chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist 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 history provided.  On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # M007728 with an expiration date 21-MAR-2018 for prophylaxis (dose, route of administration were not reported). No adverse symptoms were reported. Administered doses of GARDASIL 9 experienced the temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 3 hours. There was no previous temperature excursion. Digital data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA005006:
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative referring to a 57 year old female patient. There was no information about the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications provided. On 24-MAY-2017, the patient was vaccinated with PNEUMOVAX23 (dose and route were not reported) lot # N010105, expiration date: 15-NOV-2018 for prevention of pneumonia. On an unknown date, the patient experienced arm pain and stiffness in the arm, with difficulty bending the arm and "could not flex". The patient was prescribed a DEPO-MEDROL shot and atenolol by an unspecified provider at the office. The outcome of arm pain and stiffness was unknown. Causality assessment was not reported. A product quality complaint was not involved. Lot # N010105, expiration date: 15-NOV-2018 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 25-MAY-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, 10/1.0 mcrg/ml injection, lot # M043422 with expiration date on 07-JUL-2019 (dose, route and site of administration were not provided). No adverse effects were reported. The vaccine experienced temperature excursion of 47-77 degrees Fahrenheit for 23 hours. There were no previous temperature excursions reported. Digital data logger was used to record the excursion. There was no product quality complaint involved in this case. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA002756.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 25-MAY-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, 10/1.0 mcrg/ml injection, lot # M043422 with expiration date on 07-JUL-2019 (dose, route and site of administration were not provided). No adverse effects were reported. The vaccine experienced temperature excursion of 47-77 degrees Fahrenheit for 23 hours. There were no previous temperature excursions reported. Digital data logger was used to record the excursion. There was no product quality complaint involved in this case. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014492.
Sex: F
Vaccine: MMR
Symptoms: Migraine, Rash, Syncope, Tenderness
Clinical narrative: Information has been received from a consumer, concerning her little sister, a female patient of unknown age. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On approximately 24-MAY-2017 (reported as: 2 weeks ago), the patient was vaccinated with an unspecified dose of M-M-R II (strength, dose number, dose, anatomical location, route of administration, lot number and expiration date were not provided) for routine vaccination. On an unspecified date in 2017, the patient experienced rash, faint, tenderness and migraines; therefore the patient was hospitalized. At the time of the report, the outcome of the patient regarding the hospitalization and the adverse events were not reported. The consumer considered the adverse events to be related to M-M-R II since the reporter consider this as a really badly reaction to the M-M-R II. This is one of three reports received from the same reporter. Additional information is not expected since there reporter did not consent for further follow up. Sender's Comments: US-009507513-1706USA004399: US-009507513-1706USA004400.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, or concomitant therapies were not reported. On 07-JUN-2017, the patient was vaccinated with a properly stored but expired dose of VAQTA injection administered intramuscularly (dose was not reported) lot number K018181 and expiration date 04-JUN-2017, for prophylaxis. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Swelling
Clinical narrative: Information has been received from a consumer, concerning her brother, a male patient of unknown age. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of M-M-R II (strength, dose number, dose, anatomical location, route of administration, lot number and expiration date were not provided) for routine vaccination (prophylaxis). On an unspecified date, the patient experienced swelling and a rash all over his body and a fever that was 104F and lasted for a week. At the time of the report, the patient was recovered from the fever, and the outcome of the patient regarding swelling and a rash all over his body was not reported. The consumer considered the adverse events to be related to M-M-R II since the reporter consider this as a really badly reaction to the M-M-R II. This is one of three reports received from the same reporter. Additional information is not expected since there reporter did not consent for further follow up. Sender's Comments: US-009507513-1706USA004400: US-009507513-1706USA003434.
