chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: 01/23 arm pain became unbearable, large bruise formed at injection site. 01/24 woke up feeling out of sorts with a nasty headache, arm pain was severe, redness around site size of half cup measure and site was hot to the touch, by afternoon a low grade fever (99.4) began; fever went to 101.1 on 01/24, felt chills alternating with sweating, severe joint pain, restless sleep. 01/25 woke up in a sweat, same symptoms as the day before, site was hot, red and very sensitive to the touch; fever, spiked to 102.2, chills, sweating, severe joint pain, nasty headache, fever broke around 2:00 PM, joint pain and chills eased. Site was red and hot and very sensitive to the touch from shoulder halfway to elbow. 01/26 site still red, hot and very sensitive to the touch; called pharmacist and began taking Zyrtec in afternoon, site somewhat less sensitive and a bit less red by bedtime. 01/27 site about 50% less sensitive than original pain, but still sensitive. Redness and heat has subsided to now being from shoulder to about 4" below shoulder - covering entire front of right arm. 01/28 will call my primary care physician. Note: Shot was recommended by my pulmonologist.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations
Clinical narrative: Heart palpitations. 2-4/hr. vaccinated 13 days ago and still occurring.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: Swollen hot, large red rash itching.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: Red, small dot, size of a dime, raised 1/4 inch does not hurt. If you press on it, sensitive. Not itchy. Applied ice one night during 1st 3 days 1st 3 days lot of redness, center red & raised, very itchy & very sore.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Induration, Pyrexia, Swelling, Urticaria
Clinical narrative: Almost immediate swelling, fever, headache for 2 days. Indurated wheal of about 2 inches, flare of about 4-5 inches - lasted about 1 1/2 wks.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Wheelchair user
Clinical narrative: Unsure of advents. Patient returned to pharmacy in a wheelchair on 1-27-13 at 2:30pm requesting a copy of the VAR consent form. She said 3 weeks after getting flu shot she ended up in the hospital with a diagnosis of ADEM.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given shot on Tues 1/22/13. The next day she had swelling, itching, heat & hardness in the area. She was advised to use hydrocortisone cream. She came in on Fri 1/25/13 to show me & said swelling came down, not hot anymore, & itching was gone away.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date and route not reported) on the buttocks. No concomitant medications were reported. The reporter could not confirm if GARDASIL was administered intramuscularly. No adverse symptoms reported. No further information provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated subcutaneously with the first dose of live ZOSTAVAX (dose and lot# not reported) in January, 2011 and the second dose of live ZOSTAVAX in August, 2011. It was reported that while on live ZOSTAVAX, the patient experienced bumps in her right ear that developed into a painful scalding rash on the right side of her face. The outcome of events was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Injection site erythema, Injection site induration, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to a 5-year-old male patient (step-son) with no pertinent medical history and drug reactions/allergies. On 12-JAN-2013 the patient was vaccinated with, 0.65 milliliter (ml) ZOSTAVAX (lot#, expiration date and route not reported). Concomitant medications included: M-M-R II (lot#, expiration date and route not reported) administered on the same date. The patient was supposed to get VARIVAX and M-M-R II at the time of his check-up on 12-JAN-2013. He was given M-M-R II and ZOSTAVAX. The ZOSTAVAX was administered by mistake. He had an injection site reaction at the location of the ZOSTAVAX. It was the size of half-dollar, is red and extremely hard. Treatment was not rendered for the event. No laboratory diagnostic tests were performed. The patient called the Health Care Professional (HCP) and sought medical attention. The events did not resolve at the time of this report. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to a 17-year-old female patient (daughter). The patient states that her daughter had GARDASIL administered improperly. On an unknown date in September 2011 the patient was vaccinated with dose 2 GARDASIL (lot#, expiration date and route not reported). No concomitant medications were reported. The patient was vaccinated with dose 1 GARDASIL (lot#, expiration date and route not reported) according to the schedule on an unknown date. Patient took second dose late and never took the 3rd dosage. Medical attention was not sought by the patient. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 51 years olds female patient. On an unspecified date the patient was vaccinated with a dose of live ZOSTAVAX (lot#: 0564AE, exp, date was unspecified). On 05-NOV-2012 the patient who was administered live ZOSTAVAX complained of "soreness, swelling, redness and it felt hot to the touch at the injection site." The patient was sent to the emergency room(ER) at an unspecified hospital for an unspecified duration. The outcome of the events was unknown. The relatedness the events was unknown for live ZOSTAVAX. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient who was in her 70s. The patient was vaccinated with live ZOSTAVAX (lot # not reported) in December 2012 ("within the last month"). Concomitant medications were many but unspecified. The nurse saw the patient broke out into hives one week after receiving the vaccine. The patient sought medical attention by visiting healthcare professional (HCP). The patient was given medication for the itching. The outcome was unknown at the time of this report. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The healthcare worker reported that the patient received the first dose of GARDASIL about 2 years ago (in January 2011) and on 16-JAN-2013 the patient received the second dose of GARDASIL. No adverse event reported. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were M-M-R II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. This is one of multiple reports from the same source (other case IDs 1210USA009229, 1210USA009230 and 1210USA009231). The follow-up information was received from the medical assistant refers to a 15 months old patient. On 25-SEP-2012 the patient was vaccinated with improperly stored M-M-R II (in left thigh, lot #:0233AE, exp. date: 26-JAN-2014) and VAQTA (in right thigh, lot #:672470/1697AA, exp. date: 22-SEP-2014) which was improperly stored. Concomitant vaccines administered on the same day included VARIVAX (Merck) (lot # H007702, expiration: 30-MAR-2014, Subcutaneously) in the right thigh, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufactured by Sanofi) (lot # C4154BA, expiration: 06-OCT-2014, intramuscularly) in the left thigh, Hib conj vaccine (unspecified carrier) (manufacture by Sanofi) (lot # UH174AA, expiration: 22-OCT-2012, intramuscularly) in the left thigh and PREVNAR 13 (manufacture by Wyeth) (lot # F62923, expiration: August, 2013, intramuscularly) in the right thigh. It was reported that yes, there were patients that received improperly stored vaccines from 17-SEP-2012 through 02-OCT-2012. It was reported that they notified all the patients and told them they could go to another healthcare facility to be revaccinated because they had not received any additional vaccinations due to an on-going problem with their refrigerator. This is one of several reports received from the same reporter. The other patient's information was captured in 1210USA005704. Additional information is not expected.
Age: 1.26
Sex: U
Vaccine: HPV4
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 15 months old patient. A patient received a dose of GARDASIL (lot # was reported as H020910, exp. date 18-JUN-2015) subcutaneously "in the arm" on 22-JAN-2013. No adverse effects has been observed or reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Burning sensation, Erythema, Facial pain, Rosacea
Clinical narrative: This consumer report (initial receipt 08-Jun-2012) concerns a 72-year-old female patient, who had a medical history of drug reaction/allergy to Penicillin, DEMEROL, mushrooms and chocolate. In Nov-2010 the patient received flu vaccine (manufacturer and batch no. was not provided) and ZOSTAVAX. Two days after receiving the vaccinations the patient developed what looked like rosacea across her face which was painful, burning, had broken vessels and red skin. She also developed a cataract, rash, headaches, malaise and neck pain. The patient sought medical attention. She received surgery for the cataract. She tried all sorts of treatment including antibiotics, antivirals and prednisone but nothing worked. She was also treated with antihistamines, MEDROL and creams (not specified). All lab diagnostic studies and all kind of lab work were performed. The patient said she then developed a complex. Outcome was reported as not recovered. Follow-up (07-Jan-2013): Date of administration, additional event terms, additional treatment details and outcome.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Burning sensation, Capillary fragility, Cataract, Cataract operation, Diagnostic procedure
Clinical narrative: This consumer report (initial receipt 08-Jun-2012) concerns a 72-year-old female patient, who had a medical history of drug reaction/allergy to Penicillin, DEMEROL, mushrooms and chocolate. In Nov-2010 the patient received flu vaccine (manufacturer and batch no. was not provided) and ZOSTAVAX. Two days after receiving the vaccinations the patient developed what looked like rosacea across her face which was painful, burning, had broken vessels and red skin. She also developed a cataract, rash, headaches, malaise and neck pain. The patient sought medical attention. She received surgery for the cataract. She tried all sorts of treatment including antibiotics, antivirals and prednisone but nothing worked. She was also treated with antihistamines, MEDROL and creams (not specified). All lab diagnostic studies and all kind of lab work were performed. The patient said she then developed a complex. Outcome was reported as not recovered. Follow-up (07-Jan-2013): Date of administration, additional event terms, additional treatment details and outcome.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Erythema, Facial pain, Headache, Laboratory test, Malaise
