chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Injection site pain, Injection site swelling, Mass
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 11 year old female patient with none drug reactions or allergies. Pertinent medical history included tonsils and adenoids removal. In October 2013 (date unspecified) the patient was vaccinated with a first dose of GARDASIL (lot # J007354, expiration date 20-FEB-2016, injection (dose and route not provided). On 10-DEC-2013 the patient had administered in her left arm a second dose of GARDASIL (lot # J007354, expiration date 20-FEB-f2016, reported as which may had been from the recalled lot) injection (dose and route not provided). On the same day, 10-DEC-2013 the patient was vaccinated with an unspecified flu vaccine in her right arm which may had been AFLURIA (dose, route, lot number and expiration date not provided). No concomitant medication was reported. On 10-DEC-2013 the patient experienced pain at the left arm injection site. On an unknown date (in December 2013) the patient sought medical attention for the funny lump on her chin. The approximately 20-DEC-2013 reported as about one week ago, the patient sought medical attention for the funny lump on her chin. The funny lump was diagnosed as possibly a cyst or fatty tissue. No treatment was prescribed. No treatment was reported for the pain at her left arm injection site. The outcome of the pain at the left arm injection site was reported as resolved on an unspecified date in December 2013 and the site was at the time of report still a little swollen (onset date approximately in December 2013). The outcome of funny lump on her chin/cyst or fatty tissue was not reported. The relatedness between vaccination with GARDASIL and events was not reported. The patient did not recover from the event of vaccination site swelling at the time of this report. The relatedness between vaccination with AFLURIA and events was not reported. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 23 year old male patient. On 06-JAN-2014 the patient was vaccinated with a pediatric dose of RECOMBIVAX HB injection (route, strength, lot number and expiration date not provided). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a female consumer of unknown age referring to herself. ON 13-DEC-2013 the patient was vaccinated with GARDASIL (dosage regimen, lot# and expiry date unspecified). Concomitant medications were not reported. The consumer reported that she might have become pregnant on 22-DEC-2013 or 23-DEC-2013 with last menstrual period of approximately 08-DEC-2013 and estimated date of delivery of approximately 14-SEP-2014. Trimester of exposure was first trimester. The pregnancy outcome was pending. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Quality of life decreased, Sleep disorder
Clinical narrative: 3 weeks after administration, patient experienced pins and needles feeling in arm and hand (left) that has not resided to this date. It is interfering with her sleep and quality of life.
Sex: U
Vaccine: PNC13
Symptoms: Streptococcus test positive
Clinical narrative: This is an initial spontaneous report from Pfizer Medical Information for a contactable physician who reported for a patient. This 10 months old patient (gender unknown) received PREVNAR 13 at an unknown dose and frequency on an unknown date. Relevant medical history and concomitant medication were unknown. On an unknown date the patient was tested positive for streptococcus pneumonia while being on PREVNAR 13. Relevant laboratory data was unknown. Last action taken with PREVNAR 13 was unknown at the time of report. Therapeutic measures taken in response to the reported event were unknown. Clinical outcome of the reported event was unknown at the time of report.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Affect lability
Clinical narrative: This spontaneous report was received from a health care worker and refers to a 11 year old female patient. The patient did not have any concurrent condition and had history of drug reaction/allergy to amoxicillin. The reporter stated that a patient received her first dose of GARDASIL 90.5 ml, intramuscular, lot # J007354 exp. date. 20-FEB-2016) for immunization. The GARDASIL with this lot # was recalled. Soon after vaccination with GARDASIL, on 04-OCT-2013, the patient displayed emotional liability. The patient's mother called the physician's office and reported that the patient was laughing and crying and that her behavior was not right. The physician recommended that the patient should be seen in an Emergency Room (ER), but the patient did not go to the ER. None lab diagnostics studies were performed. The reporter called back the patient's mother the next day and reported that the patient's behavior had returned to normal. The patient recovered on 05-OCT-2013. The relatedness between GARDASIL, and events was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient (himself). Patient's medical history was not provided. Patient's drug reaction/allergies were reported as none. In January 2013 the patient was vaccinated with VARIVAX (Merck) dose 1, 0.5 ml, subcutaneous. In February 2013, 5 weeks after receiving the first dose, the patient was vaccinated with VARIVAX (Merck) dose 2, 0.5 ml, subcutaneous. Patient did not use any concomitant medications. The patient recently had a blood test for varicella titer with an equivocal result. The outcome of blood test for varicella titer with an equivocal result was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report received from a physician via field representative refers to a 60 year old female patient. On 17-DEC-2013 the patient was vaccinated with ZOSTAVAX injection lot # J008434 and expiry date 11-OCT-2014 (reported as unspecified) dose 1 for shingles prevention. Concomitant therapies