chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-JUN-2012, the patient was  was vaccinated at physician's office by the physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-JUL-2016, the patient was treated for a vesicular outbreak that was diagnosed as shingles. The patient was prescribed valacyclovir hydrochloride(VALTREX), prednisone, and  benzonatate(TESSALON) to attempt to manage and relieve her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 07-OCT-2013 the patient was vaccinated with ZOSTAVAX, 1 DF (Lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 14-NOV-2016, the patient was treated by a physician for a blistering outbreak which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed valacyclovir to attempt to manage and relieve her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 10-MAY-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 28-DEC-2016, she was treated by a physician at a hospital for a blistering vesicular outbreak, which was diagnosed as a severe case of herpes zoster, also known as shingles. On or about 25-APR-2017, she received subsequent treatment from physician at a hospital for ongoing and worsening symptoms, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and residual pain secondary to zoster infections. The patient has been prescribed acyclovir (ZORIVAX), famciclovir (FAMVIR), gabapentin, and lidocaine for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 02-NOV-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 26-MAR-2008, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of ophthalmic herpes zoster. On or about 12-MAY-2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as ophthalmic herpes zoster, or shingles with interference into the eyes. The patient has been prescribed valacyclovir to attempt to manage and relieve her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, persistent and chronic strain of ophthalmic herpes zoster/shingles was considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient called stating her arm was red, swollen, hot. Ibuprofen not helping, referred patient to doctor. On Tuesday 11/7/17, referred patient to doctor.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Nausea
Clinical narrative: Patient complained of chills, nausea, sent to ER.
Sex: U
Vaccine: FLU4
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Laboratory test, Sleep disorder
Clinical narrative: Severe pain in the Left shoulder consisting of dull pain, throbbing, stabbing pain, sharp pain, burning; weakness, difficulty moving. At this time 2 week duration. Affects sleep and ability to fully use arm.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Chills, Headache, Pain
Clinical narrative: Started wheezing that evening and by morning a rash had developed behind my left ear which had spread along my jawline, down my neck and into my chest and back area over the next few days. I also had chills and a headache that lasted 5 days along with body aches into my lower back and hips. My right hip having the most pain and still hurts today.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Skin hypertrophy, Wheezing
Clinical narrative: Started wheezing that evening and by morning a rash had developed behind my left ear which had spread along my jawline, down my neck and into my chest and back area over the next few days. I also had chills and a headache that lasted 5 days along with body aches into my lower back and hips. My right hip having the most pain and still hurts today.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Chest X-ray, Dyspnoea, Electrocardiogram, Injection site pain, Palpitations
Clinical narrative: Pt seen in primary care clinic on 31 Oct 9 days following smallpox vaccine. Pt stated C/O right muscle pain (localized at injection site). At 10 day post vaccine appt., pt stated having SOB with chest palpitations.