Clinical narrative: This consumer report (initial receipt 08-Jun-2012) concerns a 72-year-old female patient, who had a medical history of drug reaction/allergy to Penicillin, DEMEROL, mushrooms and chocolate. In Nov-2010 the patient received flu vaccine (manufacturer and batch no. was not provided) and ZOSTAVAX. Two days after receiving the vaccinations the patient developed what looked like rosacea across her face which was painful, burning, had broken vessels and red skin. She also developed a cataract, rash, headaches, malaise and neck pain. The patient sought medical attention. She received surgery for the cataract. She tried all sorts of treatment including antibiotics, antivirals and prednisone but nothing worked. She was also treated with antihistamines, MEDROL and creams (not specified). All lab diagnostic studies and all kind of lab work were performed. The patient said she then developed a complex. Outcome was reported as not recovered. Follow-up (07-Jan-2013): Date of administration, additional event terms, additional treatment details and outcome.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Neck pain, Rash, Rosacea
Clinical narrative: This consumer report (initial receipt 08-Jun-2012) concerns a 72-year-old female patient, who had a medical history of drug reaction/allergy to Penicillin, DEMEROL, mushrooms and chocolate. In Nov-2010 the patient received flu vaccine (manufacturer and batch no. was not provided) and ZOSTAVAX. Two days after receiving the vaccinations the patient developed what looked like rosacea across her face which was painful, burning, had broken vessels and red skin. She also developed a cataract, rash, headaches, malaise and neck pain. The patient sought medical attention. She received surgery for the cataract. She tried all sorts of treatment including antibiotics, antivirals and prednisone but nothing worked. She was also treated with antihistamines, MEDROL and creams (not specified). All lab diagnostic studies and all kind of lab work were performed. The patient said she then developed a complex. Outcome was reported as not recovered. Follow-up (07-Jan-2013): Date of administration, additional event terms, additional treatment details and outcome.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cough, Mass, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: This consumer report (initial receipt 14-Jan-2013) concerns a 69-year-old male patient. On 06-Dec-2012 the patient received flu vaccine (manufacturer and batch no. not specified) and on 07-Dec-2012 he received PNEUMOVAX 23 (batch no: HH009286). On 08-Dec-2012, 8 hours after receiving PNEUMOVAX 23 [2 days after receiving flu vaccine], the patients right arm swelled up to twice its normal size from the shoulder to the elbow. His arm was sore and it lasted for a week. A few days after receiving the injections the patient also developed a lump on his lip the size of a marble, a fever and a cough. The patient stated that he still had the cough. The outcome for the lump on lip and fever was not provided.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cough, Lip swelling, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: This consumer report (initial receipt 14-Jan-2013) concerns a 69-year-old male patient. On 06-Dec-2012 the patient received flu vaccine (manufacturer and batch no. not specified) and on 07-Dec-2012 he received PNEUMOVAX 23 (batch no: HH009286). On 08-Dec-2012, 8 hours after receiving PNEUMOVAX 23 [2 days after receiving flu vaccine], the patients right arm swelled up to twice its normal size from the shoulder to the elbow. His arm was sore and it lasted for a week. A few days after receiving the injections the patient also developed a lump on his lip the size of a marble, a fever and a cough. The patient stated that he still had the cough. The outcome for the lump on lip and fever was not provided.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Angioedema, Blood calcium normal, Blood chloride normal, Blood creatinine increased, Blood glucose increased
Clinical narrative: This spontaneous report was received from a patient's wife refers to a 67 years old male patient. On 14-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not provided). No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and RESTASIS. On 15-JAN-2013, the patient experienced severe allergic reaction with PNEUMOVAX23 consisting of hives, facial swelling and anaphylaxis. The patient sought medical attention and was seen in the emergency room on 16-JAN-2013, but was not admitted to the hospital until 17-JAN-2013. The patient was treated with IV BENADRYL, epinephrine, prednisone (manufacturer unknown), ADORAX and PEPCID. Electrocardiogram was performed. On 18-JAN-2013, the patient was released from the hospital. At the time of the report, the outcome of severe allergic reaction with PNEUMOVAX23 was reported as recovering. The relatedness for severe allergic reaction with PNEUMOVAX was unknown for PNEUMOVAX23. Upon internal review, severe allergic reaction with PNEUMOVAX23 treated with epinephrine was considered medically significant. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea increased, Carbon dioxide normal, Cough
