chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Dizziness, lightheadness, mild decrease in blood pressure (from 115 systolic to 102 systolic).
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PPV
Symptoms: Abnormal behaviour, Body temperature increased, Crying, Feeding disorder of infancy or early childhood, Hypersomnia
Clinical narrative: 6pm: Screaming for over an hour, not feeding, swollen thigh, odd behavior, and red rash. 7:30pm- 1am: Went to ER given Tylenol & ibuprofen. Still crying and whining. Keep in touch with pediatrician through night. Finally feel asleep at 9 pm then ate. Kept crying.  1am- home. 1am-9am:  slept without waking to feed and had to be woken up. 4/8/14: Feed well, took 1 ml of Tylenol. sleepy throughout day, half-dollar size red rash. No swelling, still irritable, 4pm: rectal temp. 100.4, given 2.5 ml of Tylenol.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PPV
Symptoms: Irritability, Local swelling, Rash erythematous, Screaming, Somnolence
Clinical narrative: 6pm: Screaming for over an hour, not feeding, swollen thigh, odd behavior, and red rash. 7:30pm- 1am: Went to ER given Tylenol & ibuprofen. Still crying and whining. Keep in touch with pediatrician through night. Finally feel asleep at 9 pm then ate. Kept crying.  1am- home. 1am-9am:  slept without waking to feed and had to be woken up. 4/8/14: Feed well, took 1 ml of Tylenol. sleepy throughout day, half-dollar size red rash. No swelling, still irritable, 4pm: rectal temp. 100.4, given 2.5 ml of Tylenol.
Age: 1.82
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Blood culture, Blood test, Hand-foot-and-mouth disease, Injection site reaction, Injection site swelling
Clinical narrative: Swollen injection site and high fever up until 8/7/2014. Was admitted into hospital 8/7/2014 and treated with antibiotics and pain medication. Monitored for two days.  Was diagnosed wih hand, foot, mouth disease and a staph/strep infection of injection site.
Age: 1.82
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Staphylococcal infection, Streptococcal infection
Clinical narrative: Swollen injection site and high fever up until 8/7/2014. Was admitted into hospital 8/7/2014 and treated with antibiotics and pain medication. Monitored for two days.  Was diagnosed wih hand, foot, mouth disease and a staph/strep infection of injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives.  Advised by NP to take Benadryl and seek care at ER in 30 minutes if hives don't subside or if breathing becomes affected.
Age: 0.64
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Right-thigh lump, raised, red, warm to touch cranky.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth, Pain, Pruritus
Clinical narrative: 5 cm warm raised area on (R) deltoid over injection site. Complains of itchy and soreness.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Faeces discoloured, Mucous stools, Pyrexia
Clinical narrative: Fever and watery green non-bloody mucousy stools developed 3 days post-vaccines/ROTATEQS.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Left deltoid area reddened, firm to touch, and c/o injection area itching.
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient had a reaction to PNEUMOVAX. Patient's injection was swollen similar to a bee sting and itching. Patient had an order for BENADRYL placed.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Had GARDASIL vaccine 8/6/14 - On 8/7/14 woke up with small dots on face and hive on elbow. Hives progressed on lt arm to wrist. Mom gave BENADRYL and hives went away but returned later. This time hives covered both arms and face. Mom advised to continue BENADRYL until hives do not return.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report from company representative refers to a patient of unknown age. Company representative learned of this event from patient. Company representative reported that the patient who is a Physician, received PNEUMOVAX 23 on a unknown date. Company representative reported the patient developed redness, soreness, and swelling around the injection site that lasted 5 days after receiving PNEUMOVAX 23. No further information was provided. Outcome of event is Recovered. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Lip numbness starting 08/07/14 at 12:30 pm. Numbness in lip and thumb and index finger of right hand 08/08/14. Will follow up with PCP.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: Patient called to report that apx. 2 hrs after receiving vaccination she began to develop significant swelling of arm, limiting mobility of arm, pain and redness that covered an area spanning from the shoulder to elbow. Pt. refused to have this evaluated.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site oedema, Injection site pain, Swelling
Clinical narrative: Local edema, inflammation, and pain around site of injection, extending down to elbow. Swelling decreased after 2 days. Patient is experiencing residual inflammation and pain.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Left arm from shoulder down to elbow with a red itchy rash, started 8/7. Treateint with BENADRYL.
