chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Atrial fibrillation, Chills, Condition aggravated, Headache, Malaise
Clinical narrative: Atrial fibrillation worse; Painful to breathe in; Thirsty; Feeling unwell/ feeling sick; Chills; Fever; Headache; This is a spontaneous case, initially received from other non-health professional via agency (reference number: SEQ19-03323) on 26-Sep-2019, concerning a 67-year-old, female patient.   The patient's current conditions included atrial fibrillation and epilepsy. The patient's concomitant medications included unspecified epilepsy medicine.  On 22-Sep-2019, the patient was administered Fluad vaccine [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number: 260380 and expiration date: Apr-2020] for influenza prophylaxis.   On 24-Sep-2019, two days after vaccination, the patient started feeling unwell, been feeling sick with chills and thirsty, experienced fever, headache and painful breathing. The patient also experienced worsening of atrial fibrillation. In addition, the patient had to take more of epilepsy medicine, but details were not specified.  At the time of initial reporting, the outcome for all events was not reported.  The case was assessed as serious and the reporter did not provide causality assessment.  Company Comment: The patient experienced atrial fibrillation aggravated, painful respiration, thirst, malaise, chills, pyrexia and headache after administration of the suspect product Fluad. Chronology is plausible. Medical history of atrial fibrillation and epilepsy may have contributed to development of the events. Causality was also confounded by therapy with concomitant medication unspecified epilepsy medicine. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The patient experienced atrial fibrillation aggravated, painful respiration, thirst, malaise, chills, pyrexia and headache after administration of the suspect product Fluad. Chronology is plausible. Medical history of atrial fibrillation and epilepsy may have contributed to development of the events. Causality was also confounded by therapy with concomitant medication unspecified epilepsy medicine. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Painful respiration, Pyrexia, Thirst
Clinical narrative: Atrial fibrillation worse; Painful to breathe in; Thirsty; Feeling unwell/ feeling sick; Chills; Fever; Headache; This is a spontaneous case, initially received from other non-health professional via agency (reference number: SEQ19-03323) on 26-Sep-2019, concerning a 67-year-old, female patient.   The patient's current conditions included atrial fibrillation and epilepsy. The patient's concomitant medications included unspecified epilepsy medicine.  On 22-Sep-2019, the patient was administered Fluad vaccine [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number: 260380 and expiration date: Apr-2020] for influenza prophylaxis.   On 24-Sep-2019, two days after vaccination, the patient started feeling unwell, been feeling sick with chills and thirsty, experienced fever, headache and painful breathing. The patient also experienced worsening of atrial fibrillation. In addition, the patient had to take more of epilepsy medicine, but details were not specified.  At the time of initial reporting, the outcome for all events was not reported.  The case was assessed as serious and the reporter did not provide causality assessment.  Company Comment: The patient experienced atrial fibrillation aggravated, painful respiration, thirst, malaise, chills, pyrexia and headache after administration of the suspect product Fluad. Chronology is plausible. Medical history of atrial fibrillation and epilepsy may have contributed to development of the events. Causality was also confounded by therapy with concomitant medication unspecified epilepsy medicine. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The patient experienced atrial fibrillation aggravated, painful respiration, thirst, malaise, chills, pyrexia and headache after administration of the suspect product Fluad. Chronology is plausible. Medical history of atrial fibrillation and epilepsy may have contributed to development of the events. Causality was also confounded by therapy with concomitant medication unspecified epilepsy medicine. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Headache, Pain
Clinical narrative: Shingle vaccine on yesterday, I am achy all over my body. It is constant. No pain. Started last night.  Worse No home treatment.  Headache started today.  Headache in fore of headache.pain level of  headache is 2-3, constant.Denies sob, chest pain or any other s/s at present.  Offered tylenol/NSAIDs
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin increased, Ultrasound antenatal screen normal
