chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: FLUX, HIBV, MMRV, PNC13, VARCEL
Symptoms: Product storage error, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 1 year old female patient. The patient did not have concurrent conditions. The patient's historical drugs and historical conditions were not reported. On 30-OCT-2017, the patient was vaccinated with PROQUAD (also reported as M-M-R II, conflicting information) lot # N019827, expiration date 09-JAN-2017, dose 1, subcutaneous in the left thigh for prophylaxis, instead M-M-R II (wrong drug administered) due to preparation and administration error. On the same date, the patient also received VARIVAX lot number N019822, expiration date 13-JUL-2019, subcutaneous in the right thigh for prophylaxis (overdose), and sterile diluent lot number M009799, expiration date 11-SEP-2018 (dose, route and indication were not reported). Concomitant therapies included PEDVAXHIB, PREVNAR and influenza virus vaccine (unspecified). No adverse events were reported. The patient did not receive treatment.
Sex: F
Vaccine: HEP
Symptoms: Balance disorder, Blood test, Paraesthesia, Weight bearing difficulty
Clinical narrative: This spontaneous report was received from a 27 year old female patient concerning on herself. The patient had no medical history, drug reaction or allergies. The patient's concurrent conditions and concomitant therapies were not reported. On 06-OCT-2017, the patient was vaccinated with the second dose of RECOMBIVAX HB by intramuscular route (strength, dose, lot number and expiration date were not reported) for prevention of infection caused by all known subtypes of hepatitis B virus. On approximately 10-OCT-2017 (reported as "4 days later"), the patient began to have tingling sensation in her right calf, which got progressively worse. In approximately 2017 (reported as "shortly after that"), the patient was unable to support her own weight on her right knee and almost fell over (joint instability). No treatment was given for the events. However she saw her physician who did some unspecified blood work and recommended that she saw a neurologist. The patient also stated that she did not have an appointment with the neurologist until January 2018. At the time of the report, the patient had not recovered from the events. The causality between the events and the RECOMBIVAX HB was not reported.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for vaccination. The patient contacted the pharmacist and reported that on an recent date, the patient developed an area on the from of his bicep that was "red, swollen and puffy" (erythema and swelling). It was unknown if any treatment was used to alleviate the reaction. At the time of reporting, the patient had not recovered from the events.    The causal assessment between the events erythema and swelling and  suspect therapy PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from the physician assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with PROQUAD via intramuscular route instead of subcutaneous route for prophylaxis (lot number and expiration date were not reported). The vaccine was reconstituted with sterile diluent. There was no adverse effect reported.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age. On 09-NOV-2017 the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). On an unknown date the patient experienced feeling abnormal. The outcome of feeling abnormal is unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N014759, expiration date 08-NOV-2017 (strength, dose and route of administration were not reported) for prophylaxis. It was reported that PROQUAD was reconstituted with properly stored sterile diluent (MERCK) lot number N011475, expiration date 08-AUG-2019. The temperature of excursion with PROQUAD was 15 to 46 Fahrenheit degrees during 11 hours and 30 minutes. Previous temperature of excursion was 15 to 46 Fahrenheit degrees for 12 hours and 45 minutes. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1711USA006109: US-009507513-1711USA006110.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a vaccine coordinator concerning a 17 year old male patient. The patient had no pertinent medical history, concurrent conditions, concomitant medications or drug/reactions allergies. On 16-AUG-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # N003703, expiration date: 29-OCT-2019, as prophylaxis (Dose and route were not reported), on the same day, the patient experienced syncope. He received an unspecified treatment for the event. The outcome of syncope was reported as recovered on an unspecified date in 2017. The causality between syncope and GARDASIL 9 was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N014759, expiration date 08-NOV-2017 (strength, dose and route of administration were not reported) for prophylaxis. It was reported that PROQUAD was reconstituted with properly stored sterile diluent (MERCK) lot number N011475, expiration date 08-AUG-2019. The temperature of excursion with PROQUAD was 15 to 46 Fahrenheit degrees during 11 hours and 30 minutes. Previous temperature of excursion was 15 to 46 Fahrenheit degrees for 12 hours and 45 minutes. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1711USA006081: US-009507513-1711USA006110.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N014759, expiration date 08-NOV-2017 (strength, dose and route of administration were not reported) for prophylaxis. It was reported that PROQUAD was reconstituted with properly stored sterile diluent (MERCK) lot number N011475, expiration date 08-AUG-2019. The temperature of excursion with PROQUAD was 15 to 46 Fahrenheit degrees during 11 hours and 30 minutes. Previous temperature of excursion was 15 to 46 Fahrenheit degrees for 12 hours and 45 minutes. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1711USA006109: US-009507513-1711USA006081.