included potassium (manufacturer unknown), hydrochlorothiazide, MAXZIDE, estrogens, PREMARIN, CELEBREX and NEURONTIN. On 20-DEC-2013, the patient experienced vesicular pox like rash after vaccination. On 27-DEC-2013 the physician had seen the patient who complained that this rash was itchy. The physician treated the patient with VALTREX and a MEDROL patch. After prescribing this, the physician told the patient to come back to the office if this adverse experience did clear up in a week. The patient did not come back to the office, so the reporter (field representative) assumed that the patient had recovered from this adverse experience. The outcome of vesicular pox like rash and rash was itchy was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: This spontaneous report refers to an approximately 19 year old female patient. On 22-MAR-2010 the patient was vaccinated with VARIVAX (Merck), subcutaneous. Lot number 1296Y was reported. Concomitant therapies included IBUPROFEN. On 03-JAN-2014, the patient experienced shingles and red rash on her mid thoracic area to right coastal margin on the abdomen, no vesicles and red bumps or erythematous papules were reported. On 03-JAN-2014, patient went to the emergency room at hospital in regards to this reaction but was not admitted. Patient was prescribed Famciclovir (manufacturer unknown) and hydrocodone (manufacturer unknown) and was also prescribed gabapentin (manufacturer unknown). The outcome of red rash on her mid thoracic area to right coastal margin on the abdomen was reported as not recovered, she was still experiencing these symptoms. The relation between the events and the VARIVAX (Merck) was unknown. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and pain (L) upper arm coming on within 30 mins of injections and persisting for 3 days.
Age: 0.33
Sex: F
Vaccine: DTAP, IPV, PNC13, RV1
Symptoms: Immediate post-injection reaction, Rash erythematous, Skin lesion, Swelling
Clinical narrative: Immediately after administration patient broke out in an erythematous rash on her face - 3-6mm in size, and 2-3 lesions on trunk. No respiratory distress. Swelling noted. Rash faded within 20 minutes of monitoring. No interventions needed in clinic (waited 1 hour).
Age: 1.52
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Rash, Rash morbilliform
Clinical narrative: Morbiliform rash began on face -> spread to trunk, was GU area LE spared non-pruritic, afebrile, mother gave BENADRYL x3 doses thinking it was as an allergic reaction. Rash resolved within one week. No further complaints.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Fear, Hallucination, tactile, Musculoskeletal stiffness, Screaming
Clinical narrative: Daughter woke up from sleeping at approx 4 Am on 1-11. She woke up screaming that there were spiders on her and to help her. She had no fever. I removed her from her bed and took her into family room where it took about 40 min to call her down. I though maybe she just had a nightmare until later on in the day while in her car seat on our way to the store she started screaming for me to help her, saying snails were on her. I pulled over to assure her she was fine and she was paralyzed with fear. Her hand and legs were very stiff and when I put my as out for her to come to me she didn't move. Almost like she was frozen. After about 10 min I called her down. We continued on to the store where inside the store she had another episode. Just out of now where she started saying, I scared...snails on me. Help me. She kept repeating that. I left my cart of groceries and we exited the store. It is now 01/13/2014 amd she is still having these hallucinations. We are very scared and don't know what to do.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Local swelling
Clinical narrative: Swollen upper arm from shoulder to elbow, numbness through hand and under arm.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Localised oedema, Pyrexia, Skin warm
Clinical narrative: Right arm has area approximately 4 inches in diameter that is red, warm and edematous.  Pt states low grade fever last night. Temp today was 98.5.
Sex: F
Vaccine: HPV4
Symptoms: Hypoacusis
Clinical narrative: This spontaneous report as received from a consumer refers to his female friend of unknown age. On an unknown date the patient was vaccinated with GARDASIL (route, dosage, dose no. and lot number unknown). On an unknown date the patient experienced she was having decreased hearing possibly stemmed from taking the GARDASIL. The outcome of she was having decreased hearing was unknown. Upon internal review decreased hearing was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic shock, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to 18 year old male patient (at the time of event). Patients current conditions and historical conditions were not reported. No Known allergies. Approximately in 1970 (at the age of 18 years), the patient was vaccinated with the first dose of MMR II. No concomitant medications were reported. Approximately in 1970, immediately after receiving the first dose of MMR II, the patient went into anaphylactic shock (medically significant) and lost consciousness (unspecified duration of loss of consciousness or date of administration). Patient received unspecified treatment for the event. the patient had limited information about the adverse event reaction at the time of the call. No PQC was involved. The outcome of anaphylactic shock was reported as recovered. The reporters causality for the event anaphylactic shock with the therapy of MMR II was not reported. Upon internal review the event anaphylactic shock was considered as medically significant event. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt says she has had hives for a week. Has been using BENADRYL. I told her to call her dr.