Age: 58.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives on lower legs and feet for 3 days.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left upper extremity redness, warmth, and swelling. Redness/warmth resolved after 2 days but swelling progressed down left arm.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Asthenia, Erythema, Loss of consciousness, Oedema peripheral, Peripheral swelling
Clinical narrative: Patient reports feeling weak upon wakening the next morning after vaccine. Patient states she got in the shower, began to feel weaker and passed out. Daughter helped her get out of shower and she noticed L. arm was fire red, hot, swollen and fluid filled. She started taking Benadryl and Tylenol and went to the urgent care near her home.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Skin warm
Clinical narrative: Patient reports feeling weak upon wakening the next morning after vaccine. Patient states she got in the shower, began to feel weaker and passed out. Daughter helped her get out of shower and she noticed L. arm was fire red, hot, swollen and fluid filled. She started taking Benadryl and Tylenol and went to the urgent care near her home.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Asthenia, Axillary pain, C-reactive protein increased, Injection site erythema, Injection site oedema
Clinical narrative: Patient reports feeling weak upon wakening the next morning after vaccine. Patient states she got in the shower, began to feel weaker and passed out. Daughter helped her get out of shower and she noticed L. arm was fire red, hot, swollen and fluid filled. She started taking Benadryl and Tylenol and went to the urgent care near her home.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Local reaction, Presyncope
Clinical narrative: Patient reports feeling weak upon wakening the next morning after vaccine. Patient states she got in the shower, began to feel weaker and passed out. Daughter helped her get out of shower and she noticed L. arm was fire red, hot, swollen and fluid filled. She started taking Benadryl and Tylenol and went to the urgent care near her home.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Red blood cell sedimentation rate increased, Skeletal injury, Streptococcus test negative
Clinical narrative: Patient reports feeling weak upon wakening the next morning after vaccine. Patient states she got in the shower, began to feel weaker and passed out. Daughter helped her get out of shower and she noticed L. arm was fire red, hot, swollen and fluid filled. She started taking Benadryl and Tylenol and went to the urgent care near her home.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Cough, Headache, Influenza, Pain
Clinical narrative: I had a flu shot but did not get a paper with the type of vaccine, lot number and manufacturer. But I have been taking flu vaccines for decades and never had an adverse reaction like this one, which feels like a mini-flu. I am experiencing, wheezing (higher than normal because sometime I wheeze due to asthma), headache, sore through, lack of energy, a little coughing at times. So I am reporting this in case other people in this area are also getting unexpected symptoms from this medical facility which may have received some "contaminated" vaccines.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: I had a flu shot but did not get a paper with the type of vaccine, lot number and manufacturer. But I have been taking flu vaccines for decades and never had an adverse reaction like this one, which feels like a mini-flu. I am experiencing, wheezing (higher than normal because sometime I wheeze due to asthma), headache, sore through, lack of energy, a little coughing at times. So I am reporting this in case other people in this area are also getting unexpected symptoms from this medical facility which may have received some "contaminated" vaccines.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient developed varicella.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Diarrhoea, Eating disorder, Haematochezia, Pyrexia
Clinical narrative: Initial screaming with abdominal pain, not eating well, loose stools, fever, and fussy on days 2-4 post vaccine. Stools became bloody. Mom was breast and syringe feeding x >2 weeks. Stools and feeding eventually returned to normal.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming, Spinal fusion surgery
Clinical narrative: Initial screaming with abdominal pain, not eating well, loose stools, fever, and fussy on days 2-4 post vaccine. Stools became bloody. Mom was breast and syringe feeding x >2 weeks. Stools and feeding eventually returned to normal.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Nausea
Clinical narrative: I passed out as soon as I walked away and that lasted about 30 minutes. I felt nauseous all day.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness around the upper arm, slight swelling, warm to the touch.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt. was given Hep B (adult) for Hep B (ped/adol).
Sex: U
Vaccine: HEP, HEPA, HIBV, MMR, RV5
Symptoms: Oxygen saturation, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-OCT-2017, the patients were vaccinated with doses of improperly stored M-M-R II lot # N002337, expiration date 20-JAN-2019 (dose and route of administration were not reported) for prophylaxis. On 16-OCT-2017, the patients were vaccinated with doses of improperly stored VAQTA lot # N017094, expiration date 31-AUG-2018 (dose and route of administration were not reported) for prophylaxis. On 16-OCT-2017, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB lot # N020613, expiration date 05-MAY-2020 (dose and route of administration were not reported) for prophylaxis. On 16-OCT-2017, the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB lot # N007749, expiration date 29-NOV-2019 and lot # N000238, expiration date on 25-OCT-2019 (dose and route of administration were not reported) for prophylaxis. On 16-OCT-2017, the patients were vaccinated with doses of improperly stored ROTATEQ orally, lot # N005617, expiration date 03-OCT-2018 (dose was not reported) for prophylaxis. The M-M-R II vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported) There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 9 and 25 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA008187:
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist  via a company representative, referring to a female patient in her 60's. The patients' medical history, concurrent conditions, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) (dose number, dose, frequency, administration route, lot number and expiration date were not reported) for prophylaxis.  Concomitant therapies included sterile diluent (lot number and expiration date were not reported). Pharmacist reported that on an unspecified date after receiving ZOSTAVAX, the patient returned to the pharmacy with a case of shingles (herpes zoster). It was also stated that the patient was upset about it (feeling abnormal). The outcome of herpes zoster and feeling abnormal was unknown. The causality assessment between ZOSTAVAX and the aforementioned events was not reported.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. The patient had no known drug allergies and no illnesses at time of vaccination. On 19-OCT-2017, the patient was vaccinated with an expired dose of ZOSTAVAX vial, 19400 PFU, 1 dose, lot # M041510, expiration date: 27-JUL-2017, subcutaneously for prophylaxis. Concomitant therapies included FLUVIRIN lot# 172070, intramuscularly and sterile diluent (STERILE DILUENT) lot# M044953. No adverse effects were reported. A prescription drug treatment was not required. The medication error occurred at the time of administration.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old female patient. There were no patient's concurrent conditions. The patient's historical condition was not reported. Moreover, there was no illness at time of vaccination. Concomitant therapies included HAVRIX, M-M-R II by "RL" as site of administration and sterile diluent. On 11-OCT-2017, the patient was vaccinated with an improperly stored first dose of VARIVAX with lot #  L050561 and expiration date of 14-DEC-2017, subcutaneously (SQ) in the "LL" as site of administration (strength and dose were unknown) for prophylaxis, which was stored from -9 Celsius degrees (°C) to 8°C (-3.3°C) for 5 hours and 45 minutes. There was no previous temperature excursion. Moreover, it was reported that the temperature excursions were detected by a data logger. No adverse effects were reported.  This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1710USA007032:
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (reporting for herself) reported that a 74-year-old female patient of an unspecified ethnicity received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received flu shot for immunization about a month ago. On an unspecified date, the patient experienced sore right arm and right shoulder. Patient reported having flu shot a month ago and do not think it to be abnormal as she did not have any problems with that. Patient also reported she was supposed to have surgery on the 31st but her doctor went on vacation and it has been rescheduled for November the 17th for the right hand as she have severe damage to it. No follow-up attempts are possible. No further information is expected. Pfizer is Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced swelling and redness at the injection site. Antibiotics or antihistamines were given for the reaction. Outcome of the events was unknown.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: On 10-28-17 the morning after receiving the flu vaccine, the patient swollen red arm. Family gave appropriate dosing of Benadryl with no change noted. On Monday 10-30-2017, patient complained of shortness of breath and her injection site increased with swelling, redness, and warmth. She was taken to the ER where she received steroids and Benadryl intravenous. She was started on Zyrtec oral and monitor, discharged home. The redness had almost disappeared by evening with no complaints of shortness of breath. 10-31-2017, she complained again of shortness of breath and the redness was returning to the arm along with developing a harsh cough. The ER Provider was called and was prescribed oral prednisone and continue with Zyrtec x 7days. 11-05-2017 was last dose of prednisone, 11-06-2017 last dose of Zyrtec. 11-07-2017 Arm is back to normal and no shortness of breath or cough noted.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Peripheral swelling
Clinical narrative: On 10-28-17 the morning after receiving the flu vaccine, the patient swollen red arm. Family gave appropriate dosing of Benadryl with no change noted. On Monday 10-30-2017, patient complained of shortness of breath and her injection site increased with swelling, redness, and warmth. She was taken to the ER where she received steroids and Benadryl intravenous. She was started on Zyrtec oral and monitor, discharged home. The redness had almost disappeared by evening with no complaints of shortness of breath. 10-31-2017, she complained again of shortness of breath and the redness was returning to the arm along with developing a harsh cough. The ER Provider was called and was prescribed oral prednisone and continue with Zyrtec x 7days. 11-05-2017 was last dose of prednisone, 11-06-2017 last dose of Zyrtec. 11-07-2017 Arm is back to normal and no shortness of breath or cough noted.