Sex: F
Vaccine: MENB
Symptoms: Condition aggravated, Seizure
Clinical narrative: This is a spontaneous report received from a contactable Physician via Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received the 3rd dose of TRUMENBA at single dose on 12Apr2017 for immunisation. Medical history included seizure history of seizures but had been seizure free for years prior to receiving TRUMENBA. She was not on any medications at the time she received TRUMENBA. The patient previously took trileptal. The patient previously received the 1st and 2nd doses of TRUMENBA at single dose on an unspecified date for immunisation. On 12Apr17, the patient had had a seizure later that night.  Her exam returned to baseline the next day and she has been seizure free since. The 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: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Aphasia, Blood immunoglobulin G decreased, C-reactive protein increased, Decreased eye contact, Encephalitis
Clinical narrative: My son lost eye contact, speech and responsiveness to those around him following his 1 year vaccinations. MMR, varicella, pneumococcal. He has immune deficiency and encephalitis.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Immunodeficiency, Unresponsive to stimuli
Clinical narrative: My son lost eye contact, speech and responsiveness to those around him following his 1 year vaccinations. MMR, varicella, pneumococcal. He has immune deficiency and encephalitis.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Headache, Skin warm, Swelling face
Clinical narrative: Received flu shot today (11/15) in my left arm. Approximately 10 minutes after receiving the shot I had swelling on the right side of my face just lateral to my cheekbone. The area was red, warm, and approximately 2 inches in length (roundish). I also am experiencing a frontal headache. There is no swelling in the left arm where I received the flu shot. No issues with breathing. Event reported to Occupational Health immediately and documented in my employee record.
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Vaccination error
Clinical narrative: Gave erroneously to patient. No other issues at this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Fall, Gait disturbance, Gait inability
Clinical narrative: Patient was unable to walk steadily the night of her immunization, she had three falls. She had recovered by the next day. There was a similar occurrence when the patient was 2, she had been walking for quite a while after DTap was unable to walk for three days, crawled during that time then did recover and walk again.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pneumonia, Pyrexia
Clinical narrative: The patient came in to get a flu shot. The flu shot was administered and by Thursday of the same week the patient developed pneumonia. The patient complained of fever and had to be seen in urgent care where she received an antibiotic.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Hypoaesthesia, Injection site pain, Nausea, Pain
Clinical narrative: Started having fever, body aches, nausea, fatigue, numbness/tingling in right arm, right shoulder pain, painful to light touch and cold sensation in arm within 3 hours of injections. Started with rash 1.5 days later in affected arm. Prescribed baclofen and gabapentin for pain and neuropathic pain. TYLENOL EXTRA STRENGTH for aches and pains.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Paraesthesia, Peripheral coldness, Pyrexia, Rash
Clinical narrative: Started having fever, body aches, nausea, fatigue, numbness/tingling in right arm, right shoulder pain, painful to light touch and cold sensation in arm within 3 hours of injections. Started with rash 1.5 days later in affected arm. Prescribed baclofen and gabapentin for pain and neuropathic pain. TYLENOL EXTRA STRENGTH for aches and pains.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Patient has pain at site of injection. She has more pain with rotating and pulling movement. It started immediately after the vaccine was administered. No treatment tried. It seems to be worse now. The patient feels that the injection was given too high on the arm. It was very painful when injected.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Mobility decreased
Clinical narrative: Pain in right shoulder and arm, limited arm movement and mobility started immediately following vaccination, arm numbness, pain at rest and at use.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, X-ray
Clinical narrative: Pain in right shoulder and arm, limited arm movement and mobility started immediately following vaccination, arm numbness, pain at rest and at use.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia, Splint application
Clinical narrative: "20 min. after flu injection employee reported numbness and tingling (Rt.) lateral aspect of palm/wrist that progressed to pain W/N 24 hours. MD note attached. Currently wearing splint to Rt. hand/wrist.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity, Injected limb mobility decreased, Injection site discolouration, Injection site swelling, Pain in extremity
