chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Pyrexia, Rash, Upper respiratory tract infection
Clinical narrative: Pt observed swelling of (R) upper arm - elbow to shoulder day following vaccination, remained swollen x 2 wks mid Feb developed severe URI symptom: fever, cough, nasal cong. Treated 2/24/13 with AUGMENTIN. 3/1 significant (L) sided mid back pain wrapping to (L) chest seen 3/4 urgent care & treated for shingles. Visible light rash, no vesicles (L) lower thoracic.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Inflammation, Pain, Pain in extremity, Pyrexia
Clinical narrative: Vaccines administered 3/12/13. 1-2 hours after pt began to notice soreness in area. In AM of 3/13/13, area was red, inflames, swollen, painful, with possible mild fever, (L) tricep area of upper arm. Has taken 400mg ibuprofen 3x on 3/14/13 inflamed area. 12 cm x 10 cm with 3.5 cm x 2 cm area having small rash.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Rash, Swelling
Clinical narrative: Vaccines administered 3/12/13. 1-2 hours after pt began to notice soreness in area. In AM of 3/13/13, area was red, inflames, swollen, painful, with possible mild fever, (L) tricep area of upper arm. Has taken 400mg ibuprofen 3x on 3/14/13 inflamed area. 12 cm x 10 cm with 3.5 cm x 2 cm area having small rash.
Age: 15.0
Sex: M
Vaccine: HEP, IPV, TD, VARCEL
Symptoms: Blindness, Dizziness, Hyperhidrosis
Clinical narrative: Client became diaphoretic, dizzy & state he could not see approx 1 min after receiving vaccine. Client use ammonia inhalant & ice packs were applied to his forehead & neck. After 10 min client's vision normalized & he was able to walk out of the clinic on his own.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant who administers vaccines concerning a patient of unknown age and gender. On 09-NOV-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 05-SEP-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 13-NOV-2012, the patient was vaccinated with the third dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Rash macular
Clinical narrative: This spontaneous report as received from a consumer stated her room mate received the ZOSTAVAX (1 time vaccine, subcutaneous, lot # was unknown) about 1 month ago (in February 2013). She went on to state that he had what she described as a blistering red blotch on his back. She only stated that there was one. He only had 1, and the diameter was not stated. She stated that he was going to the physician today(on 04-MAR-2013). The outcome of event was unknown. The relationship between ZOSTAVAX and event was unknown. Additional information is not expected.
Sex: M
Vaccine: HPV2
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practice Nurse refers to two male patients of unknown age. On 22-FEB-2013 the patients were vaccinated with a dose of CERVARIX instead of GARDASIL (dose, route, lot number not provided). No product confusion discovered, just medication error. No adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a female patient of unknown age. On 18-FEB-2013 the patient was vaccinated with a dose of CERVARIX instead of the second dose of GARDASIL (dose, route, lot number reported). Date of first dose GARDASIL was unspecified. No product confusion discovered, just medication error. No adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site cellulitis, Pyrexia
Clinical narrative: Headache, fever, injection site cellulitis.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP, PPV, DTAP, FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Inflammation, Skin warm
Clinical narrative: This spontaneous report as received from a nurse refers to a 36 year old female patient with sulfonamide allergy. On 04-MAR-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml intramuscular. Lot # was reported as H015749 (with expiry date of 08-JUN-2014). No concomitant medication was reported. On 06-MAR-2013 the patient developed redness and swelling at the injection site. The patient was evaluated at a local urgent care facility and was diagnosed with cellulitis. The patient was treated with KEFLEX. The action taken regarding PNEUMOVAX23 was not reported. The outcome of cellulitis is unknown. No causality assessment was provided. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP, PPV, DTAP, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 36 year old female patient with sulfonamide allergy. On 04-MAR-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml intramuscular. Lot # was reported as H015749 (with expiry date of 08-JUN-2014). No concomitant medication was reported. On 06-MAR-2013 the patient developed redness and swelling at the injection site. The patient was evaluated at a local urgent care facility and was diagnosed with cellulitis. The patient was treated with KEFLEX. The action taken regarding PNEUMOVAX23 was not reported. The outcome of cellulitis is unknown. No causality assessment was provided. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP, PPV, DTAP, FLU3, PPV