Sex: U
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a consumer, concerning her/his cousin, a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of M-M-R II (strength, dose number, dose, anatomical location, route of administration, lot number and expiration date were not provided) for routine vaccination (prophylaxis). It was stated that the patien treacted really badly to M-M-R II. At the time of the report, the outcome of the adverse events was not reported. The consumer considered the reacting really badly to be related to M-M-R II. This is one of three reports received from the same reporter. Additional information is not expected since there reporter did not consent for further follow up. Sender's Comments: US-009507513-1706USA003434: US-009507513-1706USA004399.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified number of patients of unknown age and gender. there was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On an unknown date, the patients were vaccinated with an improperly stored PNEUMOVAX23 lot # N003993 with an expiration date 20-OCT-2018 for prophylaxis (dose, route of administration were not reported). No adverse symptoms were reported. Administered doses of PNEUMOVAX23 experienced the temperature excursion form 47 degrees Fahrenheit to 77 degrees Fahrenheit for 3 hours and 30 minutes. There was no previous temperature excursion. A digital data logger was involved. This is one of two reports received from this reported. Additional information has been requested. Sender's Comments: US-009507513-1705USA013801.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable pediatrician communicated to a Pfizer sales representative. A female patient of an unspecified age and race/ethnicity (the grandparent of one of the reporter's patients) received PREVNAR 13 on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced heightened immunologic reaction, like rheumatoid arthritis symptoms. The patient was being managed by a rheumatologist. The event had not yet resolved at the time of report. No follow-up attempts possible. No further information expected.; Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concurrent medical conditions and concomitant medications.  However, a contributory role of PREVENAR 13 might not be completely ruled out towards the occurrence of the serious event heightened immunologic reaction like rheumatoid arthritis symptoms considering the time association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Vaccine associated varicella infection.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Red rash appeared first on forehead and cheeks, then covered almost entire face (chin, nose, cheeks, forehead.) Also patch on belly about 2" varying in height and about 4" long. Patches on backs of both hands and fingers up to his wrists. Transient itchiness mostly in morning. Rash peaked at about 5 days, then started subsiding. At day 7, he was much better. Treated with topical triamcinolone acetonide .1% cream no more than 1x per day (he had maybe 3 treatments total), herbally derived ointment, diphenhydramine, and cetirizine.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Lymphadenopathy, Pain, Peripheral swelling
Clinical narrative: Swelling and redness on arm. Gland or lymph node swelling in pit of arm. Intense pain with mobility. Applied heat initially, but icing was more helpful.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm injection site (Tdap) with redness / swelling approx 3 cm in diameter. Right arm injection site (MENVEO) with redness / swelling approx 5 cm in diameter.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray, Computerised tomogram head, Confusional state, Disorientation, Swallow study
Clinical narrative: On March 26, 2017 my husband was taken to the ER complaining of extreme fatigue and dizziness. At that time he was totally cognizant of his condition. He did not have dementia, he was appropriately forgetful (as I) for an 88 yr. old. After tested for lung x-rays and CT of his brain he was diagnosed with aspiration pneumonia or malignancy in one lung. He was admitted that evening and after being taken to his hospital room, a nurse administered PNEUMOVAX 23 to him. The next morning, I noticed he was confused and somewhat disoriented. After seeing the small card regarding the vaccine I was appalled and complained.