Clinical narrative: Patient was here for well woman exam, she reported LMP as 8/15/19.  She received the injection & waited the 15 minutes post injection to monitor for side effects. Patient was then taken to lab for the additional testing that was ordered.  While there patient requested a pregnancy test from the lab staff, a BHCG was completed at that time.  It was resulted on 9/27/19 at a level of 32. Patient was notified and instructed to recheck levels on Monday 9/30/19. Patient was unable to verify date of her last menstrual period stating " I don't know it's always somewhere in the middle like the 15th."  Patient was transferred to make her appointment.  She completed another BHCG on 10/3/19 it was resulted on 10/4/19 with a level of 1,943.  Patient was notified and advised we were ordering an OB ultrasound < 14 weeks as patient  unsure of dates and was recommended she follow up with OB.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Pallor, Posture abnormal
Clinical narrative: after vaccination, pt's head fell forward, skin pale and pt passed out. Pt placed on floor with knees up. Ice placed back of neck. Returned to consciousness, and felt better after 10 mins on floor. Sat upright, felt faint again, placed supine again. Taken to nurses office. Patient states she has history of fainting.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: Pt described filling body aches, fever, chills, and localized pain to the site about 6 hours after shot was given. The body aches, fever,chills  subsided in less then 24 hours. Patient described it as the sickest he has ever felt in his life. Patient is a family medicine provider at our clinic. He then went on to have pain in his upper arm for a couple weeks which he relates to the injection site.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Neck pain
Clinical narrative: Shooting pains up neck. Nauseous if touched
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS GIVEN A 65+ VACCINE AND HE IS ONLY 2 - WATCHED FOR 20 MINUTES AFTER VACCINE WAS GIVEN AND CONTACTED HEATLH DEPARTMENT - ADVISED MOTHER TO WATCH FOR SWELLING / PAIN / REDNESS - WILL FOLLOW UP WITH MOTHER ON 10.8.19 TO SEE HOW PATIENT IS DOING
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness,swelling and itching of upper left arm one day after injection.  Benadryl, Cephalexin and Methylprednisolone
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS GIVEN A 65+ VACCINE AND SHE IS ONLY 3 - WATCHED FOR 20 MINUTES AFTER VACCINE WAS GIVEN AND CONTACTED HEATLH DEPARTMENT - ADVISED MOTHER TO WATCH FOR SWELLING / PAIN / REDNESS - WILL FOLLOW UP WITH MOTHER ON 10.8.19 TO SEE HOW PATIENT IS DOING
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Dizziness, Genital rash, Immediate post-injection reaction, Migraine
Clinical narrative: Immediately following the vaccine shot in the left arm, my son felt his arm weaken, become soar and his joints and muscles hurt. He had a migraine headache that last for the next two days and was dizzy. He then developed a rash of hives all over his left arm and wrist, also on his stomach, leg and private parts.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Muscular weakness, Myalgia, Pain, Rash, Urticaria
Clinical narrative: Immediately following the vaccine shot in the left arm, my son felt his arm weaken, become soar and his joints and muscles hurt. He had a migraine headache that last for the next two days and was dizzy. He then developed a rash of hives all over his left arm and wrist, also on his stomach, leg and private parts.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest pain, Vomiting
Clinical narrative: Patient stated she had chest pain and her back hurt. she turned her oxygen up. looked like she wanted to keep throwing up
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Fatigue, Feeling of body temperature change, Nausea
Clinical narrative: It hit all of a sudden. I was getting dizzy. Within 10 minutes I felt nauseous. Made it to the bathroom with diarrhea.  Room spinning, could not lay down. Felt weak and tired within 30 minutes of symptoms. Several bouts of diarrhea over the next 8 hours. nausea intense and very noisy like loud gurgling (not normal for me). Never did throw up. didn't run fever, but felt hot and cold, hot and cold entire time. after about 8 hours, I could sleep and after nap woke up and could sit up. A couple hours later, nausea all gone. didn't eat anything rest of the day. Slept the night and little the next day. Feel fine now.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: It hit all of a sudden. I was getting dizzy. Within 10 minutes I felt nauseous. Made it to the bathroom with diarrhea.  Room spinning, could not lay down. Felt weak and tired within 30 minutes of symptoms. Several bouts of diarrhea over the next 8 hours. nausea intense and very noisy like loud gurgling (not normal for me). Never did throw up. didn't run fever, but felt hot and cold, hot and cold entire time. after about 8 hours, I could sleep and after nap woke up and could sit up. A couple hours later, nausea all gone. didn't eat anything rest of the day. Slept the night and little the next day. Feel fine now.
