chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: DTOX, PNC13
Symptoms: Injection site discolouration, Injection site swelling, Lip swelling, Pharyngeal oedema, Pruritus generalised
Clinical narrative: This is a spontaneous report from a contactable consumer. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 26Jul2016 at single dose in right shoulder, for immunisation.  On the same date the patient received diphtheria vaccine in left shoulder. Medical history included two previous pneumonia vaccinations on an unknown date. The patient's concomitant medications were not reported.  A couple days after vaccination, the patient started to experience the following symptoms: raised at the injection site, itching all over, scratched until bleed, red patches all over my body (on ankles, the bottom of foot, toes, close to groin). The area around injection site became brown. Also had throat swollen up, felt like had a lump in throat and in between the chest, like if she was choking, but it went away after a while.  Lips and tongue were swollen, eyes were so swollen in the urgent care, they were almost closed shut, can't sleep because the itching. The patient went to see a specialist and her doctor, also showed the arm to the pharmacist. The patient was hospitalized twice since got the injection. The nurse in the urgent care documented that the patient had hives all over the body. They gave topical cortisone cream, anti- itch cream. Patient's doctor prescribed ZYRTEC but it didn t do anything. The outcome of 'felt like had a lump in throat and in between the chest, like if she was choking' was recovered, all other events outcome were unknown.
Age: 80.0
Sex: F
Vaccine: DTOX, PNC13
Symptoms: Sensation of foreign body, Skin haemorrhage, Sleep disorder, Swollen tongue, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 26Jul2016 at single dose in right shoulder, for immunisation.  On the same date the patient received diphtheria vaccine in left shoulder. Medical history included two previous pneumonia vaccinations on an unknown date. The patient's concomitant medications were not reported.  A couple days after vaccination, the patient started to experience the following symptoms: raised at the injection site, itching all over, scratched until bleed, red patches all over my body (on ankles, the bottom of foot, toes, close to groin). The area around injection site became brown. Also had throat swollen up, felt like had a lump in throat and in between the chest, like if she was choking, but it went away after a while.  Lips and tongue were swollen, eyes were so swollen in the urgent care, they were almost closed shut, can't sleep because the itching. The patient went to see a specialist and her doctor, also showed the arm to the pharmacist. The patient was hospitalized twice since got the injection. The nurse in the urgent care documented that the patient had hives all over the body. They gave topical cortisone cream, anti- itch cream. Patient's doctor prescribed ZYRTEC but it didn t do anything. The outcome of 'felt like had a lump in throat and in between the chest, like if she was choking' was recovered, all other events outcome were unknown.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable female consumer reported for herself. A 65-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13 via an unspecified route of administration at 0.5ml, single for immunisation, influenza vaccine (FLU SHOT) via an unspecified route of administration at 1 DF, single, both on 23Oct2016 for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced sore in both arms from shots on 23Oct2016 with outcome of unknown. She stated this was normal for her, she got sore every time she gets those shot. She just called, because she wanted ask if she could have them together.
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is 2nd of two reports. A female patient of unknown age and race received TRUMENBA for immunization at single dose on unknown date via an unspecified route.  Medical history and concomitant medication were unknown. On unknown date the patient experienced syncope. The outcome of the event was unknown. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available. Linked Report(s): US-PFIZER INC-2016497578 same reporter/drug, different patient/event.
Sex: F
Vaccine: PNC13
Symptoms: Skin discolouration
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for herself. This female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date in 2015 for immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took influenza vaccine and experienced erythema, diphtheria vaccine one year before pneumococcal 13-val conj vac (dipht crm197 protein) as she was susceptible to having respiratory problems.  The patient experienced arm became brown/the area on arm was like a deck of cards size wise and a rectangular shape on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: This is a spontaneous report received from a contactable pharmacist via a Pfizer sales representative. A female patient of unspecified age and ethnicity received PREVNAR 13 (Lot# N16560, Exp date 30Sep2017), via an unspecified route of administration in deltoid left, on an unspecified date at 9:30 AM, at 0.5 ml single, for immunisation. The patient was vaccinated at the pharmacy. The patient's medical history and concomitant medications were not reported. Days after vaccination the patient experienced infection, about two inches below the site of injection was red and swollen all on an unspecified date with outcome of unknown. The events were evaluated at doctor visit. Therapeutic measures were taken as a result if the events and included treatment with topical antibiotic Bactroban. The pharmacist believed that after Prevnar 13 was administered the patient experienced infection.
