chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient's Mother called the clinic and stated that she saw on her son's " my chart" that he needed a tetanus booster. The nurse stated that she asked Dr if it was ok to give one and she confirmed it would be fine. The nurse gave an infanrix ( which is recommended for ages 6 months to 8 years and this patient was 24 years old. The error was reported to me by the billing department on 9/23/19 . I asked CDC/ IRIS if this vaccine was valid and they confirmed yes- but I needed to fill out a VAERS report.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: severe headache, joint and body aches, nausea, tiredness, chills
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: severe headache, joint and body aches, nausea, tiredness, chills
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness, Dizziness, Headache, Nausea
Clinical narrative: States had dizziness, loss of peripheral vision, nausea, headache lasting for 24 hours
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Injection site pain, Injection site reaction, Injection site swelling, Joint swelling
Clinical narrative: RIGHT THIGH SWOLLEN FROM HIP TO KNEE, WITH INVOLVEMENT OF KNEE JOINT INFRAPATELLAR ONLY.  FULL RANGE OF MOTINO.  NO REDNESS, RASH, OR WARMTH.  LIMPING HEAVILY WHILE FAVORING RIGHT LEG.  SLIGHT TENDERNESS SUPERIOR TO PATELLA AND AT RIGHT HIP JOINT.  NO FEVER.  BILATERAL OTITIS MEDIA ON EXAM
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Otitis media
Clinical narrative: RIGHT THIGH SWOLLEN FROM HIP TO KNEE, WITH INVOLVEMENT OF KNEE JOINT INFRAPATELLAR ONLY.  FULL RANGE OF MOTINO.  NO REDNESS, RASH, OR WARMTH.  LIMPING HEAVILY WHILE FAVORING RIGHT LEG.  SLIGHT TENDERNESS SUPERIOR TO PATELLA AND AT RIGHT HIP JOINT.  NO FEVER.  BILATERAL OTITIS MEDIA ON EXAM
Age: 25.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Received Flu shot from Pharmacy workplace clinic at roughly 8:30am on 10/16/2019. Shivering Fever started roughly at 1:30 pm day of vaccination. Roughly at 6pm body aches set in. The aches last through the night into the morning (10/17/2019).
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Bone pain, Injection site pain, Pyrexia
Clinical narrative: patient is in pain says on the injection site and bones. states that she has fever too. advised to take Tylenol or OTC pain medication, and let us know if she feels better or worse. Told patient that we will contact her from time to time to see how she is doing.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Erythema, Myalgia, Nodule, Pain
Clinical narrative: PATIENT STARTED EXPERIENCING EXCRUTIATING ARM/ MUSCLE PAIN, THAT EXTENDED ACROSS HER CHEST MAKING IT PAINFUL FOR HER TO RAISE UP HER ARM OR MOVE IT. SHE DEVELOPED A HUGE KNOT THAT WAS RED AND SWOLLEN. I SAW HER 24 HOURS AFTER HER DOSE AND SHE WAS STILL IN PAIN.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: PATIENT STARTED EXPERIENCING EXCRUTIATING ARM/ MUSCLE PAIN, THAT EXTENDED ACROSS HER CHEST MAKING IT PAINFUL FOR HER TO RAISE UP HER ARM OR MOVE IT. SHE DEVELOPED A HUGE KNOT THAT WAS RED AND SWOLLEN. I SAW HER 24 HOURS AFTER HER DOSE AND SHE WAS STILL IN PAIN.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: When she woke up this morning her arm where the injection was given, was red, hot, and swollen to the size of a baseball, per her call in to the pharmacy.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect reported; Patient received her first dose of GARDASIL 9 at 13 years old and her second dose at 18 years old; This spontaneous report was received from a physician referring to a 19 year old female patient. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On an unspecified date in approximately 2013, when the patient was 13 years old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, dose, lot # and expiration date were not reported). Then, on an unspecified date in approximately 2018, when the patient was 18 years old, she received the second dose of the vaccine (route, dose, lot # and expiration date were not reported) (inappropriate schedule of product administration). The vaccine was administered for prophylaxis. No adverse effect reported.
