chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 25-Oct-2012) concerns a 72-year-old female patient, who was administered two doses of AFLURIA injection within 2 weeks time. The first dose was administered on 07-Oct-2012 and the second dose (batch number: P58507) was administered in upper left arm on 22-Oct-2012. No adverse effect was reported.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Headache, Pain, Swelling
Clinical narrative: This spontaneous consumer report (initial receipt 05-Sep-2012) concerns a female patient. On an unspecified date the patient received AFLURIA (manufacturer and batch number were not provided) injection. After receiving AFLURIA, the patient experienced pain, swelling redness, chills and headache. The size of the swelling was about a tennis ball size. The patient did not seek medical attention. The event outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Dry eye, Influenza, Pharyngeal oedema
Clinical narrative: This medically confirmed spontaneous report (initial receipt 06-MAR-2012) concerns a female patient with a medical history of high cholesterol. The patient reported that they have had severe reactions to flu vaccines. Vaccine name and manufacturer was unknown. The patient had a reaction to flu vaccine in 1990 and several other times. One time she developed dry eyes and the flu. Of note, in 2009, the patient's throat swelled and she went to an unspecified emergency room (ER) after receiving a flu vaccine (manufacturer unspecified) (WAVES 2012032146). The event resolved on an unknown date. No other information was provided.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 16-Oct-2012) concerns a 72-year-old male patient. On 04-Oct-2012 the patient received AFLURIA (batch number was not provided) injection at a single dose of 0.5 mL intramuscularly. The patient noticed tingling and numbing on the side of the body where the injection occurred. The event outcome was not reported.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 25-Oct-2012) concerns a 94-year-old female patient. On 25-Oct-2012 the patient received AFLURIA MDV (batch number: 06549211A) at a dose of 0.5 mL intramuscularly in right deltoid. When the pharmacist administering the AFLURIA dose, part of the dose came out from around the injection site. No adverse effect had been observed or reported. The event outcome was not reported.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 03-Oct-2011) concerns a 67-year old male patient. on 11-Sep-2011 the patient received AFLURIA intramuscular injection. On 11-Sep-2011 the patient had pain initially and was still having pain and discomfort in the arm in which he received the shot. The patient had not sought medical attention other than calling the pharmacy to ask if what he was experiencing was normal. The event outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 07-Sep-2012) concerns female patient. On an unknown date the patient received a flu vaccine (manufacturer, brand name and batch number were not provided) and developed an unspecified 'allergic reaction'. She also had allergic reaction to other vaccines that contained egg. The patient recovered from each allergic reaction.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Local reaction
Clinical narrative: This medically confirmed spontaneous report (initial receipt : 10-Oct-2012) concerns a 63-year-old female patient. On 17-Sep-2012 the patient received flu shot (manufacturer, brand name and batch number were not provided). Concomitantly she also received ZOSTAVAX (batch number: 0468AA, exp: 04-Apr-2013) injection at a dose of 0.65 mL subcutaneously as vaccine. The patient had a local injection site reaction to ZOSTAVAX. She developed itchy redness in the upper left arm that persisted for 7 days. No lab diagnostic study was performed. The patient did not receive any treatment. She sought medical attention by phone call to the HCP (healthcare professional). The event outcome was recovered.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood pressure increased, Body temperature increased, Feeling hot, Headache
Clinical narrative: This health authority report (initial receipt 08-May-2012) concerns a 14-year-old female patient. On 10-Jan-2012 the patient received AFLURIA (batch no: N56907) intramuscularly in the right arm and GARDASIL (batch no: 1261AA) intramuscularly in the left arm. The patient previously received 3 doses of flu vaccine and no doses of GARDASIL. The patient was seen for an appointment at 09.08 where her blood pressure was 109/70 and temperature was 97.8. Five minutes after the vaccinations the patient developed a 4/10 headache, pain in the back of the head and was feeling hot. Her blood pressure increased to 129/80 and temperature to 100.8. Ten minutes after the vaccinations the patient stated that she was feeling better with a 2/10 headache, her blood pressure was 116/72 and temperature was 100.8. Reporter's comment: On 11-Jan-2012 the health authority considered the events as not serious.
