chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse 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 21-FEB-2017, the patient was vaccinated with and expired dose of M-M-R II (lot # K024825, expiration date: 02-DEC-2017) (dose, route of administration and injection site were not provided). No adverse effects were reported. No previous temperature excursions were reported. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. A male patient of an unspecified age and race/ethnicity received the first single dose of PREVNAR 13 via an unspecified route of administration, in December (unspecified date), for immunisation. Medical history included stem cell transplant. The patient's concomitant medications were not reported. The patient had a swelling and a hard nodule in the center right after injection on an unspecified date. Events outcome was unknown. No follow-up attempts possible. No further information expected.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the 1st of 2 reports. A 72-year-old male patient received PREVNAR 13 via an unspecified route of administration at single dose at upper left arm in the muscle on 04Feb2017 09:30 for immunization, received in the pharmacy. Medical history included hypertension diagnosed probably 10 years before and well maintained, PAA Diagnosed about 2 years before and well managed, mild chronic obstructive pulmonary disease (COPD), diagnosed about a year before, hasn't smoked in 50 years, arthritis. Patient took concomitant medications for arthritis but he did not feel like it is significant for this report. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 05Feb2017 the patient experienced hives, welts and itching. On 22Feb2017 he experienced minor rash. The outcome of all events was not recovered. Course of events: The patient first got welts and hives on the lower part of his legs the day after he received the PREVNAR 13. Went to the doctor 07Feb2017 and was placed on Prednisone and some other medication for anti-itching and it started helping. Prednisone was for 5 days and other medication was for 10 days. On 22Feb2017, he noticed some small welts/swelling like area. It was not as bad, under his right arm, near his armpit. On 24Feb2017 morning he went to a local provider and they basically said that everything was looking better and could be a second reoccurrence and put on hydrocortisone 1%. This was in a different part of the body though. Considered this like a mild rash. This time it was much, much smaller. Patient denied investigations. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017087330 Different patient, different drugs/events.
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of unspecified age and race received PREVNAR 13 at single dose for immunization on unknown date. Medical history and concomitant medication were unknown. On unknown date the patient experienced soreness and limited arm movement. The outcome was not reported.
Sex: F
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative. This nurse reported similar events for 2 patients. This is the first of two reports. A 16-year-old female patient received TRUMENBA at single dose on unknown date in 2017 for immunization. Medical history and concomitant medication were not reported. On unknown date the patient experienced dizziness directly after receiving the vaccine. The patient waited in the office for 15 minutes and the dizziness dissipated. No treatment was needed. The event resolved on an unknown date in 2017.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017089890 Same rter/AE/product, different patient.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative. This nurse reported similar events for 2 patients. This is the second of two reports. A 16-year-old female patient received TRUMENBA at single dose on an unknown date in 2017 for immunization. Medical history and concomitant medication were not reported. On an unknown date in 2017 the patient experienced dizziness directly after receiving the vaccine. The patient waited in the office for 15 minutes and the dizziness dissipated. No additional treatment was needed. The event resolved on an unknown date in 2017.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017089887 Same reporter/AE/product, different patient.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Injection site induration
Clinical narrative: Arm (at injection site) started swelling and became hot, warm to touch, and hard as rock with intense pain. Next day had fever, chills, extreme weakness/fatigue, loss of appetite, and generalized pain throughout body.  It has now been 6 days and still have a huge hard mass in arm.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Arm (at injection site) started swelling and became hot, warm to touch, and hard as rock with intense pain. Next day had fever, chills, extreme weakness/fatigue, loss of appetite, and generalized pain throughout body.  It has now been 6 days and still have a huge hard mass in arm.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Arm (at injection site) started swelling and became hot, warm to touch, and hard as rock with intense pain. Next day had fever, chills, extreme weakness/fatigue, loss of appetite, and generalized pain throughout body.  It has now been 6 days and still have a huge hard mass in arm.