Age: 64.0
Sex: M
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red swollen and quite a lot of pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Seizure
Clinical narrative: Seizure day off and the next day. Each during lunch time. Assumed to be within normal seizure activity for patient per the parent. Witnessed by daycare teacher. Denies fever.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Baseball sized redness.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reports itchy hives starting 1.5 days after vaccine administration. Patient states reaction has gotten worse over the past several days, with the reaction moving toward her back and up her neck (mostly itching). Patient reports taking claritin BID since the reaction started.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Confusional state, Hypoaesthesia
Clinical narrative: Numbness on left side; confusion.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Urticaria
Clinical narrative: 0900-Patient reported itching to site about 5 minutes after injection to right arm. MA reported reaction to nurse. RN noted redness and hives, reported to provider, PA. Patient denied any trouble breathing and reported itching to site only. At 0910 Benadryl 25mg given IM to right ventro-gluteal per PA's verbal order. Patient monitored post injection x 30 minutes. At 0940 patient verbalized no itching to site, redness decreased to site. Patient d/c per PA, stable at time of d/c.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This 77-year-old female subject was enrolled in an open label study. The subject received the 2nd dose of Zoster VZV-gE-AS01B (intramuscular) 50 ug on 6th June 2016. On 21st October 2016, 137 days after receiving Zoster VZV-gE-AS01B, the subject developed severe - grade 3 knee pain. Serious criteria included hospitalization. The outcome of knee pain was recovered/resolved on 21st October 2016. The investigator considered that there was a reasonable possibility that the knee pain may have been caused by Zoster VZV-gE-AS01B. Relevant Tests: unknown at this time - site to request medical records. Investigator text: unknown details at this time- site will request medical records for additional details. Additional details: Investigator has reported SAE as increase in right knee pain. "This case was deleted in database under the reason-created in error-NO SAE (planned surgery). Case was undeleted on 01Nov2017".
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Within 5 minutes I had a headache. I woke at 12:00 PM with chills and body aches and extreme fatigue. At 9:00 AM on 10/17/17 the symptoms were gone.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Symptoms for first 3 days: very swollen arm down to wrist, muscle aches in arm, shoulder and chest, bright red arm and shoulder. Symptoms days 4 - 7: pink arm area down to wrist, sore to touch, itchy arm, shoulder and chest.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: PAIN, ITCHING, REDNESS, SWELLING.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: Patient was give PNEUMOVAX 23 on 09/22/17. Patient complained of lost of feeling/numbness in fingers and having no body strength. He stated that he couldn't button up when dressing due to the lack of strength in his hands and arms. He was seen by his doctor and prescribed muscle relaxer, NSAID, and corticosteroid to treat his symptoms.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Gait disturbance, Insomnia, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: Patient was give PNEUMOVAX 23 on 09/22/17. Patient complained of lost of feeling/numbness in fingers and having no body strength. He stated that he couldn't button up when dressing due to the lack of strength in his hands and arms. He was seen by his doctor and prescribed muscle relaxer, NSAID, and corticosteroid to treat his symptoms.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Myalgia, Pain in extremity, Sensory loss, Syncope
Clinical narrative: Patient was give PNEUMOVAX 23 on 09/22/17. Patient complained of lost of feeling/numbness in fingers and having no body strength. He stated that he couldn't button up when dressing due to the lack of strength in his hands and arms. He was seen by his doctor and prescribed muscle relaxer, NSAID, and corticosteroid to treat his symptoms.