Age: 54.0
Sex: M
Vaccine: MMR
Symptoms: Pericarditis
Clinical narrative: Dx with Pericarditis
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Pharyngeal swelling, Pruritus
Clinical narrative: Pt. began itching around 9:20 am, Benadryl PO 50 mg given, around 9:25 am pt. states she feels her throat begin to close up. 9:27 am Epinephrine .50mg given IM , and then at 9:32 second dose of Epinephrine given.  Ambulance arrived at 9:35 am. Pt. transferred to Hospital.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient received an Measles, Mumps, Rubella, and Varicella in a combo injection and a separate varicella. Resulting in two varicella vaccines on the same day.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: I had itching at the site and then a large circular hive covering most of my upper left arm. I took Zertec 10 mg. I applied ice for 20 min which did provide some relief of the pain at the site but the swelling persisted. Saturday and I took Zertec 10mg twice to control the itching. The area did reduce in size but redness and swelling persisted until today (Monday).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site discomfort, Injection site erythema, Pain
Clinical narrative: Fever, chills, aches, fatigue, redness and soreness at vaccination site
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, aches, fatigue, redness and soreness at vaccination site
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Cellulitis, Injection site reaction, Injection site swelling
Clinical narrative: Parent noted the morning after immunization that the child had swelling growth on right thigh at vaccine injection site. This grew over the subsequent three days. Went to ER. Treated for cellulitis. Seen in PCP office five days after vaccination with signs that looked consistent with injection site reaction.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Faint erythema to lateral right neck and upper right arm. Given pepcid, prednisone and zyrtec. She was observed for 2 hours. Rash, itching improved. Patient sent home.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 8-31-19.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Dyspnoea, Headache, Vomiting
Clinical narrative: dysphagia, dyspnea, cough, HA, vomiting
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Patient called 2 weeks after her flu shot to report having had a reaction to the immunization.  She said she had itching, hives and some difficulty breathing.  She stated had had flu shot in past before with no issues.  Stated no allergies to eggs.
Age: 0.33
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effect reported; a four month old baby was administered with GARDASIL 9; This spontaneous report was received from a pharmacist, referring to a 4 months old female patient. Information regarding the patient's pertinent medical history, concurrent condition, drug allergies/reactions and concomitant medications was not provided. On 03-OCT-2019, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, schedule, anatomical location, route of administration, lot# and expiry date was unknown) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported. There was no associated product quality complaint.
Sex: U
Vaccine: TDAP
Symptoms: Allergy to vaccine, Contraindicated product administered, Documented hypersensitivity to administered product
Clinical narrative: Allergic reaction; Contraindicated drug administered; This case was reported by a consumer via interactive digital media and described the occurrence of documented hypersensitivity to administered product in a patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   Concurrent medical conditions included allergy to vaccine.   On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced documented hypersensitivity to administered product and contraindicated drug administered. On an unknown date, the outcome of the documented hypersensitivity to administered product and contraindicated drug administered were unknown.   It was unknown if the reporter considered the documented hypersensitivity to administered product and contraindicated drug administered to be related to dTpa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was allergic to the tetanus component of this vaccine. The patient got the DTP. The patient inquired, any other information available on that? This is 1 of 2 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Pruritus, Rash papular, Skin lesion
