chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Photopsia, Pyrexia, Sinus polyp
Clinical narrative: Patient experienced right flank pain upon waking at 5:00 AM. At 6:00 also began to have chills with diaphoresis which was immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures' x2 of 6 minutes duration. She was transported to the ER by ambulance for evaluation.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient experienced right flank pain upon waking at 5:00 AM. At 6:00 also began to have chills with diaphoresis which was immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures' x2 of 6 minutes duration. She was transported to the ER by ambulance for evaluation.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Erythema, Headache, Injection site pain, Nausea, Oedema peripheral
Clinical narrative: Pain where shot was given x72 hours. Fever > 102F x2 60 hours (even with administration of Tylenol and Motrin, fever was very difficult to bring down). Headache x 48 hours. Nausea x 24 hours. Redness and Swelling of entire arm above elbow to top of arm x 60 hours. Very fine rash to dorsal side of upper arm x 48 hours, started 4-6 hours after administration.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Pyrexia, Rash
Clinical narrative: Pain where shot was given x72 hours. Fever > 102F x2 60 hours (even with administration of Tylenol and Motrin, fever was very difficult to bring down). Headache x 48 hours. Nausea x 24 hours. Redness and Swelling of entire arm above elbow to top of arm x 60 hours. Very fine rash to dorsal side of upper arm x 48 hours, started 4-6 hours after administration.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Speech disorder, Trismus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient had presented to the emergency room at her facility with "lock jaw and could not talk." The patient had not been admitted to the hospital. The pharmacist noted that the patient's mother stated that "the only thing that was different, was that he had been administered GARDASIL. It was unspecified how many doses of GARDASIL the patient had been administered. The reporter considered that the patient cannot talk as disability. The outcome of lock jaw and cannot talk was reported as not recovered/not resolved. The relationship between the GARDASIL and the events was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Rash, Speech disorder, Trismus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient had presented to the emergency room at her facility with "lock jaw and could not talk." The patient had not been admitted to the hospital. The pharmacist noted that the patient's mother stated that "the only thing that was different, was that he had been administered GARDASIL. It was unspecified how many doses of GARDASIL the patient had been administered. The reporter considered that the patient cannot talk as disability. The outcome of lock jaw and cannot talk was reported as not recovered/not resolved. The relationship between the GARDASIL and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Convulsion, Loss of consciousness, Seizure like phenomena
Clinical narrative: This spontaneous report as received from a consumer's mother refers to a patient of unknown age. The reporter's daughter experienced seizure-like reaction, the patient convulsed for "2-3 seconds" and then "passed out" for a "few seconds" after receiving first dose of GARDASIL. (Captured in case 1308USA009926). The patient's mother called the office after her child's reaction and stated that she has done some research (source unknown) and found out that seizure-like reaction was common after GARDASIL administration and she also found from her research that someone has died from GARDASIL reaction and was concerned. In this unconfirmed AE report was reported on an unknown date this patient was vaccinated with GARDASIL (dosing information and route are unknown). On an unknown date this patient experienced GARDASIL reaction. The outcome of GARDASIL reaction was reported as fatal. No reporter causality provided. No consent to contact physician. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Borrelia test, Full blood count, Metabolic function test, Pyrexia, Rash
Clinical narrative: Fever, rash.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Activated partial thromboplastin time, Asthenia, Balance disorder, Blood folate, Diplopia
Clinical narrative: Constant headache strong, dizziness, nausea. Blurry and double vision, no body equilibrium or disbalance, flabby and weak legs and body. White matter disorder.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Electrophoresis protein, Headache, Hypotonia, Lumbar puncture
Clinical narrative: Constant headache strong, dizziness, nausea. Blurry and double vision, no body equilibrium or disbalance, flabby and weak legs and body. White matter disorder.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Muscular weakness, Nausea, Nuclear magnetic resonance imaging brain abnormal, Prothrombin time, Vision blurred
Clinical narrative: Constant headache strong, dizziness, nausea. Blurry and double vision, no body equilibrium or disbalance, flabby and weak legs and body. White matter disorder.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Vitamin B12, White matter lesion
Clinical narrative: Constant headache strong, dizziness, nausea. Blurry and double vision, no body equilibrium or disbalance, flabby and weak legs and body. White matter disorder.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia oral, Immediate post-injection reaction, Paraesthesia oral
Clinical narrative: GARDASIL administered 7/29/13. Approximately 20 minutes later patient began to complain of numbness and tingling of tip of tongue. Symptoms increased in area involved and have since decreased in area but he continues to have numbness, tingling and decreased taste on about 1 cm of tip of tongue.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia oral, Hypogeusia, Paraesthesia oral
Clinical narrative: GARDASIL administered 7/29/13. Approximately 20 minutes later patient began to complain of numbness and tingling of tip of tongue. Symptoms increased in area involved and have since decreased in area but he continues to have numbness, tingling and decreased taste on about 1 cm of tip of tongue.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 10 year old male patient. On 06-DEC-2003 the patient was vaccinated with dose 1 VARIVAX (lot #, expiration date and route not reported). The reporter stated that his second dose may have been given too soon from dose 1. Also the patients "blood-work" was done on 01-AUG-2013 and "showed a negative antibody titer to varicella". The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Itching, rash (hives?) on various parts of body.