Clinical narrative: This spontaneous report was received from a patient's wife refers to a 67 years old male patient. On 14-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not provided). No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and RESTASIS. On 15-JAN-2013, the patient experienced severe allergic reaction with PNEUMOVAX23 consisting of hives, facial swelling and anaphylaxis. The patient sought medical attention and was seen in the emergency room on 16-JAN-2013, but was not admitted to the hospital until 17-JAN-2013. The patient was treated with IV BENADRYL, epinephrine, prednisone (manufacturer unknown), ADORAX and PEPCID. Electrocardiogram was performed. On 18-JAN-2013, the patient was released from the hospital. At the time of the report, the outcome of severe allergic reaction with PNEUMOVAX23 was reported as recovering. The relatedness for severe allergic reaction with PNEUMOVAX was unknown for PNEUMOVAX23. Upon internal review, severe allergic reaction with PNEUMOVAX23 treated with epinephrine was considered medically significant. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Dizziness, Dyspnoea, Eye swelling, Flushing, Haematocrit normal
Clinical narrative: This spontaneous report was received from a patient's wife refers to a 67 years old male patient. On 14-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not provided). No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and RESTASIS. On 15-JAN-2013, the patient experienced severe allergic reaction with PNEUMOVAX23 consisting of hives, facial swelling and anaphylaxis. The patient sought medical attention and was seen in the emergency room on 16-JAN-2013, but was not admitted to the hospital until 17-JAN-2013. The patient was treated with IV BENADRYL, epinephrine, prednisone (manufacturer unknown), ADORAX and PEPCID. Electrocardiogram was performed. On 18-JAN-2013, the patient was released from the hospital. At the time of the report, the outcome of severe allergic reaction with PNEUMOVAX23 was reported as recovering. The relatedness for severe allergic reaction with PNEUMOVAX was unknown for PNEUMOVAX23. Upon internal review, severe allergic reaction with PNEUMOVAX23 treated with epinephrine was considered medically significant. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Haemoglobin normal, Hypersensitivity, Loss of consciousness, Neutrophil percentage increased, Oedema mouth
Clinical narrative: This spontaneous report was received from a patient's wife refers to a 67 years old male patient. On 14-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not provided). No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and RESTASIS. On 15-JAN-2013, the patient experienced severe allergic reaction with PNEUMOVAX23 consisting of hives, facial swelling and anaphylaxis. The patient sought medical attention and was seen in the emergency room on 16-JAN-2013, but was not admitted to the hospital until 17-JAN-2013. The patient was treated with IV BENADRYL, epinephrine, prednisone (manufacturer unknown), ADORAX and PEPCID. Electrocardiogram was performed. On 18-JAN-2013, the patient was released from the hospital. At the time of the report, the outcome of severe allergic reaction with PNEUMOVAX23 was reported as recovering. The relatedness for severe allergic reaction with PNEUMOVAX was unknown for PNEUMOVAX23. Upon internal review, severe allergic reaction with PNEUMOVAX23 treated with epinephrine was considered medically significant. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Palmar erythema, Pharyngeal oedema, Platelet count normal, Pruritus, Troponin normal
Clinical narrative: This spontaneous report was received from a patient's wife refers to a 67 years old male patient. On 14-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not provided). No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and RESTASIS. On 15-JAN-2013, the patient experienced severe allergic reaction with PNEUMOVAX23 consisting of hives, facial swelling and anaphylaxis. The patient sought medical attention and was seen in the emergency room on 16-JAN-2013, but was not admitted to the hospital until 17-JAN-2013. The patient was treated with IV BENADRYL, epinephrine, prednisone (manufacturer unknown), ADORAX and PEPCID. Electrocardiogram was performed. On 18-JAN-2013, the patient was released from the hospital. At the time of the report, the outcome of severe allergic reaction with PNEUMOVAX23 was reported as recovering. The relatedness for severe allergic reaction with PNEUMOVAX was unknown for PNEUMOVAX23. Upon internal review, severe allergic reaction with PNEUMOVAX23 treated with epinephrine was considered medically significant. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Urticaria, White blood cell count normal
Clinical narrative: This spontaneous report was received from a patient's wife refers to a 67 years old male patient. On 14-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not provided). No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and RESTASIS. On 15-JAN-2013, the patient experienced severe allergic reaction with PNEUMOVAX23 consisting of hives, facial swelling and anaphylaxis. The patient sought medical attention and was seen in the emergency room on 16-JAN-2013, but was not admitted to the hospital until 17-JAN-2013. The patient was treated with IV BENADRYL, epinephrine, prednisone (manufacturer unknown), ADORAX and PEPCID. Electrocardiogram was performed. On 18-JAN-2013, the patient was released from the hospital. At the time of the report, the outcome of severe allergic reaction with PNEUMOVAX23 was reported as recovering. The relatedness for severe allergic reaction with PNEUMOVAX was unknown for PNEUMOVAX23. Upon internal review, severe allergic reaction with PNEUMOVAX23 treated with epinephrine was considered medically significant. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Anaphylactic reaction, Electrocardiogram, Hypersensitivity, Swelling face, Urticaria