Sex: U
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling; redness; warmth; tenderness; itching; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number Y5X93, expiry date 30th June 2020) for prophylaxis.   On 3rd October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site erythema, injection site warmth, injection site tenderness and injection site itching. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, injection site tenderness and injection site itching were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, injection site tenderness and injection site itching to be related to FluLaval Tetra 2019-2020 season.  Additional details provided as follows: The patient's demographic details were not provided. The reporter did not consent to follow up. This was 1 of 5 linked cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The age group of the patients was not reported, but selected as an adult as per vaccine indication. The reporter heard about that people on the younger side of 50-65 age seem to get the headaches. The reporter did not consent to follow up. This case had been linked to the case US2019AMR180771, reported by same reporter.
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling; redness; warmth; tenderness; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 8-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number Y5X93, expiry date 30th June 2020) for prophylaxis.   On 3rd October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site tenderness to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient received vaccine by different vial with same batch number. The reporter did not link this case with product complaint. The reporter did not consent to follow up. This case was 1 of 5 linked cases reported by same reporter.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling; Redness; Warmth; Tenderness at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 38-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number Y5X93, expiry date 30th June 2020) for prophylaxis.   On 3rd October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site tenderness to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. The nurse reported that, the patient received vaccine from different vial of same batch number. The reporter did not link this case with product complaint. The reporter did not consent to follow up. This case was 1 of 5 linked cases reported by same reporter.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Rash, Vitamin D
Clinical narrative: Arm sore and swollen, rash, till her elbow/Injection site rash; Injection Site Arm red/red mark; sore to the bone; Arm sore and swollen, rash, till her elbow/sore down to her elbow; Arm sore and swollen, rash, till her elbow/Injection Site arm sore; Arm sore and swollen, rash, till her elbow/Injection Site arm swollen; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; batch/lot number and expiration date were unknown), via an unspecified route of administration at the left upper arm on Oct2019 at a single dose for immunisation. The patient had no medical history and concomitant medications. The patient reported that she was vaccinated with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) 10 days ago (as reported) and since then she had reactions to it. She has experienced arm sore and swollen, rash, till her elbow. This last she applied cortisone cream on it and made her feel better. But she wonders if this is something that has been reported. It was reported that on an unspecified date in Oct2019, the patient experienced injection site arm sore, injection site arm swollen, and sore down to elbow. And on 10Oct2019, the patient experienced injection site arm red and injection site rash. The patient further reported that she had pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) about a week ago (as reported) after her normal physical. They said it might hurt a little but her arm was still sore to the bone and swollen now after 10 days. On 10Oct2019 (yesterday) during her shower she rubbed it a little to massage it with her wash cloth but it made a red mark and rash from the side of it. States her arm is still sore down to her elbow. Her husband said he would see why her arm was sore because it looked swollen. Reports she did call the doctor two days ago 08Oct2019 on Tuesday. They tried to call back but she did not get the call. 10Oct2019 yesterday she went to the doctor's office to try to see doctor and but no one was available to see her. 10Oct2019 she applied some cortisone cream to the site. It has helped a little and the rash has gone down. Asking if this was an expected side effect after 10 days. She has never had this vaccine before. The patient reported her brother and sister had pneumonia last year and she thought she should get the shot to prevent getting sick. The patient was encouraged to seek medical advice from her primary health care provider for further follow up. The patient underwent lab tests and procedures which included vitamin D: 27 on Oct2019. The outcome of the events was recovering.   Information on the batch/lot number has been requested.
