chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Fall, Muscle rigidity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 604981) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient's concomitant therapies, concurrent illnesses and pertinent medical history were not reported. This was patient's first visit to that clinic. On 23-OCT-2015 the patient was vaccinated with FLUARIX lot # DF92Z (dose, frequency and lot expiration date were not reported) for prophylaxis, in the left arm intramuscularly and there were no signs/symptoms. The patient was then vaccinated with GARDASIL 9 lot # L004014 dose 1, intramuscularly (dose, frequency and lot expiration date were not reported) in the right arm for prophylaxis. Post vaccine administration, as the patient was talking she closed her eyes and fell forward (hyporesponsive collapse) onto the lap. The patient was slowly transferred to the floor and had another employee call her father in the room. The patient then experienced muscle rigidity. Her arms and legs went rigid for about 8 seconds and then she opened her eyes. The patient's father was now in the room and stated she has done this before with a finger stick. He also stated both he and his daughter also faint with vaccines and blood draws. The patient then sat up without assistance, spoke clearly and appropriately and stood without assistance. She was observed for an additional 10 minutes, patient denied dizziness and other symptoms. She then walked out of clinic and the father stated she will be back in 2 months for her second dose of human papillomavirus (HPV) vaccine. The outcome of events fall and muscle rigidity was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 605933). This spontaneous report refers to a 13 year old male patient. Patient had no concurrent illnesses and medical history. Patient's other medication included ibuprofen, prn only. On 28-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L013429, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5172AA, dose 1, intramuscularly in the left arm and (cold adapted ann arbor master strain) FLUMIST QUADRIVALENT lot # FJ2100, dose 1, via intranasal route for prophylaxis. On 28-OCT-2015, approximately 7 minutes after vaccines were administered, the patient fainted from a standing position and had no injury. Patient was responsive but he was dizzy and pale. Patient's blood pressure (BP) was within normal limits (WNL). Patient had full recovery after about 7-10 minutes of rest. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 607459). This spontaneous report refers to a 11 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 02-NOV-2015, the patient was vaccinated with GARDASIL 9 lot # L013429, intramuscular in the left thigh for prophylaxis. On the same day patient was also vaccinated with BOOSTRIX lot # D43LR, intramuscularly in right leg; FLUARIX lot # 4M4F3, intramuscularly in the left arm and MENACTRA lot # U4021AE, intramuscularly in the right arm for prophylaxis. On 04-NOV-2015, the patient developed 3.5 x 2.5 redness and swelling at injection site (left thigh). The outcome of injection site erythema and injection site swelling was reported as recovered. The causality assessment of the events injection site erythema and injection site swelling with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-608418). This spontaneous report refers to a 11 year old female patient. The patient had no medical history and concurrent conditions. On 30-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L016429 (unspecified dosage regimen) in the right arm for prophylaxis. Other suspect therapies included ADACEL dose 1 in the left arm, FLUZONE dose 4 in the left arm and MENACTRA in the right arm. On the same day, the patient had deltoid swollen area with erythema 3 cm x 3 cm patch with warmth. The patient was taken to emergency room. The outcome of injection site erythema, injection site warmth and injection site swelling was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-611999). This spontaneous report refers to a 13 year old male patient. No medical history, concurrent conditions and concomitant medications were reported. Other medications included NASONEX 50MCG/ACT, 1 spray in each nostril, once a day (qd), PROAIR HFA 108 MCG/ACT 2-4 puffs every 4 hours as and when required (PRN), SYMBICORT 