Sex: M
Vaccine: HEP
Symptoms: Death
Clinical narrative: My son was administered the Hep B vaccination at one day old and died at 18 days old almost to the minute of original vaccination date and time. I was told by VAERS if your gonna have a deadly reaction it will happen w/n 18 days.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Dialysis, Renal failure chronic, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 32 year old male patient. On an unknown date, as child, the patient was vaccinated with a dose of VARIVAX (merck) (Lot # and dose not reported), subcutaneously. On an unspecified date, the patient experienced end stage renal disease. The pharmacist reported that the patient was currently on dialysis and was a kidney transplant candidate. On an unspecified date, the patient was hospitalized. The pharmacist stated the an IgG assay was performed to determine varicella immunity and the titers came back negative. At the time of the report, the patient had not recovered. Upon internal review, End stage renal disease was considered to be medically significant. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Ligament sprain, Nausea, Vision blurred
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning an approximately 14 year old male patient. There were no drug reactions or allergies. On 12-AUG-2013, the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date reported as H020901 and 05-JUL-2015 respectively), intramuscularly. There were no concomitant medications. On 13-AUG-2013, the patient developed blurry vision, nausea, vomiting and lightheadedness after receiving his first dose of GARDASIL. On 14-AUG-2013, the patient experienced sprained ankle due to falling in a hole. The patient sought medical attention. The patient was seen by an unspecified optometrist on 15-AUG-2013 (yesterday). The patient was prescribed on unspecified amount of Meclizine due to the lightheadedness. No lab tests were performed. The patient was not recovered from blurry vision, nausea, vomiting and lightheadedness. The outcome of sprained ankle due to falling in a hole was unknown. The relatedness for all the events was unknown for GARDASIL. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning an approximately 14 year old male patient. There were no drug reactions or allergies. On 12-AUG-2013, the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date reported as H020901 and 05-JUL-2015 respectively), intramuscularly. There were no concomitant medications. On 13-AUG-2013, the patient developed blurry vision, nausea, vomiting and lightheadedness after receiving his first dose of GARDASIL. On 14-AUG-2013, the patient experienced sprained ankle due to falling in a hole. The patient sought medical attention. The patient was seen by an unspecified optometrist on 15-AUG-2013 (yesterday). The patient was prescribed on unspecified amount of Meclizine due to the lightheadedness. No lab tests were performed. The patient was not recovered from blurry vision, nausea, vomiting and lightheadedness. The outcome of sprained ankle due to falling in a hole was unknown. The relatedness for all the events was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patient of unknown age and gender. On an unspecified date between 16-JUL-2013 and 25-JUL-2013 the patient received an unspecified single dose of improperly stored PEDVAXHIB, injection (lot number H017031, exp. date 16-JAN-2015, route not reported) at an unspecified off site clinic. The reporter stated that PEDVAXHIB had been exposed to total time out of range a maximum of 60.5  hours at minus 2 Celsius degree. No adverse effects were reported. The outcome of events was unknown. This is one of 4 reports from the same source (MARRS # 1308USA002370, 1308USA003562, 1306USA003561, 1308USA003560). Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Haemorrhage, Head injury, Syncope
Clinical narrative: Patient fainted within minutes of administration patient hit head and was bleeding and taken to area hospital, treated and released.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site became swollen, painful, and itched. Sought treatment in ER - received IM: BENADRYL, SOLUMEDROL, and PEPCID. Rx given for: ALLEGRA and Medrol dose pak.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Local reaction, Lymphangitis, Pyrexia