Age: 84.0
Sex: U
Vaccine: PNC13
Symptoms: Anticoagulant therapy, Immediate post-injection reaction, Malaise, Pneumonia
Clinical narrative: 6-8-17. On March 26th 2017-I got the pneumococcal vaccine at my drug store given by the pharmacist. I immediately became ill-by Wed-March 29th I was in hospital with pneumonia and have been in this hospital 3 more times. They can describe my illness and the time I spent there. I have always been healthy as right now at age 84. I am on a blood thinner.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at site of vaccination. Question if SQ approach taken. No fever or rash.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Hyperacusis, Photophobia
Clinical narrative: Mom states after receiving the first GARDASIL vacc. the patient started experiencing light and noise sensitivity. When patient chews he "covers his ears". If someone speaks too loudly, patient will ran off and gets angry, or sometimes cries. Pt not experiencing anymore light sensitivity. Mom not sure when symptoms started after receiving the vaccine.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Crying, Hyperacusis, Photophobia
Clinical narrative: Mom states after receiving the first GARDASIL vacc. the patient started experiencing light and noise sensitivity. When patient chews he "covers his ears". If someone speaks too loudly, patient will ran off and gets angry, or sometimes cries. Pt not experiencing anymore light sensitivity. Mom not sure when symptoms started after receiving the vaccine.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: Onset of rhinorrhea & hives on neck & bilat shoulders, w/in 5 min of vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 31-MAY-2017, the patient was vaccinated with expired ZOSTAVAX (lot # L046896, expiration date 23-FEB-2017) for prophylaxis (dose and route of administration were not reported). The product did not have any temperature excursions prior to administration. No adverse symptoms reported. No product quality complaint was involved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Pyrexia, Urinary tract infection
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 74 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included VALTREX. On 09-MAY-2017, the patient was vaccinated with ZOSTAVAX vial 19400 plaque-forming units (PFU), subcutaneously, lot # reported as M034443, expiration date 20-APR-2017 (dose was not reported) for prophylaxis, and with sterile diluent (strength, dose, frequency, route, lot number, expiration date and indication were not reported). On 18-MAY-2017 (reported as "about 9 days after receiving a dose of ZOSTAVAX"), the patient was diagnosed with a urinary tract infection. On the same day, she consulted her health care provider and started taking MACROBID as treatment. After, taking MACROBID, her fever diminished but she was "still feeling blah". The pharmacist reported that the patient took MACROBID for 7 days. At the time of reporting, the patient "fully recovered" from the events. The causal assessment between the events and the suspect therapies ZOSTAVAX and sterile diluent was not provided. Lot number M034443 is an invalid lot number for zoster vaccine live. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urinary tract infection
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 74 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included VALTREX. On 09-MAY-2017, the patient was vaccinated with ZOSTAVAX vial 19400 plaque-forming units (PFU), subcutaneously, lot # reported as M034443, expiration date 20-APR-2017 (dose was not reported) for prophylaxis, and with sterile diluent (strength, dose, frequency, route, lot number, expiration date and indication were not reported). On 18-MAY-2017 (reported as "about 9 days after receiving a dose of ZOSTAVAX"), the patient was diagnosed with a urinary tract infection. On the same day, she consulted her health care provider and started taking MACROBID as treatment. After, taking MACROBID, her fever diminished but she was "still feeling blah". The pharmacist reported that the patient took MACROBID for 7 days. At the time of reporting, the patient "fully recovered" from the events. The causal assessment between the events and the suspect therapies ZOSTAVAX and sterile diluent was not provided. Lot number M034443 is an invalid lot number for zoster vaccine live. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 07-DEC-2016, the patient received 1 dose of HAVRIX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). In approximately 24-MAY-2017 (reported as an unspecified date "two weeks before 07-JUN-2017"), the patient was vaccinated with a dose of VAQTA 50/1.0 U/ml for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The reporter stated that the patient received the Hepatitis A vaccination series due to a requirement from the patient's nursing school and not due to low titers. No adverse effects were reported.  Additional information is not expected because there was no consent to contact the physician.