Sex: F
Vaccine: PNC13
Symptoms: Dysphonia, Vocal cord paralysis
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A female patient of an unspecified age received PREVNAR 13, on an unspecified date at 0.5 ml single for immunisation. Concomitant medications were not reported.  The patient had allergy to iodine.  On an unknown date she experienced hoarseness and paralyzed vocal cord. She had three months of speech therapy and nothing was working. The final outcome of both the events was unknown.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Dermatitis, Oedema
Clinical narrative: This is a spontaneous report from a contactable Other HCP. A 53-year-old female patient of an unspecified ethnicity received PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced edema and dermatitis on an unspecified date with outcome of unknown.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable Pharmacist communicated to a Pfizer sales representative. An 84-year-old female patient of an unspecified ethnicity received PREVNAR 13 at single dose on an unspecified date for immunisation, recommended by the doctor because she had never received the vaccine. The patient medical history and concomitant medications were not reported. The patient experienced redness at the injection site on an unspecified date for 3 to 4 days post vaccination with outcome of unknown.
Sex: U
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist.  A patient of unspecified age and gender received a single dose of PREVNAR 13 on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  The vaccine was probably administered to the patient subcutaneously since an unknown date the patient experienced a significant swelling. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of unspecified age and race/ethnicity received a single dose of TRUMENBA on an unknown date for immunization. Concomitant medications and medical history were not reported. On an unspecified date, the patient had a seizure. Outcome was unknown. The physician commented that the event did not occur directly after the dose of meningococcal group b rlp2086 and that the patient had other medical conditions. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: MENB
Symptoms: Cold sweat, Dizziness, Musculoskeletal stiffness, Nasopharyngitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, gender and race/ethnicity received a single dose of TRUMENBA for immunization on an unspecified date. Concomitant medications and medical history were not reported. On an unspecified date, the patient experienced dizzy, cold, clammy, fever 3-4 days, stiff neck. The events were evaluated in ER. Outcome was unknown.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Decreased range of motion to shoulder that is ongoing. Currently seeking treatment and physical therapy/ x-Ray/MRI ordered.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site reaction, Skin hypertrophy
Clinical narrative: 1cm by 3.5cm thickened texture at injection site. Really pink with a faint purple color. No pain or itch, but mark has been present from day of injection April 1st, 2016 to October (about 6 months).
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 1cm by 3.5cm thickened texture at injection site. Really pink with a faint purple color. No pain or itch, but mark has been present from day of injection April 1st, 2016 to October (about 6 months).
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Abasia, Arthralgia, Swelling, Urticaria
Clinical narrative: Progressively worsening hive type rash from head to toes. Generalized swelling and pain of all joints. Cannot walk due to pain.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Fatigue, Headache, Loss of consciousness, Pyrexia, Urticaria
Clinical narrative: Passed out, went unconscious. Fever. Fatigue. Hives. Headache.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Fatigue, Headache, Loss of consciousness, Myalgia, Pyrexia
Clinical narrative: Passed out, went unconscious. Fever. Fatigue. Hives. Headache.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain, Skin warm
Clinical narrative: Shoulder & neck pain on left side (the side the shot was given).  Seven days later I still have pain.  Advil takes the edge off the pain as well as heat.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Headache, Malaise, Oropharyngeal pain, Pain
Clinical narrative: From 2 days after getting the Flu shot, (still happening) I have had general malaise, body aches, non-productive cough, slight headache, sore throat.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Back pain, Muscle spasms, Musculoskeletal pain, Nausea, Pyrexia
