chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Sinusitis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age and ethnicity started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the paperwork from the pharmacy listed her dose of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) as 1mL (for clarification). On 28Sep2017, the patient experienced joint/hip pain, muscle pain, fatigue, flu-like symptoms, burning in legs and she was starting to get a sinus infection. Outcome of the event of burning in legs was recovered on an unspecified date in 2017, while outcome of the other events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Sleep disorder
Clinical narrative: This is a spontaneous report from a non-contactable consumer who reported for herself via Pfizer-sponsored program. A female patient of an unspecified age received pneumococcal 13-val conj vac  (dipht crm197 protein), on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient received pneumonia shot and on an unspecified date "her arm swelled up, really really hot and in a lot of pain". Reporter explained she had the shot (unspecified) before and "never had this before". As reported: Patient woke up in quite a bit of pain in the middle of the night and through the night still swollen and it was very painful. Final outcome of the events was unknown. No follow-up attempts are possible. No further information expected. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vaccine in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vaccine has submitted the same report to the regulatory authorities.
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This Pharmacist  reported similar events for two patients. This is 1st of two reports. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced localized redness and swelling that lasted a few days. Patient referred to Urgent Care and treated with diphenhydramine hydrochloride (BENADRYL).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017502092 same reporter/drug/event, different patients.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Injection site pain, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Influenza vaccine given in right arm. Patient now with swelling and pain into right upper arm, right shoulder, tight chest wall and right axilla. All areas warm to touch. Swelling started 24 hours after vaccine.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Vomiting
Clinical narrative: Headache and vomiting for several days following immunizations vaccines were administered on 08/27/16.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest discomfort, Dehydration, Dizziness, Dyspnoea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of dyspnea in a 45-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine). Concomitant products included vitamin d and Multivitamin. On 2nd November 2017, the patient received Influenza vaccine (intramuscular). On 2nd November 2017, less than a day after receiving Influenza vaccine, the patient experienced dyspnea (serious criteria hospitalization and disability), diaphoresis (serious criteria hospitalization and disability), dehydration (serious criteria hospitalization and disability), chest tightness (serious criteria hospitalization and disability) and light headedness (serious criteria hospitalization and disability). On 7th November 2017, the patient experienced weakness (serious criteria hospitalization and disability) and numbness of lower extremities (serious criteria hospitalization and disability). On 10th November 2017, the patient experienced tachycardia (serious criteria hospitalization and disability). On an unknown date, the outcome of the dyspnea and chest tightness were recovering/resolving and the outcome of the diaphoresis and light headedness were recovered/resolved and the outcome of the tachycardia, dehydration, weakness and numbness of lower extremities were not recovered/not resolved. It was unknown if the reporter considered the dyspnea, diaphoresis, tachycardia, dehydration, weakness, numbness of lower extremities, chest tightness and light headedness to be related to Influenza vaccine. Additional details were reported as follows: Concomitant medication included multivitamin as well. The medical student reported that the flu vaccine (GSK) was given in the patient's left upper arm. The patient was hospitalized on 7th November 2017, was discharged home, and at the time of reporting back in the hospital (unknown admission date). Only partial information was provided by the medical student.