Age: 5.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Cyanosis, Diarrhoea, Enuresis
Clinical narrative: Parent describes patient having blue lips x30 min - did not seek medical evaluation then had enuresis x 5-6 x a day for 6 days and diarrhea x 2 days. No cyanosis. Enuresis resolved.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling - redness, itching and burning at site. MD gave patient clindamycin - R/O cellulitis.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Presyncope
Clinical narrative: Near syncope episode with 10 mintues cool compresses to neck and head, apple juice -> left office well at 30 mins later.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. No information about medical history, drug reactions and allergies was specified. Pharmacist reported that a patient received a dose of ZOSTAVAX (lot # K000456, expiry date 15-DEC-2014, strength 19400 plaque-forming unit (PFU) dose, route not reported). The patient was not on any concomitant medications. The patient developed redness around the injection site, "shortly after" the administration on 29-JUL-2014. No lab diagnostics studies were performed. There was no product quality complaint. No treatment was given for the event. The patient sought medical attention at the pharmacy visit. The action taken with ZOSTAVAX is unknown. Pharmacist reports that the patient still has the redness around the injection but it is "getting better" (recovering). The causality of the event is unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Paraesthesia, Piloerection
Clinical narrative: My 13 year old son had the HPV vaccine at the doctor's office around 9am. When he went to football practice at 6, he became very winded, tingling in feet and hands, dizzy, and had goosebumps very bad! He drinks water throughout the day and he has a peanut butter and jelly sandwich before practice. I did report this reaction to his doctor.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX  HB. No adverse symptoms reported.  At the time of the report the action taken was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a consumer (brother of the patient) refers to a female patient of unknown age. Patient's medical history and drug reactions/allergies were not reported. In October 2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot # were not reporter). No concomitant therapy was reported. On an unknown date, the patient experienced itching on her arms after receiving the ZOSTAVAX. On an unknown date, the patient received treatment with BENADRYL for the itching and also used topical treatments including essential therapeutic oils. No lab diagnostics were performed. The patient did not see any medical attention. The outcome of itching on her arms after receiving the ZOSTAVAX was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 29-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # J014400, expiration date 13-NOV-2015) that was stored improperly. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. On 29-MAY-2014 the patient was being vaccinated with (Oka/Merck) VARIVAX, subcutaneously, dose number, dosage, site of administration, lot# and expiry date not reported. It was reported that the patient grabbed the syringe of (Oka/Merck) VARIVAX while it was being administered and the reporting nurse was unsure of how much (Oka/Merck) VARIVAX the patient received. No adverse effect was reported. The outcome of the events was unknown.   Follow up information received from the nurse referred to the 4 and a half years old female patient with one sibiling and no illness at time of vaccination. There were no allergies or medical conditions. On 14-MAY-2014, the patient was vaccinated with fifth dose of DTaP (dose and lot# unknown) IM. On 29-MAY-2014 at 06:54 PM, the patient was vaccinated with fifth dose of IPV (dose unknown, lot#J1561) IM in right arm and second dose of (Oka/Merck) VARIVAX, SQ (lot#J013733, expiration date 30-OCT-2015) in left arm.   While administering the vaccine on 29-MAY-2014, the patient grabbed the syringe and did not receive full dos of vaccine. No relevant diagnostic tests and laboratory data were performed. The outcome of patient grabbed the syringe and did not receive full dose of vaccine was reported as recovered on 29-MAY-2014. On 17-JUL-2014, the patient received another dose of (Oka/Merck) VARIVAX (dose, route and lot# unknown). Additional information is not expected since all follow ups requested to complete the case were received.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Diarrhoea, Fatigue, Nausea
Clinical narrative: Nausea, diarrhea, fatigue. Treated with lots of rest, probiotics. Symptoms have continued for 5 days so far.