Clinical narrative: This spontaneous report was received from a patient's wife refers to a 67 years old male patient. On 14-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not provided). No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and RESTASIS. On 15-JAN-2013, the patient experienced severe allergic reaction with PNEUMOVAX23 consisting of hives, facial swelling and anaphylaxis. The patient sought medical attention and was seen in the emergency room on 16-JAN-2013, but was not admitted to the hospital until 17-JAN-2013. The patient was treated with IV BENADRYL, epinephrine, prednisone (manufacturer unknown), ADORAX and PEPCID. Electrocardiogram was performed. On 18-JAN-2013, the patient was released from the hospital. At the time of the report, the outcome of severe allergic reaction with PNEUMOVAX23 was reported as recovering. The relatedness for severe allergic reaction with PNEUMOVAX was unknown for PNEUMOVAX23. Upon internal review, severe allergic reaction with PNEUMOVAX23 treated with epinephrine was considered medically significant. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Anaphylactic reaction, Chest X-ray, Echocardiogram, Electrocardiogram, Hypersensitivity
Clinical narrative: This spontaneous report was received from a patient's wife refers to a 67 years old male patient. On 14-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not provided). No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and RESTASIS. On 15-JAN-2013, the patient experienced severe allergic reaction with PNEUMOVAX23 consisting of hives, facial swelling and anaphylaxis. The patient sought medical attention and was seen in the emergency room on 16-JAN-2013, but was not admitted to the hospital until 17-JAN-2013. The patient was treated with IV BENADRYL, epinephrine, prednisone (manufacturer unknown), ADORAX and PEPCID. Electrocardiogram was performed. On 18-JAN-2013, the patient was released from the hospital. At the time of the report, the outcome of severe allergic reaction with PNEUMOVAX23 was reported as recovering. The relatedness for severe allergic reaction with PNEUMOVAX was unknown for PNEUMOVAX23. Upon internal review, severe allergic reaction with PNEUMOVAX23 treated with epinephrine was considered medically significant. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Local swelling, Loss of consciousness, Swelling face, Throat irritation, Urticaria
Clinical narrative: This spontaneous report was received from a patient's wife refers to a 67 years old male patient. On 14-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not provided). No other co-suspects were reported. Concomitant medications included fluticasone propionate, ADVAIR and RESTASIS. On 15-JAN-2013, the patient experienced severe allergic reaction with PNEUMOVAX23 consisting of hives, facial swelling and anaphylaxis. The patient sought medical attention and was seen in the emergency room on 16-JAN-2013, but was not admitted to the hospital until 17-JAN-2013. The patient was treated with IV BENADRYL, epinephrine, prednisone (manufacturer unknown), ADORAX and PEPCID. Electrocardiogram was performed. On 18-JAN-2013, the patient was released from the hospital. At the time of the report, the outcome of severe allergic reaction with PNEUMOVAX23 was reported as recovering. The relatedness for severe allergic reaction with PNEUMOVAX was unknown for PNEUMOVAX23. Upon internal review, severe allergic reaction with PNEUMOVAX23 treated with epinephrine was considered medically significant. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Blister, Feeling hot
Clinical narrative: Initial information has been received from a consumer concerning her husband, a 68 years old male patient with high cholesterol and unspecified drug reactions / allergies. On 10-SEP-2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Other co-suspects included influenza virus vaccine (manufacturer unknown). Concomitant medications included lovastatin. On 21-SEP-2012, the patient experienced fire from the waist down, was bright red from the chest down and almost purple, and had blisters the side of golf balls on his legs and groin. The patient stayed 4 nights at the Hospital. The patient was treated with an unspecified intravenous treatment and in isolation at the hospital. Laboratory tests were not reported. The patient's outcome was unknown. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Erythema