80-4.5 MCG/ACT, 1 puff qd. On 23-NOV-2015 the patient was seen for a white cell count (WCC) and had a blood draw and later vaccinated with GARDASIL 9 lot # L028083 dose 3 (unspecified dosage regimen), intramuscular in the right arm for prophylaxis. The patient was advised to wait in the room for few minutes. The patient went out to the front desk to leave without waiting. He felt dizzy and passed outside the room. He fell from standing position to the floor with loss of consciousness and head injury as he hit his head off floor. The patient required emergency room visit. The outcome of dizziness, loss of consciousness, head injury and fall was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613403) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old male patient. The patient's concomitant medications, pertinent medical history, current illnesses and prior vaccinations were not reported. On 23-NOV-2015, the patient was vaccinated with GARDASIL 9 lot # L013429 dose number 1, (dose, frequency and lot expiration date were not reported) intramuscularly in the right arm for prophylaxis. Other suspect therapies included MENVEO, (vaccinated date: 23-NOV-2015, lot # M15035, intramuscularly in the right arm, dose number 1, dose, frequency and lot expiration date were not reported) BOOSTRIX (vaccinated date: 23-NOV-2015, lot # 9NA32, intramuscularly in the left arm, dose number 1, dose, frequency and lot expiration date were not reported) and VAQTA (vaccinated date: 23-NOV-2015, lot # L023232, intramuscularly in the left arm, dose number 2, dose, frequency and lot expiration date were not reported) for prophylaxis. On 23-NOV-2015 after receiving the vaccines, the patient suddenly appeared pale (pallor) and fainted (syncope). The patient was lowered to the floor and legs were elevated. The patient responded within two minutes and was oriented X3. The patient reported that before he fainted he felt weak (asthenia) and dizzy (dizziness). His vital signs showed. BP: 103/74, Pulse: 65 and respiration was WNL (within normal limits). The patient was assisted to a chair and offered orange juice. At 9:43am, the patient was taken to the emergency room via wheel chair to be evaluated by a physician and was accompanied by RN (registered nurse) and his mother. The outcome of asthenia, syncope, pallor and dizziness was reported as recovered. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Abnormal behaviour, Aphasia, Autism spectrum disorder, Decreased eye contact, Encephalopathy
Clinical narrative: He woke up with a fever of 103.5, we treated with alternating MOTRIN and TYLENOL. His fever would go down after TYLENOL or MOTRIN was given and then would go back up as soon as the medication would wear off. He had a high fever for about a week and a half following this vaccine. He was diagnosed with encephalopathy. He had his MMR titers drawn in Nov 2016 and he had greater than 300 AU/ml antibodies to rubeola. The lab that performed the test questioned if he had an active case of rubeola because the values were so high. He had a result of 68.7 AU/ml antibodies to mumps. He was progressing as a normal toddler until he received this round of vaccinations. After his fever subsided he no longer spoke, he no longer made eye contact and he would no longer allow us to hug him. He was diagnosed with autism in April 2016.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Measles antibody positive, Mumps antibody test positive, Pyrexia, Rubella antibody test
Clinical narrative: He woke up with a fever of 103.5, we treated with alternating MOTRIN and TYLENOL. His fever would go down after TYLENOL or MOTRIN was given and then would go back up as soon as the medication would wear off. He had a high fever for about a week and a half following this vaccine. He was diagnosed with encephalopathy. He had his MMR titers drawn in Nov 2016 and he had greater than 300 AU/ml antibodies to rubeola. The lab that performed the test questioned if he had an active case of rubeola because the values were so high. He had a result of 68.7 AU/ml antibodies to mumps. He was progressing as a normal toddler until he received this round of vaccinations. After his fever subsided he no longer spoke, he no longer made eye contact and he would no longer allow us to hug him. He was diagnosed with autism in April 2016.