Sex: U
Vaccine: UNK
Symptoms: Exposure during pregnancy, Single umbilical artery
Clinical narrative: Single umbilical artery; Fetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 10-Oct-2019, concerning a foetus subject of unknown gender, whose mother was a 20-year-old female of body weight 175.5 lbs, height 63.2 inches and body mass index (BMI) 30.8, enrolled in a prospective observational safety study. The subject's father was 23-year-old.  The mother's medical history included asthma. Concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) and Albuterol HFA (salbutamol).   The mother's obstetrical history included one previous pregnancy which ended with spontaneous abortion. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 16-Apr-2019 and type of pregnancy was singleton. The estimated date of delivery (EDD) and corrected EDD (CEDD) of subject's mother was reported as 21-Jan-2020.   On 24-Jun-2019 and 27-Aug-2019, the subject's mother underwent ultrasound scan and no MCM was noted.   On 24-Sep-2019, at approximately 23 weeks of gestation, the mother was administered Flu Vaccine Egg Split QIV CSL (Afluria QIV) [influenza vaccine, batch number: P100118566, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.   On an unknown date, after vaccination, the subject experienced single umbilical artery (reported as pregnancy complication) .  At the time of initial reporting, the outcome of the events was not reported.   This case is linked to the case 201905215 (the corresponding mother case).  The case was assessed as serious. The reporter did not provide causality assessment to Afluria QIV.; Sender's Comments: The subject experienced single umbilical artery after foetal exposure during pregnancy with the suspect product Afluria QIV. Vaccination of the mother occurred at approximately 23 weeks of gestation. Foetal exposure during pregnancy is assessed as not related per company conventions. Umbilical arteries form by the end of 5th week of gestation so causal role of the suspect product is assessed as not related.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: on 10/16/19 patient noticed a red, raised mark at injection site that was very sore to the touch. Also had body aches and cough that started 10/15/19. Body aches and cough resolved 10/16/19 after 24 hours. Injection site redness and tenderness has continued without change.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Patient called the pharmacy this morning to report that he was having some swelling in his left arm pit.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: Arm ache increased into the afternoon.  By 5 pm had stiff neck and pain in both legs. Body ached all over like Flu. Was drained and weak and felt like in a fog. Loss of appetite
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Arm ache increased into the afternoon.  By 5 pm had stiff neck and pain in both legs. Body ached all over like Flu. Was drained and weak and felt like in a fog. Loss of appetite
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Mumps, Swelling face
Clinical narrative: She developed a swollen right face consistent with the actual mumps
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, X-ray
Clinical narrative: Patient is experiencing limited range of motion in left arm since the vaccination 2 weeks prior.  Physician has ordered an x-ray, pain and steroid medicatons, and physical therapy for the patient.
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Pharyngeal swelling
Clinical narrative: had difficulty breathing; swollen throat; This is a spontaneous report from a contactable consumer via Pfizer sales representative.  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient had difficulty breathing and swollen throat on an unspecified date with outcome of unknown. Pharmacy technician recommended that the patient go immediately to the ER. No addition information was provided in regard to outcomes or issues.  The information on the lot number has been requested.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Injection site pain, Mobility decreased, Pain, Tenderness
Clinical narrative: I am a pharmacist and I receive a season flu vaccine at the Pharmacy on Oct. 1, 2019 by one of my colleagues.  I had some soreness, at the site and thought it would go away after a few days, but on Saturday Oct. 5 I continued to have soreness, some weakness and it became painful to take off and put on t-shirts. I massaged the area and realized there was tenderness in my shoulder joint area.  It was then I realized the vaccine needle must have been inserted too high.  I have been able to effectively self treat the pain by taking some otc naproxen sodium 220mg twice daily and limiting my movement to avoid pain.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Onset 9/19/19 at 7:30 pm of bout of severe crying.  Went to Ed 09/20/19 at 0400.  Ultrasound showed transient Intussusception of the small bowel.  Pt admitted to hospital for 1 day and resolved on its own.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain for more than 7 weeks with no improvement. I will probably enter into a course of physical theraphy
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site reaction, Neuritis, Pain, Sensitive skin
Clinical narrative: On 10/04/19, patient woke up and felt pain in the right arm around the injection site. She states it was very sensitive to touch and painful if area was touched. She states no swelling or redness. She did not notice it hurting when sleeping. She states is hurts when showering , lifting arm and when getting dress. On 10/10/19, patient consulted pharmacist regarding the pain around the injection site and recommended she followed up with her primary care physician. She visited doctor on 10/10/19 at 1:45pm who examined her arm. She was diagnosed with neuritis and was prescribed Gabapentin 100mg (1QDx10). She states the once a day dosing did not work and on 10/13/19 increased to two daily but still did not get relief. On  10/16/19 she started taking Motrin 600mg every 8 hours which helped but pain continues to persist. She is waiting for doctor to follow up with her.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Injection site oedema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Widespread Maculopapular rash appeared from bilateral ankles to groin at 5:15pm. Patient complained of burning and itching. Benadryl 25mg po administered and hydrocortisone cream applied topically to rash. At 6:30pm, edema, warmth, and pain at injection site. Rash still present. Benadryl 25mg po administered again at 9:30pm. Rash receding but still present today, injection site still painful but edema resolved 10/17/2019.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Rash maculo-papular
