chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Weight gain poor, X-ray gastrointestinal tract
Clinical narrative: Patient's upper right thigh, where the vaccines were administered, was damaged immediately. The indent has since "grown" to become deeper and has turned a deep blue in her leg. This is because the fatty tissue was damaged and dissolved at time of vaccination. She has not been able to build any muscle in this limb, due to the pain and discomfort of the injury. This has affected her mobile development. After the vaccination, patient developed a severe aversion to eating in all forms (breastfeeding, would refuse all bottles and supplementation and supplementation efforts, including pumped breast milk and several formulas, and later would refuse all solid food until about 9 months of age). She would eat just barely enough to survive, hence, she fell off the growth chart and stopped gaining weight for several months. She developed severe gastrointestinal issues, including reflux, slow stomach, etc. She stopped having bowel movements and has had adverse reactions to 4 common allergens.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old female patient. The patient had none pertinent medical history or drug reactions or allergies. On 31-OCT-2017, the patient was vaccinated with PNEUMOVAX23 (lot # N012127, expiration date: 20-JAN-2019), intramuscularly in the right arm for prophylaxis. Concomitant therapies included a nicotine patch which was administered before PNEUMOVAX 23 on an unspecified area on her right arm. The area where the nicotine patch was used was wiped with alcohol swab. On 01-NOV-2017, the patient experienced a large pink area approximately 6 centimeters by 3 centimeters in an unspecified area on her right arm (erythema). It was also reported that she had pain so severe that she could not move her right arm (pain in extremity, movement disorder), along with swelling from her right shoulder to her right elbow (peripheral swelling). Despite the fact that the patient had not seen her healthcare provider in regards to her experience, she was self-treated with ice packs and acetaminophen (TYLENOL) every eight hours. No laboratory diagnostics were performed. Additionally, it was reported that no intervention to prevent serious criteria was necessary, that the patient was not hospitalized and that the patient experience was not significant disability or incapacity or life threatening. At the time of the report, it was mentioned that swelling was not as bad, and that pink area had almost disappeared, however, the outcome of pain in extremity, peripheral swelling, movement disorder and erythema was reported as not recovered. The relatedness assessment between PNEUMOVAX 23 and the aforementioned adverse events was not provided.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer via a company representative, referring to himself a 60 year old male patient. The patient had no pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant therapies. On 31-OCT-2017, the patient was vaccinated with ZOSTAVAX 19400 Plaque Forming Unit (PFU), 0.65ml (single dose), subcutaneously for prevention of herpes zoster (lot # and expiration date were not reported). Other suspect therapies included influenza virus vaccine (unspecified) (dose, route of administration, lot # and expiration date were not reported). No porduct quality complaint (PQC) was involved. On the same day, the patient experienced swelling and soreness at the injection site of where ZOSTAVAX was given and he was also feverish for approximately 12 hours after receiving the vaccines. No treatment was given for the adverse events. On an unspecified date in 2017, the patient recovered from  feverish. At the reporting time, the patient was recovering from injection site swelling and injection site pain. No further adverse event (AE) information was provided. The causality between the events and the suspect therapies was unknown.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Myalgia
Clinical narrative: Arm muscle soreness three weeks after administration.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site
Clinical narrative: Injected too high on left shoulder into bursa.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Agitation, Swelling face, Urticaria, Vomiting, Wheezing
Clinical narrative: Approximately 10 minutes after PROQUAD was given and before pt left the office, pt became agitated, developed facial swelling, hives and vomiting. Within 3-5 minutes pt began wheezing.  EPIPEN Jr. 0.15 mg in 0.3 ml was administered IM in Left thigh. Oxygen was administered. Some relief noted but within 5 minutes pt became more agitated and hives continued to develop on his face. The 2nd EPIPEN Jr. 0.15 mg in 0.3 ml was administered IM in right thigh. EMS had been called and was present for 2nd EPIPEN injection. Pt was then transported via ambulance to Hospital and later transferred to another Hospital for overnight observation. In the ER pt received one adult IM EPIPEN 0.3 mg in 0.3 ml dose, IV SOLU-MEDROL, PEPCID and normal saline bolus x2.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Other comments include: Patient presents with c/o hives, redness and itch to chest area. Denies SOB, throat discomfort, tongue swelling, chest pain. O2 sat 100% RA. Speaking in full sentences. NAD.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Head injury, Hypotonia, Nausea, Staring
Clinical narrative: Approx 5 min after injection, pt fell facedown and hit his head. Did not lose consciousness. Pt's dad lifted him up, body was tight and flexed, staring, no incontinence, was laid back on exam table by dad, oriented to time place and person, c/o nausea. Episode witnessed by parents, and health care assistant. Vitals normal, BP was on the low normal.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt contacted clinic two days after receiving vaccine. Pt states that site of injection is swollen, hard lump about the size of a golf ball, sore to touch with a rash. Pt was icing area and did take BENADRYL.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Injection site erythema, Injection site swelling, Mobility decreased
Clinical narrative: PATIENT CALLED COMPLAINING OF SWELLING AND REDNESS FROM INJECTION SITE DOWN TO HER ELBOW. ALSO COMPLAINED OF HEADACHE SO BAD COULDN'T GET OUT OF BED FOR DAYS.
