chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: Patient given Influenza vaccine in error. Tdap was ordered.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Severe arm pain and erythema at site of injection. Soreness after injection into evening, then pt woke up at 4AM 2/2 severe pain at injection site which persisted. She was seen in clinic that morning.
Age: 1.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Echo virus infection, Measles antibody, Mumps antibody test, Rash erythematous, Rash generalised
Clinical narrative: 12/11/2017- office visit for rash- generalized rash- pink to red 1-2 mm macular papular rash; all other systems in exam were within normal limits. Diagnosis of echovirus. 12/12/2017 early am- ER visit at Hospital- ER physician agreed with PCP with diagnosis of echovirus.
Age: 1.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Rash maculo-papular, Rubella antibody test
Clinical narrative: 12/11/2017- office visit for rash- generalized rash- pink to red 1-2 mm macular papular rash; all other systems in exam were within normal limits. Diagnosis of echovirus. 12/12/2017 early am- ER visit at Hospital- ER physician agreed with PCP with diagnosis of echovirus.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Vaccination site mass
Clinical narrative: Lump at site of vaccines left leg. Not painful. Afebrile.
Sex: F
Vaccine: FLU4
Symptoms: Death, Herpes zoster, Multiple organ dysfunction syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of multi-organ failure in a elderly female patient who received FLULAVAL QUADRIVALENT. Co-suspect products included VALTREX unknown for shingles. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On 17th October 2017, the patient started VALTREX 1000 mg 3 times daily (3000 mg daily). On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT and VALTREX, the patient experienced multi-organ failure (serious criteria death and GSK medically significant) and shingles. The action taken with VALTREX was unknown. On an unknown date, the outcome of the multi-organ failure was fatal and the outcome of the shingles was unknown. The reported cause of death was multi-organ failure. It was unknown if the reporter considered the multi-organ failure and shingles to be related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the multi-organ failure to be related to VALTREX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that a patient in a skilled nursing home facility was given FLULAVAL QUADRIVALENT and then developed shingles. The patient started VALTREX and went into multi-organ failure which resulted in her death. The pharmacist did not have information regarding timing of the FLULAVAL QUADRIVALENT dose given and development of shingles. The reporter had no information on batch number or expiration dates of the FLULAVAL QUADRIVALENT. The healthcare professional did not know patient's date of death.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No reported adverse reactions. Patient was given high-dose vaccine as ordered by physician. Physician examined patient and felt due to his recent illness, would benefit from high-dose vaccine, even though he is not of age range.  Physician has since reviewed the vaccination guidelines to recognize there is no indication at this time for giving high-dose to patients younger than specified range. Patient was notified and has had no effects from the adverse effects from the vaccine.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Dermatitis atopic, Eczema, Excessive eye blinking, Exfoliative rash, Inflammation
Clinical narrative: The day after the shots were administered the baby developed a rash on her chest, stomach, and back. The rash was red, inflamed, and scaly. Over the next several days, the rash appeared on the chin, neck, arms, and legs as well. The next well visit was at 4 months and she was diagnosed with intrinsic atopic dermatitis and we were told to use hydrocortisone on it twice daily. The eczema still persists despite treatment. The baby also started blinking and shaking uncontrollably as if startled or surprised several times a day. This is with no provocation.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rash, Rash erythematous, Tremor
Clinical narrative: The day after the shots were administered the baby developed a rash on her chest, stomach, and back. The rash was red, inflamed, and scaly. Over the next several days, the rash appeared on the chin, neck, arms, and legs as well. The next well visit was at 4 months and she was diagnosed with intrinsic atopic dermatitis and we were told to use hydrocortisone on it twice daily. The eczema still persists despite treatment. The baby also started blinking and shaking uncontrollably as if startled or surprised several times a day. This is with no provocation.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Burning sensation, Hypoaesthesia, Pain in extremity
Clinical narrative: Extreme soreness on right arm for two weeks compared to the amount of soreness I felt on the left arm from the flu shot. Sharp pain, burning and numbness in right arm extending into right hand for the last two months.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Immunisation, No adverse event, Product storage error