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Hypoaesthesia, Tachycardia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of dyspnea in a 45-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine). Concomitant products included vitamin d and Multivitamin. On 2nd November 2017, the patient received Influenza vaccine (intramuscular). On 2nd November 2017, less than a day after receiving Influenza vaccine, the patient experienced dyspnea (serious criteria hospitalization and disability), diaphoresis (serious criteria hospitalization and disability), dehydration (serious criteria hospitalization and disability), chest tightness (serious criteria hospitalization and disability) and light headedness (serious criteria hospitalization and disability). On 7th November 2017, the patient experienced weakness (serious criteria hospitalization and disability) and numbness of lower extremities (serious criteria hospitalization and disability). On 10th November 2017, the patient experienced tachycardia (serious criteria hospitalization and disability). On an unknown date, the outcome of the dyspnea and chest tightness were recovering/resolving and the outcome of the diaphoresis and light headedness were recovered/resolved and the outcome of the tachycardia, dehydration, weakness and numbness of lower extremities were not recovered/not resolved. It was unknown if the reporter considered the dyspnea, diaphoresis, tachycardia, dehydration, weakness, numbness of lower extremities, chest tightness and light headedness to be related to Influenza vaccine. Additional details were reported as follows: Concomitant medication included multivitamin as well. The medical student reported that the flu vaccine (GSK) was given in the patient's left upper arm. The patient was hospitalized on 7th November 2017, was discharged home, and at the time of reporting back in the hospital (unknown admission date). Only partial information was provided by the medical student.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Malaise, Migraine, Muscle spasms, Neurological examination
Clinical narrative: Quick onset of muscle spasms in bilateral temples and around bilateral orbits, sore throat, malaise, excessive fatigue, worsening migraine headache over one week until seen in clinic and received prescription for IMITREX tablet.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Streptococcus test
Clinical narrative: Quick onset of muscle spasms in bilateral temples and around bilateral orbits, sore throat, malaise, excessive fatigue, worsening migraine headache over one week until seen in clinic and received prescription for IMITREX tablet.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Balance disorder, Chills, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: Pain, red, swollen, itching from the injection site to my elbow and up to shoulder. Severe pain throughout my whole body. Extreme chills and upon walking felt like I was falling back. It is the worst pain I have ever had throughout my body. This lasted for approximately 36+ hours. Pain, red, swelling and itching lasted 4 days and I still have a little discomfort and itching in my shoulder and around the injection site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Pain, red, swollen, itching from the injection site to my elbow and up to shoulder. Severe pain throughout my whole body. Extreme chills and upon walking felt like I was falling back. It is the worst pain I have ever had throughout my body. This lasted for approximately 36+ hours. Pain, red, swelling and itching lasted 4 days and I still have a little discomfort and itching in my shoulder and around the injection site.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Blood test, Erythema multiforme, Rash, Urticaria
Clinical narrative: Large Patches of rashes that started on legs and travelled to torso and face. Rash in patches and wheals. Not resolved in 3 weeks. Taken to the ER after 3 weeks and diagnosed with Erythema Multiforme.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: 13 Cm X 13.5 cm area of redness and swelling.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site erythema, Injection site reaction, Middle insomnia, Urticaria
Clinical narrative: Patient woke in middle of night with burning sensation under right arm. Had raised, red, welts down arm to elbow. Took BENADRYL and area improved. Reports similar reaction in past to latex.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 46-year-old female patient who received FLULAVAL QUADRIVALENT. Previously administered products included Influenza vaccine (received 2 vaccinations in the past without issue). On an unknown date, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On an unknown date, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain and joint range of motion decreased. The patient was treated with Acetaminophen, ibuprofen and Methylprednisolone Dose Pack. On an unknown date, the outcome of the injection site pain and joint range of motion decreased were not recovered/not resolved. The reporter considered the injection site pain and joint range of motion decreased to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received FLULAVAL QUADRIVALENT in the deltoid muscle. The patient experienced decreased range of motion of the vaccinated arm and pain in arm. The patient did not experienced other injection site reactions or general reactions (no redness, swelling, chills, fever, or signs of infection). The patient was treated with acetaminophen and ibuprofen with no success. The patient received methylprednisolone dose pack (a 6 day taper). The healthcare practitioner reports that on the examination of patient, her passive range of motion was fine. The patient had limited active range of motion. The patient required emergency room visit.
