chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with 6 doses of PNEUMOVAX23 (lot #, dose and route not reported) with in a year. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient was fine. The physician heard this story at a conference and stated that this occurred due to poor hospital department communication. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician regarding to a 5 years old patient of an unknown gender. Patient's medical history, drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with two doses of VARIVAX (dose, route and lot number were not provided) within a 2 month period (dates unspecified). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster
Clinical narrative: This spontaneous report was received from an 84-year-old female patient with no drug reactions/allergies. Patient's weight was 140 (units unknown) and height 5". Current conditions included hypertension. On 01-JUL-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) dose and route not reported). Concomitant medications included unspecified medications for hypertension. On an unknown date in August 2012 (reported as a month after receiving the vaccine) the patient got a case of the shingles, "big red spots" a light case and with medication "a large purple pill" the symptoms disappeared. On 06-NOV-2012 the patient experienced shingles again. The outcome of this event was unknown at the time of this report. No treatment was given for the second recurrence of shingles. No lab diagnostic studies were performed. Medical attention was not sought for the events. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Injection site erythema
Clinical narrative: This spontaneous report was received from a 52-year-old female patient regarding herself. The patient's medical history included shingles. Approximately on 10-NOV-2012 (reported as Saturday) the patient was vaccinated with, 0.65 milliliter (ml) ZOSTAVAX subcutaneously on her arm. No concomitant medications were reported. Patient said that right after the ZOSTAVAX injection she felt hot and dizzy. She had a red spot on her injection arm and felt feverish. The outcome of the events were unknown at the time of this report. No further information adverse event (AE) information was provided. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a 73-year-old male patient regarding himself with no drug reactions/allergies. The patient's medical history included heart surgery. On an unknown date in August 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration not reported) subcutaneously in his left arm. Concomitant medications included tamsulosin hydrochloride, gabapentin, omeprazole and LUNESTA. The patient stated he had pain in his left arm and shoulder on an unknown date in August 2012. He described the pain, especially in the shoulder being extreme and he had to lift the arm up with his right arm due to the pain. He also stated there was redness on the arm and shoulder. He was being treated by a physician. Treatment was rendered for the events, pain medications, ZOVIRAX salve, lidocaine ointment and a bandage he wears for 12 times. The patient sought medical attention for the events. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an approximately 9 weeks old female patient. On 12-NOV-2012, the patient was vaccinated with a dose of expired ROTATEQ, oral, (lot # 669570/1456AA, expiry 03-OCT-2102) route and dose not reported. No concomitant medications were reported. No adverse effects were reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cyst, Feeling cold, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report was received from a 53 years old female consumer regarding herself. Drug reactions included codeine containing products caused vomiting in the patient. On 06-NOV-2012, the patient was vaccinated subcutaneously with 0.65 ZOSTAVAX (lot # and expiry not reported). Secondary suspect therapy included influenza virus vaccine (manufacturer unknown) (lot #, route, dose and expiry not reported) given in the opposite arm on an unknown date. No concomitant medications were reported. On 07-NOV-2012 ("8-10 hours after the vaccine"), the patient developed chills for 16 hours after receiving ZOSTAVAX and also developed a very large "beet red" at the injection site. She stated that the injection site reaction was very warm to touch and approximately 6 inches by 5 inches and almost 1 inch deep. She described it as feeling like she had developed a cyst in the arm. The patient developed the chills starting the next day at 7AM after getting the vaccine and she then noticed the large injection site lump at that time. Aspirin was given as treatment. No laboratory diagnostic studies were performed. The outcome of chills, injection site reaction was very warm to touch and very large "beet red" knot at the injection site was reported as recovering. The patient had sought medical attention (unspecified). Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse refers to an approximately 73-year-old male patient with no drug reaction/allergies. Current conditions included type 2 diabetes, hypertension, hyperlipidemia and hypothyroidism. On 18-MAR-2011 the patient was vaccinated with a dose of 0.65 milliliter (ml) ZOSTAVAX (lot # 669188/1454Z, expiration date 28-JAN-2012) subcutaneously. Concomitant medications included LEVOTHYROXINE SODIUM, SIMVASTATIN TABLETS, METFORMIN and LEXAPRO. On an unknown date in 2012 (reported as 2 weeks ago) patient reported a mild case of shingles. Treatment was given for the event, the patient was prescribed FAMVIR. No lab diagnostic studies were performed. The patient did not recover from the event at the time of this report. The patient sought medical attention for the event by office visit. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse refers to 3 patients of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration and route not reported). No concomitant medications were reported. On an unknown date in the past the patients experienced a mild case of shingles after receiving ZOSTAVAX. The outcome of the reported event was unknown. No information was provided on these 3 patients. This is one of the several reports from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacy student regarding an approximately 63 years old female patient. On 12-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot# reported as H013943, expiry: 25-OCT-2013) route an dose not reported. No concomitant medications were reported. On 12-NOV-2012, the patient developed a red, itchy area around the injection site. Patient sought medical attention(contacted pharmacy). Patient was treated with triamcinolone cream. The outcome of red, itchy area around the injection site was reported as not recovered. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. No medical history or concurrent conditions were reported. The patient was vaccinated with an expired dose of live, oral ROTATEQ on 24-OCT-2012. It was the patient's first dose of live, oral ROTATEQ. The reported lot number was 1457AA with an expiration date of 07-OCT-2012. No adverse event was reported. No further information was provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of currently 62 years old. The patient has may medical issues. On 15-NOV-2012, the patient was vaccinated with a single 0.5 cc dose of intramuscular PNEUMOVAX 23 (lot#H013399; exp date: 07-MAR-2014). Concomitant therapy includes ABILIFY, AMITIZA, atorvastatin, lorazepam, levothyroxine, mirtazapine, omeprazole, Pinaverium Bromide, SENOKOT and zolpidem tartrate. On November 2012, the patient experienced swelling, tenderness and paim at injection site and seek medical attention. The patient Doctor stated that she had a rather severe local reaction above and a bruised area. The patient was treated with glucocorticoid, antibiotic. It was reported that the patient was all better in November 2012. The relatedness of the event with PNEUMOVAX 23 was unknown. No further information provided. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) refers to a 19-year-old male patient. On 06-JUN-2008 the patient was vaccinated with dose 1 VAQTA (lot# and route not reported) 25 Units (U). No concomitant medications were reported. On 14-NOV-2012 he received dose 2 VAQTA (lot# and route not reported) 25 Units (U). No adverse effects had been observed or reported. No additional information currently available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a female patient of unknown age. On 24-JUL-2009, the patient was vaccinated with dose 1 of GARDASIL (lot#, route and dose not reported). No concomitant medications were reported. On 03-AUG-2012, the patient received the second dose of GARDASIL (lot#, route and dose not reported). No adverse effects were reported. The patient was in the office today to receive the third dose. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient with allergy to sulfa drugs and no pertinent medical history who on 12-NOV-2012, was vaccinated with a dose of ZOSTAVAX 0.65 mL, subcutaneously, right arm (Lot # reported as H016762, Exp: 11-DEC-2013). No other co-suspects were reported. There were no concomitant medications. The pharmacist reported that a patient developed a hot, red area on her right arm at the injection site after receiving ZOSTAVAX. Reaction was treated with KEFLEX. The outcome of the events was reported as not recovered/not resolved. No laboratory diagnostic studies were performed. The patient sought medical attention - came back to pharmacy and saw her physician. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient with allergy to sulfa drugs and no pertinent medical history who on 12-NOV-2012, was vaccinated with a dose of ZOSTAVAX 0.65 mL, subcutaneously, right arm (Lot # reported as H016762, Exp: 11-DEC-2013). No other co-suspects were reported. There were no concomitant medications. The pharmacist reported that a patient developed a hot, red area on her right arm at the injection site after receiving ZOSTAVAX. Reaction was treated with KEFLEX. The outcome of the events was reported as not recovered/not resolved. No laboratory diagnostic studies were performed. The patient sought medical attention - came back to pharmacy and saw her physician. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Respiratory distress, Tonic convulsion, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a Doctor of pharmacy concerning to a 60 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (Lot# H013944; Exp date: 25-OCT-2013 (dose and route not reported) on approximately 16-NOV-2012. No other co-suspects were reported. Concomitant medications included flu shot. The pharmacist administered ZOSTAVAX shot to the patient. The pharmacist indicated that the patient stopped breathing and went into anaphylaxis. The pharmacist indicated that the patient was unresponsive, had respiratory distress and tonic seizure activity. The patient went to the emergency room and was released without staying overnight. The patient was treated with a dose of epinephrine. The outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. The events were considered by pharmacist to be life threatening and medically significant because a dose of epinephrine was given. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Anaphylactic reaction, Respiratory arrest, Respiratory distress, Tonic convulsion, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a Doctor of pharmacy concerning to a 60 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (Lot# H013944; Exp date: 25-OCT-2013 (dose and route not reported) on approximately 16-NOV-2012. No other co-suspects were reported. Concomitant medications included flu shot. The pharmacist administered ZOSTAVAX shot to the patient. The pharmacist indicated that the patient stopped breathing and went into anaphylaxis. The pharmacist indicated that the patient was unresponsive, had respiratory distress and tonic seizure activity. The patient went to the emergency room and was released without staying overnight. The patient was treated with a dose of epinephrine. The outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. The events were considered by pharmacist to be life threatening and medically significant because a dose of epinephrine was given. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: "Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 22 years old female patient. The patient has a history of 3 previous pregnancies and 3 live birth(s). It was reported that the patient did not have birth defects or infant complications in previous pregnancies and with no concurrent conditions and no significant past medical history. The patient was vaccinated with lot # (0690AA) dose 1 GARDASIL on 05-SEP-2012. No other co-suspects were reported. No concomitant medications were given. Subsequently, the patient became pregnant with an LMP of 10-AUG-2012 and an EDD of 17-MAY-13. Initial exposure to GARDASIL was at 3 week(s). The patient was exposed to GARDASIL during trimester 1. It was reported that on 21-SEP-12 at 6 weeks gestation the patient experienced a spontaneous abortion, 17 days after onset of therapy. No treatment information was reported. The relatedness for spontaneous abortion was not reported for GARDASIL. At the time of the report the outcome of spontaneous abortion was not reported. Upon internal review spontaneous abortion was considered medically significant. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Asthenia, Chills, Dizziness, Feeling abnormal, Feeling cold
Clinical narrative: Tingling as I felt vaccines, Tdap left arm, Hepatitis B right arm, course through bloodstream, felt abnormally weird, felt funny, got up to walk down hall & saw spots & started leaning against wall, felt, weak, dizzy, nurse said I looked pale & yellow & like I was going to pass out, I had cold chills, & feet were very cold, had body aches, nurse laid me down for 10-15 min., checked HR which was normal, sat up & sat there another 15-20 min. before getting up, nurse have me Pepsi & peanut butter & crackers, I did not understand why just getting vaccines would make me feel so weird, still do not feel normal.
Age: 34.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain, Pallor, Paraesthesia, Peripheral coldness, Visual impairment
Clinical narrative: Tingling as I felt vaccines, Tdap left arm, Hepatitis B right arm, course through bloodstream, felt abnormally weird, felt funny, got up to walk down hall & saw spots & started leaning against wall, felt, weak, dizzy, nurse said I looked pale & yellow & like I was going to pass out, I had cold chills, & feet were very cold, had body aches, nurse laid me down for 10-15 min., checked HR which was normal, sat up & sat there another 15-20 min. before getting up, nurse have me Pepsi & peanut butter & crackers, I did not understand why just getting vaccines would make me feel so weird, still do not feel normal.