Clinical narrative: Patient received a FLUCELVAX vaccine after it had been exposed to below freezing temperatures. She did not experince any ADR, but we questioned whether or not she should be revaccinated. She received a new vaccine from her PCP per recommendation of CDC and Agency.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt C/O redness, swelling, warmth, and pain at injection site. (size: 6"x5"). Pt to apply cold compresses PRN.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Redness and swelling at inj. site (the size: 3 inches x 3 inches) inj. site was also very warm to touch and painful. Pt also reported having a fever for a few days after inj.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: Arm pain, unable to lift arm, diarrhea, nausea, body aches, headaches.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Arm pain, unable to lift arm, diarrhea, nausea, body aches, headaches.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Gingival swelling, Malaise, Oral herpes, Oropharyngeal pain, Stomatitis
Clinical narrative: She is a 11-year-old female here complaining of generally not feeling well, sore throat, sores in her mouth, puffy gums, and fever blisters. Her father states that she had her second HPV vaccination 6 days ago, and she had started feeling ill on Sunday. He thinks that she might be having a reaction to immunization. We talked about what the symptoms would be if it was a reaction and that most likely it would be a reaction locally to the injection site and this is probable viral, but we need to rule out what type of pathogen is causing her illness.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Viral infection
Clinical narrative: She is a 11-year-old female here complaining of generally not feeling well, sore throat, sores in her mouth, puffy gums, and fever blisters. Her father states that she had her second HPV vaccination 6 days ago, and she had started feeling ill on Sunday. He thinks that she might be having a reaction to immunization. We talked about what the symptoms would be if it was a reaction and that most likely it would be a reaction locally to the injection site and this is probable viral, but we need to rule out what type of pathogen is causing her illness.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Ear discomfort, Flushing
Clinical narrative: Approximately 15 minutes post injection child developed facial flushing distal to left earlobe and began tugging at left ear. At that point mother and child moved from immunization to walk in clinic to be evaluated.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Drug administered to patient of inappropriate age, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: A 51 year old female and employee received her influenza vaccination, which was the FLUZONE HD formulation, on 10/5/2017 in an employee flu clinic. She filed a compensation report the following day, 10/6/2017, stating the following: Severe swelling post flu shot. Swelling from shoulder to elbow and itching on right side of body from head to thigh. Arm from shoulder to elbow is twice the size of left arm, red and hot. Increased trouble breathing using asthma inhalers. Pain in elbow joint comes and goes. Since the adverse drug reaction happened after the employee left the flu clinic, there is no other documented information, including why the patient received a high dose formulation of the vaccine or if she has any known allergies.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pruritus
Clinical narrative: A 51 year old female and employee received her influenza vaccination, which was the FLUZONE HD formulation, on 10/5/2017 in an employee flu clinic. She filed a compensation report the following day, 10/6/2017, stating the following: Severe swelling post flu shot. Swelling from shoulder to elbow and itching on right side of body from head to thigh. Arm from shoulder to elbow is twice the size of left arm, red and hot. Increased trouble breathing using asthma inhalers. Pain in elbow joint comes and goes. Since the adverse drug reaction happened after the employee left the flu clinic, there is no other documented information, including why the patient received a high dose formulation of the vaccine or if she has any known allergies.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Approximately one week after the injection, patient was still experiencing soreness around the injection site as well as numbness in the left thumb and tingling reaching up to the elbow. The patient called us and told us she would follow up with her physician if the symptoms persisted. She says that she is feeling fine at this point.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Pt had influenza injection in Left deltoid on 11/21/2017 and several hours later started having a lot of pain. The next morning, patient awoke with redness, swelling and itching at the injection site. Pt was seen in our office on 11/22/2017 and was advised to Ice the area and to take OTC ibuprofen. Pt required an ER visit on the evening of 11/22/2017 and started on BENADRYL, dexamethasone dose at the ER along with a prednisone taper to take at home. Pt's mother called to report that all symptoms had resolved on 11/27/2017.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient reports dull ache in his arm that radiates down to his hand. It has improved over time but is still sore and a little weak.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient's spouse called stating she is experienced swelling and pain around the injection site, which radiated into the shoulder overnight.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain
Clinical narrative: The patient had severe pain in her lower back and had to be seen by the doctor. It happened the day after she got the vaccine and continued for about a month after.