Age: 16.0
Sex: F
Vaccine: HPV9, MEN, HPV9, MNQ
Symptoms: Generalised tonic-clonic seizure, Urinary incontinence
Clinical narrative: Initial unsolicited report received from a nurse on 07-APR-2017. This case involves a 16-year-old female patient who was vaccinated with an intramuscular second dose of MENACTRA (batch number: U5556BA expiry date 29 Apr 2018) in right deltoid and an intramuscular first dose of GARDASIL 9 manufacturer: Merck, batch number: M043731 in left deltoid on 04-APR-2017. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none and concomitant medications was not reported. On 04-APR-2017, same day following the vaccination, the patient experienced a syncopal episode followed by tonic/clonic movements, loss of consciousness (LOC), arched back and loss of bladder control for 30 seconds. Pt scheduled for follow up with neurologist. It was reported that the patient received a first dose of MENACTRA on an unspecified date in past 5 years ago and did not experience any adverse event post the vaccination. Lab data included on 04-APR-2017, patient's EEG was performed results were pending. Corrective treatment was not reported. On 04-APR-2017, the patient recovered from all the events (reported as events remain for 30 seconds). Upon medical review, the case was considered as serious due to important medical event: Tonic clonic movements, Loss of consciousness and Opisthotonus. List of documents held by sender: none.; Sender's Comments: Patient was vaccinated with MENACTRA and GARDASIL 9 following which patient experienced syncope episode followed by tonic clonic movements, loss of consciousness, arched back and loss of bladder control for 30 seconds. Additional information regarding time to onset, patient medical history, neurological disorder, EEG report and other etiological workup are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 16.0
Sex: F
Vaccine: HPV9, MEN, HPV9, MNQ
Symptoms: Electroencephalogram, Loss of consciousness, Opisthotonus, Syncope, Tonic clonic movements
Clinical narrative: Initial unsolicited report received from a nurse on 07-APR-2017. This case involves a 16-year-old female patient who was vaccinated with an intramuscular second dose of MENACTRA (batch number: U5556BA expiry date 29 Apr 2018) in right deltoid and an intramuscular first dose of GARDASIL 9 manufacturer: Merck, batch number: M043731 in left deltoid on 04-APR-2017. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none and concomitant medications was not reported. On 04-APR-2017, same day following the vaccination, the patient experienced a syncopal episode followed by tonic/clonic movements, loss of consciousness (LOC), arched back and loss of bladder control for 30 seconds. Pt scheduled for follow up with neurologist. It was reported that the patient received a first dose of MENACTRA on an unspecified date in past 5 years ago and did not experience any adverse event post the vaccination. Lab data included on 04-APR-2017, patient's EEG was performed results were pending. Corrective treatment was not reported. On 04-APR-2017, the patient recovered from all the events (reported as events remain for 30 seconds). Upon medical review, the case was considered as serious due to important medical event: Tonic clonic movements, Loss of consciousness and Opisthotonus. List of documents held by sender: none.; Sender's Comments: Patient was vaccinated with MENACTRA and GARDASIL 9 following which patient experienced syncope episode followed by tonic clonic movements, loss of consciousness, arched back and loss of bladder control for 30 seconds. Additional information regarding time to onset, patient medical history, neurological disorder, EEG report and other etiological workup are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 16.0
Sex: F
Vaccine: HPV9, MEN, HPV9, MNQ
Symptoms: Urinary incontinence
Clinical narrative: Initial unsolicited report received from a nurse on 07-APR-2017. This case involves a 16-year-old female patient who was vaccinated with an intramuscular second dose of MENACTRA (batch number: U5556BA expiry date 29 Apr 2018) in right deltoid and an intramuscular first dose of GARDASIL 9 manufacturer: Merck, batch number: M043731 in left deltoid on 04-APR-2017. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none and concomitant medications was not reported. On 04-APR-2017, same day following the vaccination, the patient experienced a syncopal episode followed by tonic/clonic movements, loss of consciousness (LOC), arched back and loss of bladder control for 30 seconds. Pt scheduled for follow up with neurologist. It was reported that the patient received a first dose of MENACTRA on an unspecified date in past 5 years ago and did not experience any adverse event post the vaccination. Lab data included on 04-APR-2017, patient's EEG was performed results were pending. Corrective treatment was not reported. On 04-APR-2017, the patient recovered from all the events (reported as events remain for 30 seconds). Upon medical review, the case was considered as serious due to important medical event: Tonic clonic movements, Loss of consciousness and Opisthotonus. List of documents held by sender: none.; Sender's Comments: Patient was vaccinated with MENACTRA and GARDASIL 9 following which patient experienced syncope episode followed by tonic clonic movements, loss of consciousness, arched back and loss of bladder control for 30 seconds. Additional information regarding time to onset, patient medical history, neurological disorder, EEG report and other etiological workup are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 24.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Brachial plexopathy, Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscle atrophy
Clinical narrative: C5, possibly C6 plexopathy; Pain, weakness (L) arm. Atrophy of (L) deltoid muscle.