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot#, dose, route of administration and frequency were unspecified) for prophylaxis. No adverse effects were reported. The vaccines were exposed to a temperature of 47-77 Fahrenheit degrees for a time frame of 9 hours, and there was a previous exposure at the same temperature for a time frame of 16 hours. There was no a digital data logger involved. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002759:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 05-JUN-2017, the patient was vaccinated with an expired and improperly stored dose of ZOSTAVAX (lot # M010486, expiration date: 25-MAY-2017) (route of administration and frequency were unspecified) for prophylaxis. The vaccine was exposed to a temperature of 15-46 Fahrenheit degrees for a time frame of 2 hours. It was reported that there were no previous excursions and that a data logger was involved. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 16-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9, (lot number and expiration date not reported) and then on 27-MAY-2016, the patient was vaccinated with a dose of GARDASIL 9 lot number L004014 with expiration date 04-MAR-2017 which was outside of their prescribed information, both vaccines intramuscularly, (dose and anatomical location were not reported for the both vaccines above described) for prophylaxis. No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This report was received via a sales representative. A 65-year-old female patient receive PREVNAR 13 Lot # N97936, exp date Nov2018, via an unspecified route of administration on 18Apr2017 at 0.5ml single for prevention of Pneumococcal Pneumonia. The patient medical history and concomitant medications were not reported. The patient stated the injection area was red, swollen and hot to the touch on Apr2017 with outcome of recovered. Symptoms lasted about 10 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Induration, Pain, Skin warm
Clinical narrative: Warmth, pain, redness, swelling, hardness. Patient received vaccine on 6/3/17 and symptoms were unresolved on 6/5/17. She was seen  by her MD who diagnosed her with cellulitis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Warmth, pain, redness, swelling, hardness. Patient received vaccine on 6/3/17 and symptoms were unresolved on 6/5/17. She was seen  by her MD who diagnosed her with cellulitis.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult male patient who received Hepatitis B vaccine (batch number A4NV8909AB ?, expiry date 15th November 2017. GSK note: the reported lot number did not match with any GSK lot number. Clarification has been requested). On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were provided as follows: The healthcare professional reported that after the patient received Hepatitis B in 2010 and had titer read, that showed no immunity. No side effects were reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Child received vaccines around 10:45 am and left office around 11:00 am. Within minutes from leaving the office, around 11:15 am the child developed hives on face, ears and neck. Mom gave BENADRYL and called nurse triage line. Child was scheduled for office evaluation at 12:30 pm. Presented in office with resolving urticaria/ wheals. DX with allergic urticaria. No further treatment given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Onset of warmth, redness, tenderness and swelling about 48 hours after receiving vaccine. It ultimately lasted for around a couple of weeks. No treatment was given other than the patient iced the area to make it more comfortable.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood test normal, Cardiac monitoring normal, Cardiac stress test normal, Chills
Clinical narrative: Dizziness, nausea, chills, extreme swelling at injection site, blanked out causing a fall due to extreme light-headedness, very low heart rate, extreme fatigue (sleeping 12 hrs at a time) and having no energy when awake.  It has been over 2 months and still experiencing light-headed mess.  Cardiologist did ekg, stress test, ecko cardiogram, heart monitor, and blood work and concluded that there is no problem with the heart.  GP who administered the vaccine said she never heard of having these side effects from the PNEUMOVAX 23 pneumonia vaccine but I felt perfectly fine prior to receiving the shot.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Echocardiogram normal, Electrocardiogram normal, Fall, Fatigue
Clinical narrative: Dizziness, nausea, chills, extreme swelling at injection site, blanked out causing a fall due to extreme light-headedness, very low heart rate, extreme fatigue (sleeping 12 hrs at a time) and having no energy when awake.  It has been over 2 months and still experiencing light-headed mess.  Cardiologist did ekg, stress test, ecko cardiogram, heart monitor, and blood work and concluded that there is no problem with the heart.  GP who administered the vaccine said she never heard of having these side effects from the PNEUMOVAX 23 pneumonia vaccine but I felt perfectly fine prior to receiving the shot.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Heart rate decreased, Hypersomnia, Injection site swelling, Loss of consciousness, Nausea