Age: 52.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Patient describes having no problem for a couple of hours and then all of a sudden he was overcome with excruciating pain in his right arm. He laid on the floor and could not do anything the rest of the day. Patient took prescribed oxycodone for the pain. Patient could not move his arm. The day after the immunization he is not bothered by pain unless he moves his arm. Upon moving the arm, patient feels a shooting pain.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: Patient described red rash going up left arm and part of neck appearing about 2 weeks after vaccine. Recommended he take BENADRYL for the reaction and patient said he would try that.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Acupuncture, Bursitis, Injection site pain
Clinical narrative: At time of immunization the patient reported pain to her left upper arm. Pt reported she never had pain like that and felt Immunization might have been given too high. Patient then called and spoke to clinic this week and reports she was diagnosed bursitis after immunization and getting physical therapy and acupuncture. RN notified on 12/21/17.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient inadvertently given a DTaP.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Injection site irritation, Injection site swelling
Clinical narrative: Patient complained of intense injection site irritation (swelling, temperature increase) after receiving co-administration of FLUZONE HD and PNEUMOVAX 23. Patient received both vaccines in the same arm, 1 inch apart, per patient consent. These symptoms fully developed on 12/10/2017. Patient presented to pharmacy on 12/10/2017 with prescription for Keflex 500mg to be taken twice daily for 7 days after vising medical center.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, Culture urine, Laboratory test, Lumbar puncture, Pyrexia
Clinical narrative: Pt developed fever 103-104 the evening after immunization, no response to Tylenol.
Age: 0.83
Sex: F
Vaccine: DTAPIPV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Early Injection, Nurse administered Early vaccine Kinrix to a one year old pt outside the recommending age group.
Age: 0.33
Sex: M
Vaccine: RVX
Symptoms: Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: Patient diagnosed with intussusception on 12/24/17. This was reduced with an air contrast enema. It recurred on 12/26/17 and required a second reduction. Family visiting from another state when event occurred and required treatment locally. I do not know which brand of the rotavirus vaccine the patient received.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Injection site induration, Injection site pain, Injection site swelling, Musculoskeletal chest pain
Clinical narrative: "She is reporting reaction following 45 minutes after receiving the vaccine, nausea lasted several hours, right arm soreness and entire biceps muscle with swelling and firmness at injection site, tender to touch, lightly touching even causes pain.  Pain from elbow to fingertips and radiates into shoulder and into neck. The pain moves around right shoulder blade and chest/ribcage. Turning head to right painful and stiffness. She describes as burning and paralyzing pain. Difficult picking her up off of the pillow in the left arm last. "
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Nausea, Neck pain, Pain
Clinical narrative: "She is reporting reaction following 45 minutes after receiving the vaccine, nausea lasted several hours, right arm soreness and entire biceps muscle with swelling and firmness at injection site, tender to touch, lightly touching even causes pain.  Pain from elbow to fingertips and radiates into shoulder and into neck. The pain moves around right shoulder blade and chest/ribcage. Turning head to right painful and stiffness. She describes as burning and paralyzing pain. Difficult picking her up off of the pillow in the left arm last. "
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: "She is reporting reaction following 45 minutes after receiving the vaccine, nausea lasted several hours, right arm soreness and entire biceps muscle with swelling and firmness at injection site, tender to touch, lightly touching even causes pain.  Pain from elbow to fingertips and radiates into shoulder and into neck. The pain moves around right shoulder blade and chest/ribcage. Turning head to right painful and stiffness. She describes as burning and paralyzing pain. Difficult picking her up off of the pillow in the left arm last. "
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: 3 1/2 x 4 inches flat round red area. (no itching, no pain, not hot to the touch). Patient was instructed to cover the area to avoid exposure to other people and to apply Vaseline if it became bothersome. The patient did apply Vaseline but the irritation resolved it self by Saturday 12/23/2017.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site irritation, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The area around injection site had become swollen in a circular shape of (2 1/2 x 3 1/2 inches) in size; hot and pain upon touch; itching. The pharmacy was informed on 12/20/17 at which time the patient was Instructed to take Aleve every 8 hours for 3 days and Benadryl 25mg every 6 hours for 3 days. If the irritation did not resolved or became worst to seek medical attention from her physician.  The patient informed the pharmacy that by 12/23/17 the side effects had resolved.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Ear pain, Headache, Herpes zoster, Musculoskeletal pain, Nodule