Clinical narrative: disseminated papular eruption; Intensely itchy; lesions; This case was reported by a physician via call center representative and described the occurrence of papular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included skin lesion (developed hundreds of lesions initially) and dermatitis allergic. Previously administered products included older immunization with an associated reaction of skin lesion.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced papular rash, pruritus and skin lesion. On an unknown date, the outcome of the papular rash and pruritus were recovering/resolving and the outcome of the skin lesion was unknown.   It was unknown if the reporter considered the papular rash, pruritus and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the older immunization a few years ago. She had hundreds of lesions initially and diagnosed with dermal hypersensitivity dermatitis on biopsy.  The patient experienced disseminated papular eruption which began 3 days after receiving the Shingrix injection. It was intensely itchy.  The events were better but not clear after treating with 40 mg of prednisone. The patient again started to develop new lesions, 1 month after the initial injection. No patient information or vaccine batch number or expiry date was available. The reporter did not consent to follow-up.      Lab Comments: on an unknown date, biopsy was performed
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: Received pneumonia after getting this vaccine; Received pneumonia after getting this vaccine; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in 2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received a PCV-13 in 2017 and believed she 'received pneumonia' on an unknown date after getting this vaccine. The reporter would like for Pfizer to call the patient back to clarify that additional pneumonia vaccines may be recommended in addition to the single PCV-13 that was recommended. Patient was refusing to get a PPSV23 immunization due to thinking she only needed one pneumonia vaccine. The outcome of the event was unknown.  Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results are needed for full medical assessment.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Muscle spasms, Pain
Clinical narrative: Muscle spasms/muscle spasm in her back; Pain; This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number: AG8353, expiry: Jun2021, NDC number: 0005-1971-02) in the left deltoid at 18:00 to prevent pneumonia and influenza vaccine (FLUZONE, Manufacturer: Sanofi, Lot: UJ249AA, Expiry: 30Apr2020, NDC: 49281-0405-65) in the right deltoid for immunization; both via unspecified route of administration on 30Sep2019 at a single dose at the pharmacy. Medical history included ongoing diabetes. There were no concomitant medications. The patient previously received influenza vaccine (FLUZONE) for immunization in 2018. On 01Oct2019, the patient experienced muscle spasms/muscle spasm in her back and pain. When asked about the location of the pain, the reporter stated it was in general and unbearable. Events caused hospitalization on unspecified date. Outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of muscle spasms/muscle spasm in her back and pain cannot be excluded, considering the plausible temporal association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Red Rash around injection site (approx. 3-4" wide, 4-5" high), pain at and around injection site
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pruritus
Clinical narrative: Patient stated about 6-7 hours after immunization she started having burning/itching and soreness in her muscle and it continued. I spoke with her today, 10-7-19, and she stated it is subsiding and starting to feel better.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Electrocardiogram, Electroencephalogram, Laboratory test, Seizure
Clinical narrative: PATIENT WIFE SAID THAT THE PATIENT ENDED UP HAVING SEIZURES AND HAD TO REPORT TO THE ED.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Pain in extremity, Rash erythematous
