pharmacy the week after his flu shot and stated he felt dizzy/light headed the day after receiving his vaccine. Patient stated that he had his shot Friday 8/28/20  and the incident happened Saturday 8/29/2020 - flu shot was actually administered on 8/27/2020. Patient stated that he passed out and hit his head, which required a visit to an emergency room. Patient stated that he received several stitches to his head. I asked the patient if the hospital made any mention what the cause of the dizziness/fall was (did the mention the flu shot?) and patient said they did not. Patient seemed unclear on many of the details. I told the patient to follow up with us if he had any more information or concerns. Patient stated he would be returning to doctor for a follow-up visit to have the sutures removed.
Age: 72.0
Sex: M
Vaccine: FLUA4, FLUA4, TDAP
Symptoms: Nausea, Wound
Clinical narrative: Patient called pharmacy the week after his flu shot and stated he felt dizzy/light headed the day after receiving his vaccine. Patient stated that he had his shot Friday 8/28/20  and the incident happened Saturday 8/29/2020 - flu shot was actually administered on 8/27/2020. Patient stated that he passed out and hit his head, which required a visit to an emergency room. Patient stated that he received several stitches to his head. I asked the patient if the hospital made any mention what the cause of the dizziness/fall was (did the mention the flu shot?) and patient said they did not. Patient seemed unclear on many of the details. I told the patient to follow up with us if he had any more information or concerns. Patient stated he would be returning to doctor for a follow-up visit to have the sutures removed.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Feeling cold, Gait disturbance, Headache
Clinical narrative: fever ,muscle aches, chills, headache, weakness, tires, muscle tightness, couldn't move , barely walk,  fast heart beat.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate increased, Mobility decreased, Muscle tightness, Myalgia, Pyrexia
Clinical narrative: fever ,muscle aches, chills, headache, weakness, tires, muscle tightness, couldn't move , barely walk,  fast heart beat.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Abdominal discomfort, Erythema, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: -patients arm (upper) is swollen, red & feels heavy & in pain -stomach was upset -I had our clinic nurse  practitioner look at it - she said rest  & take ibuprofen
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pyrexia, Tremor
Clinical narrative: Shaking, fever, chills, headache, pain at injection point.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient is feeling muscle soreness & stiffness at back of arm & upper portion of her back. Spoke with patient & she mentioned that her primary care provider's office thinks it might be excess inflammation possibly.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Patient developed a febrile seizure at home on September 13, 2020. She went to the Medical Center and was evaluated. No work up ensued and she went home.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Crying, Hiccups
Clinical narrative: Administration of vaccines, patient started immediately:  12:05 Mom, noted that she is having some hiccups while crying: 1207 Pt was drinking milk just before the completion of Pediarix (1st Vaccine). I  performed back slaps on the pt, then alerted our allergist . Pt was transferred to ER by 1213
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Hallucination, Pain, Tremor
Clinical narrative: Patient reported "Several hours later it was hurting badly, had my whole body shaking and I was HALLUCINATING!!! " via texted survey
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Full blood count, Hypothermia, Neutropenia, Neutrophil count decreased, Pyrexia
Clinical narrative: Developed a fever and rash for 2 days and then was hypothermic at 95.4 on 9.11 went to the ER and was found to be profoundly neutropenic, ANC 100. Admitted for fever/RO Sepsis/RO Covid but AB test was negative
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash, SARS-CoV-2 antibody test negative
Clinical narrative: Developed a fever and rash for 2 days and then was hypothermic at 95.4 on 9.11 went to the ER and was found to be profoundly neutropenic, ANC 100. Admitted for fever/RO Sepsis/RO Covid but AB test was negative
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness permanent
Clinical narrative: Pt called and reported hearing loss that is permanent. She had the vaccine on 03-05-2020 and the hearing loss was on 07-27-2020. She states that she had seen an ENT that diagnosed her with this hearing loss. She believes it is caused by the vaccination.  Patient states that she seen a ENT, but she did not mention this problem to her. Patient called me on 09-15-2020 to report side effect.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Paraesthesia oral, Pruritus
Clinical narrative: Patient states about one day after vaccine she had an itchy neck with some redness. On 9/15, she woke up with very red neck "like she just got radiation", itching and lip tingling.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; Nurse called to report a patient received improperly stored ROTATEQ on 8/4/2020; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On 04-AUG-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally( lot # 1660981,expiration date: 13-APR-2021) (dose was not reported) for prophylaxis. The vaccine was stored in above 9 degrees Celsius (C) (8.9C)(47 degrees Fahrenheit) for a timeframe of 33 minutes. No additional adverse effect reported. There was no previous temperature excursions. Digital data logger was involved.