chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: F
Vaccine: MENB, MENB
Symptoms: Wrong drug administered
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 1-month-old patient received a single dose of TRUMENBA (Lot# R47584) on an unknown date as immunization. Patient was seen on 08Jun2017 for 1 month checkup. Infant was supposed to receive hepatitis B vaccine but meningococcal group b rlp2086 was given in error on an unknown date. On an unspecified date the patient became febrile with temperature at 101 F and approximatively 10 hours later, was admitted to hospital. Patient was then transferred to another facility. Full septic work up was done and diagnosis was aseptic meningitis. Patient received antibiotics for 3 days. Also became anemic during hospital stay and received blood transfusion. Patient was discharged from hospital on an unknown date. Outcome of the events was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Mobility decreased, Sleep disorder
Clinical narrative: Constant low grade soreness. More soreness with any use e.g. Kayaking.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Constant low grade soreness. More soreness with any use e.g. Kayaking.
Age: 30.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Dyspepsia, Sensation of foreign body
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of heartburn in a 30-year-old male patient who received ENGERIX B (batch number Z25GH, expiry date 6th March 2019). Concurrent medical conditions included anxiety (the patient had been suffering anxiety all of his life, but not medically diagnosed). On 17th June 2017 12:15, the patient received the 1st dose of ENGERIX B. On 17th June 2017, less than a day after receiving ENGERIX B, the patient experienced difficulty breathing and hypokinesia. On 17th June 12:35, the patient experienced heartburn. The patient was treated with BENADRYL. On 17th June 2017, the outcome of the heartburn, difficulty breathing and hypokinesia were recovered/resolved. The reporter considered the heartburn to be unrelated to ENGERIX B. It was unknown if the reporter considered the difficulty breathing and hypokinesia to be related to ENGERIX B. Additional details were reported as follows: The patient complained about heartburn symptoms, difficulty breathing, slowing of mouth and lips. The patient denied the slowing of breathing. The patient received BENADRYL 50mg until his symptoms stopped. The patient went to emergency room and they give him some bad tasting fluid. After being transferred to medical emergency services, the healthcare provided stated that patient did not have difficulty breathing or slowing of the mouth or lips. The health care professional said that the patient had heartburn only, which the health care professional believed to be anxiety-related.
Age: 30.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Dyspepsia, Dyspnoea, Hypokinesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of heartburn in a 30-year-old male patient who received ENGERIX B (batch number Z25GH, expiry date 6th March 2019). Concurrent medical conditions included anxiety (the patient had been suffering anxiety all of his life, but not medically diagnosed). On 17th June 2017 12:15, the patient received the 1st dose of ENGERIX B. On 17th June 2017, less than a day after receiving ENGERIX B, the patient experienced difficulty breathing and hypokinesia. On 17th June 12:35, the patient experienced heartburn. The patient was treated with BENADRYL. On 17th June 2017, the outcome of the heartburn, difficulty breathing and hypokinesia were recovered/resolved. The reporter considered the heartburn to be unrelated to ENGERIX B. It was unknown if the reporter considered the difficulty breathing and hypokinesia to be related to ENGERIX B. Additional details were reported as follows: The patient complained about heartburn symptoms, difficulty breathing, slowing of mouth and lips. The patient denied the slowing of breathing. The patient received BENADRYL 50mg until his symptoms stopped. The patient went to emergency room and they give him some bad tasting fluid. After being transferred to medical emergency services, the healthcare provided stated that patient did not have difficulty breathing or slowing of the mouth or lips. The health care professional said that the patient had heartburn only, which the health care professional believed to be anxiety-related.