Symptoms: Cellulitis, Erythema, Myalgia, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 36 year old female patient with sulfonamide allergy. On 04-MAR-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml intramuscular. Lot # was reported as H015749 (with expiry date of 08-JUN-2014). No concomitant medication was reported. On 06-MAR-2013 the patient developed redness and swelling at the injection site. The patient was evaluated at a local urgent care facility and was diagnosed with cellulitis. The patient was treated with KEFLEX. The action taken regarding PNEUMOVAX23 was not reported. The outcome of cellulitis is unknown. No causality assessment was provided. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Burning sensation, Face oedema, Heart rate increased, Oedema peripheral
Clinical narrative: Facial edema, burning sensations in and feet and legs, feeling of throat closing, legs swelling, intermittent pruritis.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat tightness, White blood cell count increased
Clinical narrative: Facial edema, burning sensations in and feet and legs, feeling of throat closing, legs swelling, intermittent pruritis.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Haemorrhage
Clinical narrative: 29yrs old patient presents to immz clinic for Hepatitis B vaccine. Pt records show that she has received 2 series of Twinrix (Hep A and Hep B) in the past. So, pt was given the 3rd dose of Twinrix vaccine today to complete the 3 series. Pt was instructed to monitor herself for 15-20 minutes inside the hospital for any reactions. 5 minutes later, patient returns and complains about feeling fainting/dizziness and she noticed a small internal bleeding in her left ring finger. Patient stated that she has being drinking coffee prior before the vaccine was administered. Also, patient denials any history of bleeding disorders or any reactions after she received 2 series of Twinrix in the past, and that she doesn't usually drink coffee. Patient was told to rest on the bed with her legs elevated. Initial vital signs taken with B/P: 83/44, P: 45, Temp: 97.4 @09:45. Bottle water was given to patient and vital signs were B/P: 98/54, p: 41, Pulse ox sat: 100%, Temp: 97.4 @09:50.  At this point, patient stated that she is feeling better. Emergency room was notified about the patient reactions and they sent a wheel chair to take the patient. Last vital signs taken, B/P: 106/64, Pulse: 45, 02 sat: 100%, Temp: 97.7 @09:57. Patient states that she is now feeling better, and she was wheeled to ER for observation.
Age: 22.0
Sex: M
Vaccine: BCG
Symptoms: Erythema, Pruritus
Clinical narrative: When I was eating I noticed that my skin had a red spot, when I was done eating, I started scratching it, because it was itchy, I was good for two days and then suddenly starts again but this time was worse, was in my whole body, including in my neck, legs, forehead, chest, legs, lips, feet, it was covering my whole body! I went to store and I bought Claritin, I was fine I just stopped taking them and the allergies backed!
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cancer in remission, Chemotherapy, Hodgkin's disease, Radiotherapy
Clinical narrative: This spontaneous report as received from a registered nurse refers to approximately 21 years old female patient. On an unknown dates, the patient received the first dose and a second dose of GARDASIL (lot number, expiry date route and dose were not reported). After receiving the second dose of vaccination, on an unknown date in 2008, the patient was diagnosed with Hodgkin's lymphoma. The patient had sought medical attention (office visit). The patient was treated with chemotherapy and radiation. On an unknown date in 2008, the event Hodgkin's lymphoma had resolved and the patient was in remission from approximately the past five years. The patient had not received dose 3 of GARDASIL yet. Upon internal review, the event Hodgkins lymphoma was considered as medically significant. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Marked erythema, induration at vaccine site.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Marked erythema, induration at site of immunize. Have seen one other case in another Pt this week as well!