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Administered Vaccine which had a temperature excursion prior to excursion; This spontaneous report as received from a medical assistant refers to a 12-month-old male patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 20-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: T005405, expiration date: 12-AUG-2021, dose and route of administration were not provided). The vaccine was stored in temperatures between -14 and -10 degrees Celsius (-10.4 degree Celsius) for 2 hours and 8 minutes, between -14 and -10 degrees Celsius (-10.6 degree Celsius) for 2 hours and 7 minutes, between -14 and -10 degrees Celsius (-10.7 degree Celsius) for 3 hours and 29 minutes, between -14 and -10 degrees Celsius (-10.8 degree Celsius) for 10 hours and 6 minutes and between -14 and -10 degrees Celsius (-10.9 degree Celsius) for 2 hours and 7 minutes (total time of 19 hours and 57 minutes). There was no previous temperature excursion. Digital data lodger was involved. There was no illness at time of vaccination. Prescription drug treatment for the experience was not required.   No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX administered post temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 27-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliter (lot number S032355 which has been verified to be valid, expiration date 14-OCT-2021) (route of administration and anatomical location were not reported), for prophylaxis. The vaccine was reconstituted with sterile diluent (dose reported as 0.5 milliliter, frequency reported as once and it was unknown if it was improperly stored as well). The vaccine was exposed to temperature of -2.8 degrees Celsius for 5 hours 2 minutes. Digital data logger was involved. There was no previous temperature excursion.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: no additional AE reported; she gave a dose of PEDVAXHIB to a baby at her 6 month check up instead of 12 months; This spontaneous report was received from a medical assistant and refers to a 6-month-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not provided.  On 02-SEP-2020, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S023646, expiration date 31-MAR-2022, at a dose of 0.5 mL for prophylaxis (formulation, vaccine schedule, injection site and route of administration were not provided). Reporter stated that the vaccine was given to a baby at her 6 month check up instead of 12 months. No treatment was given. No additional adverse events were reported.
Age: 36.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a patient received an expired dose of GARDASIL 9; This spontaneous report was received from a pharmacist, physician (from the office where the vaccine was given) and from a 36-year-old male patient, who was a nurse working for the physician's office and was reporting on himself. The patient's medical history and concurrent conditions were not reported. On 09-SEP-2020, reported as yesterday (also reported as on 10-SEP-2020), the patient was vaccinated with the third expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vial, lot # N023828, expiry date: 25-JUN-2020, route of administration not reported). No adverse event was reported. It was reported that, the vaccine had never gone temperature excursion. The patient wanted to know whether, the vaccine was viable after expiration date and if he needed additional dose.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle twitching
Clinical narrative: muscle twitch in his back and arms; This case was reported by a pharmacist via call center representative and described the occurrence of twitching of limbs in a 58-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 2BB77, expiry date 30th June 2021) for prophylaxis.   On 18th August 2020, the patient received FluLaval Tetra 2020-2021 season. On 19th August 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced twitching of limbs. On an unknown date, the outcome of the twitching of limbs was not recovered/not resolved.   It was unknown if the reporter considered the twitching of limbs to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The patient received FluLaval Tetra 2020-2021 season and developed a muscle twitch in his back and arms that is getting worse. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Headache, Influenza like illness, Lethargy, Myalgia
Clinical narrative: extreme soreness in her left arm; flu like symptoms; sore throat; headache; very lethargic; muscle aches; arthritis; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2020, the patient received the 1st dose of Shingrix. On 6th September 2020, 2 hrs after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, sore throat, headache, lethargy, muscle pain and arthritis. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, influenza-like symptoms, sore throat, headache, lethargy, muscle pain and arthritis were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, sore throat, headache, lethargy, muscle pain and arthritis to be related to Shingrix.  Additional details were provided as follows: The patient received the first Shingrix injection and two hours later experienced extreme soreness in her left arm, she also developed flu like symptoms including a sore throat, headache, muscle aches were she has arthritis and feels very lethargic.  She has been taking Tylenol to relieve the symptoms but when the tylenol wears off the symptoms come back.  The symptoms were not resolved. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: extreme soreness in her left arm; flu like symptoms; sore throat; headache; very lethargic; muscle aches; arthritis; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2020, the patient received the 1st dose of Shingrix. On 6th September 2020, 2 hrs after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, sore throat, headache, lethargy, muscle pain and arthritis. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, influenza-like symptoms, sore throat, headache, lethargy, muscle pain and arthritis were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, sore throat, headache, lethargy, muscle pain and arthritis to be related to Shingrix.  Additional details were provided as follows: The patient received the first Shingrix injection and two hours later experienced extreme soreness in her left arm, she also developed flu like symptoms including a sore throat, headache, muscle aches were she has arthritis and feels very lethargic.  She has been taking Tylenol to relieve the symptoms but when the tylenol wears off the symptoms come back.  The symptoms were not resolved. The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: rash has appeared to become redder and bigger; rash at the injection site / rash has appeared to become / bigger; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix, the patient experienced injection site rash and injection site erythema. The patient was treated with cortisone (non-proprietary) (Cortisone Cream) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site rash and injection site erythema were unknown.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm.  After receiving Shingrix, the patient developed a rash at the injection site.  The rash had appeared to become redder and bigger.  The patient's pharmacist recommended ice, Cortisone cream and Benadryl.  The patient planned to consult her physician regarding the rash. The reporter consented to follow up.  All information was not available.
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Ear, nose and throat examination normal, Eye swelling, Hyperaesthesia, Oropharyngeal pain
Clinical narrative: right eye swelling; right side face sensitivity; right side scalp sensitivity; right side throat soreness/throat soreness; right ear soreness/ear and throat soreness; This case was reported by a physician via call center representative and described the occurrence of sore throat in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 31st August 2020, 91 days after receiving Shingrix, the patient experienced sore throat and ear pain. On 8th September 2020, the patient experienced eye swelling, hyperesthesia and scalp tenderness. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)), ambiguous medication nos (Cortisone (Nos)) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the sore throat and ear pain were recovered/resolved and the outcome of the eye swelling, hyperesthesia and scalp tenderness were not recovered/not resolved.   It was unknown if the reporter considered the sore throat, ear pain, eye swelling, hyperesthesia and scalp tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in right arm. After receiving Shingrix, the patient experienced right ear soreness and right sided throat soreness. On 04th September 2020, the patient was seen by ENT specialist examined ear and throat and all presented as normal. The patient also developed right eye swelling, right side face sensitivity and right-side scalp sensitivity, which were reported as ongoing at the time of the reporting. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin
Clinical narrative: right eye swelling; right side face sensitivity; right side scalp sensitivity; right side throat soreness/throat soreness; right ear soreness/ear and throat soreness; This case was reported by a physician via call center representative and described the occurrence of sore throat in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 31st August 2020, 91 days after receiving Shingrix, the patient experienced sore throat and ear pain. On 8th September 2020, the patient experienced eye swelling, hyperesthesia and scalp tenderness. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)), ambiguous medication nos (Cortisone (Nos)) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the sore throat and ear pain were recovered/resolved and the outcome of the eye swelling, hyperesthesia and scalp tenderness were not recovered/not resolved.   It was unknown if the reporter considered the sore throat, ear pain, eye swelling, hyperesthesia and scalp tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in right arm. After receiving Shingrix, the patient experienced right ear soreness and right sided throat soreness. On 04th September 2020, the patient was seen by ENT specialist examined ear and throat and all presented as normal. The patient also developed right eye swelling, right side face sensitivity and right-side scalp sensitivity, which were reported as ongoing at the time of the reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pruritus, Skin wrinkling
Clinical narrative: swelling at injection site; pain; itching; experienced itching and crinkles; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site swelling, pain and pruritus. On an unknown date, the patient experienced wrinkles. On an unknown date, the outcome of the injection site swelling, pain, pruritus and wrinkles were unknown.   It was unknown if the reporter considered the injection site swelling, pain, pruritus and wrinkles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix, a week ago from the date of reporting. After receiving Shingrix, the patient experienced swelling at injection site and tolerable pain but a week later, the patient experienced itching and crinkles.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site swelling, Pruritus