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong patient received medication
Clinical narrative: Patient was scheduled for a Well Child Check- 4 months. There was a miscommunication between provider and MA. Patient's parent wanted the flu shot. Patient received the flu shot instead of the parent. Patient, Provider and Medical Director were notified immediately. Patient didn't show any adverse signs towards the vaccine. Patient's parent was educated on signs to look for (fever, allergic reaction, etc.), if any of these signs occurred, patient's parent was told to go to the Emergency Department. Education was given to all MA's about the Administration Rights and also education was given regarding appropriate vaccines for children based on the child's age.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase, C-reactive protein, Full blood count, Metabolic function test, Musculoskeletal pain
Clinical narrative: Patient w/persistent arm/shoulder pain.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Red blood cell sedimentation rate, X-ray limb
Clinical narrative: Patient w/persistent arm/shoulder pain.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 8-week-old male patient. No information regarding the patient's pertinent medical history, drug reactions, allergies or concurrent conditions was reported. On 05-OCT-2017, the patient was vaccinated with improperly stored first doses of LIQUID PEDVAXHIB intramuscular injection (intramuscular route of administration, site of administration: left (specific localization not reported), dose not reported, lot # N003537, expiration date 17-NOV-2019), ROTARIX orally (dose was not reported; lot# Y5EJ3, expiration date was not reported), PEDIARIX (administered intramuscularly in right thigh; dose was not reported; lot#924Y3, expiration date was not reported) and PREVENAR 13 (administered intramuscularly, site of administration: left (specific localization not reported), lot#S35325, expiration date was not reported). The patient's concomitant medication included vitamin D (unspecified). There were no adverse effects reported. A drug treatment prescription was not required. The reporter stated that a temperature excursion above 46 degrees Fahrenheit (F) occurred on 04-OCT-2017, during shipment addition to the refrigerator and was lasting 36 minutes. The highest temperature was 47.6 degrees Fahrenheit (F). On that day, Digital Data Logger did not reflect the excursion, the temperatures had been cleared, prior to the evenings readings and temperatures were reflected in normal ranges. The temperature excursion was discovered on routine weekly download of Digital Data Logger on 09-OCT-2017. The reporter stated that was made contact with all involved vaccine manufacturers and all vaccines were determined to be viable. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA000885:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Gait disturbance, Pain in extremity
Clinical narrative: This spontaneous report was received from a 71 year old female patient, referring herself, who has breast cancer 6 years ago and was treated with unspecified radiation therapy. Concomitant therapies included zolpidem and levothyroxine sodium (SYNTHROID). The patient's concurrent conditions were not reported. On 11-AUG-2017, the patient was vaccinated with ZOSTAVAX 0.65 ml injection one time, in the left arm, for prevention of shingles (strength, route, frequency, lot/batch # and expiration date were not reported). On 12-AUG-2017, the patient experienced pain in her left leg (pain in extremity) and she had also got trouble walking and "trouble getting up from a seated position" (gait disturbance and movement disorder). The patient did not seek medical attention and did not perform laboratories, however she received treatment for the events (unspecified). The outcome of movement disorder, pain in extremity and gait disturbance was reported as not recovered/not resolved. The causality between movement disorder, pain in extremity and gait disturbance with ZOSTAVAX was not reported.
Sex: U
Vaccine: HEP, HIBV, MMRV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unknown number of patients of unknown gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, between March 2015 to October 2015, the patients were vaccinated with improperly stored ROTATEQ orally (doses and frequencies were not reported) lot # K010222 and expiration date: 12-DEC-2016 and with improperly stored PROQUAD (human serum albumin (HSA)) (doses, frequencies and route of administration were not reported) lot # K020756 and expiration date: 08-JUN-2016. The vaccines were reconstituted with properly stored sterile diluent (manufacturer unknown). The ROTATEQ vaccines were stored between 47 Fahrenheit degrees (°F) to 77 °F for 46 hours and 30 minutes. The PROQUAD vaccines were stored between 15 °F to 46 °F for 31 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No causality assessment was provided by the reporter.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: General physical condition abnormal, Injection site pain, Pain in jaw