Clinical narrative: Dizziness, nausea, chills, extreme swelling at injection site, blanked out causing a fall due to extreme light-headedness, very low heart rate, extreme fatigue (sleeping 12 hrs at a time) and having no energy when awake.  It has been over 2 months and still experiencing light-headed mess.  Cardiologist did ekg, stress test, ecko cardiogram, heart monitor, and blood work and concluded that there is no problem with the heart.  GP who administered the vaccine said she never heard of having these side effects from the PNEUMOVAX 23 pneumonia vaccine but I felt perfectly fine prior to receiving the shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching to face, arms, back. Child was given 25mg of BENADRYL.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Computerised tomogram head normal, Differential white blood cell count normal, Drug screen negative, Dyspnoea, Enuresis
Clinical narrative: Seizure:  Pt came home from school (early release around 1 pm), wanted to take a nap, body was very hot, M gave kids ibuprofen and pt laid down. Within 5 min M heard gasping noise. Found pt with saliva in mouth and puddle next to face. Limp, shaking (all arms and legs). Pale, whole body was white. Had enuresis. M felt that pt was gasping/trying to breathe. Called 911. Whole episode lasted 15-20 sec. After episode pt seemed "out of it" and not as responsive as usual, by time EMS put in IV she was fighting. Very sleepy upon arrival to hospital, took nap. Woke up and was pretty much back to normal self in ER.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Feeling abnormal, Feeling hot, Full blood count normal, Hypotonia, Increased upper airway secretion
Clinical narrative: Seizure:  Pt came home from school (early release around 1 pm), wanted to take a nap, body was very hot, M gave kids ibuprofen and pt laid down. Within 5 min M heard gasping noise. Found pt with saliva in mouth and puddle next to face. Limp, shaking (all arms and legs). Pale, whole body was white. Had enuresis. M felt that pt was gasping/trying to breathe. Called 911. Whole episode lasted 15-20 sec. After episode pt seemed "out of it" and not as responsive as usual, by time EMS put in IV she was fighting. Very sleepy upon arrival to hospital, took nap. Woke up and was pretty much back to normal self in ER.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Laboratory test normal, Pallor, Salivary hypersecretion, Seizure, Skin discolouration
Clinical narrative: Seizure:  Pt came home from school (early release around 1 pm), wanted to take a nap, body was very hot, M gave kids ibuprofen and pt laid down. Within 5 min M heard gasping noise. Found pt with saliva in mouth and puddle next to face. Limp, shaking (all arms and legs). Pale, whole body was white. Had enuresis. M felt that pt was gasping/trying to breathe. Called 911. Whole episode lasted 15-20 sec. After episode pt seemed "out of it" and not as responsive as usual, by time EMS put in IV she was fighting. Very sleepy upon arrival to hospital, took nap. Woke up and was pretty much back to normal self in ER.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Somnolence, Tremor, Unresponsive to stimuli
Clinical narrative: Seizure:  Pt came home from school (early release around 1 pm), wanted to take a nap, body was very hot, M gave kids ibuprofen and pt laid down. Within 5 min M heard gasping noise. Found pt with saliva in mouth and puddle next to face. Limp, shaking (all arms and legs). Pale, whole body was white. Had enuresis. M felt that pt was gasping/trying to breathe. Called 911. Whole episode lasted 15-20 sec. After episode pt seemed "out of it" and not as responsive as usual, by time EMS put in IV she was fighting. Very sleepy upon arrival to hospital, took nap. Woke up and was pretty much back to normal self in ER.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Hardness at injection site the night of injection per patient. Redness started the next morning. Redness on 6/12/17 measured approx. 15cm.
Age: 63.0
Sex: F
Vaccine: HEP, MMR, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt c/o itching on the back of her Left arm  over the site of her MMR vaccine. Pt received 3 vaccines that day. Only reacted to one. Had a red circle, ~1.5 inch diameter, over site of injection. Back of arm was also reddened where pt had been itching. Pt was going to put anti-itch cream on arm to help with itching. Said she would call if reaction worsened at all.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Dizziness, Headache, Nausea, Tremor
Clinical narrative: Patient had 3 vaccines, felt fine after this, went out to lunch, then felt nauseated, dizzy, headache 2 hours later. Called EMS. They came and found her shaky and nauseated. Gave her TYLENOL and GATORADE, then she took a nap and woke up feeling better. Did not transport her.