Clinical narrative: Widespread Maculopapular rash appeared from bilateral ankles to groin at 5:15pm. Patient complained of burning and itching. Benadryl 25mg po administered and hydrocortisone cream applied topically to rash. At 6:30pm, edema, warmth, and pain at injection site. Rash still present. Benadryl 25mg po administered again at 9:30pm. Rash receding but still present today, injection site still painful but edema resolved 10/17/2019.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Discomfort, Eyelid rash, Herpes zoster, Rash vesicular
Clinical narrative: 2 days following administration of Shingrix at local community pharmacy, patient presents to PCP with eyelid swelling and shingle-like rash over eye. PCP started valacylovir and Bactrim for shingles and facial cellulitis. Patient presents the next day (10/17/19--4 days post injection) to the ED for continued rash and feeling uncomfortable.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: 2 days following administration of Shingrix at local community pharmacy, patient presents to PCP with eyelid swelling and shingle-like rash over eye. PCP started valacylovir and Bactrim for shingles and facial cellulitis. Patient presents the next day (10/17/19--4 days post injection) to the ED for continued rash and feeling uncomfortable.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysuria, Prostate examination
Clinical narrative: I had the Shingrix vaccine on the morning on Sept 6 and that night before going to bed had a lot of difficulty urinating.       The urination difficulties continued for about three weeks and then cleared up.      Could not be determined if the urination difficulties had anything to do with the Shingrix vaccine.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain in left shoulder/upper arm after receiving Flu shot
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: It's been over a week and my entire right arm is still swollen and red.  Very sore.  For two days after the injection I was completely wiped-out.  I have not gone back to the doctor because I realize there is not much he can do.  I have kidney disease and can not take drugs that would normally bring down the swelling.  I've had flu shots for many years and have never had any problems.  I guess is you have changed some of the ingredients in the formulation.   I will never have another flu shot.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Adverse reaction
Clinical narrative: patient had a reaction; This spontaneous report as received from a patient's daughter and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza virus split virion 3v vaccine inactivated (FLUZONE (INFLUENZA VIRUS SPLIT VIRION 3V VACCINE INACTIVATED)) (exact dose, route of administration, lot # and expiration date were not reported) one shot in each arm for prophylaxis. On an unknown date in September 2019, the patient had a reaction. The outcome of the event was unknown. The relatedness between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza virus split virion 3v vaccine inactivated (FLUZONE (INFLUENZA VIRUS SPLIT VIRION 3V VACCINE INACTIVATED) and the event was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; received improperly stored VARlVAX; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 25-SEP-2019, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose and route of administration were not reported) for prophylaxis (lot number: S005078 and expiration date: 19-FEB-2021 or lot number: R019237, expiration date: 04-JUL-2020). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect reported.  The temperature excursion was from -14 degree Celsius to -10 degree Celsius (-9.74 Celsius). Time frame was unknown by the reporter. There was no previous temperature excursion noted. The digital data logger was involved.   Both lots of varicella virus vaccine live (oka/merck) (VARIVAX) that underwent the temperature excursion were added since the office did not know which lot was given to the patient.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse effects; 17 year old patient was administered an adult dose of Vaqta; This spontaneous report was received from a registered nurse and refers to a 17 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  The reporter stated that on 08-OCT-2019, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA) lot # S001360, expiration date on 06-MAR-2020, for prophylaxis (strength, dosage, frequency and route were not provided) (product administered to patient of inappropriate age).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Pyrexia, Skin discolouration