Clinical narrative: This is a spontaneous report from a contactable pharmacist calling on behalf of the doctor.  An 81-year-old female patient received PREVNAR 13 (NDC number: 0005197101, lot# M51192, Expiry Date: 17May2016), via an unspecified route of administration on 10Mar2016 at single dose indicated for her age range. Medical history included anaemia, thyroid mass, palpitations, chronic kidney disease stage 3, Anemia for Chronic Kidney Disease, History of Deep vein thrombosis , open angle glaucoma, hypertension, Hearing impairement , skin lesion, Enlarged thyroid, TMJ syndrome, Weight gain, Myofascial pain, Cervical nerve root impingement, Lumbago, Secondary Hyperthyroidism, renal, Vitamin D deficiency, Balance disorder, Gait disorder (Like stability probem), Thyroid nodule, Overactive bladder, Chronic Pain Syndrome, Inadequate Social Support,  Physical Decongestioning (She was like her body was breaking up) and Bilateral swelling of feet and ankles.  Concomitant medication included furosemide for Swelling of feet and ankles at 20 mg daily, mupirocin (Strength: 2%, Ointment), latanoprost (Strength:  0.005%, Opthalmic drops), brimonidine tartrate (ALPHAGAN) (Strength: 0.1%, Opthalmic drops), vitamin d nos (VITAMIN D) (50000 Units) , cyanocobalamin (VITAMIN B-12) (1000 mcg, Sublingual, Tablets), valsartan (160 mg, Tablet), amlodipine (2.5 mg, daily), tramadol (50 mg, as needed, One tablet, 3 times a day as needed) for pain, oxybutynin (10 mg, Exteded Release Tablet, Once a day) , ketorolac tromethamine (ACULAR) (0.5 % Ophthalmic drops in still and affected eye as directed), dexamethasone, tobramycin (TOBRADEX) (in still and affected eye as directed), diclofenac (VOLTAREN) (1% gel apply 4 gms topically four times a day), biotin (BIOTIN) (5000 mcg), acetylsalicylic acid (BABY ASPIRIN) (1 mg, One tablet at bed time) , epinastine hydrochloride (ELESTAT) (0.05% strength, Ophthalmic Ointment, One drop in both eyes) for allergy, moxifloxacin hydrochloride (VIGAMOX) (0.5% Ophthalmic ointment, in still and affected eye as directed). The patient was 81 years old at that time anyone above 65 was documented to get Prevnar followed by Pneumovax in a year. Since the patient received the Prevnar 13, the patient was stating that she had functional decline. The first time she went to see the doctor was right after, the day after her injection. She was saying she was having some injection site soreness but after she was been icing it, it seems like it's getting better (intent: improved). So she had multiple follow ups since. 4 days later she said she had some jaw pain and then she goes to see the dentist and then like April 5th, she continues follow her up for jaw pain. The outcome of the event functional decline was not recovered. The outcome of the event injection site soreness was recovering. The outcome of the event jaw pain was unknown.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Nerve pain, moves from injection site to back to inner arm, intense sporadic pain.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red swelling right underneath the injection site. Increased temperature on swelling site. Tender to pressure. No treatment given. Swelling and redness reduced after 2-3 days.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Myalgia
Clinical narrative: Painful muscles in upper arm. Intensity varies, seems to come in waves.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Ear infection, Injection site pain, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Has had flu shots for many years. States arm with usual soreness for 2 days continued past that time. Limited range of motion. First reported to our office 10/31/17. Normal activity is okay but pain at muscle injection site persists when lifting to shoulder height.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Pain, Pyrexia
Clinical narrative: Extreme swelling & redness at site of injection the size of a baseball, increased to size of a football, extreme pain & limited movement, slight fever.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster
Clinical narrative: ZOSTAVAX was administered and several days after the vaccines the patient began experiencing symptoms of shingles. Patient was treated for shingles on 10/22/17.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pruritus, Urticaria
Clinical narrative: Developed hives on her face, neck, and trunk about an hour after receiving her vaccine. Patient reported those areas were also very itchy. She also developed a warm red lump on her arm at the injection site. Patient took benadryl and recovered.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration
Clinical narrative: Erythema, induration along medial arm, biceps which began within 24.  Some spread noted overtime.  No associated fevers.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Neck stiffness, pain.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Patient received last years flu shot strain (2016-2017 formula) exp. 08MAY17.