Age: 26.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Injection site pain, Malaise, Pallor, Syncope
Clinical narrative: Administration flu vaccine first, then HPV4 in other deltoid. Within seconds, client complained of pain from the HPV, Then she grew pale and said she didn't feel well. Began to move client to lie on exam table and she fainted, revived immediately with smelling salts, lying on exam table awake x 15 min then up and feeling okay.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Fatigue, Injection site erythema, Varicella post vaccine
Clinical narrative: 12/20/13 - rec'd VARIVAX. 1/2/14 - fatigue. 1/3/14 - joint pain. 1/4/14 - vaccine site red. 1/5 - chicken pox spots. 1/13/14 - resolved.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Serum ferritin decreased
Clinical narrative: This spontaneous report as received from a patient's mother refers to an approximately 18 year old female patient. The patient's pertinent medical history included Graves' disease, blood disorder (not specified) and low ferritin levels. The patient had a history thyroid ablation (reported as ablated thyroid). The reporter stated each time after the patient received dose one, two, and three in the series with GARDASIL intramuscular (strength, dose not reported) for prevention of Human papilloma virus (HPV), she experienced tenderness at the injection site. Concomitant therapies included SYNTHROID, elimmental iron supplement (unspecified), spironolactone and JUNEL. The reporter also stated that the patient received each dose about three months apart (estimated dates of vaccinations: June 2013 for first dose of GARDAIL intramuscular (strength, dose not reported) for prevention of HPV, September 2013 for second dose and 19-DEC-2013 for third dose. No treatment was given for the events. The reporter stated the patient's physician called and told the patient that her third dose of GARDASIL which was about a week ago (approximately on 19-DEC-2013) was, from a recently recalled lot. The reporter could not confirm the lot number, but stated that it was the lot of GARDASIL that was just recalled. The reporter stated that other than tenderness at the injection site, (the patient) did not experience any other side effects. The patient did not seek medical attention. The outcome of events was reported as recovering. The relatedness between events and GARDASIL was not reported. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from an immunization coordinator refers to a 28 year old male patient. On 14-MAY-2013 and on 20-JUL-2013 the patient was vaccinated with first and second doses of GARDASIL respectively (dose and lot numbers not reported). The patient was 28 years old at the time of vaccination. No adverse effects were reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site abscess, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left anterior thigh - 8 cm x 4 cm erythema mild warmth and induration over the injection site. Dx: cellulitis and abscess of leg except foot.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Culture negative, Diarrhoea, Eye infection
Clinical narrative: Here for being ill for several weeks. Seen in ED, cultures negative, CBC noted to have a WBC of 2.7 - nl hgb/plt, nl ANC but low ALC. The father reports this is day 16 of fever. On 12/17 he had a flu shot in our office. Fever started on 12/18 with a rash that looked like hives to the family. They thought that the rash may have been from eating a peanut butter cookie. The rash was itchy. When he had the rash he had swelling of his hands. His rash has been up to 105 and has been daily. He has been to the ED and to urgent care, at one visit they noted that his eyes were injected but there was no d/c. His neck has hurt (back of neck) but no neck swelling noted. + chills, + one day loose stool + loss of energy (sleeping a lot). No bruising, no bleeding, no seizures, no photophobia, no ear pain, no emesis.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Haemoglobin normal, Hypersomnia, Local swelling, Lymphocyte count decreased, Malaise
Clinical narrative: Here for being ill for several weeks. Seen in ED, cultures negative, CBC noted to have a WBC of 2.7 - nl hgb/plt, nl ANC but low ALC. The father reports this is day 16 of fever. On 12/17 he had a flu shot in our office. Fever started on 12/18 with a rash that looked like hives to the family. They thought that the rash may have been from eating a peanut butter cookie. The rash was itchy. When he had the rash he had swelling of his hands. His rash has been up to 105 and has been daily. He has been to the ED and to urgent care, at one visit they noted that his eyes were injected but there was no d/c. His neck has hurt (back of neck) but no neck swelling noted. + chills, + one day loose stool + loss of energy (sleeping a lot). No bruising, no bleeding, no seizures, no photophobia, no ear pain, no emesis.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Neutrophil count normal, Platelet count normal, Pyrexia, Rash pruritic