Clinical narrative: Father came to office 10/25/15 to notify that client had reactions that was not on VIS, given Tylenol and kept home from school that day. Called and spoke with Mother. Client complained of left upper back/top of shoulder pain radiating between shoulder blades. Developed cramp like pain in both thighs then suddenly dropped to ground like paralyzed. C/O back pain. Around 15 minutes later Mom assisted client up after sitting with her. Client said was painful and didn't want touch or movement and was hunched over c/o nausea and had low grade fever (felt warm) in the evening. No headache that night but did have headache in the morning. Mom states client has done gymnastics in the past and flips around at home. Mom states when left for work at 3:00 PM 10/25/16 client seemed fine. Did keep home from school that day (10/25) and was giving Ibuprofen. 10/31/16 f/u with Mom: Feels things are back to normal. Did not take for evaluation. Did have left side and back pain for a couple of days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pain, redness and swelling in her upper left arm. She has noted it worsening and redness and warmth enlarging. Has had also HA and fevers and generally not feeling well. Treatment: acetaminophen (TYLENOL) 500 mg tablet; Take 1 tablet (500 mg total) by mouth every 6 (six) hours as needed for Pain. As needed. cephALEXin (KEFLEX) 500 mg capsule; Take 1 capsule (500 mg total) by mouth 4 (four) times daily.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Pain, redness and swelling in her upper left arm. She has noted it worsening and redness and warmth enlarging. Has had also HA and fevers and generally not feeling well. Treatment: acetaminophen (TYLENOL) 500 mg tablet; Take 1 tablet (500 mg total) by mouth every 6 (six) hours as needed for Pain. As needed. cephALEXin (KEFLEX) 500 mg capsule; Take 1 capsule (500 mg total) by mouth 4 (four) times daily.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Injection site cellulitis, Injection site induration, Injection site vesicles, Skin hyperpigmentation
Clinical narrative: BLISTERIING, HYPERPIGMENTED INDURATION AT INJECTION SITE WITH SURROUNDING CELLULITIS AND VESICLES WITHIN AREA OF CELLULITIS.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Joint range of motion decreased, Pain, Sleep disorder
Clinical narrative: I immediately knew that the vaccine had been administered too high in my left arm & was into the shoulder joint. Pain started keeping me awake at night. Then began affecting my daily functions: reaching for seat belt, removing clothing over my head, raising my arm to reach for items. So my range of motion has been limited. Constant pain when moving left arm.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Patient developed swollen eyes next morning after PNEUMOVAX 23. She had itchy eyes and she took Allegra 60mg (OTC) for 3 days then Claritin 10mg (OTC) for 3 days.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Hypoaesthesia, Muscular weakness, Pain, Rash
Clinical narrative: SHARP PAIN WHEN VACCINE WAS ADMINISTERED AND A WEEK LATER ARM AND LEG NUMBNESS AND WEAKNESS. ALSO A RASH AND BLISTERS OCCURRED A WEEK OR LONGER AS WELL.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Full blood count, Incisional drainage, Influenza virus test, Injection site erythema, Injection site pustule
Clinical narrative: Patient developed fever of 103.0 per mom. Next day went to local ER and fever was 101.9. Raised Erythematous area on right thigh with pustule lesion.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site swelling, Pyrexia, Respiratory syncytial virus test, Streptococcus test
Clinical narrative: Patient developed fever of 103.0 per mom. Next day went to local ER and fever was 101.9. Raised Erythematous area on right thigh with pustule lesion.
Age: 33.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy pink rash over torso, extremities, neck. No wheeze, dyspnea, lip or tongue swelling. Our office did not give the vaccines and do not have all of the details.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Patient experienced edema in the arm and redness with no lymph node and no axillary involvement. Patient denied itching or concerns anywhere else on the body.  Patient has been taking Ibuprofen and symptoms have been slowly decreasing.  Patient saw physician who determined that it may have been cellulitis and was treated with antibiotics (or could have been a hypersensitivity reaction).  Patient has recovered fully.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Pallor, Rash erythematous, Rash generalised, Rash pruritic, Skin lesion
Clinical narrative: Child developed a generalized erythematous rash 6 days after the vaccine was administered. The rash is erythematous, itches, some lesions different in sizes. Others show a pale center with an erythematous base that resemble "target lesions." Some of the erythemas are confluent behind the ears measuring approximately 2 X 3 inches. Child was placed on Benadryl Liquid 5mg/kg/day in divided doses 4 times a day. Also there was no mucosal involvement, no swelling of the tongue, no difficulty breathing, no hoarseness, no weak pulse or paleness noted. Child was happy and walking about in no apparent distress of any type.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Burning sensation, Chest X-ray normal, Computerised tomogram normal, Dizziness