Clinical narrative: On the morning of 10/7/19 you noticed a red rash on left arm where injection was and it was warm to the touch. Patient's arm is still sore.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: soreness to Rt arm and pain , and inability to lift arm since receiving vaccine ( 3 weeks ago). Patient reports intense sharp pain when grabbing or lifting items with said arm consistently over the past 3+ wks since receiving vaccine.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient deceived sore arm, radiating pain , possibly injected too hight
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain
Clinical narrative: Gave vaccine Subcutaneous and not intramuscular. Pt had left arm pain, redness, tenderness to site.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Chills, Nasal congestion, Pain, Skin lesion
Clinical narrative: blister lesions -scattered  all over body along with chills, body aches and nasal congestion one hour after exposure
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Laboratory test normal, Seizure like phenomena
Clinical narrative: 09/29/2019 in the evening the child had a 15 minute seizure like activity at home, went to Med Center had negative labs and head CT. Evening of 09/30/2019 seizure like activity again. 10/01/19 went to another Hospital, now on Kepra and scheduled for EEG and MRI.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Aphasia
Clinical narrative: Went from verbal and hitting milestones to non-verbal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pyrexia, Restlessness
Clinical narrative: Patient awoke in the middle of the night with fever, headache,  "thrashing around",  and felt very ill.   Patient took Excedrin for the headache.  Reaction was resolved by the time the patient woke up the next morning.   ***This was second vaccine in series. Patient reports she did NOT have reaction to first vaccine***
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Injection site pain, Pharyngeal swelling, Throat irritation
Clinical narrative: Burning sensation at injection site within 30 seconds, itchy throat started within 2-3 min. Then swelling of throat and eyes within 5-10 minutes. Swelling in eyes continued through today.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: LOCALIZED SWELLING AND REDNESS, WARM TO TOUCH.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pruritus
Clinical narrative: redness and itchy
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Patient developed Bell's Palsy of Left side the same day of the vaccine, hours later
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Eye pain, Headache, Influenza like illness, Injection site erythema
Clinical narrative: THE SAME EVENING, REDNESS, HEAT, & PAIN AT INJECTION SITE. SICK THE NEXT AM & WENT TO WORK. AS THE DAY PROGRESSED, BECAME SICKER & SICKER. WENT TO BED THURDAY, PM WITH FLU-LIKE SYMPTOMS & MUSCLE PAINS, ACHES, HEADACHES, WEAKNESS, EYES HURT, SCALP, HURT - COULDN'T GET UP OUT OF BED FOR 5 DAYS. CALLED PHARMACIST ADVISED TO TAKE TYLENOL, WITH NO RELIEF. SPOKE TO MY DOCTOR ON MONDAY SEPT. 9, 2019 @ 5:30 PM. SHE GAVE ME THIS PHONE # TO REPORT EVENT. ALSO, WAS ADVISED NOT TO TAKE 2ND DOSAGE OF VACCINE. ALSO, ADVISED NOT TO TAKE FLU SHOT ON THE 24TH OF SEPTEMBER, TO BE GIVEN BY MY WORK OFFICE. THIS FELT LIKE AN EPISODE OF THE FULL BLOWN FLU, WITHOUT 104 DEGREE TEMPERATURE. I AM STILL HAVING RESIDUAL HEADACHES, ALMOST EVERY DAY. I ALSO HAVE MUSCLE CRAMPS IN MY LOWER LEGS, AND GENERAL ACHINESS IN MUSCLES.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Malaise, Muscle spasms, Myalgia
Clinical narrative: THE SAME EVENING, REDNESS, HEAT, & PAIN AT INJECTION SITE. SICK THE NEXT AM & WENT TO WORK. AS THE DAY PROGRESSED, BECAME SICKER & SICKER. WENT TO BED THURDAY, PM WITH FLU-LIKE SYMPTOMS & MUSCLE PAINS, ACHES, HEADACHES, WEAKNESS, EYES HURT, SCALP, HURT - COULDN'T GET UP OUT OF BED FOR 5 DAYS. CALLED PHARMACIST ADVISED TO TAKE TYLENOL, WITH NO RELIEF. SPOKE TO MY DOCTOR ON MONDAY SEPT. 9, 2019 @ 5:30 PM. SHE GAVE ME THIS PHONE # TO REPORT EVENT. ALSO, WAS ADVISED NOT TO TAKE 2ND DOSAGE OF VACCINE. ALSO, ADVISED NOT TO TAKE FLU SHOT ON THE 24TH OF SEPTEMBER, TO BE GIVEN BY MY WORK OFFICE. THIS FELT LIKE AN EPISODE OF THE FULL BLOWN FLU, WITHOUT 104 DEGREE TEMPERATURE. I AM STILL HAVING RESIDUAL HEADACHES, ALMOST EVERY DAY. I ALSO HAVE MUSCLE CRAMPS IN MY LOWER LEGS, AND GENERAL ACHINESS IN MUSCLES.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain of skin