Age: 24.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Musculoskeletal pain, Pain in extremity, Radicular pain, Radiculitis brachial, Rotator cuff syndrome
Clinical narrative: C5, possibly C6 plexopathy; Pain, weakness (L) arm. Atrophy of (L) deltoid muscle.
Age: 24.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Brachial plexopathy, Injection site atrophy, Muscular weakness, Pain in extremity
Clinical narrative: C5, possibly C6 plexopathy; Pain, weakness (L) arm. Atrophy of (L) deltoid muscle.
Age: 15.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Rash, hives.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome given antibodies.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified adult patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was inadvertently administered only one dose of 5 microgram (mcg) of RECOMBIVAX HB (lot#, expiration date, and route were unknown) for prophylaxis, instead of two doses to make the combined total dose of 10 mcg.  No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the office manager referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. Between the dates of 27-OCT-2016 through 30-MAR-2017, the patients were vaccinated with improperly stored doses of M-M-R II (dose and route unknown, lot # L026551, expiration date 16-JUL-2017; lot # L026551, expiration date 16-JUL-2017; lot # M016234, expiration date 31-MAR-2018; lot # M015930, expiration date 29-MAR-2018) for prophylaxis, which were exposed to temperature excursion, a total time in the range of 47°Fahrenheit (F) to 77°F, for a time frame of 8 hours. There was a previous temperature excursion, the total time in the range 47°F to 77°F for 8 hours. The call was due to a "data logger". No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013739: US-009507513-1703USA013740: US-009507513-1703USA013741: US-009507513-1703USA013742: US-009507513-1703USA013155:
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13, TDAP
Symptoms: Wrong drug administered
Clinical narrative: INFANRIX ordered, BOOSTRIX given.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Condition aggravated, Eczema, Food allergy, Gastrooesophageal reflux disease, Hypersensitivity
Clinical narrative: Gradual onset of allergic responses to diet (that previously was not a problem) including increase of GERD symptoms, weight loss, and eczema. Changed diet on 11/24/2016 to hypoallergenic formula and patient showed gradual improvement of symptoms. Allergy skin test was postponed until 3/23/2017 for accuracy. Skin test confirmed severe allergies to milk, eggs, peanuts, tree nuts, and soy. No genetic history of allergies.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Milk allergy, Skin test positive, Weight decreased
Clinical narrative: Gradual onset of allergic responses to diet (that previously was not a problem) including increase of GERD symptoms, weight loss, and eczema. Changed diet on 11/24/2016 to hypoallergenic formula and patient showed gradual improvement of symptoms. Allergy skin test was postponed until 3/23/2017 for accuracy. Skin test confirmed severe allergies to milk, eggs, peanuts, tree nuts, and soy. No genetic history of allergies.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness; firmness and warmth noted left deltoid; approximately 5cm. in diameter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Redness; firmness and warmth noted left deltoid; approximately 5cm. in diameter.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MEN
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Within 15 minutes of injection patient passed out and went into a seizure.
Age: 26.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: Generalized patchy maculopapular rash with erythema anteriorly & posteriorly; Patient received Prednisone from Dr. (PCP).
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain and swelling right thigh where injection was given.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 14-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 71.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Headache, Influenza, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a 71-year-old female patient who received ENGERIX B adult (batch number 35G7C, expiry date 1st February 2019). Previously administered products included ENGERIX B adult (1st dose with no adverse event) and ENGERIX B adult (2nd dose with no adverse event). On 6th April 2017, the patient received the 3rd dose of ENGERIX B adult. In April 2017, less than a week after receiving ENGERIX B adult, the patient experienced influenza, cold, fever, vomiting, chills, headache and general body pain. On an unknown date, the outcome of the influenza, cold, fever, vomiting, chills, headache and general body pain were recovering/resolving. It was unknown if the reporter considered the influenza, cold, fever, vomiting, chills, headache and general body pain to be related to ENGERIX B adult. Additional details were reported as follows: The pharmacist reported that the patient received a dose in series of ENGERIX-B the day before reporting date and called back to report the symptoms of vomiting, fever, chills, headaches and body aches. The patient and pharmacist stated that the symptoms might be the result of a flu or cold. No further information was reported regarding the event.