Clinical narrative: Tingling feeling in neck and scalp as well as a cool feeling in arm that vaccine was administered about 20 minutes after administered. Fatigue and skin sensitivity the following 2 days. Then pins and needles sensation in both arms, scalp, neck, face and lips intermittently for the course of 3 1/2 weeks. On 10/27/16  cool/ burning sensation developed in both arms, neck, mid back and scalp along with feelings of dizziness and fatigue. Pins and needle sensation still present intermittently. Visited the physician assistant who wanted to schedule an MRI. Ended up feeling worse by 10/31/16 with feelings of generalized weakness an leg weakness. Went to ER for full work up. All tests came back normal. Now to follow up with a neurologist.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Fatigue, Laboratory test normal, Muscular weakness, Nuclear magnetic resonance imaging normal
Clinical narrative: Tingling feeling in neck and scalp as well as a cool feeling in arm that vaccine was administered about 20 minutes after administered. Fatigue and skin sensitivity the following 2 days. Then pins and needles sensation in both arms, scalp, neck, face and lips intermittently for the course of 3 1/2 weeks. On 10/27/16  cool/ burning sensation developed in both arms, neck, mid back and scalp along with feelings of dizziness and fatigue. Pins and needle sensation still present intermittently. Visited the physician assistant who wanted to schedule an MRI. Ended up feeling worse by 10/31/16 with feelings of generalized weakness an leg weakness. Went to ER for full work up. All tests came back normal. Now to follow up with a neurologist.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Skin sensitisation
Clinical narrative: Tingling feeling in neck and scalp as well as a cool feeling in arm that vaccine was administered about 20 minutes after administered. Fatigue and skin sensitivity the following 2 days. Then pins and needles sensation in both arms, scalp, neck, face and lips intermittently for the course of 3 1/2 weeks. On 10/27/16  cool/ burning sensation developed in both arms, neck, mid back and scalp along with feelings of dizziness and fatigue. Pins and needle sensation still present intermittently. Visited the physician assistant who wanted to schedule an MRI. Ended up feeling worse by 10/31/16 with feelings of generalized weakness an leg weakness. Went to ER for full work up. All tests came back normal. Now to follow up with a neurologist.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Total body itchiness and hives.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Blood test, Dizziness, Hypoaesthesia, Vomiting
Clinical narrative: Dizziness, vomiting, numbness of extremities.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in shoulder of vaccinated arm with inability to range or use arm due to pain at shoulder.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: When shot given, extreme pain down center of upper arm. Continued for 10 days then onset of excruciating pain in shoulder and arm --worse when lying on either side. Limited ability to lift, push, pull etc. Arm/shoulder does not have full range of motion as of 10/31/2016.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Peripheral swelling, Pyrexia
Clinical narrative: Low grade fever, swollen arm and itchiness around the injection site- possible mild case of the shingle.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram head normal, Disorientation, Hypertensive crisis, Laboratory test normal, Memory impairment
Clinical narrative: Disoriented, couldn't remember her own name or where she lived, talked gibberish, presented with all signs of stroke and immediately taken to ER by caregiver.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Speech disorder
Clinical narrative: Disoriented, couldn't remember her own name or where she lived, talked gibberish, presented with all signs of stroke and immediately taken to ER by caregiver.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Amnesia, Blood pressure increased, Disorientation
Clinical narrative: Disoriented, couldn't remember her own name or where she lived, talked gibberish, presented with all signs of stroke and immediately taken to ER by caregiver.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itching.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Decreased appetite, Dehydration, Diarrhoea, Influenza
Clinical narrative: 24hr post flu shot not feeling well, 10/12/16 ER Visit Flu symptoms x 12d and hasn't ate in 4d. Has cough and tactile fever. 10/16-24 admitted to hosp, dehydration, nausea, muscle spasms/pain in neck, diarrhea and pneumonia. Transferred to different hospital.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Muscle spasms, Nausea, Neck pain, Pneumonia
Clinical narrative: 24hr post flu shot not feeling well, 10/12/16 ER Visit Flu symptoms x 12d and hasn't ate in 4d. Has cough and tactile fever. 10/16-24 admitted to hosp, dehydration, nausea, muscle spasms/pain in neck, diarrhea and pneumonia. Transferred to different hospital.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: 24hr post flu shot not feeling well, 10/12/16 ER Visit Flu symptoms x 12d and hasn't ate in 4d. Has cough and tactile fever. 10/16-24 admitted to hosp, dehydration, nausea, muscle spasms/pain in neck, diarrhea and pneumonia. Transferred to different hospital.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Extreme pain on administration. Pain in shoulder, now, 3 weeks later with weakness and decreased range of motion in left shoulder - shot was given in left deltoid.