Sex: F
Vaccine: FLU4
Symptoms: Epstein-Barr virus infection
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of Epstein-Barr virus infection in a female patient who received FLUARIX TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, 14 days after receiving FLUARIX TETRA, the patient experienced Epstein-Barr virus infection. On an unknown date, the outcome of the Epstein-Barr virus infection was unknown. It was unknown if the reporter considered the Epstein-Barr virus infection to be related to FLUARIX TETRA. Additional information provided as follows: The nurse had two patients in the emergency room at hospital. Amongst them, this patient had Epstein Barr two weeks after FLUARIX. The nurse wondered if this could had been triggered by vaccine. The nurse was agreed to take follow up. This case has been linked with US2017GSK175533, as reported by the same reporter for another patient.
Age: 33.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 33-year-old female patient who received TWINRIX (batch number Z75Y2, expiry date 15th March 2020). On 8th November 2017, the patient received the 1st dose of TWINRIX 1 ml. On 10th November 2017, 2 days after receiving TWINRIX, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown. The reporter considered the pruritus to be possibly related to TWINRIX. Additional details were provided as follows: The patient experienced itching. The reporter reported that patient also did hot yoga in the interim so registered nurse thought there were confounding factors and it might not had been due to the vaccine. It was asked (via phone) if issue had resolved and the health care professional stated that he was unsure. It was reported that he was not the person who administered the vaccine, so was gathering this information second-hand.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injected limb mobility decreased, Insomnia, Musculoskeletal pain, Pain
Clinical narrative: By the end of day (10/27) my left arm felt dead. I could barely move it. For the next 2-3 days I had a burning sensation in my upper arm. I could only sleep for 2-3 hours at a time for the first 2-3 days after receiving the vaccination. Now 3 plus weeks later my shoulder still hurts. I still cannot raise my arm above my head without pain. I cannot pick up objects with my left arm without pain. The pain is mostly in my upper shoulder area.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Weight bearing difficulty
Clinical narrative: By the end of day (10/27) my left arm felt dead. I could barely move it. For the next 2-3 days I had a burning sensation in my upper arm. I could only sleep for 2-3 hours at a time for the first 2-3 days after receiving the vaccination. Now 3 plus weeks later my shoulder still hurts. I still cannot raise my arm above my head without pain. I cannot pick up objects with my left arm without pain. The pain is mostly in my upper shoulder area.
Age: 0.08
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: There was no adverse event instead it was a medication error. The provider prescribed Hepatitis B and MA administered FLULAVAL.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Feeling hot, Injection site pain, Injection site swelling
Clinical narrative: Pt was triaged on 11/20/17 by Clinic RN. Note at the time of triage is as follows: On 11/17/17,  pt noticed that her arm was sore and that she was beginning to develop hives from her deltoid to her arm pit. She states that there was heat present and that the hives were raised and painful. She reports that she applied an ice pack with some relief. She reports that evening she had some SOB that was relieved by her albuterol inhaler. She states that on Saturday she did not have any SOB, the hives subsided, but she still has pain present that had improved. She states that today she still has pain present to her left arm. She states there is some redness present, she states there is still swelling present near the injection site. She is unsure if she has had a fever, she states that she has felt warm. She denies discharge from the wound, but it is painful to the touch. She denies SOB at this time.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Pt was triaged on 11/20/17 by Clinic RN. Note at the time of triage is as follows: On 11/17/17,  pt noticed that her arm was sore and that she was beginning to develop hives from her deltoid to her arm pit. She states that there was heat present and that the hives were raised and painful. She reports that she applied an ice pack with some relief. She reports that evening she had some SOB that was relieved by her albuterol inhaler. She states that on Saturday she did not have any SOB, the hives subsided, but she still has pain present that had improved. She states that today she still has pain present to her left arm. She states there is some redness present, she states there is still swelling present near the injection site. She is unsure if she has had a fever, she states that she has felt warm. She denies discharge from the wound, but it is painful to the touch. She denies SOB at this time.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Skin discolouration, Skin warm
Clinical narrative: 10 x 10 cm large pink area with center more brownish color noted next day after injection, warm to touch, temp. 99.1, no drainage or fluctuance.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Patient said that they got a shot and 3 days later their arm started hurting and it still hurts.