Clinical narrative: Vaccine left arm deltoid, massive black-blue swelling and pain from shoulder to wrist. Completely black-blue - whole arm. Unable to use arm and painful.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: Vaccine left arm deltoid, massive black-blue swelling and pain from shoulder to wrist. Completely black-blue - whole arm. Unable to use arm and painful.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Patient came in and said about a month ago she was given PNEUMOVAX shot. When she was home it started to turn red-redness spread down arm was sore and had limited movement this lasted about 5 days. Did not call Doctor. She informed him a last appt.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Pain, Pyrexia, Swelling
Clinical narrative: Localized cellulitis, pain/swelling and fever. On antibiotics now.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Patient fainted and had nausea/vomiting.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin reaction
Clinical narrative: Local skin reaction - mild redness. Patient instructed: BENADRYL, TYLENOL, warm compresses.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Severe headache/fever.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever at 24 hrs, some irritability, No NVD. Exam=WNL Excepting T=101 degrees rectal. Still some fever at 24 hrs.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pain on the left arm go down to the left leg.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Pt. had visible swelling and tenderness on inner arm (opposite of where vaccine was administered).
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: (L) arm became very red in area of arm where a BP cuff would be applied, not where flu shot was given. Red area about 50 mm in length and acrossed. Looked square with very defined border at bottom. Redness gradually diminished gone in 5 days.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Rash pruritic, Vaccination site rash, Vaccination site swelling
Clinical narrative: Redness, swelling, heat at vaccine site on right arm plus rash that spread from injection site down arm that itched intensely. It is improving, but she still has the rash.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vaccination site warmth
Clinical narrative: Redness, swelling, heat at vaccine site on right arm plus rash that spread from injection site down arm that itched intensely. It is improving, but she still has the rash.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash
Clinical narrative: Pt. presented with a rash around injection site to (R) thigh.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Child under 3 was inadvertently given 0.5ml.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Impaired work ability, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient is experiencing  shoulder pain described as someone knuckle-punching her shoulder with any usage of her left arm. She states is affects her job and everyday tasks.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Somnolence
Clinical narrative: She had the shot in the afternoon at about 4 pm. It was Halloween. She was fine for trick or treating, home by 8pm and in bed by her normal 9:45 or so, but the fatigue she experienced for the Wed, 11/1 and Thur, 11/2, was like I had never seen in her since she was a sick as a small child. She was so tired, she slept on the floor in the bathroom at school for 45 minutes. She slept during class (this is extremely uncharacteristic of her). She slept whenever she had the slightest opportunity. I didn't think much of it at the time meaning that I wasn't worried about her, figuring that she was tired from having had the shot. I had the vaccine on 11/11/17, and then I was far more empathetic to her experience. The exhaustion and fatigue made it so napping was not something you just consider, there was no choice in the matter.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Dizziness, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Patient started with flu like symptoms the evening after flu shot and day after (stomach upset and dizziness). Wednesday she had dark red spot at injection site, a large area of light red and warm. Site is tender and has mild pain.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: Patient started with flu like symptoms the evening after flu shot and day after (stomach upset and dizziness). Wednesday she had dark red spot at injection site, a large area of light red and warm. Site is tender and has mild pain.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Fatigue, Somnolence