Age: 34.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Yellow skin
Clinical narrative: Tingling as I felt vaccines, Tdap left arm, Hepatitis B right arm, course through bloodstream, felt abnormally weird, felt funny, got up to walk down hall & saw spots & started leaning against wall, felt, weak, dizzy, nurse said I looked pale & yellow & like I was going to pass out, I had cold chills, & feet were very cold, had body aches, nurse laid me down for 10-15 min., checked HR which was normal, sat up & sat there another 15-20 min. before getting up, nurse have me Pepsi & peanut butter & crackers, I did not understand why just getting vaccines would make me feel so weird, still do not feel normal.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local reaction, Swelling, Tenderness
Clinical narrative: Exquisite local tenderness out of proportion to mild swelling and 3 coin-sized areas of erythema not directly associated with administration site.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Eye pain, Ocular hyperaemia, Photophobia
Clinical narrative: Left eye pain behind it and light sensitivity, also mildly bloodshot. As of this morning Friday november 23 it is completely red and still those other symptoms persist. Before these shots I was very healthy and well.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Significant local reaction of approximately 3 inches diameter of redness and induration at injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth around the injection site. Baseball size. These symptoms progressively worsened in intensity over the next 24 hours.  Ice the area frequently today, and continue to take Ibuprofen as needed for pain control. If the redness worsens, and spreads past the demarcated area, or patient develops fevers, or systemic signs of illness, recommend starting antibiotic-cephalexin, course provided to patient per MD.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Joint pain, fever 102 degrees.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Hive swelling at injection site, redness extends almost to elbow. Slightly painful to touch. Notice approximately 24 hours after injection. Swelling and discomfort worsened over course of next day.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, pain, and 1.5" swelling at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Itching, welt at injection site.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Discomfort, Erythema, Injection site nodule, Injection site pruritus
Clinical narrative: 1. 1 hr post injection- itching at injection site lasting 2-3 hours. 2. 15 hr post injection- soreness, redness at 1 in. diameter. 3. 36 hr post injection- total arm soreness, axillary soreness, tightness in hand. Redness (dark) at 2" x 4" in diameter, fever at injection site with palpable knot in red area.  4. 60 hr post injection- Redness is splotchy, upper arm still sore, but less sore, fever at injection site., palpable knot still present. 5. 96 hr post injection- Redness subsided, injection site sore, fever subsided at site, palpable knot still present.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth, Pain, Pain in extremity, Rash macular
Clinical narrative: 1. 1 hr post injection- itching at injection site lasting 2-3 hours. 2. 15 hr post injection- soreness, redness at 1 in. diameter. 3. 36 hr post injection- total arm soreness, axillary soreness, tightness in hand. Redness (dark) at 2" x 4" in diameter, fever at injection site with palpable knot in red area.  4. 60 hr post injection- Redness is splotchy, upper arm still sore, but less sore, fever at injection site., palpable knot still present. 5. 96 hr post injection- Redness subsided, injection site sore, fever subsided at site, palpable knot still present.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Hypopnoea, Pallor, Pulse pressure decreased, Syncope
Clinical narrative: I gave patient the Afluria vaccine at approximately 5:10 PM.  The patient waited nearby as I then gave his father the same vaccine. Patient then starting looking down thru some isles in the store.  The father went to leave and came back to get me about 5 minutes later stating that patient had fainted. I informed my technician to call 911.  I ran over to the patient to assess the situation.  Patient's skin was pasty and flushed.  He had shallow breathing but was conscious. I checked his pulse it was weak.  He then started regaining color back and his breathing rate picked back up.  I had him remain on his back and keep his feet elavated.  He said he was very thirsty.  Some one brought water and he sipped it.  The EMT's arrived and took the situation over.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Thirst
Clinical narrative: I gave patient the Afluria vaccine at approximately 5:10 PM.  The patient waited nearby as I then gave his father the same vaccine. Patient then starting looking down thru some isles in the store.  The father went to leave and came back to get me about 5 minutes later stating that patient had fainted. I informed my technician to call 911.  I ran over to the patient to assess the situation.  Patient's skin was pasty and flushed.  He had shallow breathing but was conscious. I checked his pulse it was weak.  He then started regaining color back and his breathing rate picked back up.  I had him remain on his back and keep his feet elavated.  He said he was very thirsty.  Some one brought water and he sipped it.  The EMT's arrived and took the situation over.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: ATRIAL FIB WENT TO HOSPITAL & HAD TX TO SLOW HEART RATE.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site haematoma, Injection site reaction, Injection site swelling, Wound
Clinical narrative: Large purple bruise on right shoulder, red & swollen at injection site open wound at injection site size of a dime.  Cleaned injection site  covered with neosporin and bandaid.