Clinical narrative: Here for being ill for several weeks. Seen in ED, cultures negative, CBC noted to have a WBC of 2.7 - nl hgb/plt, nl ANC but low ALC. The father reports this is day 16 of fever. On 12/17 he had a flu shot in our office. Fever started on 12/18 with a rash that looked like hives to the family. They thought that the rash may have been from eating a peanut butter cookie. The rash was itchy. When he had the rash he had swelling of his hands. His rash has been up to 105 and has been daily. He has been to the ED and to urgent care, at one visit they noted that his eyes were injected but there was no d/c. His neck has hurt (back of neck) but no neck swelling noted. + chills, + one day loose stool + loss of energy (sleeping a lot). No bruising, no bleeding, no seizures, no photophobia, no ear pain, no emesis.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria, White blood cell count decreased
Clinical narrative: Here for being ill for several weeks. Seen in ED, cultures negative, CBC noted to have a WBC of 2.7 - nl hgb/plt, nl ANC but low ALC. The father reports this is day 16 of fever. On 12/17 he had a flu shot in our office. Fever started on 12/18 with a rash that looked like hives to the family. They thought that the rash may have been from eating a peanut butter cookie. The rash was itchy. When he had the rash he had swelling of his hands. His rash has been up to 105 and has been daily. He has been to the ED and to urgent care, at one visit they noted that his eyes were injected but there was no d/c. His neck has hurt (back of neck) but no neck swelling noted. + chills, + one day loose stool + loss of energy (sleeping a lot). No bruising, no bleeding, no seizures, no photophobia, no ear pain, no emesis.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Contusion, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: 1 day after injections in the evening arm felt bruised then started to itch and swell around injection sites into a red oval.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's Palsy on (L), Note: ? onset of early sxs prior to vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: On 1-6-14 received VARIVAX (L) arm. On evening of 1-7-14, complained of itching of arm, some redness. On 1-8-14 worsening swelling, redness, continued itching. To use cool compresses, BENADRYL PO as needed prescribed 7 day course of KEFLEX.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone, Fatigue, Full blood count, Glycosylated haemoglobin, Metabolic function test
Clinical narrative: Mom claims that her weight loss started after the shot. That she is always tired. That she was not like this before the shot. Mom blames her symptoms on CERVARIX.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Prealbumin, Thyroxine, Weight decreased
Clinical narrative: Mom claims that her weight loss started after the shot. That she is always tired. That she was not like this before the shot. Mom blames her symptoms on CERVARIX.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis, Eye infection, Lymphatic disorder, Pruritus, Skin lesion
Clinical narrative: Pt said itching started 10/3/13 after receiving the vaccine since then she has had dermatitis, gland problems, lesions, and eye infections. She said she has seen 5 doctors and they feel it was a reaction to the flu shot pt did not tell us until 12/30/13.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Pt said itching started 10/3/13 after receiving the vaccine since then she has had dermatitis, gland problems, lesions, and eye infections. She said she has seen 5 doctors and they feel it was a reaction to the flu shot pt did not tell us until 12/30/13.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Redness and swelling at injection site, noted around 1800 on 1/10/14. Pt treated with oral BENADRYL and prednisolone 15mg/5ml 6ml po qd x3days.
Age: 19.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt passed out at front of store, pt states she felt lightheaded and passed out, pt immediately regained consciousness I observed pt sitting in floor, pt states that she feels fine and has no injury, pt continued to sit for 15 minutes and drink sprite, pt states that she feels fine and has not eaten since previous day.