Clinical narrative: Initial information has been received from a consumer concerning her husband, a 68 years old male patient with high cholesterol and unspecified drug reactions / allergies. On 10-SEP-2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Other co-suspects included influenza virus vaccine (manufacturer unknown). Concomitant medications included lovastatin. On 21-SEP-2012, the patient experienced fire from the waist down, was bright red from the chest down and almost purple, and had blisters the side of golf balls on his legs and groin. The patient stayed 4 nights at the Hospital. The patient was treated with an unspecified intravenous treatment and in isolation at the hospital. Laboratory tests were not reported. The patient's outcome was unknown. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Dizziness, Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Patient called pharmacy on 1/23/13 6:04 pm and stated that shortly after vaccination she felt soreness and on 2nd day around 2 AM she cannot sleep because she could not move her arm and had limited mobility and dizziness. She doesn't have dizziness now but she cannot sleep on her left side because of intensive severe pain, and she moves in certain direction there's shooting pain and hard to dress. She does not have insurance and cannot afford to see Dr.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Dizziness, Insomnia, Mobility decreased, Pain
Clinical narrative: Patient called pharmacy on 1/23/13 6:04 pm and stated that shortly after vaccination she felt soreness and on 2nd day around 2 AM she cannot sleep because she could not move her arm and had limited mobility and dizziness. She doesn't have dizziness now but she cannot sleep on her left side because of intensive severe pain, and she moves in certain direction there's shooting pain and hard to dress. She does not have insurance and cannot afford to see Dr.
Age: 4.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Dyspnoea
Clinical narrative: Patient given vaccine 1/23/13 at approximately 4p. Woke up 1/24/13 with croup attack - was taken outside & then put in steam shower by parent. Cough loosened and breathing was improved by mid morning approximately 10A - same symptoms occurred the day after flu vaccine given 11/26/12.
Age: 4.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Cough, Croup infectious
Clinical narrative: Patient given vaccine 1/23/13 at approximately 4p. Woke up 1/24/13 with croup attack - was taken outside & then put in steam shower by parent. Cough loosened and breathing was improved by mid morning approximately 10A - same symptoms occurred the day after flu vaccine given 11/26/12.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Began with itchiness and redness at vaccination site. Applied ice pack. The next day, there was a 4 cm x 9 cm itchy, red, and raised area. It became very sore. On Sunday 1/12/13 I called nurse hotline and was instructed to take Benadryl and massage the site. It is now over 2 weeks later and after a hot shower I noticed the area turned slightly red, still about 4 cm x 9 cm. Other symptoms seem to have cleared.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles on stomach and back. Officially diagnosed on 01/25/2013 but started on 01/18/2013.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Pyrexia, Sinus congestion, Vaccine positive rechallenge
Clinical narrative: Fever 104.3 followed by chills and lots of sinus congestion. Aching joints. I am in Health Care and I work on OB, I had received the first dose of MMR on 12-14-2012 due to low Titers. I had the same adverse event with the first injection, I just did not realize that it was the vaccine. I thought it was the flu. I am taking Advil and keeping the fever down for the most part, this took about 3-4 days in December to resolve. I am still running a fever 101 to 102.4 today.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea, dizziness; went to ER.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Acute disseminated encephalomyelitis, Central nervous system lesion, Demyelination, Laboratory test, Lumbar puncture
Clinical narrative: Tingling on entire right side of body from top of head to bottom of foot. Brought to doctor who ordered MRI. 2 brain lesions discovered of a demyelinating nature.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Paraesthesia
Clinical narrative: Tingling on entire right side of body from top of head to bottom of foot. Brought to doctor who ordered MRI. 2 brain lesions discovered of a demyelinating nature.
Age: 56.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Erythema, Injection site inflammation, Pyrexia
Clinical narrative: Fever, inflammation around area of vaccine administration. Fever decreased with Tylenol, however area of erythema increased over the course of 72 hours. Pt admitted to ER at 10:00 PM 01/26/2013. Patient will see her Primary Care Physician today, 01/28/12013.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Headache, Injection site erythema, Lymph node pain, Lymphadenopathy
Clinical narrative: Fever, chills, nausea, myalgia, headache, swelling and pain of the injected arm, redness at the injection site, extremely swollen and extremely tender supraclavicular and axillary lymph nodes.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Myalgia, Nausea, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, nausea, myalgia, headache, swelling and pain of the injected arm, redness at the injection site, extremely swollen and extremely tender supraclavicular and axillary lymph nodes.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Tenderness
Clinical narrative: Fever, chills, nausea, myalgia, headache, swelling and pain of the injected arm, redness at the injection site, extremely swollen and extremely tender supraclavicular and axillary lymph nodes.
