chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Arrhythmia, Death, Electrocardiogram QT prolonged, Long QT syndrome, Product label issue
Clinical narrative: This spontaneous report was received from a pharmacist via a returned survey and refers to unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported). On unknown dates, the patients experienced arrhythmogenic events, arrhythmogenic deaths or long QT episodes. The reporter found out about those events from a Food and Drug Administration (FDA) document from 2010. Since the pharmacist had a patient with congenital Long QT syndrome and the patient's family was unsure if GARDASIL was safe to give, the pharmacist wanted the same information for the most recent 6 years to make an educated assessment for the patient. The pharmacist complained that these serious events were not mentioned in the package insert, while that information was needed for the patient. The outcome of arrhythmogenic events and long QT episodes was unknown. The outcome of arrhythmogenic deaths was fatal. The reporter considered the events to be associated with GARDASIL. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: URTICARIA OVER BODY; GIVEN BENADRYL.
Age: 0.77
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Electroencephalogram, Seizure like phenomena
Clinical narrative: Atypical seizure like activity. 3 minutes for episode, 2 hours for complete return to himself. Hospital admittance, EEG.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash
Clinical narrative: Initial unsolicited report received from nurse on 26-Oct-2015. This case involves a 25-year-old female patient) who was vaccinated with an intramuscular dose of Fluzone QIV (batch number- UI463AA, expiry date- 30-Jun-2016) in left deltoid on 26-Oct-2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Other medical history and concomitant medications were not reported. On 26-Oct-2015, 40 minutes after vaccination, neck and stomach were reddened. Patient did not experience hives, difficulty breathing and other symptoms. Patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was reported as unknown. Documents held by sender: none. Follow up information received from nurse on 26 February 2016. On an unspecified date, following the vaccination, the patient had experienced rash. The patient had received Benadryl, Pepcid and prednisone as corrective treatment. On 26 October 2015, the patient was recovered from events.
Age: 43.0
Sex: M
Vaccine: DTP
Symptoms: Arthralgia, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever 101.9, muscle aches, joint aches, malaise.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Gianotti-Crosti syndrome, Pruritus
Clinical narrative: Gianotti Crosti, infantile papular acrodermatitis.  Extreme pruritus.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Adverse drug reaction, Arthralgia, Cerebral haemorrhage, Cerebrovascular accident, Decreased appetite
Clinical narrative: Loss of appetite. Pain on hip/nerve pain. On 1/2/16 went to Hospital. Had stroke, brain bleed, heart attack. Also had reaction to medications while on hospital.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Myocardial infarction, Neuralgia
Clinical narrative: Loss of appetite. Pain on hip/nerve pain. On 1/2/16 went to Hospital. Had stroke, brain bleed, heart attack. Also had reaction to medications while on hospital.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Activities of daily living impaired, Arthralgia, Groin pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: A sore throat started after vaccine. By 1/23 could hardly get out of bed; hips, groin, shoulder, neck in excruciating soreness and pain. Started taking ibuprofen which helped a little. On 2/24 had doctor visit and got prednisone for 6 days. After prednisone done had 5 more days of pain relief. 75% of pain is back. Pain at a 7. Difficulty getting up and down or put on socks. Will go back to doctor soon.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Neck pain, Oropharyngeal pain
Clinical narrative: A sore throat started after vaccine. By 1/23 could hardly get out of bed; hips, groin, shoulder, neck in excruciating soreness and pain. Started taking ibuprofen which helped a little. On 2/24 had doctor visit and got prednisone for 6 days. After prednisone done had 5 more days of pain relief. 75% of pain is back. Pain at a 7. Difficulty getting up and down or put on socks. Will go back to doctor soon.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Crying, Lymphadenopathy, Mobility decreased, Myalgia
Clinical narrative: A sore throat started after vaccine. By 1/23 could hardly get out of bed; hips, groin, shoulder, neck in excruciating soreness and pain. Started taking ibuprofen which helped a little. On 2/24 had doctor visit and got prednisone for 6 days. After prednisone done had 5 more days of pain relief. 75% of pain is back. Pain at a 7. Difficulty getting up and down or put on socks. Will go back to doctor soon.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nodule, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: A sore throat started after vaccine. By 1/23 could hardly get out of bed; hips, groin, shoulder, neck in excruciating soreness and pain. Started taking ibuprofen which helped a little. On 2/24 had doctor visit and got prednisone for 6 days. After prednisone done had 5 more days of pain relief. 75% of pain is back. Pain at a 7. Difficulty getting up and down or put on socks. Will go back to doctor soon.