Age: 63.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: 5x2cm oval red, raised area on posterior aspect of left upper arm. denies pain, reports slight itching. oral or topical Benadryl advised per MD and monitor site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had some mild redness and swelling around the injection site.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis, Influenza virus test negative, Injection site inflammation, Nausea
Clinical narrative: Patient reports developed profuse diaphoresis, chills, and nausea at 0300. Upon waking up in the morning, patient reports significant localized inflammation around the site (described by patient as a welt) approximately 1.5" in diameter.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Nodule, Swelling, Tenderness
Clinical narrative: Pain at injection site, swelling, tender nodule. No redness.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No medical history was provided. On 13-FEB-2017, the patient was vaccinated with a dose of PROQUAD subcutaneously (dose was not reported) (lot # M037011, expiration date: February 2018, albumin status: rHA) and a dose of M-M-R II subcutaneously (dose was not reported)(lot # M028131, expiration date: June 2018, albumin status: rHA) for prophylaxis. No temperature excursion and no adverse effects were reported. No concomitant therapies were reported. Additional information is not expected as no further information can be obtained.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a group of patients of unspecified number and demographics. On 16-FEB-2017, those patients were vaccinated with LIQUID PEDVAXHIB (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. It was reported that the vaccines were improperly stored for 30 minutes, in the temperature of 10 degrees Celsius (C). It was reported that there was no previous temperature excursion and that it was a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.; Sender's Comments:  US-009507513-1702USA011948: US-009507513-1702USA011949: S-009507513-1702USA011950:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-FEB-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 PFU, lot # L044529, expiration date 09-FEB-2017, for prophylaxis (dose number and route of administration were unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a group of patients of unspecified number and demographics. On 16-FEB-2017, those patients were vaccinated with ROTATEQ oral injection, (dose, lot# and expiration date were not reported) for prophylaxis. It was reported that the vaccines were improperly stored for 30 minutes, in the temperature of 10 degrees Celsius (C). It was reported that there was no previous temperature excursion and that it was a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.; Sender's Comments: US-009507513-1702USA008447: US-009507513-1702USA011949: US-009507513-1702USA011950:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a group of patients of unspecified number and demographics. On 16-FEB-2017, those patients were vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. It was reported that the vaccines were improperly stored for 30 minutes, in the temperature of 10 degrees Celsius (C). It was reported that there was no previous temperature excursion and that it was a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact. Sender's Comments: US-009507513-1702USA008447: US-009507513-1702USA011948: US-009507513-1702USA011950.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a group of patients of unspecified number and demographics. On 16-FEB-2017, those patients were vaccinated with RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. It was reported that the vaccines were improperly stored for 30 minutes, in the temperature of 10 degrees Celsius (C). It was reported that there was no previous temperature excursion and that it was a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.; Sender's Comments: US-009507513-1702USA008447: US-009507513-1702USA011948: US-009507513-1702USA011949:
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Pneumonia
Clinical narrative: The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up  information on 10Feb2017, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer Sponsored Program.  A contactable physician, a contactable consumer reporting for herself and a contactable nurse reported that this 72-year-old female received PREVNAR 13 on an unspecified date, at single dose, for immunisation and REVATIO; (Film-coated tablet) oral from 2010 and ongoing at 20 mg, 3x/day, for pulmonary hypertension. Medical history included ongoing hypertension, ongoing atrial fibrillation and ongoing depression. Concomitant medication included CELEXA ongoing, once daily, for depression. The patient experienced pneumonia on an unspecified date in Dec2016 after receiving pneumococcal 13-val conj vac (dipht crm197 protein) and sildenafil citrate. The patient was hospitalized for pneumonia from an unspecified date in Dec2016 to an unspecified date in Jan2017. The patient underwent blood test on an unknown date when she was in the hospital. The action taken in response to pneumonia for sildenafil citrate was unknown. The patient completely recovered on an unspecified date in Jan2017. The patient did not provide any information to the reporting nurse regarding pneumonia with the use of the suspect products. Follow-up (27Feb2017): New information from a contactable nurse includes: confirmation that the patient did not provide any information to the reporting nurse regarding pneumonia with the use of the suspect products. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment. Based on the information currently available, the company does not attribute the event pneumonia to sildenafil citrate. 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.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a contactable physician. A currently 57-year-old patient of unspecified race/ethnicity experienced drug allergy to pneumococcal 13-val conj vac (dipht crm197 protein), codeine and nickel on an unspecified date. Relevant medical history and concomitant medications were not provided. Outcome was unknown. No follow-up attempts needed. No further information expected.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Culture, Rash
Clinical narrative: Mild rash. Present to torso & neck, Presented over a 48 hour period, has not worsened. Sites may or may not itch at times, sites are 0.5 to 2 cm in diameter.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Malaise, Pyrexia, Skin warm
Clinical narrative: Fever to 102, reddness, warmth of extremity, malaise and fatigue.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in shoulder. Told it would be sore a few days, pain in arm still continues 4 months later. Severe pain when using arm.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Joint range of motion decreased, Limb injury, Musculoskeletal stiffness, Pain
Clinical narrative: Pain in shoulder. Told it would be sore a few days, pain in arm still continues 4 months later. Severe pain when using arm.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Excessive eye blinking
Clinical narrative: Rapid eye blinking that remains consistent daily since week of vaccination.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Altered state of consciousness, Dizziness, Feeling hot, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Immediately following shot, got very hot, sweating and dizzy. Ears started ringing and started passing out. I threw up and then got some help and laid down.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Tinnitus, Vomiting
Clinical narrative: Immediately following shot, got very hot, sweating and dizzy. Ears started ringing and started passing out. I threw up and then got some help and laid down.