Age: 1.17
Sex: F
Vaccine: MMRV
Symptoms: Body temperature increased
Clinical narrative: Elevated temperature of 101.0+ degrees Fahrenheit starting 4 days after vaccine. Temperature lasting 5+ days so far. Treating with TYLENOL every 4 hours or more.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site hypersensitivity, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Following initial vaccine administration on 11/06/17, patient presented to clinic with concerns of a pruritic, raised, hot-feeling rash covering the area of his right thigh where immunizations MMR and Dtap were given 9 days prior. Despite being afebrile and otherwise well-appearing with normal vital signs upon initial evaluation, in light of hypersensitivity reaction at injection site and unclear origin between administered vaccines, patient referred to local Allergist Dr. in Allergy/Immunology for further evaluation and treatment. Benadryl Q6-8 hours for symptom relief. Immediate evaluation advised if fever, cough, conjunctivitis, sore throat, or body papular rash, per Dr. Per Dr. advised to follow-up in one week if no improvement, sooner if symptoms worsened. Patient was seen by Dr. on 11/20/17, consult notes and subsequent recommendations awaiting provider completion, status currently pending. Awaiting recommendations and consult notes from Allergist Dr. Office will continue to follow patient status and family to ensure optimum coordination of care, providing any updates as available.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's mother called with information of swelling and redness around immunization site.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Infection, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm in pain, Dr says Infection occurred [warm arm and swollen, and fever] [Also given flu shot on left arm during same visit]. Occurred same day of getting vaccinated. Really painful, cannot move arm due to it.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Skin warm
Clinical narrative: Arm in pain, Dr says Infection occurred [warm arm and swollen, and fever] [Also given flu shot on left arm during same visit]. Occurred same day of getting vaccinated. Really painful, cannot move arm due to it.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis, Wrong technique in product usage process
Clinical narrative: Patient received her flu shot at the pharmacy and came back a few weeks later to inform staff that she had gotten tendonitis in her shoulder due to improper administration of her flu vaccination. Patient had gone into her doctor who stated it was likely due to improper vaccination technique.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Rash macular, Skin warm, Tenderness
Clinical narrative: Patient called and stated that she had an extremely sore arm and that there was a big red blotch on it.  Stated it was sore to the touch and felt warm to the touch. It was started on Sunday, one day after the the injection was given. We advised that the patient ice the arm and take Ibuprofen in the short term and follow up with a physician if the symptoms don't resolve.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Tenderness
Clinical narrative: Redness at injection site, swelling of arm from shoulder to elbow crease, itching, tenderness on arm, under arm, above breast, around back.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports swelling, heat and pain at injection site hours after receiving vaccine. Trying BENADRYL and ice.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Fever and chills and malaise for 4 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient reported rash, swelling, redness, and soreness all at injection site 2 days after receiving vaccination. Pt was counseled to take BENADRYL and Ibuprofen by mouth and apply a cold compress to the injection site. Her soreness improved the next day, but her redness and rash were still present. Pt was then counseled to continue the OTC treatment like before and if it didn't improve or got worse, she was to contact her PCP for medical treatment if needed.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash generalised
Clinical narrative: Mom reports head to toe rash, fevers of 100-102 degrees, fussy/irritable child over past 3 days (today 11/27/17).