Age: 71.0
Sex: F
Vaccine: HEP
Symptoms: Viral upper respiratory tract infection, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a 71-year-old female patient who received ENGERIX B adult (batch number 35G7C, expiry date 1st February 2019). Previously administered products included ENGERIX B adult (1st dose with no adverse event) and ENGERIX B adult (2nd dose with no adverse event). On 6th April 2017, the patient received the 3rd dose of ENGERIX B adult. In April 2017, less than a week after receiving ENGERIX B adult, the patient experienced influenza, cold, fever, vomiting, chills, headache and general body pain. On an unknown date, the outcome of the influenza, cold, fever, vomiting, chills, headache and general body pain were recovering/resolving. It was unknown if the reporter considered the influenza, cold, fever, vomiting, chills, headache and general body pain to be related to ENGERIX B adult. Additional details were reported as follows: The pharmacist reported that the patient received a dose in series of ENGERIX-B the day before reporting date and called back to report the symptoms of vomiting, fever, chills, headaches and body aches. The patient and pharmacist stated that the symptoms might be the result of a flu or cold. No further information was reported regarding the event.
Sex: M
Vaccine: MENB, MENB
Symptoms: Syncope
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of syncope in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, immediately after receiving BEXSERO, the patient experienced syncope. On an unknown date, the outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. It was reported that the sales representative would not provide any more detail of the adverse event.
Sex: M
Vaccine: MENB, MENB
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of syncope in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, immediately after receiving BEXSERO, the patient experienced syncope. On an unknown date, the outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. It was reported that the sales representative would not provide any more detail of the adverse event.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Aggression, Electrocardiogram normal, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: After patient received 3 Immunizations patient immediately passed out.  Patient required laying on back, oxygen at 2L and sternal chest rub.  Paramedics were called. Oxygen was increased to 4 liters, Blood pressure and pulse were normal ekg strip was normal. Paramedics were able to work with pt. Pt ambulated to car to home with mom and dad without difficulty was orientated. Spoke with mom on 4-17-17 she stated pt was seen for other things by family physician on 4/18/17 and mom stated Dr. believed it was adrenaline the reason he passed out. At the time of injections, Pt was fighting and had to have dad hold him with assistance from mom and secretary.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal, Loss of consciousness, Memory impairment, Pallor, Seizure
Clinical narrative: 2-3 minutes after GARDASI vaccine was administered the patient stood and walked across the hall to the restroom, she used the bathroom then came out of the restroom looking pale, she was talking with mom and the NP when she had a syncope episode, she was lower to the floor where she had a 10-15 second LOC with some convulsing of her arms. She became alert after that time and had no memory of the incident. She was moved to a nearby exam room where she drank apple juice and sat for 15 minutes. She walked out of the office without incidence. 6 hours later I checked in on the patient and she continued to feel a little "funny" but was functioning normally.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: 2-3 minutes after GARDASI vaccine was administered the patient stood and walked across the hall to the restroom, she used the bathroom then came out of the restroom looking pale, she was talking with mom and the NP when she had a syncope episode, she was lower to the floor where she had a 10-15 second LOC with some convulsing of her arms. She became alert after that time and had no memory of the incident. She was moved to a nearby exam room where she drank apple juice and sat for 15 minutes. She walked out of the office without incidence. 6 hours later I checked in on the patient and she continued to feel a little "funny" but was functioning normally.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema, swelling peri-injection site.
Age: 28.0
Sex: M
Vaccine: MMR, SMALL
Symptoms: Dermatitis, Fatigue, Lymphadenopathy, Post vaccination autoinoculation, Pyrexia
Clinical narrative: Cross inoculation near original site, low grade fever, fatigue, dermatitis, and swollen lymph node.
Age: 49.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Soreness at injection site on upper left arm, still exists 4/17/17 with lump.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Medication was administered SQ, which is the only approved route. I have never experienced such a painful reaction to vaccines administered IM. Manufacturer should consider IM route of administration 1. Itchy, painful red welt at injection site. Hot to touch, increased to size of a softball over 48 hours post injection. Welt persists today. 2. Ocular headache on 04/16/17 for 24 hrs. Treated welt with ice pack. Treated headache with Tylenol.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Medication was administered SQ, which is the only approved route. I have never experienced such a painful reaction to vaccines administered IM. Manufacturer should consider IM route of administration 1. Itchy, painful red welt at injection site. Hot to touch, increased to size of a softball over 48 hours post injection. Welt persists today. 2. Ocular headache on 04/16/17 for 24 hrs. Treated welt with ice pack. Treated headache with Tylenol.