Age: 0.33
Sex: F
Vaccine: RVX
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 4.0
Sex: M
Vaccine: DTAP, DTAPIPV, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: None stated.
Sex: U
Vaccine: FLU4
Symptoms: Eyelid function disorder, Eyelid ptosis, Lacrimation increased
Clinical narrative: Rt eye watery 1 day after vaccination til present. Cannot fully close Rt eye. Left lip (upper) droop possible Bells Palsy.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Body temperature increased
Clinical narrative: Pt rec. DTaP, HIB, IPV vaccines on 2/23 spiked temp to 104 on 2/26/17 Mom want Rx done.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood glucose normal, Cyanosis, Dizziness, Dyskinesia, Fatigue
Clinical narrative: Almost immediate after vaccine, pt became very pale with perioral cyanosis, and fainted, with associated brief tonic clinic seizure-stiffening of legs, jerking of arms. She was non responsive for 1-2  minutes, then tired and dizzy for approximately 1 hr, then fully recovered. BP and O2 Sat, HR all normal.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Generalised tonic-clonic seizure, Musculoskeletal stiffness, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Almost immediate after vaccine, pt became very pale with perioral cyanosis, and fainted, with associated brief tonic clinic seizure-stiffening of legs, jerking of arms. She was non responsive for 1-2  minutes, then tired and dizzy for approximately 1 hr, then fully recovered. BP and O2 Sat, HR all normal.
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Discomfort, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Ached after vaccine as one would expect. Radiated up whole arm. Limited range of motion. Pain with movement continues and has worsened now almost four months later. Still with limited range of motion and significant discomfort.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient noticed a burning sensation in his finger (left hand).  The sensation comes and goes.  He also notices his left upper arm hurts when he moves his arm towards the back.  He also noticed a white, slightly raised spot approximately 3 to 4 inches from his elbow (estimation).  He noticed the spot the same time as the burning sensation in his finger.