Age: 1.02
Sex: F
Vaccine: FLU3, MMRV, PNC13
Symptoms: Incisional drainage, Injection site abscess, Injection site erythema
Clinical narrative: Pt developed abscess in (R) thigh after PROQUAD vaccine. Red area - nickel size appeared 10 days after vaccine. Pt placed on SEPTRA 200/40 mg /5 mL x 10 days. Had I and D at ER on 11-30-2013.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Abdominal pain, Influenza like illness, Nausea, Urticaria
Clinical narrative: Abdominal pain, felt like pt had flu, nausea, then on 01/12/2014 pt had hives on forehead and ALL over the rest of the body.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness
Clinical narrative: Severe weakness and dizziness started within 30 minutes after injection, lasted 3 days, treated by bedrest, fluids, and Tylenol.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Ear infection, Pyrexia, Rash generalised, Rash papular, Varicella post vaccine
Clinical narrative: Varicella diagnosis at ED on 12/25/2013. Received varicella vaccine on 12/04/2013. According to mother, lasted about 12 days. Generalized rash with between 50-249 papular lesions. 104 degree fever. Also diagnosed with an ear infection shortly after being diagnosed with chickenpox.  No other known exposures.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Vaccine administrator began the immunization of the patient while being observed by RPh.  When the administration of the immunization began the injection site instantly started swelling before the injection needle was placed into the subcutaneous site completely.  The area was very tough, and the needle would not go in farther.  No Zostavax vaccine was injected at the sight due to the instant swelling.  The injection was repeat at a site near the first injection and the same event occurred. The location area swelling was the approximately the size of a pencil eraser. With the patients permission the immunization was completed by RPh at a subcutanous site a few inches away from the others.  The skin was tough when injected but was successful.  The patient reported recently falling with possible unseen bruisings. No known scar tissue in the right arm where the injection was given.  The patient reported feeling fine after the immunization was given and waited an additional 15 minutes to ensure he still felt ok.  A card was given to the patient with contact information in case any worsening at the injection site occured.  No treatment was given.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Asthenia, Burning sensation, Loss of control of legs, Myasthenia gravis
Clinical narrative: 11-9-13 to ER R/T legs "giving out" during a basketball game. Continued to have "burning" sensation and weakness through November. Referral to neurology, per neurologist, patient diagnosed with Myasthenia Gravis at the beginning of this month (Jan. 2014).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Antiacetylcholine receptor antibody positive, Antibody test abnormal, Asthenia, Myasthenia gravis
Clinical narrative: 11-9-13 to ER R/T legs "giving out" during a basketball game. Continued to have "burning" sensation and weakness through November. Referral to neurology, per neurologist, patient diagnosed with Myasthenia Gravis at the beginning of this month (Jan. 2014).
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site streaking
Clinical narrative: Seen MD Monday AM 1/13/2014. Says in copy of site reaction with red streaks.
Sex: M
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a third party claims administrator for a pharmacy concerning a male patient (age not provided). On an unspecified date the patient was vaccinated with PNEUMOVAX 23 (lot # J009827, exp. date 10AUG2014). On 21DEC2013 the patient experienced an adverse reaction. The outcome of adverse reaction is unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: The pt walked into the clinic on 1-8-14. She stated she had soreness and itching after receiving the flu vaccine on 1-3-14. The pt had a reddened area on her (L) arm. The area was in the shape of a bandaid. BENADRYL (q 6-8 hrs) and ibuprofen (1) (tid) treatment advised. Pt to call back 1/9/14 if no improvement.
Age: 7.0
Sex: M
Vaccine: FLUC3
Symptoms: Wrong drug administered
Clinical narrative: Wrong flu vaccine given.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Troponin I increased, Troponin increased
Clinical narrative: This study case was received from the investigator in a trial on 08 January 2014. A 29 year-old male subject with no reported past medical history was found to have on 19 December 2013 an elevated Troponin level of 0.33 ng/ml three years after the subject had received on 10 April 2010 the following vaccine: ACAM2000 (lot number, route and site of administration not reported). On 02 January 2014, the subject had an elevated Troponin level of .035 ng/ml and EKG was normal. The subject with no cardiac symptoms but persistently elevated troponin. Due to the remote ACAM vaccination, it was felt by the investigator the likelihood of relation to vaccine was low. Per the investigator the subject was referred appropriately. The subject's outcome was still present, no treatment (not recovered). According to investigator, the likelihood of a relation vaccine to the event of elevated troponin I was remote. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cough, Electrocardiogram normal, Paranasal sinus hypersecretion, Troponin I normal
Clinical narrative: This study case was received from the investigator in a trial on 16 August 2012. A 19-year-old male subject, with a past medical history of psoriasis, experienced a dry cough 10 days after the subject received the following vaccines on 25 July 2012: smallpox (vaccinia) vaccine (manufacturer, lot number, route and site of administration not reported). The subject had a dry cough mostly in the morning with sinus drainage. Subject denied shortness of breath (SOB), chest pain, chest pressure or palpitations. The subject had no other complaints and normal troponin and ECG on 06 August 2012. It was very unlikely that the event was cardiac in nature. No further treatment or follow-up was required. No further information was available at the time of the report. The subject's outcome was not recovered. Follow-up information was received from the investigator on 11 February 2013. Mucous sinus drainage began on 06 August 2012. No additional information was provided. Felt not to represent potential myopericarditis. Nothing more to follow. Outcome remained not recovered. The subject was lost to follow-up. Follow-up information was received from the investigator on 02 January 2014. Concomitant medication included Motrin 800mg orally three times a day beginning on 23 July 2012 for past medical history of right rib pain. Rapid troponin I was within normal limits (negative) and central troponin I was <0.10 ng/ml on 06 August 2012. Dry cough and sinus drainage with mucous were ongoing. The subject was an alcohol and tobacco user. Documents held by sender: Medical records.