Clinical narrative: brown spots on chest; fever; bronchitis; This case was reported by a pharmacist via call center representative and described the occurrence of bronchitis in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number CX5BG, expiry date 18th May 2021) for prophylaxis.   On 31st January 2019, the patient received the 1st dose of Shingrix. On 31st January 2019, less than a day after receiving Shingrix, the patient experienced bronchitis. On an unknown date, the patient experienced skin discoloration and fever. On an unknown date, the outcome of the bronchitis was recovered/resolved and the outcome of the skin discoloration and fever were unknown.   It was unknown if the reporter considered the bronchitis, skin discoloration and fever to be related to Shingrix.  Additional details were provided as follows: The patient experienced bronchitis that lasted for 12 weeks. The patient also had brown spots on her chest and a fever of 103.5 degrees F. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash appear on their face; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a rash on the face after receiving Shingrix. The reporter did not consent to follow-up. The reporter had no additional details about the patient or the vaccine.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Havrix (1st dose received on 14th January 2019) and Engerix-B (1st dose received on 14th January 2019).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received the further doses in the series, which led to incomplete course of vaccination. The reporter consented to follow up. Lot numbers were not available as the patient received the first doses at a different pharmacy. Pharmacist consents to follow up.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, X-ray limb
Clinical narrative: The day after the vaccination I noticed shoulder pain in the left arm. Over the next 2 days I was not able to raise my arm at the shoulder. This continued until Sunday when the pain started to resolve and function started to return. At time of note 10/17/2019 I have almost full function back and only slight pain upon movement.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Headache, Pain, Vomiting
Clinical narrative: 101 temperature,  vomiting, chills, body aches and headache.  for 3 days
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Child presented with rash.  No treatment needed.  Outcome was good.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: 10/3/19  4:10 am  woke with fever (99), chills, shivering, pain at injection site 10/3/19 6:30 pm  fever (100.4), shivering; right hip pain w/sciatic nerve irritation, pain at injection site 10/4/19 All day general malaise, fatigue, pain at injection site, redness below injection site 10/5/19 Riding in car - motion sickness, pain and redness at/near injection site
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Motion sickness, Pyrexia, Radiculopathy
Clinical narrative: 10/3/19  4:10 am  woke with fever (99), chills, shivering, pain at injection site 10/3/19 6:30 pm  fever (100.4), shivering; right hip pain w/sciatic nerve irritation, pain at injection site 10/4/19 All day general malaise, fatigue, pain at injection site, redness below injection site 10/5/19 Riding in car - motion sickness, pain and redness at/near injection site
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Pain
Clinical narrative: Husband showed me a picture of her arm bruised in a circle and he claimed she has been in pain up to now since she was given the vaccination .
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: The patient stated she was hospitalized due to severe fever, vomiting, and diarrhea.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: not given 28 days from dose 1
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Urticaria
Clinical narrative: rash, hives, torso, breasts, inside arms
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Discomfort, Erythema, Pain, Peripheral swelling
Clinical narrative: moderate aching for 2 days.   Swollen tender arm with big red whelps.  Itching and burning since 10/16/19.  Still uncomfortable and today is Day 4
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Tenderness, Urticaria
Clinical narrative: moderate aching for 2 days.   Swollen tender arm with big red whelps.  Itching and burning since 10/16/19.  Still uncomfortable and today is Day 4
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, very hot, and sore at injection site
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Depressed level of consciousness, Dizziness, Feeling abnormal, Feeling hot, Hyperhidrosis
Clinical narrative: Administered flu shot to patient.  Asked her to wait in waiting area afterwards to make sure no adverse effect(s).  Patient informed me that she felt dizzy, cloudy, lightheaded, hot, sweaty and felt like she was going to pass-out.  Recommended that she sit down with her head between her knees.  Provided her with water.  Patient stated no improvement in symptoms after 3 -4 minutes.  Called 9-1-1 to have her checked out.  She left on her own about 20 minutes after medics arrived.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Swelling, soreness and extreme  bruising, still very visible after 16 days
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Decreased appetite, Dyspepsia, Headache
Clinical narrative: I had a headache and sore arm when I left the office. My arm started to hurt more during the evening and then about 7 hours after the injection I got extreme chills, indigestion/loss of appetite and was  unable to lift my arm all the way or move it laterally, then fever, muscle aches and weakness. The pain in my arm, weakness and loss of appetite lasted for 4 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: I had a headache and sore arm when I left the office. My arm started to hurt more during the evening and then about 7 hours after the injection I got extreme chills, indigestion/loss of appetite and was  unable to lift my arm all the way or move it laterally, then fever, muscle aches and weakness. The pain in my arm, weakness and loss of appetite lasted for 4 days.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Red swollen area at vaccine site 3"/1.5"
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction or event
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Pain at injection site with mild erythema, fullness & warmth starting 24 hrs after injection with increased redness after 12 hrs diagnosed as local reaction - advised Benadryl, Zyrtec & ibuprofen for symptom relief with monitoring
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Urticaria
Clinical narrative: Mother states developed hives 4 hours after getting gardasil then next day covered in hives. Mother didnt call office gave Benadryl then Zyrtec. She also has nausea.