Age: 20.0
Sex: F
Vaccine: HPV9, MMR
Symptoms: Conjunctivitis, Rash, Rash macular
Clinical narrative: Fine macular rash on trunk, arms, chest and back. Conjunctivitis. No fever.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: N/a.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large baseball size red, warm raised hard sore to right delt BENADRYL/rotate heat and ice.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to two unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On 25-JAN-2017, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot# M033904 with expiration date 20-JUL-2018) for prophylaxis (strength, dose and route were not provided). The vaccines were exposed to a temperature excursion between 14 Fahrenheit degrees and 46 Fahrenheit degrees for 3 hours. Prior temperature excursion was registered on an unspecified date, between 5 Fahrenheit degrees and 14 Fahrenheit degrees for 25 minutes. The call was placed because of a Digital data logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009272:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection (lot# reported as M035695 expiration date 07-NOV-2017 and lot# reported as M034764 expiration date 26-OCT-2017) for prophylaxis (strength, dose and route were not provided). The vaccines were exposed to a temperature excursion between 14 Fahrenheit degrees and 46 Fahrenheit degrees for 2 hours. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to three unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On multiple unspecified dates, the patients were vaccinated with incorrect stored doses of VARIVAX injection (0.5 ml, lot# M035687 expiration date 18-OCT-2018) for prophylaxis (strength and route were not provided). The vaccines were exposed to a temperature excursion between -10 Celsius degrees and 8 Celsius degrees for 10 hours. The call was placed because of a Digital data logger. No previous temperature excursions and no adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 25-JAN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # M017983 expiration date 30-MAY-2018 (strength, dose and route were not provided) for prophylaxis. It was reported that, on an unspecified date, the vaccine was exposed to a temperature between 32 Fahrenheit degrees and 36 Fahrenheit degrees for 12 hours. The was no previous temperature excursion. No adverse effects were reported. The call was placed because of a Digital Data logger. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA007839.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # M011832 with expiration date 25-JAN-2018 orally (dose, frequency and dose number were unspecified) for prophylaxis. No adverse effects were reported and no product quality complaint was involved. It was stated that the temperature excursion was between 32 and 36 Fahrenheit degrees for a time frame of 14 hours and that there were no previous temperature excursions or digital data logger involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 25-JAN-2017, the patient was vaccinated with an improperly stored doses of ZOSTAVAX injection (lot# M015926 expiration date 28-JUN-2017) for prophylaxis (strength, dose and route were not provided). The vaccines were exposed to a temperature excursion between 14 Fahrenheit degrees and 46 Fahrenheit degrees for 3 hours. Prior temperature excursion was registered on an unspecified date, between 5 Fahrenheit degrees and 14 Fahrenheit degrees for 25 minutes. The call was placed because of a Digital data logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000264:
Age: 12.0
Sex: U
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown gender aged 12 (details unspecified) (reported as family member of the reporter). No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with M-M-R II (dosing details, lot#, expiry date and route were not reported) for prophylaxis. On an unknown date, the patient experienced autism. The outcome of autism was unknown. The relatedness of the event to the therapy with M-M-R II was unknown. There were no product quality complaints (PQC) involved. Upon internal review autism was determined to be medically significant. This case is related to case number 1702USA011534 and 1702USA011535 via same reporter link. Additional information is not expected as the reporter did not wish further contact. Sender's Comments: US-009507513-1702USA011534: US-009507513-1702USA011535.
Age: 17.0
Sex: U
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown gender aged 17 (details unspecified) (reported as family member of the reporter). No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with M-M-R II (dosing details, lot#, expiry date and route were not reported) for prophylaxis. On an unknown date, the patient experienced autism. The outcome of autism was unknown. The relatedness of the event to the therapy with M-M-R II was unknown. There were no product quality complaints (PQC) involved. Upon internal review autism was determined to be medically significant. This case is related to case number 1702USA011531 and 1702USA011535 via same reporter link. Additional information is not expected as the reporter did not wish further contact. Sender's Comments: US-009507513-1702USA011535: US-009507513-1702USA011531.
Age: 15.0
Sex: U
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown gender aged 15 (details unspecified) (reported as family member of the reporter). No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with M-M-R II (dosing details, lot#, expiry date and route were not reported) for prophylaxis. On an unknown date, the patient experienced autism. The outcome of autism was unknown. The relatedness of the event to the therapy with M-M-R II was unknown. There were no product quality complaints (PQC) involved. Upon internal review autism was determined to be medically significant. This case is related to case number 1702USA011531 and 1702USA011534 via same reporter link. Additional information is not expected as the reporter did not wish further contact. Sender's Comments: US-009507513-1702USA011531: US-009507513-1702USA011534.
Sex: U
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of woozy in an unspecified number of patients who received MENVEO. On an unknown date, the patients received MENVEO at an unknown dose. On an unknown date, an unknown time after receiving MENVEO, the patients experienced woozy. On an unknown date, the outcome of the woozy was unknown. It was unknown if the reporter considered the woozy to be related to MENVEO. Additional details were provided as follows: The age at vaccination for the patients was not reported. The reporter said that few patients felt woozy after vaccination with MENVEO vaccine.