Clinical narrative: I had the shot in the morning, and by the early evening, I was exhausted like I have not experienced without being sick. I did not have a choice to nap or not. I fell asleep 3! times between 5 and 11, two of the times were on the hard floor. I continued to be extremely fatigued for the next day and some of the 13th as well. I have never been so tired without being sick (or having a sick child). By the third day I felt myself again. Our daughter, 14, had the shot and had a very similar reaction and timeline. I submitted one of these forms for her as well.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Fatigue, Somnolence
Clinical narrative: Patient states that she felt very fatigued, at home, the afternoon of the immunization. She stated that she fell asleep before dinner, after dinner and also took a nap before going to bed that night. She stated that she was very tired the whole next day.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient received both influenza and pneumococcal vaccines in LD on 11/6. Later that night, patient complained that left arm swelling like a balloon. Patient tried to treat with ibuprofen and ice packs with minimal relief. Patient returned to dr office on 11/8. MD noted left upper extremity as erythematous and swollen. No evidence of lymphedema, edema, ulcerations or lesions. Patient denied shortness of breath, abdominal pain, or chest pain. MD instructed patient to take BENADRYL and ice packs as needed.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Posture abnormal
Clinical narrative: PATIENT WAS GIVEN THE IMMUNIZATIONS THEN WE WENT BACK TO THE FRONT OFFICE FOR ME TO PUT THE VACCINES IN AND PRINT OUT A SHOT RECORD FOR SCHOOL. HE CAME IN AND SAT DOWN. THEN HE PUT HIS HEAD DOWN ON THE DESK. I GAVE HIM A CUP OF WATER THEN HE STARTED LEANING OVER DROPPING THE CUP. THEN ME AND HIS GRANDMOTHER STAYED WITH HIM UNTIL HE WAS FELLING BETTER SITTING IN THE CHAIR. B/P WAS 143/64 AT 8:35 AM.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Altered state of consciousness, Asthenia, Blood test normal, Computerised tomogram head normal, Dizziness
Clinical narrative: The patient reported having arm soreness and swelling the night she received the vaccine (11/13/17). She came to the pharmacy the morning of 11/14/17 reporting these symptoms. The pharmacist examined her arm and only saw a small red spot in the right deltoid (in the area of the vaccine administration). A few hours later, the patient reported dizziness and weakness and she felt like she was going to pass out. A store employee called 911 and she was taken to the emergency room. The patient states that they did full blood work, EKG, and a CT and found nothing abnormal. On 11/15/17, when examined by the pharmacist, the patient's arm was red from the middle of her bicep down to her elbow.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram normal, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: The patient reported having arm soreness and swelling the night she received the vaccine (11/13/17). She came to the pharmacy the morning of 11/14/17 reporting these symptoms. The pharmacist examined her arm and only saw a small red spot in the right deltoid (in the area of the vaccine administration). A few hours later, the patient reported dizziness and weakness and she felt like she was going to pass out. A store employee called 911 and she was taken to the emergency room. The patient states that they did full blood work, EKG, and a CT and found nothing abnormal. On 11/15/17, when examined by the pharmacist, the patient's arm was red from the middle of her bicep down to her elbow.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 30-OCT-2017, the patient was vaccinated with an expired dose of M-M-R II lot # L041457, expiration date 22-OCT-2017 (dose and route were not reported) for prophylaxis; administered along with a sterile diluent lot # N003192, expiration date 05-JUL-2019 (dose and route were not reported) for prophylaxis. The reporter stated that there were no temperature excursions. No adverse symptoms were reported.
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a nurse via Pfizer (manufacturer control #71932MZX), referring to a male patient of unknown age. The patient's concomitant medications, medical history, concurrent conditions, drug and allergy history were not reported. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, lot # and expiration date were not provided) for prophylaxis. The nurse stated that, on an unspecified date, the patient was having side effects (adverse event) and was not feeling well (malaise). The outcome of adverse event and malaise was unknown. The causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-OCT-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, lot # M039452, expiration date: 19-DEC-2017, for prophylaxis (dose # and route of administration were unknown). The dose of ZOSTAVAX was stored between 15 to 46 Fahrenheit (F) degrees for 7 hours and was detected by a data logger. There was no previous temperature excursion. The sterile diluent(manufacturer unknown) (lot # L029308 and expiration date: 31-MAR-2018) used for reconstitution did not undergo a temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA006170.