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient complains of soreness of left arm where shot was given and it's been almost six weeks that past. Patient taking TYLENOL and started warm compresses.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient said that after receiving the flu shot her arm was sore for three weeks. It is finally better now.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site pain, Muscular weakness
Clinical narrative: Pt notified rite aid pharmacist 11/27/17 of continued pain/discomfort at injection site. Alleged  site in the crease of left elbow. Claims discomfort at site causes weakness in mobility and function of the arm. Concerns that after a month there is an issue with vaccine given or administration site causing prolonged pain and side effect.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Arm hurts the pain is radiating to neck and now to hand.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling and redness down to the elbow. Patient went to the ER and was given Cephalexin 500mg.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Major swelling, soreness, and pain at injection site for a 2-3 day period.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Experienced Redness, swelling, pain. On 11/22/2017 went to Emergency Room; physician prescribed  cephalexin to rule out cellulitis and  advised to return if symptoms worsened. Symptoms did worsen and patient returned to E.R. in evening and was admitted for acute cellulitis and was inpatient at hospital for 5 days. Discharged with 2 antibiotics: doxycycline and moxifloxacin. Patient came to Pharmacy this evening (11/27/2017) to discuss chain of events. He seems to be doing much better now.
Age: 49.0
Sex: M
Vaccine: VARCEL
Symptoms: Burning sensation, Erythema, Myalgia, Pain of skin, Papule
Clinical narrative: Rash. The problem is new. The current episode started 6 days. Since onset, the problem has been gradually worsening. Affected locations include left arm, torso, abdomen, groin and left upper leg. Symptom characteristics include redness, papules, itchiness and burning (Papular rash present to groin. Skin tender to touch. Irritated with clothes). Associated symptoms include myalgias. Negative for non-blanching rash, fever, rhinorrhea, shortness of breath, headache, anorexia, congestion, joint pain, sore throat, stiff neck, malaise, cough, diarrhea, swollen glands, vomiting, nail changes, facial edema, fatigue and painful lesions Tetanus is up to date. PMH includes MMR series and varicella series. Negative for diabetes, eczema, immunocompromised, MRSA, psoriasis, strep, asthma, and allergies.
Age: 49.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Skin irritation
Clinical narrative: Rash. The problem is new. The current episode started 6 days. Since onset, the problem has been gradually worsening. Affected locations include left arm, torso, abdomen, groin and left upper leg. Symptom characteristics include redness, papules, itchiness and burning (Papular rash present to groin. Skin tender to touch. Irritated with clothes). Associated symptoms include myalgias. Negative for non-blanching rash, fever, rhinorrhea, shortness of breath, headache, anorexia, congestion, joint pain, sore throat, stiff neck, malaise, cough, diarrhea, swollen glands, vomiting, nail changes, facial edema, fatigue and painful lesions Tetanus is up to date. PMH includes MMR series and varicella series. Negative for diabetes, eczema, immunocompromised, MRSA, psoriasis, strep, asthma, and allergies.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Lacrimation increased, Product preparation error, Skin burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning skin in a 23-year-old female patient who received RABAVERT (batch number 628011A, expiry date 30th April 2020). The patient's past medical history included animal bite (she was bitten on her back by a bat). Concomitant products included RABAVERT. On 16th November 2017, the patient received the 2nd dose of RABAVERT. On an unknown date, the dose was an unknown dose.  On 16th November 2017, less than an hour after receiving RABAVERT, the patient experienced burning skin and lacrimation. On an unknown date, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the burning skin was recovered/resolved and the outcome of the lacrimation and inappropriate preparation of medication were unknown. The reporter considered the burning skin and lacrimation to be related to RABAVERT. Additional details were reported as follows: On 16th November 2017 the patient received RABAVERT which led to the occurrence of inappropriate reconstitution technique. In less than an hour after the patient received RABAVERT she experienced burning skin and lacrimation. The caller stated that the nurse gave the patient a part of the vaccine in her left arm, which burned extremely bad bringing her to tears. She states then the nurse stated she didn't see another part of the vaccine and proceeded to give her another part in her right arm. She stated the two were spaced about 15 minutes apart. The vaccine was given at an infusion center within the hospital.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of syncope in a 12-year-old male patient who received FLULAVAL QUADRIVALENT (batch number GC32K, expiry date unknown). On 15th November 2017, the patient received FLULAVAL QUADRIVALENT. In November 2017, less than  a week after receiving FLULAVAL QUADRIVALENT, the patient experienced syncope. On an unknown date, the outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: GSK representative called to report Adverse Event had very limited information.