Clinical narrative: swelling and bruising on her arm where she got the injection; bruising on her arm where she got the injection; itching on the same arm; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced swelling arm, bruising of arm and pruritus. On an unknown date, the outcome of the swelling arm was recovered/resolved and the outcome of the bruising of arm and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, bruising of arm and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of the shingrix vaccine.  The patient stated that initially she had swelling and bruising on her arm where she got the injection.  The patient did not specify which arm. She said, this week she had intermittent itching on the same arm. The patient did not want to provide any demographic information, nor any further details about the adverse.  She disconnected the call before able to ask about health information or consent. The reporter did not consent to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: severe reaction; This case was reported by a contact via call center representative and described the occurrence of hospitalization in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patients experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patients had severe reactions and had to be hospitalized The reporter did not consent to follow up
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: She is reporting mild swelling at the injection site in the upper arm/around the site it is swollen in the muscle area of upper arm; black and blue in the muscle area/the site of the injection is black and blue; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: CY4759, Expiry Date: 13May2022, NDC number: 0005197102), via an unspecified route of administration in arm on 09Sep2020 at single dose for routine vaccination. Medical history and concomitant medications were none. Patient was reported mild swelling at the injection site in the upper arm and black and blue in the muscle area on 10Sep2020. She does not have pain. Patient came back into the store after having received the Prevnar 13 shot on 09Sep2020. The patient reported that the site of the injection is black and blue and around the site it is swollen in the muscle area of upper arm on 10Sep2020. Patient reported she woke up the day after the shot with this reaction. The pharmacist told the patient that pharmacist thought this reaction was probably not a concern. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Rash
Clinical narrative: Pain, swellin, and rash at injection site. Pain subsided after 2 days but rash has spread accross left arm. advised pt she could take ibuprofen for pain/inflammation and benedryl to try to stop the rash
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotonia, Pain in extremity, Peripheral swelling, Rash macular
Clinical narrative: patient with pain and swelling of whole upper thigh with limp for 3 days  splotching to upper thigh as well  seen in clinic next day and than 24 hrs later of treatment of Motrin, ice, and benadryl went to urgent care due to continued swelling and given steroids which resolved symptoms over next 24-48 hrs
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient received the flu shot, and was conscious after the injection. The patient proceeded to see a friend receive a Flu shot and approximately 10 minutes after her injection the patient fainted at the sight of injection. After fainting to the ground the patient had a detectable  pulse and a heart rate. Paramedics were called to the scene right away. Patient woke up 1-2 minutes later and was drowsy but alert, and stated she had not ate this morning. Paramedics arrived and patient was much more co-operative and not as drowsy. She was breathing fine at this point and was sent to the local hospital for follow up.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: fever up to 103.4, chills, aches, fatigue that started night of the vaccines
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient reported swelling, redness, pain at injection site starting day after injection. At time of visit, 6 days had past since immunization.   The induration on the left deltoid was 40cmx40cm with erythema. Nontender to palpation.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Moderate muscular pain in the upper left arm, headache, shivering, upset stomach,  tired & weak.  Symptoms began within about 6 hours of the vaccination and continued throughout the night and next day.  It?s now about 26 hours since the vaccination and symptoms seem to be dissipating.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Moderate muscular pain in the upper left arm, headache, shivering, upset stomach,  tired & weak.  Symptoms began within about 6 hours of the vaccination and continued throughout the night and next day.  It?s now about 26 hours since the vaccination and symptoms seem to be dissipating.
Age: 40.0
Sex: F
Vaccine: HEP, HEP, MMR, VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: Patient initially only received 0.5mL of pediatric Hep-B (Energix) vaccine, instead of 1mL dose of adult preparation Hep B vaccine.  Patient was later given additional 0.5mL of pediatric Hep-B vaccine to meet correct adult dose. Patient did not have any adverse events surrounding vaccinations.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Back pain, Discomfort, Muscle spasms, Muscle twitching, Myalgia
Clinical narrative: He reported that he was well at time of vaccination and only AVA was administered. One day post AVA # 3 he noticed that his left leg would twitch and he would have to stretch out to get it to relax. He reported spasms in his mid to upper back that would occur 9-10 times daily and a constant ache in his lower back. He reported that the vaccination site was sore for about 3 days. Muscle pain/spasms persisted x 10 days. He did not seek medical attention and did not take anything for the discomfort. He stated that all symptoms have resolved. ~ He reported a similar episode with receipt of AVA # 2 in Feb, in which the following day he developed back spasms and cramping. Also had spasms in left leg. Initially thought he tweaked his muscles. Symptoms lasted approx. 10 days. No recurrence of symptoms until vaccination with AVA # 3  Symptoms: MYALGIA(M791), CRAMP AND SPASM(R252).