Age: 31.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Rash
Clinical narrative: Rash. Seen in ED and given IVP Solumedrol and ranitidine.
Age: 21.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Feeling abnormal, Nausea, Tremor
Clinical narrative: Feeling nausea, shaky, out of sorts.
Age: 49.0
Sex: F
Vaccine: DTAP, FLUX, DTAP, FLUX
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: Limited mobility and pain with movement of shoulder. Pain occurs with lifting arm up or forward, and less so with moving arm behind back. Mobility is limited with active movement only, not with passive. Weakness also but may be directly due to pain.
Age: 5.0
Sex: F
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction positive, Varicella virus test positive
Clinical narrative: Herpes zoster diagnosis on 10/13/2015 in a 2-dose varicella vaccine recipient.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Activities of daily living impaired, Body temperature increased, Dizziness, Fatigue, Headache
Clinical narrative: Patient received vaccine at 9am on 3/8/16. Patient become lightheaded but did not pass out, she was given 7 Up and left the clinic without any problems. She went to school and complained of a very sore arm but no other complaints. On 3/9/16 AM, patient was not feeling well, she related headache, nausea, tired and heavy muscles. She did go to school. On 3/9/15 at approximately 5 PM, patient still not feeling well had a temp of 99.1 or 99.7 mother could not recall temp for sure. Given Advil 2 tabs and took a nap. Somewhere around 6PM, patient started to itch on hands and legs. Then somewhere between 7PM and 8:30PM she developed hives on her legs and said "start of a sore throat or tight". Mother emailed Dr., he instructed mother to give one Benadryl. Patient rested again and took regular medications at around 11 PM. On 3/10/16 Patient stayed home from school due to nausea, exhausted, and heavy muscles. On 3/11/16 Patient returned to school without any complaints.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Limb discomfort, Malaise, Muscle disorder, Nausea, Oropharyngeal pain
Clinical narrative: Patient received vaccine at 9am on 3/8/16. Patient become lightheaded but did not pass out, she was given 7 Up and left the clinic without any problems. She went to school and complained of a very sore arm but no other complaints. On 3/9/16 AM, patient was not feeling well, she related headache, nausea, tired and heavy muscles. She did go to school. On 3/9/15 at approximately 5 PM, patient still not feeling well had a temp of 99.1 or 99.7 mother could not recall temp for sure. Given Advil 2 tabs and took a nap. Somewhere around 6PM, patient started to itch on hands and legs. Then somewhere between 7PM and 8:30PM she developed hives on her legs and said "start of a sore throat or tight". Mother emailed Dr., he instructed mother to give one Benadryl. Patient rested again and took regular medications at around 11 PM. On 3/10/16 Patient stayed home from school due to nausea, exhausted, and heavy muscles. On 3/11/16 Patient returned to school without any complaints.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Pruritus, Throat tightness, Urticaria
Clinical narrative: Patient received vaccine at 9am on 3/8/16. Patient become lightheaded but did not pass out, she was given 7 Up and left the clinic without any problems. She went to school and complained of a very sore arm but no other complaints. On 3/9/16 AM, patient was not feeling well, she related headache, nausea, tired and heavy muscles. She did go to school. On 3/9/15 at approximately 5 PM, patient still not feeling well had a temp of 99.1 or 99.7 mother could not recall temp for sure. Given Advil 2 tabs and took a nap. Somewhere around 6PM, patient started to itch on hands and legs. Then somewhere between 7PM and 8:30PM she developed hives on her legs and said "start of a sore throat or tight". Mother emailed Dr., he instructed mother to give one Benadryl. Patient rested again and took regular medications at around 11 PM. On 3/10/16 Patient stayed home from school due to nausea, exhausted, and heavy muscles. On 3/11/16 Patient returned to school without any complaints.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Erythema.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left Deltoid swollen, red and warm to touch. To take Benadryl and Ibuprofen.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Cough, Influenza, Pain, Vaccination failure
Clinical narrative: Case number PHEH2016US005850 is an initial spontaneous report received from a consumer who was a physician on 09 Mar 2016. This report refers to a 75 year old male patient. His medical history included Hong Kong flu in 1957. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly on 03 Sep 2015. In Dec 2015, he developed flu. He stated that he went to visit friends and flew in Dec 2015 and within 8 to 10 days after returning home, he developed a "text book" case of flu with back pain, dry cough and achiness. He recovered from the flu in Dec 2015. The outcome of back pain, dry cough and achiness was not reported. The seriousness of the events was not reported, but the events flu and vaccination failure was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site bruising, Injection site pain, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a Consumer on 24 February 2016. This case involves a 50-year-old female patient who was vaccinated with an intramuscular dose of Fluzone (batch number, expiration date, dose, doe in series were not reported) in left deltoid 01 November 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was bunion left foot. Concomitant medications were not reported. On 17 November 2015, 16 days, (reported as two weeks to a month) following the vaccination, the patient experienced pain in the left foot near her bunion, in the joint area her toe. It hurt to wear shoes and the area hurt if you pressed down on it. No redness or swelling noted. It was reported that pain was intermittent sometimes she forgot she had it. Patient was also experiencing the same burning pain in her left hand, middle finger, joint pain. Patient also had soreness and bruising at the injection site for one week. Lab data and corrective treatment was not reported. The patient was recovered from soreness and bruising at injection site. Patient was not recovered from other events. List of documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Initial unsolicited report received from a Consumer on 24 February 2016. This case involves a 50-year-old female patient who was vaccinated with an intramuscular dose of Fluzone (batch number, expiration date, dose, doe in series were not reported) in left deltoid 01 November 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was bunion left foot. Concomitant medications were not reported. On 17 November 2015, 16 days, (reported as two weeks to a month) following the vaccination, the patient experienced pain in the left foot near her bunion, in the joint area her toe. It hurt to wear shoes and the area hurt if you pressed down on it. No redness or swelling noted. It was reported that pain was intermittent sometimes she forgot she had it. Patient was also experiencing the same burning pain in her left hand, middle finger, joint pain. Patient also had soreness and bruising at the injection site for one week. Lab data and corrective treatment was not reported. The patient was recovered from soreness and bruising at injection site. Patient was not recovered from other events. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (under manufacturer reference number- 2014065832) on 25 February 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced allergy to vaccine (tetanus shot). Laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 9.0
Sex: M
Vaccine: FLUN4, HEPA, VARCEL
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This student received vaccines (Varicella, Hepatitis A, Flu Mist) on 03/15/2016 at 2:00 PM. The varicella vaccine was administered to the right upper outer arm subcutaneously by MA. No reactions noted 15 minutes after vaccine administration and the family went home. The next morning the mother noted swelling at the right outer arm where the varicella vaccine was given. Swelling and induration was noted at site throughout the day and the mother gave Ibuprofen suspension 2 tsp at 6pm and the following morning at 7am before returning to the clinic. The student arrived at the clinic today 2 days after the vaccine administration with noted swelling of the outer aspect of the right upper arm. The mother states that the swelling is less today that yesterday. Diphenhydramine (12.5mg/5ml) 2 tsp was given orally in the clinic. Ice was applied to the site. A prescription for diphenhydramine (12.5mg/5ml) sig 2 tsp po q 6 hours prn urticarial. Ibuprofen (100mg/5ml) sig.3 tsp po q 6 hours po q 6 hours prn T> 101 or pain. Appointment (recheck of site) scheduled for two days. No acute distress noted.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Hypoacusis, Immediate post-injection reaction
Clinical narrative: Pt. became dizzy/lightheaded, instant headache after injection given. A few minutes later she reported her head and ears were "muffled". Pt. had bilateral feet elevated (supine on exam table)/cold rag given to pt./ice water (per her request, after 15 minutes from injection). Pt. was in exam room 30 minutes after injection for R.N. to observe. Pt.'s stated she was no longer dizzy and her head "was feeling better. Pt. reports today that is fine.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Aphonia, Laryngoscopy
Clinical narrative: Aphonia.
Age: 62.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Insomnia, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore upper arm, limited mobility of arm, stiffness, unable to sleep due to pain.
Age: 62.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Insomnia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore upper arm, limited mobility of arm, stiffness, unable to sleep due to pain.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: Began with itching that developed into full case of shingles.
Age: 1.01
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: My sons broken out with an awful rash from head to toe. Looks like chicken pox. His doctor said it was caused by the chicken pox shot he recieved exactly a week before.
Age: 2.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Eye movement disorder, Febrile convulsion, Full blood count, Hypotonia, Influenza virus test negative
Clinical narrative: Febrile seizure that lasted about 5 min., no jerking, just had eye rolling and limpness - went to ER.