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to two patient of unknown age and gender. On an unknown date, the two patients received ROTATEQ (lot #, dose and route not provided) and threw up the doses so another doses was given. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal
Clinical narrative: This spontaneous report was received from a current 64 year old registered nurse who is also the patient with no pertinent medical history or concurrent conditions. Drug reactions/allergies included penicillin and sulfa allergy. On an unknown date, in the late 1980's or early 1990's, the patient received the complete three doses of hepatitis b vaccine (recombinant) (manufacturer unknown), (Lot # not provided) 10 microgram one dose, intramuscularly for prevention of hepatitis. Co-suspect therapy and concomitant medications were not provided. The patient received the complete 3 doses of hepatitis b vaccine (recombinant) (manufacturer unknown), and in 2010, the hospital had drawn up titers for all hospital employees and her titers for Hepatitis B were low, so she was revaccinated with another dose of hepatitis b vaccine (recombinant) (manufacturer unknown). Nurse's titers were later drawn up and again showed that she had low titers so she completed dosing schedule with two more doses of hepatitis b vaccine (recombinant) (manufacturer unknown). A couple of months later, nurse's titers were drawn up and still showed inadequate protection. The patient's sought medical attention in hospital at employee health. The patient's outcome was not provided. Additional information has been hospital.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza like illness, Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 06 January 2014. Two patients (demographic details were not reported) had received a dose of FLUZONE (batch number UH888AB, expiry date: 30 June 2014, route and site of vaccination not reported) on an unspecified date. The patient's medical history and illness at the time of vaccination was unknown. On an unspecified date, within few hours after vaccination, the patient developed "the flu", had a fever, was achy and had flu like symptoms. It was reported that one of the patients also developed reddened, bloodshot eyes. Laboratory investigation and corrective treatment was not reported. At the time of this report, the patient had not recovered from the event. Documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Blood culture negative, Headache, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Initial case received from a literature article on 03 January 2014: A 5-year old female with sickle cell hemoglobin C disease had received a dose of PCV23 (lot number, dose number and route of administration were not reported) in the right arm and had received a dose of MCV4 (lot number, dose number and route of administration were not reported) in the left arm, both vaccines on an unspecified date. On unspecified dates, the patient had received one dose of the PPSV23 two and a half years earlier and a dose of the MCV4 6 months prior to the event. She also had received four doses of the PCV7, one dose of the PCV13, the HepB series, and annual influenza vaccinations and the patient had developed a low grade fever after receiving vaccinations, which she would treat at home with ibuprofen. The patient's past medical history included recurrent otitis media, requiring placement of tympanostomy tubes, and asthma. She also had a history of urticarial response to fire ant bites, and skin test confirmed allergies to dust, mold, mildew and cockroaches. In her previous clinic review, she reported leg pain that sometimes required pain medication and headache pain in the past 4 weeks. On an unspecified date, next day in the early morning after receiving the vaccine, the patient developed pain in her head, neck and arm and a fever of 102.9 DegreeF. Ten hours later, the patient's mother reported a fever of 101.3 Degree F and right arm swelling with edema to the extent that it was difficult to put a shirt sleeve over the arm. The patient was brought to the Hematology clinic. Upon examination, it was noted that the right arm was tender with redness over the lateral aspect and swelling down to the elbow. Blood culture was subsequently negative. The patient was discharged from the clinic. The patient had received Ibuprofen for fever, Ketorolac for pain and Ondansetron for nausea and one dose of IV Ceftriaxone and Morphine for break-through pain. On an unspecified date, the patient had recovered from swelling in the right arm within 24 hours. At the time of this report, the outcome of fever, nausea, pain were unknown. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Injection site swelling, Nausea, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: Initial case received from a literature article on 03 January 2014: A 5-year old female with sickle cell hemoglobin C disease had received a dose of PCV23 (lot number, dose number and route of administration were not reported) in the right arm and had received a dose of MCV4 (lot number, dose number and route of administration were not reported) in the left arm, both vaccines on an unspecified date. On unspecified dates, the patient had received one dose of the PPSV23 two and a half years earlier and a dose of the MCV4 6 months prior to the event. She also had received four doses of the PCV7, one dose of the PCV13, the HepB series, and annual influenza vaccinations and the patient had developed a low grade fever after receiving vaccinations, which she would treat at home with ibuprofen. The patient's past