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Pain and erythema at site, myalgias, arthralgias, low grade fever, fatigue. States sx began approx. 7-8 hours after injection. Worsened the next day. Slight improvement in constitutional sx on 2nd day but continued erythema and pain at site of injection. States similar sx in 2015 and 2016 but not as bad.
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Pyrexia
Clinical narrative: Pain and erythema at site, myalgias, arthralgias, low grade fever, fatigue. States sx began approx. 7-8 hours after injection. Worsened the next day. Slight improvement in constitutional sx on 2nd day but continued erythema and pain at site of injection. States similar sx in 2015 and 2016 but not as bad.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis, treated with oral antibiotics and anti inflammatories.
Sex: U
Vaccine: HEPA
Symptoms: Dizziness, Syncope
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fainting in a patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, unknown after receiving HAVRIX, the patient experienced fainting and dizziness. On an unknown date, the outcome of the fainting and dizziness were unknown. It was unknown if the reporter considered the fainting and dizziness to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. On day of reporting, the patient fainted following administration with HAVRIX. The health care professional refused to provide further information with was ok with information being sent via postal mail. This case has been linked with case US2017GSK177429, as reported by same reporter for same events.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain lasting for greater than 6 weeks after injection.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not provided. Between 13-SEP-2017 to 08-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (therapy type rHA) second dose, lot number N014759 and expiration date 08-NOV-2018 (frequency, route of administration were not provided) for prophylaxis; which was reconstituted with a properly stored of sterile diluent (manufacturer unknown). No adverse effects reported. The vaccine was stored at a temperature of 15° Fahrenheit to 46° Fahrenheit, time frame of 11 hours and 30 minutes with a previous temperature excursion that was reported as after the first excursion, but not after current excursion, the past excursion was of 15° Fahrenheit to 46° Fahrenheit with a time frame of 1 hour and 15 minutes. Digital Data logger was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1711USA009475:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a consumer (mother of the patient) and refers to a 11-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant therapies and the patient's allergies was provided. On 03-AUG-2016, the patient was vaccinated with first dose GARDASIL 9 injection for prophylaxis (strength, dose, route of administration, lot # and expiration date were not provided). On 27-OCT-2016, the the patient was vaccinated with second dose GARDASIL 9 injection for prophylaxis (strength, dose, route of administration, lot # and expiration date were not provided). At the time of the report, the patient had not received the third dose in the series, which was indicated in the prescribing information. No adverse event was reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
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-2008 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine ne 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 strain of herpes zoster. On or about 28-JUN-2016 the patient was treated by a Physician Assistant for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, also known as shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of her painful condition. 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: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 20-NOV-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date, the patient was inoculated (by an unspecified person) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-DEC-2015, he was treated by a physician at a medical group (facility) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster and post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to zoster infections. The male patient has been prescribed Lidocaine and acetaminophen and hydrocodone (LORTAB) for management of his painful condition. 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. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-DEC-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about "September 10, 2014" (note this is prior to reported vaccination date), the patient was treated at a health center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-JAN-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-DEC-2015, the patient was treated by a Nurse Practitioner at a health clinic for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir, ibuprofen, acyclovir and gabapentin for management of 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not provided. Between 13-SEP-2017 to 08-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (therapy type rHA) first dose, lot number N014759 and expiration date 08-NOV-2018 (frequency, route of administration were not provided) for prophylaxis; which was reconstituted with a properly stored of sterile diluent (manufacturer unknown). No adverse effects reported. The vaccine was stored at a temperature of 15° Fahrenheit to 46° Fahrenheit, time frame of 11 hours and 30 minutes with a previous temperature excursion that was reported as after the first excursion, but not after current excursion, the past excursion was of 15° Fahrenheit to 46° Fahrenheit with a time frame of 1 hour and 15 minutes. Digital Data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA004528.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Eye irritation, Eye pruritus, Hordeolum