Clinical narrative: Injection + 8 hrs: Began to feel soreness in shoulders and between shoulder blades; tingling/prickly sensation on upper right chest. Injection + 24 hrs: Developed a small, particularly painful (muscular?) knot on left lattisimus dorsi; tingling/prickly sensation moves to abdomen Injection + 48 hrs: Pustular rash develops on upper back; tingling/prickly sensation moves to forearms. Injection + 96 hrs: Pustlar rash spreads to back, right underarm and right chest. Injection + 130 hrs: Medical diagnosis of shingles; dull headaches on right side of head; occasional piercing pain in right ear.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Paraesthesia, Rash, Rash pustular
Clinical narrative: Injection + 8 hrs: Began to feel soreness in shoulders and between shoulder blades; tingling/prickly sensation on upper right chest. Injection + 24 hrs: Developed a small, particularly painful (muscular?) knot on left lattisimus dorsi; tingling/prickly sensation moves to abdomen Injection + 48 hrs: Pustular rash develops on upper back; tingling/prickly sensation moves to forearms. Injection + 96 hrs: Pustlar rash spreads to back, right underarm and right chest. Injection + 130 hrs: Medical diagnosis of shingles; dull headaches on right side of head; occasional piercing pain in right ear.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site nerve damage, Injection site pain, Injection site swelling
Clinical narrative: Patient states he had swelling at the injection site and a painful shoulder due to the shot "striking a nerve".
Age: 65.0
Sex: U
Vaccine: HEPAB
Symptoms: Injection site pain, Insomnia
Clinical narrative: Flu shot. I do not know what type flu, lot #, or exact date and time. Continual arm pain at injection site from day of injection continuing for 3 months now. Getting worse instead of better. Interfering with sleep.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Constant pain in left shoulder where shot was administered. Can't move left arm above shoulder level due to constant pain. Difficulties reaching with left arm due to the constant pain. Can't sleep on left side due to pain, so get little to no sleep.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site abscess, Injection site discharge, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt stated that the immunization was injected directly into some scar tissue on her upper left arm and the following evening (Dec 21st) she experienced pain and swelling and the area was hot to the touch and she developed an abscess. Pt also stated that it got worse over the next several days until on Dec 26th she pressed on the abscess and a bunch of fluid shot out. She went to her doctor and had the wound cleaned and he advised her to come and see me.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling at site of injection the size of an egg. Pt treated with ice and acetaminophen and was improving at last contact on 12/26/17.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Pruritus, Rash, Tenderness
Clinical narrative: Rash on arm, erythema, itching, tenderness with 24 hours of injection and lasted for 4-5 days. Denies dizziness, shortness of breath, headache, nausea or vomiting.
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient report arm pain with tingling and tenderness at injection site over a month after injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: At site of DtaP injection, large area of warmth and erythema, nontender, admits itching. Mother had given no medications for. The previous day she applied cold compress.
Age: 22.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL, VARCEL
Symptoms: Nodule, Peripheral swelling, Rash macular
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 22 year old female patient. The patient had none medical pertinent medical history, concurrent conditions or drug reactions.    On 05-JUL-2017, the patient was vaccinated with VARIVAX lot # N012618 and expiration date on 21-APR-2017 (dose, route of administration and anatomical location were not provided) for prophylaxis. The patient's concomitant therapies included sterile diluent (DILUENT MRK).        On an unspecified date in July 2017 (reporter as "on an unspecified time between then and 07-JUL-2017, when the patient returned to the pharmacy"), the patient developed a palm sized nodule on the injection site with red patchy skin surrounding it; therefore, the pharmacist referred the patient to an unspecified Patient First, where she was treated with prednisone (manufacturer unknown) 20 mg, it was reported in addition that non laboratory diagnostic studies were performed. At the reporting time, the symptoms resolved on an unspecified date in 2017 and the causality assessment between VARIVAX and the events was unknown.