Age: 6.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse and refers to a currently 8 year old male patient. There was no information regarding the patient's medical history, concomitant medication drug reactions and allergies provided. On 02-SEP-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously for prophylaxis (lot # L011535, expiration date: 03-JUL-2016) instead of VARIVAX. The vaccine was reconstituted with sterile diluent. There was no adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-OCT-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, lot # M039452, expiration date: 19-DEC-2017, for prophylaxis (dose # and route of administration were unknown). The dose of ZOSTAVAX was stored between 15 to 46 Fahrenheit (F) degrees for 7 hours and was detected by a data logger. There was no previous temperature excursion. The sterile diluent(manufacturer unknown) (lot # L029308 and expiration date: 31-MAR-2018) used for reconstitution did not undergo a temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA000183:
Age: 27.0
Sex: M
Vaccine: HEPAB, MNQ, TYP
Symptoms: Abdominal pain, Dermatitis, Fatigue, Gastrointestinal examination normal, Gastrointestinal motility disorder
Clinical narrative: IBS with alternating diarrhea and constipation along with abdominal cramping, dermatitis, paresthesias and marked fatigue beginning 12 hours after receiving HepA, Hep B, Meningococcal and typhoid immunizations on 14 Feb 2012.
Age: 27.0
Sex: M
Vaccine: HEPAB, MNQ, TYP
Symptoms: Irritable bowel syndrome, Neurological examination normal, Paraesthesia
Clinical narrative: IBS with alternating diarrhea and constipation along with abdominal cramping, dermatitis, paresthesias and marked fatigue beginning 12 hours after receiving HepA, Hep B, Meningococcal and typhoid immunizations on 14 Feb 2012.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Extreme soreness at site of injection.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Rash macular, Swelling face
Clinical narrative: Swelling and itching of the face, face became beet red; itching in the groin area. This lasted for 8 days, then the face became splotchy and itchy at different times of the day and a rash appeared on the right arm, across the abdomen, and right thigh.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Swelling and itching of the face, face became beet red; itching in the groin area. This lasted for 8 days, then the face became splotchy and itchy at different times of the day and a rash appeared on the right arm, across the abdomen, and right thigh.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Malaise, Nausea, Pain in extremity
Clinical narrative: Very Painful and swollen arm, hives from shoulder to under arm to the elbow, chills, low grade fever (99.8), weak, nauseous, general sick feeling. NO rapid heartbeat or throat swelling. Ice to arm, 50 mg of BENADRYL, then another 25 mg the next morning, lots of water, rest. Started to feel better after about 48 hours and by the 3 day, I felt pretty good.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Very Painful and swollen arm, hives from shoulder to under arm to the elbow, chills, low grade fever (99.8), weak, nauseous, general sick feeling. NO rapid heartbeat or throat swelling. Ice to arm, 50 mg of BENADRYL, then another 25 mg the next morning, lots of water, rest. Started to feel better after about 48 hours and by the 3 day, I felt pretty good.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Full blood count, Injection site pain, Injection site swelling, Injection site warmth, Metabolic function test
Clinical narrative: She developed soreness at injection site within one hour of PREVNAR administration. This continued until Sunday, 11/12/17, when she developed redness and warmth at site as well. She took one Benadryl 25 mg last night. Pain is a little better. In office today, 11/15/17,  she has an area on her anterior right arm below her right deltoid that is slightly raised, red and warm to touch. Area extends 12 inches down her arm to her elbow and across her arm 5 inches. She has no fever today. No lymphadenopathy. No other symptoms. Treated today with Benadryl 25 mg q 6 hours prn and Keflex 500 mg po BID X 7 days.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Palpitations
Clinical narrative: For about 5 hours after receiving the vaccine I felt like I couldn't catch my breath, my heart was racing and I was extremely dizzy.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with swelling, redness, warmth, and sore knots on her right arm adjacent to the injection site.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Patient complains of numbness and burning at injection site. Doctor prescribed antibiotics for cellulitis.