Clinical narrative: THE SAME EVENING, REDNESS, HEAT, & PAIN AT INJECTION SITE. SICK THE NEXT AM & WENT TO WORK. AS THE DAY PROGRESSED, BECAME SICKER & SICKER. WENT TO BED THURDAY, PM WITH FLU-LIKE SYMPTOMS & MUSCLE PAINS, ACHES, HEADACHES, WEAKNESS, EYES HURT, SCALP, HURT - COULDN'T GET UP OUT OF BED FOR 5 DAYS. CALLED PHARMACIST ADVISED TO TAKE TYLENOL, WITH NO RELIEF. SPOKE TO MY DOCTOR ON MONDAY SEPT. 9, 2019 @ 5:30 PM. SHE GAVE ME THIS PHONE # TO REPORT EVENT. ALSO, WAS ADVISED NOT TO TAKE 2ND DOSAGE OF VACCINE. ALSO, ADVISED NOT TO TAKE FLU SHOT ON THE 24TH OF SEPTEMBER, TO BE GIVEN BY MY WORK OFFICE. THIS FELT LIKE AN EPISODE OF THE FULL BLOWN FLU, WITHOUT 104 DEGREE TEMPERATURE. I AM STILL HAVING RESIDUAL HEADACHES, ALMOST EVERY DAY. I ALSO HAVE MUSCLE CRAMPS IN MY LOWER LEGS, AND GENERAL ACHINESS IN MUSCLES.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Side began to hurt on Tuesday, September 24.  I broke out with shingles on Thursday, September 26.  Went to see Dr. on Thursday, September, 26th.  She confirmed that it was shingles.  Shingles were on lower left side, from middle of back to middle of front.  Blisters began to form on September 29.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling in the upper left arm, warm to touch, and affected her COPD
Age: 53.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Pyrexia
Clinical narrative: patient called on 10/07/2019 to pharmacy to report cellulitis in left arm and fever after receiving the vaccine. she was seen in pcp and emergency room
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site discomfort, Limb discomfort, Pain
Clinical narrative: Body aches went from injection site to left side of my face. fever chills, sore arm for 2 weeks.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Nausea
Clinical narrative: Fever,headache, severe shaking, headache,lightheadedness , nausea, redness at injection sight, fatigue
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever,headache, severe shaking, headache,lightheadedness , nausea, redness at injection sight, fatigue
Age: 1.5
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Injection site discharge, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received her influenza vaccine at approximately 5 pm on 9/21.  Mom noticed redness at the site of the injection around 11 am on 9/22.  It did not seem to bother her, but looked red and a little swollen.  It got a little worse-spreading and a little more swollen throughout the day on 9/21.  This am it looked like it had spread a lot more and was much more swollen.  She does not seem to be in a lot of pain. She does itch at it.  She is walking but there may be a little bit of a limp.  She has 1 pinpoint spot that developed near the injection site. Mom saw a little drainage come from it this morning. On further clarification, the drainage was a clear yellow. She has not had any fever, URI sx, cough, vomiting. She slept fine last night.  She is eating per normal. No evidence of pain anywhere.  Energy per normal.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptoms (head ache, body aches, fatigue) for two days;  arm swollen, sensitive to touch, red, and hot for at least five days.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Flu like symptoms (head ache, body aches, fatigue) for two days;  arm swollen, sensitive to touch, red, and hot for at least five days.
Age: 10.0
Sex: M
Vaccine: FLU4, HPV9, TDAP
Symptoms: Urticaria
Clinical narrative: Hives face, chest and legs
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Lymphadenopathy, Parotid gland enlargement, Parotitis
Clinical narrative: 2.5 cm enlarged probable parotid glad no overlying erythema, not painful to touch, fluctuates in size during visit. no other s/s noted.   Dx ; Parotitis v lymphademopahy. no distress noted. playing and running around room .no fevers. labs were ordered but patient didn't have them drawn. (cbc, crp, esr-f ) ----- started Augmentin 600-42.9  mg/5ml for 10 days pt's mother stated improvement of area each day
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Contusion, Erythema
Clinical narrative: Patient reports that he had erythema and bruising in his right arm after the vaccination. This has occurred for approximately 2 weeks and has gone down since. He is not reporting any pain, fever or discomfort.