Age: 73.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large red, feverish circle appeared around injection sight producing excessive itching, redness and raised inflammation.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives on insides of legs first. Spread to front torso, down legs, armpits, and spots on arms over subsequent 24 hrs. Recommended by physician to give Benadryl. Benadryl was given.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pallor, Injection site pruritus
Clinical narrative: 8-7-14 - Itching at inj. site per pt. local soreness (L) deltoid. 8-8-14 - per mo. 4" area of redness, pallor at site of inj (L) deltoid) itching. 8-9-14 - 16 cm circumferential area around inj. site (L) deltoid. Red, blotchy warm, no swelling or tenderness noted at office visit today. Rx: DESONATE gel to AA 2x QD.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a physician refers to a 75 year old male patient. The patient current condition includes with arrhythmia, coronary artery disease and TICLID allergy. The patient's medical history included skin rash. On 26-MAY-2014, the patient was vaccinated with ZOSTAVAX for to prevent shingles. Concomitant therapies included PLAVIX, aspirin, LOPRESSOR, COZAAR, NORPRAMIN, OMEGA-3 MARINE TRIGLYCERIDES, cholecalciferol, vitamins (unspecified), ubidecarenone and calcium (unspecified), magnesium (unspecified), (unspecified) CALCIUM MAGNESIUM ZINC. On 26-JUN-2014, he developed an itchy rash without pustules on the inner aspect of both arms and both legs, on both wrists, and in the groin area. He also developed bumps on the buttocks and the back. The patient sought medical attention by seeing a dermatologist. No lab diagnostics studies were performed. On an unspecified dates, he used cortisone and DESITIN (manufacturers unspecified) topically. These provided only temporary relief. However, the rash kept returning on unspecified dates. On 04-AUG-2014, he took a single dose of prednisone 20mg (manufacturer unspecified). He stated that he felt a little bit well and the rash looks a little better since taking the prednisone. The outcome of bumps on the buttocks and the back and itchy rash without pustules on the inner aspects of both arms and both legs, on both wrists, and in the groin area was reported as recovering/resolving. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Induration, Injection site pain, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 75 year old male patient. The patient current condition includes with arrhythmia, coronary artery disease and TICLID allergy. The patient's medical history included skin rash. On 26-MAY-2014, the patient was vaccinated with ZOSTAVAX for to prevent shingles. Concomitant therapies included PLAVIX, aspirin, LOPRESSOR, COZAAR, NORPRAMIN, OMEGA-3 MARINE TRIGLYCERIDES, cholecalciferol, vitamins (unspecified), ubidecarenone and calcium (unspecified), magnesium (unspecified), (unspecified) CALCIUM MAGNESIUM ZINC. On 26-JUN-2014, he developed an itchy rash without pustules on the inner aspect of both arms and both legs, on both wrists, and in the groin area. He also developed bumps on the buttocks and the back. The patient sought medical attention by seeing a dermatologist. No lab diagnostics studies were performed. On an unspecified dates, he used cortisone and DESITIN (manufacturers unspecified) topically. These provided only temporary relief. However, the rash kept returning on unspecified dates. On 04-AUG-2014, he took a single dose of prednisone 20mg (manufacturer unspecified). He stated that he felt a little bit well and the rash looks a little better since taking the prednisone. The outcome of bumps on the buttocks and the back and itchy rash without pustules on the inner aspects of both arms and both legs, on both wrists, and in the groin area was reported as recovering/resolving. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: PNC13, PPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 3 month old infant of unknown gender. Medical history and concurrent conditions were not reported. On an unknown date, the infant was vaccinated with PNEUMOVAX 23 (reported as PPSV-23) (dose, strength, route and lot number were not reported). Other suspect therapies included PREVNAR (dose, strength, route, lot number and indication were not reported). Concomitant therapies were not reported. On an unknown date, the 3 months infant received PNEUMOVAX 23 vaccine dose instead PREVNAR. Additional information is not expected because the caller does not want to be contacted for follow-up information.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a register nurse refers to a 17 year old patient of unknown gender with allergy to specific antibiotics. On 12-MAR-2014, the patient was vaccinated with first dose of GARDASIL lot # J013324; expiration date: 12-FEB-2016, 0.5 ml, intramuscular. Secondary and concomitant therapies were not reported. Nurse stated that the patient's mother reported pain at injection site after first dose GARDASIL in March 2014. Nurse stated no other effect to report. Nurse stated that pain was enough for the mother to ask for a type of analgesic for second dose scheduled for 07-AUG-2014 (reported as today). The outcome of pain at injection site was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-AUG-2014, the patient was vaccinated with M-M-R II lot # H014649; expiration date 03-AUG-2014, 0.5 ml, subcutaneous. Secondary and concomitant therapies were not reported. The pharmacist reported that the patient was inadvertently administered M-M-R II on 06-AUG-2014 that was expired on 03-AUG-2014. No adverse effect reported.  Additional information is not expected because the reporter do not want to be contacted for follow-up.