Age: 32.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event noted as of date/time 04/17/2017 at 12:27 pm Contacted CDC- Contacted CDC- No specific safety concerns. Higher chance for rash. ZOSTAVAX is very similar to VARIVAX vaccine, higher formulation.  Therefore, ZOSTAVAX vaccine given in error will count as VARIVAX #1. Patient will need VARIVAX #2 per regular schedule in 4 weeks. Reported in VAERS.
Sex: U
Vaccine: HPV9
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. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (dose and route of administration were not reported) (lot # M028323 and expiration date 26-SEP-2018) for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion between 47 to 77 degrees Fahrenheit for 2 hours 14 minutes. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (strength, dose, lot #, expiration date and anatomical location were not reported) intramuscularly for prophylaxis; which experienced a temperature excursion at 1 Celsius degrees for 15 hours. No previous temperature excursions were reported. Data logger was involved. A product quality complaint was not involved, no adverse events were reported and no additional information was provided. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004654:
Age: 62.0
Sex: F
Vaccine: YF
Symptoms: Abasia, Arthralgia, Arthritis, Gait disturbance
Clinical narrative: Total body arthralgia with arthritis R>L hips and R>L knees lasting 9 days.  Unable to walk 100 feet to car to go to work for 2 days--severe limp for 4 days.
Age: 1.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Muscular weakness, Pyrexia, Rash erythematous, Rash generalised, Rash vesicular
Clinical narrative: Weakness in legs, fever off 100.1. Two days later on 03/16/2017 patient developed red spots all over his body like chicken pox.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: A rash developed on his upper arms, full legs, and buttocks.  Red, almost pimple like bumps that itched were present for the following 3 days.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: BEXSERO given 3/9/17. Urticaria over B/L upper and lower extremities on and off from 3/11/17 until today. Tried hydrocortisone cream W/O relief. Tried CLARITIN 10 mg 1 time, unsure if it helped as urticaria comes and goes.
Age: 41.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Chills, Erythema, Induration, Lethargy, Pain in extremity
Clinical narrative: Fever, chills, lethargy, R arm soreness with erythema, calor, induration, and TTP.
Age: 41.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Pyrexia, Skin warm, Tenderness
Clinical narrative: Fever, chills, lethargy, R arm soreness with erythema, calor, induration, and TTP.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Diarrhoea, Rash
Clinical narrative: Guardian brought child to clinic with reports of rash on 3/14/17. Rash on 3/15/17 Rash gone, Mild diarrhea.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: 11:30 shot given. 1pm left arm started to ache. A call to Dr. office-nurse said to ice it - that it could hurt for a few weeks. 10-19-16 patient could not lift arm and had no range of motion. Again told to ice it.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Ultrasound abdomen, Urinary retention, Urinary system X-ray
Clinical narrative: Patient was unable to urinate for over 36 hours after he received the Hep B vaccine. We were kept in the hospital for an extra two days due to his inability to void.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Blood thyroid stimulating hormone normal, Cough, Culture negative, Differential white blood cell count normal, Full blood count normal
Clinical narrative: Rapid onset of flu symptoms that lasted for 4 days, lingering cough for 4 weeks, recurring illnesses in February, March and April including sinus infection most recently starting on 4/12/17.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Malaise, Metabolic function test normal, Mononucleosis heterophile test negative, Sinusitis
Clinical narrative: Rapid onset of flu symptoms that lasted for 4 days, lingering cough for 4 weeks, recurring illnesses in February, March and April including sinus infection most recently starting on 4/12/17.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Streptococcus test negative
Clinical narrative: Rapid onset of flu symptoms that lasted for 4 days, lingering cough for 4 weeks, recurring illnesses in February, March and April including sinus infection most recently starting on 4/12/17.