Age: 0.26
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low grade fever in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included premature baby at 29 weeks gestation. Concurrent vaccination included HIB vaccine; manufacturer unspecified; unknown; unknown given on an unspecified date; varicella virus vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date. Approximately in March 2011, on an unspecified date, when the subject was 4 months old he received unspecified dose of PEDIARIX (unknown). Within 24 hours of receiving the PEDIARIX vaccination, the subject experienced low grade fever. Approximately in May 2011, on an unspecified date, when the subject was 6 months old he received unspecified dose of PEDIARIX (unknown). Within 24 hours of receiving the PEDIARIX vaccination, the subject experienced low grade fever. The healthcare professional who is also the subject's mother, reported the subject had received PEDIARIX at 4 and 6 months of age and had experienced low-grade fever with those vaccinations. She cannot recall what other vaccines he received on those same dates but believed he could have received the Hib and Varicella. Fevers were treated with children's TYLENOL. The fever usually presented within 24 hours. At the time of reporting the low grade fever resolved on unspecified dates. The subject experienced adverse events with INFANRIX, please see case A0988486A.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Irritability, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of crying in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), haemophilus influenzae type b vaccine (non-gsk). Concurrent vaccination included pneumococcal vaccines (non-gsk);Pfizer; unknown; unknown given on 2 May 2012. There were no concurrent medications. On 2 May 2012 at 10:30 the subject received 1st dose of PEDIARIX (unknown, left thigh), on 2 May 2012 the subject received 1st dose of haemophilus influenzae type b vaccine (Non-GSK) (unknown). On 2 May 2012, 30 minutes after vaccination with haemophilus influenzae type b vaccine (Non-GSK) and PEDIARIX, the subject experienced crying, irritability and pharmaceutical product complaint. The subject required medical attention at the doctor's office. At the time of reporting the crying and irritability were unresolved. The healthcare professional considered the events were probably related to vaccination with PEDIARIX and haemophilus influenzae type b vaccine (Non-GSK). The healthcare professional reported another case see A0976316A. Follow-up information was received on 23 May 2012 via healthcare professional who reported the events of crying and irritability resolved on 03 May 2012. The immunization series was not discontinued but it was noted that the subject will receive "Ped dt in the future". Quality Assurance (QA) results received on 05 June 2012. The nurse reported an undetermined quality concern with this box of PEDIARIX vaccines (lot AC21B323AA, expiration 31 October 2013) that resulted in two separate adverse events for two subjects, reported separately (see case A0976316A for details regarding other subject). The responsible physician would not allow the use of the remaining syringes and wished to have this investigated. Based on the fact that no precise technical problem was reported and the conforming test results, no technical investigation was performed. GlaxoSmithKline Biologicals considered the complaint as unsubstantiated.
Age: 1.25
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC
Symptoms: Accidental overdose, Nodule, Pyrexia, Urticaria
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of accidental overdose in a 15-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline), Dtap vaccine. Concurrent vaccination included pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown given on 7 September 2011. On 7 September 2011 the subject inadvertently received unspecified dose of PEDIARIX (details unknown) and unspecified dose of Dtap vaccine (details unknown), and experienced accidental overdose. The subject received two doses of the Dtap component of the vaccines. No further information was provided. Follow-up information received 22 November 2011 from a physician. The 15-month-old female subject had concurrent medical condition of otitis media. On 07 September the nurse mistakenly gave the subject a dose of PEDIARIX (.5 ml, intramuscular, left thigh) instead of varicella along with a regular dose of Dtap vaccine (non-GSK) (.5 ml, intramuscular, right thigh). The physician associated the accidental overdose of tetanus as an erroneous administration. Later the same day on 7 September 2011, the subject experienced red welts and leg knots. On 8 September 2011 the subject experienced fever. On 13 September 2011 the fever resolved. On 15 September 2011 the red welt and knot on thigh resolved. PEDIARIX and Dtap immunization series were not discontinued as a result of the events. The physician considered the events of red welt and knot on thigh as probably related to vaccination with PEDIARIX and the event of fever as possibly related to vaccination with PEDIARIX.