Age: 1.5
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient given expired dose of MMR. No reaction for patient.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient had fainting spell after vaccine was given.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptom repot. Vaccine expired on 5-1-17. Vaccine given 5-16-17; will repeat dose 6/30/17.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Incisional drainage, Wound, Wound infection
Clinical narrative: Doctor - general surgery saw pt on 8/10/16 for R thigh wound - Outpatient surgery on 8/12/16 for incision and drainage of infected R thigh wound. Last seen on 8/22/16 for post op check - healing and will take probably another 4-6 weeks.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Local reaction
Clinical narrative: Localized vaccine reaction (L) arm (9 cm x 10 cm).
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Cellulitis Left upper arm, mild fever. Rx cephalexin 500mg 4xd x 5 days.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Swelling and redness of left arm. He presented to clinic 6/3/2017 for the swelling and redness and was daignosed with Cellulitis and given antibiotics and arm was marked. He returned there the next day because the swelling had spread furthur although redness had faded. He was given a different antibiotic to start if the swelling worsened.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia, Varicella post vaccine
Clinical narrative: Fever 100.7 F, joint achiness, myalgias, headache on 06/04/2017, developed chickenpox lesions on face, scalp, chest and body on 06/06/2017.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Injection site nodule, Pain in extremity
Clinical narrative: Knot in deltoid persists for one month following injection; joint pain in fingers; pain in left arm (injection in left deltoid).
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Syncope
Clinical narrative: Pt with syncope within minutes of HPV # 1 admin. Brief loc, became pale - safely laid on exam table BP 90/52 - 15 min later, 118/66, alert oriented x3. Patient fasting.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Pt received the 1st GARDASIL 9 vaccine this morning. Within 2-3 minutes he became pale and fainted, was assisted to ground. His vital signs were monitored, legs elevated, cool rag on forehead. He awoke within 1 minute or less, color improved. He did report some lingering dizziness. He had history of fainting during an xray. He was given hard candy, juice, water. Was monitored in office approx. 50 minutes before discharge home. Initially BP 146/74, HR 90. At discharge BP 111/73, HR 67.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis. Tx- EPI, KENALOG, monitoring symptoms resolved with treatment.
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: DTaP 5 given on (L) arm that resulted with 4 inches (10 cm) induration and redness with local pain.
Age: 39.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: (R) arm redness, swelling and itching. States she noticed it when she got home and it was that way all weekend. She took TYLENOL Friday. Her NP put cold pack and gave BENADRYL topically.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. Spreading under arm. Reported on 6-12-17. Went to doctor on 6-12-17 and diagnosed with cellulitis. Given DURICEF antibiotic.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: Per provider, pt. had dizziness x 12 hours, and had emesis x 2 weeks.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red spots on her left leg, Patient was asked to take BENADRYL 50mg by his PCP.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient contacted pharmacy complaining of a red, swollen, painful rash 6 inches wide around the vaccine injection site.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram, Fatigue, Influenza virus test negative