Age: 6.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swelling erythema and warmth with pain to RUE in the area of the vaccine within 1 day. pt has similar but less severe reaction the year prior to same vaccine starting several days post vaccine
Age: 6.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Localised infection, Rash
Clinical narrative: swelling erythema and warmth with pain to RUE in the area of the vaccine within 1 day. pt has similar but less severe reaction the year prior to same vaccine starting several days post vaccine
Age: 60.0
Sex: F
Vaccine: FLUX, MEN
Symptoms: Erythema, Feeling cold, Injection site erythema, Muscle spasms, Night sweats
Clinical narrative: Horrible chills and spasms, violent shaking, high fevers, night sweats, low grad fevers 101.4 with Thera Flu tea. Lastly cold soars in mouth, red patches and very painful knot in left arm. A big red one on injection site, 4 small
Age: 60.0
Sex: F
Vaccine: FLUX, MEN
Symptoms: Nodule, Oral herpes, Pain, Pyrexia, Tremor
Clinical narrative: Horrible chills and spasms, violent shaking, high fevers, night sweats, low grad fevers 101.4 with Thera Flu tea. Lastly cold soars in mouth, red patches and very painful knot in left arm. A big red one on injection site, 4 small
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever 102.5 with seizures. Took to Hospital ER. Dr. said it was due to fever-febrile seizures. Dr. told mother to continue Tylenol and Motrin for fever.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: she did a pregnancy test and found out she was pregnant a day after receiving GARDASIL 9; This spontaneous prospective pregnancy report was received from a 27-year-old female patient referring to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in arm (exact dose, route of administration, lot # and expiry date were not reported) for prophylaxis to lessen risk of abnormal cells growing on cervix. On 17-SEP-2019, she did a pregnancy test and found out she was 4 weeks pregnant. The patient's last menstrual period was on 19-AUG-2019 and estimated delivery date on 25-MAY-2020. The pregnancy outcome was pending.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; the patient was inadvertently administered a dose ofPROQUAD, on 9/24/2019, that had been improperly stored; This spontaneous report as received from a vaccine coordinator 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 24-SEP-2019, the patient was inadvertently vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S003326, expiration date 02-AUG-2020), (lot # R030805, expiration date 22-APR-2020) (dose and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent. There was no adverse effect reported. The administered vaccines experienced the temperature excursion of 27.1 degrees Fahrenheit for 40 minutes. There was no previous excursion. The data logger was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: severe herpes zoster or shingles; did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On or about 04-NOV-2014,  the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles at a pharmacy. On an unknown date, the vaccine did not prevent shingles as intended and the pt subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the pt was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of  zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving  zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles, the pt suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions the pt suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the pt had suffered and would continue to suffer significant medical expenses, and pain and suffering and other damages. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Immunoglobulin therapy, Infection, Vaccination failure
Clinical narrative: impaired anti-pneumococcal polysaccharide antibody response; impaired anti-pneumococcal polysaccharide antibody response; Literature Report: This literature marketed report has been received from the authors of a published article, titled as above, and refers to a female adult patient with primary selective IgG subclass deficiencies (IgG1, IgG4). The patient's clinical presentation included bronchiectasis.  On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX-23) (strength, dose, frequency, route of administration, indication, lot# and expiration date were not reported).  It was reported that pre and 4 weeks post-vaccination pneumococcal polysaccharide antibody titers were measured using multiplexed immunoassay (to remove cross-reactive antibodies).  On an unknown date, the patient had impaired anti-pneumococcal polysaccharide antibody response.  On an unknown date, the patient started treatment with intravenous immunoglobulin replacement therapy (IVIG), 800 mg/dL, but she was lost to follow-up after 4 months from starting immunoglobulin therapy. Nonetheless, during those 4 months, she had 2 episodes of infections requiring antibiotics.   The outcome of vaccine response impaired and antibody test negative was unknown.  The authors assessed the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX-23).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports derived from the same literature article (cross referenced with #1909USA012600).; Sender's Comments:  US-009507513-1909USA012600:
Sex: U
Vaccine: FLU4
Symptoms: Injection site mass
Clinical narrative: Good sized knots; This case was reported by a other health professional via sales rep and described the occurrence of injection site lump in an unspecified number of adult patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to FluLaval Quadrivalent.  Additional case details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patients were employees and they had good sized knots after receiving the flu vaccination. The reporter consented to follow up. This case has been linked to US2019AMR176824, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Redness; Swelling; This case was reported by a other health professional via sales rep and described the occurrence of erythema in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were recovered/resolved.   It was unknown if the reporter considered the erythema and swelling to be related to FluLaval Quadrivalent.  Additional case details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, there were several patients who had redness and swelling for several days after administration of flu vaccination. The reporter consented to follow up. This case has been linked to US2019AMR176811, reported by the same reporter.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Red patch on arm; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 79-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was unknown.   It was unknown if the reporter considered the localized erythema to be related to Shingrix.  Additional case details were provided as follows: On Monday (before the reporting date), the patient received Shingrix. The patient got a large red patch on arm after vaccination. The patient asked, whether 2nd dose should be received or not.