Age: 69.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69 year-old female patient of unknown race received PREVNAR 13 (lot R49357, expiry date May2018, NDC number: 00005197102) intramuscular in the left deltoid on 21Jun2017 at 10 am at 0.5 ml single for immunisation.  Medical history included ongoing allergy to latex, concomitant medications were not reported.  No other vaccines were administered the same day or within four weeks. The patient experienced arm swollen with redness at injection site, serious as medically significant events, and sharp pains in the arm, serious per disability, on 21Jun2017 in the evening. Due to the events the patient went to the doctor's office. Testing/investigations were not known. The patient was not recovered from the reported events. The reporter stated that the patient had a latex allergy, but they assured that there was no contact with latex at time of vaccination. The events were assessed as related to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the events of sharp pains, and vaccination site redness and swelling. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 69.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69 year-old female patient of unknown race received PREVNAR 13 (lot R49357, expiry date May2018, NDC number: 00005197102) intramuscular in the left deltoid on 21Jun2017 at 10 am at 0.5 ml single for immunisation.  Medical history included ongoing allergy to latex, concomitant medications were not reported.  No other vaccines were administered the same day or within four weeks. The patient experienced arm swollen with redness at injection site, serious as medically significant events, and sharp pains in the arm, serious per disability, on 21Jun2017 in the evening. Due to the events the patient went to the doctor's office. Testing/investigations were not known. The patient was not recovered from the reported events. The reporter stated that the patient had a latex allergy, but they assured that there was no contact with latex at time of vaccination. The events were assessed as related to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the events of sharp pains, and vaccination site redness and swelling. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt complained of pain and swelling of injection site.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Excessive eye blinking, Eye movement disorder, Fatigue, Injection site erythema, Injection site induration
Clinical narrative: Please note that I am unsure what kinds of DTaP he received. A day after getting the shot, my son was playing outside and I noticed that he was feeling a bit warm. I gave him some water and had him rest in the shade to cool him down, but that didn't seem to work. So about twenty minutes after initially noticing that he felt warm, I took him into the house where it was cooler. I then took his temperature. It was 100.8 F by mouth. I gave him some acetaminophen and water, but after a bit he seemed really tired. He laid his head back, and then his eyes rolled back in his head and his eyelids began to blink. I watched him for a couple of seconds, unsure what was happening, then started to shake him to wake him up. He took about 5 seconds of being shaken and called to before he came back to consciousness, and then did this two more times. I called the after-hours emergency line at his doctor's office, and was told a doctor would contact me within thirty minutes. There was no return call for patient. On 07/07/17, I took my other son to the doctor to have his vaccine site inspected as it was edematous, erythemic, and indurated. I mentioned my fear that patient had suffered a seizure from the vaccine during this appointment, but the doctor laughed it off, thinking I was joking. I then called my father, who is a paramedic, and explained the incidence, and sent him a video of another child undergoing the same thing I had seen on my son, and my father confirmed that this was, in fact, a seizure that I had seen in my son.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site oedema, Loss of consciousness, Seizure, Skin warm
Clinical narrative: Please note that I am unsure what kinds of DTaP he received. A day after getting the shot, my son was playing outside and I noticed that he was feeling a bit warm. I gave him some water and had him rest in the shade to cool him down, but that didn't seem to work. So about twenty minutes after initially noticing that he felt warm, I took him into the house where it was cooler. I then took his temperature. It was 100.8 F by mouth. I gave him some acetaminophen and water, but after a bit he seemed really tired. He laid his head back, and then his eyes rolled back in his head and his eyelids began to blink. I watched him for a couple of seconds, unsure what was happening, then started to shake him to wake him up. He took about 5 seconds of being shaken and called to before he came back to consciousness, and then did this two more times. I called the after-hours emergency line at his doctor's office, and was told a doctor would contact me within thirty minutes. There was no return call for patient. On 07/07/17, I took my other son to the doctor to have his vaccine site inspected as it was edematous, erythemic, and indurated. I mentioned my fear that patient had suffered a seizure from the vaccine during this appointment, but the doctor laughed it off, thinking I was joking. I then called my father, who is a paramedic, and explained the incidence, and sent him a video of another child undergoing the same thing I had seen on my son, and my father confirmed that this was, in fact, a seizure that I had seen in my son.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Cough, Headache, Rash, Rash erythematous
Clinical narrative: Headache, stomach ache followed by 4 red bumps 2 on face, 2 on arm. Shortly after that, severe cough and cold symptoms. Mother then developed same symptoms on week 3 with unknown red bumps on back of neck, nausea, chest cold, flu like symptoms.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral upper respiratory tract infection
Clinical narrative: Headache, stomach ache followed by 4 red bumps 2 on face, 2 on arm. Shortly after that, severe cough and cold symptoms. Mother then developed same symptoms on week 3 with unknown red bumps on back of neck, nausea, chest cold, flu like symptoms.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Urticaria