Sex: F
Vaccine: RAB
Symptoms: Burning sensation, Immediate post-injection reaction, Incorrect product formulation administered, Lacrimation increased, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a adult female patient who received RABAVERT (batch number C2A011A, expiry date April 2020). On an unknown date, the patient received RABAVERT. On an unknown date, immediately after receiving RABAVERT, the patient experienced pain, burning sensation, eyes tearing, muscle pain and inappropriate preparation of medication. On an unknown date, the outcome of the pain, burning sensation, eyes tearing, muscle pain and inappropriate preparation of medication were unknown. The reporter considered the pain, burning sensation, eyes tearing and muscle pain to be related to RABAVERT. Additional information was reported as follows: The age at vaccination was not reported. At 9 am the patient received only the diluent portion of the RABAVERT which led to inappropriate preparation of medication. Immediately after the diluent portion was given, the patient reported pain, burning, muscle hurts and tear to eye. As of 10:40 am, the patient was still experiencing the symptoms. The patient received the correct RABAVERT dose in the right arm, after the incorrect dose was given. Lot number or expiry date was not given for the correct dose given. The patient went home. No additional information was provided.
Sex: F
Vaccine: RAB
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a adult female patient who received RABAVERT (batch number C2A011A, expiry date April 2020). On an unknown date, the patient received RABAVERT. On an unknown date, immediately after receiving RABAVERT, the patient experienced pain, burning sensation, eyes tearing, muscle pain and inappropriate preparation of medication. On an unknown date, the outcome of the pain, burning sensation, eyes tearing, muscle pain and inappropriate preparation of medication were unknown. The reporter considered the pain, burning sensation, eyes tearing and muscle pain to be related to RABAVERT. Additional information was reported as follows: The age at vaccination was not reported. At 9 am the patient received only the diluent portion of the RABAVERT which led to inappropriate preparation of medication. Immediately after the diluent portion was given, the patient reported pain, burning, muscle hurts and tear to eye. As of 10:40 am, the patient was still experiencing the symptoms. The patient received the correct RABAVERT dose in the right arm, after the incorrect dose was given. Lot number or expiry date was not given for the correct dose given. The patient went home. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling face, Tenderness
Clinical narrative: PT reported-had a ZOSTAVAX vaccine; She said she had a reaction the day after her vaccines; itching on the upper part of her face (over eyes and cheekbones) and her face is a little pink, puffy, and tender, but does not have a rash. No other information given. Exact product start date is unknown. Initial delivery date provided for approximation purposes.
Sex: M
Vaccine: FLUX
Symptoms: Tinnitus
Clinical narrative: About a year ago I caught my first ever Flu from a co-worker. Back then after a few days of having high temperature, nausea and headache accompanied with cough and runny nose I developed tinnitus in my right ear. It lasted about a week before it started fading but then new symptom in the same ear happened. Change in pitch of sounds that I heard. Slowly over the course of about another 1 to 2 weeks all symptoms in my Right ear went away but before that happened I developed same issue in my left ear too. Eventually after about 3 weeks most flu symptoms vanished and tinnitus also went away after about a month to a month and a half. Yesterday (November 25th 2017) I got my flu shot at a pharmacy. Now a few hour after getting the shot (maybe about 5 hours later). I have same symptoms I had with the actual flu when it comes to my ears only. No high fever, no coughing no runny nose small headache but accompanied with tinnitus in my right ear (again).