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Periarthritis
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. This  nurse reported for herself that a 56-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13, intramuscularly at left arm in Oct2016 at 0.5 ml, single for immunisation. The patient's medical history and concomitant medications were not reported. Patient received vaccination in left arm and stated it felt like a "frozen shoulder" and was unable to raise left arm for 4 to 5 days after use of product in 2016. The outcome of the events was unknown.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Pain, Torticollis
Clinical narrative: Sudden onset of significant acquired torticollis about 6 hrs after injection requiring an inability to sleep due to pain, significant pain.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Fatigue, Headache, Nasal congestion, Tenderness, Vertigo
Clinical narrative: Initially, mild arm tenderness noted. 11/3 & 11/4 fatigue noted. 11/5 stuffy nose, nasal congestion noted. 11/6 - increased nasal congestion and mild wheezing noted with activity. 11/7 - nasal congestion worsening, headache, intermittent vertigo, and moderate wheezing noted with any amount of exertion/activity.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Wheezing
Clinical narrative: Initially, mild arm tenderness noted. 11/3 & 11/4 fatigue noted. 11/5 stuffy nose, nasal congestion noted. 11/6 - increased nasal congestion and mild wheezing noted with activity. 11/7 - nasal congestion worsening, headache, intermittent vertigo, and moderate wheezing noted with any amount of exertion/activity.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth and itching of left upper arm. Site 15 cm X 7 cm.  No drainage or fluctuance.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Feeling abnormal, Feeling cold, Headache, Lower respiratory tract infection
Clinical narrative: Got the vaccine about 3:30pm and about 9:30pm started feeling quite sick and not right. Went to lay in bed and was super cold despite the house being at 72 degrees and being under covers. Even after additional cover and electric blanket still cold. Terrible muscle aches all over body. Even after taking 3 Advil there was very little improvement in severity of aches/pain. Skin felt weird like it does when you have a fever or the flu. Very painful lymph nodes in neck behind jaw. Terrible headache that was not relieved with Advil or Tylenol. Lay in bed miserable and freezing for about 2 hours and then started feeling very nauseous and at about 11:30 threw up violently about 6 times. It has been almost a decade since I have thrown up for ANYTHING so that was alarming, as was the severity of the headache and body aches. Finally fell asleep and woke up the following morning feeling better but still had residual weakness and also had feeling in chest like you get with a chest infection. The chest feeling lasted two more days then resolved.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain, Malaise, Myalgia, Nausea, Pain
Clinical narrative: Got the vaccine about 3:30pm and about 9:30pm started feeling quite sick and not right. Went to lay in bed and was super cold despite the house being at 72 degrees and being under covers. Even after additional cover and electric blanket still cold. Terrible muscle aches all over body. Even after taking 3 Advil there was very little improvement in severity of aches/pain. Skin felt weird like it does when you have a fever or the flu. Very painful lymph nodes in neck behind jaw. Terrible headache that was not relieved with Advil or Tylenol. Lay in bed miserable and freezing for about 2 hours and then started feeling very nauseous and at about 11:30 threw up violently about 6 times. It has been almost a decade since I have thrown up for ANYTHING so that was alarming, as was the severity of the headache and body aches. Finally fell asleep and woke up the following morning feeling better but still had residual weakness and also had feeling in chest like you get with a chest infection. The chest feeling lasted two more days then resolved.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Vomiting
Clinical narrative: Got the vaccine about 3:30pm and about 9:30pm started feeling quite sick and not right. Went to lay in bed and was super cold despite the house being at 72 degrees and being under covers. Even after additional cover and electric blanket still cold. Terrible muscle aches all over body. Even after taking 3 Advil there was very little improvement in severity of aches/pain. Skin felt weird like it does when you have a fever or the flu. Very painful lymph nodes in neck behind jaw. Terrible headache that was not relieved with Advil or Tylenol. Lay in bed miserable and freezing for about 2 hours and then started feeling very nauseous and at about 11:30 threw up violently about 6 times. It has been almost a decade since I have thrown up for ANYTHING so that was alarming, as was the severity of the headache and body aches. Finally fell asleep and woke up the following morning feeling better but still had residual weakness and also had feeling in chest like you get with a chest infection. The chest feeling lasted two more days then resolved.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Urticaria
Clinical narrative: My phone call with patient: Spoke with patient. He had a flu and PREVNAR shot on October 19th, reported that four days after that vaccination, he developed hives in his lower abdomen, which spread to the back of his legs and part of his trunk in arm. He went to see his dermatologist who put him on triamcinolone, which seemed to help, but then worsened following day. He then went to urgent care, at the urging of his sister who is a pharmacist, and put on prednisone which then helped resolve his hives. He never had reactions before to the vaccine and wanted to know the information about the vaccines- so we gave him the MFR, NDC, LOT, etc.. So he could review it with his pharamcist. Potential adverse reaction to the combination of the two- he has never had PV13 before so potentially this could be the culprit and he has had no problems with the flu. He is asymptomatic currently. Patient aware I will report this to VAERS and his infromation will be put in. Patient is satisifed after conversation.