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable physician. A 78-year-old female patient of unspecified race/ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein) (unspecified trade name), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergy to pneumococcal 13-val conj vac (dipht crm197 protein) and hives both on an unspecified date with outcome of unknown. No follow-up attempts needed. No further information expected.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician and received via a Pfizer sales representative. A 16-year-old male patient of other race received TRUMENBA at 0.5 ml single, in right arm and MENACTRA at 1 DF single, in left arm, both on 26Jun2017, for immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced fatigue and headache, both on 26Jun2017, with unknown outcome. The doctor recommended ibuprofen and taking a nap. There was no local aggravation of injection site prior to injection.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Skin warm, Swelling, Tenderness
Clinical narrative: Right arm tenderness, swelling, redness, warm to touch, fever.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme shoulder pain with decreased ROM of the right shoulder. Treatment included NSAID and physical therapy.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-JUN-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL, lot number reported as M014939, expiry date 27-MAY-2017 (dose and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding to the patients' medical history, concurrent conditions, and drug and allergy history. On an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX, subcutaneously, lot # N000682, expiration date 06-JUN-2019, and lot# M049126, expiration date 15-DEC-2018, for prophylaxis, which were reconstituted with properly stored diluent MRK (lot# and expiration date were not provided). The doses of VARIVAX were exposed to a temperature excursion of -9°Celsius (°C) to 8°C (-7.5°C) during a time frame of 6 hours, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA009579.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of ROTATEQ lot # reported as M043836 and expiration date on 14-MAY-2018 (strength and dose were not reported), administered orally for prophylaxis. The storage temperature was 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours with multiple temperature excursions for a total cumulative time frame of 720 hours (dates between 02-MAR-2017 and 30-MAY-2017). Data logger was involved but no adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA011485: US-009507513-1706USA011490: US-009507513-1706USA011487: US-009507513-1706USA011488: US-009507513-1706USA011489: US-009507513-1706USA011484: US-009507513-1706USA002362.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: Cellulitis with erythema, swelling and warmth was treated with KEFLEX and resolved after antibiotic course on follow-up exam.
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Skin rash (hives) to face and neck.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Interchange of vaccine products, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient began experiencing numbness immediately after injection and then neck stiffness and pain shortly after vaccination. All of this was on the left side of her arm and neck area. She had Gardasil 4 on 11/12/2014 but first Gardasil 9 injection.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pain
Clinical narrative: Severe and prolonged pain. Ongoing Phys. Therapy. Pain medication. Steroid injection.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling, Vaccination complication
Clinical narrative: Swelling at IM injection on Sunday. Lt arm/vaccines adverse reaction.
Age: 41.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Musculoskeletal stiffness, Nodule, Pain in extremity, Skin warm
Clinical narrative: Client reported pain/stiffness in arm on 6/15/17 in the evening. She said that the pain/stiffness gradually got worse and on the 2nd day, she had a knot and it was hot/red. She went to the ER on 6/21/17 and was treated with Clindamycin inj., and Prednisone.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Severe swelling of arm below the point of the elbow.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Severe swelling of the arm to below the point of the elbow.
Sex: U
Vaccine: MMR, PNC13
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 13-JUN-2017, the patient was vaccinated with two doses of M-M-R II injection (albumin status, dose, route and site of administration, lot number and expiration date were not reported) reconstituted with sterile diluent (manufacturer unknown) injection (dose, route and site of administration, lot number and expiration date were not reported). On the same day, the patient received two doses of PREVNAR 13 (formulation, dose, route and site of administration, lot number and expiration date were not reported). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Seizure, Syncope
Clinical narrative: This spontaneous report as received from a patient's father refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 22-JUN-2017, the patient was vaccinated with GARDASIL 9 injection (intramuscularly; 3 doses given on months 0, 2 and 6; lot# and expiration date were not provided), for prevention of Human Papillomavirus (HPV). Immediately after a physician administered an injection with GARDASIL 9, the patient fainted, hit her head on the floor and experienced seizure-like-convulsions. The patient did not seek medical attention and no treatment was given for the adverse events. The father reported, that the patient recovered from the adverse experiences (approximately in June 2017) and that no additional adverse experiences occurred. The relatedness between the adverse events and GARDASIL 9 was not assessed. Upon internal review, the event of seizure-like-convulsions was determined to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA011266.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Localized erythema, edema and tenderness at injection site; developed within 10-12 hours of injection. Has continued for 36 hours.