Age: 28.0
Sex: M
Vaccine: ANTH, JEVX
Symptoms: Cellulitis, Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Redness; Tenderness; Cellulitis; Itching; Swelling.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Arterial injury, Diarrhoea, Erythema, Feeling abnormal, Haemorrhage
Clinical narrative: When vaccine was injected, the nurse hit a vein or artery, which bled a lot (and HURT!). My upper arm got very black and blue, but on Saturday, it started getting hard and itchy and is now very red and hot, and I have been having diarrhea and nausea and feeling lousy. I plan to call my doctor in the morning and will probably go in for an appointment or go to the hospital to get this checked out.  I took an amoxicillin that I had in the house, because I think it's infected and I wanted to start an antibiotic.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Injection site pain, Nausea, Pruritus, Skin discolouration
Clinical narrative: When vaccine was injected, the nurse hit a vein or artery, which bled a lot (and HURT!). My upper arm got very black and blue, but on Saturday, it started getting hard and itchy and is now very red and hot, and I have been having diarrhea and nausea and feeling lousy. I plan to call my doctor in the morning and will probably go in for an appointment or go to the hospital to get this checked out.  I took an amoxicillin that I had in the house, because I think it's infected and I wanted to start an antibiotic.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Venous injury
Clinical narrative: When vaccine was injected, the nurse hit a vein or artery, which bled a lot (and HURT!). My upper arm got very black and blue, but on Saturday, it started getting hard and itchy and is now very red and hot, and I have been having diarrhea and nausea and feeling lousy. I plan to call my doctor in the morning and will probably go in for an appointment or go to the hospital to get this checked out.  I took an amoxicillin that I had in the house, because I think it's infected and I wanted to start an antibiotic.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Fever 99.3, rash at shot location starting at around 8:00 AM, treated with Tylenol at 10:30.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Vertigo
Clinical narrative: Severe vertigo and flu like aches.  Symptoms lasted until 07/22/2014 (10 days).
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Local swelling, Rash macular, Tenderness
Clinical narrative: Entire upper thigh swollen, 8-inch around redness, splotching, tenderness. Took to ER on 8/10, diagnosed with cellulitis, prescribed 2 antibiotics.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient had severe nausea, vomiting, and diarrhea.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: First it was severe upper abdominal pain and nausea lasting 7-10 minutes, followed by severe diarrhea lasting on/off about 4 hours. Body aches, chills, headache and soreness at injection site throughout following day. Very tired for the 2 days following injection. Treatment was water and rest.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: First it was severe upper abdominal pain and nausea lasting 7-10 minutes, followed by severe diarrhea lasting on/off about 4 hours. Body aches, chills, headache and soreness at injection site throughout following day. Very tired for the 2 days following injection. Treatment was water and rest.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: After receiving his vaccines, the student was seated next to his mother when he fainted.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dysphagia, Exposure during pregnancy, Throat tightness
Clinical narrative: Starting with throat closing, difficulty swallowing. By the time we reached the ER I became very lightheaded.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Somnolence
Clinical narrative: Extreme fatigue, sleepiness, lack of energy.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. On an unkonwn date in 2007, the patient was vaccinated with GARDASIL dose 1, intramuscular. On an unknown date in 2008, the patient was vaccinated with GARDASIL dose 2, intramuscular. The patient received doses of GARDASIL on 06-JUN-2010, 26-JUL-2011 and 01-AUG-2014 while she had been a patient of the physician. After the patient received what she thought was her third dose of GARDASIL on 01-AUG-2014, she realized, after she returned home, that she might have received the entire GARDASIL series at another physician's practice while she was living in another state. The patient informed the physician by telephone that she may have received 2 doses of GARDASIL on unspecified dates in 2007 and one dose of GARDASIL on an unspecified date in 2008. The physician had not reviewed the vaccination records that were currently in the patient's possession to confirm these previous vaccinations. The patient had not reported or demonstrated any adverse effects. Additional information is not expected as the physician was not comfortable providing the patient's name.