Age: 9.0
Sex: F
Vaccine: FLUX, VARCEL, FLUX, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes Zoster in a vaccinated individual. Painful unilateral rash lasting less than 4 weeks. Unknown if treatment was given.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes Zoster in a vaccinated individual. Unilateral rash lasting less than 4 weeks. Given a prescription of valtrex to treat illness.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Swollen, painful and red upper arm. Area from shoulder to elbow almost doubled in size also itchy. Red area started at injection site and about 4 inches in diameter. Next day (Saturday) red  are increased in size and shifted down and around arm towards body. Sunday less swollen but still red. Still itchy and painful. Monday swelling and redness gone. Friday and Saturday I took 2 Benadryl questions 2hrs while awake.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Fatigue, Headache, Nausea, Pain
Clinical narrative: Body aches, Headache, Fatigue, Nausea, Abdominal cramping.
Age: 0.5
Sex: F
Vaccine: 6VAX-F, FLUX, PPV, RVX, 6VAX-F, FLUX, PPV, RVX
Symptoms: Allergy test positive, Discomfort, Food allergy, Gastrointestinal disorder, Gluten sensitivity
Clinical narrative: Severe rash all over body and gi issues.
Age: 0.5
Sex: F
Vaccine: 6VAX-F, FLUX, PPV, RVX, 6VAX-F, FLUX, PPV, RVX
Symptoms: Milk allergy, Pruritus, Rash generalised
Clinical narrative: Severe rash all over body and gi issues.
Age: 0.5
Sex: F
Vaccine: 6VAX-F, FLUX, PPV, RVX, 6VAX-F, FLUX, PPV, RVX
Symptoms: Allergy test positive, Discomfort, Food allergy, Gastrointestinal disorder, Milk allergy
Clinical narrative: Severe rash all over body and gi issues.
Age: 0.5
Sex: F
Vaccine: 6VAX-F, FLUX, PPV, RVX, 6VAX-F, FLUX, PPV, RVX
Symptoms: Pruritus, Rash generalised
Clinical narrative: Severe rash all over body and gi issues.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Sudden death, Sudden infant death syndrome
Clinical narrative: Sudden unexplained infant death.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives to face 10-15 minutes after administration. Refused BENADRYL. Will follow up with allergist.
Age: 21.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Skin lesion
Clinical narrative: He took 1st oral typhoid last nite at 2130. Woke up this a.m. with itching neck and upper chest and 1 lesion (R) upper arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left shoulder swelling and redness, not painful. Icepack, monitor x SX of infection.
Age: 28.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Underdose
Clinical narrative: The adult patient was given a pediatric dose of Hepatitis A. She had already received her first dose of Hepatitis A. The error was caught after administration. The local health department was called for guidance and the patient contacted and notified of the error and that she would need an adult dose.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Surgery
Clinical narrative: This spontaneous report as received from a female office manager of unknown age. There was no information about the patient's concurrent conditions, medical history, any known allergies, reactions or concomitant medications. On an unknown date, the patient was vaccinated with GARDASIL, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, after completing the full dose series of GARDASIL (dose, route of administration, lot number and expiration date were not reported) given on an unknown dates, the patient was diagnosed by her obstetric gynecologist "ob/gyn" physician with cervical intraepithelial neoplasia (CIN) grade 2 (cervical dysplasia); however, it was not confirmed if the cervical intraepithelial neoplasia (CIN) grade 2 diagnose was cancer (cervix carcinoma). She received treatment for the event (date and type of treatment were unspecified), but it was reported that they were not able to remove it all. The patient did not recover from the events. No additional information was provided. No overdose and no product quality complaint were involved. Upon internal review, cervix carcinoma was determined to be medically significant. Additional information is not expected because there was no consent to contact physician.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Skin test negative, Swollen tongue
Clinical narrative: Developed tongue swelling, shortness of breath and dizziness within 1 hour of receiving flu vaccine. Used EPIPEN and proceeded to ER. Given IV steroids in ER.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient feels dizziness, injection site warm to the touch, slightly raised and red.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dyspnoea, Gait disturbance, Guillain-Barre syndrome, Hyporeflexia