Age: 37.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: Fever which started approx 9 days after MMR vaccine. Chills, body aches, rash on face, limbs, trunk beginning 14 days after vaccine. No childhood vaccinations.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Crying, Diet refusal, Hypersomnia, Irritability, Pyrexia
Clinical narrative: Date of onset, baby awoke from nap very irritable, crying, nothing was of comfort. Wouldn't eat. This continued on entire day. Next day, 2/16 baby slept nearly all day, except when I would wake baby to take bath to bring down fever and when I'd wake baby to try and eat/drink. Next day 2/17 baby woke with rash/smooth bumps all over stomach/torso, baby slept nearly all day except when I woke to bathe/attempt to bring down fever and encourage eating/drinking. On 2/18, baby was feeling 'slightly' better, but still very irritated, constantly crying, fever was almost gone. Slept 2 extra hours at nap time and went to bed early. 2/19 baby feeling much better, had interest in playing and eating/drinking. The rash/bumps were starting to fade.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Date of onset, baby awoke from nap very irritable, crying, nothing was of comfort. Wouldn't eat. This continued on entire day. Next day, 2/16 baby slept nearly all day, except when I would wake baby to take bath to bring down fever and when I'd wake baby to try and eat/drink. Next day 2/17 baby woke with rash/smooth bumps all over stomach/torso, baby slept nearly all day except when I woke to bathe/attempt to bring down fever and encourage eating/drinking. On 2/18, baby was feeling 'slightly' better, but still very irritated, constantly crying, fever was almost gone. Slept 2 extra hours at nap time and went to bed early. 2/19 baby feeling much better, had interest in playing and eating/drinking. The rash/bumps were starting to fade.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient got the vaccination not 5 years apart.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Left arm is swollen and rash.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Antinuclear antibody, Anxiety, Autoimmune thyroiditis, Blood thyroid stimulating hormone, C-reactive protein
Clinical narrative: Idiopathic tachycardia- hospitalized and placed on medication. Daily headaches, Fibromyalgia (pain, insomnia, depression and anxiety), Hashimotos thyroiditis (2012, 2014).
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Depression, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Fibromyalgia
Clinical narrative: Idiopathic tachycardia- hospitalized and placed on medication. Daily headaches, Fibromyalgia (pain, insomnia, depression and anxiety), Hashimotos thyroiditis (2012, 2014).
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Headache, Insomnia, Nuclear magnetic resonance imaging, Pain, Stress echocardiogram
Clinical narrative: Idiopathic tachycardia- hospitalized and placed on medication. Daily headaches, Fibromyalgia (pain, insomnia, depression and anxiety), Hashimotos thyroiditis (2012, 2014).
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Tachycardia, Thyroxine, Tilt table test, Tri-iodothyronine
Clinical narrative: Idiopathic tachycardia- hospitalized and placed on medication. Daily headaches, Fibromyalgia (pain, insomnia, depression and anxiety), Hashimotos thyroiditis (2012, 2014).
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On 25-JAN-2017, the patients were vaccinated with improperly stored doses of PROQUAD, (lot number M038860 with an expiration date of 13-MAR-2018, lot number M034692 with an expiration date of 24-JAN-2018, lot number M032496 with an expiration date of 02-JAN-2018, and lot number M023931 with an expiration date of 09-NOV-2017; strength, dose, route of administration and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour and 10 minutes at a temperature of -0.5 degrees Celsius on unspecified date. No previous temperature excursion was reported and a data logger issue was involved. No adverse event and no product quality complaint (PQC) were reported. Additional information has been requested. Sender's Comments: US-009507513-1702USA009658.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received via a company representative from a female patient of unknown age, who is a nurse; referring to herself. The patient's medical history included herpes zoster 20 years ago, approximately in 1997; and gastric bypass.  The patient was not pregnant. The patient's concurrent conditions and drug reactions/allergies were not reported. Concomitant therapies included unspecified antibiotics. Approximately in 2012 (reported as 4 or 5 years ago), the patient was vaccinated with ZOSTAVAX 0.65 ml (route, frequency, lot # and expiration date were not reported) to prevent shingles. Near the end of 2016, the patient broke out with shingles (herpes zoster). None laboratory diagnostic studies were performed. The patient did not seek medical attention and it was unknown if she received any treatment. On an unknown date, the patient recovered from the shingles. The causality between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 64 year old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 13-NOV-2012, the patient was vaccinated with ZOSTAVAX, (dose, frequency, anatomical location, lot # and expiration date were