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Vaccination site pain
Clinical narrative: He reported that he was well at time of vaccination and only AVA was administered. One day post AVA # 3 he noticed that his left leg would twitch and he would have to stretch out to get it to relax. He reported spasms in his mid to upper back that would occur 9-10 times daily and a constant ache in his lower back. He reported that the vaccination site was sore for about 3 days. Muscle pain/spasms persisted x 10 days. He did not seek medical attention and did not take anything for the discomfort. He stated that all symptoms have resolved. ~ He reported a similar episode with receipt of AVA # 2 in Feb, in which the following day he developed back spasms and cramping. Also had spasms in left leg. Initially thought he tweaked his muscles. Symptoms lasted approx. 10 days. No recurrence of symptoms until vaccination with AVA # 3  Symptoms: MYALGIA(M791), CRAMP AND SPASM(R252).
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Patient received his first MCV4,and HPV on 8/27/2020. He broke out in a red, raised, itchy rash all over his body that lasted 5 days.  No treatment, resolved on it's own. Mom didn't report until 2 weeks later at her appointment.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient had redness, swelling and pain at sight of injection larger than a deck of cards for 10 days. Slight fever treated with Ibuprofen
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysstasia, Heart rate increased, Injection site pain, Injection site swelling
Clinical narrative: I got my annual flu shot like I do every year. I did not have any previous illness, signs or symptoms previous to being injected. My arm was unusually swollen and tender at the injection site. About 3 hours after receiving the vaccine, I started getting severe dizziness, photosensitivity and my heart was beating  rapidly like I had just run 5 miles. The dizziness was relentless and I could barely stand up. I decided to lay in bed in hopes that the dizziness would subside. After about 8 hours the dizziness finally went away and my heart had calmed down. My eyes were still extremely sensitive to light for about 24 hours. I did not report this to my doctor because the dizziness went away and I didn't feel as though I needed to bug my doctor about it. I now understand that I should have reported it ASAP because it is important public health information.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Photophobia, Photosensitivity reaction
Clinical narrative: I got my annual flu shot like I do every year. I did not have any previous illness, signs or symptoms previous to being injected. My arm was unusually swollen and tender at the injection site. About 3 hours after receiving the vaccine, I started getting severe dizziness, photosensitivity and my heart was beating  rapidly like I had just run 5 miles. The dizziness was relentless and I could barely stand up. I decided to lay in bed in hopes that the dizziness would subside. After about 8 hours the dizziness finally went away and my heart had calmed down. My eyes were still extremely sensitive to light for about 24 hours. I did not report this to my doctor because the dizziness went away and I didn't feel as though I needed to bug my doctor about it. I now understand that I should have reported it ASAP because it is important public health information.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Computerised tomogram normal, Cyanosis, Eye movement disorder, Pallor
Clinical narrative: Patient was talking as shot was administered, but after completed he became quiet, his eyes rolled up into his head, his body was completely tense. Father and pharmacist moved him to a lying position, and the seizure was over in about 20 seconds. Pharmacist asked for a technician to call 911. He began to ask what happened. He was very pale and his lips were blue. His stomach was not feeling well, but he did not throw up. Father reports patient has had flu shots in the past with no issues. Patient has never had a seizure in the past. First responders arrived and checked him out. They told dad that he could wait for ambulance to arrive or transport him to the ER himself. Dad chose to take him to the er himself. He carried the child to his car and drove to the ER. The ER checked him out and did a CT. Everything was normal so he went home. They will follow up with a specialist this week. I also reported the incident to the Primacy Care Physician. I spoke with employee at Dr's office on 9/15/20.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure, Tension
Clinical narrative: Patient was talking as shot was administered, but after completed he became quiet, his eyes rolled up into his head, his body was completely tense. Father and pharmacist moved him to a lying position, and the seizure was over in about 20 seconds. Pharmacist asked for a technician to call 911. He began to ask what happened. He was very pale and his lips were blue. His stomach was not feeling well, but he did not throw up. Father reports patient has had flu shots in the past with no issues. Patient has never had a seizure in the past. First responders arrived and checked him out. They told dad that he could wait for ambulance to arrive or transport him to the ER himself. Dad chose to take him to the er himself. He carried the child to his car and drove to the ER. The ER checked him out and did a CT. Everything was normal so he went home. They will follow up with a specialist this week. I also reported the incident to the Primacy Care Physician. I spoke with employee at Dr's office on 9/15/20.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: redness warmth extension 2/3 upper arm No fever Rx as cellulitis at urgent care