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via the consumers husband refers to a 66 year old female patient with hypothyroidism. On 10-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number was reported as H021711 and expiry date was 07-MAR-2014), 0.65 millimeter (ml), subcutaneous in the left arm. On 11-MAR-2013, the next day after vaccination patient experienced quarter size swelling at the injection site of the left arm, the site was firm, tender, has some warmth, but no pain and no rash. The patient had sought medical attention (the patients husband had called the pharmacy). The outcome of all the reported events was not recovered/not resolved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Back pain
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 16 year old female patient. Pertinent medical history was unspecified. On 29-NOV-2012, the patient was vaccinated with a dose of GARDASIL (Lot#,route, dose not reported). No concomitant medications were reported. ON 04-FEB-2013, the patient experienced lower back pain and hair loss. It was unspecified if patient received treatment. The outcome of lower back pain and hair loss was unknown. No medical attention was sought by patient. Additional information has been requested.,
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to 5 patients of unknown age and gender. Since 13-DEC-2012, the patients were inadvertently vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot# not reported) that had been improperly stored. No adverse effects reported. No concomitant medications were reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified amount of patients of unknown age and gender. It was reported that an unspecified number of RECOMBIVAX HB vaccines were administered to unspecified patients on unspecified date. GARDASIL was involved in an unsupported temperature excursion in August 2013 (reported on 26-FEB-2013). No further information was available. The case is linked to 1302USA012759, 1303USA007275 and 1303USA007276 which respectively describe unsupported temperature excursion of vaccine, VAQTA, live, oral ROTATEQ and RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified amount of patients of unknown age and gender. It was reported that an unspecified number of ROTATEQ, Oral vaccines were administered to unspecified patients on unspecified dates. ROTATEQ, Oral was involved in an unsupported temperature excursion in August 2013 (reported on 26-FEB-2013). No further information was available. The case is linked to 1302USA012759, 1303USA007279 and 1303USA007276 which respectively describe unsupported temperature excursion of vaccine VAQTA, GARDASIL and RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date, the patient received his second dose of GARDASIL, (lot number, expiry date and route was not reported), 27days after the first dose and no adverse effect reported. The outcome of patient received his second dose of GARDASIL 27days after 1st dose. No adverse effect was reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 19 year old male patient. On 07-JUL-2011, the patient was intramuscularly vaccinated with first dose of GARDASIL (lot number, expiry date was not reported). On 12-MAR-2013, the patient was intramuscularly vaccinated with second dose of GARDASIL (lot number, expiry date was not reported). No adverse effect was reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no reported medical history. On 02-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot number H01997; 02/2014), subcutaneous (dose unknown) in the arm. No other suspect therapies or concomitant medications were reported. On an unspecified date in 2013, reported as "the past few days" the patient experienced rash and itching over the entire arm where the vaccine was administered. The patient noted this rash and itching comes and goes. No treatment information was reported. The outcome of itching over the entire arm and rash over the entire arm was reported as not recovered/not resolved. The reporters relatedness of rash and itching over the entire arm to ZOSTAVAX is unknown. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: DPP, HIBV, IPV, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practiced nurse refers to a 4 month old patient. On 08-MAR-2013 (also reported as 11-MAR-2013), the patient was vaccinated with an expired second dose of ROTATEQ, (lot number reported as 0287AA, expiry date 15-NOV-2012, route orally). No adverse event was reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 50 year old female patient. On 18-JAN-2013 the patient was vaccinated with dose 1, 0.5 milliliter (ml) M-M-R II (lot# 0184ae, expiration date 18-JAN-2014) subcutaneously. On 21-FEB-2013 the patient was vaccinated with dose 2, M-M-R II (lot# 1404aa, expiration date 06-SEP-2013). Other suspect therapies included 0.5 ml VARIVAX (Merck) (lot# H01660, expiration date 05-SEP-2014) administered on 04-FEB-2013. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age, unknown gender. On 11-MAR-2013 the patient was vaccinated with the third dose of an expired ROTATEQ, oral (lot # 670243/0921AA, expiry date 15-DEC-2012). No adverse effect reported. The outcome was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified amount of patients of unknown age and gender. It was reported that an unspecified number of RECOMBIVAX HB vaccines were administered to unspecified patients on unspecified dates. RECOMBIVAX HB was involved in an unsupported temperature excursion in August 2013 (reported on 26-FEB-2013). No further information was available. The case is linked to 1302USA012759, 1303USA007275 and 1303USA007279 which respectively describe unsupported temperature excursion of VAQTA, ROTATEQ, Oral and GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified amount of patients of unknown age and gender. It was reported that an unspecified number of VAQTA vaccines were administered to unspecified patients on unspecified dates. VAQTA was involved in an unsupported temperature excursion in August 2013 (reported on 26-FEB-2013). No further information was available. The case is linked to 1303USA007279, 1303USA007275 and 1303USA007276 which respectively describe unsupported temperature excursion of GARDASIL, ROTATEQ, Oral and RECOMBIVAX HB. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Platelet count normal, Pyrexia, Rash erythematous
Clinical narrative: This spontaneous report regarding a 1 year old female patient was received from the patient mother. The patient's medical history included roseola 2 months prior to this event. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot#, dose, route not reported) 1 week after turning 1 year old. The patient concomitantly received a hepatitis virus vaccine (unspecified) (manufacturer unknown) and other unspecified vaccines. On an unknown date, the patient developed a high fever between the following Monday-Friday mornings. The patient then developed a raised red rash. The rash got worse on the following Saturday and spread to her face in little red pinpoint dots. The following Monday the patient was given a platelet count test that came back normal. Patient sought medical attention (unspecified). The outcome of high fever and raised red rash was unknown. Additional information is not expected.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Pain, Pain in extremity, Urticaria
Clinical narrative: Reported hives after he received the vaccine. Arm sore, achy, intermittent dizziness.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 6 year old female patient. No drug reaction or medical history was reported. On an unknown date in 2007, the patient was vaccinated with dose 1 of 0.5 ml of VARIVAX (Merck) (lot #, route not reported). On an unknown date in January 2011, the patient was vaccinated with dose 2 of VARIVAX (Merck) (lot #, route not reported), 0.5 ml. No concomitant medications were reported. ON 08-MAR-2013, the patient broke out with shingles. Shingles are on her right arm, C6 dermatome. Patient sought medical attention. Child was taken to her pediatrician and at first they thought she had mosquito bites, so hydrocortisone was given as treatment. On 11-MAR-2013, shingles was confirmed and child was put on acyclovir therapy. No laboratory tests were performed. The child was recovering from shingles but the rash was running its course. Additional information is not expected.
Age: 1.27
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomited 3 times 3/13/13 and diarrhea during the day.  No fever and still eating.  No vomiting 3/14/13 but loose stools.  Alert and otherwise child is doing well per parent.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Site was painful and red. Then a large ball; spread with a red circle around the hard ball area where the vaccine was administered, by Sunday. Provider instructed client to take Claritin for an allergic reaction and to apply ice to the area. Client took Benadryl instead of the Claritin. Site still was "itchy" yesterday. Site is clear today, March 15, 2013.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Cough, Dizziness, Dyspnoea, Headache
Clinical narrative: Congestion, runny nose, cough, head ache, body ache, dizziness, difficulty breathing, weakness.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Congestion, runny nose, cough, head ache, body ache, dizziness, difficulty breathing, weakness.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site joint pain, Pain
Clinical narrative: Constant pain in shoulder (where vaccine was administered) and surrounding areas from second dose of Hepatitis A vaccine. First one given in April 2012 with no adverse reaction. So far pain has lasted 5 month.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Anxiety, Blood creatine phosphokinase MB normal, Blood creatine phosphokinase normal, C-reactive protein normal, Differential white blood cell count normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Full blood count normal, Insomnia, Metabolic function test normal, Muscle twitching, Pallor