Clinical narrative: Two weeks after receiving a rputine Tdap vaccine, i had mild tingling in feet for a few days, then progressed to calf muscles leading to weakness and tingling, then was followed by tingling in hands and ascending weakness and weird tingling sensation ascending on legs and arms. Goose bumps on legs and arms without being cold would preceed weakness. Very strange sensation of having weak heavy limbs that were slow to move. Walking was more like sliding my feet along the ground. I could not go up and down the stairs hardly at all, but when i did I would get severe muscle twitching and it took all my energy. It took about 2 weeks to get to the worst of the symptoms, landing me in the ER three times because paralysis was creeping up my hips through stomach and lower back. My primary saw me amd ordered a MRI and got the results sent to neuro. The day I went to the neurologist was the worst day of symptoms with shortness of breath. Neurologist said most likely not Guillian Barre but might be a mild case. He said my reflexes were not absent but they were very slow. He honestly was stumped as to what was going on. He said most likely a polio type virus with neurological symptoms. He said it could have been caused by Tdap vaccine but not likely since it was over two weeks after vaccine to the onset of symptoms. MRI was unremarkable. He told me to not get any more vaccines. My primary doctor told me not to get any more vaccines. My functional medicine doctor said to never get anymore vaccines.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Limb discomfort, Muscle twitching, Neurological symptom, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Two weeks after receiving a rputine Tdap vaccine, i had mild tingling in feet for a few days, then progressed to calf muscles leading to weakness and tingling, then was followed by tingling in hands and ascending weakness and weird tingling sensation ascending on legs and arms. Goose bumps on legs and arms without being cold would preceed weakness. Very strange sensation of having weak heavy limbs that were slow to move. Walking was more like sliding my feet along the ground. I could not go up and down the stairs hardly at all, but when i did I would get severe muscle twitching and it took all my energy. It took about 2 weeks to get to the worst of the symptoms, landing me in the ER three times because paralysis was creeping up my hips through stomach and lower back. My primary saw me amd ordered a MRI and got the results sent to neuro. The day I went to the neurologist was the worst day of symptoms with shortness of breath. Neurologist said most likely not Guillian Barre but might be a mild case. He said my reflexes were not absent but they were very slow. He honestly was stumped as to what was going on. He said most likely a polio type virus with neurological symptoms. He said it could have been caused by Tdap vaccine but not likely since it was over two weeks after vaccine to the onset of symptoms. MRI was unremarkable. He told me to not get any more vaccines. My primary doctor told me not to get any more vaccines. My functional medicine doctor said to never get anymore vaccines.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Piloerection
Clinical narrative: Two weeks after receiving a rputine Tdap vaccine, i had mild tingling in feet for a few days, then progressed to calf muscles leading to weakness and tingling, then was followed by tingling in hands and ascending weakness and weird tingling sensation ascending on legs and arms. Goose bumps on legs and arms without being cold would preceed weakness. Very strange sensation of having weak heavy limbs that were slow to move. Walking was more like sliding my feet along the ground. I could not go up and down the stairs hardly at all, but when i did I would get severe muscle twitching and it took all my energy. It took about 2 weeks to get to the worst of the symptoms, landing me in the ER three times because paralysis was creeping up my hips through stomach and lower back. My primary saw me amd ordered a MRI and got the results sent to neuro. The day I went to the neurologist was the worst day of symptoms with shortness of breath. Neurologist said most likely not Guillian Barre but might be a mild case. He said my reflexes were not absent but they were very slow. He honestly was stumped as to what was going on. He said most likely a polio type virus with neurological symptoms. He said it could have been caused by Tdap vaccine but not likely since it was over two weeks after vaccine to the onset of symptoms. MRI was unremarkable. He told me to not get any more vaccines. My primary doctor told me not to get any more vaccines. My functional medicine doctor said to never get anymore vaccines.
Age: 32.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: FAINTED/EXCESS SWEATING.
Age: 40.0
Sex: F
Vaccine: HEP, MNQ, PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Patient reports on Monday 4/17/2017 that she was unable to pick up either of her arms on Sunday 4/16/2017.  She reports she is having neck stiffness. Has raised injection site reactions..