Age: 74.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Contusion, Erythema, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: should have gone to Dr but didn't. Arm swelled up  with large amt of fluid, redness, heat from  injection site in left arm down to forearm. Some  bruising below injection site took 10 days to recover
Age: 74.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Oedema, Peripheral swelling, Skin warm
Clinical narrative: should have gone to Dr but didn't. Arm swelled up  with large amt of fluid, redness, heat from  injection site in left arm down to forearm. Some  bruising below injection site took 10 days to recover
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Heart rate increased, Malaise, Tremor
Clinical narrative: shaking; breathing difficulties; rapid heart rate; very ill; This case was reported by a consumer via call center representative and described the occurrence of tremor in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tremor, difficulty breathing, heart rate increased and malaise. Shingrix was discontinued. On an unknown date, the outcome of the tremor, difficulty breathing, heart rate increased and malaise were recovered/resolved.   It was unknown if the reporter considered the tremor, difficulty breathing, heart rate increased and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st Shingrix vaccine and developed shaking, breathing difficulties and rapid heart rate.  The patient was very ill and his symptoms lasted for about 6 to 7 hours. His physician advised that he not get the 2nd Shingrix vaccine. The reporter did not consent to follow up.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 48 year old male patient administration Fluzone High Dose, no AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 48 year old male patient who received a vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] at inappropriate age.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ469AB and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age.  At the time of 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.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt reported a painful/ itchy rash starting a day after the pt reported it not going  away for the past 2 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient had full body rash,especially in warm areas of body. pharmacist advised to keep cool take benadryl or zyrtec, and calamine for itch.  dr called in prednisone and loratadine on 6/26/20.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Myalgia, Paraesthesia
Clinical narrative: patient has new muscle pain the radiates up into the neck, also has "shocking" sensation on and off since Saturday. advised patient to follow up with md to ensure issue not from another unknown source
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: 2 hours after injection I was unable to raise my arm above the shoulder level. Severe pain when raising arm. Then 24 hours later there was a red raised area at site of injection. It was HOT to touch. 2-3" in diameter. An extremely tender painful area. Raised at least 1/2" and a solid "mass" like area.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain
Clinical narrative: 2 hours after injection I was unable to raise my arm above the shoulder level. Severe pain when raising arm. Then 24 hours later there was a red raised area at site of injection. It was HOT to touch. 2-3" in diameter. An extremely tender painful area. Raised at least 1/2" and a solid "mass" like area.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: My left side of my whole body is numb from my head to toes.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Loss of consciousness
Clinical narrative: Patient presents to Clinic with 2.5 inch by 2.5 inch hard, red, raised area to left deltoid.  Patient states that the area is very itchy as well.   Also compains of right arm being extremely painful and that she passed out while receiving the vaccine (Bexsero) on 09/14/2020.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: Patient presents to Clinic with 2.5 inch by 2.5 inch hard, red, raised area to left deltoid.  Patient states that the area is very itchy as well.   Also compains of right arm being extremely painful and that she passed out while receiving the vaccine (Bexsero) on 09/14/2020.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Intensive care
Clinical narrative: She felt awful,legs felt warm,chills,leg pain.The next day after the vaccination.She vomited once. She then felt slightly better until 9/04/2020 when she had a headache,nausea and fatigue.Found to have an extremely elevated WBC. Sent to ED for admission .Admitted to the PICU on 9/11/2020 ,Diagnosed with T cell ALL .Currently in the hospital.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Mononucleosis heterophile test, Nausea, Pain in extremity, Skin warm
Clinical narrative: She felt awful,legs felt warm,chills,leg pain.The next day after the vaccination.She vomited once. She then felt slightly better until 9/04/2020 when she had a headache,nausea and fatigue.Found to have an extremely elevated WBC. Sent to ED for admission .Admitted to the PICU on 9/11/2020 ,Diagnosed with T cell ALL .Currently in the hospital.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: T-cell type acute leukaemia, Vomiting, White blood cell count increased