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness, Myalgia, Spinal pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 27-Sep-2012) concerns a 27-year-old female patient. On 26-Sep-2012 the patient received AFLURIA (batch number: P59608) injection at a dose of 0.5 mL once intramuscularly. On 26-Sep-2012, after receiving a dose of AFLURIA, the patient developed muscle pain and stiffness on her neck and some pain in the arm of the injection site. She stated that the pain was along the spine of her neck. The patient sought medical attention. The event outcome was recovering.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient. Between 24-Sep-2012 and 27-Sep-2012 (exact date of vaccination was unspecified) the patient received AFLURIA (batch number: P58306) injection. Following vaccination, the patient developed injection site reactions. The reaction was described as being localised at the injection site 3 inches in diameter, red, hot and hard to the touch. The injection site reaction did not start to resolve quickly (stayed red, hot and hard longer, but no exact time frame provided). The patient sought medical attention. The event outcome was recovering.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient. Between 24-Sep-2012 and 27-Sep-2012 (exact date of vaccination was unspecified) the patient received AFLURIA (batch number: P58306) injection. Following vaccination, the patient developed injection site reactions. The reaction was described as being localised at the injection site 3 inches in diameter, red, hot and hard to the touch. The patient sought medical attention. The event outcome was recovering.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: This medically confirmed report (initial receipt 04-May-2012) concerns a female patient. The patient had an allergy to flu vaccine (manufacturer and batch number unknown). The patient sought medical attention and received treatment not specified. No further information was available. The event outcome was recovered.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 27-Sep-2012) concerns a 24-year-old female patient, who had no pertinent medical history or drug reactions / allergies. She was not taking any concomitant medication. On 25-Sep-2012 the patient received AFLURIA (batch number: P59207) injection at a dose of 0.5 mL once intramuscularly. On 26-Sep-2012, after receiving a dose of AFLURIA, the patient's skin turned light pinkish color about the size of a baseball at the injection site. The patient sought medical attention by calling the pharmacist. No treatment was given for the event. No lab diagnostics study was performed. The event outcome was not recovered.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-Oct-2012) concerns a 39-year-old female patient. On 15-Oct-2012, the patient received AFLURIA (batch number: P59407A) injection intramuscularly in the deltoid. Within 24 hours after receiving AFLURIA, the patient developed an injection site reaction. The injection site reaction was described as a red, swollen, hot and itchy area at AFLURIA injection site. On 17-Oct-2012 the injection site reaction was about 4 cm in diameter and reported to be improving (still swollen, red and hot, but slightly smaller in size and with less itching). No lab diagnostic study was performed. The patient did not receive any treatment for the events. The event outcome was recovering.
Age: 1.0
Sex: M
Vaccine: FLUX, HIBV, MMR, PNC
Symptoms: Rash generalised
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 23-Oct-2012) concerns a 1-year-old male patient. On 12-Oct-2012 the patient received a flu vaccine (manufacturer, brand name and batch number were not provided). On the same day the patient also received MMR II (batch number: 1644Z) injection at a dose of 0.5 mL for 'prevention of pneumococcal virus' (as reported), HIB and PREVNAR. On 12-Oct-2012 the patient had full body rashes, but no itching. The event outcome was recovered.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site rash, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 2-year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On 14 May 2012 at 11:30 the subject received a 1st dose of PEDIARIX in the left bicep. This dose of PEDIARIX was the subject's 2nd DTaP and hepatitis B and his 1st IPV. On 18 May 2012, 4 days after vaccination with PEDIARIX, the subject experienced swelling injection site and injection site rash. The healthcare professional considered the events were clinically significant (or requiring intervention) as the subject had to return to the physician's office. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 06 June 2012. The subject received a 0.5 ml dose of PEDIARIX on 14 May 2012. It was reported that the subject experienced a local reaction following administration of PEDIARIX. The subject "did not seem himself" (not being oneself) one day following vaccination, on 15 May 2012. The injection site rash was noted on 20 May 2012, 6 days following PEDIARIX injection. The rash was reported to be the same as of 21 May 2012 and resolved by 23 May 2012. Injection site swelling was noted with onset of 18 May 2012, 4 days following PEDIARIX administration. The outcome of not being oneself and injection site swelling were not known. It was reported that PEDIARIX would not be used for this patient in the future, but alternative products.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Blister