Age: 2.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Streptococcus test negative
Clinical narrative: Febrile seizure that lasted about 5 min., no jerking, just had eye rolling and limpness - went to ER.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Abasia, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swollen (Rt) leg after vaccines - 2 days after 4x cm swollen (Lt) leg after vaccines - 2 days after 7 x 7 cm not walking "painful", fever 101.0
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Red, swollen, circular bump/hive, itchy, no pain.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about patient's concomitant medications, concurrent conditions and medical history was not reported. On an unknown date the patient was vaccinated with a dose of improperly stored (temperature: 58 F and time frame: 2 hours)ROTATEQ (dose not reported, lot # L020865 with expiration date 09-FEB-2017) orally. It was reported that there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about patient's concomitant medications, concurrent conditions and medical history was not reported. On an unspecified date the patient was vaccinated with a dose of improperly stored (temperature: 58 F and time frame: 2 hours) ROTATEQ (dose not reported, lot # L020865 with expiration date 09-FEB-2017) orally. It was reported that there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date in 2015 last year, the patient was vaccinated with PNEUMOVAX 23 dose 1, intramuscularly (lot number, expiry date and dosage not reported). The patient had intact immune system and in spite of that the physician suggested a second protective dose PNEUMOVAX 23 which was administered on 07-MAR-2016. No adverse effects reported. No further information provided. This case is linked to case#1603USA004161 via same reporter link. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from patient's wife, a healthcare worker refers to a male patient of an unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 dose 1, intramuscularly (lot number, expiry date and dosage not reported). On an unknown date, the patient developed heart conditions, it was reported that, an unspecified physician "who recognized history of heart conditions" suggested a second "protective" dose of PNEUMOVAX 23 which was administered at an unspecified time in 2008. No adverse effects reported from second dose of PNEUMOVAX 23. No product quality complaint was involved. The outcome of the event was unknown. The reporter did not provide any causality assessment between event and PNEUMOVAX 23. No further information provided. This case is linked to case #1603USA007174 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unknown number of patients of unknown age and gender. Information about patients' concurrent medications, concurrent conditions and medical history was not reported. The nurse reported that since 09-MAR-2016 the patients were vaccinated with doses of MMR II (dose and route not reported, lot number K024825 with expiration date 02-DEC-2016 and lot number L005291 with expiration date 17-FEB-2017) that had been improperly stored (temperature: 47.1F and time frame: 30 minutes). It was reported that there was a previous temperature excursion with 48.7F for 30 minutes. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unknown number of patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. The nurse reported that since 09-MAR_2016 the patients were vaccinated with doses of ROTATEQ (dose not reported, lot number K019370 with expiration date 16-JUL-2016 and lot number L027070 with expiration date 30-APR-2017, orally) that had been improperly stored (temperature: 47.1F and time frame: 30 minutes). It was reported that there was a previous temperature excursion with 48.7F for 30 minutes. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unknown number of patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. The nurse reported that since 09-MAR-2016 the patients were vaccinated with doses of PNEUMOVAX 23 (dose and route not reported, lot number L014420 with expiration date 23-FEB-2017, lot number L019835 with expiration date 23-MAR-2017 and lot number K021881 with expiration date 30-JUL-2016) that had been improperly stored (temperature: 47.1F and time frame: 30 minutes). It was reported that there was a previous temperature excursion with 48.7F for 30 minutes. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a 22 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 11-MAR-2016 the patient was vaccinated with an expired dose of GARDASIL, lot # J007354, expiration date 20-FEB-2016 (route unspecified) (expired product administered). No adverse effects had been reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache
Clinical narrative: Daily headaches needing ibuprofen for relief.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dizziness, Heart rate increased, Pain in extremity
Clinical narrative: Dizziness- began about 15 min post shot & lasted about 15-20 min. Increased heart rate - began about 1 hr post shot & lasted 2-3 hrs- said she counted 120 beats/min & states she is normally @ 80-9-/min. Lt wrist and hand hurt for short time on Sunday AM (3 days post shot) Did not seek medical treatment - states as a child she had problems with vaccinations, i.e. fever of 102 degrees.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to 4 patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (rHA,, lot # L040414 with expired date 13-APR-2017, dose and route were unknown). No concomitant medication was reported. No adverse effect was reported. This was one of several reports from the same source. Additional information is not expected since the reporter refused further contact.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Consciousness fluctuating, Dizziness, Immediate post-injection reaction, Laboratory test, Presyncope