Sex: U
Vaccine: MENB
Symptoms: Back pain, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 1 day after receiving BEXSERO, the patient experienced injection site pain, back pain and fever. On an unknown date, the outcome of the injection site pain, back pain and fever were unknown. It was unknown if the reporter considered the injection site pain, back pain and fever to be related to BEXSERO. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered BEXSERO in the arm. On an unknown date, the patient's body temperature was recorded as 101 degree F or so. The patient went to the hospital, but the reporter does not believe that they were hospitalized over night. The reporter has had frequent communication and follow-up with the patient.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a adult female patient who received BOOSTRIX (batch number U5267AA ?, expiry date 11th February 2017) and (batch number U5267AA, expiry date 11th February 2018). Concomitant products included FLUZONE. On 24th October 2017 10:00, the patient received BOOSTRIX (injection) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the shoulder pain to be related to BOOSTRIX. Additional details were provided as follows: On 8th October 2017, the patient received FLUZONE vaccine. The patient received BOOSTRIX vaccine on the left arm. The pharmacist asked if she could be transferred to medical information because she just had a quick question and she would call back to answer additional questions. The batch number (U5267AA) of BOOSTRIX did not exist in sales database and was updated to U5267AA ?. However, clarification was requested.
Sex: U
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site reaction in a an unspecified number of patients who received FLUARIX TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to FLUARIX TETRA. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that she was not sure, but there might had an increased rate of localized injection site reactions at her facility with quadrivalent FLUARIX in patients compared to trivalent flu vaccines. The reporter stated that she was not sure of how many patients might have affected. This case is linked with US2017159879, as reported by same reporter.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Immediate post-injection reaction, Injury associated with device, Therapy non-responder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 54-year-old male patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine, Hepatitis B vaccine and ENGERIX B. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On 28th April 2017, the patient received the 4th dose of ENGERIX B. On 28th April 2017, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and less than a day after receiving ENGERIX B, the patient experienced therapy non-responder and needle injury. On an unknown date, the outcome of the therapy non-responder and needle injury were unknown. It was unknown if the reporter considered the therapy non-responder and needle injury to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and ENGERIX B. Additional details were provided as follows: In 2009, the patient received 3 doses of Hepatitis B vaccine. On 28th April 2017, immediately after receiving 4th dose of ENGERIX B vaccine, the patient had a needle prick. The Medical Doctor wanted to know what the guidance was with regards to vaccination of this patient or health care professional due to a dirty needle prick. On 28th April 2017, the patient's antibody concentrations against hepatitis B was 9 mIU per mL. On 26th May 2017, the patient received 5th dose of ENGERIX B.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of enlargement of lymph nodes in a 16-year-old female patient who received BEXSERO (batch number 15C801, expiry date 30th April 2018). Concomitant products included MENACTRA. On 16th November 2017, the patient received BEXSERO. On 20th November 2017, 4 days after receiving BEXSERO, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved. It was unknown if the reporter considered the enlargement of lymph nodes to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on right deltoid and MENACTRA on left deltoid. The patient experienced swollen lymph node under their right arm pit and the swelling was remained ongoing and health care professional was unsure if the swelling was related to the BEXERO. On 22nd November 2017, the patient was evaluated by their primary care doctor, and no hospitalization or emergency room visit was required. The health care professional did not feel the swelling was disabling. The patient also received MENACTRA in the left deltoid, and no swelling was noted under the left arm pit.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: FLUA3
Symptoms: Electromyogram, Musculoskeletal disorder, Myalgia, Neuralgic amyotrophy, Nuclear magnetic resonance imaging
Clinical narrative: 10/13-sore under right shoulder muscle. 10/16-hand froze up and lost use of hand. 10/20-21-diagnosed Parsonage-Turner syndrome. Under physical therapy.
Sex: U
Vaccine: FLUA3
Symptoms: X-ray
Clinical narrative: 10/13-sore under right shoulder muscle. 10/16-hand froze up and lost use of hand. 10/20-21-diagnosed Parsonage-Turner syndrome. Under physical therapy.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Dyspnoea, Throat tightness
Clinical narrative: Administered ZOSTAVAX vaccine. Within 5 minutes patient experienced anaphylactic reaction-said her throat was closing and could not breath-administered 1 dose of epinephrine-complete recovery.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Pt reported no redness, but intense pain and some swelling starting 8 hours after immunization. Unable to move arm w/o pain; however recovering daily.