Age: 89.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Feeding disorder, Malaise
Clinical narrative: Patient  reports feeling wiped out. Received flu vaccine Tuesday afternoon and then went home but could not get out of bed the next AM. He was unable to eat until lunch time next day. He also did not feel well the day after that.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Soreness at the injection site. Taking an NSAID to help treat the soreness. Outcome: soreness is persisting. NSAID helps.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Blister
Clinical narrative: Blisters all over left chest left arm left shoulder and up my neck into my hairline one blister on rt shoulder.
Age: 18.0
Sex: F
Vaccine: FLUC4, HEPA, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive, Ultrasound antenatal screen normal
Clinical narrative: Patient did not know at the time of vaccination that she was pregnant nor was she trying to get pregnant. Patient did sign a consent form for the vaccines and it did ask if she was pregnant or intended on becoming pregnant in the next few months, and she answered no since she had no idea that she was pregnant. She missed her period the following week and took an at home pregnancy test 10/14/17 which came back positive. She went to her first OB appointment 10/31/2017 and had an ultrasound. Fetus was measuring 6 weeks and 3 days with a due date of 6/23/2018.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Diarrhoea
Clinical narrative: The day after chills and a general feeling of upset stomach. Early the next morning diarrhea that lasted until the next morning. Now just a feeling of upset stomach, unsettled.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Hypersensitivity, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Injection was given too high on the arm, and into the bursa/tendon area. Intense pain and sharp pain began immediately, and then 4 hours later the arm was immobile. ROM was decreased, pain had increased and the pain had moved from shoulder to upper arm to elbow.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Injection was given too high on the arm, and into the bursa/tendon area. Intense pain and sharp pain began immediately, and then 4 hours later the arm was immobile. ROM was decreased, pain had increased and the pain had moved from shoulder to upper arm to elbow.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Within 10 minutes of receiving the vaccine, client reports he had a very stiff neck. This went away in 15 minutes. On Sunday, 10/29 at 3 a.m., client woke up covered in sweat and had a cough with muscle aches. Since that time, client states symptoms are progressively getting worse. These SX include fever, chills, sore throat, muscle aches, fatigue, cough, headache and runny nose. Today went to the doctor. Lungs were clear. Was told he didn't have the the flu, bronchitis or strep throat. Client was given steroids for itching to his skin. Was told to go to the health department to fill out a VAERS.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Myalgia, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Within 10 minutes of receiving the vaccine, client reports he had a very stiff neck. This went away in 15 minutes. On Sunday, 10/29 at 3 a.m., client woke up covered in sweat and had a cough with muscle aches. Since that time, client states symptoms are progressively getting worse. These SX include fever, chills, sore throat, muscle aches, fatigue, cough, headache and runny nose. Today went to the doctor. Lungs were clear. Was told he didn't have the the flu, bronchitis or strep throat. Client was given steroids for itching to his skin. Was told to go to the health department to fill out a VAERS.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Mass, Pyrexia, Rash generalised
Clinical narrative: Patient calls with body rash, fever, and "squishy" lump on left wrist. No office visit patient declined.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus
Clinical narrative: Child arm had small bruise at Admin's site-and red-itchy patch on arm around and below inject site (Pt said itch started about 24 hr after shot). Mom using BENADRYL cream on site.