Clinical narrative: Fever 102 degrees F large local reaction (8 x 8 cm) with lymphangitic streaking to (L) axilla.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Localized reaction around injection site (redness and swelling) improved with BENADRYL.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients received an unspecified number of doses of improperly stored PEDVAXHIB (lot number, exp. date and route not reported). The reporter stated that PEDVAXHIB has been exposed to total time out of range a maximum of 60.5 hours at minus 2 Celsius degree. No adverse effects were reported. The outcome of events was unknown. This is one of 4 reports from the same source. 1308USA002370; 1308USA003562; 1308USA003561; 1308USA003560. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: This spontaneous report was received from a physician refers to a 18 year old male patient. On 20-AUG-2013, after the patient was vaccinated with dose 1 of GARDASIL 0.5 ml, intramuscular and he had an anaphylactic reaction in the office. On 20-AUG-2013, ten minutes after receiving GARDASIL concomitantly with NEVEO, the patient's through closed up and he could not breathe. His oxygen levels were examined and he was give 50 mg of BENADRYL. There was no other anaphylactic reaction other than difficulty breathing. The patient had decided not to continue the GARDASIL dosing. The outcome of difficulty breathing was reported as recovered approximately in August 2013. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 4 year old child of unknown gender. On 12-JUL-2010 the patient was vaccinated with a first dose of M-M-R II (rHA), (0.5 ml, subcutaneous, site of injection not reported). On 25-JUL-2013 the patient was vaccinated with expired dose of M-M-R II (rHA) (0.5 ml subcutaneous, site of injection not reported) (671438/1118AA, expiration date 12-JUL-2013) (second dose). No adverse effects reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient with high blood pressure and with no drug reactions/allergies. On 01-AUG-2013, the patient was vaccinated with ZOSTAVAX (Lot number and expiry date was not reported), 0.65 milliliter (ml), subcutaneous. Concomitant therapies included lisinopril (manufacturer unknown) and nifedipine (manufacturer unknown). Approximately on an unknown date in August 2013, the patient experienced rash and lump around the injection site following vaccination. Patient sought medical attention (pharmacy visit). Patient was treated with ice pack. None of the lab diagnostic tests were performed. Approximately on an unknown date in August 2013, the event rash around the injection site was resolved, but the event lump around the injection site was not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients received an unspecified number of dose of improperly stored GARDASIL, injection (lot number 1291AA, exp. date 12-APR-2014, route not reported). The reporter stated that GARDASIL had been exposed to total time out of range a maximum of 60.5 hours at minus 2 Celsius degree. No adverse effects were reported. The outcome of events was unknown. This is one of 4 reports from the same source: 1308USA002370; 1308USA003562; 1308USA3561; 1308USA003560. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pallor, Syncope
Clinical narrative: This spontaneous report as received from a medical assistant, who refers to a 12 year old male patient. There was no information about patient medical history and drug allergies or drug reactions. ON 29-JUL-2013 the patient was vaccinated intramuscularly with a first dose of GARDASIL, 0.5 ml (lot # J003727, exp. date 11-JUN-2015). Concomitant medications were not reported. On 29-JUL-2013, 4 min after administration of GARDASIL the patient fainted. Ammonia was immediately used to wake the patient. The medical assistant reported that after the patient awoke, his ears, eyes and nose were checked and everything was okay. The patient was a little pale and was given candy and popsicle to eat. The patient sought medical attention, via physician's office. After 20 minutes, the patient's blood pressure and pulse were determined to be normal and the patient was allowed to leave the physicians office. None laboratory diagnostic studies were performed. The patient recovered from adverse event on 29-JUL-2013. It was reported that the therapy with GARDASIL was continued. The relatedness between therapy with GARDASIL and adverse event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patient of unknown age and gender. On an unspecified date between 16-JUL-2013 and 25-JUl-2013 the patient received an unspecified single dose of improperly stored GARDASIL, injection (lot number 1291AA, exp. date 12-APR-2014, route not reported) at an unspecified off site clinic. The reporter stated that GARDASIL has been exposed to total time out of range a maximum of 60.5 hours of minus 2 Celsius degree. No adverse effects were reported. The outcome of events was unknown. This is one of 4 reports from the same source (MARRS#1308USA002370; 1308USA003562; 1308USA003561; 1308USA003560). Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Increased upper airway secretion, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 8/12/2013 Patient received the Tdap (ADACEL) vaccination in his (L) delt at approx 11:45 am. On 8/15/2013, patient called dr office, spoke to nurse. Patient stated that he felt fine and with no complaints after the vaccination until approx 8pm on the evening of 8/14/2013. Patient stated that felt chills/fever, excess phlegm , c/o had trouble sleeping and the site was painful, red/swollen. Patient stated he took a MUCINEX and went to bed. Patient stated that he felt better this a.m. and stated that he is having no problems today. Patient declined an appt offered.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Insomnia, Pyrexia
Clinical narrative: 8/12/2013 Patient received the Tdap (ADACEL) vaccination in his (L) delt at approx 11:45 am. On 8/15/2013, patient called dr office, spoke to nurse. Patient stated that he felt fine and with no complaints after the vaccination until approx 8pm on the evening of 8/14/2013. Patient stated that felt chills/fever, excess phlegm , c/o had trouble sleeping and the site was painful, red/swollen. Patient stated he took a MUCINEX and went to bed. Patient stated that he felt better this a.m. and stated that he is having no problems today. Patient declined an appt offered.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Redness rash and heat distal to injection site.
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 unspecified teenage boys each received an expired dose of GARDASIL (lot # 669308/0636AA, expiry date 11-AUG-2013, route and dose were unknown) as their first dose in the series on 12-AUG-2013. No adverse effect reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Redness and mild swelling both arms. Warm to touch both arms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted momentarily about 20 seconds. Recovered immediately, vitals were stable. Patient as given ginger ale.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Skin lesion
Clinical narrative: Patient had redness and hot sensations in arm below injection site 2-3 days later. 3-4 days after injection went to Walk-In Clinic and stated she had several egg shape bumps in arm below site with hot and painful sensations. Day six, pt. stated she had  a lesion on her leg and got a prescription for Valacyclovir.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: AFLURIA given on 8/16/2013. Significant redness, hardness, bruising, warm to touch at site. Area demarcated 3 inch in diameter. Also occurred last year with FLUZONE 2013.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dysphonia, Malaise, Wheezing
Clinical narrative: General malaise lead to hoarseness and wheezing on 8/19/13. Developed back pain.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Disorientation, Dizziness, Palpitations
Clinical narrative: Pt. experienced dizziness, palpitations, disorientation upon administration of HPV vaccine (about 2 minutes post injection - while pt. was waiting in waiting room). Called fire dept. and pt. was escorted to hospital.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Blood test, Computerised tomogram, Convulsion, Dizziness, Headache
Clinical narrative: Pt. experienced dizziness, palpitations, disorientation upon administration of HPV vaccine (about 2 minutes post injection - while pt. was waiting in waiting room). Called fire dept. and pt. was escorted to hospital.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Palpitations, Syncope, Urine analysis, X-ray
Clinical narrative: Pt. experienced dizziness, palpitations, disorientation upon administration of HPV vaccine (about 2 minutes post injection - while pt. was waiting in waiting room). Called fire dept. and pt. was escorted to hospital.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: Pt states she woke up this morning (8/23/13) with left neck pain. Took Ibuprofen 600 mg Lymph node swelling noted (left side). (Left AC lymph node).