not reported), subcutaneously for prevention of shingles. On 20-NOV-2012, one week after the vaccination with ZOSTAVAX, the patient developed shingles (herpes zoster). The patient sought medical attention from an unspecified primary physician and received an unspecified treatment. It was unknown if laboratory diagnostic studies were performed. At the time of this report, the outcome of the event was unknown. The causality between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to 4 patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reaction/allergies and concomitant medications were not reported. On an unknown date in 2013 (reported as about 4 years ago), the patients were vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, after receiving ZOSTAVAX, the patients were diagnosed with shingles (herpes zoster). On an unknown date, all 4 unspecified patients recovered from the shingles. The causality between shingles and ZOSTAVAX was not reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information was received on 20-FEB-2017 from a pharmacist, who reported unspecified patient received PNEUMOVAX 23 (lot # M036728, expiration date 20-MAY-2018) intramuscularly on 17-FEB-2017. The pharmacist reported that "PNEUMOVAX 23 was diluted with about 0.7 milliliter sterile water." No side effects were reported. No further information was available. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On 25-JAN-2017, the patients were vaccinated with improperly stored doses of VARIVAX (lot number M037008 with an expiration date of 25-AUG-2018, lot number M031969 with an expiration date of 30-JUN-2018, lot number M017292 with an expiration date of 04-APR-2018, and lot number M008173 with an expiration date of 16-FEB-2018; strength, dose, route of administration and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour and 10 minutes at a temperature of -0.5 degrees Celsius on unspecified date. No previous temperature excursion was reported and a data logger issue was involved. No adverse event and no product quality complaint (PQC) were reported. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000894:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 13-FEB-2017, the patients were vaccinated with a dose of improperly stored PROQUAD (route, lot #, expiration date and dosage number were not reported), for prophylaxis. Nevertheless, no adverse effects were noted. The vaccines experienced the following temperature excursions during 6 hours of more than -10 degree Celsius (C) but less than 8 degree C. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001135: US-009507513-1703USA001136: US-009507513-1703USA001137: US-009507513-1703USA001138: US-009507513-1703USA001139.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 year old male patient. The patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. On 27-JAN-2017, the patient was vaccinated with first dose of GARDASIL 9 lot # M028323 with expiration date: 26-SEP-2018, intramuscularly. Then, on 17-FEB-2017 with second dose of GARDASIL 9 lot # M036059 03-JUN-2019, intramuscularly for prophylaxis.   There was no product quality complaint (PQC) involved.   Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 13-FEB-2017, the patients were vaccinated with a dose of improperly stored VARIVAX (route, lot #, expiration date and dosage number were not reported), for prophylaxis. Nevertheless, no adverse effects were noted. (2) The vaccines experienced the following temperature excursions during 6 hours of more than -10 degree celsius (C) but less than 8 degree C. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA009844: US-009507513-1703USA001136: US-009507513-1703USA001137: US-009507513-1703USA001138: US-009507513-1703USA001139:
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Night sweats, Viral upper respiratory tract infection
Clinical narrative: Redness, sweating at night, cold, localized reaction.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Chest pain, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Red, warm, tender, swollen upper arm with pain radiating to lt axilla and chest. ibuprofen and heat.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Tenderness
Clinical narrative: Red, warm, tender, swollen upper arm with pain radiating to lt axilla and chest. ibuprofen and heat.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Arm swollen, itchy, painful to touch.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MEN, MENB, TDAP
Symptoms: Back pain, Chills, Skin warm
Clinical narrative: Child's mother reports that son has been complaining of chills, warm to touch, and lower back pain of vaccinations 02/23/2017. Only continues with back pain now; taking medication that helps. Mother states she has not taking the child to the doctor yet. The mother is encourage to take child to a provider for further evolution.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Arteriogram carotid normal, Blindness unilateral, Coagulation test normal, Nuclear magnetic resonance imaging brain normal, Retinal artery occlusion
Clinical narrative: Occular artery occlusion with resultant unilateral blindness in right eye.
Age: 63.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site bruising
Clinical narrative: Large bruise at injection site still visible when patient came by pharmacy 2pm 3/2/17.