Clinical narrative: The pt is a healthy 24 yo who was admitted with concern for myopericarditis. The patient states he received the smallpox vaccination about 10 days prior to chest pain development. However he states that he started getting low grade fever, body aches and fatigue about 3-4 days after immunization. He then came to work and reports that on Saturday he had high fever up to 103F and developed sharp chest pain that was constant but worse with inspiration. He also note 2 episodes of syncope on Thursday. He states he was walking and suddenly woke up on the ground. He denies any prodromal of palpitations or light headedness and he did not suffer any signs of trauma. Cardiologist reports: The patient's symptoms of pleuritic chest pain is consistent with pericarditis. He has elevated troponin consistent with myocarditis. His EKG is consistent with both given tachycardia and PR depression/elevation (for pericarditis) and TWI diffuse which is more of a myocarditis. Currently starting treatment for pericarditis with ASA 650mg TID and colchicine, and discontinue ASA when pain resolves.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Myocarditis, Pain, Painful respiration, Pleuritic pain, Pyrexia
Clinical narrative: The pt is a healthy 24 yo who was admitted with concern for myopericarditis. The patient states he received the smallpox vaccination about 10 days prior to chest pain development. However he states that he started getting low grade fever, body aches and fatigue about 3-4 days after immunization. He then came to work and reports that on Saturday he had high fever up to 103F and developed sharp chest pain that was constant but worse with inspiration. He also note 2 episodes of syncope on Thursday. He states he was walking and suddenly woke up on the ground. He denies any prodromal of palpitations or light headedness and he did not suffer any signs of trauma. Cardiologist reports: The patient's symptoms of pleuritic chest pain is consistent with pericarditis. He has elevated troponin consistent with myocarditis. His EKG is consistent with both given tachycardia and PR depression/elevation (for pericarditis) and TWI diffuse which is more of a myocarditis. Currently starting treatment for pericarditis with ASA 650mg TID and colchicine, and discontinue ASA when pain resolves.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Syncope, Tachycardia, Troponin increased
Clinical narrative: The pt is a healthy 24 yo who was admitted with concern for myopericarditis. The patient states he received the smallpox vaccination about 10 days prior to chest pain development. However he states that he started getting low grade fever, body aches and fatigue about 3-4 days after immunization. He then came to work and reports that on Saturday he had high fever up to 103F and developed sharp chest pain that was constant but worse with inspiration. He also note 2 episodes of syncope on Thursday. He states he was walking and suddenly woke up on the ground. He denies any prodromal of palpitations or light headedness and he did not suffer any signs of trauma. Cardiologist reports: The patient's symptoms of pleuritic chest pain is consistent with pericarditis. He has elevated troponin consistent with myocarditis. His EKG is consistent with both given tachycardia and PR depression/elevation (for pericarditis) and TWI diffuse which is more of a myocarditis. Currently starting treatment for pericarditis with ASA 650mg TID and colchicine, and discontinue ASA when pain resolves.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blindness, Chills, Hypotonia, Immediate post-injection reaction, Mydriasis
Clinical narrative: Immediately after the shot was given, child began to shiver, within a minute or so after eyes were dilated, and the child walked to her mother and said she could not see and lost all color. Seeing she was going to faint the nurses brought her to an exam room and she went limp and fainted. They sat her down. She came to and was administered a Pedialyte ice pop. Stayed about 10 minutes and color returned and was able to walk out. This child never had an adverse reaction to any other shot before.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Syncope
Clinical narrative: Immediately after the shot was given, child began to shiver, within a minute or so after eyes were dilated, and the child walked to her mother and said she could not see and lost all color. Seeing she was going to faint the nurses brought her to an exam room and she went limp and fainted. They sat her down. She came to and was administered a Pedialyte ice pop. Stayed about 10 minutes and color returned and was able to walk out. This child never had an adverse reaction to any other shot before.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: HIVES ON AFFECTED FOREARM STARTING AT BEND IN ARM.