Age: 1.42
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Crying, Erythema, Gait disturbance, Induration, Inflammation
Clinical narrative: Pt seen in clinic on 11/21/17. Painful, red large bruise on right thigh after vaccines x 2. Didn't walk for next 2 days per mother. Started walking a little on 11/20/17 but still hurts and she cries. Mother has been massaging the area but did not use ice initially or TYLENOL or ibuprofen for the pain. Has new shoes from the mall and is walking (just learning and is unstable with a wide stance) with the right foot on her toes a bit. She has no fever and is eating well with no problems when finally falls asleep. 11/22/17 - Pt seen again. Chief complaint: crying more. Was seen by Dr. 11/21/17, a little worse than yesterday. Localized erythema and induration only. Toddler refusing to bear wt. on affected left leg. Recommended heat, ibuprofen - once inflammation resolved, child should start walking and weight bearing again. Typical Ag-Ab complex reaction - should resolve within 1 wk. Parents reassured.
Age: 1.42
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Weight bearing difficulty
Clinical narrative: Pt seen in clinic on 11/21/17. Painful, red large bruise on right thigh after vaccines x 2. Didn't walk for next 2 days per mother. Started walking a little on 11/20/17 but still hurts and she cries. Mother has been massaging the area but did not use ice initially or TYLENOL or ibuprofen for the pain. Has new shoes from the mall and is walking (just learning and is unstable with a wide stance) with the right foot on her toes a bit. She has no fever and is eating well with no problems when finally falls asleep. 11/22/17 - Pt seen again. Chief complaint: crying more. Was seen by Dr. 11/21/17, a little worse than yesterday. Localized erythema and induration only. Toddler refusing to bear wt. on affected left leg. Recommended heat, ibuprofen - once inflammation resolved, child should start walking and weight bearing again. Typical Ag-Ab complex reaction - should resolve within 1 wk. Parents reassured.
Age: 1.58
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Immediate post-injection reaction, Rash pruritic, Urticaria
Clinical narrative: Father describes immediate hives. Child developed pruritic rash, which had persisted since immunization.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local redness and swelling at inj. site.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Full blood count, Immunoglobulin therapy, Increased tendency to bruise, International normalised ratio, Platelet count decreased
Clinical narrative: Immune thrombocytopenia purpura.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Prothrombin time
Clinical narrative: Immune thrombocytopenia purpura.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased, Red blood cell count normal, White blood cell count normal
Clinical narrative: Immune thrombocytopenia purpura.
Age: 71.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 71-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 06-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, lot # N019983, expiration date 03-MAR-2017 for pneumonia prevention. Other suspect therapies included unspecified influenza virus vaccine (manufacturer unknown). On 06-NOV-2017, the patient began experiencing swelling in right deltoid, shortness of breath, fever and chills. The patient took acetaminophen (TYLENOL) for pain and swelling. No lab tests were performed. The outcome of the events and relatedness between the events and PNEUMOVAX 23 was not reported. The reporter requested urgent lot check.
Age: 71.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Chills, Dyspnoea, Pain, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 71-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 06-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, lot # N019983, expiration date 03-MAR-2017 for pneumonia prevention. Other suspect therapies included unspecified influenza virus vaccine (manufacturer unknown). On 06-NOV-2017, the patient began experiencing swelling in right deltoid, shortness of breath, fever and chills. The patient took acetaminophen (TYLENOL) for pain and swelling. No lab tests were performed. The outcome of the events and relatedness between the events and PNEUMOVAX 23 was not reported. The reporter requested urgent lot check.
Age: 56.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 56 year old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 10-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N024384, expiration date: 18-MAY-2019) (dose, frequency and route of administration were unspecified) for prophylaxis. On an unspecified date in November 2017, the patient went to the emergency room complaining of redness and swelling at the injection site, along with fever and feeling sick. The patient was given unspecified antibiotic as treatment. Additionally, the pharmacist reported that PNEUMOVAX 23 did not undergo a temperature excursion. At the time of the report, the outcome of injection site erythema, malaise, pyrexia and injection site swelling was reported as recovering. The relatedness assessment between PNEUMOVAX 23 and the aforementioned adverse events was not provided.