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 03-Oct-2012) concerns a 34-year-old female patient, who had a pertinent medical history of ankle ulcers and unspecified diffuse connective tissue disease and was allergic to penicillin and sulfa drugs. Concomitant medications included methylprednisolone acetate, hydroxychloroquine phosphate, oxycocet, hydrocodone; paracetamol combination, calcium carbonate, folic acid, nifedipine and prednisone. On 28-Sep-2012 the patient received AFLURIA (batch number: P58507) injection at a dose of 0.5 mL intramuscularly in left arm. On 30-Sep-2012, after receiving AFLURIA, the patient developed blisters on both legs, below the knees. The patient sought medical attention by calling to office. No treatment was given for the event. No lab diagnostics study was performed. The event outcome was not reported.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Patient received 2 vaccinations separated by 1 inch in the same deltoid muscle. Next day he feels pain around the arm, and the next day it was red and swelling. Patient received intravenous BENADRYL and recover promptly.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Local swelling, Oedema mouth, Pharyngeal oedema
Clinical narrative: Symptom of severe headache approx one hour after I got home from being vaccinated - then at approx one hour later I developed swelling of throat/mouth/tongue, huge local swelling, heat, face was red and hot.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swollen tongue
Clinical narrative: Symptom of severe headache approx one hour after I got home from being vaccinated - then at approx one hour later I developed swelling of throat/mouth/tongue, huge local swelling, heat, face was red and hot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called complaining of itch and redness/swelling at injection site. Recommended BENADRYL and hydrocortisone cream.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: 1 day after vaccines had acute swelling of left deltoid area with erythema. To ER dx with cellulitis & treated with oral Clindamycin x 1 week.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: 1 day after vaccines had acute swelling of left deltoid area with erythema. To ER dx with cellulitis & treated with oral Clindamycin x 1 week.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia, Tenderness
Clinical narrative: On 1/9/2013 employee developed swollen, red and hot to touch area the size of a tennis ball around injection site. Arm is sore to touch and muscle is sore when she move it. Pt taking ALEVE & using moist heat.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Fear of needles, Syncope
Clinical narrative: Patient fainted approx 2-3 minutes after admin. She had not eaten all day & had come from working out. Approx 3 pm during the day. Also has phobia of needles.
Sex: F
Vaccine: FLU3
Symptoms: Erythema of eyelid, Eyelid oedema, Eyelids pruritus
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 19-Oct-2012) concerns a female patient, who had no drug allergy or taking any concomitant medication. On 18-Oct-2012 the patient received AFLURIA (batch number was not provided) injection at a dose of 0.5 mL intramuscularly. On 18-Oct-2012, within 20 minutes of receiving AFLURIA, the patient developed swelling of her eyelids, both upper and lower. After swelling was noticed, the eyelids became very itchy and within 2 hours of vaccination, both eyelids became very red as well. The patient took two PEPCID AC tablets for swelling on 18-Oct-2012. She was followed up the next morning and she still had some residual puffiness and redness around both eyelids. No lab diagnostic study was performed. The patient was observed by the nurse who gave the injection. The event outcome was recovering.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Body temperature increased, Fontanelle bulging, Lumbar puncture normal
Clinical narrative: This case was reported by a physician and described the occurrence of bulging anterior fontanel in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included HIB (non-GSK) ; non-GSK manufacturer; unknown; unknown given on 6 April 2012; live ROTARIX ; GlaxoSmithKline; unknown given on 6 April 2012; PREVNAR (non-gsk); non-GSK manufacturer; unknown; unknown given on 6 April 2012. There were no concurrent medications. On 6 April 2012 the subject received 2nd dose of PEDIARIX (unknown, left thigh); lot number was reported as "ACZ21B315DA". On 7 April 2012, 1 day after vaccination with PEDIARIX, the subject experienced bulging anterior fontanel and fever. The physician reported the subject was administered the standard dose of PEDIARIX on 06 April 2012. One day after the injection the mother brought the subject to the office, it was noted that the subject had a bulging anterior fontanel. The subject's axillary temperature was 99.7 degrees [fever]. The subject was sent to the emergency department. A spinal tap was done and showed nothing. It was negative. The subject was sent home. The physician noted the events resolved and when the subject had her six month physical, all events resolved. No other events were noted. The immunization series was delayed. At the time of reporting the bulging anterior fontanel and fever were resolved. The physician considered the events were possibly related to vaccination with PEDIARIX. Follow up information received from the physician on 03 July 2012. The physician reported that the subject was brought to the office on 07 April 2012, one day after receiving PEDIARIX with bulging fontanel and low grade fever. The subject was sent to the emergency room for spinal tap which was negative. The physician noted that the PREVNAR was given intramuscularly (IM), the ROTARIX was given orally and the haemophilus influenzae type b vaccine was given IM. Only the PEDIARIX was listed as a suspect product.