Clinical narrative: Swelling-large lump-red, blk and blue-hives, rash. Stye-in right eye, hard to breathe, itching. This lasted for a week or so-right eye is causing more trouble-scratching and feels irritated. Pharmacist said I might need surgery on my right eye.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Mass, Pruritus, Rash, Skin discolouration, Swelling
Clinical narrative: Swelling-large lump-red, blk and blue-hives, rash. Stye-in right eye, hard to breathe, itching. This lasted for a week or so-right eye is causing more trouble-scratching and feels irritated. Pharmacist said I might need surgery on my right eye.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Swelling-large lump-red, blk and blue-hives, rash. Stye-in right eye, hard to breathe, itching. This lasted for a week or so-right eye is causing more trouble-scratching and feels irritated. Pharmacist said I might need surgery on my right eye.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: AE: local swelling at injection site , redness and tender to touch. Treatment: cephalexin 500mg tid for 10 days and medrol dose pak 6 day taper.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Muscle spasms, pain in right mid back rib cage area.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Fungal skin infection, Skin discolouration, Skin exfoliation
Clinical narrative: On 11/2/2017 She noticed a dark discoloration to skin and fungal looking rash under her breast. Decided to apply antifungal cream and powder to site for a week. Within a week the rash dried and skin started to peel as of today the rash is gone and skin color back to normal.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Limb injury
Clinical narrative: Left shoulder pain and decreased ROM after vaccine which has progressively worsened even with supportive care.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Anxiety, Immediate post-injection reaction, Rash, Rash erythematous, Tearfulness
Clinical narrative: Erythematous, lacy rash noted on trunk (chest primarily) immediately after receipt of vaccines. Child alert and not in respiratory distress though tearful and anxious.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Guillain-Barre syndrome
Clinical narrative: Patient received the high dose flu vaccine on 9/27/17 and patient presented approximately 2 days after treatment with what was thought to be a cerebellar syndrome, possibly related to 5FU infusion. However, he developed progressive weakness. The working diagnosis was Guillain Barre related to the flu vaccine on 9/27/17. The patient is doing better. He can now lift his legs and stand.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea
Clinical narrative: Anaphylactic reaction- chest tightness with difficulty breathing.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event. Patient received an expired dose of MMR. Given 11/1/17 when exp date +10/22/17.
Sex: U
Vaccine: HEPA
Symptoms: Dizziness, Syncope
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fainting in a patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, unknown after receiving HAVRIX, the patient experienced fainting and dizziness. On an unknown date, the outcome of the fainting and dizziness were unknown. It was unknown if the reporter considered the fainting and dizziness to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient fainted following administration with HAVRIX from last week. The health care professional refused to provide further information, but ok with information being sent via postal mail. This case has been linked with case US2017176451 as reported by same reporter for same events.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient received dose of MMR after the expiration date.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: My right arm is in intense pain at my shoulder. I can hardly lift it. I've tried using heat and ice and taking ADVIL, which doesn't help. This started one hour after getting the flu shot. I messaged my dr today to report this.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient was adminstered dose after the expiration date on the vial.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Dull pain from site slowly traveled to elbow, began approx 48hrs after injection.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abdominal X-ray, Abdominal pain, Crying, Faeces pale, Pyrexia
Clinical narrative: Fever, abdominal pain, crying (inconsolable for more than 3 hours), pale gray/clay colored stools (4).
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Stool analysis
Clinical narrative: Fever, abdominal pain, crying (inconsolable for more than 3 hours), pale gray/clay colored stools (4).