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Adverse reaction on left thigh, 10x9 cm, reddened and warm. Treatment plan includes ice and BENADRYL.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Rt deltoid red warm, fatigue achiness in arm starting evening after received vaccine and still present 8/16/2013.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Vision blurred
Clinical narrative: 3" x 1" red warm to touch area. Currently blurred vision on 08-16-13 evening, resolved. Tx: ice 20min Q-2-3 hours, ADVIL/ALEVE 1-2 days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Nausea, Photophobia
Clinical narrative: Patient woke up with a severe headache, nausea, photophobia. Mother called the office was advised to give 400 mg ibuprofen. Patient went to sleep and was symptom-free in the morning.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Infant rec'ed immunizations on 8/15/13 approx. 10:15 A.M. Mom called back to office after lunch and started infant continuously crying - came back in - was monitored and given TYLENOL.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Ocular hyperaemia, Swelling face, Throat irritation, Throat tightness
Clinical narrative: 8/21/13 Received IM FLUZONE at 1100 AM. Reported to ED at 1743 with reddened eyes, itching throat - felt like it was closing and states it was hard to breathe and face was swollen.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Erythema 3.5 x 3.5 with 2 x 2 cm induration at site of injection (L) thigh and warm to touch cellulitis.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Rash
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. Patient's current condition included heart problems. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient developed a rash after receiving ZOSTAVAX. Patient sought medical attention for the same (saw the doctor). Patient underwent Routine blood work (results were not provided). No treatment was given. The outcome of developed a rash was reported as recovering/resolving. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Local swelling, Pain in extremity, Pyrexia, Swelling face
Clinical narrative: This spontaneous report was received from a physician and registered nurse via a company representative to a 17 year old female patient. On 25-JUL-2007, report was vaccinated with dose 1 GARDASIL (lot #, expiration date and route not reported). On 19-OCT-2007 the patient was vaccinated with dose 2 GARDASIL (lot #, expiration date and route not reported) in the arm. Other suspect therapies included MENACTRA given in the same arm where GARDASIL was administered and TDAP on the other arm on 19-OCT-2007. On an unknown date the patient developed face swelling, pain in the arm, arm swelling and high fever of 104-105 degrees Farenheit. Treatment information was unspecified by the reporter. The events resolved on an unknown date. It was unspecified whether patient sought medical attention. Laboratory diagnostic tests performed were unspecified by the reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Blood gases, Blood test, Coma, Fall, Gastrointestinal tube insertion
Clinical narrative: Started falling (x4). Rushed to hospital. Slipped into coma. Placed on respirator. Transfer to another medical center 2% chance of survival. Respirator 8 days. Coma 6 days. Six plasmapheresis. Woke up paralyzed. Much physical therapy. Dec 2012 walking with walker. August 2013 by self in walking.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Mechanical ventilation, Paralysis, Plasmapheresis, Scan abnormal
Clinical narrative: Started falling (x4). Rushed to hospital. Slipped into coma. Placed on respirator. Transfer to another medical center 2% chance of survival. Respirator 8 days. Coma 6 days. Six plasmapheresis. Woke up paralyzed. Much physical therapy. Dec 2012 walking with walker. August 2013 by self in walking.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Walking aid user
Clinical narrative: Started falling (x4). Rushed to hospital. Slipped into coma. Placed on respirator. Transfer to another medical center 2% chance of survival. Respirator 8 days. Coma 6 days. Six plasmapheresis. Woke up paralyzed. Much physical therapy. Dec 2012 walking with walker. August 2013 by self in walking.