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Sinusitis, Vaccination complication
Clinical narrative: This medically confirmed report (initial receipt 25-Sep-2012) concerns a 37-year-old female patient who had a medical history of drug allergies to morphine sulfate controlled-release (CR) 100 mg tablet and hydrocodone-acetaminophen 7.5-500. Concomitant medications included acetaminophen, diphenhydramine, heparin, lidocaine, sodium chloride, EPIPEN, CYMBALTA, diclofenac, KLONOPIN, AXERT, NORVASC, albuterol, DILAUDID, AUGMENTIN, vitamin E and ZIAC. On an unspecified date the patient received a flu shot (manufacturer and batch no. not specified) and PRIVIGEN (batch no: 4350900263) 60 gm every 3 weeks intravenously for common variable immunodeficiency. On an unspecified date the patient experienced a reaction to the flu shot and a sinus infection. The patient missed 2 days of work. The outcome for the events was unknown. Reporter's comment: The reporter considered the events as non-serious and unlikely related to PRIVIGEN. The patient experienced a reaction to the flu shot. A relationship between the sinus infection and flu shot was not specified.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient. On 27-Sep-2012 the patient received AFLURIA (batch number: P59107) injection. Following vaccination, the patient developed injection site reactions. The reaction was described as being localised at the injection site 3 inches in diameter, red, hot and hard to the touch. The patient sought medical attention. The event outcome was recovering.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 27-Sep-2012) concerns a 58-year-old female patient, who was allergic to latex. On 25-Sep-2012 the patient received AFLURIA (batch number: P59207) injection at a dose of 0.5 mL once intramuscularly. On 26-Sep-2012, after receiving a dose of AFLURIA, the patient's skin turned light pinkish color about the size of a baseball at the injection site. The patient sought medical attention by calling the pharmacist. Treatment included diphenhydramine cream and tablets. The event outcome was not recovered.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient. On 24-Sep-2012 the patient received AFLURIA PFS (batch number was not provided) injection. Following vaccination, the patient developed injection site reactions. The reaction was described as being localised at the injection site 3 inches in diameter, red, hot and hard to the touch. The patient sought medical attention. The event outcome was recovering.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient. On 25-Sep-2012 the patient received AFLURIA PFS (batch number: P59808) injection. Following vaccination, the patient developed injection site reactions. The reaction was described as being localised at the injection site 3 inches in diameter, red, hot and hard to the touch. The patient sought medical attention. The event outcome was recovering.
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: This consumer report (initial receipt 29-Aug-2012) concerns a female patient. On 28-Aug-2012 the patient received a flu shot (manufacturer and batch no. not specified). On 28-Aug-2012 the patient experienced severe pain at the injection site and developed a fever. Her temperature went up to 104.2 F. She also experienced chills overnight. The outcome for the events was recovering.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This medically confirmed report (initial receipt 04-Sep-2012) concerns a female patient. In the past the patient received influenza vaccine (manufacturer and batch no. not provided) and experienced a severe reaction. No further information was available.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Dysuria, Oedema peripheral
Clinical narrative: This consumer report (initial receipt 27-Aug-2012) concerns a 47-year-old male patient. On an unspecified date, the patient received an unspecified influenza vaccine (batch number not specified). On the same day, the patient also received HIZENTRA (Immune Globulin Subcutaneous (Human)) via subcutaneous route, at a dose of 9 grams per week for immunodeficiency (see WAVES 2012033226). On an unspecified date the patient experienced dysuria and bilateral swelling of the feet. The outcome of the event was unknown. Reporter's comment: The reporter did not provide serious criteria or causality statement. The patient did not experience an adverse event with six prior weeks of therapy with HIZENTRA.