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Excessive cerumen production, Tinnitus
Clinical narrative: Patient came back to the pharmacy on 11/22/17 at around 10:35am seeking advice regarding new ringing in his ears that started on 11/14/17 approximately one day after his influenza vaccination on 11/13/17. He claims that the ringing comes and goes and that he thinks it is getting better but he is not sure and that it is "annoying" to him. He also said that his wife could see evidence of ear wax buildup and he thinks that could be contributing to the problem as well. He said that he re-read the VIS that was provided to him during the time of vaccination and he did not see where ringing of the ears was a common side effect. I also informed him that ringing of the ears was not common and that I would report his adverse event per our protocol. He did not seem too worried but just wanted to make sure there were no long term effects from getting this particular flu shot. I additionally informed him that he is the first person to have this side effect from this batch/lot of FLUZONE HD that we have been providing this flu season. I did end up providing him with DEBROX to potentially help with the ear wax and I also asked him to keep me updated with his condition should it get worse.
Age: 47.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: RN filled out Pharmacy Requistion form for Vaccines requesting Tdap. Pharmacy Technician gave RN DTaP instead of Tdap, the pharmacist who checked it did not recognize it was the wrong vaccine. RN received DTaP and did not recognize it was the wrong vaccine and it was given to patient. RN called to enter lot number into our system and pharmacy technician could not locate and discovered it was for the wrong vaccine (DTaP and not Tdap). Pharmacist called RN to ask which vaccine she had and realized she had given wrong vaccine to patient. Patient was also revaccinated with correct Tdap.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient was administered MMR dose after the expiration date.
Age: 22.0
Sex: F
Vaccine: MENB, TD
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Client reports that about an hour and a half after the immunizations were given she started to feel sweaty and got the chills. Later that same day a very bad headache started along with tiredness and localized pain to the left deltoid injection site. The next day the same symptoms persisted and then the arm pain at the site of injection became worse and it was hot and red. The symptoms decreased, but the arm pain at injection site became more painful and a red bulls eye looking area formed around the injection site. The left arm where the Men B was given is still painful today, but client states there is extreme achiness and pain in her joints on this entire arm all the way down to her wrist. In the past 2 days, this joint pain and achiness has also started to affect her right arm where the TD was given as well. The client is a 22 year old nursing student and states that on a scale of 1-10, her pain in her joints are a 7. I told client I would get a hold of the state health department for clarification. I am filling out a VAERS report, I looked over the VIS and the Men B insert in the vaccine box as well. These are all noted reactions and I will get a hold of the client and let her know what was found and done. I also recommended to the client to go see a physician if the pain continues, gets worse or other symptoms occur. She will need to discuss with the physician if she should get the 2nd booster shot as well.
Age: 22.0
Sex: F
Vaccine: MENB, TD
Symptoms: Injection site erythema, Injection site joint pain, Injection site pain, Injection site warmth
Clinical narrative: Client reports that about an hour and a half after the immunizations were given she started to feel sweaty and got the chills. Later that same day a very bad headache started along with tiredness and localized pain to the left deltoid injection site. The next day the same symptoms persisted and then the arm pain at the site of injection became worse and it was hot and red. The symptoms decreased, but the arm pain at injection site became more painful and a red bulls eye looking area formed around the injection site. The left arm where the Men B was given is still painful today, but client states there is extreme achiness and pain in her joints on this entire arm all the way down to her wrist. In the past 2 days, this joint pain and achiness has also started to affect her right arm where the TD was given as well. The client is a 22 year old nursing student and states that on a scale of 1-10, her pain in her joints are a 7. I told client I would get a hold of the state health department for clarification. I am filling out a VAERS report, I looked over the VIS and the Men B insert in the vaccine box as well. These are all noted reactions and I will get a hold of the client and let her know what was found and done. I also recommended to the client to go see a physician if the pain continues, gets worse or other symptoms occur. She will need to discuss with the physician if she should get the 2nd booster shot as well.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Ageusia, Anosmia, Ear discomfort
Clinical narrative: By the time I got home from Dr. office I had no sense of smell or taste. Ears became stopped up.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented to Adult Clinic on 11/20/2017 c/o redness, pain, itchiness, and swelling to right deltoid at injection site for PCV 13. Patient denies SOB, throat swelling, and/difficulty breathing. Patient states symptoms are getting better from initial vaccine administration day. Advised pt to continue to monitor, place ice pack to area 10-20 mins every 2-3 hours as needed, can use OTC Benadryl cream for itchiness. Will notify MD. Patient will continue to monitor and return to clinic if has any new or worsening symptoms.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient was administered an MMR Vaccine after the expiration date.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Lt arm swelling, redness, warm to the touch. 2+ swelling. Swelling and redness extending from site of injection to just above elbow area.