Age: 22.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL, VARCEL
Symptoms: Erythema, Injection site nodule
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 22 year old female patient. The patient had none medical pertinent medical history, concurrent conditions or drug reactions.    On 05-JUL-2017, the patient was vaccinated with VARIVAX lot # N012618 and expiration date on 21-APR-2017 (dose, route of administration and anatomical location were not provided) for prophylaxis. The patient's concomitant therapies included sterile diluent (DILUENT MRK).        On an unspecified date in July 2017 (reporter as "on an unspecified time between then and 07-JUL-2017, when the patient returned to the pharmacy"), the patient developed a palm sized nodule on the injection site with red patchy skin surrounding it; therefore, the pharmacist referred the patient to an unspecified Patient First, where she was treated with prednisone (manufacturer unknown) 20 mg, it was reported in addition that non laboratory diagnostic studies were performed. At the reporting time, the symptoms resolved on an unspecified date in 2017 and the causality assessment between VARIVAX and the events was unknown.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Allodynia, Hypoaesthesia, Paraesthesia, Rash erythematous, Rash macular
Clinical narrative: Patient received vaccine on 11/14/17.About 1.5 weeks later he had the abrupt onset of numbness of his vertex accompanied by a blotchy red rash (explicitly non-vesicular) that affected his scalp face, trunk and extremities. This lasted for about 12 hours and resolved spontaneously. Then several days after that he noticed allopdynia of his right hemicranium associated with some objective swelling (indentation of his glasses earpiece), like pinpricks with even light touch. Fortunately this has subsided about 50% by now.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Swelling
Clinical narrative: Patient received vaccine on 11/14/17.About 1.5 weeks later he had the abrupt onset of numbness of his vertex accompanied by a blotchy red rash (explicitly non-vesicular) that affected his scalp face, trunk and extremities. This lasted for about 12 hours and resolved spontaneously. Then several days after that he noticed allopdynia of his right hemicranium associated with some objective swelling (indentation of his glasses earpiece), like pinpricks with even light touch. Fortunately this has subsided about 50% by now.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Patient received vaccine on 11/14/17.About 1.5 weeks later he had the abrupt onset of numbness of his vertex accompanied by a blotchy red rash (explicitly non-vesicular) that affected his scalp face, trunk and extremities. This lasted for about 12 hours and resolved spontaneously. Then several days after that he noticed allopdynia of his right hemicranium associated with some objective swelling (indentation of his glasses earpiece), like pinpricks with even light touch. Fortunately this has subsided about 50% by now.
Sex: M
Vaccine: PPV, PPV
Symptoms: Bacteraemia, Dyspnoea, Joint injury, Limb injury, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. This male patient of an unspecified age received at physician's office, pneumococcal 13-val conj vac (dipht crm197 protein) via an unspecified route of administration on an unspecified date in spring 2016 (maybe May2016) at single dose for immunization (pneumonia prevention). The patient was not sure about the vaccine tradename, stated that the manufacturer was either Pfizer or Merck, he received one pneumococcal vaccine on two separate occasions. The patient medical history and concomitant medications were not reported. He was diagnosed with streptococcus pneumonia in middle Oct2017. He was hospitalized on 16Oct017 and discharged the next Monday night. The pneumonia was isolated from sputum in his lungs. He did not have any symptoms except that he could not breathe. He did not have a cough. He does not remember any other test done at the hospital. He supposed they did an xray but did not remember. He was in bacteria isolation. The pneumonia was treated with IV Vancomycin and LEVAQUIN. The outcome of the events was recovering. The information on the batch number has been requested.
Sex: M
Vaccine: PPV, PPV
Symptoms: Sepsis, Streptococcus test positive
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. This male patient of an unspecified age received at physician's office, pneumococcal 13-val conj vac (dipht crm197 protein) via an unspecified route of administration on an unspecified date in spring 2016 (maybe May2016) at single dose for immunization (pneumonia prevention). The patient was not sure about the vaccine tradename, stated that the manufacturer was either Pfizer or Merck, he received one pneumococcal vaccine on two separate occasions. The patient medical history and concomitant medications were not reported. He was diagnosed with streptococcus pneumonia in middle Oct2017. He was hospitalized on 16Oct017 and discharged the next Monday night. The pneumonia was isolated from sputum in his lungs. He did not have any symptoms except that he could not breathe. He did not have a cough. He does not remember any other test done at the hospital. He supposed they did an xray but did not remember. He was in bacteria isolation. The pneumonia was treated with IV Vancomycin and LEVAQUIN. The outcome of the events was recovering. The information on the batch number has been requested.