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction, Arthralgia, Lumbar puncture
Clinical narrative: This medically confirmed report (initial receipt 25-Jun-2012) concerns a female patient. In 2009, the patient received influenza vaccine (manufacturer and batch number not specified). The patient suffered a severe reaction. She experienced an arthritic episode. She sought medical attention, had a spinal tap and received medical treatment. The episode lasted 2 months. Reporter's comment: Upon follow up with the physician's office on 10-Jul-2012, the CMA (clinic medical assistant) mentioned that there was no record of the patient receiving any influenza vaccine. The CMA stated that the patient had called the physician's office in Jun-2012 to inquire about when she received the influenza vaccine. The CMA stated that the patient was told at that time that there was no record of the patient receiving an influenza vaccine. Follow up (10-Jul-2012): reporter's comment.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy, Pharyngeal oedema
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 19-Jul-2012) concerns a 33-year-old female patient, who had allergies to codeine, penicillin, promethazine and sulfa. On an unknown date the patient received flu vaccine (brand, manufacturer and batch number were not provided). The patient experienced swollen lymph nodes and throat after receiving the flu vaccine. No lab diagnostic studies was performed. No treatment was given for the event. The event outcome was recovered.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Vomiting
Clinical narrative: Difficulty breathing. Vomited. Coughing.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test, Laceration
Clinical narrative: This consumer report (initial receipt 07-Aug-2012) concerns a 55-year-old male patient who had a medical history of high blood pressure and high cholesterol. Concomitant medications included unspecified high blood pressure medication and neomycin. The patient had previously experienced drug reactions/allergies to sulfa drugs and neomycin. The patient received flu vaccination (manufacturer and batch number unspecified) and afterwards cut himself. The patient visited his doctor, unspecified blood tests were performed. The patient recovered on an unspecified date after stopping therapy. No further information was available.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine, Nausea, Rash
Clinical narrative: This medically confirmed report (initial receipt 30-Apr-2012) concerns a patient. The patient had an allergy to influenza virus vaccine (manufacturer and batch no. not specified) and experienced a rash and nausea. No further information was provided.
Sex: F
Vaccine: FLUX
Symptoms: Oedema peripheral
Clinical narrative: This medically confirmed report (initial receipt 02-May-2012) concerns a female patient. On an unspecified date 6 years ago the patient was administered a dose of influenza vaccine (manufacturer was unknown, batch number not specified). Following administration the patients arm swelled up. The patient recovered. No further information was available.
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-Jun-2012) concerns a female patient, who was allergic to latex. The patient had 'an allergic reaction' to influenza vaccine (manufacturer unknown) 'years ago'. She sought medical attention. The patient was not able to confirm the manufacturer of the influenza vaccine or to provide any further details. The event outcome was recovered.
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Skin test positive, Type IV hypersensitivity reaction
Clinical narrative: This literature report (initial receipt 04-Sep-2012) concerns an 11-year-old female patient who had a medical history of von Willebrand disease and family history of atopic dermatitis and hay fever. 6 months after influenza vaccination (manufacturer and batch no. not specified) and 14 months after DTaP vaccination (manufacturer and batch no. not specified) the patient presented for evaluation of delayed-type hypersensitivity reaction. Symptoms included swelling, erythema and pruritus at the injection site and concurrent pruritic, erythematous eruption of arms and legs. The pruritic eruptions were partially relieved by oral antihistamines. A patch test was positive for aluminum chloride hexahydrate (2+).
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 11-Oct-2012) concerns a 3 year old patient. On 11-Oct-2012, the patient was inadvertently administered AFLURIA (batch P58807) via intramuscular route at a dose of 0.5 ml. No adverse effect was reported. The event outcome was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 17-Oct-2012) concerns a patient, who had an 'allergic reaction' to a 'flu vaccine' (manufacturer, brand name and batch number were not provided) on an unknown date. The event outcome was not reported.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 16-Oct-2012) concerns a 31-year-old female patient, who had no pertinent medical history or drug allergies. She was not taking any concomitant medication. On 16-Oct-2012 the patient received AFLURIA (batch number: P59908) injection at a dose of 0.5 mL intramuscularly. On 16-Oct-2012 the patient experienced dysgeusia immediately after administration of AFLURIA. No lab diagnostic study was performed. The patient sought medical attention in the pharmacy. No treatment was given to treat the event. The event outcome was not recovered.