Age: 1.58
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HEPA, PNC13
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Pt received incorrect vaccine. Pt was supposed to received HIB, but received PENTACEL. Pt received two doses of DTaP and one unnecessary IPV.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: A couple hours after receiving the vaccine, patient's whole right arm swelled up, especially the elbow region below the injection site. The arm was also sore and itchy. It lasted a total of 3 days, but the swelling went down significantly after 2 days.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt received BEXSERO vaccine and MENACTRA  on 5-19-2017.  No adverse reaction occurred.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Type III immune complex mediated reaction, Urticaria
Clinical narrative: 24-28 hours after vaccination, patient developed urticarial reaction diffusely over body. Hives all blanch, none larger than 1 cm in size. No respiratory or GI involvement, no mucosal involvement. Also with a large red area over left upper arm consistent with an arthus reaction.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Pt was given BEXSERO and MENACTRA one month prior to this vaccination event. Later in the evening pt developed generalized muscle aches, low grade fever, and malaise. Pt had also played in a high school baseball game following administration of vaccine.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Eye swelling, Gait disturbance, Lip swelling, Pain in extremity
Clinical narrative: 7/1 at 6am. Rash on hands/palms. 10am. Rash spread to knees, feet. Went to urgent care received CLARITIN and BENADRYL. Later same day at 4pm. Swollen lips and eyes, hives/welts on arms, ribs. Called 911. Transported to ER. Received "IV cocktail". Prescription for Prednisone 40 mg for 3 days. 7/2: Hard to walk due to hives/rash on feet. 7/3: Went to urgent care difficulty breathing. Had xray, breathing treatment. Was given inhaler and EPIPEN. Also prescription for tapering prednisone for 3 more days. 7/5: Went to see my Dr. still having symptoms of rash/painful feet.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria, X-ray
Clinical narrative: 7/1 at 6am. Rash on hands/palms. 10am. Rash spread to knees, feet. Went to urgent care received CLARITIN and BENADRYL. Later same day at 4pm. Swollen lips and eyes, hives/welts on arms, ribs. Called 911. Transported to ER. Received "IV cocktail". Prescription for Prednisone 40 mg for 3 days. 7/2: Hard to walk due to hives/rash on feet. 7/3: Went to urgent care difficulty breathing. Had xray, breathing treatment. Was given inhaler and EPIPEN. Also prescription for tapering prednisone for 3 more days. 7/5: Went to see my Dr. still having symptoms of rash/painful feet.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Culture, Rash macular, Viral test
Clinical narrative: Scattered erythematous macules, vesicles on the hands, foots. Clustered vesicles on the perineal areas, anus area, bilateral elbows, scatterred vesicles on the legs, around mouths.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased eye contact, Hyporesponsive to stimuli, Staring
Clinical narrative: While at home suddenly became very poorly responsive to mom, no eye contact, no vocalization, "looked empty".  Lasted about 1.5 hrs the resolved completely and has been normal since.