Age: 73.0
Sex: F
Vaccine: TYP
Symptoms: Erythema, Feeling abnormal, Paraesthesia oral, Pruritus, Swelling face
Clinical narrative: Pt reported that minutes after taking her first dose of oral Typhoid she began to "feel funny", her tongue began to feel thick, her skin turned beat red, her hands and arms began to itch, she had facial swelling, pt was taken to the local ER room where she was treated with oral Atarax and released within 24 hours.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Body ache, very tired, temperature spike to 103.9 lasted 18 hours.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Periarthritis, X-ray
Clinical narrative: Flu shot - 09/28/2012. Sore shoulder - 09/30/2012. Very painful frozen shoulder - 10/15/2012. Tramadol - 04/16/2013 - couldn't take got sick ibuprofen (6 per day) and acetaminophen (6 per day) - 04/23/2013 - current. Feldenkrais practitioner - 05/20, 05/24, 05/29, 05/31, 06/02, and 06/05. Chiropractor - 05/31 and 06/05.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: Began on the 8th on Rt. wrist as an itchy spot.  Put otc cortisone later that day.  Thought it was a mosquito bite.  The next day Hives had spread to both arms and Friday night spread to Torso.  Took Benadryl that evening. Seen a physician on 8-10-13 with no prescriptions. Took 2 Benadryl and have taken one every night until the 20th. Seen my Dr. on the 15th and prescribed Pepcid and Zoloft for itching. Had to go to ER on the 20th for Lt. side throat swelling with hives on torso, arms and legs. Nausea.  Treated with Zofran. Prescribed Z-Pack, Prednisone, generic Claritin.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Chickenpox began to appear and continued to appear over the next four days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Joint range of motion decreased, Monoplegia, Neuralgia, Neuralgic amyotrophy
Clinical narrative: Left arm paralysis and neuropathic pain eventually diagnosed as brachial plexus neuritis and treated with physical therapy, to date has not regained strength and range of motion proximal arm.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Left arm paralysis and neuropathic pain eventually diagnosed as brachial plexus neuritis and treated with physical therapy, to date has not regained strength and range of motion proximal arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Unresponsive to stimuli
Clinical narrative: CHILD BECAME UNRESPONSIVE FOR A FEW SECONDS. EMT CALLED. CHILD WAS ALERT AND CRYING WHEN EMT ARRIVED.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: Erythema, Pruritus generalised, Rash generalised, Rash maculo-papular
Clinical narrative: While driving home, developed itching in ears, then itchy scalp, then felt hot all over. When she arrived home (45 min drive time) she notices skin was red with macular-papular rash all over.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt walked in clinic w/ father c/o the R upper arm swelling, redness, tender to touch. Pt received Tdap and Menveo on R arm. Skin intact and T- 99.8. Advised of local reaction, ice, home treatment, and monitor for increased pain and swelling. Advised to seek MD care if worse. Parent agreed w/ plan.
Age: 8.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness, warmth, tenderness, swelling at site of vaccination on right deltoid.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Reddened area approximately 5 cm with swelling and warmth.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Heat rash
Clinical narrative: Received phone call from Mother stating that child woke up this morning with rash on both arms and legs. Described by Mom as "heat rash". Denies any itching or swelling, no discharge.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Mass, Tenderness
Clinical narrative: Golf-ball sized lump. Tender to touch. Advised to apply heat and to take Ibuprofen. Advised to go to ER for any worsening symptoms or symptoms of anaphylactic reaction.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Erythema, Heart rate increased, Injection site erythema
Clinical narrative: Diarrhea, fever of 101.5, dizzy, severe pain where I cannot move arm, arm is swollen at injection site and far below, 3 days later and entire arm still swollen and bright red and is hot to touch, fast heart rate.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Mobility decreased, Oedema peripheral, Pain
Clinical narrative: Diarrhea, fever of 101.5, dizzy, severe pain where I cannot move arm, arm is swollen at injection site and far below, 3 days later and entire arm still swollen and bright red and is hot to touch, fast heart rate.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Diarrhea, fever of 101.5, dizzy, severe pain where I cannot move arm, arm is swollen at injection site and far below, 3 days later and entire arm still swollen and bright red and is hot to touch, fast heart rate.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Abnormal behaviour, Confusional state, Decreased appetite, Nausea