Age: 4.0
Sex: U
Vaccine: DTAP, FLUX, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient. At an unknown date, the patient was vaccinated with MMR II, VARIVAX (Merck), Influenza Virus Vaccine (manufacturer unspecified) and DTaP given concomitantly. No concomitant medications were reported. On an unknown date, the patient experienced hives develop on arm (location unspecified) 30 minutes after vaccination. The patient returned to office the following day, and was sent to emergency room (location unknown). Hives were present for at least a week after vaccination. The registered nurse reported the adverse event to Vaccine Adverse Event Reporting Service (VAERS). No further information was provided. No treatment information was reported. The outcome of hives develop on arm (location unspecified) was not provided. The relatedness for hives develop on arm (location unspecified) for MMR II, Influenza Virus Vaccine (manufacturer unknown) and VARIVAX (Merck) was not provided by the reporter. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Localized reaction at injection site - redness, heat, swelling, itching, pain 1 day after vaccination.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in jaw
Clinical narrative: The patient has experienced jaw pain since receiving her flu shot.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site pain, Myalgia, Skin warm
Clinical narrative: Pain at injection site, muscle achiness, radiates from bicep to pectoral muscle. Warm to touch. Discomfort lasting up to 5 days.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Myalgia, Pain, Pruritus, Skin warm
Clinical narrative: Muscle tenderness in left bicep, tricep & radiating into pectoral muscle. Warm to touch. Increased pain with reaching & moving. Swelling, itching x 5 days.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Muscle tenderness in left bicep, tricep & radiating into pectoral muscle. Warm to touch. Increased pain with reaching & moving. Swelling, itching x 5 days.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site swelling, Muscular weakness
Clinical narrative: Pt received HI DOSE FLUZONE & PNEUMOVAX 23 injections in the left deltoid. Upon awakening the next day, the pt had muscular weakness all over. It was predominant in the (L) arm x 3-4 days and the all-over weakness subsided within 1 day. Pt also had extreme redness/swelling at injection site, but no infection. (Pt is physician). The pts wife had to help him out of bed the morning after the flu shot.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Skin warm, Tenderness
Clinical narrative: Patient describes right arm soreness that radiates to Rt pectoral muscle can't lay on arm, tender to touch & warm. Symptoms x 6 plus days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypotension, Immediate post-injection reaction, Injection site swelling, Loss of consciousness
Clinical narrative: (17:53) Swelling at site of injection immediately pt reported blacking out following wheezing/shortness of breath following. (17:56) EPIPEN administered, 911 called. Patient left with paramedics.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: (17:53) Swelling at site of injection immediately pt reported blacking out following wheezing/shortness of breath following. (17:56) EPIPEN administered, 911 called. Patient left with paramedics.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP, PPV
Symptoms: Cellulitis, Injection site erythema, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 62 years old female patient without pertinent medical history or drug reactions/allergies who on 14-NOV-2012 was vaccinated intramuscularly (IM) with a 0.5 ml dose of PNEUMOVAX23 (lot number reported as H013399, expiration date: 07-MAR-2014) along with BOOSTRIX in separate arms. No other co-suspects were reported. Concomitant medications included CITRACAL, omega-3 marine triglycerides and phytonadine. The registered nurse reported that the patient experienced warmth and pain at the injection site and was diagnosed with cellulitis on 15-NOV-2012 in the arm where PNEUMOVAX23 was administered. ROCEPHIN was administered intramuscular (IM) for the adverse event. Labs diagnostics studies were not performed. The patient sought unspecified medical attention. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for PNEUMOVAX23. This is one of the several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP, PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 62 years old female patient without pertinent medical history or drug reactions/allergies who on 14-NOV-2012 was vaccinated intramuscularly (IM) with a 0.5 ml dose of PNEUMOVAX23 (lot number reported as H013399, expiration date: 07-MAR-2014) along with BOOSTRIX in separate arms. No other co-suspects were reported. Concomitant medications included CITRACAL, omega-3 marine triglycerides and phytonadine. The registered nurse reported that the patient experienced warmth and pain at the injection site and was diagnosed with cellulitis on 15-NOV-2012 in the arm where PNEUMOVAX23 was administered. ROCEPHIN was administered intramuscular (IM) for the adverse event. Labs diagnostics studies were not performed. The patient sought unspecified medical attention. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for PNEUMOVAX23. This is one of the several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture negative, Cellulitis, Chills, Full blood count, Pyrexia