Age: 27.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Computerised tomogram normal, Headache, Injected limb mobility decreased, Injection site erythema, Loss of personal independence in daily activities
Clinical narrative: Chief complaints: Right sided arm pain and not feeling well. Onset: Quickly after Tdap vaccine on 2-21-17 Duration: 1.5 days Severity: Patient has left work early for 2 days in a row. Pain in arm is severe. Reports being unable to have full ROM with right arm.  Characteristics: Patient reports that whole right arm is more swollen then left and there is redness at site of TDaP injection. Reports that when shirt rubs against arm that he is in a lot of pain. Patient also reports experiencing whole body aches and a super bad headache. Reports that he has taken Meloxicam but it "just makes everything worse". Feels like neck is in a lot of pain as well.
Age: 27.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Malaise, Neck pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Chief complaints: Right sided arm pain and not feeling well. Onset: Quickly after Tdap vaccine on 2-21-17 Duration: 1.5 days Severity: Patient has left work early for 2 days in a row. Pain in arm is severe. Reports being unable to have full ROM with right arm.  Characteristics: Patient reports that whole right arm is more swollen then left and there is redness at site of TDaP injection. Reports that when shirt rubs against arm that he is in a lot of pain. Patient also reports experiencing whole body aches and a super bad headache. Reports that he has taken Meloxicam but it "just makes everything worse". Feels like neck is in a lot of pain as well.
Age: 27.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Tenderness
Clinical narrative: Chief complaints: Right sided arm pain and not feeling well. Onset: Quickly after Tdap vaccine on 2-21-17 Duration: 1.5 days Severity: Patient has left work early for 2 days in a row. Pain in arm is severe. Reports being unable to have full ROM with right arm.  Characteristics: Patient reports that whole right arm is more swollen then left and there is redness at site of TDaP injection. Reports that when shirt rubs against arm that he is in a lot of pain. Patient also reports experiencing whole body aches and a super bad headache. Reports that he has taken Meloxicam but it "just makes everything worse". Feels like neck is in a lot of pain as well.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Blindness, Confusional state, Fatigue, Headache, Migraine
Clinical narrative: Mental Confusion, Brain hurt, intermittent blindness, extreme fatigue, severe headache/migraine. Victim fell asleep-slept for about 12 hours as if in a coma.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Somnolence
Clinical narrative: Mental Confusion, Brain hurt, intermittent blindness, extreme fatigue, severe headache/migraine. Victim fell asleep-slept for about 12 hours as if in a coma.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Disturbance in attention, Fatigue, Headache, Incoherent, Swelling face
Clinical narrative: Mental Confusion, Brain hurt, intermittent blindness, extreme fatigue, severe headache/migraine. Victim fell asleep-slept for about 12 hours as if in a coma.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Unresponsive to stimuli, Vision blurred
Clinical narrative: Mental Confusion, Brain hurt, intermittent blindness, extreme fatigue, severe headache/migraine. Victim fell asleep-slept for about 12 hours as if in a coma.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Electroencephalogram, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Limb injury
Clinical narrative: Post left arm injury post Sanofi FLUZONE QUADRIVALENT administration. Staff member reports unable to use left arm from pain in shoulder, numbness in neck and fingers post vaccine.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Post left arm injury post Sanofi FLUZONE QUADRIVALENT administration. Staff member reports unable to use left arm from pain in shoulder, numbness in neck and fingers post vaccine.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Peripheral swelling, Pyrexia
Clinical narrative: Patient complains that her left arm is now swollen, red, and hard. She has a fever of 101. She took TYLENOL, hydroxyzine and SINGULAIR. No rash noted at 10:13. No swelling to face. No complaint of difficulty of swallowing or difficulty breathing.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Left arm continued pain.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Apnoea, Blood culture, Culture urine, Differential white blood cell count, Full blood count
Clinical narrative: Preterm infant with severe apnea requiring resuscitation following administration of PEDIARIX vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Resuscitation, Sepsis
Clinical narrative: Preterm infant with severe apnea requiring resuscitation following administration of PEDIARIX vaccine.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: 24 hrs post vaccination of MENACTRA and BOOSTRIX - pt had red raised itchy area surrounding the site of each vaccine. Left arm (MENACTRA) was larger 8 x 9 cm. Right arm (BOOSTRIX) was 3x3 cm. Started Amoxicillin for possible cellulitis.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased, Irritability
Clinical narrative: Vaccines yesterday. This am rectal temp 101.6. Baby is fussy according to mom.