Clinical narrative: Within one hour of receiving his second injection of Gardasil, my son began to behave as if he was drunk, he was confused, he was nauseated and lost his appetite. The symptoms eased a bit within an hour, but the nausea lasted for approximately 3 hours, and afterward he was tired for the remainder of the day.  It took several hours for his appetite to return.  Most frightening:  he cannot clearly remember what happened.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy hives on legs, abdomen and arms.  Onset in the middle of the night that spread from legs upward and progressively got worse until morning when patient sought medical treatment.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (dose and route not reported); (Lot #G007459; exp. date: 02-AUG-2013). No other co-suspect therapy was reported. Concomitant medications were not provided. Medical Assistant reported that an expired dose of VARVIAX (Merck) was administered to a patient on 20-AUG-2013. No adverse effects had been reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from   a licensed practical nurse to a 1 year old male patient. The patient had no pertinent medical history and no known drug reactions or allergies. On 28-APR-2003, the patient ws vaccinated with a dose of VARIVAX (Merck) lot # reported as 643082/0593M expiration date 21-JUN-2004 (dose and route were not provided). There was no concomitant medications. On 09-MAY-2003, 12 days after onset of therapy. The patient experienced chickenpox after receiving VARIVAX (Merck). The patient's mother called the doctor's office. BENADRYL and CALADRYL were given as treatment. There were not laboratory diagnostics studies performed. The outcome of chickenpox was reported as recovered/resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a female consumer reporting on herself who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that on an unknown date she had experienced a rash and fever lasting for 10 days after receiving ZOSTAVAX. At the time of the report, the patient's outcome was unknown. The relatedness for rash and fever and ZOSTAVAX was unknown. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Rash, Swelling
Clinical narrative: Large local reaction with redness and swelling the size of a large hand. Rash. Diphenhydramine 25MG QID PO.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had a medical history of allergy/reaction to sympathomimetics (unspecified). On 04-JAn-2013 the patient was vaccinated subcutaneously with the first dose of ZOSTAVAX, lot number H018092, expiration date: 04-JAN-2014, dose: 0.65 ml. On 08-AUG-2013 the patient was vaccinated subcutaneously with the second dose of ZOSTAVAX, lot number; J001010, expiration date 24-APR-2014, dose: 0.65ml. Concomitant medications included: pravastatin, potassium (manufacturer unknown), omeprazole (manufacturer unknown), hydrochlorothiazide (also reported as hctz) and COSOPT. The pharmacist reported that after receiving the second dose of ZOSTAVAX, in approximately August 2013 the patient hadn't been feeling well (specific symptoms unspecified). The patient sought medical attention and she called to the pharmacy. The patient's outcome ws not reported. The relatedness between the adverse event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a Registered Nurse refers to a 22 year old female patient. On 10-JUL-2012 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported). On 12-SEP-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot not reported). The patient was administered a dose of GARDASIL while she was pregnant, the patient is 4 months pregnant at the time of the report. The patient LMP was calculated as 12-OCT-2012, the estimated date of conception as 26-OCT-2012 and the estimated delivery date as 02-AUG-2013. On 12-FEB-2013, the patient was administrated the third dose of GARDASIL (dose, route and lot not reported. The patient was receiving obstetrical care by an unspecified provider. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site pruritus, Injection site rash, Rash
Clinical narrative: Patient states she developed rash on left deltoid with itching and rash spread across chest to right deltoid. Rash developed evening she received vaccines.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash macular
Clinical narrative: 8/16/13 --> exam 8/19/13. (L) arm circumference = 8 1/2" (vs 7" on (R)) - swelling, redness, itching 8 1/2 length 5" width erythematous patch upper arm --> forearm. Blotchy erythema with serpiginous border volar surface forearm --> wrist
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Back pain, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: First symptoms - arm pain, back pain, tiredness, lack of sleep. Next - difficulty breathing, fast heart beat, dizziness, weakness, vomiting, diarrhea, mild fever.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Heart rate increased, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: First symptoms - arm pain, back pain, tiredness, lack of sleep. Next - difficulty breathing, fast heart beat, dizziness, weakness, vomiting, diarrhea, mild fever.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: First symptoms - arm pain, back pain, tiredness, lack of sleep. Next - difficulty breathing, fast heart beat, dizziness, weakness, vomiting, diarrhea, mild fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Local swelling, Musculoskeletal pain
Clinical narrative: Telephone call from mother stating childs arm is very swollen with white circles and c/o shoulder pain 2 days after Kinrix was given. She states she plans to take child to urgent clinic for evaluation.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Skin lesion