Age: 24.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin increased, Pregnancy test urine positive
Clinical narrative: Pt LMP on 6-23-2017 and was normal. Urine preg positive on 6-28-2017, serum Hcg level 24,115. Unknown EDC, referred to OB.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Joint range of motion decreased, Pain in extremity, Skin warm
Clinical narrative: Redness, skin warm/hot to touch, tenderness/ache in arm, limited range of motion, swelling, hardening of arm. Pt tried heat/ice, ALEVE, TYLENOL, since symptoms began in the afternoon of 07/06, the outcome was no change in status.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Redness, skin warm/hot to touch, tenderness/ache in arm, limited range of motion, swelling, hardening of arm. Pt tried heat/ice, ALEVE, TYLENOL, since symptoms began in the afternoon of 07/06, the outcome was no change in status.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Pt. is described as having full blown chicken pox as result of vaccine. (Unofficial Dx - per MD visit w/a family member). Advised pt. to seek medical attention - she declined.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Rash erythematous, Urticaria
Clinical narrative: Red welt the size of a checkbook with red bumps occurred on the leg.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Cartilage injury, Drug administered at inappropriate site, Injection site pain, Insomnia
Clinical narrative: The injection was given in the top of my left shoulder with instant pain and burning. I had difficulty sleeping that evening and pain when using my left arm. I had an aqua fitness class to teach the next morning and had pain using that arm. This pain continued and worsened with use. It was difficult or impossible to sleep. I called the dr. office the 4th day to let them know about the intense pain. I went to immediate care on July 1st and was told that my shot probably went into the wrong place on my shoulder and was given muscle relaxants to see if that would help. It didn't ease the shoulder pain. I just learned not to use that arm and to hold it close to my body. I went back to my dr on July 5th to let them know what I was feeling and they set up an MRI. My MRI the following day showed bursitis and a split tear in the labrum of the left shoulder. An appoint was made to see an orthopedic surgeon.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity
Clinical narrative: The injection was given in the top of my left shoulder with instant pain and burning. I had difficulty sleeping that evening and pain when using my left arm. I had an aqua fitness class to teach the next morning and had pain using that arm. This pain continued and worsened with use. It was difficult or impossible to sleep. I called the dr. office the 4th day to let them know about the intense pain. I went to immediate care on July 1st and was told that my shot probably went into the wrong place on my shoulder and was given muscle relaxants to see if that would help. It didn't ease the shoulder pain. I just learned not to use that arm and to hold it close to my body. I went back to my dr on July 5th to let them know what I was feeling and they set up an MRI. My MRI the following day showed bursitis and a split tear in the labrum of the left shoulder. An appoint was made to see an orthopedic surgeon.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site reaction, Nuclear magnetic resonance imaging abnormal
Clinical narrative: The injection was given in the top of my left shoulder with instant pain and burning. I had difficulty sleeping that evening and pain when using my left arm. I had an aqua fitness class to teach the next morning and had pain using that arm. This pain continued and worsened with use. It was difficult or impossible to sleep. I called the dr. office the 4th day to let them know about the intense pain. I went to immediate care on July 1st and was told that my shot probably went into the wrong place on my shoulder and was given muscle relaxants to see if that would help. It didn't ease the shoulder pain. I just learned not to use that arm and to hold it close to my body. I went back to my dr on July 5th to let them know what I was feeling and they set up an MRI. My MRI the following day showed bursitis and a split tear in the labrum of the left shoulder. An appoint was made to see an orthopedic surgeon.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tendon disorder, Tendon rupture
Clinical narrative: The injection was given in the top of my left shoulder with instant pain and burning. I had difficulty sleeping that evening and pain when using my left arm. I had an aqua fitness class to teach the next morning and had pain using that arm. This pain continued and worsened with use. It was difficult or impossible to sleep. I called the dr. office the 4th day to let them know about the intense pain. I went to immediate care on July 1st and was told that my shot probably went into the wrong place on my shoulder and was given muscle relaxants to see if that would help. It didn't ease the shoulder pain. I just learned not to use that arm and to hold it close to my body. I went back to my dr on July 5th to let them know what I was feeling and they set up an MRI. My MRI the following day showed bursitis and a split tear in the labrum of the left shoulder. An appoint was made to see an orthopedic surgeon.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a dose of  PROQUAD injection (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The temperature of excursion was 0.2 Centigrade degrees for 7 hours and 14 minutes. Previous temperature of excursion was 0.2 Centigrade degrees for 9 hours and 18 minutes. The temperatures of excursion were detected by a data logger. No adverse symptoms were reported and no product complaint (PQC) was involved. This is one of two reports from the same reporter 1706USA003512. Additional information has been requested. Sender's Comments:  US-009507513-1706USA003512.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Eye irritation, Headache, Injection site pain, Myalgia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient of unspecified race/ethnicity received PREVNAR 13 ((Lot# Q02071, Exp date 31Jan2018, NDC 00005197102, UPC 300051971022), via an unspecified route of administration, on 15Jun2017, at single dose, for immunisation and LIPITOR film-coated tablet, via an unspecified route of administration, from/to an unspecified date, at an unspecified posology, for an unspecified indication. Relevant medical history included diabetic. Concomitant medications included VICTOZA for diabetes mellitus, metformin (unspecified trade name) for diabetes mellitus, GLUCOTROL for diabetes mellitus and TYLENOL for knee pain. The patient experienced severe headache on 26Jun2017 with outcome of not recovered, eyes burn on 26Jun2017 with outcome of unknown, arm muscle pain on 26Jun2017 with outcome of recovering, soreness of the site of injection on 26Jun2017 with outcome of recovering, soreness on 26Jun2017 with outcome of unknown.