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Red blood cell sedimentation rate normal, Tremor, Trismus, Troponin T normal, Urine analysis normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Alanine aminotransferase normal, Anion gap normal, Anxiety, Aspartate aminotransferase normal, Basophil count normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Basophil percentage decreased, Bilirubin urine, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Blood creatinine normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Carbon dioxide normal, Chills, Chromaturia, Dyspnoea, Electrocardiogram normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Eosinophil count normal, Eosinophil percentage, Full blood count normal, Glucose urine absent, Haematocrit normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Haemoglobin normal, Haemoglobin urine absent, Initial insomnia, Joint stiffness, Lymphocyte count normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Monocyte count normal, Monocyte percentage, Muscle twitching, Neutrophil count normal, Neutrophil percentage
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Platelet count normal, Protein urine absent, Red blood cell count normal, Red blood cell sedimentation rate normal, Red blood cells urine negative
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Red cell distribution width normal, Specific gravity urine normal, Tachycardia, Tachyphrenia, Tremor
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin T normal, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, White blood cell count normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: pH urine normal
Clinical narrative: Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Patient contacted our Immun Clinic.  He states redness, swelling and pain greater than expected; involving his deltoid region extending halfway to elbow.  Denies SOB, dyspnea, dizziness, facial/tongue swelling.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: 4 cm cutaneous urticarial rxn 6 dys after immunization.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving vaccines. Vaccines administered at 1503, fainted at 1510, monitored until 1545 and discharged to home.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Approx 27 hrs after vaccine given, flu-like symptoms appeared, w/ fever 102+ and chills. Condition returned to normal the following day.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local redness, pain, swelling at injection site. Painful radiation to Lt axilla.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Crying, Decreased appetite, Injection site swelling, Irritability, Pyrexia
Clinical narrative: MY 15 MONTH OLD DAUGHTER WOKE UP IN THE MIDDLE OF THE NIGHT AT 1:15 AM SHAKING AND CRYING.  SHE HAD 102.1F FEVER AND SCREAMING UNCONTROLLABLY.  SHE DIDN'T GO BACK TO SLEEP UNITL 6:00 AM.  AT 8:15AM WE NOTICED A LARGE ROUND SWELLING WHERE THE CHICKEN POX vaccine WAS ADMINISTERED. EVERY MORNING SINCE THE vaccine SHE WAKES UP SCREAMING FOR ABOUT 2 HOURS AND DOES NOT GO BACK TO SLEEP UNTIL 1 TO 2 AM. SHE HAS ALSO STOPPED EATING. SHE HAS NEVER DONE THAT. SHE ATE, SLEPT AND WAS A HAPPY BABY UPTO THE CHICKEN POX VACCINE. HER NORMAL TIME HAS ALWAYS BEEN 9:15 PM.  SHE IS CONSTANTLY HAVING FEVERS AND IS ALWAYS IRRITABLE.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Screaming, Tremor
Clinical narrative: MY 15 MONTH OLD DAUGHTER WOKE UP IN THE MIDDLE OF THE NIGHT AT 1:15 AM SHAKING AND CRYING.  SHE HAD 102.1F FEVER AND SCREAMING UNCONTROLLABLY.  SHE DIDN'T GO BACK TO SLEEP UNITL 6:00 AM.  AT 8:15AM WE NOTICED A LARGE ROUND SWELLING WHERE THE CHICKEN POX vaccine WAS ADMINISTERED. EVERY MORNING SINCE THE vaccine SHE WAKES UP SCREAMING FOR ABOUT 2 HOURS AND DOES NOT GO BACK TO SLEEP UNTIL 1 TO 2 AM. SHE HAS ALSO STOPPED EATING. SHE HAS NEVER DONE THAT. SHE ATE, SLEPT AND WAS A HAPPY BABY UPTO THE CHICKEN POX VACCINE. HER NORMAL TIME HAS ALWAYS BEEN 9:15 PM.  SHE IS CONSTANTLY HAVING FEVERS AND IS ALWAYS IRRITABLE.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Dyskinesia, Syncope
Clinical narrative: Pt with syncope episode and jerking motions lasting <10 seconds upon standing approx 2 min after vaccination with 3 vaccines.
Age: 0.06
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Admin error - on 2/7/2013 pt. was administered ENGERIX B - Adult dose instead of Pediatric/Adolescent dose.
Age: 0.31
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying
Clinical narrative: At 5 hrs --> inconsolable crying for 1 hour.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Lymphadenopathy, Swelling
Clinical narrative: (L) arm is swollen from armpit to just above elbow on underside (medial). Area is slightly red & firm. No streaking noted. Pt reports his lymph node was swollen yesterday & that arm was more red & swollen. Advised him to see his doctor. Client had same reaction to either flu shot at age 45 or Td vaccine at age 45. Client was not sure which vaccine caused the reaction.
Age: 22.0
Sex: F
Vaccine: HEPAB, MMR, MNQ, TDAP
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Localized swelling and redness and a hard lump; little itchy bumps. On both arms and both injection sites.
Age: 22.0
Sex: F
Vaccine: HEPAB, MMR, MNQ, TDAP
Symptoms: Injection site swelling, Local swelling, Mass
Clinical narrative: Localized swelling and redness and a hard lump; little itchy bumps. On both arms and both injection sites.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: I had a shingles vaccination and have developed a terrible rash all over my body in Dec 12 and it is still active as of March 15, 2013. It is terrible - itching and continues to break out all over my body - will it ever cease?