Sex: F
Vaccine: HPV9
Symptoms: Hypersomnia
Clinical narrative: slept for 18 hours; This spontaneous report as received from a nurse and refers to a 12-year-old female patient. The patient's current conditions included asthma, allergy to latex and unspecified seasonal and environmental allergies. Concomitant therapies included montelukast sodium (SINGULAIR) and fluticasone propionate (FLONASE) and unspecified PROAIR.  On 18-JUL-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) one dose, lot #1614897, expiration date 20-SEP-2019 (exact dose, site and route of administration were not reported) for prophylaxis. After receiving the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient went home and on the same day, she slept for 18 hours. There was no treatment given , no lab diagnostics performed and patient did not sought medical attention. The outcome of sleeping for 18 hours was reported as recovered/resolved on an unknown date in 2019. The relatedness between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and sleeping for 18 hours was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine at an unspecified date; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) one dose (exact dose, site and route of administration were not reported) lot # S007075, exipration number 06-SEP-2020 for prophylaxis. The outcome of the event was unknown. Administered dose of vaccine experienced the temperature excursion at 32.5 degrees Fahrenheit for 8 hours. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine on an unspecified date; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) one dose (exact dose, site and route of administration were not reported) lot # S007075, exipration number 06-SEP-2020 for prophylaxis. The outcome of the event was unknown. Administered dose of vaccine experienced the temperature excursion at 32.5 degrees Fahrenheit for 8 hours. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-OCT-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S012246, expiration date 10-FEB-2021 (dose and route of administration were not reported). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 68 degrees Fahrenheit for 8 hours. Data logger was involved. There was previous excursions reported: 57 degrees Fahrenheit for 2 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, Pyrexia, Rash
Clinical narrative: severe rash; swelling; fever; chills; This is like having the flu as a child; been sick; vomiting; This case was reported by a consumer via call center representative and described the occurrence of flu like symptoms in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included measles (the patient even did not know if had the chickenpox as a child, but had the red measles).   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 flu like symptoms, sickness, vomiting, rash, swelling, fever and chills. On an unknown date, the outcome of the flu like symptoms, sickness, vomiting, rash, swelling, fever and chills were recovered/resolved.   It was unknown if the reporter considered the flu like symptoms, sickness, vomiting, rash, swelling, fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Afterwards with Shingrix vaccination, the patient had been sick for 2 days with vomiting and not diarrhea. Also the patient had a severe rash, swelling, fever and chills.  This case has been linked to US2019AMR173623, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling, Vomiting
Clinical narrative: severe rash; swelling; fever; chills; This is like having the flu as a child; been sick; vomiting; This case was reported by a consumer via call center representative and described the occurrence of flu like symptoms in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included measles (the patient even did not know if had the chickenpox as a child, but had the red measles).   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 flu like symptoms, sickness, vomiting, rash, swelling, fever and chills. On an unknown date, the outcome of the flu like symptoms, sickness, vomiting, rash, swelling, fever and chills were recovered/resolved.   It was unknown if the reporter considered the flu like symptoms, sickness, vomiting, rash, swelling, fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Afterwards with Shingrix vaccination, the patient had been sick for 2 days with vomiting and not diarrhea. Also the patient had a severe rash, swelling, fever and chills.  This case has been linked to US2019AMR173623, reported by the same reporter.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Vomiting
Clinical narrative: Vomiting, chills, fatigue
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Skin warm
Clinical narrative: severe uncontrollable shivering for >3 hours, body was hot, but I was freezing and shivering.
Age: 59.0
Sex: M
Vaccine: FLUN4
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Myalgia, Pain of skin
Clinical narrative: Has received Flu vaccine in the past with no problem.  At 10pm, had achiness on joints and broke out with very itchy hives on chest and back.   Took 50mg of Benadryl, called doctor and told to go to ER.   At ER, no testing done, given choice of steroid or Benadryl; patient choose Benadryl and it did help. Patient was not admitted to hospital.  Next day patient felt terrible; symptoms included: muscular aches, fatigue with exertion, hives settled down but skin was still burning and tender to touch.    Patient went to pharmacy on 10/16 to report problem and get vaccine packet insert for reference.     Patient feels much better today--at 85 % recovery.    Daughter is pharmacy student and mentioned that the other patients had similar problems.   County health department also mentioned to wife that they were not administering that vaccine since problems were reported.