Age: 1.6
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: Started acting tired. Then he laid down on the floor and stared and became unresponsive for a few seconds, no convulsions, did have some gasping type breathing for a few minutes. Was running a low grade temp.
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Restlessness, Wheezing
Clinical narrative: Increased redness of face, trunk, and extremities. Audible wheezing and restlessness.
Age: 0.37
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC, RVX
Symptoms: Incorrect dose administered
Clinical narrative: Misadministration of vaccine - double dose of DTaP given.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Cheilitis, Lip swelling, Pain
Clinical narrative: Red swollen lips.  Painful burning of lips.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain, Ultrasound scan normal
Clinical narrative: Patient given FLUZONE in (R) deltoid on 10/19. Upon administration had immediate fairly severe shooting pain in area. Now with persistent pain; intermittent shooting in spite of NAPROSYN & Prednisone.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased eye contact, Lethargy, Speech disorder, Speech disorder developmental
Clinical narrative: Evening after vaccinations infant lethargic, would not make eye contact or vocalizations as per normal. Phone call to physician - instructed to watch. Infant continued to be less responsive, decreased vocalizations, no eye contact, physician evaluation 8-6-12, change in status per parent continued for several days did not begin to babble or coo again until 9 1/2 months.
Age: 81.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Delirium, Laboratory test normal
Clinical narrative: Patient was fine & going home in morning. Was given pneumonia shot & went into total delirium. 12-25-12 to 1-1-13 in hosp. then released to re-hab for 10 days. Doctors never found test results to back up this behavior and expensive stay. Only thing to go on was the shot. Why do they need to push them on you?
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Joint range of motion decreased, Musculoskeletal pain, Periarthritis
Clinical narrative: Frozen shoulder, shoulder pain, numbness in arm & hand limited range of motion.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Injection site abscess
Clinical narrative: Abscess at injection site, observed at office 01/25/13. Treated with topical and oral antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MNQ, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given a vaccine that he was not due for.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Syncope
Clinical narrative: Pt fainted 3-5 seconds after injection. Pt was seated at the time, became very pale then fainted. He slouched in chair. I guided him to floor as he was sliding out of chair. I cleared the area & he woke up within about 5 sec. from the time he fainted. We moved him to a chair & gave him water & crackers and pt was fine.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient states soreness at the site of injection persisting 2 weeks post administration. No swelling or redness.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Paranasal sinus hypersecretion, Pharyngeal mass
Clinical narrative: 1/11 2:00AM - Awoke with chills & shivering, headache, sinus drainage with a lump at the back of my throat and a fever of 101.1. Extreme fatigue - no energy. Fever gradually went down and was normal by evening. 1/12 All symptoms were gone and I was back to normal.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 1/11 2:00AM - Awoke with chills & shivering, headache, sinus drainage with a lump at the back of my throat and a fever of 101.1. Extreme fatigue - no energy. Fever gradually went down and was normal by evening. 1/12 All symptoms were gone and I was back to normal.
Age: 20.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Dyskinesia, Loss of consciousness, Syncope
Clinical narrative: Syncopal episode with some jerking movements. Passed out.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Pt reports that he got a very itchy rash all over his body from arms, to trunk & down thighs. He developed rash within 24 hours of receiving vaccine. He called his surgeon & doctor said to take BENADRYL. Pt reports that rash improved with BENADRYL. He still has a small rash.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Aplastic anaemia, Transfusion, White blood cell count decreased
Clinical narrative: This spontaneous consumer report (initial receipt 15-Jan-2013) concerns a 73 year old female patient. On 23-Dec-2012, the patient received a flu vaccine (batch and manufacturer unspecified). On 25-Dec-2012, the patient developed aplastic anemia and has been in the hospital since being admitted on 25-Dec-2012. The patient has had several blood transfusions while in the hospital and her white blood count was as low as 0.4. The patient had blood drawn frequently. The event outcome was recovering. Reporter's comments: The reporter considered events serious due to hospitalisation.