Sex: U
Vaccine: MENB
Symptoms: Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician and nurse via Pfizer sales representative. This physician and nurse reported similar events for 6 patients. This is 1st of 6 reports. An approximate 16-year-old patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose (1st dose) for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rash\hives following first dose of meningococcal group b rlp2086 on an unspecified date. The outcome of the events was recovered after few days. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017286372 same reporter/product/event, different patient; US-PFIZER INC-2017286373 same reporter/product/event, different patient; US-PFIZER INC-2017286375 same reporter/product/event, different patient; US-PFIZER INC-2017286374 same reporter/product/event, different patient; US-PFIZER INC-2017286371 same reporter/product/event, different patient ;US-PFIZER INC-2017286375 same reporter/product/events, different patient.
Sex: U
Vaccine: MENB
Symptoms: Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician and nurse via Pfizer sales representative. This physician and nurse reported similar events for 6 patients. This is 3rd of 6 reports. An approximate 16-year-old patient received the first dose of TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunization. The patient experienced rash\hives following first dose of meningococcal group B RLP2086. The symptoms were moderate and resolved after few days. Sender's Comments: Linked Report(s): US-PFIZER INC-2017286355 same reporter/product/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician and nurse via a Pfizer sales representative. This physician and nurse reported same events for 6 patients. This is 4th of 6 reports. An approximately 16-year-old patient of an unspecified ethnicity and gender received the first shot of series for TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash\hives following first dose of meningococcal group b rlp2086 after use of product on an unspecified date. The outcome of the event was recovered after few days. Sender's Comments: Linked Report(s): US-PFIZER INC-2017286355 same reporter/product/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician and a contactable nurse via Pfizer sales representative. This physician and nurse reported same events for 6 patients. This is the 6th of 6 reports. An approximately 16-year-old patient of an unspecified ethnicity and gender received the first single dose of TRUMENBA for immunization. Medical history and concomitant drug was unknown. Patient experienced rash/hives following first dose of meningococcal group b rlp2086. Symptoms were moderate and resolved after few days. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017286355 same reporter/product/events, different patient.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Electromyogram abnormal, Guillain-Barre syndrome, Heart rate increased, Hyperaesthesia
Clinical narrative: Initially, full-body tingling which led to muscle weakness. After three days from initial symptoms, paralysis from neck down, inability to breathe on own, elevated heart rate, major pains, hypersensitivity to touch, perceived (but not actual) extremely high skin temperature. Treatment was critical care, ventilation, breathing treatments, pain management, physical therapy and rehab, occupational therapy. Current status is: independent and working full-time but with neuropathy (limited/different physical sensation and limited strength) in feet. This makes running and quick movements infeasible currently.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture normal, Mechanical ventilation, Muscular weakness, Nerve conduction studies abnormal, Neuropathy peripheral
Clinical narrative: Initially, full-body tingling which led to muscle weakness. After three days from initial symptoms, paralysis from neck down, inability to breathe on own, elevated heart rate, major pains, hypersensitivity to touch, perceived (but not actual) extremely high skin temperature. Treatment was critical care, ventilation, breathing treatments, pain management, physical therapy and rehab, occupational therapy. Current status is: independent and working full-time but with neuropathy (limited/different physical sensation and limited strength) in feet. This makes running and quick movements infeasible currently.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Paralysis, Sensory disturbance, Skin warm