Sex: F
Vaccine: HPV4
Symptoms: Gastrointestinal disorder, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to her unknown age daughter who is the patient and also has a twin sister. Information regarding concurrent conditions and medical history was not provided. Approximately 1 year and 2 months ago, in June 2013 the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route were not provided). And at the time of the report the patient would like to receive the second dose. The consumer mentioned her daughter/patient began having unspecified "digestive system problems: after receiving the vaccine (date unspecified). The outcome of the events was not provided. This case is linked to SR#1-1206874903 (marrs# was not created yet), which has adverse information for the other twin. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, PNC13, VARCEL, PNC13, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 12 months old white female patient. On 14-APR-2014   13:30, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX lot # J009729 (Expiry: 07-AUG-2015) (dose, route, and frequency were not reported) which was exposed to 13C for 68 hours. The patient was also vaccinated on 14-APR-2014 at 13:30 with the fourth dose of PREVNAR 13, intramuscular in her right leg. There were not illnesses at time of vaccination. No adverse event reported. The patient was also vaccinated with a dose of M-M-R II incorrectly stored (MARRS#1404USA010752). This is one of several reports from the same source.  Additional information is not expected.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: Apparent life threatening event, Blood culture negative, C-reactive protein increased, Culture urine negative, Differential white blood cell count normal
Clinical narrative: This is a report from Non-Pfizer sponsored interventional study, based on the information received by Pfizer from GlaxoSmithKline (Manufacturer control number: Z0022910A). This subject was enrolled in a study. On 09Jul2014, a two-month-old female subject of unknown ethnicity received the 1st dose of INFANRIX HEXA at 0.5 ml single dose by intramuscular route, PREVNAR 13 at 0.5 ml single dose by intramuscular route and ROTARIX at 2 ml single dose by oral route. There was no relevant medical history. There was no history of seizure disorder in the family. No concomitant medications. It was reported that on the evening of 09Jul2014 the baby was very irritable then finally fell asleep. Her mother went to check on the baby and the skin and lips were pale (no cyanosis), breathing was noted to be very shallow. The mother states that the baby acted like she was trying to let out a big cry unsuccessfully and that the extremities were floppy. The mother was instructed by the afterhours nurse on call to take the baby to the ER to be evaluated. The baby was taken in and from there admitted to the hospital. The baby did well with some mild fussiness and decreased stooling. The baby was discharged from the hospital on 10Jul2014. On unknown date the following tests were performed: CBC showed white blood count of 16 (units not specified), urine culture and blood culture were negative, CRP was 20. Apparent life threatening event and leukocytosis were reported as adverse events. The investigator considered the events as life-threatening. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. It was also reported that the events did not occur after breastfeeding or during feeding. The events resolved on 09Jul2014. This is a preliminary report for notification of a fatal/life threatening events.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: Faecal volume decreased, Floppy infant, Full blood count normal, Hypopnoea, Hypotonia
Clinical narrative: This is a report from Non-Pfizer sponsored interventional study, based on the information received by Pfizer from GlaxoSmithKline (Manufacturer control number: Z0022910A). This subject was enrolled in a study. On 09Jul2014, a two-month-old female subject of unknown ethnicity received the 1st dose of INFANRIX HEXA at 0.5 ml single dose by intramuscular route, PREVNAR 13 at 0.5 ml single dose by intramuscular route and ROTARIX at 2 ml single dose by oral route. There was no relevant medical history. There was no history of seizure disorder in the family. No concomitant medications. It was reported that on the evening of 09Jul2014 the baby was very irritable then finally fell asleep. Her mother went to check on the baby and the skin and lips were pale (no cyanosis), breathing was noted to be very shallow. The mother states that the baby acted like she was trying to let out a big cry unsuccessfully and that the extremities were floppy. The mother was instructed by the afterhours nurse on call to take the baby to the ER to be evaluated. The baby was taken in and from there admitted to the hospital. The baby did well with some mild fussiness and decreased stooling. The baby was discharged from the hospital on 10Jul2014. On unknown date the following tests were performed: CBC showed white blood count of 16 (units not specified), urine culture and blood culture were negative, CRP was 20. Apparent life threatening event and leukocytosis were reported as adverse events. The investigator considered the events as life-threatening. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. It was also reported that the events did not occur after breastfeeding or during feeding. The events resolved on 09Jul2014. This is a preliminary report for notification of a fatal/life threatening events.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: Irritability, Leukocytosis, Pallor, White blood cell count normal