Age: 59.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus, Skin burning sensation, Urticaria
Clinical narrative: Has received Flu vaccine in the past with no problem.  At 10pm, had achiness on joints and broke out with very itchy hives on chest and back.   Took 50mg of Benadryl, called doctor and told to go to ER.   At ER, no testing done, given choice of steroid or Benadryl; patient choose Benadryl and it did help. Patient was not admitted to hospital.  Next day patient felt terrible; symptoms included: muscular aches, fatigue with exertion, hives settled down but skin was still burning and tender to touch.    Patient went to pharmacy on 10/16 to report problem and get vaccine packet insert for reference.     Patient feels much better today--at 85 % recovery.    Daughter is pharmacy student and mentioned that the other patients had similar problems.   County health department also mentioned to wife that they were not administering that vaccine since problems were reported.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Myalgia, Nausea, Vomiting
Clinical narrative: NAUSEA, VOMITING, MUSCLE PAIN,  SWEATING
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Lacrimation increased, Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient is complaining of shoulder pain since vaccination. Unable to lift arm about shoulder. Pain is bringing tears to her eyes. She has previously been treated for an injury to the shoulder vaccine was given in.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Swelling
Clinical narrative: Kinrix received 10/9/19 on left upper arm and ~ 18 hours later arm became red & swollen a not ithchy, started improving w/ redenss cleared by 5th day and now w/ firm swollen bump, never had fever, area now itchy. No reaction to prior IZs. No meds given
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Complains of ache and soreness in the arm x9 days. Denies redness, swelling, or any knots at the injection site.
Age: 74.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Confusional state, Seizure
Clinical narrative: Pt reported trip to emergency room with confusion and convulsions. this occurred the same day 10-14-19 but later in the evening the same day he received the vaccines.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia
Clinical narrative: Shoulder joint pain still going on been month
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, redness, warmth, & stiffness at site of injection. Pt given cephalexin 500mg TID for 10 days.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness
Clinical narrative: Swelling, pain, redness, warmth, & stiffness at site of injection. Pt given cephalexin 500mg TID for 10 days.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: left arm injection site appears to be in deltoid ( 3 cm from acromial process) with induration 3-4 cm surround injection site, warmth and erythema. tender to palpation.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Chest discomfort, Computerised tomogram, Echocardiogram normal, Electrocardiogram, Laboratory test
Clinical narrative: Went at 0917. PT went to the ED for chest tightness and tach.  Treatment: IV/LR 1L 0825. 0917 Asprin 324MG.  Procedures: CT, ECG, LABS.  Outcome: PT was admitted to MSU
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Tachycardia
Clinical narrative: Went at 0917. PT went to the ED for chest tightness and tach.  Treatment: IV/LR 1L 0825. 0917 Asprin 324MG.  Procedures: CT, ECG, LABS.  Outcome: PT was admitted to MSU
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Chest pain, Dyspnoea exertional, Electrocardiogram T wave inversion, Myocarditis, Troponin increased
Clinical narrative: Went at 0917. PT went to the ED for chest tightness and tach.  Treatment: IV/LR 1L 0825. 0917 Asprin 324MG.  Procedures: CT, ECG, LABS.  Outcome: PT was admitted to MSU
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity, Pyrexia
Clinical narrative: Subjective reporting of fever after 1 day.  Subjective reporting of right arm pain and decrease ROM.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Muscle disorder, Muscle tightness
Clinical narrative: Patient states that muscle has felt badly ever since the shot was administered. The muscle is tense all the time without releasing.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash
Clinical narrative: same day heat at site of injection followed by a bothersome "breakout" in the groin area; the patient has not sought medical help, but only wanted to report symptoms.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Injection site pain, Pain in extremity
Clinical narrative: Sore right arm and shoulder. Flu-like exhaustion requiring sleep through the day following the vax. Very achy joints in addition to the right shoulder.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis, Middle insomnia
Clinical narrative: Patient woke up in the night with severe chills and profusely sweating.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Around 5 minutes after vaccination, patient had swelling around the injection site and the site was hot to touch. Patient applied ice and took aspirin, the swelling went down after about half hour but patient still felt soreness around left arm.