Age: 1.5
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Electroencephalogram, Seizure like phenomena, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: Pt. taken to ER after seizure like activity. Mom reported to ER that pt. had seizure like activity that lasted approx 3-5 min at 20:30 on 11-16-17 (day after vaccines admin). Father observed approx 3 min of generalized shaking while the child stared into space and did not respond. Resolved spontaneously. *See reports provided.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Tremor
Clinical narrative: This spontaneous report as received from a consumer (the patients daughter) refers to a female patient of unknown age. The patient's concomitant medication included acetaminophen(+)hydrocodone bitartrate and other unspecified medications. Her pertinent medical history included diabetes. The patient had no drug reactions or allergies. In approximately 2016, (reported as "last year") the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route of administration were not provided) for shingles prevention. On unknown date in 2016, (reported as right after the vaccine was given) the patient had a burning and itching sensation. On an unspecified date in approximately 2017, (reported as a year after receiving the ZOSTAVAX) the patient experienced the shingles. The reporter stated that on unknown date (reported as on Saturday) the patient had shingles on the right side of her body, back, chest and arms. The primary reporter also stated that the patient had shakes since an unspecified date. The outcome of shingles, shakes, itching and burning sensation was unknown. The relatedness between the events and ZOSTAVAX was not defined by reporter. The patient sought medical attention and got unspecified therapy for the reported adverse events.  No lab diagnostics were performed due to the events.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-JAN-2013 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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 strain of herpes zoster. On or about 20-APR-2015, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 22-APR-2015, the patient sought subsequent treatment from a physician for ongoing and worsening symptoms of shingles infections, and was also d iagnosed with post-herpetic neuralgia a chronic condition of nerve damage and pain secondary to zoster outbreaks. The patient has been prescribed valacyclovir (VALTREX) and pregabalin (LYRICA) for management of his 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: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 20-NOV-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 03-APR-2014 the patient was inoculated by an unspecified healthcare worker at a medical center with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-DEC-2016, he was treated by a physician at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The male patient has been prescribed gabapentin for management of his 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. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-SEP-2016, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-SEP-2017, the patient was treated by a physician for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Condition aggravated, Parkinson's disease, Tremor
Clinical narrative: Initial unsolicited report received from a physician on 12-Oct-2017. This case is linked with: 2017SA199339, 2017SA199365, 2017SA199373, 2017SA199379, 2017SA199386 (same reporter). This case involves a male patient (age not reported), who was vaccinated FLUZONE HIGH-DOSE (batch number: UI845AB, expiry date, dose, route and dose in series and site of administration not reported) on an unknown date. Patient's medical history included early mild Parkinson's (ongoing). Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had significant increased tremors on underlying early mild Parkinson's. Lab test and corrective treatment was not reported. Outcome of the events were not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: Initial unsolicited report received from a non-health care professional on 12-Oct-2017. This case is considered as invalid as patient identifier was not reported. This case involves vaccination with dose of FLUZONE HD (Batch number, expiry date, dose, dose in series, expiry date, route and site not reported) on an unknown date. The patient's medical history was not reported. Concomitant medications was not reported. On an unknown date, following the vaccination, the patient had cold chills. Lab data and corrective treatment were not reported. Outcome of the events were not reported. List of documents held by sender: none