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Injection site urticaria, Musculoskeletal stiffness
Clinical narrative: Hives at injection site on/off 3-4 days followed by (L) shoulder tenderness & stiffness.
Age: 0.21
Sex: F
Vaccine: HIBV
Symptoms: Computerised tomogram head, Crying, Insomnia, Irritability
Clinical narrative: Fussiness, high pitch crying, unable to soothe/comfort, decreased sleeping in a breastfed infant.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Decreased appetite, Fatigue, Irritability, Pyrexia
Clinical narrative: My son got his chickenpox vaccine on Mar. 6th (2013) at his 1 year check-up visit. On Mar. 11, I found a few rashes on his face when I got home around 6:30pm. The rashes turned out more and more in the evening and I found them on his scalp, back and chest. Then the next day morning (Mar. 12), I brought him to doctor's office because some of the rashes have blisters. The doctor checked him and told me it was the chickenpox rash due to the vaccination 5 days ago. She told me to do symptomatic treatment - using TYLENOL if he has fever and BENADRYL if he feels itchy. He had a mild fever around 102F in the night of March 12. Then on Wednesday of March 13, more rashed were seen even on his bottom and his penis. The baby was very fussy and looked very tired, with much less appetite than usual. He had a high fever of approximately 103F through the night on Wednesday. I gave him one dose of TYLENOL based on his weight around 4am. The fever was retreated but came back around 8 am Thursday (Mar. 14). During the day of Thursday, the baby has mild fever but new rashes stopped coming out. The old rashes began to dry. There was no fever on Thursday night and Friday (Mar. 15th). I completed the adverse effect report form on Friday (Mar. 15th). By the time I reported, my son has not fully recovered.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: My son got his chickenpox vaccine on Mar. 6th (2013) at his 1 year check-up visit. On Mar. 11, I found a few rashes on his face when I got home around 6:30pm. The rashes turned out more and more in the evening and I found them on his scalp, back and chest. Then the next day morning (Mar. 12), I brought him to doctor's office because some of the rashes have blisters. The doctor checked him and told me it was the chickenpox rash due to the vaccination 5 days ago. She told me to do symptomatic treatment - using TYLENOL if he has fever and BENADRYL if he feels itchy. He had a mild fever around 102F in the night of March 12. Then on Wednesday of March 13, more rashed were seen even on his bottom and his penis. The baby was very fussy and looked very tired, with much less appetite than usual. He had a high fever of approximately 103F through the night on Wednesday. I gave him one dose of TYLENOL based on his weight around 4am. The fever was retreated but came back around 8 am Thursday (Mar. 14). During the day of Thursday, the baby has mild fever but new rashes stopped coming out. The old rashes began to dry. There was no fever on Thursday night and Friday (Mar. 15th). I completed the adverse effect report form on Friday (Mar. 15th). By the time I reported, my son has not fully recovered.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient called nurse triage stating had 4 inch red, warm circle on arm where received her shingles vaccine. Patient was offered an appointment but declined and stated will continue with home care. Applying hydrocortisone cream to area and oral BENADRYL as needed. Advised appointment if any difficulty breathing or red streak appears.