Clinical narrative: Cellulitis (L) arm with chills & fever.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Cellulitis (L) arm with chills & fever.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient was vaccinated with the first dose of GARDASIL on 04-NOV-2011, was in the office on 19-NOV-2012 to receive the second dose in the GARDASIL immunization series (dose, route and lot #, expiration date not reported). It was unspecified if the patient sought medical attention. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unknown number of patients of unknown age and gender. On an unknown date, the registered nurse reported that some patients might have received GARDASIL (lot #, expiry, route and dose not reported) doses outside of recommended dosing schedule. No concomitant medications were reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Upper arm swollen to elbow on left arm.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Headache, Rash
Clinical narrative: Dark erythema. Local rash. Severe headache.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Left thigh redness/swelling/discomfort in region of his DTaP vaccine received on Wednesday, 10/21/12. Pt can still walk and has had no fever or bruising. Pt. to try ice pack, ibuprofen, and a little BENADRYL to treat swelling. Pt to return to clinic if fever/red streaking occurs.
Age: 1.13
Sex: F
Vaccine: HEPA, HIBV, MMR
Symptoms: Injection site mass, Injection site rash
Clinical narrative: Patient developed a rash on bilateral legs and a lump at injection site on left thigh. Grandmother will continue to monitor & RTC with worsening of symptoms. Is returning in 2 weeks for recheck.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Skin lesion
Clinical narrative: Rash/lesion (L) arm. Doxycycline (given by another facility).
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Received varicella vaccine on 10-25-12. (Went out of town) states had redness at injection site - hard, approximate size of a softball. Mild itching no medication used. Returned to work on 10/31/12: 1st day redness resolved.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Fever and vomiting <1 day after receiving vaccine. Rash, swelling, redness at injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Nonspecific reaction
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. On 05-NOV-2012 (reported as 2 days ago) the patient was vaccinated with ZOSTAVAX (lot#, expiration date and route not reported). No concomitant medication were reported. The patient came back to the pharmacy with a prescription for MEDROL DOSEPACK to treat an unspecified condition on 07-NOV-2012. Outcome of the event was unknown. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Breast pain, Chest pain, Musculoskeletal chest pain, Neuropathy peripheral
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an 68-year-old female patient. Current conditions included asthma, hyperlipidemia, gastric carcinoma, type 2 diabetes, allergy to MACRODANTIN, sulfacetamide sodium, SULFA GLUCOPHAGE and ASPIRIN. On 29-OCT-2012 the patient was vaccinated with, 0.65 milliliter (ml) ZOSTAVAX (lot # reported as H016230, expiration date 20-NOV-2013) subcutaneously. Concomitant medications included SEREVENT, FLOVENT, FLONASE, vitamins (unspecified), ALLEGRA and ALBUTEROL. Medical assistant reported that a patient who received ZOSTAVAX had developed pain on the right side of her body. She had pain near her breast area and rib area. Sometimes the pain was sharp and sometimes the pain was dull. The patient said the pain was a "10" on a scale of one to ten when the pain was sharp. The [patient said the pain is a "1" on a scale of one to ten when the pain was dull. Movement and coughing sometimes increased the pain. The physician then got on the phone to report that the patient seemed to have pain and neuropathy that goes from the breast and rib area and wraps around towards the patient's back. The pain did not cross the midsection. There was no rash. No other details. No treatment was given for the events. No lab studies were performed. The events did not resolve at the time of this report. The patient sought medical attention, the patient was in the office at the time of this report. The medical assistant had also mentioned that the patient experienced a fever when she received PNEUMOVAX23 on 11-NOV-2005 (MARRS # 1211USA006088). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an 68-year-old female patient. Current conditions included asthma, hyperlipidemia, gastric carcinoma, type 2 diabetes, allergy to MACRODANTIN, sulfacetamide sodium, SULFA GLUCOPHAGE and ASPIRIN. On 29-OCT-2012 the patient was vaccinated with, 0.65 milliliter (ml) ZOSTAVAX (lot # reported as H016230, expiration date 20-NOV-2013) subcutaneously. Concomitant medications included SEREVENT, FLOVENT, FLONASE, vitamins (unspecified), ALLEGRA and ALBUTEROL. Medical assistant reported that a patient who received ZOSTAVAX had developed pain on the right side of her body. She had pain near her breast area and rib area. Sometimes the pain was sharp and sometimes the pain was dull. The patient said the pain was a "10" on a scale of one to ten when the pain was sharp. The [patient said the pain is a "1" on a scale of one to ten when the pain was dull. Movement and coughing sometimes increased the pain. The physician then got on the phone to report that the patient seemed to have pain and neuropathy that goes from the breast and rib area and wraps around towards the patient's back. The pain did not cross the midsection. There was no rash. No other details. No treatment was given for the events. No lab studies were performed. The events did not resolve at the time of this report. The patient sought medical attention, the patient was in the office at the time of this report. The medical assistant had also mentioned that the patient experienced a fever when she received PNEUMOVAX23 on 11-NOV-2005 (MARRS # 1211USA006088). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 70-year-old female patient. Current conditions included hypertension, hypercholesterolemia, hypothyroidism, penicillin allergy and sulfonamides allergy. On 06-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H013023, expiration date 09-OCT-2013) subcutaneously in the right arm. No concomitant medications were reported. The pharmacist reported that the patient developed redness at the injection site. The patient came to the pharmacy on 13-NOV-2012, and was found to have "a red spot" at the injection site without pain, swelling, or itching. No further information provided. Treatment was not given for the events. No lab studies were performed for the event. The patient did not recover from the events at the time of this report. The patient sought medical attention for the event. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown demographics. On 08-NOV-2012 the patient was vaccinated with PNEUMOVAX23 (lot # H016283 in verification process, expiration date 21-FEB-2014) intramuscularly. No concomitant medications were reported. Within 24 hours (on 09-NOV-2012) after the injection the patient developed extensive swelling of the arm that received the injection. The patient was given SOLU-MEDROL (manufacturer unspecified). No lab studies were performed. The patient was recovering from the event. The patient sought medical attentions for the event by calling physician. This is one of the two reports from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Induration, Mass, Oedema peripheral
Clinical narrative: This spontaneous report was received from a 64-year-old female patient regarding herself. Current conditions included high blood pressure, allergy to codeine. On 22-OCT-2012 the patient was vaccinated with a single dose of ZOSTAVAX (lot #, expiration date not reported) subcutaneously in her left arm. Concomitant medications included blood pressure medications, sleeping medication and TRAZADOL. Patient stated that on 23-OCT-2012 she got a hard lump, pain, swollen from elbow to wrist, in her left arm where the ZOSTAVAX was given. She described it as warm and with headache, redness, itchy. The redness had subsided but the lump was still there. She would be going to her physician on 15-NOV-2012. No treatment was given for the events. The outcome of rest of the events were unknown at the time of this report. The patient sought medical attention for the events. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: This spontaneous report was received from a 64-year-old female patient regarding herself. Current conditions included high blood pressure, allergy to codeine. On 22-OCT-2012 the patient was vaccinated with a single dose of ZOSTAVAX (lot #, expiration date not reported) subcutaneously in her left arm. Concomitant medications included blood pressure medications, sleeping medication and TRAZADOL. Patient stated that on 23-OCT-2012 she got a hard lump, pain, swollen from elbow to wrist, in her left arm where the ZOSTAVAX was given. She described it as warm and with headache, redness, itchy. The redness had subsided but the lump was still there. She would be going to her physician on 15-NOV-2012. No treatment was given for the events. The outcome of rest of the events were unknown at the time of this report. The patient sought medical attention for the events. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a company representative refers to an unknown number of patients. The patients were vaccinated (date and route of administration unknown) with VARIVAX (Merck) (lot number and expiry date not provided). No other co-suspects were reported. No concomitant medications were reported. The reporter heard from an unspecified employee that an unknown number of patients, who may have received VARIVAX (Merck) in the past, have been diagnosed with varicella. No treatment information was reported. The outcome of varicella is unknown. The relatedness for varicella is unknown for VARIVAX (Merck). The reporter stated that she is attempting to collect additional information. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 9 months old patient of unknown gender. On 12-NOV-2012, the patient was vaccinated intramuscular with, 0.5 ml VAQTA (lot # not provided). No concomitant medications were reported. The Physician stated that on 12-NOV-2012, a 9 month old patient was given "Hepatitis C vaccine instead of Hepatitis A vaccine". Initially the physician stated Hepatitis C vaccine was given. Follow up information was received on 12-NOV-2012 at 3:40 PM from the physician and stated that, the 9 month old patient received VAQTA in stead of hepatitis B vaccine. No adverse effect reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an office manager regarding to a 67 years old male patient with diabetes. On 12-NOV-2012, the patient was vaccinated with, 0.5 cc dose of PNEUMOVAX23 INJ, intramuscular, (Lot number reported as H01339, expiration date 07-MAR-2014). No other co-suspects were reported. Concomitant medications included LANTUS, ALTACE, AVODART, ENABLEX, FLOMAX, glimepiride, losartan potassium (manufacturer unknown), NASACORT, NASONEX, NOVOLOG, TRICOR, VYTORIN and ZYRTEC. On an unknown date, the patient experienced swelling, tenderness and pain at the injections site. The office manager reported that all the events were better now. The patient sought medical attention, consulted office. At the time of the report, the patient was recovering from the adverse events. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a 40 year old female patient. The patient was vaccinated with dose 1 PNEUMOVAX23 on 05-NOV-2012 at 11:40. The dose was not reported, the route was described as RD (right deltoid), intr (lot number reported as H016295). No other co-suspects and no concomitant medications were reported. PNEUMOVAX23 was administered although the patient was 40 years of age. No adverse event was reported. Additional information has been requested.
Age: 81.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 81 years old patient (gender not reported). On 20-NOV-2012, the patient received an expired dose of ZOSTAVAX lot # 671190/1270AA, exp. date 05-NOV-2012 (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect had been observed or reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a male patient of unknown age. On 12-NOV-2012 the patient was vaccinated with PNEUMOVAX23 (lot # H016283 in verification process, expiration date 21-FEB-2014) intramuscularly. No concomitant medications were reported. Within 24 hours after the injection the patient developed extensive swelling of the arm that received the injection. No lab studies were performed. The patient was recovering from the event. The patient sought medical attention for the event by calling the physician. This is one of the two reports from the same source. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial information was received from a medical assistant concerning a 5 months old patient, who on an unspecified date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, indication and lot, expiration date were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. No treatment information was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Myalgia, Pain, Swelling
Clinical narrative: Redness, pain, swelling 3" x 5", joint and muscle aches.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: SEVERE BODY ACHES, DULL FEVER, FATIGUE.  SAW PHYSICIAN FOR CARE, NO TREATMENT, 3 DAYS OF ILLNESS AND REST.
Age: 4.0
Sex: M
Vaccine: FLUX, MMR
Symptoms: Chills, Hyperhidrosis, Oropharyngeal pain, Pyrexia, Rash erythematous
Clinical narrative: We were against the MMR and tried to avoid giving it to him but our School forced us, no MMR shot no school! So Doctor gave him the first MMR shot AND the FLU Shot at the same time. I would NEVER would have let him give both shots, only MMR. Pretty stupid choice from Dr!!!Awoke with chills, super wet, super high fever 105.2. Red bumps, hives, sore throat. We soaked him in the bath with room temp water until the fever came down. It is now 11/24/2012 and we have been giving patient 2 tsp doses of Motrin since 11/17/2012, every 6 to 8 hours. If we stop his fever jumps back up to 103 to 104.8. Took him back to Doctor, asking for blood work to be done, and was told that we should wait until Sunday 11/25/2012. If his fever doesn't break by then to bring him in for blood work. This is why I refused as I knew that this would not turn out well!