medical history included recurrent otitis media, requiring placement of tympanostomy tubes, and asthma. She also had a history of urticarial response to fire ant bites, and skin test confirmed allergies to dust, mold, mildew and cockroaches. In her previous clinic review, she reported leg pain that sometimes required pain medication and headache pain in the past 4 weeks. On an unspecified date, next day in the early morning after receiving the vaccine, the patient developed pain in her head, neck and arm and a fever of 102.9 DegreeF. Ten hours later, the patient's mother reported a fever of 101.3 Degree F and right arm swelling with edema to the extent that it was difficult to put a shirt sleeve over the arm. The patient was brought to the Hematology clinic. Upon examination, it was noted that the right arm was tender with redness over the lateral aspect and swelling down to the elbow. Blood culture was subsequently negative. The patient was discharged from the clinic. The patient had received Ibuprofen for fever, Ketorolac for pain and Ondansetron for nausea and one dose of IV Ceftriaxone and Morphine for break-through pain. On an unspecified date, the patient had recovered from swelling in the right arm within 24 hours. At the time of this report, the outcome of fever, nausea, pain were unknown. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Pyrexia
Clinical narrative: Initial case received from a literature article on 03 January 2014: A 5-year old female with sickle cell hemoglobin C disease had received a dose of PCV23 (lot number, dose number and route of administration were not reported) in the right arm and had received a dose of MCV4 (lot number, dose number and route of administration were not reported) in the left arm, both vaccines on an unspecified date. On unspecified dates, the patient had received one dose of the PPSV23 two and a half years earlier and a dose of the MCV4 6 months prior to the event. She also had received four doses of the PCV7, one dose of the PCV13, the HepB series, and annual influenza vaccinations and the patient had developed a low grade fever after receiving vaccinations, which she would treat at home with ibuprofen. The patient's past medical history included recurrent otitis media, requiring placement of tympanostomy tubes, and asthma. She also had a history of urticarial response to fire ant bites, and skin test confirmed allergies to dust, mold, mildew and cockroaches. In her previous clinic review, she reported leg pain that sometimes required pain medication and headache pain in the past 4 weeks. On an unspecified date, next day in the early morning after receiving the vaccine, the patient developed pain in her head, neck and arm and a fever of 102.9 DegreeF. Ten hours later, the patient's mother reported a fever of 101.3 Degree F and right arm swelling with edema to the extent that it was difficult to put a shirt sleeve over the arm. The patient was brought to the Hematology clinic. Upon examination, it was noted that the right arm was tender with redness over the lateral aspect and swelling down to the elbow. Blood culture was subsequently negative. The patient was discharged from the clinic. The patient had received Ibuprofen for fever, Ketorolac for pain and Ondansetron for nausea and one dose of IV Ceftriaxone and Morphine for break-through pain. On an unspecified date, the patient had recovered from swelling in the right arm within 24 hours. At the time of this report, the outcome of fever, nausea, pain were unknown. Documents held by sender: None.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Nasopharyngitis, Pain, Pruritus, Rash
Clinical narrative: Rash on back noticed last night started and looked like a bug bite then spread down leg has been scratching but states that it hurts, no fever, cough and cold sx off and on all the time, slept ok last night, eating well and still playful, no recent changes.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Discomfort, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 01-09-14 developed increasing erythema, edema and pain to (L) deltoid - went to ER that PM for eval. Ibuprofen, ice and BENADRYL recommended and taken. On 1-10-14 f/u in clinic erythema, edema and discomfort increased - 1-11-14 f/u clinic visit edema and redness extended to (L) elbow. KEFLEX TID started PO. Client played a basketball game on 1-11-14. today on 1-13-14 mom reports it's "much better".
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pyrexia, Urticaria
Clinical narrative: This case was reported by a healthcare professional (physician assistant) and described the occurrence of anaphylaxis in a 10-week-old male subject who was vaccinated with Dtap (GlaxoSmithKline), Hepatitis B, ROTARIX, Hib, PREVNAR (non-gsk) and IPV (non-gsk). Concurrent medical conditions included premature birth (infant). On 17 August 2013 the subject received unspecified dose of Dtap (unknown, "leg" (unknown thigh)), unspecified dose of Hepatitis B (unknown), unspecified dose of ROTARIX (oral), unspecified dose of Hib (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of IPV (Non-GSK) (unknown). On 17 August 2013, less than one day after vaccination with Dtap, Hib, Hepatitis B, IPV (Non-GSK), PREVNAR and ROTARIX, the subject experienced anaphylaxis, hive and fever. The subject also developed throat swelling, the reporter stated it was unclear when it started. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). Immunization series with DTap was delayed. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with Dtap, Hepatitis B, ROTARIX, Hib, PREVNAR and IPV (Non-GSK).