Age: 81.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site pain, Pain
Clinical narrative: Pt initially reported right arm pain at/near site of injection beginning 2-3 days after injection. Occurs mostly when he touches the area or with certain arm movement. Pt consulted with primary care physician at an appointment that had been scheduled prior to the incident.
Age: 1.67
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong patient received medication
Clinical narrative: The patient and 2 other siblings came in for a routine flu vaccination. I had all three flu vaccinations pulled up including 1 flu less than 3 for patient, and 2 flu over 3 for the two older siblings. Usually the youngest one goes first or last so I had them in order. One of the siblings was having a hard time cooperating for the vaccine. So, the patient went second. I accidently gave the patient, who is 20 months of age, a flu 3 and older shot. I recognized this right away and reported it to the patient's mom and my supervisor.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient stated that she has had a sore arm since receiving her vaccination. She came in a week after the vaccination stating that her arm was sore. I assured her that it should get better and if not to contact her PCP and let us know. She called back this week and informed us that she went to Urgent Care to treat the soreness in the arm which patient said MD didn't believe it was from the shot. Patient claims going to orthopedic specialist and will get an MRI. Specialist also doesn't believe it is from the shot but patient claims it is.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chest pain, Computerised tomogram, Diplegia, Dyspnoea
Clinical narrative: On October 25, 2017 I was given my flu shot. On November 6, 2017 around 11:30pm, i was awoken by sharp, stabbing pain by my ribcage moving upward towards chest. I went into the living room and had taken aleeve, zantac, and pepto bismol. Shortly after taking the aleeve, I used my inhaler to help with shortness of breath and thereafter, i felt tingling in my hands, feet, and face. The tingling turned into paralysis where i could not move my hands, legs, and my shortness of breath continued. I called 911 and within 30 mins, i was able to control my breathing and the tingling went away only in my hands and NOT my legs. I was taken to the hospital by ambulance. When i arrived at the hospital, i could not longer move my hands, legs and arms. I had shortness of breath, i could barely speak and ER staff immediately intubated me and began running tests.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram, Electroencephalogram, Endotracheal intubation, Lumbar puncture, Mobility decreased
Clinical narrative: On October 25, 2017 I was given my flu shot. On November 6, 2017 around 11:30pm, i was awoken by sharp, stabbing pain by my ribcage moving upward towards chest. I went into the living room and had taken aleeve, zantac, and pepto bismol. Shortly after taking the aleeve, I used my inhaler to help with shortness of breath and thereafter, i felt tingling in my hands, feet, and face. The tingling turned into paralysis where i could not move my hands, legs, and my shortness of breath continued. I called 911 and within 30 mins, i was able to control my breathing and the tingling went away only in my hands and NOT my legs. I was taken to the hospital by ambulance. When i arrived at the hospital, i could not longer move my hands, legs and arms. I had shortness of breath, i could barely speak and ER staff immediately intubated me and began running tests.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal chest pain, Nuclear magnetic resonance imaging, Paraesthesia, Paralysis, Sleep disorder
Clinical narrative: On October 25, 2017 I was given my flu shot. On November 6, 2017 around 11:30pm, i was awoken by sharp, stabbing pain by my ribcage moving upward towards chest. I went into the living room and had taken aleeve, zantac, and pepto bismol. Shortly after taking the aleeve, I used my inhaler to help with shortness of breath and thereafter, i felt tingling in my hands, feet, and face. The tingling turned into paralysis where i could not move my hands, legs, and my shortness of breath continued. I called 911 and within 30 mins, i was able to control my breathing and the tingling went away only in my hands and NOT my legs. I was taken to the hospital by ambulance. When i arrived at the hospital, i could not longer move my hands, legs and arms. I had shortness of breath, i could barely speak and ER staff immediately intubated me and began running tests.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder, Urine analysis