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Pneumonia streptococcal, Sputum retention, Streptococcus test positive, X-ray
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. This male patient of an unspecified age received at physician's office, pneumococcal 13-val conj vac (dipht crm197 protein) via an unspecified route of administration on an unspecified date in spring 2016 (maybe May2016) at single dose for immunization (pneumonia prevention). The patient was not sure about the vaccine tradename, stated that the manufacturer was either Pfizer or Merck, he received one pneumococcal vaccine on two separate occasions. The patient medical history and concomitant medications were not reported. He was diagnosed with streptococcus pneumonia in middle Oct2017. He was hospitalized on 16Oct017 and discharged the next Monday night. The pneumonia was isolated from sputum in his lungs. He did not have any symptoms except that he could not breathe. He did not have a cough. He does not remember any other test done at the hospital. He supposed they did an xray but did not remember. He was in bacteria isolation. The pneumonia was treated with IV Vancomycin and LEVAQUIN. The outcome of the events was recovering. The information on the batch number has been requested.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Facial paralysis
Clinical narrative: Bell's Palsy.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody, Blindness unilateral, Computerised tomogram, Nuclear magnetic resonance imaging brain, Red blood cell sedimentation rate
Clinical narrative: Right eye lost vision.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old male patient without any drug reactions/allergies. Information about concomitant medication and pertinent medical history was not provided. On 12-OCT-2017 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, frequency and route unspecified) for prevention of shingles with sterile diluent (manufacturer unknown) (lot#, expiration date, dose, frequency and route unspecified).    On 17-NOV-2017, the patient developed bruising around the injection site (unspecified arm) after administration of vaccine. No treatment and no lab diagnostic/ studies were performed. The patient sought medical attention via calling the pharmacist. At the time of the report, the pharmacist reported that the patient had the bruising for the past 6 weeks and it was not resolving. The causality was not provided.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 22-NOV-2017, the patient was vaccinated with an expired dose of ROTATEQ orally, (lot # M025565 with an expiration date in 06-NOV-2017), dose 2, for prophylaxis (dose was not provided). No adverse effects were reported.
Age: 0.08
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 month old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. Historical drugs included hepatitis b virus vaccine given on 29-OCT-2017. On 30-NOV-2017, the patient was inadvertently vaccinated with one dose of VAQTA intramuscularly, lot # N019924 (formulation, strength and dose were not reported) for prophylaxis, instead of intended hepatitis B vaccine. The patient had no illness at time of vaccination. The nurse reported that this was due to user error because " a certified medical assistant took the box of hepatitis A vaccine out of the refrigerator instead of hepatitis B". The vaccines were located next to each other in the refrigerator. The patient's mother was notified. No treatment was given to the patient. No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a Registered Nurse via a company representative, referring to a 16 year old female patient. The patient had none pertinent medical history, concurrent conditions or drug reactions. The patients concomitant therapy included "menicol".    On 29-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, lot # N015087 and expiration date on 20-OCT-2019 (dose and anatomy location were not provided) for prophylaxis. On the same day (reported as "later that night), the patient started vomiting. It was reported that, the patient called the nurse, however she did not receive treatment for the adverse event and none laboratory diagnostic studies were performed. At the reporting time, the patient had recovered form vomiting on 30-NOV-2017 (reported as "the morning of the following day") and the causality assessment between GARDASIL 9 and the event was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 3 months old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date in 2017, the patient was vaccinated with an improperly stored ROTATEQ lot # N013885 (dose was not provided). Data logger was not involved. No adverse effects were reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA012873: US-009507513-1712USA012874: US-009507513-1712USA012875: US-009507513-1712USA012876: US-009507513-1712USA012877: US-009507513-1712USA012878:
Age: 1.33
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Insomnia, Product storage error