Age: 1.8
Sex: F
Vaccine: MMR
Symptoms: Dysphemia
Clinical narrative: This spontaneous report was received from a consumer referring to her 22 months old female daughter with none drug reactions or allergies and a history of an ear infection which was treated with an unspecified regimen of amoxicillin for an unspecified number of days until 27-FEB-2013. On 04-MAR-2013 the patient was vaccinated with an unspecified dose number in series of MMR II (lot number and expiration date not specified) (dose and route not reported). The consumer reported that on 10-MAR-2013 her daughter developed a "stutter when talking". At the time of the report the patient has not recovered from the "stutter when talking". The reporter stated that no treatment was given for the "stutter when talking". No laboratory diagnostic studies were performed. The reporter stated she sought medical attention by a phone call to the physician's office. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old male patient (also a physician) with no drug allergies. The patient's medical history included shingles. On 08-MAR-2008 (about 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported), 0.65 ml, subcutaneously in the right arm. Patient is on Medicare par B. On 10-MAR-2013, the patient experienced shingles again. The reaction was on the dermatome on the back. Patient received acyclovir as treatment for 10 days. The patient stated to the pharmacist that the shingles was not severe as the case as before. Patient sought medical attention (saw an unspecified physician). No laboratory tests were performed. The outcome of shingles was reported as recovering. Causality was not provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash, Pain in extremity, Pruritus
Clinical narrative: Rash around injection site, itchy, pains down arm.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Patient received pneumonia vaccine per hospital protocol.  She had previously had fevers and after the vaccine was given she had fever spike and had swelling at injection site and hives on neck and arm.  She was treated with acetaminophen and then ibuprofen.  Symptoms subsided and at discharge her only instruction was to apply ice to the site if soreness continued.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: His left leg was swollen from the knee to hip 2 x the right leg. Evaluated by physician and will use warm compress.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: He has been vomiting for three days now and cannot keep any food down after the DTaP vaccine.
Age: 1.27
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was administered Hepatitis A #2 vaccine too early. No adverse signs symptoms were noted. Mother wanted this brought to the staff's attention.
Age: 24.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Nausea, Nervousness, Vomiting
Clinical narrative: Went home ate supper.  Had nausea and vomiting. (during the night)  Started feeling "shakey and dizzy." Donor still feels shaky.  States she took her own temp. evening of 3/13/13-101.6. Donor now hydrating with 5th bottle of H2O, with no vomiting.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Convulsion, Dizziness, Loss of consciousness, Presyncope
Clinical narrative: Patient felt dizzy and needed to sit down after receiving Adacel and Havrix.  Patient seemed to lose consciousness, and appeared to convulse as she came to.  911 was called and EMS arrived quickly.  EMS recommended the patient go to the hospital.  Patient's mother returned to pharmacy a few hours later and reported that patient was fine and was told she had a vasovagal reaction.
Age: 33.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Vision blurred
Clinical narrative: Patient states that he has been having dizziness. States that symptoms are mild. Denies headache, nausea, vomiting, change in gait or balance. Does state he has had blurring of vision. Advised to immediately see his primary care provider or go to the emergency department if it is after hours.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever of 103 for 24 hours followed by full body rash for a week.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Redness & swelling lasting 48 hours. Soreness at injection site for 36 hours.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, PNC13, TDAP
Symptoms: Pain, Skin discolouration, Skin warm, Swelling, Tenderness
Clinical narrative: Patient mom states that was administered 6 different immunizations and had continued pain, swelling, tenderness, discoloration and area was hot to touch for three days after injection. Provider prescribed Keflex, Benadryl and ibuprofen and recommended cold compress to site, massaging area. Patient appointment was made two day after for follow up of symptoms.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Fatigue, Injection site erythema, Myalgia
Clinical narrative: Injection site reaction reported as "red spot," muscle aches, joint pain, and fatigue.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: PATIENT REPORTS PAIN AT TIME OF INJECTION AND HAS CONTINUED SINCE. PAIN RATED AT 8 OR 9 OUT OF 10 WHEN LEFT ARM IS LIFTED TO HORIZONTAL POSITION. AT REST PATIENT REPORTS NO PAIN EXCEPT SOMETIMES.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Myalgia, Pain, Sleep disorder
Clinical narrative: Patient complained of muscle pain at the injection site and the left arm the pain is more constant and intense and lasts more than one week. She feels sharper pain when lifting up the arm. She cannot sleep on that side.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, FLU3, MMRV
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Left arm swelling, localized redness and warmth. Provider notified no treatment indicated.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging brain, Strabismus
Clinical narrative: Mother reported potential reaction to patient on 3/15/13. States 7 days after FLUMIST child experienced esotropia. Child was seen by 2 ophthal consult as well as neurologist & infectious disease. Mother states sx has almost completely resolved however Inf. Disease MD advised to report to VAERS.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Rash pruritic, Skin discolouration
Clinical narrative: One to two weeks after the injection developed a rash. Denies fever, swollen lymph nodes. Rash, burns & itches. Skin turning dark. Has not resolved in 2 months.