Clinical narrative: Initially, full-body tingling which led to muscle weakness. After three days from initial symptoms, paralysis from neck down, inability to breathe on own, elevated heart rate, major pains, hypersensitivity to touch, perceived (but not actual) extremely high skin temperature. Treatment was critical care, ventilation, breathing treatments, pain management, physical therapy and rehab, occupational therapy. Current status is: independent and working full-time but with neuropathy (limited/different physical sensation and limited strength) in feet. This makes running and quick movements infeasible currently.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 days of redness, warmth and local swelling at injection site. MOTRIN and cold compresses.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncope, lasted a few seconds immediately after vaccines were administered. No injuries, spontaneously recovered.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Fainted for a few seconds within minutes of his vaccine administration. His sister had fainted after her vaccine just minutes before, which he also witnessed. Spontaneously recovered, no injuries sustained.
Age: 12.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Blood iron normal, Blood thyroid stimulating hormone, Bowel movement irregularity, Feeling cold
Clinical narrative: Received HPV on 10/10/2016 - returned to office on 10.31.16: Child threw up once on 10/18 at school, had blood in it. His stool on that day had blood in it as well, per child. No more symptoms until he threw up a small amount while in the shower once last week. Per child, he did see some blood in it again. Has no more vomiting since then, has a good appetite with no abdominal pain. Child does not get a bm every day but every 4-5 days, denies having hard stools. MIRALAX recommended and ordered Stool Occult test - no specimen was ever received by parent/patient. Seen on 2.21.17: Frontal headache off and on for few months. Happens at any time of the day, no vomiting but does c/o blurred vision with headache. Usually takes a nap and it helps some. Has not been taking any medication for pain regularly. He does c/o stomachache off and on, no vomiting. Appetite is fine. Referred to Neurologist. Seen on 7.7.17: His symptoms started after getting HPV, per mom. Has had vaccines on 10/10/2016, started spitting up blood once a week after that. Seen in the office on 10/30/16. Symptoms resolved but then he started c/o headaches and blurred vision off and on, seen in the office on 10/31/2016. Child referred to Neurologist for further management. Has seen Dr. twice, prescribed iron supplement and amitriptyline for migraine headache. His iron was normal at his 12 year old Physical. Mom is concerned about HPV reaction as the child developed all these symptoms after getting shot on 10/10/2016. Has a followup appointment with Neurologist on 7/11. He constantly c/o being cold, stays in warm room constantly. Mom is really concerned. Mom is really concerned about HPV reaction as child developed symptoms after that visit. Will file Vaccine Adverse Reaction report. Mom notified.  Ordering TSH and Free T4 due to sensation of feeling cold.
Age: 12.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP
Symptoms: Haematemesis, Headache, Migraine, Occult blood, Thyroxine free
Clinical narrative: Received HPV on 10/10/2016 - returned to office on 10.31.16: Child threw up once on 10/18 at school, had blood in it. His stool on that day had blood in it as well, per child. No more symptoms until he threw up a small amount while in the shower once last week. Per child, he did see some blood in it again. Has no more vomiting since then, has a good appetite with no abdominal pain. Child does not get a bm every day but every 4-5 days, denies having hard stools. MIRALAX recommended and ordered Stool Occult test - no specimen was ever received by parent/patient. Seen on 2.21.17: Frontal headache off and on for few months. Happens at any time of the day, no vomiting but does c/o blurred vision with headache. Usually takes a nap and it helps some. Has not been taking any medication for pain regularly. He does c/o stomachache off and on, no vomiting. Appetite is fine. Referred to Neurologist. Seen on 7.7.17: His symptoms started after getting HPV, per mom. Has had vaccines on 10/10/2016, started spitting up blood once a week after that. Seen in the office on 10/30/16. Symptoms resolved but then he started c/o headaches and blurred vision off and on, seen in the office on 10/31/2016. Child referred to Neurologist for further management. Has seen Dr. twice, prescribed iron supplement and amitriptyline for migraine headache. His iron was normal at his 12 year old Physical. Mom is concerned about HPV reaction as the child developed all these symptoms after getting shot on 10/10/2016. Has a followup appointment with Neurologist on 7/11. He constantly c/o being cold, stays in warm room constantly. Mom is really concerned. Mom is really concerned about HPV reaction as child developed symptoms after that visit. Will file Vaccine Adverse Reaction report. Mom notified.  Ordering TSH and Free T4 due to sensation of feeling cold.