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 08-Oct-2012) concerns a female patient, who experienced itching after receiving flu vaccine (manufacturer, brand name and lot number were not provided) recently (date unspecified). The event outcome was not reported.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 09-Oct-2012) concerns a 3-year-old patient. On 09-Oct-2012 the patient was vaccinated with AFLURIA (batch number was not provided) injection intramuscularly. No known adverse effects were reported.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient, who has a pertinent medical history of COPD (chronic obstructive pulmonary disease) and hypertension. She was allergic to codeine. Concomitant medications included tiotropium bromide, fluticasone propionate, metoprolol succinate and hydrochlorothiazide. The patient experienced swelling and soreness at the injection site, following multiple prior doses of influenza vaccine (manufacturer, brand name and batch number were not provided) administered on unspecified dates over many years. The event outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: This spontaneous consumer report (initial receipt: 24-Aug-2012) concerns a female patient. On an unknown date the patient received flu vaccine (manufacturer, brand name and batch number were not provided). After receiving the flu vaccine, the patient had a bad experience. The event outcome was not reported.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Erythema, Headache, Immediate post-injection reaction, Ocular hyperaemia
Clinical narrative: This spontaneous consumer report (initial receipt 08-Oct-2012) concerns a 77-year-old male patient. On 03-Oct-2012 the patient received AFLURIA (batch number was not provided). Almost immediately the patient developed chills, body ache, redness of eyes, headache and itchy throat. The patient sought medical treatment and received an unspecified injection to treat the events. The outcome for the events was recovered.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Throat irritation
Clinical narrative: This spontaneous consumer report (initial receipt 08-Oct-2012) concerns a 77-year-old male patient. On 03-Oct-2012 the patient received AFLURIA (batch number was not provided). Almost immediately the patient developed chills, body ache, redness of eyes, headache and itchy throat. The patient sought medical treatment and received an unspecified injection to treat the events. The outcome for the events was recovered.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Rash pruritic, Rhinorrhoea, Swelling, Upper respiratory tract congestion
Clinical narrative: This spontaneous consumer report (initial receipt 12-Oct-2012) concerns a 69-year-old female patient, who had no pertinent medical history or taking any concomitant medication. She was allergic to penicillin, codeine and a few unspecified antibiotics. On 08-Oct-2012, the patient received AFLURIA (batch number was not provided) injection as flu shot. On 08-Oct-2012 the patient's lips swelled up and she had a rash that was itching on her arms and back. The next morning she was congested, nose was running and it felt swollen in her nose. No lab diagnostic study was performed. The patient sought medical attention by visiting to physician office and phone call to the pharmacy. The patient did not received any treatment for the events. At the time of reporting the patient's lips were still swollen but recovering.
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: This spontaneous consumer report (initial receipt 15-Oct-2012) concerns a female patient. Earlier this month the patient received AFLURIA (batch number was not reported) and experienced vertigo. The event outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a patient. On 17-Oct-2012 the patient received a partial dose of AFLURIA (batch number was not provided) injection intramuscularly due to a leaking AFLURIA prefilled syringe. The rest of the dose leaked out of the syringe onto the patient's arm. No known adverse effect was reported.
Age: 15.0
Sex: M
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Swelling (size of softball), redness, warm, hard to the touch. Patient was put on 7 day course of cephalexin 500 mg 1 capsule 4 times daily.
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 19-Oct-2012) concerns a male patient, who received an unspecified flu vaccine (manufacturer, brand name and batch number were not provided) on an unspecified date and developed an unspecified allergic reaction. The event outcome was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt 26-Oct-2012) concerns a female patient. On 02-Oct-2012 the patient received AFLURIA (batch number: P58306) injection intramuscularly. After the AFLURIA injection, the patient developed pain in the arm where injection was received. The date the pain started was unspecified. The patient sought medical attention by seeing her pharmacist. No lab diagnostic study was performed. No treatment was given for the event. The event outcome was recovering.