Clinical narrative: This spontaneous report was received from a mother referring to her 16 months year-old son. The patient had no medical history, drug reactions/allergies or concomitant medications to be reported. On an unknown date, the patient was vaccinated with M-M-R II; VAQTA; and VARIVAX, all recommended to avoid disease (prophylaxis); the doses, lot# and expiration dates were not reported. On an unknown date (reported as "when he was about a year old"), the patient stopped sleeping at night. The patient did not seek medical attention or received any treatment. He neither did undergo tests regarding his inability to sleep at night. On 14-DEC-2017 (reported as today), the clinic that administered the vaccines contacted the patient's mother to tell her the vaccines the patient received had been stored improperly at the time they were administered. The patient was currently 2 and a half year old and his status at the time of the report was reported as "healthy" so the outcome of insomnia was recovered. The causality assessment between the aforementioned vaccines and the event of insomnia was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 08-NOV-2017, the patient was vaccinated with improperly stored dose of VARIVAX (lot# M048203, expiration date 07-DEC-2018, dose and route of administration were not reported) reconstituted with properly stored sterile diluent (STERILE DILUENT MRK) for prophylaxis. Reporter stated that the vaccines were stored in 7 degrees Fahrenheit for 2 hours 1 minute. There was previous temperature excursions on 30-OCT-2017, indicated as 17.6 degrees Fahrenheit for 2 hours 15 minutes. The digital data logger was used. The patient did not experienced any adverse events. Product quality complaint was not involved. This is one of three reports from the same reporter.; Sender's Comments: US-009507513-1712USA009982: US-009507513-1712USA000444:
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified dates in December 2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # N021727, expiration date 06-FEB-2019; # M043307, expiration date 24-APR-2018, and VARIVAX lot # N008077, expiration date 09-MAR-2019, # N001528, expiration date 13-JAN-2019; #N012134, expiration date 17-APR-2019, (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccines were exposed to a temperature range of 20.1 °F, during a time frame of 2 hours and 12 minutes. No previous temperature excursions were reported. The call was because of a data logger. No adverse effects were reported.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 65 year old patient of unknown gender. No information was provided regarding the patient's medical history or concurrent conditions. On 13-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU, lot number M038350, expiration date 06-DEC-2017, for prophylaxis (route of administration was not reported). The dose of ZOSTAVAX was reconstituted with sterile diluent (MERCK) which was not expired (lot number M044949, expiration date 18-JUN-2019). No adverse effects were reported. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1712USA012708.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number: N001528 (expiration date: 13-JAN-2019) for prophylaxis (strength, route, dose or units were not provided) reconstituted with a properly stored sterile diluent (STERILE DILUENT). There was digital data logger involved. The storage characteristics were the following: - Temperature: 6 F to 14 F (8.4 F) for 9 hours and 45 minutes - Previous temperature excursion: 6 F to 14 F (10.9 F) multiple excursions involved; cumulative total 29 hours. No adverse effects were reported.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 65 year old patient of unknown gender. No information was provided regarding the patient's medical history or concurrent conditions. On 15-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU, lot number M038350, expiration date 06-DEC-2017, for prophylaxis (route of administration was not reported). The dose of ZOSTAVAX was reconstituted with sterile diluent(MERCK STERILE DILUENT) which was not expired (lot number M044949, expiration date 18-JUN-2019). No adverse effects were reported. This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1712USA011549:
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to an adolescent male patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with the third dose of VAQTA for prophylaxis (strength, route, dosage schedule and lot number were not reported). No adverse effects were reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass, Ultrasound scan
Clinical narrative: This spontaneous report was received from a physician referring to a 12 year old male patient. The patient had no medical history, drug reactions/allergies or concomitant medications to be reported. On 10-JUL-2017, the patient was vaccinated with the second dose of GARDASIL 9 in the right arm for prophylaxis; the route of administration was unknown (lot # N003703, expiration date: 29-OCT-2019). On 10-JUL-2017 (reported as "since injection"), the patient experienced a "lump" at the injection site (vaccination site mass). On 26-DEC-2017, the patient was seen in the office and the physician ordered an ultrasound of the injection site for the same date (results were not available at the time of the report). The patient reported no pain or other symptoms and no treatment was given for the event. At the time of the report, the outcome of vaccination site mass was not recovered. The causality assessment between the GARDASIL 9 and the aforementioned event was not reported.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Migraine
Clinical narrative: Patient received the first series of the TRUMENBA 11/22/2017. Patient woke up on the morning of 11/25/17 with a migraine. He took EXCEDRIN and then slept for 5-6 hours and when he woke up his migraine was gone. Patient received the 2nd dose of the TRUMENBA 12/22/17. Patient woke on the morning of 12/24/17 with a migraine. Again he took EXCEDRIN and slept for 5 hours and when he woke up his migraine was gone.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site pain, Peripheral swelling, X-ray
Clinical narrative: Patient's arm swollen and red the following day. Treated with ice and MOTRIN. Symptoms subsided but patient went to MD on 12/26 with recurrent symptoms and shoulder pain.