Clinical narrative: This is a report from Non-Pfizer sponsored interventional study, based on the information received by Pfizer from GlaxoSmithKline (Manufacturer control number: Z0022910A). This subject was enrolled in a study. On 09Jul2014, a two-month-old female subject of unknown ethnicity received the 1st dose of INFANRIX HEXA at 0.5 ml single dose by intramuscular route, PREVNAR 13 at 0.5 ml single dose by intramuscular route and ROTARIX at 2 ml single dose by oral route. There was no relevant medical history. There was no history of seizure disorder in the family. No concomitant medications. It was reported that on the evening of 09Jul2014 the baby was very irritable then finally fell asleep. Her mother went to check on the baby and the skin and lips were pale (no cyanosis), breathing was noted to be very shallow. The mother states that the baby acted like she was trying to let out a big cry unsuccessfully and that the extremities were floppy. The mother was instructed by the afterhours nurse on call to take the baby to the ER to be evaluated. The baby was taken in and from there admitted to the hospital. The baby did well with some mild fussiness and decreased stooling. The baby was discharged from the hospital on 10Jul2014. On unknown date the following tests were performed: CBC showed white blood count of 16 (units not specified), urine culture and blood culture were negative, CRP was 20. Apparent life threatening event and leukocytosis were reported as adverse events. The investigator considered the events as life-threatening. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. It was also reported that the events did not occur after breastfeeding or during feeding. The events resolved on 09Jul2014. This is a preliminary report for notification of a fatal/life threatening events.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: Blood culture negative, C-reactive protein increased, Culture urine negative, Faecal volume decreased, Full blood count
Clinical narrative: This is a report from Non-Pfizer sponsored interventional study, based on the information received by Pfizer from GlaxoSmithKline (Manufacturer control number: Z0022910A). This subject was enrolled in a study. On 09Jul2014, a two-month-old female subject of unknown ethnicity received the 1st dose of INFANRIX HEXA at 0.5 ml single dose by intramuscular route, PREVNAR 13 at 0.5 ml single dose by intramuscular route and ROTARIX at 2 ml single dose by oral route. There was no relevant medical history. There was no history of seizure disorder in the family. No concomitant medications. It was reported that on the evening of 09Jul2014 the baby was very irritable then finally fell asleep. Her mother went to check on the baby and the skin and lips were pale (no cyanosis), breathing was noted to be very shallow. The mother states that the baby acted like she was trying to let out a big cry unsuccessfully and that the extremities were floppy. The mother was instructed by the afterhours nurse on call to take the baby to the ER to be evaluated. The baby was taken in and from there admitted to the hospital. The baby did well with some mild fussiness and decreased stooling. The baby was discharged from the hospital on 10Jul2014. On unknown date the following tests were performed: CBC showed white blood count of 16 (units not specified), urine culture and blood culture were negative, CRP was 20. Apparent life threatening event and leukocytosis were reported as adverse events. The investigator considered the events as life-threatening. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. It was also reported that the events did not occur after breastfeeding or during feeding. The events resolved on 09Jul2014. This is a preliminary report for notification of a fatal/life threatening events.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: Hypopnoea, Hypotonia, Irritability, Leukocytosis, Pallor
Clinical narrative: This is a report from Non-Pfizer sponsored interventional study, based on the information received by Pfizer from GlaxoSmithKline (Manufacturer control number: Z0022910A). This subject was enrolled in a study. On 09Jul2014, a two-month-old female subject of unknown ethnicity received the 1st dose of INFANRIX HEXA at 0.5 ml single dose by intramuscular route, PREVNAR 13 at 0.5 ml single dose by intramuscular route and ROTARIX at 2 ml single dose by oral route. There was no relevant medical history. There was no history of seizure disorder in the family. No concomitant medications. It was reported that on the evening of 09Jul2014 the baby was very irritable then finally fell asleep. Her mother went to check on the baby and the skin and lips were pale (no cyanosis), breathing was noted to be very shallow. The mother states that the baby acted like she was trying to let out a big cry unsuccessfully and that the extremities were floppy. The mother was instructed by the afterhours nurse on call to take the baby to the ER to be evaluated. The baby was taken in and from there admitted to the hospital. The baby did well with some mild fussiness and decreased stooling. The baby was discharged from the hospital on 10Jul2014. On unknown date the following tests were performed: CBC showed white blood count of 16 (units not specified), urine culture and blood culture were negative, CRP was 20. Apparent life threatening event and leukocytosis were reported as adverse events. The investigator considered the events as life-threatening. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. It was also reported that the events did not occur after breastfeeding or during feeding. The events resolved on 09Jul2014. This is a preliminary report for notification of a fatal/life threatening events.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RV1, 6VAX-F, PNC13, RV1