Age: 1.29
Sex: F
Vaccine: DTAP, FLU3, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Patient given varicella vaccine 1/3/13. Left leg was red, swollen and warm for 1 week after injection. Child was fussy & irritable. Red area larger than a half dollar.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was administered a 0.5 ml dose of PNEUMOVAX 23 with expiration date 27-SEP-2012 and LOT number 669776/0614AA on 18-JAN-2013. No adverse affects reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Dyspnoea, Herpes zoster, Pain
Clinical narrative: Extreme diarrhea and vomiting w/i 8 hours extreme body pain & shortness of breath. Shingles breakout 3 days later Dr. prescribed valacyclovir 10 mg. Continued abdominal stress-pain!!! Dr. prescribed Bella Donna Alkaloids w/PB. Pain-pain-pain.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Extreme diarrhea and vomiting w/i 8 hours extreme body pain & shortness of breath. Shingles breakout 3 days later Dr. prescribed valacyclovir 10 mg. Continued abdominal stress-pain!!! Dr. prescribed Bella Donna Alkaloids w/PB. Pain-pain-pain.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare worker reported that live (Merck) VARIVAX were expose to unspecified temperature conditions during a power failure for an unspecified period of time, were then administered to unspecified patients on unspecified dates. The indication, dose, route and lot # of the vaccine was not reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender who on 13-NOV-2012, was vaccinated with dose 1 GARDASIL (dose, route and lot # not provided). On 19-DEC-2012, was vaccinated with dose 2 GARDASIL (dose, route and lot # not provided). On 22-JAN-2013, was vaccinated with dose 2 GARDASIL (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The medical assistant stated the patient did not experienced any adverse event. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Lymphadenopathy, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a 58 years old female registered nurse refers to herself with allergy to thimerosal, latex and penicillin and no pertinent medical history. On 18-JAN-2013 the patient was vaccinated subcutaneously in her right arm with a 0.65 ml dose of ZOSTAVAX (lot# not reported). There was no other concomitant medication. It was reported regarding ZOSTAVAX administered to her on 18-JAN-2013 and swelling at the injection site. Nurse experienced swelling, redness and pain that went down her entire arm to her elbow and also a swollen lymph node under her right arm. Arm compresses administered to treat swollen area of arm. None lab diagnostics studies were performed. The patient did not seek medical attention. The outcome of the events was unknown. The relatedness for the events unknown for ZOSTAVAX. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Neck pain, Pruritus, Rash pustular
Clinical narrative: Muscle pain - neck mainly. Rash with small pustules as described via pt telephone communication; on back only very itchy.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Fatigue, Gait disturbance, Hypoaesthesia, Influenza
Clinical narrative: Difficulty walking; Pneumonia, influenza, general malaise & fatigue, high fever, elevated WBC hands & feet numbness, stomach cramps.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Malaise, Pneumonia, Pyrexia, White blood cell count increased
Clinical narrative: Difficulty walking; Pneumonia, influenza, general malaise & fatigue, high fever, elevated WBC hands & feet numbness, stomach cramps.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a physician via company representative refers to two patients of unknown age (gender unspecified). Approximately on an unknown date in 2008 (reported as occurred 5 years ago), the patient were vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route not reported). No concomitant medfivations were reported. Approximately on an unknown date in 2008, the patients developed rashes and a few lesions on their arms after being vaccinated with ZOSTAVAX. Treatment rendered for the event was antiviral medication. The patient sought medical attention. This is one of the two reports received from the same reporter. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 70 year (reported as patient in his early 70's) old male patient. Approximately on an unknown date in 2008 (reported as occurred 5 years ago0, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date and route not reported). No concomitant medications were reported. Approximately on an unknown date in 2008, the patient experienced shingles on his forehead after being vaccinated with ZOSTAVAX. Treatment rendered for the event was antiviral medication. The outcome of the event shingles on his forehead was unknown. The patient sought medical attention. This is one of the two reports received from the same reporter. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Cough, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever/cough/congestion/chills/body aches x 24 hours.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: This medically confirmed report (initial receipt 16-Jan-2013) concerns a 20-year-old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 14-Jan-2013, the patient received AFLURIA (batch no: 07149221A) intramuscularly in the left arm. On 15-Jan-2013 (the day following vaccination), the patient developed a 3 inch injection site reaction including an irregular red welt, itching, pain and a low grade fever. The patient was seen by her physician who diagnosed cellulitis. The patient was treated with cephalexin. The outcome was reported as recovering.