Clinical narrative: On October 25, 2017 I was given my flu shot. On November 6, 2017 around 11:30pm, i was awoken by sharp, stabbing pain by my ribcage moving upward towards chest. I went into the living room and had taken aleeve, zantac, and pepto bismol. Shortly after taking the aleeve, I used my inhaler to help with shortness of breath and thereafter, i felt tingling in my hands, feet, and face. The tingling turned into paralysis where i could not move my hands, legs, and my shortness of breath continued. I called 911 and within 30 mins, i was able to control my breathing and the tingling went away only in my hands and NOT my legs. I was taken to the hospital by ambulance. When i arrived at the hospital, i could not longer move my hands, legs and arms. I had shortness of breath, i could barely speak and ER staff immediately intubated me and began running tests.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis Originally unsuccessfully treated with BACTRIM. Successfully treated with Doxycycline 100 mg.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Burning sensation, Peripheral swelling, Rash, Vaccination complication
Clinical narrative: We received a prescription for an antibiotic for the above patient on 11/10/17. As the pharmacist was counseling the patient regarding the prescription she picked up on 11/10/17, the patient informed the pharmacist that the reason she was picking up the antibiotic was because of the reaction she had to the immunizations she had received on 11/8/17. The patient stated that the evening of the day she received the above immunizations, she started to experience a burning sensation, rash, and swelling in the same arm in which she received the immunizations. She told the pharmacist the doctor said that her condition was a reaction to the immunizations she had received from this pharmacy on 11/08/2017.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Swelling, redness, and hot to the touch on right arm from below inject site to wrist. Patient complained extremely painful and cannot lift her arm. Patient's doctor was contacted and followed up with patient. Counseled patient to seek medical help at urgent care as ibuprofen did not help.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness, and hot to the touch on right arm from below inject site to wrist. Patient complained extremely painful and cannot lift her arm. Patient's doctor was contacted and followed up with patient. Counseled patient to seek medical help at urgent care as ibuprofen did not help.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient presented to the pharmacy today with a small rash around the injection site. Per patient report the rash appeared "redder and more itchy" this morning. No reports of trouble breathing or other notable symptoms. Patient had not yet tried an antihistamine or a cold compress. Recommended she starts both of these options today. Also recommended the patient goes in to see a doctor if the rash spreads further or becomes more irritated. The patient is going to keep an eye on the rash and will go in to see a doctor if the rash is not resolved within the next day after trying an antihistamine and cold compress.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a 2 year old male patient. The patient had no pre-existing physician-diagnosed allergies, birth defects or medical conditions. On 12-OCT-2017, the patient was vaccinated at private doctor's office/hospital with an improperly stored dose of PROQUAD dose 1, lot number N014758 and expiration date on 08-NOV-2018, administered subcutaneously in the right arm for prophylaxis, reconstituted using the sterile diluent (MERCK), which did not experience temperature excursion. It was reported that on an unspecified date, the vaccine was exposed to a temperature between -14 Centigrade degrees and -10 Centigrade degrees for 50 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA005693: US-009507513-1711USA005694.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of M-M-R II intramuscularly, with lot # M045402 and expiration date of 14-NOV-2017 (strength and dose were unknown) for prophylaxis. No adverse effects were reported.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 4 month old patient of unknown gender (date of birth 14-MAY-2017). The patient's concurrent conditions and medical history were not reported. On 12-OCT-2017, the patient was vaccinated with a first dose of ROTATEQ orally, lot # N004816, expiration date 12-OCT-2018 (dose and frequency were not reported) for prophylaxis (inappropriate schedule of drug administration). No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient did not have concurrent conditions, medical history, historical drugs or concomitant therapies. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced rash, pain and swelling which went from injection site up to her shoulder. The event were recovered after three days. The causal relationship between the events and PNEUMOVAX 23 was not reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hyperventilation, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old female patient. The patient's medical history and concurrent conditions were not provided. It was reported no drug reactions or allergies. On 25-OCT-2017, the patient was vaccinated with one shot of PNEUMOVAX 23 (strength, dose, dose number and administration route were not reported) lot number M041686, expiration date 20-MAY-2018, according to Centers for Disease Control and Prevention (CDC) recommendations. Concomitant therapies included SYNTHROID 75 micrograms and CELEBREX 200 mg. Since 25-OCT-2017 (reported as "for around 5 days" and "later that day"), the patient had been experiencing nausea, chills, fever, pain in the back with deep breaths. The pharmacist also reported the patient had redness, warmth and swelling around injection site for around 5 days. Treatment was not given for the adverse events. The patient had not sought medical attention but she was scheduled to see her physician on 30-OCT-2017. At the reporting time, the outcome of back pain, pyrexia, chills, nausea, vaccination site warmth, vaccination site erythema, vaccination site swelling and hyperventilation was not resolved. The causality assessment between PNEUMOVAX 23 and the aforementioned events were not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old female patient. The patient's medical history and concurrent conditions were not provided. It was reported no drug reactions or allergies. On 25-OCT-2017, the patient was vaccinated with one shot of PNEUMOVAX 23 (strength, dose, dose number and administration route were not reported) lot number M041686, expiration date 20-MAY-2018, according to Centers for Disease Control and Prevention (CDC) recommendations. Concomitant therapies included SYNTHROID 75 micrograms and CELEBREX 200 mg. Since 25-OCT-2017 (reported as "for around 5 days" and "later that day"), the patient had been experiencing nausea, chills, fever, pain in the back with deep breaths. The pharmacist also reported the patient had redness, warmth and swelling around injection site for around 5 days. Treatment was not given for the adverse events. The patient had not sought medical attention but she was scheduled to see her physician on 30-OCT-2017. At the reporting time, the outcome of back pain, pyrexia, chills, nausea, vaccination site warmth, vaccination site erythema, vaccination site swelling and hyperventilation was not resolved. The causality assessment between PNEUMOVAX 23 and the aforementioned events were not provided.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported.  Concomitant therapies included sterile diluent (MERCK) that was properly stored. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number M049126 with expiration date on 15-DEC-2018 or with other lot number reported as "N012201 with expiration date on 09-JUN-2019" (anatomical location, dose, and administration route were not reported); the unspecified patients could be also vaccinated with improperly stored doses of PROQUAD lot number N019826 with expiration date on 09-JAN-2019; Lot number N015622 with expiration date on 15-NOV-2018 or lot number N015621 with expiration date on 15-NOV-2018 (anatomical location, dose, and administration route were not reported) or with improperly stored doses of ZOSTAVAX lot number N020945 with expiration date on 26-OCT-2018 (anatomical location, dose, and administration route were not reported) all the vaccines used for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 6 Fahrenheit (F) to 14 F, during a time frame of 1 hour and 12 minutes. It was confirmed that no previous temperature excursions occurred and a digital data logger was involved. Lot number N012201 is an invalid lot number for varicella virus vaccine live (oka/merck)."
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical drug and allergy history or concurrent conditions. On 08-NOV-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M030140 and expiration date on 18-AUG-2017, subcutaneously (dose was not reported) for prophylaxis. It was reported that the sterile diluent (MRK) lot # L014262 and expiry date on 17-FEB-2018, was not expired.
Age: 6.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient is 6 years old and received a FLUAD Vaccine which is intended for 65 years and older. Patient experience no symptoms or adverse reactions to this immunization.
Age: 1.17
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The patient received a FLUCELVAX vaccine which is intended for 4 years and older and the patient is 14 months. The patient did not have any side effects or adverse reactions.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain
Clinical narrative: Pt received the PPSV23 vaccine in office on 10/25/17, per pt report that night she began to have body aches, redness in her arm. Her arm began to swell and continued swell at injection site 48 hours after injection. Pt was seen at an urgent care on 10/27/17 was given antibiotic cream due to increased risk for infection due to her diabetes. Then she follow up in this office on 10/30/17 due to continues swelling and redness. Pt was advised on 10/30/17 to ice/heat and use NSAIDS on area until reaction cleared.
Age: 12.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Local reaction 5x7 cm non tender but indurated and erythematous.