Age: 12.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP
Symptoms: Vision blurred
Clinical narrative: Received HPV on 10/10/2016 - returned to office on 10.31.16: Child threw up once on 10/18 at school, had blood in it. His stool on that day had blood in it as well, per child. No more symptoms until he threw up a small amount while in the shower once last week. Per child, he did see some blood in it again. Has no more vomiting since then, has a good appetite with no abdominal pain. Child does not get a bm every day but every 4-5 days, denies having hard stools. MIRALAX recommended and ordered Stool Occult test - no specimen was ever received by parent/patient. Seen on 2.21.17: Frontal headache off and on for few months. Happens at any time of the day, no vomiting but does c/o blurred vision with headache. Usually takes a nap and it helps some. Has not been taking any medication for pain regularly. He does c/o stomachache off and on, no vomiting. Appetite is fine. Referred to Neurologist. Seen on 7.7.17: His symptoms started after getting HPV, per mom. Has had vaccines on 10/10/2016, started spitting up blood once a week after that. Seen in the office on 10/30/16. Symptoms resolved but then he started c/o headaches and blurred vision off and on, seen in the office on 10/31/2016. Child referred to Neurologist for further management. Has seen Dr. twice, prescribed iron supplement and amitriptyline for migraine headache. His iron was normal at his 12 year old Physical. Mom is concerned about HPV reaction as the child developed all these symptoms after getting shot on 10/10/2016. Has a followup appointment with Neurologist on 7/11. He constantly c/o being cold, stays in warm room constantly. Mom is really concerned. Mom is really concerned about HPV reaction as child developed symptoms after that visit. Will file Vaccine Adverse Reaction report. Mom notified.  Ordering TSH and Free T4 due to sensation of feeling cold.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: Child was given a Kinrix combination vaccine instead of a Pentacel.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Injection site swelling
Clinical narrative: Patient came in on 6/28/17 for her 2nd MMR and told us about her reaction to the first one. She stated the injection site became raised and swollen. 2 days later it was the size of a baseball and raised about one inch. She did not seek treatment at the Dr or ER It lasted about four or five days. She stated she has a latex allergy and we refused to do a second MMR and referred her to her physician for a medical exemption for school.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site warmth, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 30Jun2017, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers, received via a sales representative. A 16-year-old female patient received on 07Jun2017 TRUMENBA (lot S26962, NDC: 000021841) intramuscular, in right deltoid, at 0.5 ml single and MENACTRA (lot U5514AB) in left deltoid, at 0.5 ml, both for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 07Jun2017, within 30 minutes after vaccination, the patient experienced excruciating pain to right arm (rated 8/10), hurt to move arm, tender to touch, arm looked swollen, injection site was warm to touch and slightly red. The events did not require a treatment and resolved on an unknown date in Jun2017.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Tenderness
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 30Jun2017, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers, received via a sales representative. A 16-year-old female patient received on 07Jun2017 TRUMENBA (lot S26962, NDC: 000021841) intramuscular, in right deltoid, at 0.5 ml single and MENACTRA (lot U5514AB) in left deltoid, at 0.5 ml, both for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 07Jun2017, within 30 minutes after vaccination, the patient experienced excruciating pain to right arm (rated 8/10), hurt to move arm, tender to touch, arm looked swollen, injection site was warm to touch and slightly red. The events did not require a treatment and resolved on an unknown date in Jun2017.