Clinical narrative: Patient was given injection, then fainted immediately. She faded in and out of conciousness 3 times. Ammonia stick was used to bring her to, Epi-pen was not used. Gave her glucose tablets to raise her blood sugar. She visited medical facility. Patient experienced a Vagal reflex response. Patient was woozy until the following day, but felt fine after 24 hours.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Patient was given injection, then fainted immediately. She faded in and out of conciousness 3 times. Ammonia stick was used to bring her to, Epi-pen was not used. Gave her glucose tablets to raise her blood sugar. She visited medical facility. Patient experienced a Vagal reflex response. Patient was woozy until the following day, but felt fine after 24 hours.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching Mom gave Benadryl.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Dyspnoea, Feeling hot, Flushing, Immediate post-injection reaction
Clinical narrative: Immediately c/o difficulty breathing, feeling hot, face flushed, back pain. IV of NS started, O2 on.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Feeling hot, Flushing, Paraesthesia oral, Pyrexia
Clinical narrative: Immediately c/o difficulty breathing, feeling hot, face flushed, back pain. IV of NS started, O2 on.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Very severe pain in left shoulder where vaccine was given and unable to move left arm any direction without extreme pain. Temperature of 100 for 24 hours. Redness and swelling of left shoulder in the area of the vaccine. 48 hours later still very painful but have mobiity in my left arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Very severe pain in left shoulder where vaccine was given and unable to move left arm any direction without extreme pain. Temperature of 100 for 24 hours. Redness and swelling of left shoulder in the area of the vaccine. 48 hours later still very painful but have mobiity in my left arm.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Information on patient's concurrent condition and pertinent medical history was not reported. On an unknown date, patient was vaccinated with ZOSTAVAX (dose, route and lot number not reported). Concomitant medications were unspecified. On an unknown date, following the administration of ZOSTAVAX the patient experienced shingles. The physician reported that the patient was presently better (date unspecified). No further information was provided. Causality assessment was not provided by the reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a nurse via a company representative regarding a currently 81 year old male patient. No medical history and concurrent condition were reported. On an unknown date in 2012 the patient was vaccinated with ZOSTAVAX, strength 19400 PFU, dose 0.65 ml for prevention of shingles (route, lot# and expiration date unknown). On an unknown date approximately in 2012, the patient experienced significant unspecified reaction. The patient has been seeing an unspecified rheumatologist since getting the ZOSTAVAX shot as a result of the adverse reaction. The outcome of adverse reaction was unknown. Causality assessment was provided. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 14-MAR-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose: 0.5 ml, via intramuscular route, lot # K007262, expiration date 25-NOV-2015). There was no adverse event reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 13 years old patient of unknown gender. Pertinent medical history and drug reactions/allergies were not reported. The patient received first dose GARDASIL (dose, route, lot# and expiration date were not reported) in 2012. The reporter stated that the patient received "catch up dose" (dose 2) (dose, route, lot# and expiration date were not reported) on 11-JAN-2016 and third dose (Lot K007264 expiration date 02-MAR-2017, dose and route were not reported) on 14-MAR-2016 (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 10-MAR-2016 the patient was vaccinated with an expired dose of MMR II (lot # K002528 with expiration date 28-FEB-2016, dose, strength and route unknown). The reporter was not aware of any adverse effects. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema, Pain, Pyrexia, Rash erythematous, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 73 year old female patient. Information regarding the patient's pertinent medical history and drug reaction/allergies was not reported. Concomitant therapies included CLARITIN. On 09-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose and route of administration was not reported). On an unspecified day in March 2016, the patient developed an extreme rash that was a strawberry sunburn color on her lower abdomen and both forearms following the administration of ZOSTAVAX. The patient also developed a fever of 100 to 101 F, vomiting and sharp pain when she touched her abdomen. The patient stated that when she touched her abdomen, her finger left an indentation in her skin. She sought medical attention by contact with pharmacist. There was no product quality complaint. No treatment was given for the events. The patient was recovering the events, at the time of the report. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 25-FEB-2016, the patient was vaccinated orally with a dose of ROTATEQ oral liquid, lot # L013292, expiry date 19-JAN-2017 (dose was not specified). The administered dose of ROTATEQ underwent temperature excursions at minimum 35 Fahrenheit degrees for 7 days. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 25-FEB-2016, the patient was vaccinated with a dose of RECOMBIVAX HB injection, lot # L025738, expiry date 14-AUG-2017 (dose, route of administration and anatomical location were not specified). The administered dose of RECOMBIVAX HB underwent temperature excursion at minimum 35 Fahrenheit degrees for 7 days. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 29-FEB-2016, the patient was vaccinated orally with a dose of ROTATEQ oral liquid, lot # reported as L023936, expiry date 15-MAR-2017 (dose was not specified). The administered dose of oral, ROTATEQ underwent temperature excursion at minimum 35 Fahrenheit degrees for 7 days. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, improperly stored doses of LIQUID PEDVAXHIB lot # K015464 with expiration date 09-JUL-2017 (dose and route of administration not reported) were administered to the patients. It was reported that the vaccines underwent a temperature excursion of 34.4 degrees Fahrenheit for 8 hours. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 27-FEB-2016, the patient was vaccinated with a dose of VAQTA injection, lot # L023936, expiry date 15-MAR-2017 (dose, route of administration and anatomical location were not specified). The administered dose of VAQTA underwent temperature excursion at minimum 35 Fahrenheit degrees for 7 days. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Varicella, Varicella zoster virus infection
Clinical narrative: VZV rash on right arm and hand.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Patient noticed an itchy rash beginning the evening after the IMZ was given. She said it was on her back, stomach, arms, and legs. She began taking Benadryl and said it helped some. She called to report the reaction on 3/16/16 and said that it had cleared up some but was still itchy. I told her to continue taking the Benadryl and to inform her doctor if it didn't clear up or if the rash seemed to get worse.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, X-ray limb
Clinical narrative: Severe Pain on Injection, progressively worsening shoulder pain with increasingly restricted motion over the next several weeks. Orthopedic surgeon appointment on 11/20/15, had an xray-received a steroid injection into the shoulder joint.  Pain improved for 1-2 weeks and then returned.  Shoulder MRI on 3/7/16 with f/u appointment with orthopedic surgeon on 3/9/16.  Received another steroid injection, surgeon recommended surgery, scheduled PT to begin at the end of the month instead.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 7cm Red, slightly raised, warm to touch area on right thigh, no treatment at present time, site marked to be monitored for increase in redness.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster, without prior history of varicella infection.
Age: 0.18
Sex: M
Vaccine: DTAPIPV, HEP, HIBV
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on face, abdomen, and bilateral LE.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injection site warmth, Muscle spasms, Pyrexia, Tenderness
Clinical narrative: Tdap vaccination on 3-5-16 and on 3-10-16 he began to develop the following symptoms in L arm: joint pain, arm spasm states for 48 hours straight and now just off and on, tenderness, fever, warmth at site. Symptoms had been improving as of 3/15/16.
Age: 23.0
Sex: F
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Chest discomfort, Dyspnoea, Hypotension, Throat tightness
Clinical narrative: After receiving vaccine and bicillin, Pt c/o of chest tightness, shortness' OF BREATH, AND THROAT TIGHTNESS, PT WAS HYPOTENSIVE. PT WAS GIVEN Epi-pen, Sol-u-Medrol 125 mg, Benadryl 25 mg.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Ankylosing spondylitis, Blood test, Blood testosterone decreased, Erectile dysfunction, Fibromyalgia
Clinical narrative: HIGH BLOOD PRESSURE, STOPPED BREATHING, Erectile Dysfunction, Low Testosterone, Ankylosing Spondylitis, Degenerative Disc Disease, Fibromyalgia.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: HLA marker study positive, Hypertension, Intervertebral disc degeneration, Local swelling, Migraine
Clinical narrative: HIGH BLOOD PRESSURE, STOPPED BREATHING, Erectile Dysfunction, Low Testosterone, Ankylosing Spondylitis, Degenerative Disc Disease, Fibromyalgia.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Peripheral swelling, Respiratory arrest, Vomiting
Clinical narrative: HIGH BLOOD PRESSURE, STOPPED BREATHING, Erectile Dysfunction, Low Testosterone, Ankylosing Spondylitis, Degenerative Disc Disease, Fibromyalgia.
Age: 0.32
Sex: M
Vaccine: HIBV, MMR, TDAP, VARCEL
Symptoms: Blood pressure increased, Diet refusal, Hypopnoea, Injection site discolouration, Injection site swelling
Clinical narrative: He became purple, swollen at injection sites. Would not eat for approximately 12 hours, screamed the entire time, blood pressure skyrocketed, breathing shallowed. Also was speech delayed, and has spd, which led to speech and occupational therapy.