Age: 8.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Erythema, Extra dose administered, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt received DAPTACEL vs Tdap, pt received extra dose of polio and MMRV. 10-28 - 10-30 (R) arm red, hot, and pain, swollen.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Painful right arm after influenza vaccination. 6 weeks duration - treated area with ice and anti-inflammatories. Had a high dose vaccine the prior year without adverse effects.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Influenza, Joint swelling
Clinical narrative: Developed flu symptoms and swelling of right arm.
Age: 18.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site pruritus
Clinical narrative: Itching at injection site no pain, no rash just itching.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Large area of redness of left upper arm at site at PNEUMOVAX 23.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Topical reaction at injection site, warm, itching, back of right arm is red. Advised to take BENADRYL as directed.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Mild topical reaction top back of area down to elbow is red and warm, Advised to take BENADRYL as directed.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Mild topical reaction top back of area down to elbow is red and warm, Advised to take BENADRYL as directed.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Tremor
Clinical narrative: Trembling 10 minutes after vaccine. Feeling weak for 3 weeks.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Fatigue, Influenza like illness
Clinical narrative: Pt described mild flu-like symptoms that lasted 3 days. Fatigue. Temp 101 degree.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: Itching with rash on torso and back of arms.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and pain in arm starting the day after vaccine. Patient insisted vaccines be given in same arm.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Induration
Clinical narrative: Local: induration: 3.5 x 5.25 cm. No secondary infection noted. Has F.U. 1 week.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Mobility decreased
Clinical narrative: Unable to lift arm.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Soreness in arm radiating down past elbow. Fever, headache, nausea, achiness, shortness of breath.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Soreness in arm radiating down past elbow. Fever, headache, nausea, achiness, shortness of breath.
Age: 85.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Arm was red on upper right arm and hot - advised to take BENADRYL as directed.
Age: 85.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema
Clinical narrative: Arm was red on upper right arm and hot - advised to take BENADRYL as directed.
Age: 1.1
Sex: M
Vaccine: UNK
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Day 10. Varicella type truncal rash-mostly papular some papulovesicles-same as face a few in inguinal area.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Anaemia, Chest X-ray abnormal, Feeling hot, Influenza like illness, Malaise
Clinical narrative: Experienced flu like symptoms/Hot approximately 4 hrs after shot. 10-26-16 ER visit primary diagnosis 1) Viral infection, 2) Muscle pain. 10-28-16 Hosp visit - primary diagnosis - post immunization RXN also malaise, red blood cell breakdown, abnormal chest x-ray, anemia, type 2 diabetes.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Red blood cell analysis, Type 2 diabetes mellitus, Viral infection
Clinical narrative: Experienced flu like symptoms/Hot approximately 4 hrs after shot. 10-26-16 ER visit primary diagnosis 1) Viral infection, 2) Muscle pain. 10-28-16 Hosp visit - primary diagnosis - post immunization RXN also malaise, red blood cell breakdown, abnormal chest x-ray, anemia, type 2 diabetes.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Differential white blood cell count normal, Full blood count normal, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, heat, and pain to injection site. Treated with steroid and antibiotic for potential cellulitis. CBC checked (wnl).
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Redness, swelling, heat, and pain to injection site. Treated with steroid and antibiotic for potential cellulitis. CBC checked (wnl).
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Swelling
Clinical narrative: Right thigh became tender to touch 1 day after IM injection. Swelling started to worsen on day 2 after injection up until initial treatment on Oct. 22. Swelling did not decrease until 10/24/16.