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered at inappropriate site, Erythema multiforme, Laboratory test, Rash
Clinical narrative: This case was reported by a healthcare professional (physician assistant) and described the occurrence of anaphylaxis in a 10-week-old male subject who was vaccinated with Dtap (GlaxoSmithKline), Hepatitis B, ROTARIX, Hib, PREVNAR (non-gsk) and IPV (non-gsk). Concurrent medical conditions included premature birth (infant). On 17 August 2013 the subject received unspecified dose of Dtap (unknown, "leg" (unknown thigh)), unspecified dose of Hepatitis B (unknown), unspecified dose of ROTARIX (oral), unspecified dose of Hib (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of IPV (Non-GSK) (unknown). On 17 August 2013, less than one day after vaccination with Dtap, Hib, Hepatitis B, IPV (Non-GSK), PREVNAR and ROTARIX, the subject experienced anaphylaxis, hive and fever. The subject also developed throat swelling, the reporter stated it was unclear when it started. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). Immunization series with DTap was delayed. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with Dtap, Hepatitis B, ROTARIX, Hib, PREVNAR and IPV (Non-GSK).
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis allergic, Drug administered at inappropriate site, Erythema multiforme
Clinical narrative: This case was reported by a healthcare professional (physician assistant) and described the occurrence of anaphylaxis in a 10-week-old male subject who was vaccinated with Dtap (GlaxoSmithKline), Hepatitis B, ROTARIX, Hib, PREVNAR (non-gsk) and IPV (non-gsk). Concurrent medical conditions included premature birth (infant). On 17 August 2013 the subject received unspecified dose of Dtap (unknown, "leg" (unknown thigh)), unspecified dose of Hepatitis B (unknown), unspecified dose of ROTARIX (oral), unspecified dose of Hib (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of IPV (Non-GSK) (unknown). On 17 August 2013, less than one day after vaccination with Dtap, Hib, Hepatitis B, IPV (Non-GSK), PREVNAR and ROTARIX, the subject experienced anaphylaxis, hive and fever. The subject also developed throat swelling, the reporter stated it was unclear when it started. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). Immunization series with DTap was delayed. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with Dtap, Hepatitis B, ROTARIX, Hib, PREVNAR and IPV (Non-GSK).
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil count, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: This case was reported by a healthcare professional (physician assistant) and described the occurrence of anaphylaxis in a 10-week-old male subject who was vaccinated with Dtap (GlaxoSmithKline), Hepatitis B, ROTARIX, Hib, PREVNAR (non-gsk) and IPV (non-gsk). Concurrent medical conditions included premature birth (infant). On 17 August 2013 the subject received unspecified dose of Dtap (unknown, "leg" (unknown thigh)), unspecified dose of Hepatitis B (unknown), unspecified dose of ROTARIX (oral), unspecified dose of Hib (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of IPV (Non-GSK) (unknown). On 17 August 2013, less than one day after vaccination with Dtap, Hib, Hepatitis B, IPV (Non-GSK), PREVNAR and ROTARIX, the subject experienced anaphylaxis, hive and fever. The subject also developed throat swelling, the reporter stated it was unclear when it started. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). Immunization series with DTap was delayed. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with Dtap, Hepatitis B, ROTARIX, Hib, PREVNAR and IPV (Non-GSK).
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, Blood potassium increased, Blood sodium normal, Blood urea normal, C-reactive protein increased
Clinical narrative: This case was reported by a healthcare professional (physician assistant) and described the occurrence of anaphylaxis in a 10-week-old male subject who was vaccinated with Dtap (GlaxoSmithKline), Hepatitis B, ROTARIX, Hib, PREVNAR (non-gsk) and IPV (non-gsk). Concurrent medical conditions included premature birth (infant). On 17 August 2013 the subject received unspecified dose of Dtap (unknown, "leg" (unknown thigh)), unspecified dose of Hepatitis B (unknown), unspecified dose of ROTARIX (oral), unspecified dose of Hib (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of IPV (Non-GSK) (unknown). On 17 August 2013, less than one day after vaccination with Dtap, Hib, Hepatitis B, IPV (Non-GSK), PREVNAR and ROTARIX, the subject experienced anaphylaxis, hive and fever. The subject also developed throat swelling, the reporter stated it was unclear when it started. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). Immunization series with DTap was delayed. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with Dtap, Hepatitis B, ROTARIX, Hib, PREVNAR and IPV (Non-GSK).