Age: 56.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 56 year old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 10-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N024384, expiration date: 18-MAY-2019) (dose, frequency and route of administration were unspecified) for prophylaxis. On an unspecified date in November 2017, the patient went to the emergency room complaining of redness and swelling at the injection site, along with fever and feeling sick. The patient was given unspecified antibiotic as treatment. Additionally, the pharmacist reported that PNEUMOVAX 23 did not undergo a temperature excursion. At the time of the report, the outcome of injection site erythema, malaise, pyrexia and injection site swelling was reported as recovering. The relatedness assessment between PNEUMOVAX 23 and the aforementioned adverse events was not provided.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site irritation, Injection site rash
Clinical narrative: Irritation to injection site, raised red rash, on tricep of right arm. Size of rash is 9x5 cm.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Injection site erythema, Injection site warmth, Irritability, Pain
Clinical narrative: Vaccine given at 12:30 PM. Fever & fussiness started at 5 PM. Administered 2.5 ml of Infant TYLENOL (generic). Baby went to sleep from 6-8. Woke up screaming in pain. Took a brief nap from 9:30-10:00. Woke up crying inconsolably. Finally able to administer another 2.5 ml of TYLENOL at 11:45 pm. Cried nonstop until 4:50 am. Currently sleeping but very painful. Seems painful when laid down so can only hold upwards. Fever present. Site of injection very warm and slightly red.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Screaming
Clinical narrative: Vaccine given at 12:30 PM. Fever & fussiness started at 5 PM. Administered 2.5 ml of Infant TYLENOL (generic). Baby went to sleep from 6-8. Woke up screaming in pain. Took a brief nap from 9:30-10:00. Woke up crying inconsolably. Finally able to administer another 2.5 ml of TYLENOL at 11:45 pm. Cried nonstop until 4:50 am. Currently sleeping but very painful. Seems painful when laid down so can only hold upwards. Fever present. Site of injection very warm and slightly red.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist referring an 81 year old female patient. The patient's current conditions and historical drugs included drug reactions/ allergies to erythromycin and sulfa drugs. Medical history, concomitant medications were not reported. On 07-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, dose, frequency and anatomical location were unknown) with lot # N013541 and expiration date 23-JAN-2019 for routine vaccination. On an unknown date in October 2017 (reported as soon after receiving the PNEUMOVAX 23"), the patient experienced  a red itchy rashe (rash pruritic and rash erythematous) that spanned from the injection site to her elbow. At the time of reporting, the patient had recovered from the events of rash pruritic and rash erythematous. The pharmacist did not mention the causality assessment between the events of rash pruritic and rash erythematous, and PNEUMOVAX 23.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with her second VAQTA (50U/1.0 ml PF SYR)(route, dose, frequency, anatomical location, lot # and expiration date were unknown) with lot # N020950 and expiration date 17-OCT-2018 one week before the recommended schedule in the prescribing information,for prophylaxis. No adverse effects were reported in the patient.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 15 month old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-NOV-2017, the patient was subcutaneously vaccinated with a dose of PROQUAD lot # N016994, expiry date 29-NOV-2018, therapy type: rHa (exact dose was not reported) for prophylaxis. On the same day, the patient was vaccinated with a dose of VARIVAX (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The lot # and expiration date for the sterile diluent used to reconstitute the vaccines was not provided. No adverse effects were reported.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 19 month old male patient. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 03-NOV-2017, the patient was vaccinated with improperly stored dose of VAQTA lot # N019924 in the left thigh (exact dose and expiry date were not reported) for prophylaxis. The dose of vaccine was stored in a temperature of 51 degrees Fahrenheit (F) for 4 hours and 50 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported (reported as everything went well).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 06-NOV-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (dose, dose number, frequency, and anatomical location were unknown) with lot # L043702 and expiration date 03-NOV-2017, subcutaneous route for prophylaxis, and was reconstitute with a sterile diluent (MERCK) (lot # was not known). No adverse effects reported.