Age: 14.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Dizziness, Laboratory test, Paraesthesia, Postural orthostatic tachycardia syndrome
Clinical narrative: Dizziness; Pots; Paresthesias; PM Hx JRA.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 14-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 02-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 920 hours and 0 Celsius degrees for 168 hours with lowest temperature recorded of 34 and 32 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 30-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored VAQTA (lot # M003011, expiration date 15-NOV-2017; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 05-JAN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified). which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 328 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 16-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to temperatures excursion of 1.1 Celsius degrees for 920 hours and 0 Celsius degrees for 168 hours with lowest temperatures recorded of 34 and 32 Fahrenheit degrees respectively. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 09-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacy intern referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On approximately 13-OCT-2016 (reported as "Thursday or Friday of last week"), the patient was vaccinated with an expired dose of VARIVAX (dose, route and lot number were unknown; expiration date May 2016). No adverse effect was reported. Additional information is not expected as the reporter did not wish to be contacted.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 18-year-old male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site pain, injection site warmth and injection site redness. On an unknown date, the outcome of the injection site pain, injection site warmth ad injection site redness were recovered/resolved. The reporter considered the injection site pain, injection site warmth and injection site redness to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The field representative reported that the doctor's patient experienced injection site arm soreness, redness and warmth lasting for 24 to 48 hours after 1st vaccination of BEXSERO. The vaccination date was reported as May 2016, but it was not clear if it belong to 1st or 2nd dose of vaccine. For tolerance to 2nd dose, refer case US2016GSK159486.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of GARDASIL lot # L033347, expiration date 23-JUL-2017 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperature and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 01-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 33 degrees Fahrenheit (0.555555556 degrees Celsius) (lowest recorded temperature) for 368 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 18-year-old male patient who received BEXSERO. Previously administered products included BEXSERO with an associated reaction of adverse event (1st dose received on an unknown date and experienced injection site soreness, redness and warmth. See case US2016GSK156435). On an unknown date, the patient received the 2nd dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site pain, injection site warmth, injection site redness and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site redness and injected limb mobility decreased were recovered/resolved. The reporter considered the injection site pain, injection site warmth, injection site redness and injected limb mobility decreased to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The field representative reported that the doctor's patient experienced injection site arm extreme soreness with difficulty moving arm, redness and warmth at injection site lasting for 3 days after 2nd vaccination of BEXSERO. The vaccination date was reported as May 2016, but it was not clear if it belong to 1st or 2nd dose of vaccine.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-MAR-2016, the patient was vaccinated with VAQTA "10Pk 25U/0.5 ml SD LLok w Cap Ped", lot # L030442 with expiration date 19-DEC-2016, which was stored at 1.11 Celsius Degrees for 216 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patient were administered improperly stored ROTATEQ (dose and route unknown, lot # M004542, expiration date: 18-OCT-2017). The vaccines were exposed to temperature excursions in 3 different refrigerators, but not exposed to multiple excursions. The three refrigerators are described as " A: temperature: max 48 Fahrenheit degree for 15 hours, B: temperature: max 49.3 Fahrenheit degree for 15 hours, and C: temperature max 51.4 Fahrenheit degree for 15 hours". There were no previous excursions. There was no data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLUX, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a nurse refers to a 5 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with an expired dose of M-M-R II lot # K020188, 22-OCT-2016 subcutaneous in the right thigh. The patient was also administered KINRIX and influenza virus vaccine (unspecified) and VARIVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-MAY-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # J006245, expiration date 03-FEB-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 32 hours with the lowest recorded temperature of 31 Fahrenheit degree. The total cumulative excursion time of the second time was 152 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the third time was 584 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the fourth time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. The patient's pertinent medical history, drug allergies and concomitant medications were unknown. On an unknown date the patient was vaccinated with VARIVAX, lot#, expiry date, dose and route were unknown when she was "5 weeks and 2 days" pregnant. The last menstrual period (LMP) and expected delivery of date (EDD) were not known. The pregnancy outcome was pending. The fetal outcome was unknown. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information as received from a nurse concerning an unspecified number of unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On an unknown date, the patients were administered improperly stored doses of ROTATEQ (lot# M025568, expiration date 07-NOV-2017) (strength, dose, frequency and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information as received from a nurse concerning unspecified number of unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On an unknown date, the patients were administered improperly stored doses of M-M-R II (lot # L036851, expiration date 23-SEP-2017; lot # L039551, expiration date 07-OCT-2017; lot # M004063, expiration date 25-JAN-2018; lot # M004063, expiration date 16-FEB-2018) (strength, dose, frequency and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.