Symptoms: White blood cell count normal
Clinical narrative: This is a report from Non-Pfizer sponsored interventional study, based on the information received by Pfizer from GlaxoSmithKline (Manufacturer control number: Z0022910A). This subject was enrolled in a study. On 09Jul2014, a two-month-old female subject of unknown ethnicity received the 1st dose of INFANRIX HEXA at 0.5 ml single dose by intramuscular route, PREVNAR 13 at 0.5 ml single dose by intramuscular route and ROTARIX at 2 ml single dose by oral route. There was no relevant medical history. There was no history of seizure disorder in the family. No concomitant medications. It was reported that on the evening of 09Jul2014 the baby was very irritable then finally fell asleep. Her mother went to check on the baby and the skin and lips were pale (no cyanosis), breathing was noted to be very shallow. The mother states that the baby acted like she was trying to let out a big cry unsuccessfully and that the extremities were floppy. The mother was instructed by the afterhours nurse on call to take the baby to the ER to be evaluated. The baby was taken in and from there admitted to the hospital. The baby did well with some mild fussiness and decreased stooling. The baby was discharged from the hospital on 10Jul2014. On unknown date the following tests were performed: CBC showed white blood count of 16 (units not specified), urine culture and blood culture were negative, CRP was 20. Apparent life threatening event and leukocytosis were reported as adverse events. The investigator considered the events as life-threatening. The investigator considered that there was a reasonable possibility that the apparent life threatening event with leukocytosis may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. It was also reported that the events did not occur after breastfeeding or during feeding. The events resolved on 09Jul2014. This is a preliminary report for notification of a fatal/life threatening events.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: None stated.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: None stated.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: None stated.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: None stated.
Sex: F
Vaccine: FLUX
Symptoms: Monoplegia, Vaccination complication
Clinical narrative: This medically confirmed spontaneous report (initial receipt 31-Jul-2014) concerns a female patient. On an unknown date, the patient received Influenza (batch number not provided). On an unknown date, the patient had a severe reaction to a flu vaccine. The patient developed partial paralysis of her arm. Outcome was reported as unknown.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: While receiving MENACTRA, pt experienced near syncope, then sat up, alert and responsive - pt monitored for 20-30 min after injection. No complications noted thereafter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, small bump under skin at injection site, Dr told her it was infected gave Doxycycline.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Guillain Barre syndrome - ascending paralysis - feet to mouth. See ER hosp. admission notes attached.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Angioedema, Dysgeusia, Dysphagia
Clinical narrative: Complained of alcohol taste in mouth and difficulty swallowing. Per ED report also had mild angioedema. Solumedrol and Benadryl administerd IV. Admitted to inpatient unit.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apparent death, CSF test abnormal, Convulsion, Disability, Epilepsy
Clinical narrative: After leaving the doctors office the day of the immunization, we arrived at home and I had noticed my child had a huge knot on his leg were the vaccine was administered, he went into a seizure that lasted two hours + he is now epileptic..etc.....The seizures are global..physicians have determined that he has a chemical sitting on top of his brain in his cranial fluids that isn't supposed to be there caused from the vaccine....
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site nodule, Vaccination complication
Clinical narrative: After leaving the doctors office the day of the immunization, we arrived at home and I had noticed my child had a huge knot on his leg were the vaccine was administered, he went into a seizure that lasted two hours + he is now epileptic..etc.....The seizures are global..physicians have determined that he has a chemical sitting on top of his brain in his cranial fluids that isn't supposed to be there caused from the vaccine....