Age: 0.32
Sex: M
Vaccine: HIBV, MMR, TDAP, VARCEL
Symptoms: Screaming, Speech disorder, Speech disorder developmental
Clinical narrative: He became purple, swollen at injection sites. Would not eat for approximately 12 hours, screamed the entire time, blood pressure skyrocketed, breathing shallowed. Also was speech delayed, and has spd, which led to speech and occupational therapy.
Age: 29.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Dizziness, Injection site infection, Injection site rash, Mobility decreased, Pain in extremity
Clinical narrative: Day 1:arm pained him to point he couldn't raise or use it. He felt dizzy also. Day 2:rash formed at injection. fever. arm in sling. Starting Cephalexin for suspected infection of injection site. Day 3:rash larger. fever of 103.2. Rash in shape of deltoid muscle, not circular.
Age: 29.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Pyrexia
Clinical narrative: Day 1:arm pained him to point he couldn't raise or use it. He felt dizzy also. Day 2:rash formed at injection. fever. arm in sling. Starting Cephalexin for suspected infection of injection site. Day 3:rash larger. fever of 103.2. Rash in shape of deltoid muscle, not circular.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unspecified dates since 20-JAN-2016, improperly stored PROQUAD (Merck) were administered to an unspecified patients, lot numbers (L037561, expiry date: 29-SEP-2017; L039093, expiry date: 06-OCT-2017; L032396, expiry date: 26-MAR-2017) (strength, dosage and route were not reported). Her freezer "cycles" 4 times a day. Each "cycle" lasts less than 30 minutes, according to her data logger. The highest temperature during these cycles was -13.6 C. She was not aware of any adverse effects. No additional information was provided. On 09-MAR-2016, reporters were tried to be contacted but was unsuccessful. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 14-MAR-2016 (today), the patient was inadvertently vaccinated with PROQUAD lot # L040414, expiry date 13-APR-2017, 0.5 ml, subcutaneously. No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date approximately in 2016 (also reported as unspecified dates since 01-FEB-2016) the patient was vaccinated with VAQTA (lot # L023232, expiry date 25-FEB-2015) (Lot # L023936, expiry date 15-MAR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the vaccines were exposed to a temperature of 33.4 degrees farenheit for 2 hours and 51.4 degrees farenheit for 1.5 hours. No adverse effects were reported. It was reported that the vaccines that underwent temperature excursion were administered. It was reported that there was no previous temperature excursion. It was also reported that this case was being reported due to a data logger. This case is linked to case numbers 1603USA007489, 1603USA007490, 1603USA007491 via same reporter link. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Joint stiffness, Musculoskeletal chest pain, Pyrexia
Clinical narrative: Received MMR on 3/9/16 at 4pm. Called on call MD 3/10/16 at 7pm states she developed severe joint pain, pain under (R) rib cage, fatigue, low grade fever (normal body temp 96 -> went to 98.; with pain. Advised to take ibuprofen 600 mg every 4-6 hours. Saw MD 3/11/16 at 10:30 am pain elbow, wrists, hips, hands feel stiff, ankles knees. No rash, no SOB or joint effusions. Continue ibuprofen and alternate with TYLENOL increase hydration. 3/15/16 Pt. called she feels 90% better declined follow up appointment that was scheduled for 3/16/16. She states once in awhile she gets a wave of fatigue, low grade fever for her and hands fell stiff. Lasts approx. 45 minutes. Advised to call office if doesn't continue to improve or if worsens.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: Pt came into office on 3/16/16 to show us the effect. She had hives/welts on left deltoid. We gave pt Rx for prednisone.
Age: 53.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 53 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 26-JAN-2016, the patient was vaccinated with the third dose of RECOMBIVAX HB, lot number L029631, expiration date 14-AUG-2017, (dose, anatomical location and route were not reported) that experienced temperature excursion. There was no concomitant medication reported. No adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 29.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 29 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 08-JAN-2016, the patient was vaccinated with the third dose of RECOMBIVAX HB, lot number L029631, expiration date 14-AUG-2017, (dose, anatomical location and route were not reported) that experienced temperature excursion. There was no concomitant medication reported. No adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Eye movement disorder, Fall, Syncope
Clinical narrative: Syncope, eyes rolling back, fell down (no injury) low grade temp. 99.0.