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. The patient's drug reactions/allergies were unknown by reporter. On unknown dates, also reported as "years ago, when the patient was an adolescent", he received two doses of M-M-R II for prophylaxis (strength, dose, route, Lot # and expiration date were not reported). On an unknown date, it was discovered that, during a routine titer level testing as part of screening for entering nursing school, the patient's titer level for mumps was good but the patient's titer level for both measles and rubella were low. Because of that low titers, the patient was prescribed to receive an additional dose of M-M-R II. He was scheduled to receive the additional dose on Monday, 06-NOV-2017; thus, the physician reconstituted the additional dose on this same date in preparation for giving the shot, but the physician chose to delay the vaccine administration because the patient received an unspecified routine screening injection test for tuberculosis on this same date, 06-NOV-2017 and to not administer the vaccine concomitantly with the shot test for tuberculosis. The physician then, refrigerated the reconstituted M-M-R II for prophylaxis (strength, dose, route, Lot # and expiration date were not reported) until 08-NOV-2017, when it was administered; procedure which was not recommended in the product label but this was considered the treatment for the adverse experiences reported. Additionally, it was reported that the physician would re-vaccinate the patient or would run the titers again. At the reporting time, the outcome of measles antibody negative and rubella antibody negative was unknown. The causality assessment between the events and vaccination with M-M-R II was not provided.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Impaired work ability, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a female patient of unknown age reporting herself. There was no information about the patient's concurrent conditions, allergies or reactions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with the second dose of PNEUMOVAX 23, for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified date, after receiving her second dose, her shoulder down to her elbow was swollen, red, and sore. In addition,  patient's arm was "two times larger than normal" (Inflammation localized). Consequently, she visited her pharmacy where she was recommended and received treatment with acetaminophen (TYLENOL), ibuprofen (MOTRIN), and diphenhydramine (BENADRYL). The patient also mentioned that she would have to miss work an unspecified day (reported as today) with the pain. No product quality complaint was involved. The outcome of the events and the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse on 17-NOV-2017, referring to a 75 year old female patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. Concomitant therapies included an unspecified dose of influenza virus vaccine (unspecified). On 02-OCT-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 for prophylaxis (strength, dose, route, frequency, lot # and expiration date were not reported). On an unknown date in 2017, the patient experienced severe swelling, tenderness and pain at the site of the PNEUMOVAX 23 injection and was diagnosed with cellulitis. At the time of reporting, the outcome of vaccination site cellulitis was unknown. Additionally, the causality assessment between injection site cellulitis and PNEUMOVAX 23 was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Immunosuppression, Lung neoplasm malignant, Pulmonary embolism, Pulmonary resection, Rash vesicular
Clinical narrative: This spontaneous report was received from an unspecified health care worker via a company representative and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date in 2009, the patient was vaccinated with ZOSTAVAX, subcutaneously for prevention from shingles (dose, lot # and expiration date were not reported). On an unknown date, the patient was diagnosed with lung cancer, has half a lung (Lung neoplasm malignant) and had a pulmonary embolism (all at unspecified times since the ZOSTAVAX was administered). It was also reported that the patient had an appointment with the physician on 21-NOV-2017 because he "has a right side mid upper body zoster rash (Rash vesicular)". The patient was immunosuppressed. At the reporting time, the outcome of lung neoplasm malignant and pulmonary embolism was unknown and the patient had not recovered from Immunosuppression and Rash vesicular. No further information provided. The causality between the events and ZOSTAVAX was not reported. Upon internal review, the events Lung neoplasm malignant, pulmonary embolism and Immunosuppression were considered to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Infertility female, Polycystic ovaries
Clinical narrative: This spontaneous report was received from a consumer who was involved in Research regarding a female patient (reporter's friend) of unknown age via a market research agency. Information on pertinent medical history, concomitant medications and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, frequency, route of administration, lot# and expiry date were not reported) for prophylaxis. On an unknown date (also reported as just months after the vaccine), the patient developed polycystic ovary syndrome (PCOS) and she was considered as infertile. Outcome of the events was unknown. Causality of the events was not reported. The reporter also stated that she personally did not want to take that risk (details unspecified). Sender's Comments: US-009507513-1711USA008955.