Clinical narrative: Erythematous patch with vesicular lesions and surround erythema.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Vaccine administered 8-20-13. Within 24 hours started having rash 0.5 cm over left trunk, traveled to right side down to buttocks and pubic area. Described as a constant itch with no pain. Started 50mg Q4 diphenhydramine. Patient had no improvement. Today patient given 1% topical hydrocortisone for a trial. Referred to MD.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 6 month old patient of unknown gender. The patients medical history was unknown. On 19-JUN-2013 the patient was vaccinated with ROTATEQ, oral solution. On an unknown date, after the administration of ROTATEQ, the patient experienced blood in the stool. The patient was taken to the emergency room because of the event. The event resolved on an unknown date. The physician did not rate the causality between ROTATEQ and blood in stool. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Pt's right arm got red and swollen about 6 hrs after receiving his immunizations. He had a shooting pain down his arm and took ibuprofen for the pain. After 24 hrs, the pt said he was improving but still experiencing symptoms.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Pt's right arm got red and swollen about 6 hrs after receiving his immunizations. He had a shooting pain down his arm and took ibuprofen for the pain. After 24 hrs, the pt said he was improving but still experiencing symptoms.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site lymphadenopathy
Clinical narrative: 5 days following Tdap to (L) deltoid developed lymphadenopathy under the (L) clavicle - 2 small rubbery firm nodes. Today is 9 days post Tdap and nodes still present.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Nodule
Clinical narrative: 8/17/13 (R) lateral thigh cellulitis, approximately 4 inches of erythema and induration. Taking BENADRYL. Tx BENADRYL 125 mg PO Q6 hours x 2 days, warm compresses. 8/23/13 - Per mom still a small knot, < 1 inch, no heat, no sensibility.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: DTAP and MMR administered same arm (L) came back 2 days later for PPD reading (L) arm swollen, hot to touch no pain and itching noticed the swelling and redness next day and T-99.7.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site bruising, Rash, Tremor
Clinical narrative: Experienced shakiness immediately after vaccine and 5 days after has 'bumpy' rash on arms (R) leg and abdomen and back. Mom reports she had bruising on (R) leg at immunization site. Had no rash on (L) leg per mom. Reaction/sxs not witnessed by provider.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Left thigh swollen and tender. Blisters on thigh (8x10 cm) erythematous, swollen, tender.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Antinuclear antibody, Arthralgia, Borrelia test, C-reactive protein, Culture
Clinical narrative: Rt hip/upper thigh pain that started when she woke up today (08-23-13). Able to walk but has to limp. Had MMR and VARIVAX in the form of PROQUAD on 8-13-13. Did run fever after vaccines for 1-2d. The Rt hip/leg pain started the minute she woke up. Her appetite has been good and she has been sleeping good. Dx toxic synovitis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Full blood count, Gait disturbance, Pain in extremity, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Rt hip/upper thigh pain that started when she woke up today (08-23-13). Able to walk but has to limp. Had MMR and VARIVAX in the form of PROQUAD on 8-13-13. Did run fever after vaccines for 1-2d. The Rt hip/leg pain started the minute she woke up. Her appetite has been good and she has been sleeping good. Dx toxic synovitis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rheumatoid factor, Streptococcus test, Synovitis, X-ray of pelvis and hip
Clinical narrative: Rt hip/upper thigh pain that started when she woke up today (08-23-13). Able to walk but has to limp. Had MMR and VARIVAX in the form of PROQUAD on 8-13-13. Did run fever after vaccines for 1-2d. The Rt hip/leg pain started the minute she woke up. Her appetite has been good and she has been sleeping good. Dx toxic synovitis.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Laboratory test, VIIth nerve paralysis
Clinical narrative: L - Bell's palsy.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Broke out in hives approximately 9am on 8/22/13 - very sudden per mom; was < 24 hours since vaccines; no difficulty breathing went to ED; face, neck and torso not on limbs - on prednisone and BENADRYL.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Pt was given 5 vaccines on 8/16/13 and found out she was pregnant on 8/21/13. Pt is in her 1st trimester.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pt was given 5 vaccines on 8/16/13 and found out she was pregnant on 8/21/13. Pt is in her 1st trimester.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Mass
Clinical narrative: Pt's mother reported that a "large baseball sized lump" appeared on left arm the day after vaccination was given. Patient was seen at hospital emergency and took Ibuprofen. Ice, Benadryl and Ibuprofen moderately alleviated redness and swelling. Patient does not complain of pain or itching.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Skin atrophy, Skin warm
Clinical narrative: Red hot to touch and indented 45cm x 25cm.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck) dose 2 (route, dosage and lot number unknown). The nurse practitioner reported that a patient received her scheduled 2 doses of VARIVAX in the past but stated "titers are equivocal". So, nurse practitioner noted that the patient's school is requiring another dose of VARIVAX (Merck) because the titers do not meet their requirements. The outcome of the event was unknown.  Additional information has been requested.