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a health services employee, concerning an approximately 52 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The reporter informed that on 28-NOV-2017, the patient was mistakenly vaccinated with VARIVAX Injection, 0.5ml, one time, for prophylaxis, lot #M035688 and expiration date 10-AUG-2018 (strength and route of administration were not reported). The reporter advised that the patient was supposed to be vaccinated with M-M-R II to prevent measles, mumps and rubella (strength, dose, frequency, route of administration, lot number and expiration date were not reported), and that instead the patient was vaccinated with VARIVAX. The reporter stated that it was unknown if there was a specific adverse symptom related to the error.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 17-NOV-2017, the patient was vaccinated with improperly stored dose of VARIVAX (lot# M048203, expiration date 07-DEC-2018, dose and route of administration were not reported), reconstituted with properly stored sterile diluent (STERILE DILUENT MRK) for prophylaxis.  Reporter stated that the vaccines were stored in 7 degrees Fahrenheit for 2 hours 1 minute. There was previous temperature excursions on 30-OCT-2017, indicated as 17.6 degrees Fahrenheit for 2 hours 15 minutes. Vaccinations occurred after first excursion on 30-OCT-2017. The digital data logger was used. The patient did not experience any adverse events. Product quality complaint was not involved. This is one of three reports from he same reporter.; Sender's Comments:  US-009507513-1712USA009982: US-009507513-1712USA009987:
Sex: U
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 30-NOV-2017, the patient was vaccinated with improperly stored doses of VARIVAX (lot# N019127, expiration date: 22-JUN-2019) and GARDASIL 9 (lot# N012093, expiration date: 13-JAN-2020), both for prophylaxis, route of administration and doses were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (lot# N001534, expiration date: 30-JUL-2019) used to reconstitute improperly stored VARIVAX; it was unspecified if the sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse effects were reported. The temperature exposure was reported as follows: VARIVAX (lot# N019127, expiration date: 22-JUN-2019) underwent a temperature below 32°F for 1 hour, and 47°F to 77°F for 2 hours, with no previous temperature excursion. Digital data logger was involved. GARDASIL 9 (lot# N012093, expiration date: 13-JAN-2020) underwent a temperature of 15°F to 46°F for 1 hour 30 minutes, and 47°F to 77°F for 2 hours, with no previous temperature excursion. Digital data logger was involved. Subsequently, the nurse called back on 14-DEC-2017 and clarified that the GARDASIL 9 was not improperly stored and confirmed that no adverse effects were involved; so GARDASIL 9 was assessed as a concomitant vaccine.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an adult male patient. The patient may have been vaccinated with M-M-R II during childhood. On 31-JUL-2017, the patient was vaccinated with a dose of M-M-R II injection (dose, route of administration, lot number and expiration date were not reported). The dose of vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). On an unknown date in 2017 the patient had "a low titer". The outcome of the event was unknown at the time of the report. The relatedness between the low titer and M-M-R II was not reported.
Sex: M
Vaccine: PNC13
Symptoms: Nasopharyngitis
Clinical narrative: This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (also the patient) reported that a 67-year-old male patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization, VIAGRA, via an unspecified route of administration from an unspecified date to an unspecified date at unspecified dosage for an unspecified indication. The patient medical history was not reported. Concomitant medication included influenza vaccine, MUCINEX, ALKA-SELTZER PLUS. The patient got a cold on an unspecified date. The patient was 195 and was little bit weight, might be about 200 pounds now. The patient received that shot at doctor's office. The consumer didn't remember the date of experiencing of cold. The consumer confirmed that cold was improved. The action taken in response to the events for sildenafil citrate was unknown. The outcome of the event cold was recovering, for the other event was unknown.