Sex: F
Vaccine: MENB
Symptoms: Injection site abscess, Injection site pain, Injection site scar, Injection site swelling
Clinical narrative: Injection Site Pain; Injection site swelling; Injection site abscess; Scarring; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, less than 2 months after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site abscess and scar. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site abscess and scar were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site abscess and scar to be related to Bexsero.  Additional case details were provided as follows: The patient was 17 years or 18 years of age at the time of reporting. Age at vaccination was not reported. The patient had received 1st dose in an unknown arm and had an abscess, pain, swelling at injection site and scarring. The reporter stated that, the patient did come for her 2nd dose in about 30 days after this dose. The reporter agreed to follow up. This case has been linked to US2019AMR176855, reported for the same patient.
Sex: F
Vaccine: MENB
Symptoms: Injection site abscess
Clinical narrative: Injection site abscess; This case was reported by a nurse via sales rep and described the occurrence of injection site abscess in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of injection site abscess (1st dose received on an unknown date, for tolerance refer case US2019AMR176837).   On 25th September 2019, the patient received the 2nd dose of Bexsero. In September 2019, less than a week after receiving Bexsero, the patient experienced injection site abscess. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the injection site abscess was unknown.   It was unknown if the reporter considered the injection site abscess to be related to Bexsero.  Additional case details were provided as follows: The patient was 17 years or 18 years of age at the time of reporting. Age at vaccination was not reported. The patient came back for 2nd dose and they administered it in the other arm. The patient's mother told the reporter that, the patient again started to have abscess in this other arm. The reporter agreed to follow up. This case has been linked to US2019AMR176837, reported for the same patient.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: extremely ill; This case was reported by a consumer via call center representative and described the occurrence of unwell in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On 24th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient felt extremely ill after receiving Shingrix. The patient did not consent to follow-up and did not provide any additional information. This case has been linked to US2019176216, reported for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site discomfort, Injection site erythema, Limb discomfort
Clinical narrative: Arm became very hot; Arm became very hard; Arm became very red/ redness covered a 3 inch X 4 inch area of upper arm; Smaller patch of purplish/red showed near the injection area; Smaller patch of purplish/red showed near the injection area; Injection site discomfort; This case was reported by a consumer and described the occurrence of skin warm in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced skin warm, induration, erythema of extremities, red rash, rash and arm discomfort. On an unknown date, the outcome of the skin warm, induration, erythema of extremities, red rash, rash and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the skin warm, induration, erythema of extremities, red rash, rash and arm discomfort to be related to Shingrix.  Additional case details were provided as follows: The patient asked some questions about the side effects developed after vaccination. The age at vaccination was not reported. The patient's arm became very hot, hard and red after the vaccination. The redness covered a 3 inch by 4 inch area of upper arm.  These events lasted for 5 days, then it cleared and the patient felt fine.  The patient stated, nearly a week after clearing these events, a smaller patch of purplish or red colour showed near the injection area along with renewed discomfort.  This had lasted 5 days so far. The patient had consulted pharmacist and doctor. They said to contact back if it got worst or did not get better.  The patient felt fine otherwise and asked if this just an abnormal reaction to the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Arm became very hot; Arm became very hard; Arm became very red/ redness covered a 3 inch X 4 inch area of upper arm; Smaller patch of purplish/red showed near the injection area; Smaller patch of purplish/red showed near the injection area; Injection site discomfort; This case was reported by a consumer and described the occurrence of skin warm in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced skin warm, induration, erythema of extremities, red rash, rash and arm discomfort. On an unknown date, the outcome of the skin warm, induration, erythema of extremities, red rash, rash and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the skin warm, induration, erythema of extremities, red rash, rash and arm discomfort to be related to Shingrix.  Additional case details were provided as follows: The patient asked some questions about the side effects developed after vaccination. The age at vaccination was not reported. The patient's arm became very hot, hard and red after the vaccination. The redness covered a 3 inch by 4 inch area of upper arm.  These events lasted for 5 days, then it cleared and the patient felt fine.  The patient stated, nearly a week after clearing these events, a smaller patch of purplish or red colour showed near the injection area along with renewed discomfort.  This had lasted 5 days so far. The patient had consulted pharmacist and doctor. They said to contact back if it got worst or did not get better.  The patient felt fine otherwise and asked if this just an abnormal reaction to the vaccine.