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Dyspnoea, Feeling abnormal, Injection site induration, Injection site rash, Injection site reaction
Clinical narrative: Pt started feeling bad immediately after leaving HD. Pt awoke 8/11/14 with warm, hive-like rash to DTaP/IPV injection site.  Pt did awaken during the night of 8/11/14 et had c/o SOA, parent states resolved on its' own (pt fell back asleep).  Rash is now solid "peach-sized," warm, firm and has encompassed both injection sites.  Pt has not received any OTC treatment for rash or inflammation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth, Middle insomnia, Urticaria
Clinical narrative: Pt started feeling bad immediately after leaving HD. Pt awoke 8/11/14 with warm, hive-like rash to DTaP/IPV injection site.  Pt did awaken during the night of 8/11/14 et had c/o SOA, parent states resolved on its' own (pt fell back asleep).  Rash is now solid "peach-sized," warm, firm and has encompassed both injection sites.  Pt has not received any OTC treatment for rash or inflammation.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial information received from a healthcare professional on 09 July 2014. A 29-year-old female patient whose medical history and concomitant medications were not reported had received first intramuscular dose of ADACEL (Lot number C4543AA, expiration date was not reported) on 09 July 2014. It was reported the patient had vaccine exposure during pregnancy with no adverse event. The patient's estimated date of delivery was on 01 August 2014. Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Fatigue, Skin test negative, Throat tightness, Tongue disorder
Clinical narrative: By 1405 pt was c/o throat feeling tight, tongue feeling thick and fatigue.  The symptoms continued unchanged x 15 min and pt was given 0.3 mg EpiPen.  15 min later symptoms resolved.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Abasia
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 12 months female patient. The patient's medical history and current conditions were not specified. On 24-FEB-2014, the patient was vaccinated with VARIVAX (Merck) (lot # J004156, expiration date: 05-APR-2015) (first dose, 0.5 ml, subcutaneous). Concomitant medications were not specified. On 24-MAR-2014 (also reported as 4 weeks after administration of first dose) the patient stopped walking. The nurse reported that the patient was initially evaluated by an unspecified pediatrician but no diagnosis was made and no diagnostic testing was performed. The patient sought medical attention and visited the office. The nurse practitioner evaluated the patient in the office for the first time on 05-AUG-2014. The event patient stopped walking was considered as significant disability or incapacity. The outcome of the event was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Discomfort, Pain, Rash papular, Rash pruritic, Skin lesion
Clinical narrative: Received SPV on 23 Jul '14 and 14 days later developed acral papulovesicular eruptions on knees and elbows which are painful and pruritic. On 8 Aug pt went to ER and the VHC Call Center was contacted. Pictures were sent and a short history taken on pt. This patient was given steroid cream for his lesions and told to F/U with his PCP on Monday. Today, patient was called and his cream is gone - applying clobetasol 0.05% cream tid - and is very uncomfortable. Consulted with Dr and it is agreed that patient should go to local ER and receive oral prednisone 50mg po qd x 10 ds, then 40mg x 2ds and decreasing doses by 10 mg until weaned.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site warmth
Clinical narrative: Itching, redness, warmth and nickel size induration at the vaccine site. The induration enlarged to quarter size on Friday 8/8/14, with onset of diarrhea by 5pm. On Saturday 8/9/2014 the diarrhea resolved and the area on induration increased to the size of a golf ball. Sunday the induration decreased to size of quarter and Monday as of this writing is nickel sized.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. The pharmacist reported that these unspecified patients may had received improperly stored ROTATEQ (lot#, dose not reported, orally) on an unknown date. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. 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 pharmacist refers to unspecified patients of unknown age and gender. The pharmacist reported that those unspecified patients may had received improperly stored GARDASIL (lot #, dose, route not specified) on an unknown date. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. The pharmacist reported that these unspecified patients may had received improperly stored PNEUMOVAX23 (lot#, dose, route, not reported) on an unknown date. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. the pertinent medical history included hypertension. On 12-JUL-2014 the patient was vaccinated with OSTAVAX (lot # J016259, expiration date 27-FEB-2014, dose 1, route subcutaneous. The reporter stated that the patient was a case of ocular shingles 4 weeks back and on 18-JUL-2014, the patient was diagnosed with exacerbation of the ocular shingles is being treated with an unspecified antiviral medication by her unspecified ophthalmologist. The outcome of exacerbation of the ocular shingles  was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. Additional information his not expected as reporter refused additional contact.