Sex: U
Vaccine: MENB
Symptoms: Local reaction, Product quality issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a patient who received BEXSERO (batch number 1645401A, expiry date April 2018) and (batch number 165401A, expiry date April 2018). This case was associated with a product complaint. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced local reaction and product complaint. On an unknown date, the outcome of the local reaction and product complaint were unknown. It was unknown if the reporter considered the local reaction to be related to BEXSERO. Additional details were reported as follows: The patient developed a local reaction after receiving a dose of BEXSERO. One of the reactions was severe enough, it required the patient to follow up with an orthopaedic doctor. The healthcare provider was on a tight schedule and didn't have time to go through the adverse event details with the reporter. The physician said she would try and call back on Tuesday, 6th June 2017 with more details. This case is one of the 3 cases which were reported by the same reporter for the patients who received the same lot of BEXSERO. The batch number reported for BEXSERO could 165401A or 1645401A, clarification has been requested for the same. No further details were given.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Extensive swelling of vaccinated limb, Feeling hot, Injection site erythema, Skin warm
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received MENVEO (batch number MT6084, expiry date April 2018). Concurrent medical conditions included multiple allergies (allergy to cats, tree nuts and peanuts). On 30th May 2017 16:30, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. In May 2017, less than a week after receiving MENVEO, the patient experienced injection site erythema and feeling hot. On 30th May 2017 18:30, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and feeling hot were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and feeling hot to be related to MENVEO. Additional details were provided as follows: The case was reported by an office manager. The patient received MENVEO in right deltoid. Approximately 2 hours after vaccination, the patient experienced swelling on the right arm. On 31st May 2017, the swelling was increased and redness was also noted. The physician's office was notified. On 1st June 2017, the patient returned to the office with extreme swelling, redness and warmth in an area of the right arm measured as 6 inches in length and 5.5 inches in width. The patient was able to lift the arm.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received MENVEO (batch number MT6084, expiry date April 2018). Concurrent medical conditions included multiple allergies (allergy to cats, tree nuts and peanuts). On 30th May 2017 16:30, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. In May 2017, less than a week after receiving MENVEO, the patient experienced injection site erythema and feeling hot. On 30th May 2017 18:30, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and feeling hot were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and feeling hot to be related to MENVEO. Additional details were provided as follows: The case was reported by an office manager. The patient received MENVEO in right deltoid. Approximately 2 hours after vaccination, the patient experienced swelling on the right arm. On 31st May 2017, the swelling was increased and redness was also noted. The physician's office was notified. On 1st June 2017, the patient returned to the office with extreme swelling, redness and warmth in an area of the right arm measured as 6 inches in length and 5.5 inches in width. The patient was able to lift the arm.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Redness and lump at site, minor itching.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: 4/24/17 Fever and rash. 5/1/17 Rash changed. 5/12/17 Rash resolved.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Intestinal resection, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Given ROTARIX 6-2-2017 called on 6-7-17 with vomiting led to visit-US showed intussusception hosp. 6-7 through 6-13 lost 15 cm ileum surgery.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Enema administration, Ileectomy, Intussusception, Surgery, Ultrasound abdomen abnormal
Clinical narrative: Given ROTARIX 6-2-2017 called on 6-7-17 with vomiting led to visit-US showed intussusception hosp. 6-7 through 6-13 lost 15 cm ileum surgery.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Given ROTARIX 6-2-2017 called on 6-7-17 with vomiting led to visit-US showed intussusception hosp. 6-7 through 6-13 lost 15 cm ileum surgery.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Patient said have redness on bicep area. Patient said tender to touch and warm. Advised patient to check with her doctor. Doctor prescribed her an antibiotic just in case of a bacterial infection. Patient did not report any issues since.
Age: 0.5
Sex: F
Vaccine: PNC10
Symptoms: Adverse reaction, Contusion, Haemoglobin decreased, Immune thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: First, where the vaccine were administered which wasn't healing, it turned brown. A bruise appeared in her leg, everyday a bruise would come up especially in that area, then red dots appeared in her arms and tongue and a big purple black bruise on her palatal. It took us several days to figure out it was something that was not normal, therefore we took her to the ER in April 6th, 2015 around 3:00am. Her labs results came back with an alarming platelet count of 1k. Labs were repeated after more than 5 nurses tried to draw blood from different areas of her body because non of her veins worked. She was rushed in ambulance to a Hospital with Pediatric Hematology services. She was admitted in ICU and they administered Intravenousl Imuno Globulins. She had an adverse reaction to the treatment and her hemoglobin dropped.