Sex: F
Vaccine: FLU3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 04-Oct-2012) concerns a female patient with a medical history of NEOSPORIN allergy. In 2008, the patient received AFLURIA (batch unspecified) vaccination. AFLURIA is contraindicated in patient with hypersensitivity to neomycin. The patient was fine with AFLURIA vaccination, no adverse reaction. The event outcome was unknown.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: The pt was given a full dose of flu pf which is only licensed for 36 months & older the pt is only 4 months.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 26-Oct-2012) concerns a 35-year-old female patient. On 26-Oct-2012 the patient received AFLURIA (batch number was not provided) injection intramuscularly in left deltoid. AFLURIA was drawn up from a vial and placed into one of the syringes. When administering AFLURIA, the syringe came apart and only half of the dose was administered to the patient. Some of the vaccine leaked onto the patient's arm. No adverse effects reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt 26-Oct-2012) concerns a female patient. On 27-Sep-2012 the patient received AFLURIA (batch number: P58306) injection intramuscularly. After the AFLURIA injection, the patient developed pain in the arm where injection was received. The date the pain started was unspecified. The patient sought medical attention by seeing her pharmacist. No lab diagnostic study was performed. No treatment was given for the event. The event outcome was recovering.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood creatine phosphokinase normal, Headache, Pain, Red blood cell sedimentation rate increased
Clinical narrative: Could not make her words make sense 10/3 achy all over - severe 10/4 weak in shoulder girdle headache.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: Could not make her words make sense 10/3 achy all over - severe 10/4 weak in shoulder girdle headache.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: This medically confirmed report (initial receipt 26-Oct-2012) concerns a 90-year-old female patient with a medical history of hypertension and hyperlipidemia. On 22-Oct-2012 the patient received AFLURIA (batch no: P50408) intramuscularly in her right arm at a dose of 0.5ml. On the same day the patient developed pain and swelling in her right arm. On 26-Oct-2012 the pain and swelling continued. The patient consulted a pharmacist and was planning to see a physician. The outcome for the events was not yet recovered.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: PT received pneumonia 23 vaccine & started to experience large swelling & rash/redness wrapping around top right arm area. Symptoms got larger through next day. PT saw provider & was released with meds.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain/soreness on the injection site few hours after shot w/c didn't go away up to this point. Consistent soreness.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 22-Oct-2012) concerns a male patient. On 18-Oct-2012 the patient received AFLURIA PFS (batch number: P50708) injection. After receiving AFLURIA, the patient experienced metallic taste. The event outcome was not reported.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient received ZOSTAVAX at 11:51 am on 01-10-13 and called the pharmacy at 6:30 pm of same day to report that she had "head to toe hives". Patient treated with OTC BENADRYL.
Age: 1.5
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This medically confirmed report (initial receipt 23-Oct-2012) concerns an 18 month old male patient who did not have a relevant medical history, concomitant medications, past drug history or relevant laboratory data. On 23-Oct-2012 this infant received his first dose of AFLURIA, 0.5 mL given by intramuscular route (vastus lateral muscle). The reported batch number was P58406 with an expiry date of 27-Jun-2013. AFLURIA use was discontinued. The patient outcome is unknown. Reporter Comment: It was realized that AFLURIA is not indicated for children under 5 years of age as per the package insert.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and pruritus that began about 1 hour after vaccines, on her torso and extremities mainly. No airway compromise. Resolved with BENADRYL.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Red, swollen arm approximately 2 days after admin seen by MD, diagnosed w/ cellulitis & treated w/ Clindamycin 300mg 1 PO TID.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: This consumer report (initial receipt 25-Oct-2012) concerns a 53-year-old female patient, who had a medical history of an allergy to penicillin. On 24-Oct-2012, the patient received AFLURIA (batch no. was not provided) intramuscularly in left arm. On 25-Oct-2012, the patient had a red ring around the injection site on her left arm. She stated that it almost looked like a fungal ring or ringworm. The ring was red, inflamed and swollen. it was getting bigger and bigger and redder and redder. She sought medical attention by calling her employee health department. No treatment was given.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a 65 year-old female patient, who had no known allergy. On 11-Oct-2012 the patient received AFLURIA (batch number: P50008) injection at a dose of 0.5 mL intramuscularly. After receiving AFLURIA, the patient developed bruise around injection. The patient sought medical attention by speaking to the pharmacist. No treatment was given for the event. The event outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever - 102 degrees for one day, redness at site.