Clinical narrative: She felt awful,legs felt warm,chills,leg pain.The next day after the vaccination.She vomited once. She then felt slightly better until 9/04/2020 when she had a headache,nausea and fatigue.Found to have an extremely elevated WBC. Sent to ED for admission .Admitted to the PICU on 9/11/2020 ,Diagnosed with T cell ALL .Currently in the hospital.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Cheilitis, Dysphonia, Fatigue, Headache, Hypoaesthesia oral
Clinical narrative: as I got into my car, I started sneezing. During drive, my lips started to go numb, and swelled a little. I arrived home less than a half hour later. My voice was hoarse and irritation at back of my nose and throat.  I went inside and took a double dose of children's liquid benedryl.  The rest of the day and evening very tired and lips still a bit irritated. Following morning (9/15/2020) I saw the normal bruising  at the injection site, but approximately 3 inches below, there is a huge welt. (Like I get after one of my allergy shots).  At approximately 10am, I started to sneeze again, lips went numb, an rapid onset explosive headache, left temple, and my vision reminded me of when I almost fainted many years ago. I drank another double dose of children's liquid benadryl, and within a few minutes, the symptoms subsided..except  the red welt on left upper arm is still there.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site urticaria, Lip swelling, Nasal discomfort, Sneezing
Clinical narrative: as I got into my car, I started sneezing. During drive, my lips started to go numb, and swelled a little. I arrived home less than a half hour later. My voice was hoarse and irritation at back of my nose and throat.  I went inside and took a double dose of children's liquid benedryl.  The rest of the day and evening very tired and lips still a bit irritated. Following morning (9/15/2020) I saw the normal bruising  at the injection site, but approximately 3 inches below, there is a huge welt. (Like I get after one of my allergy shots).  At approximately 10am, I started to sneeze again, lips went numb, an rapid onset explosive headache, left temple, and my vision reminded me of when I almost fainted many years ago. I drank another double dose of children's liquid benadryl, and within a few minutes, the symptoms subsided..except  the red welt on left upper arm is still there.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Throat irritation, Visual impairment
Clinical narrative: as I got into my car, I started sneezing. During drive, my lips started to go numb, and swelled a little. I arrived home less than a half hour later. My voice was hoarse and irritation at back of my nose and throat.  I went inside and took a double dose of children's liquid benedryl.  The rest of the day and evening very tired and lips still a bit irritated. Following morning (9/15/2020) I saw the normal bruising  at the injection site, but approximately 3 inches below, there is a huge welt. (Like I get after one of my allergy shots).  At approximately 10am, I started to sneeze again, lips went numb, an rapid onset explosive headache, left temple, and my vision reminded me of when I almost fainted many years ago. I drank another double dose of children's liquid benadryl, and within a few minutes, the symptoms subsided..except  the red welt on left upper arm is still there.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Hypotonia, Respiratory distress
Clinical narrative: Loss of muscle tone of legs and arms, respiratory distress
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Body temperature fluctuation, Conjunctivitis, Dyspnoea, Headache
Clinical narrative: Labored breathing, temp fluctuating from 97-101, nauseous, awful joint pain everywhere, headache, conjunctivitis, throat sore, nodules in throat enormous...I?ve never ever ever had any adverse reactions to the annual flu shot.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Nodule, Oropharyngeal pain
Clinical narrative: Labored breathing, temp fluctuating from 97-101, nauseous, awful joint pain everywhere, headache, conjunctivitis, throat sore, nodules in throat enormous...I?ve never ever ever had any adverse reactions to the annual flu shot.
Age: 89.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis, Insomnia, Pyrexia
Clinical narrative: 9/8/20 Chills, couldn't sleep until 4:00 am. Fever 101.8 F 8:00 am 9/9, slept most of 9/9 with temperatures above 99.0 F. Sweats and fever night of 9/9/20 100.5 down to 99.5 F.  Slight fever 9/10/20 morning but normal by 12:00 pm.  All symptoms gone by 1:00 pm 9/10/20.  Took Tylenol 2-tabs night of 9/9/20.  Had to use down comforter and sweat suit night of 9/8/2020.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: fever, headache, nausea, body aches, burning at injection site
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient had just received vaccination and briefly lost consciousness. After verbal stimuli and sternal chest rub, patient resumed consciousness. He was out no longer than 10 seconds. Patient was then laid down on exam table with assistance of his mother, legs elevated. Patient advised to wait 15 minutes. At the end of this time, patient reported feeling "back to normal."